The US Food and Drug Administration (FDA) has authorized for emergency use the Novavax COVID-19 Vaccine, Adjuvanted as a first booster dose at least 6 months following the completion of primary vaccination with an authorized or approved COVID-19 vaccine.
The authorization applies 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 for 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 US Centers for Disease Control and Prevention (CDC) will need to sign off on the new booster before it can be used.
The Novavax COVID-19 Vaccine, Adjuvanted is engineered from the genetic sequence of SARS-CoV-2 using the company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. The vaccine contains the company’s saponin-based Matrix-M™ adjuvant technology to enhance and prolong immune responses.
In July 2022, the FDA granted emergency use authorization (EUA) to the Novavax COVID-19 Vaccine, Adjuvanted as a primary 2-dose series for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine is administered intramuscularly as a 2-dose primary series (0.5 mL each), separated by 3 weeks.
The booster authorization was based on data from the randomized, placebo-controlled phase 3 PREVENT-19 trial (ClinicalTrials.gov Identifier: NCT04611802), which was designed to evaluate the efficacy, safety, and immunogenicity of the Novavax COVID-19 Vaccine, Adjuvanted in participants 18 years of age and older in the US and Mexico. Participants received a booster dose at least 6 months after the primary 2-dose series.
Findings showed that the booster dose elicited robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series of the vaccine. When administered at 8 or 11 months after the primary series, the booster increased neutralizing antibodies by 34- to 27-fold compared with pre-boost levels.
The EUA submission also included data from the randomized, controlled, phase 2 COV-BOOST trial. Findings from this study showed that the Novavax COVID-19 Vaccine, Adjuvanted booster produced a significant antibody response after use of another COVID-19 vaccine for the primary series.
The Novavax COVID-19 Vaccine, Adjuvanted was associated with local and systemic reactions with a median duration of approximately 2 days. The incidence of grade 3 or higher events remained relatively low.
“The US 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 of Novavax. “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 Novavax COVID-19 Vaccine, Adjuvanted is supplied as a suspension in a carton containing 10 multidose vials; each vial contains 10 doses of 0.5 mL each.
US FDA grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a booster for adults. News release. Novavax, Inc. Accessed October 19, 2022. https://www.prnewswire.com/news-releases/us-fda-grants-emergency-use-authorization-for-novavax-covid-19-vaccine-adjuvanted-as-a-booster-for-adults-301653765.html
This article originally appeared on MPR