Novavax Announces Positive Results of its Investigational COVID-19 Vaccine in Pediatric Population

Novavax announced today it had reach the primary efficacy endpoint for the pediatric extension of their PREVENT-19 phase 3 clinical trial, which showed its COVID-19 vaccine, NVX-CoV2373, was 82% effective against the Delta variant.

"We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options for COVID-19," Novavax Chief Medical Officer, Filip Dubovsky, MD, said. "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 study enrolled 2247 participants who were between 12 and 17 years old. They did this across 73 US sites with the aim to evaluated its safety and immunogenicity.

This was a placebo-controlled study with participants randomized 2:1 to receive active vaccine or placebo. According to Novavax, participants underwent blinded crossover to alternate study material after the required safety data were collected to ensure that all participants received active vaccine. During the period of placebo-controlled observation, NVX-CoV2373 demonstrated overall protective efficacy of 79.5% (95% CI: 46.8, 92.1) against COVID-19.

The efficacy endpoints were accrued from May 24 through September 27, 2021, during the Delta surge. Sequence data are available for 11 of the 20 confirmed cases, 100% of which were determined to be caused by the Delta variant.

The company said they expect to submit their regulatory filings for a pediatric indication in adolescents aged 12 through 17-years to global regulatory authorities during the first quarter of this year, and they also expect they will initiate additional studies globally evaluating younger age groups during the second quarter of this year.

At the end of January, the company submitted a request to the Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for its vaccine for people 18 year of age and older.

The company submitted their EUA based off of 2 phase 3 clinical trials they conducted with 1 using nearly 30,000 participants that were randomized between December 27, 2020 and February 18, 2021, and the other using nearly 15,000 participants who were randomized between September 28, 2020 to November 28, 2020.

Both studies’ results were published in the New England Journal of Medicine.

In the former, which was name the PREVENT-19 trial, they had participants in the US and Mexico and the latter had people from the United Kingdom participating.

Clinicians recently weighed in on the potential benefits of the Novavax vaccine being added to the US market as well as how it might be important to the international market.