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

ByPrimary Researcher

Executive Summary

  • The degree to which the pharmaceutical companies control the FDA 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 FDA did not approve the vaccines, 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 included with the vaccines are not followed. This smacks of not providing any information that can be used against the vaccines.

Addressing the Damage

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  • We also cover the broader problems with dosage calculation in medicine at the article The Problem With Dosage Calculation in Medicine, as this is an issue much larger than for one drug. 

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