Novavax pediatric COVID-19 vaccine trial yields positive results

Novavax has announced positive results of their phase 3 PREVENT-19 clinical trial (NCT04511802) evaluating the company’s recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373.¹

The vaccine both achieved the primary effectiveness endpoint—neutralizing antibody responses noninfoerior to those seen in young adult participants of PREVENT-19—and demonstrated an 80% overall efficacy when the Delta SARS-CoV-2 variant was predominant.

The pediatric expansion of the PREVENT-19 trial enrolled 2247 adolescents aged 12 to 17 years across 73 sites in the United States. Trial investigators emphasized the importance of ensuring “well balanced racial and ethnic representation among participants.”

Results of the pivotal phase 3 primary PREVENT-19 trial were published in the New England Journal of Medicine.² The trial enrolled 30,000 adult participants across the United States and Mexico and demonstrated a 90.4% overall efficacy, as well as high safety and tolerability.

“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, in the statement. “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.”

Novavax anticipates submitting regulatory findings for a pediatric indication to global regulatory authorities during the first quarter of 2022, and plans to initiate “additional studies globally evaluating younger age groups” during the second quarter of 2022.

NVX-CoV2373 has received authorization from numerous global regulatorily bodies, including a conditional marketing authorization from the European Commission and an emergency use listing from the WHO. NVX-CoV2372 is currently under review by the FDA.

This article was originally published by sister publication Drug Topics.

References

1. Novavax announces positive results of COVID-19 vaccine in pediatric population of PREVENT-119 phase 3 clinical trial. News release. Novavx, Inc. February 10, 2022. Accessed February 14, 2022. https://ir.novavax.com/2022-02-10-Novavax-Announces-Positive-Results-of-COVID-19-Vaccine-in-Pediatric-Population-of-PREVENT-19-Phase-3-Clinical-Trial?sf159912464=1
2. Dunkle LM, Kotloff KL, Gay CL, et al; for the 2019nCoV-301 Study Group. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. N Engl J Med. 2022;386(6):531-543. Doi:10.1056/NEJMoa2116185