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COVID vaccine: Novavax requests WHO to expand Emergency Use Listing of Nuvaxovid for adolescents aged 12 through 17
The WHO previously granted EUL for Nuvaxovid in adults aged 18 and older in December 2021.
New Delhi: Novavax has announced the submission of a request to the World Health Organization (WHO) to expand the Emergency Use Listing (EUL) of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 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.
Read also: Novavax COVID vaccine Nuvaxovid gets European Commission conditional nod for adolescents
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.
Read also: Novavax COVID vaccine gets USFDA emergency use nod for 18 years and older
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.
Read also: Novavax, SK bioscience expand agreement to manufacture COVID vaccine containing Omicron variant
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751