FDA Finally Greenlights Novavax Covid Vaccine

15.07.2022 - It took longer than expected, but the US Food and Drug Administration (FDA) on July 13 finally granted an Emergency Authorization (EUA) to Nuaxovid, the protein-based sCovid-19 shot developed by Novavax.

With four Covid vaccines at its disposal, the US now has pulled up to Europe, which approved Nuaxovid at the end of last year. An advisory panel to the FDA gave its blessing in June.

Altogether, the shot’s launch was delayed several times due to its relatively long, two-year development time, manufacturing issues and the need for authorities to study all trial data for the only protein-based shot in the mix. Like Moderna and BioNTech, Novavax had never had a commercial product.

Next week, an advisory panel to the Centers for Disease Control (CDC) will meet to draw up guidelines for deployment. The two-doses are recommended to be given three weeks apart, similar to the procedure for the mRNA shots.    

Also like the vaccines made by Pfizer/BioNTech and Moderna, the Novavax shot will carry a warning that it is linked to an elevated but small risk of myocarditis and pericarditis. The FDA’s reviewers reportedly identified six cases of the heart muscle inflammation in around 40,000 trial participants.

The administration of US president Joe Biden has ordered 3.2 million doses, sufficient to immunize 1.6 million people. The rollout will begin when Novavax completes its quality testing, expected in the next several in the next several weeks. The Serum Institute of India, world’s largest vaccine producer, is manufacturing the shot.

Nuaxovid is authorized as a primary immunization series for adults, rather than a booster, which could limit its market at first. The US government hopes it will appeal to the 22% still unvaccinated, though this would contrast with the experience in Europe, where only 12.6 million Novavax doses were distributed between its authorization in and the end of last month.

The Maryland firm received development aid from Operation Warp Speed, the US federal government’s 2020 campaign to find vaccines for the then-novel coronavirus, but it is unclear how much was actually paid out.

 The original terms called for Novavax to receive up to $1.6 billion in funding if it the vaccine proved  effective in clinical trials, and 100 million doses were produced by the beginning 2021. The target was missed by a wide margin.

Novavax is now working on new versions of its vaccine targeted at Omicron and  subvariants.  Early trial data reportedly showed one of them to produce a strong immune response to the original Omicron strain, which, however, has since mutated further. More details are due in September.

Author: Dede Williams, Freelance Journalist