Novavax COVID-19 vaccine meets trial endpoints
pharmafile | February 11, 2022 | News story | Medical Communications |
Novavax has announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness endpoint in the paediatric expansion of its PREVENT-19 pivotal Phase 3 trial.
The company has shared that the vaccine demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the US. The study enrolled 2,247 adolescents aged 12 through 17-years across 73 sites in the US to evaluate safety, effectiveness (immunogenicity), and efficacy of the vaccine.
“We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options for COVID-19,” said Filip Dubovsky, MD, Chief Medical Officer, Novavax. “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 primary PREVENT-19 pivotal Phase 3 trial conducted in adults aged 18 years and older, enrolled approximately 30,000 participants in the US and Mexico. NVX-CoV2373 achieved 90.4% efficacy overall and demonstrated a reassuring safety and tolerability profile. The results of the trial were published in The New England Journal of Medicine (NEJM).
Serious and severe adverse events in adults were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed in adults during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
Novavax will continue to collect and analyse real-world data, for both the primary PREVENT-19 trial and the paediatric expansion, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
Novavax is a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases.
Ana Ovey
