The request is based on the totality of preclinical-, clinical-, and manufacturing-related data provided to the FDA, including the results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90% and a reassuring safety profile, according to the company.

Novavax conducted two pivotal phase III clinical trials: Prevent-19, which comprised approximately 30,000 participants in the U.S. and Mexico, with results that were published in the New England Journal of Medicine (NEJM), and an additional trial of almost 15,000 participants in the U.K., which was also published in NEJM.

In both trials, NVX-CoV2373 demonstrated efficacy, with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, said Novavax. The most common adverse reactions observed were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants as the vaccine is distributed in authorized markets. As part of the Prevent-19 trial, a booster study is ongoing to evaluate the safety and effectiveness of a third dose of the vaccine, as well as a study in adolescents ages 12 to 17.

NVX-CoV2373 has been granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission. It has received an emergency use listing from the World Health Organization, with additional filings that are currently under review.