90 Miles From Tyranny : FDA Approves Pfizer Vaccine Even Though Multiple Safety Studies Won’t Be Completed For Years

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Tuesday, August 24, 2021

FDA Approves Pfizer Vaccine Even Though Multiple Safety Studies Won’t Be Completed For Years

The Food and Drug Administration announced Monday that it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine to be given to Americans as young as 16, even though several safety and efficacy studies will not be completed for years. The approval appears to only cover the first two doses of the vaccine, with subsequent boosters covered by the emergency use authorization.
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
The Pfizer vaccine—now called Comirnaty—is the first COVID-19 vaccine to receive FDA approval. Health officials are hoping the rushed authorization of the vaccine will encourage more unvaccinated people to get the jab.

“I am hopeful this approval will help increase confidence in our vaccine,” Pfizer CEO Albert Bourla said in a statement. “Vaccination remains the best tool we have to help protect lives.”

In a statement from the White House, Joe Biden stayed on message, telling vaccine skeptics “it’s time for you to get your vaccination, and get it today.”

The FDA said in a statement that “based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.”
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
There was no mention in the FDA’s statement of how many boosters might be required after the vaccine’s effectiveness wears off.

The FDA approval came with the condition that Pfizer submit study results in the years to come analyzing the safety and effectiveness of the vaccine in infants, children, teenagers, and young adults, as well as pregnant women.

In its approval letter to BioNTech, the FDA mandated Pfizer to submit several study results evaluating the occurrence of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart’s surrounding membrane) following administration of the vaccine.

The final results of a study “entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY is due October 31, 2025.

The final results of another study evaluating the occurrence of myocarditis and pericarditis following administration of the vaccine is due on September 30, 2024.

A natural history study of myocarditis and pericarditis following administration of COMIRNATY is also due on September 30, 2024.

A “prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination...

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Bear Claw Chris Lapp said...

As if they think we believe all three letter agencies aren't corrupt.

Handy Handsome said...

From what I've read, they only approved their application for the vax.

Bear Claw Chris Lapp said...


JG said...

This shows the FDA is corrupt. This approval is political as past vaccine approvals took years of testing.

MolonLabe2012 said...

Now it's an official, Government approved, mass medical experiment! Doesn't that make everyone feel better about it? I'm finding that no one I've met or known who's gotten the shots had known about or was told that the Government and pharmaceutical companies are all granted full immunity from criminal or civil liability for vaccine injury or death.