10/16/23 Health Advisory: FDA Authorized New Novavax COVID-19 Vaccine Formulation

• 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.
  • Report unused original Novavax COVID-19 vaccine as wastage and update your inventory in Washington State Immunization Information System (WAIIS).
  • Discard unused 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.

Resources

• Interim Clinical Considerations for Use of COVID-19 Vaccines, CDC.
• EUA Fact Sheet for Healthcare Providers, FDA.
• EUA Fact Sheet for Recipients and Caregivers, FDA.
• Novavax COVID-19 Vaccine New Adjuvanted (2023–2024) Formula, FDA.
• FDA Resources for Fall Respiratory Illness Season, FDA.
• Updated mRNA COVID-19 Vaccines Better Protect Against Currently Circulating Variants, FDA.
• Updated COVID-19 Vaccines for Fall 2023, FDA.
• Vaccines and Related Biological Products Advisory Committee Meeting June 15, 2023, FDA.
• COVID-19 Vaccine Information for Healthcare Providers, Washington State Department of Health (DOH).
• 2023–2024 COVID-19 Vaccine Product Information, DOH.

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