The FDA authorized an updated Novavax COVID-19 vaccine for individuals 12 years of age and older. This authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness, and manufacturing quality. Although authorized, distribution plans are still underway at the federal level. Many vaccine providers in Missouri are currently awaiting supply.
The protein-based vaccine, Novavax, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023-2024 formula).
What does this mean for the public?
There is an additional COVID-19 vaccine available for this respiratory virus season (2023-2024). Differing from the available mRNA COVID-19 vaccines, the Novavax vaccine uses proteins to initiate an immune response, similar to the vaccines for shingles, hepatitis B, and influenza.
What does this mean for providers?
With the authorization of a 2023-2024 formula, the previous (Original) formula is no longer authorized for emergency use. CDC is currently in the process of updating the Interim Clinical Considerations guidance and will share allocation and ordering details with public providers as soon as the updated vaccines have been received. Updated authorization details, including provider and patient fact sheets, are available on the FDA website.
Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is authorized for use in individuals 12 years of age and older as follows:
- Individuals previously vaccinated with any COVID-19 vaccine: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is administered at least 2 months after receipt of the last previous dose of an original monovalent (Original) or bivalent (Original and Omicron BA.4/BA.5) COVID-19 vaccine.
- For individuals not previously vaccinated with any COVID-19 vaccine: two doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) are administered three weeks apart.
- Immunocompromised individuals: an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 Formula). Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.
Pfizer and Moderna’s seasonal COVID-19 vaccines are now available (some locations may be limited in supply). Check this link to locate a vaccine provider near you, and be aware that the current availability of Novavax is extremely limited. Greater access to COVID-19 vaccines is anticipated in the coming weeks.