GAITHERSBURG, Md. — A Maryland company may soon see a large purchase from the U.S. government for a fourth COVID vaccine, as long as it receives all the necessary agency approvals. Novavax and the U.S. Department of Health and Human Services announced an agreement Monday to secure 3.2 million doses of Novavax' COVID-19 vaccine (NVX-CoV2373).
The Gaithersburg-based Novavax product is based on non-mRNA vaccine technology, and an approved shot would provide an option for people who are vaccine-hesitant because of the newer technology or for those who are allergic to other shots.
The government deal is contingent on the U.S. Food and Drug Administration (FDA) approving Novavax' request for emergency use authorization (EUA) filed in January, and the Centers for Disease Control signing off. The FDA's Vaccines and Related Biological Products Advisory Committee has recommended the EUA approval for anyone 18 and older. The FDA advisory panel voted that the benefits of two primary Novavax doses outweigh its risks — but they had a lot of questions about the shots’ role at this point in the pandemic. Nearly 83% of those in the U.S. over the age of five are currently vaccinated, according to the Centers for Disease Control and Prevention.
"We are pleased to come one step closer to potentially offering our vaccine to physicians, healthcare organizations, and consumers who have been awaiting a protein-based vaccine option," said Stanley C. Erck, president and CEO of Novavax. "We are grateful for the U.S. government's ongoing support and partnership to bring Novavax' COVID-19 vaccine to the U.S., and we look forward to the FDA's decision on an emergency use authorization."
Novavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, according to the Associated Press, either for initial vaccinations or as mix-and-match boosters.
Novavax has said the overall efficacy of its vaccine candidate is 90.4%.
Efficacy is the measurement of how well a vaccine prevents disease. The company's trial measured specific effectiveness against a number of SARS-CoV-2 variants; of the variants considered of "concern" or of "interest," as defined by the CDC, efficacy was 93.2%.
All cases of COVID-19 in trial vaccine recipients were mild, according to Novavax, and there were 10 moderate and four severe COVID-19 cases in the placebo group. Novavax says this means its vaccine touts 100% efficacy against moderate and severe disease.