The U.S. Food and Drug Administration said on May 25 it may decline to review and process new emergency use authorization requests for COVID-19 vaccines for the rest of the pandemic if a company has not already begun discussions.
So far, vaccines from Pfizer, Moderna, and Johnson & Johnson have been authorized for emergency use in the United States.
Novavax has had discussions with regulators and said it does not expect to seek regulatory authorization for its COVID-19 shot in the United States, Britain and Europe until the third quarter of 2021.
AstraZeneca also has discussed plans for its COVID-19 vaccine with U.S. officials. However, the Wall Street Journal earlier this month reported that it was considering skipping U.S. emergency-use authorization and will instead pursue the more time-intensive application for a full-fledged license to sell the shot.
AstraZeneca and Novavax did not immediately respond to requests for comment.