How The FDA’s Emergency Use Authorization Testing Protocols For Covid Vaccines Are Secret

Last Updated on June 26, 2022 by Shaun Snapp

Executive Summary

  • The degree to which the FDA is controlled by the pharmaceutical companies is shown in how they keep their testing of drugs a secret.

Introduction

The FDA keeps its testing protocol for drug manufacturing secret from the public, even though the FDA states that they are part of the US government. This shocking reality is explained in this article.

The Problem With The FDA’s Emergency Use Authorization

The vaccines were not approved by the FDA, they were given emergency use authorization. The problem with this status is explained in the following quotation.

The bar for an FDA emergency use authorization is lower than the bar for FDA approval or licensure. But, as a practical matter, in the case of the first COVID-19 vaccine to receive the FDA’s blessing, the emergency action is almost tantamount to approval. It provides all the authority needed to immunize everyone age 16 and up, potentially for the duration of the current public health emergency.

Diana Zuckerman, president of the nonprofit National Center for Health Research, zeroed in on FDA statements that manufacturing quality and consistency data was adequate to support an emergency use authorization.

“My gut reaction is that it’s damning with faint praise to say something is adequate for an EUA, for 2 reasons,” Zuckerman said by email.

“Saying something is adequate is a low bar—shouldn’t the standard be that evidence is persuasive? Or at least ‘good’?” Zuckerman wrote. “The FDA’s standards for an EUA are acknowledged to be quite a bit lower than the standards for approval, so being adequate for an EUA is an especially low bar,” she added.

Authorization isn’t the last word. The system includes subsequent lines of defense for the public.

As with other vaccines, the FDA-approved instructions to people administering the shots call for them be on the lookout for signs of trouble.

 

“Inspect the vaccine in the vial,” the instructions say. “The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter.”

The instructions count on people administering the vaccine to strike a careful balance. “Gently invert the vial . . . 10 times to mix,” they say. The instructions also say, “Do not shake.” That direction is underlined.

POGO asked the FDA to explain the reason for that instruction and what could happen if the vaccine is shaken before it’s injected. The FDA declined to answer and said to ask Pfizer.

Pfizer’s Danehy said the company included the instruction “to maintain the integrity of the vaccine.” The company wouldn’t say what could result if the vaccine is shaken. – POGO

There are so many problems with what is contained in this quotation. One is the EUA, but the second is that neither the FDA nor Pfizer will explain what happens if the instructions are not followed that are included with the vaccines. This smacks of not providing any information that can be used against the vaccines.

The FDA’s Testing on Emergency Use Authorization Drugs Is Secret

The following quotation is absolutely shocking.

That’s for products that have received FDA licensure—the term for FDA approval when it comes to biological products such as vaccines.

But emergency use authorizations for COVID-19 vaccines “do not require lot release,” an FDA spokesperson said in an email to POGO.

In other words, the FDA could depend on test results submitted by the manufacturer.

For clarity, we requested a “yes” or “no” answer to the follow-up question, “Is it accurate to say that the FDA itself has not tested samples of the vaccines granted emergency use authorizations for COVID-19?”

On this point, too, the FDA was less than transparent.

“In general, FDA testing strategies, including testing frequency of samples are non-public information,” the FDA spokesperson wrote. – POGO

Interesting. Why is it not public? Who does the FDA work for? Because that answer makes it appear as if the FDA works for the pharmaceutical companies. 

Conclusion

By lying about the effectiveness and safety of the vaccines, and through shutting down critiques of the vaccines, censoring information about the vaccines the medical establishment violated their own rule regarding informed consent.

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