Dec 31 – Novavax Inc (NVAX.O) will submit a request to the U.S. Food and Drug Administration to authorize its COVID-19 vaccine next month, the company said on Friday.
The announcement follows submission of final data related to the vaccine’s manufacturing processes to the regulator, which was a prerequisite for the emergency use authorization application.
This indicates further delay for the vaccine developer, which said earlier this month it will make the submission for EUA by the end of the year.
Novavax has had to delay its U.S. submission multiple times due to development and manufacturing setbacks. A report earlier this year said the methods Novavax used to test the efficacy of its vaccine had fallen short of regulators’ standards. read more
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Reporting by Leroy Leo in Bengaluru; Editing by Aditya Soni and Shinjini Ganguli
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