Novavax Inc. (NASDAQ: NVAX) has received approval from the European Commission (EC) for the Nuvaxovid COVID-19 vaccine’s expanded conditional marketing authorization (CMA) in the EU for teenagers between 12 and 17 years. This approval comes on the back of positive recommendations on June 23, 2022, by the European Medicine Agency’s Committee for Medicinal Products for Human Use.
Ongoing PREVENT-19 expansion study findings supported the approval
CEO and President of Novavax Stanley C. Erck said, “With this authorization, we are extremely pleased to be able to offer our Nuvaxovid COVID-19 vaccine to adolescents in the EU. 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 approval was supported by findings from PREVENT-19’s continuing pediatric extension, a crucial Phase 3 study that included 2,247 teenagers between the ages of 12 and 17 at 73 sites around the United States to assess the efficacy (immunogenicity) and safety of Nuvaxovid. When the Delta variation of SARS-CoV-2 was the most prevalent strain spreading in the United States at the time of the trial, Nuvaxovid showed 80 percent clinical effectiveness overall and met its primary efficacy endpoint.
Nuvaxovid is well tolerated in subjects.
The trial’s initial safety results revealed that the vaccination was usually well-tolerated. Severe and serious side effects were infrequent and evenly distributed between both the vaccine and placebo groups; they were not thought to be vaccine-related. After the first and subsequent doses, systemic and local reactogenicity was typically less than or comparable to that of adults.
The most often reported adverse responses were headaches, myalgia, weariness, and malaise, along with soreness or pain at the site of injection. Comparing younger (12 to 15-year-old) teenagers to older (15 to 18-year-old) teenagers, there was no change in reactogenicity. Through the course of the placebo-controlled part of the investigation, no new safety indication was noticed.
In December 2021, the EC approved a CMA for Nuvaxovid to treat COVID-19 in people 18 and older.