This message was sent to AIM, FAB, Health Systems, INE, IAP, LHD Health Officers, LHD Medical Directors, MACI, MACI 2, PH Imms Leads, MCIR Region Contacts, COVID-19 Vaccine Providers, and Imms All Staff. I apologize for any duplications.

Dear Immunization Partners,

Please share the following information with your providers.

On June 19, 2022, the Centers for Disease Control and Prevention (CDC) issued 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. 

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. There is currently no FDA-approved or FDA-authorized COVID-19 vaccine for children younger than 6 months. These children should not receive any COVID-19 vaccine doses (including partial doses of vaccine products approved or authorized for people ages 6 months and older) at this time unless part of a clinical trial.

1. New guidance for use of Pfizer-BioNTech COVID-19 Vaccine in children ages 6 months through 4 years (Maroon cap vial with maroon border):*

• Age range: Children ages 6 months through 4 years
• Schedule: 3-dose primary series (the same vaccine should be used for the whole series)¹
  • Interval between doses:
    • 3-8 weeks between dose 1 and dose 2²
    • At least 8 weeks between dose 2 and dose 3
  • Dose volume: 0.2mL
  • Dilute with 2.2mL of provided diluent
  • Currently, a booster is not authorized for this age group

*Important note for Pfizer: The vial labels may state “Age 2y to < 5y” or “Age 6m to < 5y” and carton labels may state “For age 2 years to < 5 years” or “For age 6 months to < 5 years”. Vials with either printed age range can be used for individuals 6 months through 4 years of age.

2. New guidance for use of Moderna COVID-19 Vaccine in children ages 6 months through 5 years (Magenta border):

• Age range: Children ages 6 months through 5 years
• Schedule: 2-dose primary series (the same vaccine should be used for the whole series)¹
  • Interval between doses:
    • 4-8 weeks between dose 1 and dose 2²
  • Currently, a booster dose is not authorized for children 6 months through 4 years of age. In addition, a booster dose is not authorized for children 6 months through 5 years of age who received Moderna as a primary series.

3. Reorganization of sections on COVID-19 vaccination recommendations and schedules:

• COVID-19 vaccination guidance for people who are not moderately or severely immunocompromised
• COVID-19 vaccination guidance for people who are moderately or severely immunocompromised

4. Addition of new section in Special populations for infants and young children:

• In accordance with general best practices, preterm infants (infants born before 37 weeks’ gestation), regardless of birth weight, should receive COVID-19 vaccination at their chronological age and according to the same schedule and guidance as for full-term infants and children (see Table 2).
• Infants of mothers who were vaccinated and/or had COVID-19 or SARS-CoV-2 infection before or during pregnancy should be vaccinated according to the recommended schedule (see Table 2).

¹Interchangeability of COVID-19 vaccine products:

In general, the same mRNA vaccine product should be used for all doses in the primary series.

In exceptional situations in which the mRNA vaccine product administered for a previous dose(s) of the primary series cannot be determined or is not available, any age-appropriate mRNA COVID-19 vaccine product may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 primary vaccination series.

Children ages 6 months through 4 years who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered at least 8 weeks after the second dose to complete the 3-dose primary series.

²An 8-week interval may be optimal for some people ages 6 months–64 years, especially for males ages 12–39 years. A shorter interval (3 weeks for Pfizer-BioNTech; 4 weeks for Moderna) between the first and second doses remains the recommended interval for people who are moderately or severely immunocompromised; adults ages 65 years and older; and in situations in which there is increased concern about COVID-19 community levels or an individual’s higher risk of severe disease.

Guidance on transitioning from a younger to older age group:

People should receive the recommended age-appropriate vaccine dosage based on their age on the day of vaccination. If a person moves from a younger age group to an older age group during the primary series or between the primary series and receipt of the booster dose(s), they should receive the vaccine product and dosage for the older age group for all subsequent doses.

Pfizer-BioNTech COVID-19 Vaccine:

Children who will turn from age 4 years to 5 years: FDA authorization of the Pfizer-BioNTech COVID-19 Vaccine allows children who will turn from age 4 years to 5 years between any dose in the primary series to receive:

• A 2-dose primary series using the Pfizer-BioNTech COVID-19 vaccine product authorized for children ages 5 through 11 years, OR
• A 3-dose primary series initiated with the Pfizer-BioNTech COVID-19 vaccine product authorized for children ages 6 months–4 years. Each of doses 2 and 3 may be with the Pfizer-BioNTech COVID-19 Vaccine product authorized for children ages 6 months–4 years, or the Pfizer-BioNTech COVID-19 Vaccine product authorized for children ages  5–11 years

Children who will turn from age 11 years to 12 years: FDA authorization of the Pfizer-BioNTech COVID-19 Vaccine allows children who will turn from age 11 years to 12 years between their first and second dose in the primary series to receive, for either dose: (1) the Pfizer-BioNTech COVID-19 Vaccine product authorized for children ages 5–11 years or (2) the Pfizer-BioNTech COVID-19 Vaccine product authorized for people ages 12 years and older.

Guidance on Coadministration:

• COVID-19 vaccines may be administered without regard to timing of other vaccines. This includes simultaneous administration of COVID-19 vaccine and other vaccines on the same day.
• Extensive experience with non-COVID 19 vaccines has demonstrated that immunogenicity and adverse event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone. Data assessing the outcomes of simultaneous administration of COVID-19 vaccines with other vaccines are limited currently, including any potential increase in reactogenicity when COVID-19 and other vaccines are administered at the same visit.
• In accordance with general best practices, routine administration of all age-appropriate doses of vaccines simultaneously is recommended for children for whom no specific contraindications exist at the time of the healthcare visit. When deciding whether to co-administer another vaccine(s) with COVID-19 vaccine, providers and parents/guardians may consider whether a child is behind or at risk of becoming behind on recommended vaccines and the likelihood of the child returning for another vaccination; the child’s risk of becoming infected with a vaccine-preventable disease and their risk for severe disease if infected; and the reactogenicity profile of the vaccines.

Guidance on Vaccine Administration Errors:

For guidance on vaccine administration errors, please reference Appendix C titled “Vaccine administration errors and deviations" in CDC’s Interim Clinical considerations.

Thank you for all you do to help protect Michiganders from vaccine preventable diseases.

Your Immunization Nurse Education Team,
Andrea, Dianne, Heidi, Sarah, and Terri