The U.S. government has secured 3.2 million doses of Novavax’ COVID-19 vaccine (NVX-CoV2373), Novavax Inc. announced on Monday.
The Department of Health and Human Services (HHS), in collaboration with the Department of Defense, has signed the agreement that will come into effect should the vaccine receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and a recommendation from the Centers for Disease Control and Prevention (CDC).
The Novavax press release says that “the vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.”
Novavax is a member of the Biotechnology Innovation Organization (BIO).
“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,” said Novavax’s President and Chief Executive Officer, Stanley C. Erck.
The Director of FDA’s Center for Biologics Evaluation and Research (CBER), Dr. Peter Marks, said in June that “a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines” for COVID-19.
As we previously reported, the vaccine, called Nuvaxovid, is “similar in design to a flu shot that’s been available in the U.S. since 2013” and is considered “an alternative for people hesitant to get an mRNA vaccine.”
Per the company’s data, the vaccine is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein.
Novavax phase 3 trial data
On June 28, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee held a meeting during which the latest data of the Novavax COVID-19 vaccine’s clinical trials was presented.
Data showed high levels of protection in two phase 3 trials, with an overall efficacy of 90%. The vaccine showed 100% protection against severe disease in both UK and US/Mexico trials.
The level of protection offered against “variants of interest and variants of concern” in circulation at the time studies were conducted was 86% in the UK trial and 93% in US/MX trial.
“Novavax technology induces cross-reactive immunity driven by recognition of conserved epitopes on Novavax recombinant spike protein,” said the data. The adjuvant “enhances breadth and duration of the immune response.”