FDA May Not Review New COVID-19 Vaccine Emergency Use Requests

The FDA, on Tuesday, said that it might decline to review and process new emergency use authorization (EUA) requests for COVID-19 vaccines for the rest of the pandemic if a company has not already begun discussions.
So far, vaccines from Pfizer Inc (NYSE:PFE)- BioNTech SE (NASDAQ:BNTX), Moderna Inc (NASDAQ:MRNA), and Johnson & Johnson (NYSE: JNJ) are authorized for emergency use in the U.S.
The move will push later COVID-19 vaccine entrants to go the long route and submit a full marketing application with more manufacturing and safety data rather than use the shortened EUA process.
Novavax Inc (NASDAQ:NVAX) has had discussions with regulators and said it does not expect to seek regulatory authorization for its COVID-19 shot in the U.S., Britain, and Europe until the third quarter of 2021.
Canadian drug developer Medicago said it was in discussions with the FDA for a EUA for its plant-based COVID-19 vaccine candidate, which is enhanced by a GlaxoSmithKline plc (NYSE:GSK) adjuvant.
AstraZeneca Plc (NASDAQ:AZN) also has discussed plans for its COVID-19 shots. However, the Wall Street Journal reported earlier that it was considering skipping U.S. emergency-use authorization and instead pursue the more time-intensive application for a full-fledged license to sell the shot.
The revised guidance was issued on the same day that Ocugen Inc (NASDAQ:OCGN) had submitted its master file to FDA in anticipation of requesting a EUA for the whole-virion inactivated COVID-19 vaccine Covaxin.