Europe Approves First Protein-based COVID-19 Vaccine for Adolescents
Maryland-based Novavax, Inc. announced today that the European Commission (E.C.) had approved the expanded conditional marketing authorization (CMA) of the Nuvaxovid™ COVID-19 vaccine in the European Union (E.U.) for adolescents aged 12 through 17.
The E.C. authorization was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 clinical trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the USA.
In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% overall clinical efficacy when the Delta variant was the predominant circulating SARS-CoV-2 strain.
The U.S. Food and Drug Administration has not authorized Novavax's vaccine for use in the USA.
Stanley C. Erck, President, and CEO, of Novavax, stated in a press release issued on July 5, 2022, "Our protein-based vaccine was developed using an innovative approach to traditional technology and has demonstrated efficacy and safety in both adolescents and adults."
Preliminary safety data from the clinical study showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number, balanced between vaccine and placebo groups, and not considered related to the vaccine.
And no new safety signal was observed through the placebo-controlled portion of the study.
The E.C. granted authorization for adults in December 2021.
In addition, India recently granted authorization to the 12 through the 17-year-old population.
Note: The company's press release was manually curated for mobile readers.