FDA approves emergency use of Novavax COVID-19 vaccine booster

Oct. 19 (UPI) -- The FDA has authorized emergency use of a third dose of Novavax's Adjuvante vaccine as a COVID-19 booster shot for adults.

"The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster," Stanley C. Erck, president and CEO of Novavax, said in a statement. "According to CDC data, almost 50% 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."

Novavax said the vaccine was developed to protect against the original COVID-19 strain and will also induce an immune response against the Omicron BA.5 variant.

The FDA emergency use authorization was based on data from the Phase 3 Prevent-19 clinical trial as well as from the British-sponsored COV-BOOST trial.

A fact sheet for healthcare providers from the FDA cautioned that Novavax's primary series seems to carry some risk of heart inflammation, similar to that seen in primary COVID-19 vaccines from Pfizer and Moderna, primarily in young men and adolescent boys.

The FDA granted emergency use authorization to the Novavax vaccine as a two-dose primary vaccine in July. This new authorization is for the booster version and can be administered after a primary series of any COVID-19 vaccine.

Novavax said in its statement that the next step for the vaccine booster is "a policy recommendation for use as a first booster from the Centers For Disease Control and Prevention."

According to Novavax, doses of the vaccine are available for use in the United States pending this final step and can be located on vaccines.gov.