U.S. FDA Cannot Review EUA’s New COVID-19 Vaccine Requests During Pandemic –

U.S. FDA Cannot Review EUA’s New COVID-19 Vaccine Requests During Pandemic – fr

A woman is holding a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in this illustration taken on October 30, 2020. REUTERS / Dado Ruvic / File Photo

The U.S. Food and Drug Administration said on Tuesday it may refuse to review and process new emergency use authorization (EUA) applications for COVID-19 vaccines for the remainder of the pandemic, if a company has not already started discussions.

So far, vaccines from Pfizer Inc (PFE.N), Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N) have been authorized for emergency use in the United States. (https://bit.ly/3fOpP2S)

Novavax Inc (NVAX.O) has had discussions with regulators and said it does not plan to seek regulatory clearance for its COVID-19 in the United States, Britain and Europe until Q3 of 2021. read more

Canadian drug developer Medicago has said it is in discussions with the FDA for an EUA for its herbal COVID-19 vaccine candidate, which is enhanced by GlaxoSmithKline (GSK.L) treatment.

AstraZeneca (AZN.L) also discussed plans for its COVID-19 vaccine with U.S. officials. However, the Wall Street Journal reported earlier this month that it plans to skip the US emergency use authorization and instead pursue the longer application for a full license for sell the shot. Read more

AstraZeneca and Novavax did not immediately respond to requests for comment.

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