Novavax to submit COVID-19 vaccine EUA request to US FDA next month

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Novavax Inc will submit a request to the US Food and Drug Administration to authorize its COVID-19 vaccine next month, further delaying the submission it had expected by the end of this year.

The company's announcement on Friday follows submission of final data related to the vaccine's manufacturing processes to the regulator, which is a prerequisite for the emergency use authorization application .

Data released in June from a late-stage US trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta.

 

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