Novavax COVID-19 vaccine conditionally authorized in the EU for adolescents aged 12 through 17
Novavax Inc. announced July 5 that the European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) for adolescents aged 12 through 17. The approval follows the positive recommendation made by the European Medicines Agency’s Committee for Medicinal Products for Human Use on June 23, 2022.
“With this authorization, we are extremely pleased to be able to offer our Nuvaxovid COVID-19 vaccine to adolescents in the EU,” said Stanley C. Erck, president and CEO, Novavax. “Our protein-based vaccine was developed using an innovative approach to traditional technology and has demonstrated efficacy and safety in both adolescents and adults.”
The authorization was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase III trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the United States to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80 percent clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the United States.
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. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. 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.
The EC granted CMA for Nuvaxovid to prevent COVID-19 in individuals aged 18 and over in December 2021. In addition to the EC’s expanded CMA, India has granted emergency use authorization in the 12 through 17 year-old population.
NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.
Source: PR Newswire