FDA Advisors Vote 21-0, with One Abstention, to Authorize Novavax’s Covid-19 Vaccine to be the Fourth US Option
A panel of FDA’s outside experts recommended 21 to 0, with one member abstaining, that the agency give emergency use authorization for Novavax’s two-dose Covid-19 vaccine for people aged 18 years and older.
The advisors’ vote of confidence was delivered days after the FDA’s scientists determined the vaccine to be effective but with the caveat of potential rare heart inflammation. Last autumn, pre-Omicron, the vaccine was found to have a 90.4% efficacy in a trial comprising 17,272 people given a vaccine and 8,385 people given a placebo.
“The Advisory Committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology,” CEO Stanley Erck said in a statement. “We have heard in today’s VRBPAC meeting the significant support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. We look forward to the FDA decision.”
Read the full article at: endpts.com
- About the Author
- Latest Posts
BioBuzz is a community led, experience focused, biotech and life sciences media and events company. BioBuzz highlights regional breaking news, industry professionals, jobs, events, and resources for business and career growth. Their weekly newsletter is subscribed to by thousands in the BioHealth Capital Region and Greater Philadelphia as the go-to for industry updates.
