FDA Authorizes Booster Dose of Novavax COVID-19 Vaccine, Adjuvanted

The 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 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
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 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 (S) 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 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 (0.5mL 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 evaluated 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.

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