Novavax announced that NVX-CoV2373 COVID-19 vaccine has been recommended for Extended Conditional Marketing Authorization (CMA) in the European Union (EU) for adolescents 12-17 years of age.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its opinion on the results of the PREVENT-19 Phase 3 clinical trial. This is a pivotal Phase 3 study involving 2,247 adolescents aged 12 to 17 years old in 73 US sites to assess the safety, efficacy (immunogenicity) and effectiveness of a vaccine. In the study, the vaccine met its primary efficacy endpoint and showed an overall clinical efficacy of 80% at the time the Delta variant was the predominant SARS-CoV-2 strain circulating in the United States.

Preliminary safety data from the study showed that the vaccine was generally well tolerated. The number of serious and serious adverse events was low and balanced between the vaccinated and placebo groups. They were not considered vaccine related. Local and systemic reactogenicity after the first and second doses was lower or similar to that in adults.

The most common side effects observed were injection site tenderness/pain, headache, myalgia, fatigue and malaise. There was no increase in reactogenicity in younger adolescents (12 to <15 years of age) compared to older adolescents (15 to <18 years of age). Fever was more common in adolescents than in adults. These symptoms are usually mild to moderate and will disappear within a few days of vaccination.

Recall: The European Commission (EC) granted a marketing authorization for NVX-CoV2373 to prevent COVID-19 in people aged 18 and over in December 2021.

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