FDA Denies 2 Covid-19 Vaccine Petitions

FDA has denied in full citizen petitions filed on 3/24/21 and 8/12/22 by the Informed Consent Action Network relating to certain provisions of the emergency use authorizations (EUAs) for Covid-19 vaccines. The agency response lists the lengthy and detailed requests made in the petitions.

The 2021 petition asked FDA to take specific listed actions to assure enforcement of conditions in the EUAs for Covid vaccines. The 2022 petition asked for the removal of certain conditions of authorization of the EUAs for Covid vaccines.

FDA says it denied the 2021 petition because enforcement actions are within agency discretion and are not a proper subject for a citizen petition. To the extent that the first petition sought anything other than enforcement action, it says, it and the second petition were denied because “they do not contain facts demonstrating any reasonable grounds for the requested actions.”