Novavax reports success for NVX-CoV2373 in pediatric group of phase 3 trial

Novavax said that its Covid-19 vaccine NVX-CoV2373 achieved its primary effectiveness endpoint in the pediatric expansion of its phase 3 PREVENT-19 trial.

According to the American biotech company, the recombinant nanoparticle protein-based vaccine has overall shown 80% efficacy overall at a time when the Delta variant was the main circulating strain in the US.

The PREVENT-19 trial enrolled 2,247 adolescents aged between 12 and 17 at 73 sites in the US. The late-stage trial assessed the safety, immunogenicity, and efficacy of the NVX-CoV2373 Covid-19 vaccine.

Filip Dubovsky — Chief Medical Officer of Novavax said: “We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options for COVID-19.

“We believe the Novavax vaccine offers a differentiated technology and option for this younger population given its established protein-based technology already used in other vaccines, and the positive responses demonstrated against variants.”

In the primary PREVENT-19 trial held in adults aged 18 and over, NVX-CoV2373 demonstrated 90.4% efficacy. The late-stage trial enrolled nearly 30,000 participants in the US and Mexico.

NVX-CoV2373 is yet to be authorized in the adolescent population for protection against Covid-19.

Novavax said that it anticipates submitting its regulatory filings for a pediatric indication in adolescents in the the12-17 age group to global regulatory authorities during Q1 2022.

The American biotech company is also likely to initiate more studies around the world to evaluate NVX-CoV2373 in younger age groups during Q2 2022.

So far, the NVX-CoV2373 Covid-19 vaccine candidate has secured authorization from various global regulatory authorities, which include conditional marketing authorization from the European Commission, the UK’s Medicines and Healthcare products Regulatory Agency, and an emergency use listing (EUL) from the World Health Organization (WHO).