Novavax Says COVID Vaccine will Receive FDA Approval in Weeks

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  • Novavax is confident that its COVID-19 vaccine will be approved by the Food and Drug Administration's advisory committee in June, CEO Stanley Erck said this week
  • The FDA committee is scheduled to meet on June 7 to review Novavax's application, and the Chief Commercial Officer Johns Trizzino said in an interview with Bank of America that all signs point toward a positive response from the FDA
  • The FDA has been reviewing Novavax's submission for a few months. In January, the vaccine manufacturer asked the drug regulator to authorize the vaccine in January but federal health authorities said the application was complex
  • “This is an incredibly complex review process that involves review of not just clinical data but also manufacturing data that will be needed to make a determination about emergency use authorization,” Dr. Doran Fink, deputy director of clinical review at the FDA’s vaccine division, told the Centers for Disease Control and Prevention’s committee of independent vaccine advisors last month
  • If the FDA approves the vaccine in the coming weeks, it will be the first new shot approved for rollout in more than a year. Pfizer, Moderna, and Johnson & Johnson vaccines are currently the only ones approved for use in the U.S.