US FDA may not review new Covid-19 vaccine EUA requests during pandemic

Reuters May 26 | Updated on May 26, 2021

So far, vaccines from Pfizer, Moderna and Johnson & Johnson authorised for emergency use in US

The US Food and Drug Administration said on Tuesday that it may decline to review and process new emergency use authorisation (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, Moderna Inc and Johnson & Johnson have been authorised for emergency use in the US.

Ocugen submits ‘Master File’ to FDA on Covid vaccine Covaxin

Novavax Inc has had discussions with regulators and said it does not expect to seek regulatory authorisation for its Covid-19 shot in the US, Britain and Europe until the third quarter of 2021.

Medicago in discussions

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.

US FDA gears up for rapid review of potential Covid-19 booster shots

AstraZeneca also has discussed plans for its Covid-19 vaccine with US officials. However, the Wall Street Journal earlier this month reported that it was considering skipping US emergency-use authorisation and instead pursue the more time-intensive application for a full-fledged licence to sell the shot.

AstraZeneca and Novavax did not immediately respond to requests for comment

Published on May 26, 2021

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