Latest vaccine will provide an additional option for the American public, pending FDA Emergency Use Authorization and CDC recommendation
The US Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives US Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC). The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.
“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.”
Securing these vaccines leverages preexisting US Government agreements with Novavax, including a July 2020 agreement for the development and demonstration of large-scale manufacturing of a SARS-CoV2 vaccine. The government will be taking delivery of COVID-19 vaccine doses manufactured using funds remaining on the existing agreement, pending completion of all quality testing.
The Novavax COVID-19 Vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax vaccine contains a very small amount of the SARS-CoV-2 spike protein, which elicits an immune response, in combination with an adjuvant, which boosts the immune system response to vaccine. FDA-approved protein-based vaccines have been used widely for decades; Examples of more recently approved vaccines that contain a purified protein combined with an adjuvant include vaccines to prevent hepatitis B and shingles. The Novavax COVID-19 Vaccine offers an option to individuals who may have an allergic reaction to mRNA vaccines or who have a personal preference for receiving a vaccine other than a mRNA-based vaccine.
On June 7, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in support of granting EUA for the Novavax COVID-19 vaccine for individuals 18 years and older. Both FDA EUA and CDC recommendation are pending for the Novavax COVID-19 vaccine.
To award the contract, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), collaborated with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) who led this effort in partnership with the Defense Assisted Acquisition Cell (DA2), Defense Health Agency and US Army Contracting Command.