The FDA Emergency Use Authorisation decision was based on the findings of the phase 3 Prevent-19 clinical trial and the UK-sponsored COV-BOOST trial
A participant in the Prevent-19 trial receiving Novavax COVID-19 Vaccine, Adjuvanted. (Credit:Novavax)
Biotechnology company Novavax has secured the emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a booster for individuals 18 years of age and older.
The vaccine is intended to be given as a first booster dose at least six months post-completion of primary vaccination to adults for whom an FDA-authorised mRNA bivalent COVID-19 booster vaccine is either not accessible or clinically suitable.
Novavax said that the vaccine is also intended for adults who opt to receive the Novavax COVID-19 Vaccine, Adjuvanted as they will otherwise not get a booster dose of a COVID-19 vaccine.
Novavax president and CEO Stanley Erck said: “The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster.
“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’s EUA decision was supported by data from the phase 3 Prevent-19 trial and the COV-BOOST trial, which enrolled participants aged 18 and older. The participants received one booster dose of the Novavax COVID-19 Vaccine, Adjuvanted, about eight or 11 months following their primary vaccine series.
Novavax found that antibody levels increased considerably relative to pre-boost levels after a booster dosage. When boosted at eight or 11 months, neutralising antibodies also increased 34 to 27-fold above pre-boost levels.
Additionally, the biotechnology company announced that the US Centers for Disease Control and Prevention (CDC) recommended the use of Novavax COVID-19 Vaccine, Adjuvanted as a booster for adults.
The recommendation will allow individuals ages 18 years and older the option to receive the Novavax COVID-19 Vaccine, Adjuvanted as a booster if they have completed primary series vaccination.