Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, will modify its existing agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373).

The agreement will maintain the U.S. public’s access to Novavax’ vaccine and support the development of smaller dose vials, strain selection in line with U.S. FDA recommendations, and a smooth transition to the commercial market.

“This agreement acknowledges the need to offer the American people a diverse COVID-19 vaccine portfolio and underscores the importance of Novavax’ partnership with the U.S. government to ensure continuous access to a protein-based option as part of public health measures,” said John Jacobs, president and CEO, Novavax. “We look forward to continuing our collaboration with the U.S. government on the development of our COVID-19 vaccine to meet the requirements of the FDA and our commercial customers for the upcoming 2023/2024 vaccination campaign.”

The contract will support the U.S. government’s continued efforts to make Novavax’ protein-based vaccine available for free to states, jurisdictions, federal pharmacy partners and federally qualified health centers.

The Novavax COVID-19 Vaccine, Adjuvanted received emergency use authorization from the U.S. FDA for use to prevent COVID-19 in adults aged 18 and older in adolescents 12 through 17 as a primary series, and as a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals aged 18 and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals aged 18 and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

The contract is supported with previously allocated federal funds from HHS, the Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority, through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract Number W15QKN-16-9-1002, Project Number MCDC2011-001.

The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the U.S. FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) as a primary series in individuals 12 years of age and older.

Furthermore, the Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.