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Health Advisory: FDA Authorized New Novavax COVID-19 Vaccine Formulation

Published Oct. 12, 2023.

  • On Oct. 3, 2023, U.S. Food and Drug Administration (FDA) authorized for emergency use a new adjuvanted (2023–2024) formulation of Novavax COVID-19 vaccine for people 12 years or older.
    • The new formulation better protects against currently circulating COVID-19 variants.
    • Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) includes this new formulation in its 2023–2024 COVID-19 recommendations.
  • FDA deauthorized the original Novavax COVID-19 vaccine.

The new adjuvanted (2023–2204) formulation of Novavax COVID-19 vaccine is authorized for people 12 years or older as follows:

  • Previously received any COVID-19 vaccine—May get 1 dose of the new formulation, at least 2 months after their last dose of COVID-19 vaccine.
  • Never previously received any COVID-19 vaccine—May get 2 doses of the new formulation, separately administered 3 weeks apart.
  • Immunocompromised people—May get an additional dose of the new formulation, at least 2 months after their last dose of the new formulation. Administer additional dose at the healthcare provider’s discretion, with the timing based on the person’s clinical circumstances. 

Updated 2023–2024 COVID-19 vaccine availability may be limited and vary by location. Help patients understand this situation and thank them for their patience.

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