IMPORTANT: Updated Interim Clinical Considerations for use of COVID-19 Vaccines

Dear Immunization Partners,

Please share the following information with colleagues and staff in your practice.

On March 14, 2023, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.

On March 16, 2023, the Centers for Disease Control and Prevention (CDC) issued two important updates to the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. The updates are outlined below. 

• New recommendation for children ages 6 months through 4 years who previously completed a 3-dose monovalent Pfizer-BioNTech primary series to receive 1 bivalent Pfizer-BioNTech booster dose at least 2 months after completion of the 3-dose monovalent primary series.
• Note that since December 2022, children ages 6 months through 4 years of age who received the first two doses with monovalent Pfizer-BioNTech COVID-19 Vaccine should complete their three-dose primary series with the Pfizer-BioNTech COVID-19 bivalent vaccine. Children in this age group are not eligible for a booster dose of a bivalent vaccine at this time and are expected to have protection against the most serious COVID-19 outcomes.
• The March 14, 2023, FDA authorization is for those children 6 months through 4 years of age who completed their 3-dose primary vaccination series with the monovalentPfizer-BioNTech COVID-19 Vaccine, before the Pfizer-BioNTech bivalent COVID-19 vaccine was authorized to provide the third dose in the 3-dose primary series.
• You can find the updated EUA fact sheets here:
• EUA Fact Sheet for Healthcare Providers: 6 Months Through 4 years of Age, Maroon Cap - Monovalent and Bivalent (must dilute)
• EUA Fact Sheet for Recipients & Caregivers: 6 Months Through 4 Years of Age-Monovalent and Bivalent

• Vaccination providers are now required to report cases of myocarditis and pericarditis after receipt of a Janssen COVID-19 Vaccine to the Vaccine Adverse Event Reporting System(VAERS).

COVID-19 vaccination is recommended for everyone ages 6 months and older in the United States for the prevention of COVID-19. CDC recommends that people get up to date with COVID-19 vaccination as soon as feasible.

Thank you,

Oakland County Health Division, Immunization Action Plan