“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”

The FDA EUA decision was based on data from the Phase 3 Prevent-19 clinical trial and from the U.K.-sponsored COV-BOOST trial. In the Phase 3 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants aged 18 and older approximately eight or 11 months after their primary series. Following a booster dose, antibody levels increased significantly relative to pre-boost levels, rising above levels associated with protection in the Phase 3 trials. Neutralizing antibodies also increased by 34- to 27-fold compared to pre-boost levels when boosted at eight or 11 months. In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted increased antibody titers when used as a third dose following initial dosing with another authorized COVID-19 vaccine (heterologous boosting).