Covid mRNA Vaccines Required No Safety Oversight By Debbie Lerman | The Brownstone Institute

 

The BioNTech/Pfizer Covid mRNA vaccines were authorized for use in the entire population of the United States based on the application of the following sequence of agreements and determinations:

1. Department of Defense uses “contract-like” Other Transaction Authority (OTA) to buy aspirational products. DoD is not responsible for overseeing clinical trials or manufacturing. Pfizer is responsible for getting authorization from the FDA.

2. The FDA is permitted to issue Emergency Use Authorization (EUA) to Pfizer for mRNA vaccines because the HHS Secretary declares that there is an emergency that warrants EUA.

3. FDA makes its EUA determination based on whatever evidence and considerations it feels are appropriate, given the emergency situation. There are no legal standards that apply to the FDA’s considerations, except that it believes the product may be effective, the benefits outweigh the risks based on available information, and there is no alternative product.

4. The Health and Human Services Secretary grants total legal immunity through the PREP Act to anyone involved in developing, making, shipping, or administering the vaccines, based on his determination that there is an emergency that justifies this action. 

That’s what the “safe and effective” claim for the BioNTech/Pfizer Covid mRNA vaccines was based on in December 2020, when millions of people – including children and pregnant women – were mandated to take the injections.