05/04/23 Health Advisory: Bivalent COVID-19 Vaccine Use Expanded, Monovalent No Longer Authorized

| May 4, 2023
Warning yellow triangle with black exclamation point on left. "Health Advisory" on right.

Requested actions

  • Monovalent Moderna and Pfizer COVID-19 vaccines are no longer authorized for use in the United States.
    • Read below for how to discard and report as waste.
  • Use the new simplified schedule to administer COVID-19 vaccine.
  • People who are 65 years or older or have immune compromise can now get a second bivalent booster dose.

CDC and FDA simplified the COVID-19 vaccine schedule.

On April 18, 2023, Food and Drug Administration (FDA) amended its emergency use authorizations (EUAs) for Moderna and Pfizer bivalent COVID-19 vaccines to simplify the vaccine schedule.

On April 19, 2023, Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) simplified its COVID-19 vaccine recommendations to include a second bivalent booster dose for people who are 65 years or older or immune compromised.

Start following CDC’s simplified recommendations.

  • People 65 years or older can get a second bivalent booster dose at least 4 months after their last dose.
  • Certain people with immune compromise can get a second bivalent booster dose at least 2 months after their last dose.
  • Everyone 6 years or older can get one bivalent booster dose.
    • Most people 6 years or older who already got one bivalent booster dose don’t need to take any action.
  • Recommendations for young children continue to include multiple doses that vary by age and which vaccines they previously received.

Check out the FDA’s updated fact sheets for healthcare professionals, vaccine recipients and caregivers for Pfizer COVID-19 vaccine and Moderna COVID-19 vaccine.

CDC will soon update its interim clinical considerations for use of COVID-19 vaccine to give further clinical guidance.

Washington State Department of Health (DOH) will soon update its COVID-19 vaccine webpages and resources to reflect these changes. Standing orders are pending.

Discard unused monovalent vaccines and report as waste. 

  • Discard unused monovalent Moderna and Pfizer COVID-19 vaccines.
  • In Washington State Immunization Information System (WAIIS), report these unused monovalent vaccines as waste and update your inventory.
    • Use “Category – Expired, Reason – Open Multidose Vial.”

Additional considerations

  • You can no longer order monovalent Moderna or Pfizer COVID-19 vaccine through WAIIS.
  • Because Western States Scientific Safety Review Workgroup (WSSSRW) has ended, it will not review the new bivalent-only plan.
  • CDC authorization is complete.
  • Standing orders and interim clinical considerations are pending.
  • People who cannot or will not get mRNA vaccine can get monovalent Novavax or Johnson & Johnson vaccine. CDC’s changes do not affect these vaccines.
  • CDC and ACIP continue to monitor COVID-19 disease levels and vaccine effectiveness. They will discuss potential updates to happen this fall.

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