FDA to Review Emergency Use Application for Non-mRNA Vaccine From Novavax
The U.S. Food and Drug Administration’s Vaccine and Related Biological Products Advisory Committee will hold an advisory meeting on June 7 to consider an emergency use authorization for the Novavax COVID-19 vaccine for use in adults 18 and older.
One of the key differences in the Novavax vaccine compared with the Pfizer or Moderna COVID-19 vaccines, which are already approved for use in the U.S., is that it does not use mRNA, but is protein-based.
Similar to flu vaccines, the Novavax shot uses recombinant proteins grown in cell cultures.
Global health experts believe EUA approval from the FDA for the Novavax COVID-19 vaccine could potentially help change the minds of people who are still vaccine hesitant in the U.S. based on concerns over the mRNA technology used in other vaccines.
Previous research from the Maryland-based biotech company shows the original COVID-19 vaccine demonstrated broad cross-reactivity against omicron and other circulating variants from a primary two-dose regimen, with responses that increased following a third dose at six months.
Results from a February phase 3 clinical trial in the U.K. also show it is 83% effective against all COVID-19 infections, and 100% effective at combating severe disease.
The Novavax vaccine received approval from the World Health Organization and European Commission for the primary vaccination series in adults 18 and older in 2021, and has also been cleared for use in Japan and India.
Novavax announced on May 31 that it will initiate a phase 3 strain change trial to determine if its omicron-specific vaccine can protect against the omicron variant compared with the company’s Wuhan prototype vaccine.
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