Healthcare Advisory: FDA authorized new Novavax COVID-19 vaccine formulation

Note: This advisory is for healthcare professionals. To read public health advisories, visit kitsappublichealth.org/news/categories/advisories

Actions requested

BE AWARE that 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 provides better protection against currently circulating COVID-19 variants.

• Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) includes this new formulation in its2023–2024 COVID-19 recommendations.

BE AWARE that the FDA deauthorized the original Novavax COVID-19 vaccine.

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

• Discard unused original Novavax COVID-19 vaccine.

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

• Patients who previously received any COVID-19 vaccine can get 1 dose of the new formulation, at least 2 months after their last dose of COVID-19 vaccine.

• Patients who never previously received any COVID-19 vaccine can get 2 doses of the new formulation, separately administered 3 weeks apart.

• Patients who are immunocompromised can 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. 

As an adjuvanted vaccine, Novavax is an alternative for people who prefer not to receive an mRNA COVID-19 vaccine or are unable to receive an mRNA vaccine due to a prior adverse reaction.

BE AWARE that availability of the 2023–2024 COVID-19 vaccines remains limited and varies by location. Refer patients to Vaccines.gov for information about accessing updated vaccines. 

Additional resources

• CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines

• FDA's EUA Fact Sheet for Healthcare Providers

• FDA's Novavax COVID-19 Vaccine New Adjuvanted (2023–2024) Formula

• FDA's Resources for Fall Respiratory Illness Season

• FDA's Updated mRNA COVID-19 Vaccines Better Protect Against Currently Circulating Variants

• FDA's Updated COVID-19 Vaccines for Fall 2023

• Vaccines.gov's Provider Resources

• Washington State Department of Health's COVID-19 Vaccine Information for Healthcare Providers

• Kitsap Public Health District's "Health Advisory: New COVID-19 vaccines authorized; bivalent COVID-19 vaccines deauthorized"

• Kitsap Public Health District's "Be prepared for respiratory illness season"

Contacting the health district

• Call: 360-728-2235 and leave a message. Includes reporting notifiable conditions 24 hours a day, 7 days a week. Leave the patient’s name, date of birth and disease.

• Fax: 360-813-1168.

This advisory is also posted on the health advisory page of our Provider Resources website, providers.kitsappublichealth.org.