Novavax to submit COVID-19 vaccine EUA request to U.S. FDA next month
Source: Reuters
Novavax to submit COVID-19 vaccine EUA request to U.S. FDA next month
Fri, December 31, 2021, 1:24 PM·2 min read
Novavax Inc will submit a request to the U.S. 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 (EUA).
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.
Data released in June from a late-stage U.S. trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta.
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Read more: https://news.yahoo.com/novavax-submits-data-u-fda-172426032.html