NVAX Stock – U.S. FDA may not review new COVID-19 vaccine EUA requests during pandemic
(Reuters) – The U.S. Food and Drug Administration said on Tuesday it may 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.
Novavax Inc 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 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.
(Reporting by Amruta Khandekar; Editing by Shounak Dasgupta)