COVID-19 Vaccine for Children 6 Months–4 Years Old Preliminary Considerations for Pediatric Planning

Overview

In October 2021, CDC released the first Pediatric Operational Planning Guide outlining key aspects of a COVID-19 vaccination program for children younger than 12 years old. At the beginning of November, COVID-19 vaccine for children ages 5–11 years old was authorized by FDA and recommended by the Advisory Committee on Immunization Practices (ACIP) and subsequently the CDC Director. Currently, the Pfizer-BioNTech two-dose series remains the only recommended COVID-19 vaccine for this age group.

Pfizer and Moderna are conducting clinical trials and data collection for children 6 months through 4 years old (henceforth referred to as 6m–4 years old or under 5 years old). An Emergency Use Authorization (EUA) application for the Pfizer-BioNTech vaccine for children 6m-4 years old has been submitted to the FDA and may receive authorization before other vaccines. Therefore, this guidance will include details about the anticipated Pfizer-BioNTech product and may be updated as other manufacturers submit applications for FDA review. This preliminary planning guide is intended to inform jurisdictional, federal partner, and pharmacy planning for distribution of vaccine for children 6m-4 years old should it receive Emergency Use Authorization (EUA). Additional operational planning guidance will be released as it becomes available.

Facts

• There are approximately 18 million children 6 months through 4 years old in the United States. The U.S. government has procured enough vaccine to support vaccination of this population, pending FDA EUA and CDC recommendations.
• The current products for adults, adolescents, and children ages 5–11 years old should NOT be used in children under 5 years old.
• Any potential products currently in clinical trials would likely have configurations and storage and handling requirements similar to the other mRNA COVID-19 vaccine products in use.
• The Pfizer-BioNTech vaccine for 6m–4-year-olds has a similar product configuration to the 5–11-year-old pediatric vaccine, but with a different color cap, different dose, a new national drug code (NDC), and potentially a different schedule. The packaging configuration for vaccine product for children 6m–4 years is expected to be 10-dose vials in cartons of 10 vials each (100 doses total) with a minimum order quantity of 100 doses.
  • A new NDC will be used for any product with an under 5 years old indication and so will require additional coding and information technology accommodations, which are underway.
• The Pfizer-BioNTech COVID-19 vaccine for 6m–4 years old children will require diluent. The diluent will be provided with ancillary supplies to support 100 doses per kit.
• Once open, doses in vials must be used within 12 hours.
• The PREP Act and the PREP Act Declaration issued by the Secretary of the Department of Health and Human Services authorize and provide liability protections to licensed providers and others identified in the declaration to administer COVID-19 vaccines authorized by FDA, including COVID-19 vaccines authorized for administration to children. This authorization preempts state requirements that would otherwise prohibit, or effectively prohibit, the providers from administering the vaccine. The PREP Act Declaration authorizes certain providers listed in the Declaration to administer vaccines regardless of state requirements. For example, the Declaration authorizes pharmacists, pharmacy interns and pharmacy technicians nationwide to order and/or administer COVID-19 vaccines, influenza vaccines, and other vaccines authorized by FDA and recommended by CDC for children ≥3 years old (Please see: https://www.hhs.gov/sites/default/files/prep-act-guidance.pdf)

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