Statement from HHS Secretary Xavier Becerra on the Authorization of Protein-Based Novavax COVID-19 Vaccine

In response to the Centers for Disease Control and Prevention’s (CDC’s) recommendation to make the protein-based Novavax COVID-19 vaccine available to the American people, U.S. Department of Health and Human Services Secretary Xavier Becerra issued the statement below on the CDC’s recommendation of this additional COVID-19 vaccine option. CDC’s recommendation followed the Food and Drug Administration’s (FDA’s) authorization of the Novavax COVID-19 vaccine for emergency use in individuals 18 years and older as a primary vaccination series against COVID-19, and an Advisory Community on Immunization Practices’ (ACIP’s) recommendation for use of this vaccine.

“The Novavax vaccine is one more important tool in our COVID-19 response, and it marks one more way we’re working to make safe and effective vaccines available to the public,” said Secretary Becerra. “Based on CDC and FDA action, the Novavax vaccine will be available for people age 18 and up who require or prefer a protein-based vaccine. We will leave no stone unturned to protect people against COVID-19 and save lives.”

The Novavax COVID-19 vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax COVID-19 vaccine contains SARS-CoV-2 recombinant spike protein, which is also known as an “antigen” of the SARS-CoV-2 virus, in combination with an adjuvant, which enhances the immune system response to the spike protein.

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 be allergic to a component in the mRNA vaccines, or who have a personal preference for receiving a vaccine other than an mRNA-based vaccine.