U.S. FDA may not review new Covid-19 vaccine EUA requests during pandemic

• The U.S. Food and Drug Administration said on Tuesday 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.

A medical worker holds a vial of AstraZeneca COVID-19 vaccine at a vaccination center, amid the coronavirus disease outbreak, in Ronquieres, Belgium April 6, 2021.

Yves Herman | 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, 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.

Canadian drug developer Medicago said it was in discussions with the FDA for an EUA for its plant-based Covid-19 vaccine candidate, which is enhanced by a GlaxoSmithKline treatment.

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.