FDA Proposes Annual COVID Vaccines (Even for Kids) Without Data

When I first started writing about COVID vaccines, I knew Pfizer’s ultimate plan was for there to be annual COVID shots like we have annual flu shots. This was discussed during a Pfizer Feb. 2021 earnings call to investors where CEO Albert Bourla eased concerns they would continue to make bank even after the pandemic ended.

During the 2021 Barclays’ Global Health Conference, former Pfizer CFO Frank D’Amelio said the company didn’t “see this as a one-time event” but “as something that’s going to continue for the foreseeable future.”

Bourla on Feb. 25, 2021 told NBC:

“Every year, you need to go to get your flu vaccine. It’s going to be the same with COVID. In a year, you will have to go and get your annual shot for COVID to be protected.”

In the same NBC article, Pfizer claimed its vaccine was 95% effective at preventing COVID — something now disproven — and the company likely already knew this because it began testing a third vaccine dose despite having an almost “perfectly effective” vaccine and was preparing the public for neverending boosters.

Meanwhile, we were told we only needed two primary doses of Pfizer and Moderna, or one dose of the Johnson & Johnson shot to prevent COVID and “protect our neighbors.”

It has been almost two years since these original claims were made, and the U.S. Food and Drug Administration (FDA) announced today it is proposing annual COVID shots to “simplify” the nation’s strategy. In addition, the FDA asked its Vaccine and Related Biological Products Advisory Committee (VRBPAC) to consider the usage of two COVID vaccine shots a year for some young children, older adults, and immunocompromised persons. If you’re wondering if there have been any clinical trials conducted to determine if the bivalent booster is safe for children or immunocompromised people, the answer is also “no.” It’s logical to assume yearly COVID vaccines will also enjoy the same benefits of bypassing rigorous regulatory standards.

The FDA publicly outlined the strategy in briefing documents published before a VRBPAC meeting on Thursday, where the agency’s vaccine advisors will vote on the proposal. Missing from the FDA’s briefing documents is any mention of myocarditis or the study Pfizer was required to submit on Dec. 31, 2022, on subclinical myocarditis in men.

Instead, we get a pitch for yearly untested experimental boosters.

Per the FDA, vaccine makers would update the annual shot by magically predicting what might be the dominant strain in the coming winter each spring. This is the same process pharmaceutical companies use to formulate flu shots and primarily results in vaccines that are not, according to CDC data, effective. (For example, the CDC has acknowledged that in recent years, influenza vaccines have only been around 43% effective.)

This process also allows vaccine makers to forgo rigorous clinical trials for safety and efficacy—and provides them with continued liability protection for experimental shots gone wrong. It also allows a pharmaceutical company to deem their vaccine effective merely because it increases antibodies, which VRBPAC said during a previous meeting (and Dr. Peter Marks acknowledged) is not even remotely accurate at determining whether a vaccine is actually effective, and there is “no established correlate of protection” for COVID vaccines.

Currently, people who want to be fully vaccinated against COVID have to first get two shots of the original vaccine targeting the Wuhan variant that no longer exists, followed at least two months later by an untested booster tailored to the original variant and Omicron subvariants that are largely obsolete. The most recent data shows vaccines yield negative efficacy with each successive dose — making the vaccinated more susceptible to disease. This was also not mentioned in FDA briefing documents.

Under the new approach, people would be advised to get whatever the latest version of the vaccine is, like the flu vaccine.

Yet, if vaccine makers can “predict” the variant that will be dominant in the future and the success of a vaccine’s protection is contingent upon its ability to target that variant, wouldn’t they have known from the outset their vaccine would yield diminished efficacy as the virus mutates — and that it makes little sense to continue to vaccinate people with a vaccine targeting a COVID strain that no longer exists?

Wasn’t it misleading to condition people to believe they could be endlessly protected against all variants forever with just two doses of a shot against a virus scientists knew mutated? Wouldn’t it be unethical to use any of this as a basis for vaccine mandates?

According to Reuters, the Biden administration has also been planning for a fall vaccination booster campaign each year.

This is not the first time the Biden administration has intervened in what should be an independent process. As I previously reported, the Biden administration decided third booster doses would be offered in September 2021 to the general population prior to boosters undergoing review or receiving approval by the FDA, and against consensus among U.S. health experts there wasn’t enough data.

Still, the White House moved forward with its plan to make Americans eligible for a third dose of either Pfizer or Moderna’s vaccines eight months after the date of their second dose, even though that plan required authorization from the FDA and CDC first. Two senior vaccine regulators resigned amid the action, saying they were pressured by the administration to sign off on the decision without sufficient data.

Even if VRBPAC votes not to approve the FDA’s new proposal, FDA director Dr. Robert Califf can override it.

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