COVID vaccine: Novavax requests WHO to expand Emergency Use Listing of Nuvaxovid for adolescents aged 12 through 17

This request is based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

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Preliminary safety data from the trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events 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. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the study.

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In the 12 through 17 year-old population, Nuvaxovid has been granted authorization in India, the European Union, Australia, and Japan, and is actively under review in other markets.

The WHO previously granted EUL for Nuvaxovid in adults aged 18 and older in December 2021.

The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.