US FDA grants EUA for Novavax COVID-19 vaccine, adjuvanted for adolescents aged 12 through 17 years

The US Food and Drug Administration (FDA) has provided Emergency Use Authorisation (EUA) to the Novavax COVID-19 vaccine, adjuvanted (NVX-CoV2373) for providing a two-dose primary series for active immunisation to prevent COVID-19 caused by Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 years, a statement from Novavax has notified.

The FDA EUA decision was based on data from the ongoing paediatric expansion of the phase-III Prevent-19 trial of 2,247 adolescents aged 12 through 17 years across 75 sites in the US, to evaluate the safety and effectiveness of the Novavax COVID-19 vaccine, adjuvanted. In paediatric expansion, the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29 per cent (95% CI: 37.55%, 92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the US. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults, the statement said.

Safety data from the paediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe Adverse Reactions (ARs) were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. No new safety signal was observed through the placebo-controlled portion of the study. Among participants 12 through 17 years of age, solicited ARs following administration of any dose of the Novavax COVID-19 vaccine, adjuvanted were injection site pain/tenderness (75 per cent), headache (56.9 per cent), fatigue/malaise (57.9 per cent), muscle pain (49 per cent), nausea/vomiting (19.9 per cent), joint pain (16.2 per cent), fever (16.9 per cent), injection site swelling (8 per cent) and injection site redness (7.5 per cent). Most were mild-to-moderate in severity and lasted less than two days, added the statement.