Novavax begins rolling review of COVID-19 vaccine candidate

Keith A. Reynolds

The drug maker has started reviews with regulatory agencies across the world.

Novavax has begun the rolling review process to seek authorization of NVX-CoV2373, a COVID-19 coronavirus vaccine candidate.

According to a news release, the reviews by the Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, European Medicines Agency, and Health Canada have commenced while Novavax completes its Phase 3. Trials in the U.K and U.S.

“The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide,” Gregory M. Glenn, MD, president of research and development, says in the release. “We appreciate the agencies’ confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination.”

Previously, the company showed that the candidate showed 89.3 percent efficacy in a Phase 3 clinical trial in the U.K. with more than 50 percent of study cases showing the U.K variant, and 60 percent efficacy in a Phase 2b clinical trial in South Africa. More than 90 percent of the cases in this test were the South African variant.

The race to find an end to the pandemic has shown promising results in the past few months with a pair of two-dose vaccines currently being distributed and a single-dose vaccine candidate produced by Johnson & Johnson currently awaiting a vote from the FDA for emergency use authorization.

Once the Johnson & Johnson candidate receives the EUA, the company says it plans to supply the federal government with 100 million doses in the first half of this year.