© Reuters. FILE PHOTO: A woman holds a small bottle labelled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in this illustration taken October 30, 2020. REUTERS/Dado Ruvic/File Photo
(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.
So far, vaccines from Pfizer Inc (NYSE:), Moderna (NASDAQ:) Inc and Johnson & Johnson (NYSE:) have been authorized for emergency use in the United States. (https://
Novavax (NASDAQ:) 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 (NASDAQ:) 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.
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