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 PFE- BioNTech SE BNTX, Moderna Inc MRNA, and Johnson & Johnson 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 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 GSK adjuvant.
AstraZeneca Plc 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 OCGN had submitted its master file to FDA in anticipation of requesting a EUA for the whole-virion inactivated COVID-19 vaccine Covaxin.