FDA Dismisses Petition to Yank EUAs for Moderna, J&J COVID-19 Shots

The FDA has rejected a citizen petition seeking to revoke the Emergency Use Authorizations (EUAs) of both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines.

Aaron Siri, of New York-based law firm Siri & Glimstad, submitted the petition to the agency in late September arguing that, since Pfizer’s COVID-19 shot had secured full regulatory approval, there was no longer a need for alternative vaccines authorized on an emergency use basis.

Siri pointed to the ample supply of the Pfizer vaccine as another reason why the EUAs for Moderna and J&J shots were no longer needed, noting that there are more than “53 million [doses] sitting in U.S. government storage waiting to be distributed and another 200 million doses that Pfizer will be delivering to the U.S. government over the coming months.”

But the FDA rejected that line of thinking in its response to the petition, citing both the ongoing nature of the pandemic and the agency’s discretion bestowed by Congress to maintain EUAs as it sees fit.