Novavax Submits Request to Expand Conditional Marketing Authorization of COVID-19 Vaccine in the European Union to Adolescents (Ages 12-17)

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced submission of its request to expand the conditional marketing authorization (CMA) of Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) in the European Union (EU) to adolescents aged 12 through 17 years.

“We are continuing to see spikes in COVID-19 across Europe and recognize the need to improve vaccination rates, particularly in the pediatric population,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We look forward to a decision from the European Medicines Agency and firmly believe in the benefit of diversified vaccine options.”

The submission includes clinical data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 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 Novavax’ COVID-19 vaccine. The vaccine, also known as NVX-CoV2373, achieved its primary effectiveness endpoint in the trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S.

Additionally, preliminary safety data from the pediatric expansion of PREVENT-19 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.

The submission builds on Novavax’ efforts to expand authorizations of its COVID-19 vaccine to younger populations. The Drugs Controller General of India recently approved  NVX-CoV2373 for restricted use in emergency situation for adolescents aged 12 through 17 years in India. SK bioscience, Novavax’ licensee in South Korea, also recently submitted a regulatory filing for adolescent authorization of the vaccine to the Korean Ministry of Food and Drug Safety. Novavax expects to initiate rolling submissions of regulatory filings in this age group to additional regulatory authorities worldwide and to initiate additional studies globally evaluating younger age groups during the second quarter of 2022.

The European Commission granted CMA for Nuvaxovid to prevent COVID-19 in people 18 years of age and older in December 2021. Doses of Nuvaxovid began shipping to EU member states shortly thereafter.