Citizen Petition - Experts  Demanding FDA ‘Slow Down and Get the Science Right’ Before Approving COVID Vaccines


July 23, 2021 


This petition for administrative action is submitted on behalf of CAALM, the Coalition Advocating for Adequately Licensed Medicines ("Petitioner") pursuant to 21 C.F.R. § 10.30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act to request that the Commissioner of Food and Drugs (the "Commissioner") require that the vaccine manufacturers provide the FDA with the data outlined in the "Actions Requested" section below before approval of any COVID-19 vaccine.

The Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) to three COVID-19 vaccines, enabling rapid, and widespread vaccine rollout across the United States. These EUAs do not have any built-in expiration date, and therefore vaccines can continue to be lawfully distributed under EUA even after a future date when a public health emergency no longer exists. 

Approximately seven months have passed since the first EUAs were granted, and two vaccine manufacturers now seek licensure (approval) and have submitted Biologics License Applications (BLAs). Other manufacturers have indicated similar intentions, as well as intentions for EUAs for additional pediatric populations. 

We believe 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 popReaulation. We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure. 

In this petition, we outline efficacy and safety measures that must be met before serious consideration is given to granting a BLA of any COVID-19 vaccine. ...