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.

Questions?

Call Grays Harbor County Public Health at (360) 532-8631, Monday–Friday, 8 a.m.–4:30 p.m. After hours, call Duty Officer phone for immediately notifiable conditions at (360) 581-1401.