FDA advisory committee finds that pediatric Pfizer vaccine benefits outweigh risks for children ages 5 to 11

Note: This post has been updated to refer to the Pfizer vaccine doses by micrograms, not mL.

Today, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of medical experts, recommended Emergency Use Authorization (EUA) for administration of the Pfizer COVID-19 vaccine to children ages 5 to 11. The Pfizer vaccine for this age group is a smaller dose (10 micrograms) than the Pfizer vaccine for ages 12+ (30 micrograms).

Based on the information presented by the FDA, the Centers for Disease Control and Prevention (CDC), and Pfizer BioNTech, VRBPAC voted 17-0 that the benefits of administering the pediatric Pfizer vaccine outweighed the risks for children ages 5 to 11. In addition to preventing COVID-19 illnesses and hospitalizations among children, the committee noted that the vaccine could address other negative impacts of the disease on children in this age group, such as:

If the FDA approves Pfizer’s EUA request:

  • The CDC’s Advisory Committee on Immunization Practices (ACIP) would review the FDA’s evaluation and make recommendations regarding which children should receive the vaccine. The ACIP is expected to meet Nov. 2-3.
  • The CDC director will review ACIP recommendations and provide formal guidance on the use of the Pfizer vaccine in children 5-11 years old.
  • The Western States Scientific Safety Review Workgroup will assess the CDC guidance in light of the data, and provide their recommendations to the Governors.
  • Oregon Health Authority (OHA) would then establish state guidance and policy regarding the administration of the Pfizer vaccine to youth ages 5 to 11 in Oregon.

When COVID-19 vaccines become available to younger children, OHA anticipates that they will be widely available in clinics, community health centers, and pharmacies. OHA is also working with the Oregon Department of Education, local public health authorities, the health care industry, pharmacies, community-based organizations and other vaccine providers to make vaccines readily available at public and private schools, childcare facilities, community sites, and other locations easily accessible to families and education providers.  

 OHA is preparing now for the possibility that children in this age group will soon be eligible for vaccination. OHA is collaborating with health care providers, including clinics, pharmacies, community health centers, and health systems, across the state to ensure that the vaccines will be available throughout Oregon on the day vaccinations are permitted for children ages 5 to 11.

To learn more, read how federal decisions on COVID-19 vaccines make their way to Oregon consumers.