Novavax (Nasdaq:NVAX) announced that its protein-based NVX-CoV2373 COVID-19 vaccine could be the first of its type to be available in the U.S., assuming it wins backing from the FDA and CDC.
The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) have secured 3.2 million doses of Novavax’s COVID-19 vaccine.
There are currently two FDA-approved mRNA vaccines and an authorized adenovirus vector vaccine.
The protein-based Novavax vaccine is built using a more traditional technique than rivals and is adjuvanted to enhance the immune response. Hepatitis B and shingles vaccines are also protein-based and adjuvanted.
The vaccine includes a small amount of the SARS-CoV-2 spike protein.
In June, an FDA advisory committee recommended authorization of the Novavax vaccine.
Typically, FDA grants authorization soon after hearing from its advisors but has not yet authorized the Novavax vaccine.
Novavax noted in a news release that it anticipates that it can “complete all necessary quality testing in the next few weeks, which would support final release of the product.”
Assuming the Novavax vaccine wins a regulatory nod, HHS and DOD will make the vaccine available at no cost to states, jurisdictions, federal pharmacy partners and federally qualified health centers.
“We remain committed to working to ensure that anyone eligible who wants a vaccine can get one,” said HHS Coordination Operations and Response Element (H-CORE), COO Jason Roos. “While more than two-thirds of the American public are already fully vaccinated, we must maintain a sense of urgency to ensure all eligible individuals get vaccinated, particularly heading into the Fall. This latest vaccine would offer people another choice to help protect themselves from severe disease or hospitalization caused by COVID-19.”
In late afternoon trading, the company’s stock was down 68.88