Novavax Inc. (NASDAQ: NVAX) had announced that its recombinant nanoparticle protein-based SARS-CoV-2 vaccine, CoV2373, attained primary efficacy endpoint in the paediatric expansion of the pivotal PREVENT-19 third phase study and showed 80% efficacy overall during the period when Delta variant was predominantly circulating in the US.
2,247 teenagers enrolled in the study
The trial enrolled 2,247 teenagers aged 12 to 17 years old from 73 locations across the United States to assess safety, efficacy (immunogenicity), and effectiveness, focusing on ensuring a diverse ethnic and racial representation among subjects.
The company’s chief medical officer Filip Dubovsky 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.”
The PREVENT-19 pivotal third phase trial results, which enrolled roughly 30,000 adults aged above 18 in the US and Mexico, were published in The New England Journal of Medicine (NEJM). Overall, NVX-CoV2373 was 90.4 percent effective, with favourable tolerability and safety profile. Adults experienced a low incidence of serious and severe side events evenly distributed between the vaccination and placebo groups. The most common side effects identified in adults during clinical investigations were headaches, vomiting or nausea, arthralgia, myalgia, injection site pain/tenderness, exhaustion, and malaise.
NVX-CoV2373 yet to receive approval for the teenage population
As the vaccine is delivered, the company will continue to gather and analyze actual data for both the original PREVENT-19 study and the paediatric expansion, encompassing safety monitoring and variation evaluation.
In the teenage population, NVX-CoV2373 is yet to be approved. Regulatory submissions for a paediatrics indication in teenagers aged 12 to 17 years are expected to be submitted to worldwide regulatory agencies in Q1 2022, according to Novavax. During Q2 2022, Novavax plans to start more global trials testing younger age groups. NVX-CoV2373 has EU, MHRA and WHO’s emergency use listing.
