Novavax COVID-19 Vaccine Booster Gets FDA EUA

Novavax’s COVID-19 vaccine (NVX-CoV2373) has received emergency use authorization (EUA) from the FDA for a first booster dose at least six months after completion of primary vaccination. The EUA applies to people 18 years of age and older for whom an mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to people 18 years of age and older who elect to receive the Novavax COVID-19 vaccine, Novavax said in a statement.

Stanley C. Erck

“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 chief executive officer of Novavax, said in a press release. “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.”

The vaccine comes at a time when Americans’ pace of receiving COVID-19 booster doses is waning. Only around 5% of eligible Americans have received the updated booster bivalent vaccine, according to the Biden Administration.

The FDA’s EUA decision for the Novavax booster was based on data from the phase 3 Prevent-19 clinical trial and from the UK-sponsored COV-BOOST trial. In the phase 3 trial, antibody levels increased significantly relative to pre-boost levels, rising above levels associated with protection. Neutralizing antibodies also increased by 34- to 27-fold compared with pre-boost levels when boosted at eight or 11 months, Novavax said.

In the COV-BOOST trial, the Novavax COVID-19 vaccine increased antibody titers when used as a third dose following initial dosing with another authorized COVID-19 vaccine. In the trial, the incidence of grade 3 or higher adverse events remained relatively low. Among participants 18 years of age and older, adverse reactions following the booster dose of the vaccine were injection site pain/tenderness (81.1%), fatigue/malaise (63.4%), muscle pain (63.0%), headache (52.9%), joint pain (30.3%), nausea/vomiting (14.7%), injection site swelling (8.4%), injection site redness (6.3%), and fever (6.3%).

The next step for the vaccine is a policy recommendation for use as a first booster from the CDC.

The FDA granted EUA for a two-dose primary series in adults aged 18 and older in July and for adolescents aged 12 through 17 in August. Following those EUAs, the CDC recommended the vaccine for use as a primary series for both age groups.