Dr. Paul Offit, a member of the U.S. FDA’s vaccine advisory committee, has written in the New England Journal of Medicine, the world’s top medical journal, calling for an end to the mass vaccination of anyone at low risk from the virus.
In an op-ed titled “Bivalent COVID-19 Vaccines – A Cautionary Tale”, Dr. Offit writes that Covid boosters are “probably best reserved for the people most likely to need protection against severe disease”.
“I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later,” he writes.
Dr. Offit, who is Professor of Vaccinology and Professor of Paediatrics at the University of Pennsylvania, goes through in detail the process that led to bivalent vaccines being recommended in the U.S. for everyone over five years of age with no relevant data from humans. He is clearly very unhappy about it.
On June 28th 2022, researchers from Pfizer-BioNTech and Moderna presented data on their bivalent vaccines to the FDA’s Vaccines and Related Biological Products Advisory Committee (of which I am a member). The results were underwhelming. Bivalent boosters resulted in levels of neutralising antibodies against BA.1 that were only 1.5 to 1.75 times as high as those achieved with monovalent boosters. Previous experience with the companies’ vaccines suggested that this difference was unlikely to be clinically significant. Safety data were reassuring. At the time of the FDA presentation, BA.1 was no longer circulating in the United States, having been replaced by more immune-evasive and contagious Omicron subvariants. But winter was around the corner. The FDA advisory committee, sensing the urgency of responding to these immune-evasive strains, voted to authorise bivalent vaccines with an understanding that they would target Omicron subvariants BA.4 and BA.5, which at the time had accounted for more than 95% of circulating strains.
A series of rapid-fire policy decisions followed. On June 29th 2022, the day after the advisory committee meeting, the Biden administration agreed to purchase 105 million doses of Pfizer-BioNTech’s bivalent vaccine containing BA.4 and BA.5 mRNA. One month later, on July 29th 2022, the administration agreed to purchase 66 million doses of Moderna’s bivalent vaccine, intending to offer both vaccines in the fall and winter. On September 1st 2022, the FDA withdrew its emergency use authorisation for monovalent vaccine boosters and the CDC recommended bivalent vaccine boosters for everyone 12 years of age or older. On October 12th 2022, the CDC extended this recommendation to include everyone five years of age or older. At that point, no data from humans, including immunogenicity data, were available for comparing the relative capacities of the monovalent and bivalent vaccines to protect against BA.4 and BA.5.
On October 24th 2022, David Ho and colleagues released the results of a study examining levels of neutralizing antibodies against BA.4 and BA.5 after receipt of a monovalent or bivalent booster dose. They found “no significant difference in neutralisation of any SARS-CoV-2 variant”, including BA.4 and BA.5, between the two groups. One day later, Dan Barouch and colleagues released the results of a similar study, finding that “BA.5 [neutralising-antibody] titers were comparable following monovalent and bivalent mRNA boosters”. Barouch and colleagues also noted no appreciable differences in CD4+ or CD8+ T-cell responses between participants in the monovalent-booster group and those in the bivalent-booster group. Neither research group found the bivalent boosters to elicit superior immune responses. The results are now published in the Journal.
The likely reason the bivalent vaccines failed is immune imprinting, Dr. Offit explains.
The immune systems of people immunised with the bivalent vaccine, all of whom had previously been vaccinated, were primed to respond to the ancestral strain of SARS-CoV-2. They therefore probably responded to epitopes shared by BA.4 and BA.5 and the ancestral strain, rather than to new epitopes on BA.4 and BA.5.
When epidemiological data did become available, they showed very poor protection.
On November 22nd 2022, the CDC published data on the effectiveness of the BA.4 and BA.5 mRNA vaccines for preventing symptomatic infection within two months after receipt of the booster dose. For people who had received a monovalent vaccine two to three months earlier, the extra protection associated with the bivalent booster dose ranged from 28% to 31%. For those who had received a monovalent vaccine more than eight months earlier, the extra protection ranged from 43% to 56%. Given the results of previous studies, it’s likely that this moderate increase in protection against probably generally mild disease will be short lived.
The bivalent vaccine had very poor take-up and the variants it was targeted against were quickly gone.
As of November 15th 2022, only about 10% of the population for whom the bivalent vaccine had been recommended had received it. By December 2022, the BA.4 strain was no longer circulating, and BA.5 accounted for less than 25% of circulating SARS-CoV-2 strains, having been partially replaced by more immune-evasive strains, such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1.
It’s welcome that Dr. Offit is breaking ranks and expressing dismay about the poor process and the lack of data, and calling for the end of the mass vaccination campaign. The intervention is particularly significant because it denotes a failure of the central U.S. biosecurity strategy of trying to use fast-track mRNA vaccines to provide a lightning response to an emerging biological threat. It is thus likely that his conclusions will be strongly resisted by those who are invested – financially, psychologically and politically – in this strategy.
That Dr. Offit is only doing so now, and not with any recognition of any safety problems, is less welcome, of course. Still, he will likely not be thanked by his paymasters, and it is in the right direction, so he should receive credit for that.
We still await the acknowledgement that the benefit of these vaccines was never favourable for people at low risk from the virus, who never needed them, and that their safety profile is far worse than the companies and regulators have led the public to believe.
Stop Press: CNN reports that Dr. Offit is “angry” that Moderna failed to include unfavourable infection data in its submission to the FDA last year. “I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” Dr. Offit said. According to CNN: “The data that was not presented to the experts looked at actual infections: who caught COVID-19 and who did not. It found that 1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected.” Does it make you wonder what else they’re not telling you, Dr. Offit?
Australian Health Authorities Call For More COVID Boosters… But The Public Says No
Australia and New Zealand suffered some of the worst pandemic mandate conditions of any country in the western world, crossing the line into totalitarianism on a number of occasions.
Australian authorities restricted residents of larger cities to near house arrest, with people not being allowed to go more than 3 miles from their homes. Citizens were given curfew hours between 9pm and 5am. They were banned from public parks and beaches without a mask, even though it is nearly impossible to transmit a virus outdoors and UV light from the sun acts as a natural disinfectant.
In the worst examples, Australian citizens received visits from police and government officials for posting critical opinions about the mandates on social media. Some were even arrested for calling for protests against the lockdowns. In Australia and New Zealand, covid camps were built to detain people infected with covid. Some facilities were meant for those who had recently traveled, others were meant for anyone who stepped out of line.
As the fears over covid wane and the populace realizes that the true Infection Fatality Rate of the virus is incredibly small, restrictions are being abandoned and things seems to be going back to normal. It’s important, however, to never forget what happened and how many countries faced potentially permanent authoritarianism under the shadow of vaccine passports. If the passports rules had been successfully enforced, we would be living in a very different world today in the west.
Luckily, the passports were never implemented widely. Australian health authorities are once again calling for the public to take a fourth covid booster shot, but with very little response. Only 40% of citizens took the third booster, and new polling data shows that 30% are taking the fourth booster.
With an astonishing rise in excess deaths by heart failure in Australia coinciding exactly with the introduction of the covid mRNA vaccines, perhaps people are deciding to finally er on the side of caution. Why take the risk of an experimental vaccine over a virus that 99.8% of the population will easily survive?This post was originally published at Zero Hedge
NIH Failed To Monitor EcoHealth Alliance: Federal Watchdog
After an 18-month audit, a federal watchdog says that the National Institutes of Health (NIH) failed to adequately monitor and address problems involving EcoHealth Alliance, a New York City-based nonprofit that was used to offshore risky gain-of-function research to Wuhan, China after the Obama administration banned the practice in 2014.
According to the report from the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS), the “NIH did not effectively monitor or take timely action to address” compliance issues with EcoHealth.
In April 2020, after then-President Donald Trump claimed the SARS-CoV-2 virus could have come from the WIV lab, NIH terminated the EcoHealth grant with little explanation. That step was widely condemned by scientists, and OIG’s report now says NIH improperly executed the termination because it did not provide a valid reason or provide EcoHealth with required information for appealing the decision.
A few months later, NIH reinstated the award but immediately suspended it, setting conditions for resumption that EcoHealth said it could not meet. NIH permanently terminated the WIV subaward as of August 2022 for compliance issues, including WIV’s failure to provide NIH with laboratory notebooks related to the funded experiments. –Science
The audit examined the above grant, as well as two others from 2014 to 2021 which totaled $8 million, but largely focused on $600,000 of it which went to the Wuhan Institute of Virology.
The NIH faulted EcoHealth for failing to promptly report gain-of-function results in some experiments, however the company has blamed a computer glitch at NIH for the 2-year delay.
Digging into the report is US Right to Know’s Emily Kopp, who has broken down various aspects of the OIG report.
Meanwhile, the audit also found that the nonprofit billed NIH for $89,171 in disallowed costs, including expenses such as alcohol, and a staffer’s $3,285 trip to a conference that was miscoded, and should have instead been billed to a non-NIH grant.
The OIG recommends that the WIV (but not EcoHealth) be banned from receiving future NIH funds.
Meanwhile, EcoHealth just scored a fresh $3 million grant from the Department of Defense.This post was originally published at Zero Hedge
Rand Paul, GOP Senators Push Bill To Reinstate Service Members Fired For Refusing COVID Vaccines
“We still have service members who have not been rehired, promoted, or received back pay and benefits.”
GOP Senator Rand Paul has joined others in promoting an updated bill to reinstate military service members who were previously fired for refusing to comply with the Biden Administration’s COVID vaccine mandate.
The legislation, named the Allowing Military Exemptions, Recognizing Individual Concerns About New Shots (AMERICANS) Act of 2023, includes a requirement that the Secretary of Defense offer reinstatement to active members who were removed from duty for not taking the shots.
Senator Paul noted “The COVID-19 vaccine mandate has ruined the livelihoods of men and women who have honorably served our country. This inept bureaucratic policy should have never been imposed, and while it has since been rolled back, we still have service members who have not been rehired, promoted, or received back pay and benefits.”
He continued, “The AMERICANS Act will address these issues and others that the Biden administration has failed to consider at the expense of service members’ lives and our nation’s national security interests.”
Senator Ted Cruz, who is also co-sponsoring the bill added “Our military continues to feel the effects of the Biden administration’s reckless, misguided, and now-prohibited vaccine mandates.”
“I’m glad that we were able to remove the COVID-19 vaccine mandate last Congress, but there is more work to do,” Cruz urged, adding “The AMERICANS Act would correct the wrongs done to unvaccinated service members who were discharged for exercising their conscience.”
As they noted in their statements, the Senators were previously successful in getting the mandate scrapped by threatening to block the passage of the National Defense Authorization Act.
Representative Dan Bishop, who has introduced a companion bill in the House, also noted that “While last year’s NDAA directed that SECDEF rescind the DOD’s authoritarian COVID vaccine mandate, it didn’t prohibit the DOD from issuing a similar mandate in the future.”
He continued, “The bill also didn’t provide any meaningful remedies for service members who were kicked out due to the mandate. This is completely unacceptable. Sen. Cruz and my bill, the AMERICANS Act, will close these glaring loopholes and bring justice to military members who were purged by Secretary Austin’s egregious vaccine mandate.”
Specifically, the legislation will require the Department of Defense to:
- Reinstate any service member separated solely for COVID-19 vaccine status who wants to return to service, crediting the service member with the time of involuntary separation for retirement pay calculations;
- Restore the rank of any service member demoted solely for COVID-19 vaccine status, compensating the service member for any pay and benefits lost due to that demotion;
- Adjust to “honorable” any “general” discharge given to a service member solely due to COVID-19 vaccine status;
- Expunge from a service members’ record any adverse action based solely on COVID-19 vaccine status, regardless of whether the service member previously sought an accommodation;
- Make every effort to retain service members not vaccinated against COVID-19, providing them with professional development, promotion, and leadership opportunities equal to that of their peers; and
- Provide a COVID-19 vaccine exemption process for service members with natural immunity, a relevant underlying health condition, or a sincerely held religious belief inconsistent with being vaccinated.
The Military Times estimates that more than 3,400 troops were “involuntarily separated from the service” due to non-compliance with the vaccine mandate.
Despite Republican attempts to stop mandatory vaccines for active duty personnel, and to uphold exemption rights, the Biden administration has continually pushed for dishonourable discharges and even court martialing for troops who disobey orders to get the shots.
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