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Covid: Novavax, Ema approves vaccine for 12-17 years

2022-07-05T07:40:43.532Z

Novavax has announced that the European Commission has approved the extended Conditional Marketing Authorization (CMA) for Nuvaxovid, the vaccine against COVID-19, in adolescents in Europe between the ages of 12 and 17. (HANDLE)



Novavax has announced that the European Commission has approved the extended Conditional Marketing Authorization (CMA) for Nuvaxovid, the vaccine against COVID-19, in adolescents in Europe between the ages of 12 and 17.

The approval follows the positive opinion expressed on 23 June by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the company said in a note.

"We are extremely pleased that Nuvaxovid, our COVID-19 vaccine, is now also available for adolescents in Europe," said Stanley C. Erck, Novavax President and CEO.

"Our protein-based vaccine - developed using an innovative approach to traditional technology - has demonstrated efficacy and safety in both adolescents and adults."

The authorization is based on data from the pediatric extension of PREVENT-19, an ongoing pivotal phase III study of 2,247 adolescents aged 12 to 17 years at 73 US sites, aimed at assessing safety, immunogenicity and the effectiveness of Nuvaxovid.

Over the course of the study, Nuvaxovid met its primary efficacy endpoint and demonstrated an overall clinical efficacy of 80% at a time when the Delta variant was the predominant SARS-CoV-2 strain in the United States.

Preliminary safety data from the study showed that the vaccine is generally well tolerated.

Serious adverse events were few and balanced between the vaccine arm and the placebo arm, and were not considered vaccine related.

Local and systemic reactogenicity was generally less than or similar to that in adults after the first and second doses.

The most common adverse reactions observed were injection site tenderness / pain, headache, myalgia, fatigue and malaise.

There was no increase in reactogenicity in younger adolescents (12 to 15 years) compared to older adolescents (15 to 18 years).

No new safety signals were observed in the entire placebo-controlled part of the study.

The EC granted CMA for Nuvaxovid for the prevention of COVID-19 in individuals 18 years of age and older in December 2021. In addition to the EC's extended CMA, India has been granted authorization for emergency use in range 12-17 years.

Source: ansa

All life articles on 2022-07-05

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