USFDA grants emergency use nod for Novavax COVID vaccine,Adjuvanted as booster for adults
Gaithersburg: Novavax, Inc. has announced that the company's COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (USFDA) to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
"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).
In the trial, following the booster, local and systemic reactions had a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of the Novavax COVID-19 Vaccine, Adjuvanted, often seen with increased immunogenicity.
The next step for the vaccine is a policy recommendation for use as a first booster from the Centers for Disease Control and Prevention (CDC).
Novavax' vaccine is also available for use as a booster in adults aged 18 and older in the European Union, Japan, Australia, New Zealand, Switzerland, and Israel. In addition, a number of countries have policy recommendations allowing use of the vaccine as a heterologous or homologous booster dose. In the U.S., 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 these EUA's, the CDC recommended the vaccine for use as a primary series for both age groups.
Read also: Novavax seeks updated Emergency Use Listing from WHO for Nuvaxovid as booster in adults
