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US FDA may not review new Covid-19 vaccine emergency use authorisation requests during pandemic
People line up as health care workers and military personnel work to distribute doses of the coronavirus disease vaccine at the New York State Covid-19 vaccination site at the Jacob K. Javits Convention Centre January 13, 2021. u00e2u20acu201d Reuters pic

WASHINGTON, May 26 ― The US Food and Drug Administration said yesterday 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 United States.

Novavax Inc has had discussions with regulators and said it does not expect to seek regulatory authorisation 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 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. ― Reuters

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