U.S. FDA may decline new COVID-19 vaccine EUA requests during pandemic

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.

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.