Citizen Petition to the FDA…

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In early June, UncoverDC reported on a group of twenty-seven scientists, clinicians, and patient advocates, who submitted a formal “Citizen Petition” with the United States Food and Drug Administration (FDA), requesting the agency to halt any consideration of a “full approval” of COVID-19 vaccines. On July 5th, the group submitted an amended petition on behalf of CAALM, the Coalition Advocating for Adequately Licensed Medicines. The move will allow CAALM, which is the updated name of the original 27 signatories, to pursue other potential avenues in addition to the FDA Petition. 

The Message Remains the Same

The group’s message to the FDA of slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine” remains the same. The petition points out that the Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) to three COVID-19 vaccines (PfizerModerna, and Johnson & Johnson), enabling accelerated and widespread vaccine rollout across the country. With no pre-set expiration date, the EUA’s can continue to be lawfully distributed even after a future date when there is no longer a public health emergency

CAALM reasserts its belief that the FDA should not “prematurely grant a license to any COVID-19 vaccine until all necessary efficacy and safety studies are completed, and substantial evidence demonstrates the benefits of an individual COVID-19 vaccine product outweigh the harms for the indicated, recipient population.” Of concern is that, despite the fact COVID-19 “vaccine” products have only been administered for approximately seven months, at least two vaccine manufacturers now seek licensure (approval) and have submitted Biologics License Applications (BLAs). Other manufacturers have indicated they will follow suit, as well as seek EUAs “for additional pediatric populations.”

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