FDA authorizes Novavax Covid vaccine for adults; CDC approval awaited


The U.S. Food and Drug Administration (FDA) issued an emergency use authorisation (EUA) Wednesday for the Novavax Covid-19 vaccine in individuals 18 years of age and older.

The Novavax vaccine, the fourth shot to get emergency approval since the pandemic began, will be available as two-dose primary series for adults, three weeks apart.

The FDA decision follows the unanimous vote by its committee of independent vaccine experts in June. The committee had given its seal of approval after an all-day public meeting in which they weighed data on the vaccine’s safety and its effectiveness at preventing illness from Covid.

Pharmacies and healthcare providers, however, can start administering shots only after a Centers for Disease Control and Prevention (CDC) sign off. CNBC reported that the FDA authorization of Novavax’s vaccine was delayed for weeks as the agency reviewed changes to the company’s manufacturing process.

An FDA statement said that the known and potential benefits of the vaccine outweigh its known and potential risks in people 18 years of age and older, and the vaccine may be effective in preventing Covid-19.

The Novavax vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual, according to the FDA.

To be sure, Novavax was one of the first candidates to join the vaccine race and had received $1.8 billion funding as part of the U.S. government’s Operation Warp Speed. However, according to CNBC, the small Maryland biotech company “struggled to quickly get manufacturing in place and its clinical trial data read out much later than Pfizer or Moderna.”