The FDA has expanded its COVID-19 vaccine boosters authorizations

Moderna's (MRNA) shares are rising presumably in anticipation of rising demand for its COVID-19 vaccine amid authorization for younger population and the fear of another global infection wave. Shares of popular COVID-19 vaccine maker, Moderna, Inc. MRNA have gained 33.9% in the past 10 days, following a decline of nearly 70% since September 2021. In fact, Moderna’s shares have declined 33.3% so far this year compared with the industry’s decrease of 19.1%.Image Source: Zacks Investment ResearchThe company's total sales of $18.5 billion in 2021 were majorly driven by the supply of its mRNA-based COVID-19 vaccine, Spikevax, and its booster doses in several countries across the globe. However, waning COVID-19 infection cases across the globe during the past six months may have heightened uncertainty among investors about its COVID-19 vaccine and booster doses. Investors might have also been concerned about the company’s prospects amid rising competition.The recent recovery in share price has likely been driven by an anticipated rise in demand for its COVID-19 vaccine amid authorizations for younger population in different countries as well as the increasing risk of a new wave.Risk of New WaveSpeculations of a new COVID wave are rife following a surge in infection cases in many countries. There have been recent reports of lockdowns in China following reportedly the largest surge of Covid-19 infections by the Omicron variant since the coronavirus first emerged in 2020. There has also been a rise in COVID-19 infection cases in Western Europe, following which some experts and health authorities have warned about another wave of the pandemic in the United States.A rise in COVID-19 cases is likely to drive demand for vaccines and booster doses. Another wave of COVID-19 infection cases across the globe may lead to increase in COVID-19 vaccination programs in different countries.Amid the hope of rising demand for Moderna’s Spikevax and booster doses, investors are also cheering the company’s initiatives to sign more advance purchase agreements. Earlier this week, Moderna signed an agreement with Japan’s government for the supply of additional 70 million doses of booster doses in 2022 on top of the existing agreement for 93 million doses of its vaccine. The company also expanded its agreement with Colombia for an additional 10.8 million doses last month.Expanding Target PopulationModerna’s COVID-19 vaccine and booster doses are getting approved for use in children below 12 years in many countries. The expanded patient population for the vaccine is likely to boost its demand further amid a potential new wave of infections. Moreover, Spikevax is yet to gain authorization for use in adolescents in the United States. A potential approval amid the surging infection cases will be beneficial for Moderna.Moreover, the company’s Omicron-specific booster dose is currently in a pivotal clinical study evaluating it in adults. An effective Omicron-specific booster has the potential to drive revenues higher for the company in 2022.Estimates for Moderna’s earnings per share for 2022 have also improved 2.6% in the past 90 days, implying strong fundamentals.Another COVID-19 vaccine-maker, BioNTech’s BNTX shares have also increased for the majority of the past two weeks, presumably in anticipation of rising demand for its vaccine. BioNTech has developed Comirnaty in collaboration with Pfizer PFE. BioNTech and Pfizer’s vaccine has already received authorization for use in children aged five to eleven years of age in the United States. A regulatory application seeking authorization to use the second booster dose of Comirnaty in older adults was submitted by Pfizer and BioNTech earlier this week.CompetitionAlthough the COVID-19 pandemic is priming for yet another wave of infections, we note that the competition scenario can be different for vaccines compared to last year with the availability of effective COVID-19 drugs, especially from Pfizer and Merck MRK. Pfizer and Merck have developed oral COVID-19 drugs — Paxlovid and molnupiravir —, which have already gained emergency use authorization in the United States. Earlier this month, the world Health Organization (“WHO”) recommended the use of molnupiravir for non-severe COVID-19 patients with the highest risk of hospitalization.ConclusionModerna’s shares have started a recovery since Mar 7, which is likely to continue going forward on the back of an anticipated rise in demand for Spikevax and boosters due to rising infections cases. The company is gaining regulatory authorization for use in the younger population as well as in new countries, which are likely to aid its top line going forward. Its focus on signing purchase agreements bodes well. However, competition from other COVID-19 vaccines and therapeutics may hurt demand. Moreover, the demand for vaccines will be hurt if COVID-19 infections are effectively restricted by different countries.Moderna, Inc. Price Moderna, Inc. price | Moderna, Inc. QuoteZacks RankModerna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. 7 Best Stocks for the Next 30 Days Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops." Since 1988, the full list has beaten the market more than 2X over with an average gain of +25.4% per year. So be sure to give these hand-picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX): Free Stock Analysis Report To read this article on Zacks.com click here......»»

Novavax (NVAX) initiates a phase III study to evaluate the booster dose of its COVID vaccine. WHO recommends administering the company's COVID vaccine booster to immunocompromised persons. Novavax NVAX announced that it has initiated dosing patients in an extension of the phase III PREVENT-19 study, which will evaluate the third or “booster” dose of its protein-based COVID-19 vaccine, NVX-CoV2373.The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373. The primary endpoint of the study is the first occurrence of polymerase chain reaction-confirmed mild, moderate or severe COVID-19, with onset at least seven days after the third or booster dose of the vaccine.Per the company, the third dose will be identical to the two-dose regimen of NVX-CoV2373 administered to participants in the phase III PREVENT-19 study. Novavax recommends administering the third dose at least six months after the initial two-dose regimen. All participants in the PREVENT-19 study who were administered the primary two-dose series of Novavax’s COVID vaccine are eligible to participate in this extension study.This extension study will also evaluate two additional groups who are eligible to receive a booster dose — one group that participated in the previous PREVENT-19 study, which initially received placebo but subsequently received a different COVID vaccine; and another group in which the participants of the PREVENT-19 study were unblinded after receiving the vaccine but did not subsequently receive another vaccine.Shares of Novavax have rallied 71.4% so far this year against the industry’s 19.5% decline.Image Source: Zacks Investment ResearchIn a separate press release, Novavax announced that the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for the use of the company’s COVID vaccine. While SAGE recommends the primay two-dose regimen of NVX-CoV2373 in people aged 18 years and older, it recommended administering a third dose of the vaccine to immunocompromised persons after one to three months of the second dose of NVX-CoV2373.Earlier this month, the company was granted an emergency use listing for two versions of its COVID vaccine by WHO — one marketed by the Serum Institute of India under the trade name Covovax and another version produced by NVAX that is marketed under the trade name Nuvaxovid. Nuvaxovid was granted conditional marketing authorization in the European Union this week. Covovax, marketed with the Serum Institute of India, was authorized for emergency use in Indonesia and the Philippines.Novavax is already lagging quite behind the COVID-19 vaccine race. The companyis yet to apply in the United States for an emergency use authorization of its COVID vaccine. Novavax expects to submit the complete chemistry, manufacturing and controls data package to the FDA for the same by 2021-end.Please note that vaccine developing companies Johnson & Johnson JNJ, Moderna MRNA, and Pfizer PFE have already secured FDA approvals for authorizations for not only their COVID vaccines but also their respective vaccine boosters.In October 2021, J&J’s booster dose was the first to receive authorization in all adults who have completed at least two months of their primary vaccination with J&J’s single-shot COVID-19 vaccine.Last month, the FDA expanded the emergency use authorization (EUA) previously granted to the mRNA vaccine boosters developed by Pfizer and Moderna for administering in all adults. Earlier, the booster doses of Pfizer’s Comirnaty and Moderna’s mRNA-1273 were granted EUA for use in people aged 65 years or older and in immunocompromised adults.The booster doses of vaccines developed by J&J, Moderna, and Pfizer are authorized for homologous as well as heterologous administration. Heterologous or mix-and-match administration allows the administration of booster doses of any of the vaccines, irrespective of the primary vaccination regimen.Novavax, Inc. Price Novavax, Inc. price | Novavax, Inc. QuoteZacks RankNovavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Breakout Biotech Stocks with Triple-Digit Profit Potential The biotech sector is projected to surge beyond $2.4 trillion by 2028 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Recommendations from previous editions of this report have produced gains of +205%, +258% and +477%. The stocks in this report could perform even better.See these 7 breakthrough stocks now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Johnson & Johnson (JNJ): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report Novavax, Inc. (NVAX): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Pfizer, Moderna Jump After FDA Clears Covid Booster Shot For Adults Update (830am ET):  Pfizer has joined Modern in trading sharply higher - and hitting new record highs - when moments after the Moderna announcement, Pfizer and BioNTech also said the U.S. Food and Drug Administration has expanded the emergency use authorization of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 18 years of age and older.  The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series. * * * Outright bans across numerous (mostly Nordic) countries due to widespread reports it is causing myocarditis in children and adults? No problem: moments ago the FDA cleared Moderna's Covid-19 booster shot for all Americans 18 and older, making millions more people eligible for extra protection as concern about a potential winter wave of infections grows. As to whether those millions will take the booster shot knowing that the "vaccine" doesn't actually prevent them from catching covid, and at best mitigates the severity of the disease even as it creates risks of other, just as unpleasant side-effects, is unclear. The U.S. Food and Drug Administration said adults who received their second dose of the company’s shot at least six months ago are now eligible to receive a third, according to a statement Friday from Moderna. The booster from Pfizer Inc. and BioNTech SE is expected to gain a similar clearance on Friday. The FDA based the EUA on scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose (n=344) A panel of experts who advise the Centers for Disease Control and Prevention on vaccine policies are expected to review the evidence and make further guidance for administering booster shots at a meeting on Friday afternoon; there will be no surprises as the CDC will side with the FDA. Booster shots of mRNA vaccines - also called "gene therapy" by those who then see their twitter account be banned in perpetuity - have been available for people 65 and over, as well as others who could be at higher risk of severe disease, since mid-September. Under federal guidelines, recipients can receive any of the three authorized shots as a booster, regardless of the brand of their initial vaccine. More than a third of fully vaccinated seniors had received a booster as of Thursday, according to the Centers for Disease Control and Prevention, and 17% of fully vaccinated adults overall have had an additional shot. Worry that the effectiveness of initial inoculations could fade as the weather cools and more people socialize indoors has driven the most recent push for wider use of boosters. Data presented to U.S. drug regulators by Pfizer, Moderna and Johnson & Johnson suggested all three of the currently authorized vaccines in the U.S. have seen their efficacy diminish. Pfizer asked the FDA to expand access to its booster to all adults earlier this month. The company and partner BioNTech SE said data from a large clinical trial demonstrated a relative vaccine efficacy of 95% for booster recipients when compared with those who didn’t get a booster. Moderna shares surged as much as 6.8% to $268.70 in premarket trading Tyler Durden Fri, 11/19/2021 - 08:30.....»»

These are Insider's biggest healthcare stories for October 21. Hello,Welcome to Insider Healthcare. I'm healthcare editor Leah Rosenbaum, and today in healthcare news:The FDA authorized booster shots for the Moderna and Johnson & Johnson COVID-19 vaccines;Best Buy lays out its plan for entering the healthcare space;Dermatology startup Zerigo raised a $34 million Series B round to treat skin conditions with UV light.If you're new to this newsletter, sign up here. Comments, tips? Email me at lrosenbaum@insider.com or tweet @leah_rosenbaum. Let's get to it... An employee (R) of Japan's Suntory Holdings receives the Moderna coronavirus vaccine for Covid-19. KAZUHIRO NOGI/AFP via Getty Images The FDA just authorized booster shots of Moderna's and Johnson & Johnson's COVID-19 vaccines and is letting users mix and match shotsThe FDA authorized booster shots of the Moderna and J&J vaccines on Wednesday.The agency also authorized people to get different vaccine brand as a booster shot.J&J recipients can get a booster after two months. Moderna recipients should wait six months. Check it out>> Shoppers enter a Best Buy in New York. Associated Press/Bebeto Matthews A top Best Buy healthcare executive laid out how the retailer wants to help doctors care for patients in their homesBest Buy, known for selling electronics, is pushing deeper into healthcare.Best Buy Health President Deborah DiSanzo laid out its strategy at the HLTH conference in Boston.The retailer wants to help doctors care for patients at home through a new acquisition.Get the full story>> Zerigo makes a light-therapy device to treat skin conditions such as eczema. ipopba/Getty Images See the 17-slide presentation that convinced Livongo's Glen Tullman to invest in a dermatology treatment startupZerigo is a dermatology startup that treats conditions like psoriasis and eczema.It raised $43 million in Series B funding on Thursday led by Glen Tullman's 7wireVentures.Its smart device uses UVB light therapy to treat chronic dermatological conditions.See the slides now>>More stories we're reading:Pfizer says its booster shot has 95.6% efficacy against COVID-19 amid the Delta variant (Insider)A doctor developed a blood test for fibromyalgia. But did he tell the truth to his customers? (STAT)Blood tests that can detect cancer are about to hit the market. But experts are still waiting to see if they can upend deadly disease. (Insider)These doctors have been spreading COVID-19 vaccine misinformation for months (CNN)Pfizer's vaccine cuts the risk of COVID-19 hospitalization in teens by 93% in a CDC analysis (Insider)-LeahRead the original article on Business Insider.....»»

FDA Authorizes New Covid-19 Shots From Pfizer, Moderna The matrix keeps glitching... Now that only the most mentally unstable liberals are demanding that the government protect them from near certain death by forcing them to wear face diapers that don't - and have never - worked, on the afternoon of September 11 US drug regulators - many of whom are undoubtedly hoping to get a job offer at either Pfizer or Moderna as soon as they quit the public sector - authorized new COVID-19 vaccines to try to counter the poor effectiveness the current slate provide. The U.S. Food and Drug Administration (FDA) cleared shots from Moderna and Pfizer that will be available to Americans as young as 6 months of age later this month. It's a different question if anyone will take said shots following the recent newsflow suggesting that the side effects of the covid shots are far more dangerous than the so-called "vaccine" which doesn't actually prevent infection. "Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," Dr. Peter Marks, a top FDA official, said in a statement.  "We very much encourage those who are eligible to consider getting vaccinated." The FDA approved the Moderna and Pfizer vaccines for people aged 12 and older. Regulators granted emergency authorization for the shots for people aged 6 months to 11 years of age. There was no mention of Novavax, whose vaccine is also available in the United States. The shots target XBB.1.5, a subvariant of the Omicron virus variant. That subvariant has already largely been displaced by newer strains, including EG.5, according to the U.S. Centers for Disease Control and Prevention (CDC). The authorizations came despite a lack of data from clinical trials. As Epoch Times reports, Moderna says its new shot in a trial induced immune responses against EG.5 and other newer variants. Pfizer says preclinical data has shown antibodies generated by its new vaccine "effectively neutralize" EG.5, also known as Eris. The new shots were authorized based on studies on neutralizing antibody levels that appeared to show "a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection," the FDA said. "This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants." The CDC plans to meet with its advisers on Tuesday to consider to which populations it should recommend receive the new vaccines. If the panel recommends a vaccine, the federal government must pay for it. Many countries have suggested younger, healthy people not to receive COVID-19 vaccinations as the disease has died down. The United Kingdom, for instance, in August, said that vaccination this fall was only recommended for select groups, including people designated as at-risk. The CDC scaled back its recommendations earlier this year for some populations. CDC Director Dr. Mandy Cohen said earlier this year that the CDC was poised to recommend annual COVID-19 shots. Pfizer and Moderna have said the new shots will cost approximately $110 to $130. Number of Shots The new shots are cleared for varying numbers of shots, depending on age group and prior vaccination. People aged 5 years and older, whether or not they've received a vaccine, are eligible to receive a single dose of one of the new shots. Children aged 6 months through 4 years who have previously been vaccinated can receive one or two doses of one of the new vaccines. Children in that age group who have not been vaccinated can receive three doses of the new Pfizer vaccine or two doses of the new Moderna vaccine. Another Replacement The FDA cleared, and the CDC recommended, updated shots in the fall of 2022 amid waning effectiveness. Those shots were bivalent, containing components of the Wuhan strain and Omicron. Those shots have not performed well against infection or severe disease, according to observational data. They were authorized and recommended based on animal testing. Just 17 percent of the U.S. population had received a bivalent dose as of May 10, the last date the CDC lists the data for. Some doctors have opted against receiving them. The FDA said it expects to update the vaccines on an annual basis. That's currently done for the influenza vaccines. A survey of more than 2,000 adults in Arizona found that the primary reason for not receiving a bivalent was having protection from prior infection. Other common reasons included wariness about side effects, belief the booster would not add protection, and belief the booster would not protect against infection. Novavax had said its newer shot performed well against newer variants, but the FDA did not clear it. Novavax said in a statement that its updated vaccine is "under review" by the FDA, which did not respond to a request for comment. Criticism Some experts have criticized U.S. authorities for clearing the new shots without strong data. "There's essentially no data," Florida Surgeon General Dr. Joseph Ladapo told a recent press conference. "Not only that, but there are a lot of red flags." He pointed to studies finding effectiveness of the vaccines turn negative over time. Other papers have found the vaccines cause cardiac problems like heart inflammation, the doctor noted. "It's truly irresponsible for FDA, CDC, and others to be championing something ... when we don't know the implications of it," he said. Dr. Paul Offit, an FDA adviser, suggested to the Daily Mail that younger, healthy people who have already been vaccinated do not need one of the new doses. "We are best served by targeting these booster doses to those who are most at risk of severe disease," such as people over 75 years of age, Dr. Offit said. "Boosting otherwise healthy young people is a low-risk, low-reward strategy," he added. Tyler Durden Mon, 09/11/2023 - 15:25.....»»

FDA, CDC Hid Data On Spike In COVID Cases Among The Vaccinated: Documents Authored by Zachary Stieber via The Epoch Times (emphasis ours), COVID-19 cases among vaccinated seniors soared in 2021, according to newly disclosed data that was acquired by U.S. health agencies but not presented to the public. Syringes and vials of the Pfizer-BioNTech COVID-19 vaccine are prepared to be administered at a drive-up vaccination site from Renown Health in Reno, Nev., on Dec. 17, 2020. (Patrick T. Fallon/AFP via Getty Images) Humetrix Cloud Services was contracted by the U.S. military to analyze vaccine data. The company performed a fresh analysis as authorities considered in 2021 whether COVID-19 vaccine boosters were necessary amid studies finding waning vaccine effectiveness. Humetrix researchers found that the proportion of total COVID-19 cases among the seniors was increasingly comprised of vaccinated people, according to the newly disclosed documents. For the week ending on July 31, 2021, post-vaccination COVID-19 cases represented 73 percent of the cases among people 65 and older, the company found. The elderly were 80 percent fully vaccinated at the time. Breakthrough infection rates were higher among those who were vaccinated early, the researchers found. They estimated that the rates were twice as high in those who had been vaccinated five to six months prior, when compared to people vaccinated three to four months before. The breakthrough cases started in January 2021, according to the data. Protection against hospitalization was also fading, researchers discovered. In the week ending on July 31, 2021, 63 percent of the COVID-19 hospitalizations in seniors were among the fully vaccinated, according to the documents. The same pattern of weaker protection among people who were vaccinated early was found. Researchers calculated that the vaccine effectiveness (VE) against infection was just 33 percent while the effectiveness against hospitalization had dropped to 57 percent. Seniors who previously had COVID-19 and recovered were more likely to avoid hospitalization, the researchers also found. Risk factors included serious underlying conditions such as obesity and being in the oldest age group, or older than 85. The cohort analysis was completed on 20 million Medicare beneficiaries, including 5.6 million seniors who received a primary series of a COVID-19 vaccine. "Our observational study VE findings show a very significant decrease in VE against infection and hospitalization in the Delta phase of the pandemic for individuals vaccinated with either the Pfizer or Moderna vaccine for those 5–6 months post vaccination vs. those 3–4 months post vaccination," Dr. Bettina Experton, Humetrix's president and CEO, said in a Sept. 15, 2021, email to top U.S. Food and Drug Administration (FDA) officials. Humetrix also found that among the beneficiaries, there had been 133,000 cases, 27,000 hospitalizations, and 8,300 intensive care admissions among the fully vaccinated since the start of the COVID-19 pandemic. Dr. Experton disclosed that Humetrix shared the data with the U.S. Centers for Disease Control and Prevention (CDC) in August 2021. "It would have been nice to know [the military] was conducting this prior to now. Also might have been nice for CDC to share the data," Dr. Peter Marks, one of the FDA officials, told colleagues in response. "This is more worrisome than the other data we have in my opinion," Dr. Janet Woodcock, the FDA's acting commissioner at the time, said in reply. The presentation and emails were obtained by the Informed Consent Action Network, a nonprofit that seeks to provide transparency around medical issues, through the Freedom of Information Act (FOIA). "It is hard to see this as anything other than a failure of our health authorities to assess, share, make public, and act upon valuable, real-world data in the midst of a so-called pandemic," Del Bigtree, founder of the network, told The Epoch Times via email. "And without FOIA, the public likely would never be made aware of these failures which, of course, allows them to be perpetrated again and again." The FDA and CDC declined to comment. Dr. Francis Collins, the director of the U.S. National Institutes of Health at the time, wrote in a separate email obtained through FOIA that the results of the study provided "pretty compelling evidence that VE is falling 5–6 months post vaccination for both infection and hospitalization for those over 65." He added, "Even for those 3–4 months out there is a trend toward worsening VE.” The CDC, FDA, and National Institutes of Health did not share the data with the public as they considered whether to clear and recommend COVID-19 vaccine boosters. The CDC held a meeting with its vaccine advisers on Aug. 30, 2021. During the meeting, CDC officials went over emerging data on waning vaccine effectiveness. But the military study was not included. The FDA held a similar meeting on Sept. 17, 2021. The CDC participated. The Humetrix analysis was also not presented during that meeting. Both agencies have aggressively promoted COVID-19 vaccines throughout the pandemic, including hyping them as strongly protective against severe disease even after their own data have suggested that is not the case. The CDC did present (pdf) data from COVID-NET, one of its systems, that showed effectiveness against COVID-19-associated hospitalization was falling among the elderly since the emergence of the Delta variant but that data still showed 80 percent effectiveness. The presentation also included data from outside researchers and Israel that estimated the protection during the Delta era against infection ranged from 39 percent to 84 percent and that the effectiveness against hospitalization ranged from 75 to 95 percent. The FDA ended up clearing a Pfizer booster for many Americans. The CDC advised most people to receive it. The agencies later expanded booster clearance and recommendations to virtually all Americans aged 5 and older, with Moderna's shot as another option. Authorities have since replaced the old shots due to their lack of durability, and are preparing to roll out another slate of shots this fall. Tyler Durden Sun, 09/03/2023 - 14:30.....»»

Never Forget: Leftists Showed Their True Authoritarian Colors During COVID Authored by Brandon Smith via Alt-Market.us, When I think back to the first days of the covid pandemic lockdowns, I suspect the majority of people, even many conservatives and liberty movement types, had a healthy concern about the effects of the virus and the potential for structural upheaval if it turned out to be as deadly as the World Health Organization initially claimed. If covid had an Infection Fatality Rate of 3% or more as global health officials warned, then the damage would be substantial enough to change our world for many years to come. Anyone who was not at least partially concerned about a biological disaster (or biological warfare) was probably an idiot. Anyone who was smart was prepared.  However, after a few months of the spread of the virus and after the first flurry of scientific data, several facts became evident: 1) The lockdowns did nothing to stop the spread, they were simply destroying our economy. 2) The masks were useless and did nothing to prevent transmission of the virus. 3) The IFR of covid was a tiny 0.23%, and that’s not accounting for all the co-morbidity deaths that were falsely labeled as covid deaths. 4) The vaccines did not prevent transmission for millions of people. They did not prevent infection in many cases and numerous vaccinated people have died from the virus. Not only that, but unvaccinated people with natural immunity were better protected than those that took the vaccine and boosters. 5) Studies show that the vaccines cause dangerous side effects at a much greater rate than the CDC admitted. Everything government officials told us during the pandemic was a lie. It was not a mistake, it was not bureaucratic confusion, it was a lie. Even after this information became available, they KEPT GOING – They kept people locked down, kept them masked and they even tried to force-vaccinate the population. There were some Republican politicians that also went along with the panic, many of them Neocons (fake conservatives).  However, the majority of red states quickly ended the restrictions once the contradictory data was made public.  In the meantime, the blue states looked ridiculous and paranoid as they desperately clung to the mandates. I believe the only reason Biden, the Democrats and globalist institutions eventually stopped was not because they realized their science was incorrect; it was because they realized millions of conservatives and independents were ready start a shooting war over the mandates and they knew they would lose. Even today, months after Biden was forced to finally end the national emergency status on covid, there are still a lot of people out there running around with masks, still isolating in their homes and still complaining all over social media that the public has moved on from the pandemic hysteria. Where does this behavior originate? And why did so many Americans (mainly leftists) jump on the authoritarian bandwagon when it comes to lockdowns and forced vaccination? I want to explore the psychology of such people here, because I think it’s the natural inclination of the public today to move on quickly from the discomfort of terrible events and ignore the deeper implications. We cannot move on from this, because the ultimate problem was never solved. These same leftists and globalists were never admonished for their behavior, they never had to admit they were wrong and they WILL attempt the same draconian measures again in the future if left unchecked. Here is what I think happened during the covid cult frenzy… A Useful Weapon Against The Constitution Leftists are quick these days to change the subject or outright deny their authoritarian activities during covid. It makes sense, they view the next election as a defining election and they want people to forget that we almost lost what remains of our constitutional rights because of their policies. But again, we can’t allow these things to fade into the ether. Here’s a list of the worst trespasses on the part of leftists and globalists during the pandemic: They lied about the effectiveness of the lockdowns. They lied about the effectiveness of the masks. They lied about the effectiveness of the vaccines. They lied about how extensive the testing was for the covid vaccines. They lied about the “pandemic of the unvaccinated.” They enforced lockdowns OUTSIDE where it is nearly impossible to contract a virus. They tried to put the population under house arrest. They put legislation in motion in some states to build “covid camps” in the US. In some countries, they did build covid camps, not just for travelers, but for everyone. They conspired to suppress ample evidence linking the Wuhan Lab in China with the outbreak. They (Government and Big Tech) conspired to use social media as a tool for mass censorship of conflicting data. They exploited algorithms through search engines to bury any and all contrary information. As many leftists openly admitted, the goal was to make life so difficult for the unvaccinated that they would eventually comply in order to survive. In this way, establishment elites and leftists could claim that people “volunteered” for the vaccines and no one was forced. What they really meant was, no one was forced at gunpoint, but we all knew that threat was coming next.  In fact, polling showed that a large percentage of Democrats were willing to scrap the Bill of Rights altogether and declare war on the unvaccinated… Finally, the vast majority of leftists supported Biden’s vaccine passport executive orders for workers in companies with 100 employees or more, which would have ultimately led to vaccine passports for everyone. This would have destroyed the constitution as we know it and created a society in which economic participation is completely controlled by the government. Keep in mind, all of this was being justified by a virus with a tiny 0.23% median death rate. Since the political left views the Bill of Rights as an obstacle to the majority of their political goals, I argue that they simply saw the pandemic as a vehicle they could exploit to remove constitutional protections they always wanted to get rid of anyway. The Mentally Ill Took Over The Country Around 23% of the US population is estimated to have at least one mental illness. On average, around 3% of the population suffers from psychotic episodes and 1% of the population is full blown psychopathic (incapable of empathy and takes joy in the suffering of others). America is a sick nation full of psychologically disturbed people, and there is currently no recourse for fixing the problem. Instead, under the leftist methodology, the mentally ill are elevated, idolized and enabled while violent criminals are released onto the streets over and over again. Take one look at all the major cities on the west coast of the US where progressive policies rule and see the disturbing decline. But what does this have to do with medical tyranny under covid? The political left uses the mentally ill as a bludgeon, an easily manipulated tool for chaos. During the lockdowns and restrictions the establishment and the media stoked the fires of paranoia.  By themselves they have no power; they need the crazed mob as a weapon to keep the rest of the country afraid and in line. They needed good little Stasi, always watching, always correcting, always screaming at those without masks, attacking those that refused to get vaxxed and mocking those that spoke out about scientific inconsistencies. And, in return, the establishment made the mentally ill feel as if they were normal. For a fleeting moment in time, the most unstable and narcissistic people on the planet were made to feel like THEY were on the right side of history and rationality. It was a parasitic feedback loop that almost destroyed the last vestiges of America. Tiny Tyrants Begging For Scraps From The Globalist Table There are generally two kinds of people in the world – Those that want power over others, and those that just want to be left alone. The progressive ideology seems to be a breeding ground for “tiny tyrants”: People who have no individual power, little accomplishment and no influence to speak of, but are still stricken with an obsession to micromanage the world around them. These folks see crisis and government overreach as an opportunity rather than a threat. There are also those people who view their existence as so devoid of interest or excitement that they tend to live vicariously through calamity and conflict. They saw the covid outbreak and the lockdowns as a moment that gave their lives “meaning.” Yes, it’s sad and pathetic, but this is how many people out there cope with obscurity and lack of merit. These opportunists didn’t want the pandemic to end. They wanted it to go on forever, because if it did they could feed off the establishment power shift. They could gather scraps from the globalist table, and like carrion, feast on the corpse of our Republic. The motive? Selfish vanity, that is all. All of this could very well happen again. The big tyrants and tiny tyrants are still out there, waiting for the next crisis; the next panic event to take the public off their guard. Another viral event is unlikely, but they do seem anxious to use climate change, war and economic turmoil as the next great “reset” button. In the end, there will have to be a dramatic shift in how the liberty minded interact with the authoritarian left. It is clear that we cannot share the same country, or the same civilization. Our values are fundamentally at odds. It’s only a matter of time before a single spark ignites a firestorm. *  *  * If you would like to support the work that Alt-Market does while also receiving content on advanced tactics for defeating the globalist agenda, subscribe to our exclusive newsletter The Wild Bunch Dispatch.  Learn more about it HERE.   Tyler Durden Fri, 08/11/2023 - 23:40.....»»

Is Everybody Lying? Authored by John Rubino via Substack, It took a while, but some of the biggest “official narrative” scams and cons of the past few years are finally being exposed. High-ranking US officials have apparently been lying about public health, election integrity, and (of course) war. Among the things that have just come to light: The Secretary of State created the laptop letter Secretary of State Anthony Blinken is being investigated by the Committee on the Judiciary and the Permanent Select Committee on Intelligence for his prominent role in persuading 51 former intelligence officials to falsely discredit the “New York Post story regarding Hunter Biden’s laptop as supposed Russian disinformation” during the 2020 Presidential election. The intelligence assessment led to a nearly blanket censorship of investigative stories exposing the alleged corruption. During the campaign, Blinken was a senior campaign advisor to then former Vice President Joe Biden and recruited the direct assistance of then former Deputy Director of the Central Intelligence Agency (CIA) Michael Morell, who was one of the 51 signatories of the public statement. The CDC director lied about vaccine efficacy In a hearing Wednesday, Rochelle Walensky told the House Appropriations subcommittee that funds her agency that COVID vaccines only stopped preventing transmission of the virus due to "an evolution of science," contradicting her own agency's uncertainty about the products during the early mass vaccination campaign and its contemporaneous data. The exchange was prompted by Rep. Andrew Clyde (R-Ga.) reminding Walensky that she told MSNBC host Rachel Maddow March 29, 2021 that CDC data suggest "vaccinated people do not carry the virus" or "get sick," based on both clinical trials and "real-world data." Walensky responded that the statement was true at the time, when the "wild-type" virus was dominant, but then revised it by saying "even if they got sick" infected people could not transmit COVID. Because of the "evolution of the virus" that's no longer true, she told Clyde. Hearing watchers quickly noted the CDC pulled the rug out from Walensky three days after her Maddow interview in a statement to The New York Times. "The evidence isn't clear" on transmission by "fully vaccinated" people, which is "possible," the agency said. Fauci lied about using Twitter to push vaccinations “A lot of people are spouting out a lot of things about me and Twitter,” Fauci told Fox News. “I’ve never had a Twitter account. I don’t intend on having a Twitter account, and I’ve had nothing to do with Twitter. So I don’t know what they’re talking about when they say that.” Fauci made similar claims during an almost 7-hour deposition. While under oath, the then-medical advisor to President Biden denied using Twitter or even paying attention to social media. “I don’t do social media.” “Since I don’t have a Twitter account, I don’t see tweets.” “I’m so dissociated from social media … I’ve never gotten involved in any of that.” “The social media and Twitter, I told you, I don’t have a Twitter account. I don’t tweet. I don’t do Facebook. I don’t do anything.” Not true according to a new Twitter File showing Anthony Fauci…taking over the White House’s Twitter account. “Dr. Anthony Fauci did an account takeover for @WHCOVIDResponse,” reads a Twitter internal COVID-19 monthly update. Recent Pentagon leaks show everyone was lying to everyone else Among other things, recent leaks showed South Korean leaders avoiding calls from US officials trying to convince them to arm Ukraine, Egypt secretly sending weapons to Russia, Hungary labeling the US an “adversary,” the US and Ukraine both lying about the state of Ukraine’s military. Scariest of all, the US now has soldiers operating secretly on Ukrainian soil. Speculation is now rife that the strange circumstances of this leak point to it being a false flag designed to justify expanded surveillance of online forums. Before dismissing this out of hand, recall that many, if not most of the past few years’ conspiracy theories have turned out to be true. Bill Gates’ BioNTech pump ‘n dump In 2019 — before the pandemic — the Bill and Melinda Gates Foundation invested $55 million in vaccine startup BioNTech. Gates then spent the next two years telling everyone who would listen that covid was deadly and the new vaccines were our only hope for survival. In 2022 he cashed out for a massive profit — and then immediately started saying things like this: We also need to fix the three problems of [COVID-19] vaccines. The current vaccines are not infection-blocking. They’re not broad, so when new variants come up you lose protection, and they have very short duration, particularly in the people who matter, which are old people. What we have here is a classic pump ‘n dump of the type employed by scuzzy hedge funds and low-rent investment banks to fleece their sheep. It’s illegal but also hard to prove, and Gates is part of the “too big to jail” aristocracy, so his stock manipulation will go unpunished. What does all this mean? It means Wake Up, virtually everything you see or hear on corporate media outlets or in government briefings has been shaped not to clarify or educate but to further a narrative that benefits one or another team. When truths occasionally emerge, they’re frequently part of a strategy to surround a Big Lie with enough verifiable data to make it seem plausible. The solution? Seek out sources of information that aren’t operating as propaganda arms for corporations and/or governments. Many of those sources can be found here on Substack. Many others are on independent news outlets like this, this, this, and this. Reality is out there. It’s just not available on CNN, MSNBC, Fox (with one apparent exception), or in the White House briefing room. Tyler Durden Mon, 04/24/2023 - 14:25.....»»

Some Americans Shouldn’t Get Another COVID-19 Vaccine Shot, FDA Says Authored by Zachary Steiber via The Epoch Times (emphasis ours), Some Americans cannot receive another COVID-19 vaccine dose, U.S. regulators said on April 18, as they made sweeping changes to the vaccine system. The U.S. Food and Drug Administration (FDA) announced the changes, including replacing the old Pfizer and Moderna vaccines with updated bivalent shots that had previously only been available as boosters. Regulators are also scaling back the number of recommended doses for most individuals, including people who haven’t received a shot. Key changes include: Most unvaccinated Americans are still being encouraged to get a COVID-19 vaccine but only need a single dose of a bivalent, the FDA said. The exception is young children. Children aged 6 months through 5 years can receive two doses of Moderna’s bivalent while those aged 6 months through 4 years can get three doses of Pfizer’s bivalent. Americans who have received a primary series of a COVID-19 vaccine and one of the bivalent boosters still cannot get an additional dose, unless they’re in certain groups. Any individual 65 years old or older can receive a bivalent dose, even if they’ve already received one, provided four months or more has elapsed since their last shot. People aged 5 and older and deemed immune compromised can get another bivalent at least two months after their last shot, even if it was a bivalent, and can get additional doses “at the discretion of, and at intervals determined by, their healthcare provider.” A college student gets a COVID-19 vaccine at the California State University–Long Beach in Long Beach, Calif., on Aug. 11, 2021. (Patrick T. Fallon/AFP via Getty Images) Little Data to Support Bivalents The FDA authorized the original vaccines in late 2020 based on clinical trial efficacy data. The original vaccines targeted the Wuhan virus strain, which hasn’t circulated since 2020. The updated bivalents target the Wuhan strain and the BA.4 and BA.5 subvariants of the Omicron strain. The subvariants were displaced in 2022. Regulators authorized the bivalents as boosters in 2022 despite no clinical trial data being available. In letters formally announcing the bivalents as replacing the old vaccines, the FDA made clear that scientists aren’t sure whether the bivalents protect against COVID-19. “Based on the totality of the scientific evidence available, FDA concluded that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine, Bivalent may be effective in individuals 6 months of age and older for the prevention of COVID-19,” the letter to Pfizer states. The same language was used for Moderna’s shot. Most of the data supporting Pfizer’s expanded authorization comes from the old vaccines and a bivalent that has never been used in the United States. The only trial data for the available bivalent showed that children had higher levels of neutralizing antibodies when they received a bivalent. Antibodies are thought to protect against COVID-19. Read more here... Tyler Durden Wed, 04/19/2023 - 12:30.....»»

Inside The Secret Government Meeting On COVID-19 Natural Immunity Authored by Zachary Stieber via The Epoch Times (emphasis ours), Four of the highest ranking U.S. health officials—including Dr. Anthony Fauci—met in secret to discuss whether or not naturally immune people should be exempt from getting COVID-19 vaccines, The Epoch Times can reveal. National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci during a Senate hearing in Washington on May 17, 2022. (Shawn Thew/Pool/AFP via Getty Images) The officials brought in four outside experts to discuss whether the protection gained after recovering from COVID-19—known as natural immunity—should count as one or more vaccine doses. “There was interest in several people in the administration in hearing basically the opinions of four immunologists in terms of what we thought about … natural infection as contributing to protection against moderate to severe disease, and to what extent that should influence dosing,” Dr. Paul Offit, one of the experts, told The Epoch Times. Offit and another expert took the position that the naturally immune need fewer doses. The other two experts argued natural immunity shouldn’t count as anything. The discussion did not lead to a change in U.S. vaccination policy, which has never acknowledged post-infection protection. Fauci and the other U.S. officials who heard from the experts have repeatedly downplayed that protection, claiming that it is inferior to vaccine-bestowed immunity. Most studies on the subject indicate the opposite. The meeting, held in October 2021, was briefly discussed before on a podcast. The Epoch Times has independently confirmed the meeting took place, identified all of the participants, and uncovered other key details. Dr. Jay Bhattacharya, a professor of medicine at Stanford University who did not participate in the meeting, criticized how such a consequential discussion took place behind closed doors with only a few people present. “It was a really impactful decision that they made in private with a very small number of people involved. And they reached the wrong decision,” Bhattacharya told The Epoch Times. An email obtained by The Epoch Times shows Dr. Vivek Murthy contacting colleagues to arrange the meeting. (The Epoch Times) The Participants From the government: Fauci, the head of the U.S. National Institute of Allergy and Infectious Diseases and the chief medical adviser to President Joe Biden until the end of 2022 Dr. Vivek Murthy, the U.S. surgeon general Dr. Rochelle Walensky, the head of U.S. Centers for Disease Control and Prevention (CDC) Dr. Francis Collins, head of the U.S. National Institutes of Health, which includes the National Institute of Allergy and Infectious Diseases, until December 2021 Dr. Bechara Choucair, the White House vaccine coordinator until November 2021 From outside the government: Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the U.S. Food and Drug Administration on vaccines Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and a former member of Biden’s COVID-19 advisory board Akiko Iwasaki, professor of immunobiology and molecular, cellular, and developmental biology at Yale University Dr. Peter Hotez, co-director of Texas Children’s Hospital Center for Vaccine Development and dean of the Baylor College of Medicine’s School of Tropical Medicine Fauci and Murthy decided to hold the meeting, according to emails The Epoch Times obtained. “Would you be available tonight from 9-9:30 for a call with a few other scientific colleagues on infection-induced immunity? Tony and I just discussed and were hoping to do this sooner rather than later if possible,” Murthy wrote in one missive to Fauci, Walensky, and Collins. All three quickly said they could make it. Walensky asked who would be there. Murthy listed the participants. “I think you know all of them right?” he said. Walensky said she knew all but one person. “Sounds like a good crew,” she added. From top left, clockwise: Dr. Vivek Murthy, Dr. Francis Collins, Dr. Anthony Fauci, and Dr. Rochelle Walensky. (Getty Images) ‘Clear Benefit’ During the meeting, Offit put forth his position—that natural immunity should count as two doses. At the time, the CDC recommended three shots—a two-dose primary series and a booster—for many Americans 18 and older, soon expanding that advice to all adults, even though trials of the boosters only analyzed immunogenicity and efficacy among those without evidence of prior infection. Research indicated that natural immunity was long-lasting and superior to vaccination. On the other hand, the CDC published a paper in its quasi-journal that concluded vaccination was better. Osterholm sided with Offit, but thought that having recovered from COVID-19 should only count as a single dose. “I added my voice at the meeting to count an infection as equivalent to a dose of vaccine! I’ve always believed hybrid immunity likely provides the most protection,” Osterholm told The Epoch Times via email. Hybrid immunity refers to getting a vaccine after recovering from COVID-19. Some papers have found vaccination after recovery boosts antibodies, which are believed to be a correlate of protection. Other research has shown that the naturally immune have a higher risk of side effects than those who haven’t recovered from infection. Some experts believe the risk is worth the benefit but others do not. Hotez and Iwasaki, meanwhile, made the case that natural immunity should not count as any dose—as has been the case in virtually the entire United States since the COVID-19 vaccines were first rolled out. Iwasaki referred to a British preprint study, soon after published in Nature, that concluded, based on survey data, that the protection from the Pfizer and AstraZeneca vaccines was heightened among people with evidence of prior infection. She also noted a study she worked on that found the naturally immune had higher antibody titers than the vaccinated, but that the vaccinated “reached comparable levels of neutralization responses to the ancestral strain after the second vaccine dose.” The researchers also discovered T cells—thought to protect against severe illness—were boosted by vaccination. There’s a “clear benefit” to boosting regardless of prior infection, Iwasaki, who has since received more than $2 million in grants from the National Institutes of Health (NIH), told participants after the meeting in an email obtained by The Epoch Times. Hotez received $789,000 in grants from the NIH in fiscal year 2020, and has received other grants totaling millions in previous years. Offit, who co-invented the rotavirus vaccine, received $3.5 million in NIH grants from 1985 through 2004. Hotez declined interview requests through a spokesperson. Iwasaki did not respond to requests for comment. No participants represented experts like Bhattacharya who say that the naturally immune generally don’t need any doses at all. In an email obtained by The Epoch Times, Akiko Iwasaki wrote to other meeting participants shortly after the meeting ended. (The Epoch Times) Public Statements In public, Hotez repeatedly portrayed natural immunity as worse than vaccination, including citing the widely criticized CDC paper, which drew from just two months of testing in a single state. In one post on Twitter on Oct. 29, 2021, he referred to another CDC study, which concluded that the naturally immune were five times as likely to test positive compared to vaccinated people with no prior infection, and stated: “Still more evidence, this time from @CDCMMWR showing that vaccine-induced immunity is way better than infection and recovery, what some call weirdly ‘natural immunity’. The antivaccine and far right groups go ballistic, but it’s the reality.” That same day, the CDC issued a “science brief” that detailed the agency’s position on natural immunity versus the protection from vaccines. The brief, which has never been updated, says that available evidence shows both the vaccinated and naturally immune “have a low risk of subsequent infection for at least 6 months” but that “the body of evidence for infection-induced immunity is more limited than that for vaccine-induced immunity.” Evidence shows that vaccination after infection, or hybrid immunity, “significantly enhances protection and further reduces risk of reinfection” and is the foundation of the CDC’s recommendations, the agency said. Several months later, the CDC acknowledged that natural immunity was superior to vaccination against the Delta variant, which was displaced in late 2021 by Omicron. The CDC, which has made misleading representations before on the evidence supporting vaccination of the naturally immune, did not respond to a request for comment regarding whether the agency will ever update the brief. Iwasaki had initially been open to curbing the number of doses for the naturally immune—”I think this supports the idea of just giving one dose to people who had covid19,” she said in response to one Twitter post in early 2021, which is restricted from view—but later came to argue that each person who is infected has a different immune response, and that the natural immunity, even if strong initially, wanes over time. Osterholm has knocked people who claim natural immunity is weak or non-existent, but has also claimed that vaccine-bestowed immunity is better. Osterholm also changed the stance he took in the meeting just several months later, saying in February 2022 that “we’ve got to make three doses the actual standard” while also “trying to understand what kind of immunity we get from a previous infection.” Offit has been the leading critic on the Vaccines and Related Biological Products Advisory Committee, which advises U.S. regulators on vaccines, over their authorizations of COVID-19 boosters. Offit has said boosters are unnecessary for the young and healthy because they don’t add much to the primary series. He also criticized regulators for authorizing updated shots without consulting the committee and absent clinical data. Two of the top U.S. Food and Drug Administration (FDA) officials resigned over the booster push. No FDA officials were listed on invitations to the secret meeting on natural immunity. Fauci and Walensky Downplay Natural Immunity Fauci and Walensky, two of the most visible U.S. health officials during the pandemic, have repeatedly downplayed natural immunity. Fauci, who said in an email in March 2020 that he assumed there would be “substantial immunity post infection,” would say later that natural immunity was real but that the durability was uncertain. He noted the studies finding higher antibody levels from hybrid immunity. In September 2021, months after claiming that vaccinated people “can feel safe that they are not going to get infected,” Fauci said that he did not have “a really firm answer” on whether the naturally immune should get vaccinated. “It is conceivable that you got infected, you’re protected—but you may not be protected for an indefinite period of time,” Fauci said on CNN when pressed on the issue. “So I think that is something that we need to sit down and discuss seriously.” After the meeting, Fauci would say that natural immunity and vaccine-bestowed immunity both wane, and that people should get vaccinated regardless of prior infection to boost their protection. Walensky, before she became CDC director, signed a document called the John Snow Memorandum in response to the Great Barrington Declaration, which Bhattacharya coauthored. The declaration called for focused protection of the elderly and otherwise infirm, stating, “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk.” The memorandum, in contrast, said there was “no evidence for lasting protective immunity to SARS-CoV-2 following natural infection” and supported the harsh lockdown measures that had been imposed in the United States and elsewhere. In March 2021, after becoming director, Walensky released recommendations that the naturally immune get vaccinated, noting that there was “substantial durability” of protection six months after infection but that “rare cases of reinfection” had been reported. Walensky hyped the CDC study on natural immunity in August 2021, and the second study in October 2021. But when the third paper came out concluding natural immunity was superior, she did not issue a statement. Walensky later told a blog that the study found natural immunity provided strong protection, “perhaps even more so than those who had been vaccinated and not yet boosted.” But, because it came before Omicron, she said, “it’s not entirely clear how that protection works in the context of Omicron and boosting.” Walensky, Murthy, and Collins did not respond to requests for interviews. Fauci, who stepped down from his positions in late 2022, could not be reached. Murthy and Collins also portrayed natural immunity as inferior. “From the studies about natural immunity, we are seeing more and more data that tells us that while you get some protection from natural infection, it’s not nearly as strong as what you get from the vaccine,” Murthy said on CNN about two months before the meeting. Collins, in a series of blog posts, highlighted the studies showing higher antibody levels after vaccination and urged people to get vaccinated. He also voiced support for vaccine mandates. Read more here... Tyler Durden Thu, 02/02/2023 - 21:10.....»»

Growing Number Of Doctors Say They Won’t Get COVID-19 Booster Shots Authored by Zachary Stieber via The Epoch Times (emphasis ours), A growing number of doctors say that they will not get COVID-19 vaccine boosters, citing a lack of clinical trial evidence. “I have taken my last COVID vaccine without RCT level evidence it will reduce my risk of severe disease,” Dr. Todd Lee, an infectious disease expert at McGill University, wrote on Twitter. A vial of the Pfizer-BioNTech COVID-19 vaccine is seen in a file photograph. (Justin Sullivan/Getty Images) Lee was pointing to the lack of randomized clinical trial (RCT) results for the updated boosters, which were cleared in the United States and Canada in the fall of 2022 primarily based on data from experiments with mice. Lee, who has received three vaccine doses, noted that he was infected with the Omicron virus variant—the vaccines provide little protection against infection—and described himself as a healthy male in his 40s. Dr. Vinay Prasad, a professor of epidemiology and biostatics at the University of California, San Francisco, also said he wouldn’t take any additional shots until clinical trial data become available. “I took at least 1 dose against my will. It was unethical and scientifically bankrupt,” he said. Allison Krug, an epidemiologist who co-authored a study that found teenage boys were more likely to suffer heart inflammation after COVID-19 vaccination than COVID-19 infection, recounted explaining to her doctor why she was refusing a booster and said her doctor agreed with her position. She called on people to “join the movement to demand appropriate evidence,” pointing to a blog post from Prasad. “Pay close attention to note this isn’t anti-vaccine sentiment. This is ‘provide [hard] evidence of benefit to justify ongoing use’ which is very different. It is only fair for a 30 billion dollar a year product given to hundreds of millions,” Lee said. Dr. Mark Silverberg, who founded the Toronto Immune and Digestive Health Institute; Kevin Bass, a medical student; and Dr. Tracy Høeg, an epidemiologist at the University of California, San Francisco, joined Lee and Prasad in stating their opposition to more boosters, at least for now. Høeg said she did not need clinical trials to know she’s not getting any boosters after receiving a two-dose primary series, adding that she took the second dose “against my will.” “I also had an adverse reaction to dose 1 moderna and, if I could do it again, I would not have had any covid vaccines,” she said on Twitter. “I was glad my parents in their 70s could get covid vaccinated but have yet to see non-confounded data to advise them about the bivalent booster. I would have liked to see an RCT for the bivalent for people their age and for adults with health conditions that put them at risk.” The U.S. Food and Drug Administration (FDA) granted emergency use authorization to updated boosters, or bivalent shots, from Pfizer and Moderna in August 2022 despite there being no human data. Observational data suggests the boosters provide little protection against infection and solid shielding against severe illness, at least initially. Five months after the authorization was granted, no clinical trial data has been made available for the bivalents, which target the Wuhan strain as well as the BA.4 and BA.5 subvariants of Omicron. Moderna presented efficacy estimates for a different bivalent, which has never been used in the United States, during a recent meeting. The company estimated the booster increased protection against infection by just 10 percent. The FDA is preparing to order all Pfizer and Moderna COVID-19 vaccines be replaced with the bivalents. The U.S. Centers for Disease Control and Prevention, which issues recommendations on vaccines, continues advising virtually all Americans to get a primary series and multiple boosters. Professor Calls for Halt to Messenger RNA Vaccines A professor, meanwhile, became the latest to call for a halt to the Pfizer and Moderna vaccines, which are both based on messenger RNA technology. “At this point in time, all COVID mRNA vaccination program[s] should stop immediately,” Retsef Levi, a professor of operations management at the Massachusetts Institute of Technology, said in a video statement. “They should stop because they completely failed to fulfill any of their advertised promise[s] regarding efficacy. And more importantly, they should stop because of the mounting and indisputable evidence that they cause unprecedented level of harm, including the death of young people and children.” Levi was referring to post-vaccination heart inflammation, or myocarditis. The condition is one of the few that authorities have acknowledged is caused by the messenger RNA vaccines. Read more here... Tyler Durden Thu, 02/02/2023 - 19:10.....»»

"It's Time For The Scientific Community To Admit We Were Wrong About COVID & It Cost Lives" Real "mea culpa", ongoing and rapid revision of history, or further narrative management with regard 'amnesty' over what "the others" did to those who thought for themselves over the last few years... You decide... In no lesser liberal rag that Newsweek, Kevin Bass (MS MD/PHD Student, Medical School) has penned a quite surprising (and 'brave') op-ed saying that "it's time for the scientific community to admit we were wrong about COVID and it cost lives..." [ZH: emphasis ours] As a medical student and researcher, I staunchly supported the efforts of the public health authorities when it came to COVID-19. I believed that the authorities responded to the largest public health crisis of our lives with compassion, diligence, and scientific expertise. I was with them when they called for lockdowns, vaccines, and boosters. I was wrong. We in the scientific community were wrong. And it cost lives. I can see now that the scientific community from the CDC to the WHO to the FDA and their representatives, repeatedly overstated the evidence and misled the public about its own views and policies, including on natural vs. artificial immunity, school closures and disease transmission, aerosol spread, mask mandates, and vaccine effectiveness and safety, especially among the young. All of these were scientific mistakes at the time, not in hindsight. Amazingly, some of these obfuscations continue to the present day. But perhaps more important than any individual error was how inherently flawed the overall approach of the scientific community was, and continues to be. It was flawed in a way that undermined its efficacy and resulted in thousands if not millions of preventable deaths. What we did not properly appreciate is that preferences determine how scientific expertise is used, and that our preferences might be—indeed, our preferences were—very different from many of the people that we serve. We created policy based on our preferences, then justified it using data. And then we portrayed those opposing our efforts as misguided, ignorant, selfish, and evil. We made science a team sport, and in so doing, we made it no longer science. It became us versus them, and "they" responded the only way anyone might expect them to: by resisting. We excluded important parts of the population from policy development and castigated critics, which meant that we deployed a monolithic response across an exceptionally diverse nation, forged a society more fractured than ever, and exacerbated longstanding heath and economic disparities. A students adjusts her facemask at St. Joseph Catholic School in La Puente, California on November 16, 2020, where pre-kindergarten to Second Grade students in need of special services returned to the classroom today for in-person instruction. - The campus is the second Catholic school in Los Angeles County to receive a waiver approval to reopen as the coronavirus pandemic rages on. The US surpassed 11 million coronavirus cases Sunday, adding one million new cases in less than a week, according to a tally by Johns Hopkins University.FREDERIC J. BROWN / AFP Our emotional response and ingrained partisanship prevented us from seeing the full impact of our actions on the people we are supposed to serve. We systematically minimized the downsides of the interventions we imposed—imposed without the input, consent, and recognition of those forced to live with them. In so doing, we violated the autonomy of those who would be most negatively impacted by our policies: the poor, the working class, small business owners, Blacks and Latinos, and children. These populations were overlooked because they were made invisible to us by their systematic exclusion from the dominant, corporatized media machine that presumed omniscience. Most of us did not speak up in support of alternative views, and many of us tried to suppress them. When strong scientific voices like world-renowned Stanford professors John Ioannidis, Jay Bhattacharya, and Scott Atlas, or University of California San Francisco professors Vinay Prasad and Monica Gandhi, sounded the alarm on behalf of vulnerable communities, they faced severe censure by relentless mobs of critics and detractors in the scientific community—often not on the basis of fact but solely on the basis of differences in scientific opinion. When former President Trump pointed out the downsides of intervention, he was dismissed publicly as a buffoon. And when Dr. Antony Fauci opposed Trump and became the hero of the public health community, we gave him our support to do and say what he wanted, even when he was wrong. Trump was not remotely perfect, nor were the academic critics of consensus policy. But the scorn that we laid on them was a disaster for public trust in the pandemic response. Our approach alienated large segments of the population from what should have been a national, collaborative project. And we paid the price. The rage of the those marginalized by the expert class exploded onto and dominated social media. Lacking the scientific lexicon to express their disagreement, many dissidents turned to conspiracy theories and a cottage industry of scientific contortionists to make their case against the expert class consensus that dominated the pandemic mainstream. Labeling this speech "misinformation" and blaming it on "scientific illiteracy" and "ignorance," the government conspired with Big Tech to aggressively suppress it, erasing the valid political concerns of the government's opponents. And this despite the fact that pandemic policy was created by a razor-thin sliver of American society who anointed themselves to preside over the working class—members of academia, government, medicine, journalism, tech, and public health, who are highly educated and privileged. From the comfort of their privilege, this elite prizes paternalism, as opposed to average Americans who laud self-reliance and whose daily lives routinely demand that they reckon with risk. That many of our leaders neglected to consider the lived experience of those across the class divide is unconscionable. Incomprehensible to us due to this class divide, we severely judged lockdown critics as lazy, backwards, even evil. We dismissed as "grifters" those who represented their interests. We believed "misinformation" energized the ignorant, and we refused to accept that such people simply had a different, valid point of view. We crafted policy for the people without consulting them. If our public health officials had led with less hubris, the course of the pandemic in the United States might have had a very different outcome, with far fewer lost lives. Instead, we have witnessed a massive and ongoing loss of life in America due to distrust of vaccines and the healthcare system; a massive concentration in wealth by already wealthy elites; a rise in suicides and gun violence especially among the poor; a near-doubling of the rate of depression and anxiety disorders especially among the young; a catastrophic loss of educational attainment among already disadvantaged children; and among those most vulnerable, a massive loss of trust in healthcare, science, scientific authorities, and political leaders more broadly. My motivation for writing this is simple: It's clear to me that for public trust to be restored in science, scientists should publicly discuss what went right and what went wrong during the pandemic, and where we could have done better. It's OK to be wrong and admit where one was wrong and what one learned. That's a central part of the way science works. Yet I fear that many are too entrenched in groupthink—and too afraid to publicly take responsibility—to do this. Solving these problems in the long term requires a greater commitment to pluralism and tolerance in our institutions, including the inclusion of critical if unpopular voices. Intellectual elitism, credentialism, and classism must end. Restoring trust in public health—and our democracy—depends on it. The problem was not people's ignorance of the facts, it was the organized antagonism and censorship against anyone presenting data that was contradictory to the mandate agenda. This is setting aside proclamations like those from the LA Times, which argued that mocking the deaths of "anti-vaxxers" might be necessary and justified.  After two years of this type of arrogant nonsense it's hard to imagine people will be willing to pretend as if all is well. The active effort to shut down any opposing data is the root crime, though, and no, it can never be forgotten or forgiven. People are still livid... One cannot help but notice that the timing of the Atlantic's appeal for passive forgetfulness and now this op-ed mea culpa coincides with the swiftly approaching end of the COVID emergency declarations, amid a growing political backlash to the last two years of meaningless lockdowns and mandates, and Democrats were instrumental in the implementation of both.  A large swath of the population sees one party as the cause of much of their covid era strife.   Perhaps the mainstream media is suddenly realizing that they may have to face some payback for their covid zealotry?  “We didn't know! We were just following orders!”  It all sounds rather familiar. Tyler Durden Tue, 01/31/2023 - 09:59.....»»

2022 Greatest Hits: The Most Popular Articles Of The Past Year And A Look Ahead One year ago, when looking at the 20 most popular stories of 2021, we said that the year would be a very tough act to follow as "the sheer breadth of narratives, stories, surprises, plot twists and unexpected developments" made 2021 the most memorable year yet in our brief history, and that it would be an extremely tough act to follow. And yet despite the exceedingly high bar for 2022, not only did the year not disappoint but between the constant news barrage, the regime shifts, narrative volatility, market rollercoasters, oh and the world being on the verge of a nuclear Armageddon for much of the year, the past year was the most action, excitement, and news (including fake news)-packed yet. Where does one even start? While covid - which was the story of 2020 - finally faded away from the front page and the constant barrage of fearmongering coverage (with recent revelations courtesy of Elon Musk's "Twitter Files" showing just how extensively said newsflow was crafted, orchestrated and -y es - censored by the government, while a sudden U-turn by China in its Covid Zero policy prompting a top Chinese research to admit that the "fatality rate from the omicron variant of the virus is in line with the flu"), and the story of 2021 was the scourge of soaring inflation (which contrary to macrotourist predictions that it would prove "transitory" just kept rising, and rising, and rising, until it hit levels not seen since the Volcker galloping inflation days of the 1980s)... ... then the big market story of 2022 was the coordinated central bank crusade to put the inflation genie back into the bottle and to contain soaring prices (which were no longer transitory, especially after Putin launched his "special military operation" in Ukraine which we will discuss shortly)... ... even if it meant crushing the housing market... ... sparking a global recession, or as Goldman calls it a "broad-based but necessary slowdown in global growth"... ... and leaving millions out of work (the BLS still pretends hundreds of thousands of workers are being added to payrolls even though as we all know - as does the Philadelphia Fed - that is a lie, and the real employment number has not changed since March)... ... not to mention triggering the worst bear market in both stocks and bonds since the global financial crisis. Yes, less than a year after the S&P hit a record just above 4800 in January of this year, both global stock and bond markets have cratered, and in a profound shock to an entire generation of "traders" who have never lived through a hiking cycle and rising inflation, for the first time since 2008 no central banks are riding to the market's rescue. Meanwhile, with a drop of more than 20% in 2022 translating into a record $18 trillion wipeout, the MSCI All-Country World Index is on track for its worst performance since the 2008 crisis, amid the Fed's relentless rate hiking campaign. Add bond market losses - because in 2022 everything was sold - and you get a staggering $36 trillion in value vaporized, which in absolute terms is nearly double the damage from the Lehman failure and the global financial crisis. None of this should come as a surprise: the staggering liquidity injections that started in 2020, continued throughout 2021 and extended into the first half of 2022 before gently reversing as QT finally returned; the final tally is that after $3 trillion in emergency liquidity injections in the immediate aftermath of the pandemic to "stabilize the world", the Fed injected another $2 trillion in the subsequent period, most of which in 2021, a year where economists were "puzzled" why inflation was soaring (this, of course, excludes the tens of trillions of monetary stimulus injected by other central banks as well as the boundless fiscal stimulus that was greenlighted with the launch of helicopter money). And then, when a modest $500 billion in Fed balance sheet liquidity was withdrawn... everything crashed. This reminds us of something we said two years ago: "it's almost as if the world's richest asset owners requested the covid pandemic." Well, last year we got confirmation for this rhetorical statement, when we calculated that in the 18 months after the covid pandemic hit, the richest 1% of US society saw their net worth increase by over $30 trillion, which in turn officially made the US into a banana republic where the middle 60% of US households by income - a measure economists use as a definition of the middle class - saw their combined assets drop from 26.7% to 26.6% of national wealth, the lowest in Federal Reserve data, while for the first time the super rich had a bigger share, at 27%. Yes, for the first time ever, the 1% owned more wealth than the entire US middle class, a definition traditionally reserve for kleptocracies and despotic African banana republics. But as the Fed finally ended QE and started draining its balance sheet in 2022, the party ended with a thud, and this tremendous wealth accumulation by the top 1% went into reverse: indeed, just the 500 richest billionaires saw their fortunes collapse by $1.4 trillion with names such as Mark Zuckerberg, Elon Musk, Jeff Bezos, Masa Son and Larry Page and Sergey Brin all losing more than a third (in some cases much more) of their net worth. This also reminds us of something else we said a year ago: "this continued can-kicking by the establishment - all of which was made possible by the covid pandemic and lockdowns which served as an all too convenient scapegoat for the unprecedented response that served to propel risk assets (and fiat alternatives such as gold and bitcoin) to all time highs - has come with a price... and an increasingly higher price in fact. As even Bank of America CIO Michael Hartnett admits, Fed's response to the the pandemic "worsened inequality" as the value of financial assets - Wall Street -  relative to economy - Main Street - hit all-time high of 6.3x." In other words, for all its faults, 2022 was a year in which inequality finally reversed - if only a little - and as Michael Hartnett said in one of his final Flow Shows, "Main St finally outperformed Wall St significantly in 2022" as the value of financial assets relative to the economy slumped from 6.3x to 5.4x. Sadly, we doubt that this will cheer anyone up - be it workers - who have seen their real, inflation-adjusted earnings decline for a record 20 consecutive months (or virtually all of Joe BIden's presidency)... ... or investors who have seen crushing losses across all industries, with the exception of the one sector we have been pounding-the-table-on bullish on since the summer of 2020: energy (with our favorite stock, Exxon, blowing away the competition with its nearly triple digit return YTD). There is some good news for jittery bulls looking ahead at 2023: statistics show that two consecutive down years are rare for major equity markets — the S&P 500 index has fallen for two straight years on just four occasions since 1928, and they usually marked market crashes or social cataclysms -  the Great Depression, World War II, the 1970s oil crisis and the bursting of the dot-com bubble. The scary thing though, is that when they do occur, drops in the second year tend to be deeper than in the first. And with Joe Biden at the helm, betting on a second great depression may be prudent. Even if that sounds hyperbolic, when it comes to markets the big question for 2023 is simple: have markets bottomed or is there much more room to fall, in other words, are we facing a hard or soft landing. And speaking of Joe Biden at the helm, another glaring risk factor for 2023 is - of course- nuclear war. Because while the great inflation fight and Biden bear market were the defining features of 2022 from an economic and capital markets standpoint, the biggest event in terms of geopolitical and social importance was the war between Russia and Ukraine. While one could write - pardon the pun - the modern day equivalent of "war and peace" on the causes behind the war in Ukraine, for the sake of brevity we will merely note that a conflict that had been simmering for years if not decades... ... finally got its proverbial spark in February when - encouraged by NATO to join the military alliance in an act that Russia had repeatedly warned would be casus belli against Ukraine - Putin ordered a "special military operation" against Ukraine, sending Russian troops to invade the country because, as he subsequently explained, "if Russia did not do this now, it itself would be invaded by neighboring NATO countries a few years later." And speaking of what else Putin said in the lead up to the Ukraine war, the following snapshots reveal much of the Russian leader's thinking about the biggest geopolitical conflict since World War II. And while the geopolitical implications of the war are staggering and long-reaching, the single most important consequence to the world, and especially Europe, is the threat of persistent energy shortages over the coming years as Russian energy output has been sanctioned and curtailed for the foreseeable future... ... in the process sending energy prices in Europe and elsewhere soaring, and pushing inflation sharply higher. Which is especially ironic, because the same central banks we showed above that are hiking rates like crazy in hopes of containing inflation are doing precisely nothing to address the elephant in the room, namely that inflation is not demand-driven (which the Fed can control by adjusting the price of money) but entirely on the supply-side. And since the Fed can't print oil or gas, all that central banks are doing is executing Vladimir Putin's indirect bidding and pushing the world into a global recession if not all out depression as they hope to crush enough energy demand to lower prices in a world where energy supply is also much lower. What they forget is that this will lead to tens of millions of unemployed people, and while that is not a major issue yet, something tells us that the coming mass layoffs - both in the US and around the globe - and not just in tech but across all industries, will be the story of 2023. One final thing worth mentioning in the context of the Ukraine war is what it means strategically for the future of the world, and here we would argue that some of the best analysis belong to former NY Fed repo guru, Zoltan Pozsar whose periodic dispatches throughout 2022 (all of which are available to professional subscribers), and whose year-end report on the fate of Bretton Woods III, the petrodollar, the petroyuan and petrogold, are all must-read for anyone who hopes to be ahead of the curve in today's rapidly changing world. Away from Inflation and the Ukraine war, the next most important topic in the past year, were the revelations from the Twitter Files, exposed by the social medial company's new owner, Elon Musk, who paid $44 billion so that the world can finally see first hand just how little free speech there really is in the so-called land of the free and the home of the First Amendment, and how countless three-lettered, deep-state alphabet agencies - and the military-industrial complex - will do anything and everything to control both the official discourse and the unofficial narrative to keep their preferred puppets in the White House, and keep those they disapprove of - censored and/or locked up, both literally and metaphorically... or simply designate them "conspiracy theorists." None other than Matt Taibbi wrote the best summary of what the Twitter Files revealed, namely America's stealthy conversion into a crypto-fascist state where some unelected government bureaucrat tells corporations what to do: This last week saw the FBI describe Lee Fang, Michael Shellenberger and me as “conspiracy theorists” whose “sole aim” is to discredit the agency. That statement will look ironic soon, as we spent much of this week learning about other agencies and organizations that can now also be discredited thanks to these files. A group of us spent the last weeks reading thousands of documents. For me a lot of that time was spent learning how Twitter functioned, specifically its relationships with government. How weird is modern-day America? Not long ago, CIA veterans tell me, the information above the “tearline” of a U.S. government intelligence cable would include the station of origin and any other CIA offices copied on the report. I spent much of today looking at exactly similar documents, seemingly written by the same people, except the “offices” copied at the top of their reports weren’t other agency stations, but Twitter’s Silicon Valley colleagues: Apple, Facebook, Microsoft, LinkedIn, even Wikipedia. It turns out these are the new principal intelligence outposts of the American empire. A subplot is these companies seem not to have had much choice in being made key parts of a global surveillance and information control apparatus, although evidence suggests their Quislingian executives were mostly all thrilled to be absorbed. Details on those “Other Government Agencies” soon, probably tomorrow. One happy-ish thought at month’s end: Sometime in the last decade, many people — I was one — began to feel robbed of their sense of normalcy by something we couldn’t define. Increasingly glued to our phones, we saw that the version of the world that was spat out at us from them seemed distorted. The public’s reactions to various news events seemed off-kilter, being either way too intense, not intense enough, or simply unbelievable. You’d read that seemingly everyone in the world was in agreement that a certain thing was true, except it seemed ridiculous to you, which put you in an awkward place with friends, family, others. Should you say something? Are you the crazy one? I can’t have been the only person to have struggled psychologically during this time. This is why these Twitter files have been such a balm. This is the reality they stole from us! It’s repulsive, horrifying, and dystopian, a gruesome history of a world run by anti-people, but I’ll take it any day over the vile and insulting facsimile of truth they’ve been selling. Personally, once I saw that these lurid files could be used as a road map back to something like reality — I wasn’t sure until this week — I relaxed for the first time in probably seven or eight years. Well said Matt, and we say this as one of the first media outlets that was dubbed "conspiracy theorists" by the authorities, long before everyone else joined the club. Oh yes, we've been there: we were suspended for half a year on Twitter for telling the truth about Covid, and then we lost most of our advertisers after the Atlantic Council's weaponized "fact-checkers" put us on every ad agency's black list while anonymous CIA sources at the AP slandered us for being "Kremlin puppets" - which reminds us: for those with the means, desire and willingness to support us, please do so by becoming a premium member: we are now almost entirely reader-funded so your financial assistance will be instrumental to ensure our continued survival into 2023 and beyond. The bottom line, at least for us, is that the past three years have been a stark lesson in how quickly an ad-funded business can disintegrate in this world which resembles the dystopia of 1984 more and more each day, and we have since taken measures. Two years ago, we launched a paid version of our website, which is entirely ad and moderation free, and offers readers a variety of premium content. It wasn't our intention to make this transformation but unfortunately we know which way the wind is blowing and it is only a matter of time before the gatekeepers of online ad spending block us for good. As such, if we are to have any hope in continuing it will come directly from you, our readers. We will keep the free website running for as long as possible, but we are certain that it is only a matter of time before the hammer falls as the censorship bandwagon rolls out much more aggressively in the coming year. Meanwhile, for all those lamenting the relentless coverage of politics in a financial blog, why finance appears to have taken a secondary role, and why the political "narrative" has taken a dominant role for financial analysts, the past three years showed conclusively why that is the case: in a world where markets gyrated, and "rotated" from value stocks to growth and vice versa, purely on speculation of how big the next stimulus out of Washington will be, now that any future big stimulus plans are off the table until at least 2024 thanks to a divided Congress, and the Fed is still planning on hiking until it finally crushing inflation, we would like to remind readers of one of our favorite charts: every financial crisis is the result of Fed tightening, and something always breaks. Which brings us to the simplest forecast about the coming year: 2023 will be the year when something finally breaks. As for more nuanced predictions about the future, as the past three years so vividly showed, when it comes to actual surprises and all true "black swans", it won't be what anyone had expected. And so while many themes, both in the political and financial realm, did get some accelerated closure, dramatic changes in 2022 persisted and new sources of global shocks emerged, and will continue to manifest themselves in often violent and unexpected ways - from the ongoing record polarization in the US political arena, to "populist" upheavals around the developed world, to the gradual transition to a global Universal Basic (i.e., socialized) Income regime, to China deciding that the US is finally weak enough and the time has come to invade Taiwan. As always, we thank all of our readers for making this website - which has never seen one dollar of outside funding (and despite amusing recurring allegations, has certainly never seen a ruble from either Putin or the KGB either, sorry CIA) and has never spent one dollar on marketing - a small (or not so small) part of your daily routine. Which also brings us to another critical topic: that of fake news, and something we - and others who do not comply with the established narrative - have been accused of. While we find the narrative of fake news laughable, after all every single article in this website is backed by facts and links to outside sources, it is clearly a dangerous development, and a very slippery slope that the entire developed world is pushing for what is, when stripped of fancy jargon, internet censorship under the guise of protecting the average person from "dangerous, fake information." It's also why we are preparing for the next onslaught against independent thought and why we had no choice but to roll out a premium version of this website. In addition to the other themes noted above, we expect the crackdown on free speech to only accelerate in the coming year - Elon Musk's Twitter Files revelations notwithstanding, especially as the following list of Top 20 articles for 2022 reveals, many of the most popular articles in the past year were precisely those which the conventional media would not touch with a ten foot pole, both out of fear of repercussions and because the MSM has now become a PR agency for either a political party or some unelected, deep state bureaucrat, which in turn allowed the alternative media to continue to flourish in an information vacuum (in less than a decade, Elon Musk's $44 billion purchase of Twitter will seem like one of the century's biggest bargains) and take significant market share from the established outlets by covering topics which established media outlets refuse to do, in the process earning itself the derogatory "fake news" condemnation. We are grateful that our readers - who hit a new record high in 2022 - have realized that it is incumbent upon them to decide what is, and isn't "fake news." * * * And so, before we get into the details of what has now become an annual tradition for the last day of the year, those who wish to jog down memory lane, can refresh our most popular articles for every year during our no longer that brief, almost 14-year existence, starting with 2009 and continuing with 2010, 2011, 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020 and 2021. So without further ado, here are the articles that you, our readers, found to be the most engaging, interesting and popular based on the number of hits, during the past year. In 20th spot with just over 510,000 views, was one of the seminal market strategy reports of 2022 by the man who has become the most prescient and accurate voice on Wall Street, former NY Fed repo guru Zoltan Pozsar, whose periodic pieces previewing the post-war world - one where Bretton Woods III makes a stunning comeback, where the petrodollar dies, and is replaced by the Petroyuan - have become must-read staple fare for Wall Street professionals. In "Wall Street Stunned By Zoltan Pozsar's Latest Prediction Of What Comes Next", Zoltan offered his first post-Ukraine war glimpse of the coming "Bretton Woods III" world, "a new monetary order centered around commodity-based currencies in the East that will likely weaken the Eurodollar system and also contribute to inflationary forces in the West." Subsequent events, including the growing proximity of Russia, China and various other non-G7 nations, coupled with stubborn inflation, have gone a long way to proving Zoltan's thesis. The only thing that's missing is the overhaul of the world reserve currency. In 19th spot, some 526,000 learned that amid the relentless crackdown against free speech by a regime which Elon Musk's Twitter Files have definitively revealed is borderline fascist (as in real fascism, not that clownish farce which antifa thugs pretend to crusade against) Zero Hedge was among the first websites to be targeted by the CIA when that deep state mouthpiece, the Associated Press, said that "intelligence officials accused a conservative financial news website [Zero Hedge] with a significant American readership of amplifying Kremlin propaganda." As we explained in "Now We've Done It: We Pissed Off The CIA" - the 19th most viewed article of 2022 - we have done no such thing but as the AP also revealed, the real motive behind the hit piece is that "Zero Hedge has been sharply critical of Biden and posted stories about allegations of wrongdoing by his son Hunter." Of course, only a few weeks later we would learn that reports of wrongdoing by "his son Hunter" as unveiled in the infamously censored laptop story fiasco, were indeed accurate (despite dozens of "former intel officials" saying it is Russian disinfo) but since only "Kremlin propaganda" sites dare to attack Joe Biden while the MSM keeps deathly silent, nobody in the so-called "free press" bothered to mention it. Incidentally, since the CIA did a full background check on us and republishing some pro-Russian blogs was the best they could find, we are confident that  On the other hand, since being designated a pro-Russian operation meant that we have been blacklisted by most advertisers, we are increasingly reliant on you, dear readers (and not Vladimir Putin) for support, and we would be extremely grateful to everyone who can sign up for our premium product to support us into 2023 and onward. In 18th spot, and suitably right below our little tete-a-tete with the CIA, was the disclosure of a huge trove of corruption Hunter Biden's "laptop from hell." In April, with over 568,000 page views, readers learned that "450GB Of 'Deleted' Hunter Biden Laptop Material To Be Released Within Weeks." The ultimate result was the long overdue confirmation by the mainstream press (NYT and WaPo) that the Biden notebook was indeed real (again, despite dozens of "former intel officials" saying it is Russian disinfo) but since the state-corporatist apparatus had already achieved its goal, and suppressed and censored the original NYPost reporting just ahead of the 2020 presidential election and Biden had been elected president, few cared (just a few months later, thanks to Elon Musk and the Twitter files would we learn just how deep the censorship hole went, and that it involved not only the US government, the Democratic Party, the FBI, but also the biggest tech and media companies, all working together to censor anything that they found politically unpalatable). Yes, 2022 was also a midterm year, and with more than 617,000 views, was our snapshot of what happened on Nov 8 when in a carbon copy of 2020 it initially seemed like Republicans would sweep Congress as we described in the 17th most popular article of 2022, "Election Night Results: FL "Catastrophic" For Dems, Vance Takes OH, Fetterman Tops Oz"... but it was not meant to be and as the mail-in votes crawled in days and weeks later, the GOP lead not only fizzled (despite a jarring loss among Florida Hispanics), but in the end Democrats kept the Senate. Ultimately the result was anticlimatic, and with Congress divided for the next two years, governance will be secondary to what the Fed will do, which in our humble view, will be the big story of 2023. For all the political, market and central bank trials and tribulations of 2022, one could make the argument that the biggest story of the past year was Elon Musk's whimsical takeover of twitter, which started off amicably enough as laid out in the 16th most popular article of 2022 (with more than 627,000 page views) "Buffett Says "Musk Is Winning...It's America" As TWTR Board Ponders Poison Pill", then turned ugly and hostile, transitioned into a case of buyer's remorse with Musk suing to back out of the deal only to find out he can't, and culminated with the release of the shocking Twitter Files, Musk's stunning expose of the dirt and secrets of how the world's most popular news outlet had effectively become a subsidiary not only of the Democratic party but also of the FBI, CIA and various other deep state alphabet agencies, validating once again countless "conspiracy theories" and confirming once and for all that any outlet that still dares to oppose the official party line is the biggest enemy of the deep state. And speaking of the deep state, we had a glaring reminder in September why one should be very careful when crossing the US secret police FBI when pro-Trump celeb pillow entrepreneur Mike Lindell was intercepted by the Feds during a hunting trip and had his cell phone seized as described in "FBI Tracks Down Mike Lindell On Hunting Trip, Surrounds His Car And Seizes Cell Phone". That this happened to one of the most vocal critics of the 2020 election just two months before the midterms, was surely a coincidence, as over 625,000 readers obviously concluded. 2022 was not a good year for markets, and certainly wasn't good for retail investors whose torrid gains from the meme stock mania of 2021 melted down almost as fast as the Fed hiked rates (very fast). But not everyone was a loser, and one story stood out: that of 20-year-old student Jake Freeman (who together with his uncle) bought up a substantial, 6.2% stake in soon-to-be-broke retailer Bed Bath and Beyond, and piggybacking on the antics of one Ryan Cohen, quietly cashed out after making a massive $110 million by piggybacking on one of the most vicious short/gamma squeezes in recent history. The "Surreal Story Of A 20-Year-Old Student Who Acquired 6% Of Bed Bath & Beyond, And Made $110 Million In 3 Weeks" was the 14th most read article of 2022. The 13th most read story of 2022 with over 668,000 reads was the bizarre interlude involving superstar-trader and outgoing House Speaker Nancy Pelosi's husband, Paul, and his bizarre attack by a "right wing" progressive as described in "Paul Pelosi Undergoing Brain Surgery Following 'Brutal' Attack; Suspect Identified." While authorities have struggled to craft a narrative that the attacker, nudist transient David Depape of Berkeley, was a pro-Trumper and the attack was politically motivated, the evidence has indicated that he suffered from serious mental illness and drug addiction and lacked any coherent political ideology; some have even claimed that there was a sexual relationship between him and Pelosi, a theory that could be easily disproven if only the police would release the bodycam footage from the moment of the arrest. Unfortunately, San Fran PD has vowed to keep it confidential. Depape's trial is set to be 2023's business, so expect more fireworks. 2022 was also a year in which Europeans realized how brutally expensive electricity can be when the biggest commodity, nat gas and oil supplier to Europe, Russia, is suddenly cut off. And judging by the 668,500 people who read "How In The Name Of God": Shocked Europeans Post Astronomical Energy Bills As 'Terrifying Winter' Approaches" and made it into the 12th most popular article of the year, the staggering number were also news to our audience: indeed, the fact that Geraldine Dolan, who owns the Poppyfields cafe in Athlone, Ireland, and was charged nearly €10,000 for just over two months of energy usage, was shocking to everyone. To be sure, there were countless other such stories out of Europe and with the Russia-Ukraine war unlikely to end any time soon, Europe's commodity hyperinflation will only continue. Adding insult to injury, Europe is on a fast track to a brutal recession, but the ECB remains stuck in tightening mode, perhaps because it somehow believes that higher rates will ease energy supplies. Alas that won't happen and instead the big question for 2023 will be whether Europe is merely hit with a recession or if instead the ECB's actions escalates the local malaise into a full-blown depression. Earlier we said that one of the most prophetic voices on Wall Street in 2022 (and prior) was that of Zoltan Pozsar, who laid out his theory of a Bretton Woods III regime in the days immediately following the Russian invasion of Ukraine. Well, just one month later we saw the first tentative steps toward just such a paradigm shift when in April the Russian central bank offered to buy gold from domestic commercial banks at a fixed price of 5000 rubles per gram; by doing so the Bank of Russia both linked the ruble to gold and, since gold trades in US dollars, set a floor price for the ruble in terms of the US dollar. We described this in "A Paradigm Shift Western Media Hasn't Grasped Yet" - Russian Ruble Relaunched, Linked To Gold & Commodities", an article red 670,000 times making it the 11th most popular of the year. This concept of "petrogold" was also the subject of extensive discussion by Pozsar who dedicated one of his most recent widely-read notes to the topic; if indeed we are witnessing the transition to a Bretton Woods 3 regime, 2023 will see a lot of fireworks in the monetary system as the dollar's reserve status is challenged by eastern commodity producers. The 10th most popular article of 2022, with 686K views was a reminder of just how much "the settled science" can change: as described in "You Murderous Hypocrites": Outrage Ensues After The Atlantic Suggests 'Amnesty' For Pandemic Authoritarians, many were shocked when after pushing for economy-crushing lockdowns, seeking to block children from going to school (and stunting their development), and even calling for the incarceration or worse of mask, vaccine and booster holdouts, the liberal left - realizing that it was completely wrong about everything to do with covid, a virus with a 99% survival rate - suddenly and politely was hoping to "declare a pandemic amnesty." Brown Professor Emily Oster - a huge lockdown proponent, who now pleads from mercy from the once-shunned - wrote "we need to forgive one another for what we did and said when we were in the dark about COVID. Let’s acknowledge that we made complicated choices in the face of deep uncertainty, and then try to work together to build back and move forward." The response from those who lost their small business, wealth, or worse, a family member (who died alone or from complications from the experimental gene therapy known as "vaccines" and "boosters") was clear and unanimous; as for those seeking preemptive pardons from the coming tribunals, their plea was clear: “We didn't know! We were just following orders."  And from one covid post we segue into another, only this time the focus is not on the disease but rather the consequences of mandatory vaccines: over 730K readers were shocked in February when a former finance professional discovered a surge in "excess mortality", or unexplained deaths among otherwise healthy young adults, yet not linked directly to covid (thus leaving vaccines as the possible cause of death), as we showed in "Long Funeral Homes, Short Life Insurers? Ex-Blackrock Fund Manager Discovers Disturbing Trends In Mortality." This wasn't the first time we had heart of a surge in excess mortality: a month earlier it was the CEO of insurance company OneAmerica to observe that the death rate for those aged 18-64 had soared by 40% over pre-pandemic levels (this was another post that received a lot of clicks). While the science is clearly not settled here - on either covid or the vaccines - the emerging trend is ominous: at this rate the excess deaths associated with covid (and its vaccines) will soon surpass the deaths directly linked to covid. And anyone who dares to bring this up will be branded a racist, a white supremacists, or a fascist, or all three. One of the defining features of 2022 was the record surge in the price of food. And while much of this inflation could be attributed to the trillions in helicopter money injected over the past three years, as well as the snarled supply chains due to the war in Ukraine, a mystery emerged when one after another US food processing plant mysteriously burned down. And with almost 800,000 page views, a majority of our readers wanted to know why "Another US Food Processing Plant Erupts In Flames", making it the 8th most read post of the year. While so far no crime has been alleged, the fact that over 100 "accidental fires" (as listed here) have taken place across America's food facilities since the start of 2021, impairing the US supply chain, remains one of the biggest mysteries of the year. While some will argue that runaway inflation was the event of 2022, we will counter that the defining moment was the war between Ukraine and Russia, which broke out in February after what the Kremlin said was a long-running NATO attempt to corner Russia (by pushing Ukraine to seek membership in the military alliance), forcing it to either launch an invasion now, or wait several years and be invaded by all the neighboring NATO countries. Still, many were shocked when Putin ultimately gave the order to launch the "special military operations", as most had Russia to merely posture. But it was not meant to be and nearly 840K readers followed the world-changing events on February 2 when "Putin Orders "Special Military Operation" In Ukraine's Breakaway Regions." The war continues to this day with no prospects of peace or even a ceasefire. And from one geopolitical hotspot we go to another, namely China and Taiwan, which many expect will be the next major military theater at some time in the near future when Beijing finally invades the "Republic of China" and officially brings it back into the fold. Thing here got extra hot in early August when Democrat Nancy Pelosi decided to make an unexpected trip to the semiconductor-heavy island, sparking an unprecedented diplomatic escalation, with many speculating that China could simply fire at Nancy's unsanctioned airplane. In the end, however, as nearly 950,000 found out, the situation fizzled as "China Summoned US Ambassador Overnight, Says Washington "Must Pay The Price"." Since then Pelosi's political career has officially ended, and while China has not yet invaded Taiwan, it is only a matter of time before it does. While Covid may have been a 2021 story, that was also the year when nobody was allowed to talk about the Chinese pandemic. Things changed in 2022 when liberal censorship finally crashed under its own weight, and long overdue discussions of Covid became mainstream. nowhere more so than on Twitter where Elon Musk fired all those responsible for silencing the debate over the past three years, and of course, the show of the always outspoken Joe Rogan, where mRNA inventor Robert Malone, gave a fascinating interview to Joe Rogan which aired on New Year's Eve 2022 and which took the world by storm in the first days of the new year. It certainly made over 908,000 readers click on "COVID, Ivermectin, And 'Mass Formation Psychosis': Dr. Robert Malone Gives Blistering Interview To Joe Rogan." The doctor, who had been suspended by both LInkedIn and Twitter, for the crime of promoting "vaccine hesitancy" argued that if the risks of vaccines are not discussed, informed consent is not possible. As Malone concluded "Informed consent is not only not happening, it's being actively blocked." Luckily, now that Elon Musk has made it possible to discuss covid - and so much more - on twitter without fears of immediate suspension, there is again hope that not only is informed consent once again possible, but that the wheels of true justice are starting to steamroll liberal censorship. A tragic and bizarre interlude took place in early July when "Former Japanese PM Abe Shot Dead During Speech, "Frustrated" Assassin Arrested", a shocking development which captured the attention of some 927,000 readers.  While some expected the assassination to be a Archduke Ferdinand moment, coming at a time of soaring inflation around the globe and potentially catalyzing grassroots anger at the ruling class, the episode remained isolated as it did not have political motives and instead the killer, Yamagami, said that he killed the former PM in relation to a grudge he held against the Unification Church, to which Abe and his family had political ties, over his mother's bankruptcy in 2002. That's the good news. The bad news is that with the fabric of society close to tearing across most developed nations, it is only a matter of time before we do get a real Archduke 2.0 moment. Just days after Rogan's interview with Malone (see above), another covid-linked "surprise" emerged when Projected Veritas leaked military documents hidden on a classified system showing how EcoHealth Alliance approached DARPA in March 2018, seeking funding to conduct illegal gain of function research of bat borne coronaviruses. But while US infatuation with creating viral bioweapons is hardly new (instead it merely outsourced it to biolabs in China), one of the discoveries revealed in "Ivermectin 'Works Throughout All Phases' Of COVID According To Leaked Military Documents" - the third most popular post of 2022 with 929K page views, is that the infamous "horse paste" Ivermectin was defined by Darpa as a "curative" which works throughout all phases of the illness because it both inhibits viral replication and modulates the immune response. Of course, had that been made public, it would have prevented Pfizer and Moderna from making tens of billions in revenue from selling mRNA-based therapies (not vaccines) whose potentially deadly side effects we are only now learning about (as the 9th most popular post of 2022 noted above confirms). The fake news apparatus was busy spinning in overtime this past year (and every other year), and not only when it comes to covid, inflation, unemployment, the recession, but also - or rather especially - the Ukraine fog of propaganda war. A striking example was the explosion of both pipelines connecting Russia to Europe, Nord Stream I and II, which quickly escalated into a fingerpointing exercise of accusations, with Europe blaming Putin for blowing up the pipelines (even though said pipelines exclusively benefit the Kremlin which spent billions building them in the recent past), while the Kremlin said it was the US' fault. This we learned in "EU Chief Calls Nord Stream Attack "Sabotage", Warns Of "Strongest Possible Response", which was also the 2nd most read article of the year with just over 1,050,000 page views. In the end, there was no "response" at all. Why? Because as it emerged just two months later in that most deep state of outlets, the Washington Post, "Evidence In Nord Stream Sabotage Doesn't Point To Russia." In other words, it points to the US, just as professor Jeffrey Sachs dared to suggest on Bloomberg, leading to shock and awe at the pro-Biden media outlet. The lesson here, inasmuch as there is one, is that the perpetrators of every false flag operation always emerge - it may take time, but the outcome is inevitable, and "shockingly", the culprit almost always is one particular nation... Finally, the most read article of 2022 with nearly 1.1 million page views, was "White House Says Russian Forces 20 Miles Outside Ukraine's Capital." It cemented that as least as far as ZH readers were concerned, the biggest event of the year was the war in Ukraine, an event which has set in motion forces which will redefine the layout of the world over the next century (and, if Zoltan Pozsar is right, will lead to the demise of the US dollar as a reserve currency and culminate with China surpassing the US as the world's biggest superpower). Incidentally, while Russian forces may have been 20 miles outside of Kiev, they were repelled and even though the war could have ended nearly a year ago and the world would have returned to some semblance of normalcy, it was not meant to be, and the war still goes on with little hope that it will end any time soon. And with all that behind us, and as we wave goodbye to another bizarre, exciting, surreal year, what lies in store for 2023, and the next decade? We don't know: as frequent and not so frequent readers are aware, we do not pretend to be able to predict the future and we don't try, despite repeat baseless allegations that we constantly predict the collapse of civilization: we leave the predicting to the "smartest people in the room" who year after year have been consistently wrong about everything, and never more so than in 2022 (when the entire world realized just how clueless the Fed had been when it called the most crushing and persistent inflation in two generations "transitory"), which destroyed the reputation of central banks, of economists, of conventional media and the professional "polling" and "strategist" class forever, not to mention all those "scientists" who made a mockery of both the scientific method and the "expert class" with their catastrophically bungled response to the covid pandemic. We merely observe, find what is unexpected, entertaining, amusing, surprising or grotesque in an increasingly bizarre, sad, and increasingly crazy world, and then just write about it. We do know, however, that with central banks now desperate to contain inflation and undo 13 years of central bank mistakes - after all it is the trillions and trillions in monetary stimulus, the helicopter money, the MMT, and the endless deficit funding by central banks that made the current runaway inflation possible, the current attempt to do something impossible and stuff 13 years of toothpaste back into the tube, will be a catastrophic failure. We are confident, however, that in the end it will be the very final backstoppers of the status quo regime, the central banking emperors of the New Normal, who will eventually be revealed as fully naked. When that happens and what happens after is anyone's guess. But, as we have promised - and delivered - every year for the past 14, we will be there to document every aspect of it. Finally, and as always, we wish all our readers the best of luck in 2023, with much success in trading and every other avenue of life. We bid farewell to 2022 with our traditional and unwavering year-end promise: Zero Hedge will be there each and every day - usually with a cynical smile (and with the CIA clearly on our ass now) - helping readers expose, unravel and comprehend the fallacy, fiction, fraud and farce that defines every aspect of our increasingly broken economic, political and financial system. Tyler Durden Sat, 12/31/2022 - 11:05.....»»

Drowning In New Cases, China Finally Stops Releasing Daily Fabricated Covid "Data" And just like that, Nearly three full years after China first started reporting daily covid data which even the most naive claimed were fabricated, and just days after Beijing's top health authority estimated that nearly 37 million Chinese were infected every single day last week as China finally gave up on its catastrophic zero-covid policy,  on Sunday China’s National Health Commission finally gave up rigging the data and announced it would stop publishing daily Covid-19 case numbers, after the accuracy of its data was questioned as millions were infected nationwide and the official tally remained strikingly low. The data had come into question after several Chinese cities reported daily infections that far surpassed the official tally, adding to doubt of the numbers provided by the NHC. And speaking of official numbers, the 25,000 or so daily cases are just a little below the 37 million new cases revealed recently, or 250 million in 3 weeks. And speaking of official data, it looks roughly as follows: The commission didn’t provide a reason for the change in policy in a statement on Sunday, but said that the Chinese Center for Disease Control and Prevention will release Covid-related info for studies and reference. As reported previously, as many as a quarter billion people, or nearly 18% of the population, may have contracted the virus in the first 20 days of December, according to minutes from an internal meeting of China’s National Health Commission held on Wednesday. And while hospitals in major cities including Beijing and Shanghai have been overwhelmed, while some crematoriums are "struggling to cope", this is all a perfectly normal transition, and a long overdue step toward herd immunity, something China should have done long ago. And since there aren't literally piles of dead bodies strewn across China's landscape, one can make their own conclusions about just how deadly and dangerous covid was, and how much propaganda went into the covid narrative over the past two years. In an illustration of just how fake China's data has been all along, consider the following: Zhejiang province, next to Shanghai, said it has more than 1 million daily Covid infections and expects the number to peak at 2 million, Zhejiang Daily reported Sunday, citing local officials as saying at a health briefing. The city of Dongguan in the southern province of Guangdong said Friday that 250,000 to 300,000 people were being infected on a daily basis. Qingdao city in the eastern province of Shandong is seeing 490,000 to 530,000 daily cases based on data projections, according to a local newspaper report. And yet, the official NHC tally for Dec. 23 was 4,103 cases. Of course, this is very similar to the sheer garbage reported by the US Bureau of Labor Statistics when it comes to the monthly jobs report, which keeps claiming that the US is generating hundreds of thousands of jobs even amid mass layoffs and a US consumer that has now imploded. As for China, the biggest trade-off of such a stark conclusion to "zero covid" is that while China faces an even more acute economic crunch in the coming weeks (see "China’s Economy Is Showing Increasing Strain From the Covid Tsunami"), it will then come out in mid/late-January with a clean economic slate and a naturally immune population that has nothing to fear as China's economic rebound is unleashed on the world, sending a credit impulse shockwave around the globe. And to make sure it gets there faster, on Sunday China expanded the use of a homegrown Covid vaccine. A National Health Commission’s statement said that people who are three and above can receive a Covid vaccine developed by the Chongqing Zhifei Biological Products’ unit. Until now, it was approved only for adults. Those who are fully vaccinated with a Zhifei product can get one booster shot after six months, according to the statement. It's unclear if Chinese "vaccines" have as many adverse and long-lasting side-effects as those developed by the likes of Pfizer and Moderna. Tyler Durden Sun, 12/25/2022 - 20:34.....»»

Pfizer (PFE) and partner BioNTech seek label expansion to use their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in young children under five years. Pfizer, Inc. PFE and partner BioNTech BNTX announced that they have submitted a regulatory filing to the FDA seeking emergency approval for its Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. The vaccine will be used as the third dose (3-µg) in its three-dose primary series for children aged six months through four years.Please note that in children of this age group, Pfizer is not seeking approval of the Omicron BA.4/BA.5 jab as a booster but as a part of the primary series. Currently, the FDA has authorized a three-dose vaccine series of Pfizer/BioNTech’s monovalent COVID-19 vaccine for use in individuals aged six months through four years.If the FDA grants this EUA, children aged under five years would receive a primary two-dose regimen consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine followed by a third 3-µg dose of the bivalent COVID-19 vaccine.Pfizer and BioNTech are also undergoing discussions with the health authorities in Europe with regard to a regulatory filing seeking authorization for the use of their bivalent BA.4/5-adapted Omicron vaccine in individuals aged six months through four years. The bivalent vaccine is authorized in Europe as a booster dose for individuals aged five years and older.Shares of Pfizer have lost 14.1% in the year so far against the industry’s 11.5% rise.Image Source: Zacks Investment ResearchThe bivalent vaccine contains an mRNA encoding the spike protein in the original/monovalent Pfizer/BioNTech vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.This Omicron BA.4/BA.5 bivalent vaccine is already authorized for use in individuals aged five years and older.In August, the FDA granted EUA to Pfizer/BioNTech and Moderna’s MRNA Omicron BA.4/BA.5-adapted bivalent vaccines for a single booster dose. The Pfizer/BioNTech and Moderna booster vaccines can be given at least two months following primary or booster vaccination.While a 50-µg dose of Moderna’s Omicron booster is authorized for adults aged 18 years and older, a 30-µg dose of Pfizer/BioNTech’s version is authorized for use in adults and adolescents aged 12 and older.The EUA was expanded this October to include children as young as five years. Following the EUA expansion, a 10-µg dose of Pfizer/BioNTech’s bivalent vaccine is authorized for individuals aged between five and 11 years. A 25-µg and 50-µg dose of Moderna’s bivalent vaccine is authorized for children aged six to 11 years and adolescents aged 12 to 17 years, respectively.The above authorizations granted to Pfizer and Moderna are based on clinical studies on their bivalent Omicron BA.1-adapted vaccines and pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines.Last month, Pfizer/BioNTech announced updated data from a phase II/III study on its Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. The data showed that BA.4/BA.5 booster elicited substantially higher immune responses against BA.4/BA.5 sub-lineages compared with the companies’ original COVID-19 vaccine. In individuals older than 55 years, the booster produced approximately four-fold higher neutralizing antibody titers against Omicron BA.4/BA.5 sub-lineages compared with the original COVID-19 vaccine. The bivalent vaccine has also elicited a greater increase in neutralizing antibody titers against newer Omicron sub-lineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1, than the original vaccines.Pfizer Inc. Price  Pfizer Inc. price | Pfizer Inc. Quote Zacks Rank & Stocks to ConsiderPfizer currently carries a Zacks Rank #3 (Hold).A better-ranked large drug stock is Merck MRK, which carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 60 days, estimates for Merck’s 2022 earnings per share have risen from $7.37 to $7.68. During the same period, the earnings estimates per share for 2023 have risen from  $7.17 to $7.34  Shares of Merck have gained 43.5% in the year-to-date period.Earnings of Merck beat estimates in each of the last four quarters, witnessing a surprise of 16.07%, on average. In the last reported quarter, Merck’s earnings beat estimates by 10.78%. 7 Best Stocks for the Next 30 Days Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops." Since 1988, the full list has beaten the market more than 2X over with an average gain of +24.8% per year. So be sure to give these hand-picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment Research.....»»

Moderna's (MRNA) Omicron-targeting bivalent COVID vaccines exhibit substantial antibody response compared with an original booster dose of Spikevax. Shares of Moderna MRNA were up 4.6% after management announced that the phase II/III study evaluating two of its mRNA-based bivalent Omicron-targeting COVID-19 vaccines, mRNA-1273.222 and mRNA-1273.214, achieved their study goals.The phase II/III study evaluated the bivalent COVID vaccines against a booster dose of the original COVID vaccine, Spikevax (mRNA-1273), in previously vaccinated and boosted participants aged 19-89 years. The study achieved its primary endpoint of generating a superior antibody response in study participants compared with the booster dose of Spikevax. The bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain.The bivalent vaccine contains an mRNA encoding the spike protein in the original/monovalent vaccine and an mRNA encoding the spike protein common in the Omicron variants. While mRNA-1273.222 contains the spike protein in the BA.4/5 Omicron subvariants, mRNA-1273.214 contains the spike protein in the BA.1 Omicron subvariant.An exploratory data analysis also revealed that both the bivalent vaccines demonstrated robust neutralizing activity against BQ.1.1, an emerging COVID-19 variant. The result from this analysis confirmed that the bivalent vaccines are effective against new and evolving variants. However, the neutralizing activity of these vaccines against the BQ.1.1 variant dropped 5-fold in titers compared with the BA.4/5 variants.Shares of Moderna have declined 29.5% so far this year compared with the industry’s 19.3% fall.Image Source: Zacks Investment ResearchManagement also stated that the frequency of adverse events observed in patients administered the bivalent vaccines was less than compared with participants who had received the second or third dose of Spikevax.This August, the FDA granted EUA to Moderna and Pfizer PFE/BioNTech’s BNTX Omicron BA.4/BA.5-adapted bivalent vaccines for a single booster dose. The Pfizer/BioNTech and Moderna booster vaccines can be given at least two months following primary or booster vaccination.While Moderna’s Omicron booster is authorized for adults aged 18 years and older, Pfizer/BioNTech’s version is approved for people 12 and older.The EUA was expanded last month to include children as young as five years. Following the EUA expansion, a 10-µg dose of Pfizer/BioNTech’s bivalent vaccine is authorized for individuals aged between five and 11 years. A 25-µg and 50-µg dose of Moderna’s bivalent vaccine is authorized for children aged six to 11 years and adolescents aged 12 to 17 years, respectively.The above FDA authorizations granted to Pfizer/BioNTech and Moderna are based on clinical studies on their bivalent Omicron BA.1-adapted vaccines and pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines. Unlike all previously-approved COVID-19 vaccines, the authorization granted to these booster shots is not supported by data from any human clinical studies demonstrating the vaccine’s effectiveness. Encouraging data reported by these companies will help them support their regulatory filings for these vaccines across different countries.Moderna, Inc. Price Moderna, Inc. price | Moderna, Inc. QuoteZacks Rank & Key PickModerna currently carries a Zacks Rank #5 (Strong Sell). A better-ranked stock in the overall healthcare sector is Vertex Pharmaceuticals VRTX which sports a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Vertex’s stock has risen 39.4% this year so far. While Vertex’s earnings estimates for 2022 have risen from $14.21 to $14.61 per share in the past 30 days, estimates for 2023 have increased from $15.10 to $15.60 per share during the same period.Vertex beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 3.16%. In the last reported quarter, Vertex reported an earnings surprise of 8.67%. Zacks Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time. This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.Free: See Our Top Stock and 4 Runners Up >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer Inc. (PFE): Free Stock Analysis Report Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Pfizer And Moderna To Investigate Their Own Vaccines For Myocarditis Risks Why is Big Pharma investigating their own covid vaccines for myocarditis side effects if the vaccines were already supposedly tested and proven safe and effective? Both Pfizer and Moderna have announced that they will be undertaking studies to determine the longer term risks of Myocarditis (an inflammatory condition of the heart which can lead to death) for people who have been injected with the mRNA based covid vaccines.  The decision comes after the release of multiple medical studies which show a correlation and causation between the vaccines and an exponential increase in heart problems, specifically among men 40 years old and younger.  Only a year ago the link between covid vaccinations and myocarditis was widely denied.  Studies also show that myocarditis risk increases with the number of boosters a person has taken. Before the year 2020, the average vaccine was tested and re-tested by pharmaceutical companies and the FDA for 10 to 15 years before it could be released to the public.  This was done not only because testing is a complex process with a lot of red tape involved, but also because it is the only way to discover any long term side-effects that might be associated with a particular immunization product.  If you read any medical journal or scientific outline on vaccine development published before 2020, they all agree that long term testing is necessary for public safety. Suddenly, after 2020 and the advent of public activism against the covid mandates, a host of medical “professionals” and bureaucrats began arguing that the mRNA vaccines do not need the same lengthy testing time frame because government funding allowed for everything to be accomplished much faster.  This is a lie.   What really happened?  Governments fast tracked approval using national emergency measures allowing Big Pharma to skip necessary tests and trials.  Example:  Pfizer representatives recently admitted under oath that they never tested the covid vaccine to see if it actually prevented transmission of the virus.  They simply claimed that it did without verification.  And governments began trying to enforce vaccines requirements on the populace based on the false claim that vaccination stops the spread.   Mainstream media “fact checkers” insist that the covid vaccines were “initially effective” in preventing transmission of the original strains of the virus.  There is no concrete evidence to confirm this.  In fact, covid cases of the original variants began to plunge in the US and in other countries before the vaccines were widely distributed.  This is a fact, and the incredible drop in cases was likely due to an increase in natural immunity within the population.   Some government and Big Pharma funded scientists also argue that mRNA technology as a whole has been tested for many years.  This is a dishonest misdirection.  The technology and concept might have been tested in various experiments for years, but the specific covid vaccines were not, and this matters.  Any scientist that says this claim is a foundation for safety confirmation for the vaccines should be ashamed of themselves.   Studies which take natural immunity and asymptomatic reactions into account when studying vaccine efficacy are highly limited.  There is no way to know if a person survived covid or avoided infection because they were vaccinated, or because they already had the virus, experienced minor symptoms or no symptoms, and developed natural immunity.  Government paid virologists and scientists don't seem to care about testing the distinction.  What we do know from various studies is that natural immunity is far superior in every way to mRNA vaccination. The dangers of releasing a pharmaceutical cocktail for mass consumption or even forced mass consumption without long term study cannot be overstated.  The bottom line?  Given the current information, no one knows for sure what will happen in terms of vaccine effects over a long timeline (several years).  Pharma companies don't know and governments don't know (if we take their production claims for the vaccines as accurate). In all likelihood, Pfizer and Moderna are trying to get out ahead of burgeoning side effects with their own studies as a means to spin or mitigate bad press in the future.  The chances of these studies providing honest data driven assessments are low.   It's been less than two years since widespread distribution of the covid vaccines and we are already seeing signs of negative health issues through myocarditis and blood clotting disorders.  One has to wonder what further terrible developments will unfold for vaccinated people in another two years.  Tyler Durden Tue, 11/15/2022 - 02:00.....»»

BioNTech and Pfizer continue to build on global COVID-19 vaccine leadership with first-to-market Original/Omicron BA.4/BA.5-adapted bivalent vaccine launches across multiple countries and regions worldwide Approximately 300 million doses of the Original/Omicron BA.1- and BA.4/BA.5-adapted bivalent vaccines invoiced as of mid-October 2022 In infectious diseases, Phase 1 trial initiated with a combination vaccine candidate, incorporating the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and Pfizer's quadrivalent modified RNA (modRNA) influenza vaccine candidate, both based on BioNTech's proprietary mRNA platform Continued oncology pipeline expansion with three new first-in-human trial starts for BNT116, BNT142, and BNT313 Presented positive follow-up data from the Phase 1/2 trial evaluating the Company's novel CAR-T cell therapy candidate, BNT211, in patients with relapsed or refractory solid tumors at ESMO 2022 For the nine months ended September 30, 2022, revenues of €13.0 billion1 (9M 2021: €13.4 billion1), net profit of €7.2 billion (9M 2021: €7.1 billion) and fully diluted earnings per share of €27.70 or $29.472 (9M 2021: €27.46 or $32.852) Strong liquidity of €13.4 billion cash and cash equivalents plus total trade receivables of €7.3 billion outstanding as of September 30, 2022; €3.2 billion of the €7.3 billion trade receivables were received in cash as of October 15, 2022 BioNTech raises the lower end of its 2022 full year financial guidance to include estimated COVID-19 vaccine revenue of €16 - 17 billion Conference call and webcast scheduled for November 7, 2022, at 8:00 am ET (2:00 pm CET) MAINZ, Germany, November 7, 2022 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or the ", Company")) today reported financial results for the three and nine months ended September 30, 2022 and provided an update on its corporate progress. "I would like to thank our growing BioNTech team for their outstanding performance in the first nine months of 2022 which allowed us to be the first Company to provide access to a BA.4/BA.5 variant adapted bivalent vaccine at an unprecedented speed. We are working to leverage this experience and apply the lessons learned from the development of Omicron-adapted vaccines to other disease areas and product candidates," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "The next chapter of BioNTech's evolution is becoming tangible; we continue to expand our COVID-19 vaccine and infectious disease portfolio and advance our oncology pipeline. We reaffirm our commitment to improving the health of people worldwide by developing immunotherapies that utilize the full potential of the immune system to fight cancer, infectious and other serious diseases." Financial Review for the Third Quarter and First Nine Months of 2022 in millions, except per share data Third Quarter 2022 Third Quarter 2021 First Nine Months 2022 First Nine Months 2021 Total Revenues1 €3,461.2 €6,087.3 €13,032.3 €13,444.2 Net Profit €1,784.9 €3,211.0 €7,155.7 €7,126.3 Diluted Earnings per Share €6.98 €12.35 €27.70 €27.46 Total revenues reported were €3,461.2 million1 for the three months ended September 30, 2022 (Q3 2021: €6,087.3 million1). As expected, the course of the pandemic remains dynamic and led to fluctuations in quarterly revenues. For the nine months ended September 30, 2022, total revenues were €13,032.3 million1 (9M 2021: €13,444.2 million1). Under the collaboration agreements, territories have been allocated between BioNTech, Pfizer Inc. ("Pfizer") and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma") based on marketing and distribution rights: During the three months ended September 30, 2022, BioNTech's commercial revenues included €2,554.2 million1 gross profit share (Q3 2021: €4,358.5 million1). For the nine months ended September 30, 2022, BioNTech's commercial revenues included €9,128.4 million1 gross profit share (9M 2021: €10,202.7 million1). BioNTech's share of the collaboration partners' gross profit is based on COVID-19 vaccine sales in Pfizer's and Fosun Pharma's territories and represents a net figure. In addition, during the three and nine months ended September 30, 2022, BioNTech recognized €564.5 million and €2,284.6 million of direct COVID-19 vaccine sales to customers in BioNTech's territory, Germany and Turkey, as well as €259.4 million and €1,470.9 million from sales of products manufactured by BioNTech for its collaboration partners. During the comparative prior year periods, €1,350.8 million and €2,586.2 million were recognized from sales to customers in BioNTech's territory as well as €312.3 million and €514.3 million from sales of products manufactured by BioNTech for its collaboration partners respectively. Cost of sales were €752.8 million for the three months ended September 30, 2022 (Q3 2021: €1,211.4 million). For the nine months ended September 30, 2022, cost of sales were €2,811.5 million (9M 2021: €2,328.3 million). The change in cost of sales resulted mainly from the recognition of costs related to BioNTech's COVID-19 vaccine revenues which included the share of gross profit owed to the Company's collaboration partner Pfizer. In addition, cost of sales were impacted by expenses arising from inventory write-offs and expenses for production capacities derived from contracts with contract manufacturing organizations. Research and development expenses were €341.8 million for the three months ended September 30, 2022 (Q3 2021: €260.4 million). For the nine months ended September 30, 2022, research and development expenses were €1,027.2 million (9M 2021: €677.7 million). The increase was mainly due to increased headcount and higher expenses in the context of the share-based payments. General and administrative expenses were €141.0 million for the three months ended September 30, 2022 (Q3 2021: €68.2 million). For the nine months ended September 30, 2022, general and administrative expenses were €361.8 million (9M 2021: €154.9 million), mainly due to recognizing increased expenses for purchased external services as well as an increase in headcount. Income taxes were accrued with an amount of €659.2 million for the three months ended September 30, 2022 (Q3 2021: €1,456.4 million). For the nine months ended September 30, 2022, income taxes were accrued in an amount of €2,625.8 million (9M 2021: €3,206.2 million). The derived effective income tax rate for the nine months ended September 30, 2022 was 26.8%. Net profit was €1,784.9 million for the three months ended September 30, 2022 (Q3 2021: €3,211.0 million). For the nine months ended September 30, 2022, net profit was €7,155.7 million (9M 2021: €7,126.3 million). As of September 30, 2022, cash and cash equivalents were €13,423.7 million. Trade receivables remained outstanding as of September 30, 2022, mainly due to the contractual settlement of the gross profit share under the COVID-19 collaboration with Pfizer, which has a temporal offset of more than one calendar quarter. As Pfizer's fiscal quarter for subsidiaries outside the United States differs from BioNTech's financial reporting cycle, it creates an additional time lag between the recognition of revenues and the payment receipt. Trade receivables for example include the gross profit share for the second quarter of 2022 (as defined by the contract) for which the settlement payment was received subsequent to the end of the reporting period in October 2022. Of the total trade receivables of €7,309.4 million which were outstanding as of September 30, 2022, €3,185.9 million were received in cash as of October 15, 2022. "Thanks to our strong execution in the third quarter of 2022, we updated our COVID-19 vaccine revenue guidance for the year 2022 to the upper end of the original range. We started shipments of our Omicron-adapted bivalent vaccines early in September and we expect to carry on with our deliveries throughout the fourth quarter of 2022," said Jens Holstein, CFO of BioNTech. "We believe in the potential of our COVID-19 franchise and plan to build on our leading position with ongoing innovations in this field. The power of our scientific innovation combined with our strong financial position allows us to accelerate and expand our diversified clinical pipeline and to create future growth in the interest of all stakeholders." Updated Outlook for the 2022 Financial Year: Raised COVID-19 vaccine revenue target to upper end of original guidance. Reiterate planned expenses and capex. Updated the estimated annual effective income tax rate. The Company's outlook includes the following components: BioNTech COVID-19 Vaccine Revenues for the 2022 Financial Year: Estimated BioNTech COVID-19 vaccine revenues for the full 2022 financial year €16 billion - €17 billion  (previously €13 billion - €17 billion) BioNTech updates its 2022 financial guidance, raising its COVID-19 vaccine revenue estimate to the upper end of the original range: €16 - 17 billion (previously: €13 - 17 billion). The updated guidance reflects the shipment of the Omicron-adapted bivalent vaccine boosters, which started early in September and is expected to continue throughout the fourth quarter of 2022 as well as higher prices and a positive foreign currency effect. This revenue estimate reflects expected revenues related to BioNTech's share of gross profit from COVID-19 vaccine sales in the collaboration partners' territories, from direct COVID-19 vaccine sales to customers in BioNTech's territory and expected revenues generated from products manufactured by BioNTech and sold to collaboration partners. BioNTech's COVID-19 vaccine gross profit share from Pfizer is impacted by inventory write-offs. Pfizer inventory write-offs for COVID-19 products reduce BioNTech's gross profit share and therefore, reduce BioNTech's vaccine revenues. Planned 2022 Financial Year Expenses and Capex: R&D expenses €1,400 million - €1,500 million SG&A expenses €450 million - €550 million Capital expenditures €450 million - €550 million The ranges reflect current base case projections and do not include potential effects caused by or driven from additional collaborations or potential merger and acquisition transactions. Estimated 2022 Financial Year Tax Assumptions: BioNTech Group estimated annual effective income tax rate ~27% (previously ~28%) Operational Review of the Third Quarter 2022 and Key Post Period-End Events COVID-19 Vaccine Programs – BNT162 (COMIRNATY) BioNTech and Pfizer continue to build on their global COVID-19 vaccine leadership with first-to-market Original/Omicron BA.4/BA.5-adapted vaccine launches. The Companies have now three commercial stage COVID-19 vaccine products on the market that include the original COVID-19 vaccine and two Omicron adapted vaccines: Original/BA.1- and BA.4/5.-adapted bivalent vaccines. BioNTech's flexible mRNA platform and production infrastructure supported rapid development and manufacturing of variant-adapted vaccines at an unprecedented speed. BioNTech will continue to innovate to advance a diverse pipeline of follow-on and next generation product candidates. BioNTech believes its COVID-19 vaccine franchise will remain a long-term sustainable business opportunity. Commercial updates Following regulatory approvals, BioNTech and Pfizer immediately began shipping Original/Omicron BA.1 and BA.4/BA.5-adapted bivalent COVID-19 vaccines in September 2022 in time for fall and winter booster campaigns. Shipments in the United States began approximately two months after the U.S. Food and Drug Administration (FDA) provided its guidance for the BA.4/BA.5-adapted bivalent COVID-19 vaccine. As of mid-October 2022, BioNTech and Pfizer have invoiced approximately 300 million doses of Original/Omicron-adapted bivalent vaccine. As part of BioNTech and Pfizer's 2-billion-doses-pledge to support equitable access to medicines, the companies have delivered approximately 1.6 billion doses of the companies' COVID-19 vaccine in total to low- and middle-income countries in line with the demand. BioNTech expects to invoice up to 2.1 billion doses of the COVID-19 vaccine in 2022. Some dose deliveries have been shifted into 2023 due to the evolving dynamics of demand. BioNTech believes that it and Pfizer are well positioned to supply the quantities required by global market demand. Clinical development and regulatory updates During the third quarter of 2022, BioNTech and Pfizer's COVID-19 vaccine received multiple regulatory approvals and authorizations, including for Omicron-adapted bivalent vaccines, label expansions for pediatric vaccinations and ongoing conversions from conditional or emergency approvals to full regulatory approvals across various regions worldwide. The companies' Original/Omicron BA.4/BA.5-adapted bivalent vaccine has received approvals in more than 45 countries and regions, as of October 25, 2022. Adapted bivalent vaccine boosters In August 2022, BioNTech and Pfizer started a randomized Phase 2/3 trial evaluating the safety, tolerability and immunogenicity of the Original/Omicron BA.4/BA.5-adapted bivalent vaccine in individuals aged 12 years and older. First data from this trial were reported in October 2022. A 30-µg booster dose of the vaccine demonstrated a substantial increase in the Original/Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken seven days after administration, with similar responses seen across individuals aged 18 to 55 years and those older than 55 years of age (40 participants in each age group). The Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated with early data indicating a favorable safety profile, similar to that of the original vaccine. On August 31, 2022, BioNTech and Pfizer received U.S. FDA Emergency Use Authorization (EUA) for a 30-µg booster dose of the Original/Omicron BA.4/BA.5-adapted bivalent vaccine for individuals aged 12 years and older. On September 1, 2022, BioNTech and Pfizer received a positive European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) opinion and subsequent EC approval for the Original/Omicron BA.1-adapted bivalent vaccine and on September 12, 2022 for a 30-µg booster dose of the Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals aged 12 years and older. In September 2022, BioNTech and Pfizer initiated a Phase 1/2/3 study to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of the Original/Omicron BA.4/BA.5-adapted bivalent vaccine in children 6 months through 11 years of age. This pediatric study follows a previous Phase 1/2/3 trial in these age groups that demonstrated the original vaccine is well-tolerated and offers a high level of protection against COVID-19. In September 2022, BioNTech and Pfizer submitted a request to the U.S. FDA for EUA for Original/Omicron BA.4/BA.5-adapted bivalent vaccine booster and also completed a submission for conditional Marketing Authorization (cMA) in the European Union for children 5 through 11 years of age. In October 2022, the companies received U.S. FDA EUA for a 10-µg booster dose of the Original/Omicron BA.4/BA.5-adapted bivalent vaccine in children 5 through 11 years of age. The Centers for Disease Control and Prevention has added COVID-19 vaccines to the agency's lists of recommended regular immunizations and recommends that people ages 5 years and older receive one updated bivalent booster if it has been at least 2 months since their last COVID-19 vaccine dose. In November 2022, BioNTech and Pfizer reported updated 30-day clinical data from the randomized Phase 2/3 trial evaluating the safety, tolerability and immunogenicity of the companies' Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, given as a 30-µg booster dose, which started in August 2022. The data demonstrate a robust and broadly neutralizing immune response one month after a 30-µg booster dose. Immune responses were markedly higher for those who received the bivalent vaccine compared to the original COVID-19 vaccine, with similar favorable safety and tolerability profile demonstrated between both vaccines. Clinical data demonstrated that Omicron BA.4/BA.5-neutralizing antibody titers rose 13.2-fold from pre-booster levels in adults over 55 years and 9.5-fold for adults 18 to 55 years, one month post bivalent booster compared to 2.9-fold rise in titers elicited in the same time frame by the original vaccine booster. These results reinforce the early clinical data measured seven days after a booster dose of the bivalent vaccine, as well as the pre-clinical data, and suggest that a 30-µg booster dose of the Original/Omicron BA.4/BA.5 bivalent vaccine may induce higher level of protection against the Omicron BA.4 and BA.5 subvariants than the original vaccine. BioNTech and Pfizer have shared these data with the U.S. FDA and plan to share with the EMA and other global health authorities as soon as possible.   Original COVID-19 vaccine In August 2022, BioNTech and Pfizer announced updated efficacy data from a Phase 2/3 trial evaluating a 3-μg dose series of the original COVID-19 vaccine in children 6 months through 4 years of age. Vaccine efficacy, a secondary endpoint in the trial, was 73.2% in children without evidence of prior COVID-19 infection, during a period of circulating Omicron BA.2. The vaccine previously received EUA from the U.S. FDA and the companies submitted for extension of the cMA in the European Union for this age group. In September 2022, BioNTech and Pfizer were granted approval in the European Union for COMIRNATY as a 10-µg booster (third) dose of the original vaccine given at least six months after completion of a primary series for children 5 through 11 years of age. In October 2022, BioNTech and Pfizer received EC approval for the conversion of the cMA to full Marketing Authorization (MA). The conversion applies to all existing and upcoming indications and formulations of the COMIRNATY product group authorized in the European Union, including Original/BA.1 and BA.4/BA.5-adapted bivalent vaccines as booster doses for individuals aged 12 years and older. In October 2022, BioNTech and Pfizer received EC approval for full MA for a 3-µg dose of COMIRNATY as a three-dose series for children aged 6 months through 4 years. In October 2022, BioNTech and Pfizer received EC approval for a fourth dose booster of COMIRNATY in individuals 12 years of age and older at an interval of at least three months between the administration of COMIRNATY and the last prior dose of a COVID-19 vaccine. The COVID-19 vaccine continues to offer protection post booster vaccination against severe disease, hospitalization and deaths for circulating Omicron sublineages. BioNTech and Pfizer continue to monitor protection offered by the original and Original/Omicron adapted bivalent vaccines against emerging SARS-CoV-2 variants. Recently published data (Muik et al. Exposure to BA.4/BA.5 Spike glycoprotein drives pan-Omicron neutralization in vaccine-experienced humans and mice; bioRxiv 2022.09.21.508818) suggest that when administered as boosters, mono- and bivalent Original/Omicron BA.4/BA.5-adapted vaccines may enhance neutralization breadth against Omicron sublineages BA.1, BA.2, BA.2.12.1, and BA.4/BA.5. The preclinical data support the assumption that boosting with an Original/Omicron BA.4/5-adapted bivalent vaccine is a suitable strategy to confer a broader neutralization and address both currently circulating Omicron variants as well as potential future emerging Omicron sublineages or new variants of concern that are closer to the wild-type strain. Next generation COVID-19 vaccine In addition to variant adapted vaccines, BioNTech and Pfizer are identifying and investigating novel next generation vaccine approaches to maintain a broad and longer lasting immune response and high levels of protection against COVID-19 as SARS-CoV-2 evolves. The long-term strategy takes a multipronged approach devised to develop multiple engineered vaccine candidates with the aim of delivering a pan-SARS-CoV-2-type vaccine that will help to better manage future variants of concern. The companies expect that scientific data derived from those different approaches will support the selection of the vaccine candidate for evaluation in a pivotal trial. BioNTech and Pfizer plan to test several novel vaccine constructs that have been engineered to engage multiple arms of the immune system, including antibodies and T cells. In July 2022, BioNTech and Pfizer started a Phase 2 study with a first enhanced spike antigen vaccine candidate. The first T cell enhancing SARS-CoV-2 vaccine product candidate (BNT164b4) in combination with the Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is expected to enter the clinic in the fourth quarter of 2022. COVID-19 – Influenza Combination mRNA Vaccine Program (BNT162b2 + BNT161)In October 2022, BioNTech and Pfizer initiated a Phase 1 open-label, dose-finding study to evaluate the safety, tolerability and immunogenicity of a combination of the COVID-19 and influenza mRNA vaccines to help protect individuals against two severe respiratory viral diseases. The combination vaccine consists of Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and quadrivalent modRNA influenza vaccine candidate and will be tested at different dose levels in approximately 180 healthy adults 18 to 64 years of age. The companies are building on the experiences made in the BNT161 program, which pursues development of an influenza vaccine based on BioNTech's suite of mRNA platforms. Influenza Vaccine Program (BNT161) BNT161 - BioNTech is collaborating with Pfizer to develop an influenza vaccine based on BioNTech's suite of mRNA platforms. In July 2022, positive immunogenicity data from the Phase 2 expansion study of BNT161 were reported. In September 2022, Pfizer announced that the first participants have been dosed in a pivotal Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of a quadrivalent modRNA influenza vaccine candidate in approximately 25,000 healthy U.S. adults. Upon potential approval and commercialization, BioNTech is eligible to receive milestone payments and a royalty on Pfizer's worldwide sales. Shingles Vaccine Program BioNTech is collaborating with Pfizer to develop the first mRNA-based shingles vaccine candidate. A clinical trial is expected to start in the fourth quarter of 2022. Further Infectious Disease Programs BioNTech is applying its validated mRNA vaccine platform across multiple high-need infectious diseases. BioNTech is on track to initiate a first-in-human clinical trial in the fourth quarter of 2022 for mRNA-based product candidate BNT163, designed to address herpes simplex virus type 2 (HSV 2). A first-in-human clinical trial of an mRNA vaccine to protect against malaria (BNT165) is expected to start in the fourth quarter of 2022 or early 2023. A first-in-human clinical trial of an mRNA vaccine to protect against tuberculosis (BNT164) is expected to start early 2023. In 2023, BioNTech expects to start up to five vaccine clinical trials in infectious diseases. Oncology BioNTech's immuno-oncology strategy is based on pioneering approaches that harness the immune response to treat cancer. The Company has multiple clinical stage assets across different therapeutic classes which may have the potential to tackle tumors using complementary strategies, either by targeting tumor cells directly or by modulating the immune response against the tumor. These drug classes include mRNA therapeutic vaccines, cell therapies (CAR-, TCR-, and neoantigen-specific T-cell therapies), mRNA-encoded effector molecules (RiboMabs and RiboCytokines), next generation immune checkpoint inhibitors and agonists, anti-tumor antibodies and immune-modulatory small molecules. Many product candidates have the potential to be combined with other pipeline assets or already approved therapies. BioNTech's clinical stage oncology pipeline includes a total of 19 product candidates in 24 ongoing clinical trials including five randomized Phase 2 clinical trials: two FixVac programs (BNT111 and BNT113), two indications for the iNeST product candidate autogene cevumeran (BNT122/RO7198457) and the bispecific antibody immune checkpoint modulator BNT311 (GEN1046). In the third quarter of 2022, BioNTech started three first-in-human clinical trials: BNT116, a FixVac program for non-small cell lung cancer (NSCLC), BNT142, a bispecific RiboMab targeting CD3 on T cells and Claudin-6 (CLDN6) in solid tumors and, most recently, BNT313, a HexaBody targeting CD27, a new product candidate from BioNTech's collaboration with Genmab A/S being evaluated in solid tumors. BioNTech expects continued pipeline advancement and expansion as well as one more data readout from an ongoing trial for the remainder of 2022. In 2023, BioNTech expects to provide up to ten clinical trial updates in oncology.   Third Quarter 2022 Clinical Oncology Pipeline Update BNT116, BioNTech's FixVac product candidate for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC), encodes for six tumor-associated antigens that cover up to 100% of patients in all major histologic subtypes of NSCLC and aims to elicit a tumor-antigen-specific immune response. FixVac is an off-the-shelf cancer immunotherapy approach based on BioNTech's uridine mRNA lipoplex technology targeting shared non-mutated antigens.   In July 2022, the first participant was dosed in a first-in-human clinical trial evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combination with cemiplimab (anti-PD-1, Regeneron's Libtayo) in patients with advanced or metastasized NSCLC. The trial is intended to establish a safe dose for BNT116 monotherapy as well as for BNT116 in combination with cemiplimab in patients who have progressed on prior PD-1 inhibitor treatment or are not eligible for chemotherapy, and in combination with docetaxel in patients who have received prior platinum-based chemotherapy. A second trial evaluates BNT116 alone and in combination with cemiplimab as first-line treatment of patients with advanced NSCLC whose tumors express programmed cell death ligand-1 (PD-L1) in ≥ 50% of tumor cells. The primary objective of the Phase 1/2 trial is to assess the ...Full story available on Benzinga.com.....»»

Short-term supply constraints led Moderna to cut its 2022 revenue outlook to a range of $18 billion to $19 billion. Administering Moderna's Covid-19 vaccine in London.Dinendra Haria/SOPA Images/LightRocket via Getty Images Moderna shares fell as much as 14% on Thursday following the COVID vaccine maker's financial update. The company cut its 2022 revenue outlook to a range of $18 billion to $19 billion.  Third-quarter per-share earnings of $2.53 on total revenue of $3.36 billion missed Wall Street's projections.  Moderna shares sharply dropped Thursday after the COVID vaccine maker reduced its 2022 sales guidance and delivered third-quarter financial results that fell short of Wall Street's targets. Shares fell by as much as 14% to $128 during premarket trade, the weakest price since October 24. The shares on a year-to-date basis had already fallen by 41%.  The company forecast $18 billion to $19 billion in 2022 revenue from its coronavirus vaccine, lower than its previous outlook of around $21 billion. The vaccine is Moderna's sole product that's commercially available. The "delay of certain deliveries into 2023 due to short-term supply constraints" was cited as the reason for the lowered projection in Moderna's third-quarter report. Earnings fell by 67% to $2.53 a share and total revenue came in at $3.36 billion, down from $4.97 billion a year earlier. Analysts polled by FactSet had expected earnings of $3.29 a share on revenue of $3.53 billion for the quarter that ended on September 30. Moderna said quarterly product sales fell by 35% to $3.1 billion because of the timing of market authorizations for its vaccine boosters and the related manufacturing ramp-up.The company said it's making progress on its respiratory vaccine pipeline, including potential vaccines against influenza and Respiratory Syncytial Virus, or RSV, which can cause lung and respiratory tract infections.Read the original article on Business Insider.....»»

If Red States Want Protection From Collapse They Will Have To Build Alternative Economies Authored by Brandon Smith via Alt-Market.us Economic centralization is the ultimate form of organized conspiratorial power, because it allows a small group of people to dictate the terms of trade for a society and therefore dictate the terms of each person’s individual survival. For example, the Federal Reserve as a banking entity has free rein to assert policy controls that can disrupt the very fabric of the US economy and the buying power of our currency. They can (and do) arbitrarily create trillions of dollars from thin air causing inflation, or arbitrarily raise interest rates and crash stock markets. And according to former Fed chairman Alan Greenspan, they answer to no one, including the US government. I have started to see a new narrative being spread within mainstream media platforms as well as alternative media platforms suggesting that the Fed is necessary because it is working to “counter” the agenda of Joe Biden and the Democrats. Some people claim the central bank is “protecting” America from the schemes of the UN and European interests. This is perhaps the most moronic theory I’ve ever heard, but it makes sense that the central bank and its puppets would be trying to plant the notion that the Fed is some kind of “hero” secretly fighting a war on our behalf. The money elites associated with the Fed have inflated perhaps the largest financial bubble in the history of the world over the past 14 years. They did this with bailouts, they did this with QE, they did this with covid pandemic checks and loans, and now the bubble is popping. They know it is popping, because they WANT it to pop. As I have warned for years, the Fed has been staging a massive controlled demolition of the US economy. Why? Because the US economy must be diminished in order to make way for the “Great Reset,” a term created by the World Economic Forum to describe an unprecedented paradigm shift in the global economy and how it operates, and a complete upending of society. The end game is openly admitted – A one world digital currency system and one world governance controlled by a league of corporate partners working in concert with politicians. This is not conspiracy theory, this is conspiracy reality. This is undeniable fact. The Fed does not care about the US economy, its loyalty is to a global agenda and it takes its marching orders from a consortium of banking institutions called the Bank for International Settlements (BIS). This is how global central banking policies are coordinated to either work in harmony to create artificial stability, or to work in conflict, creating artificial crisis events. The truth is, the foundations of global governance already exist, but what the establishment does not have is public acceptance and total submission to their authority. What the banks want is to create a crisis so profound that the masses will run to THEM, begging for help. Once a population begs their captors for relief or resolution and it is given, it’s far less likely that the people will revolt against those captors in the future. Psychologically, the central banks and the establishment elites are trying to create a planetary Stockholm Syndrome, and we are seeing it already with the Federal Reserve being painted as the “shield” holding back the tide of economic ruin that they actually engineered. The initial stages of the Great Reset have already been launched. With the economic bubble expanded to incredible levels, the Fed is now staging an aggressive implosion using interest rate hikes into economic weakness. There are multiple threats that come with this dynamic: Stagflation With stagflation, normal credit market interventions do not necessarily work right away. As we saw recently with the official CPI print rising despite the Fed’s rate hikes, prices are not going to go down that easily. During the last stagflation event 40 years ago, the Fed raised rates to around 20% before prices finally stopped their epic climb, and back then the US did not have $31 trillion in debt nor did it just print over $8 trillions in the span of two years. Rates are likely to go much higher than many people expect. Treasury Bond Crisis The Fed replaced foreign investors like Japan and China as the primary buyers of US government Treasury Bonds, and they did so years ago. Now, with the Fed cutting purchases, reducing its balance sheet and raising rates, who is going to buy all that US debt and keep the government funded? Well, the answer is no one. For now, foreign purchases are enough to give a semblance of stability, but with geopolitical tensions rising it’s only a matter of time before countries like China dump their T-bond and dollar holdings completely. Then, the dollar’s world reserve status will come into question and inflation becomes an even greater threat as the trillions of greenbacks held overseas come flooding into the US again. Stock Market Spiral Without the Federal Reserve as the backstop fueling corporate share buybacks with cheap money, stocks will continue to slide. They’ll jump every now and then on rumors that the Fed will pivot away from tightening, and when the Fed doesn’t, stocks will start dropping again. Without stimulus and near zero rates there is no hope for equities beyond the occasional jawboning. The Fed has the ability to slow down or speed up all of the conditions above, and so far they appear to be speeding things up. We obviously can’t rely on the Biden Administration to do anything about these problems; in all likelihood Biden and his handlers are joyful in the prospect of the inevitable calamity. No one in government is trying to do anything legitimate to stop the landslide and no one is trying to prepare Americans for the consequences. In fact, Americans are being told there are no consequences. Thus, it’s up to individuals to prepare and warn their friends and family, but what about a larger organized response? Despite numerous claims that conservatives would “do nothing” to stop the rise of medical fascism in the name of the covid pandemic, almost half the states in the US stood their ground against the mandates and the push for vaccine passports. If this had not happened, America would look like China does today with endless lockdowns and draconian tracking apps. I don’t think enough people understand just how close we came to losing every freedom we have left – We were on the doorstep of an Orwellian hell, and probably civil war. The red state defiance of covid restrictions represented an organized action at the state and interstate level. What if these states did the same thing in the face of the economic crisis? Without organization at the state level to create alternatives to the mainstream economy the plight of the public becomes much more daunting and dangerous. Rather than trying to start completely from scratch, there are solutions that can be pursued at the state level to help mitigate the disaster. Currency Alternatives States like Texas, Utah and Louisiana (currently Dem controlled) all have legislation in place to utilize gold and silver as legal tender. Such efforts need to be expanded to as many states as possible, and the list of alternatives needs to grow. Gold, silver, copper, and other commodities like oil, electricity, wheat and grains could be used to back a state recognized currency system. Is it constitutional? Not technically, but the federal government violated the constitutional money creation mandate over a century ago when they allowed the institution of the Federal Reserve. The system is already broken. If states were to offer commodity backed currencies in parallel with the dollar, then they could actually stave off price inflation and possibly reverse it. This can’t be achieved by only one or two states, though. It would have to be organized among multiple states with multiple trade agreements in place. State Banks North Dakota has its own state run bank that provides credit opportunities specifically to ND locals and ND businesses. It has operated successfully for decades. Why has no other state adopted this model? Why should we rely on banks that are all tied back to corporate conglomerates that want to destroy us? State banks are the answer to the problem of leftists and globalists using corporate banks as a weapon against conservatives and liberty activists. Localized Trade Alternatives States should be utilizing the resources within their own borders to generate real jobs (rather than precarious and temporary service sector jobs) and economic prosperity. Why are states and citizens in those states allowing the federal government under Biden to dictate the terms of how they grow their economies? Leftists will claim that resource management needs to be supervised by federal agencies, but why? These people have consistently proven themselves to be incompetent and destructive. Why should they be trusted to control our ability to expand in our own states? Conservation and intelligent handling of state resources should not be relegated to bureaucrats who live outside of those states and who care nothing about the citizens of those states. State Incentives For Industry The vast majority of retail goods purchased by US citizens are made outside the US. It is a simple matter of profit incentives involving cheap labor overseas. But, what if there were big tax reductions for companies that manufacture in America? What if state banks offered easier credit to companies that build factories within that state’s borders and hire American workers at a reasonable wage? It can be done in the US – It’s been done in the past. If we don’t restart domestic production, our country is doomed to remain dependent on international corporations and foreign entities that do not have our best interests in mind. The only hope any state has to weather the coming storm is to localize production and manage their resources to kick-start trade. Local production would act as a redundancy should the mainstream economy collapse (which it will). States don’t need Biden’s permission to make this happen. They don;t need the Federal Reserve’s permission either. They can and should take action now before it’s too late. Tyler Durden Thu, 10/27/2022 - 23:40.....»»