FDA authorizes changes to simplify use of bivalent mRNA COVID vaccines; monovalent Moderna and Pfizer no longer authorized

U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines. The amended EUAs authorize bivalent Moderna and Pfizer products to be used for all doses administered to individuals six months of age and older. The EUA amendments also authorize an additional booster dose of bivalent vaccine for certain populations.

Following FDA regulatory action, Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) members expressed their support for FDA’s recommendations.

Changes include:

• Monovalent (original) COVID-19 mRNA vaccines will no longer be authorized for use in the United States.
• CDC’s new recommendations allow an additional updated (bivalent) vaccine dose for adults ages 65 years and older and an additional dose for certain people who are immunocompromised.
• CDC recommends that everyone ages six years and older receive an updated (bivalent) mRNA COVID-19 vaccine, regardless of whether they previously completed their (monovalent) primary series.
• Individuals ages six years and older who have already received an updated mRNA vaccine do not need to take any action unless they are 65 years or older or immunocompromised.
• For young children, multiple doses continue to be recommended and will vary by age, vaccine, and which vaccines were previously received.

Questions? Contact Covid.Vaccine@doh.wa.gov.