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The Next Steps for the COVID-19 Vaccine and Young Children

Public health leaders will meet February 15 to review data

February 03, 2022

The COVID-19 vaccine rollout will reach another milestone this month as the nation’s federal public health agencies review Pfizer-BioNTech’s vaccine for use in children 6 months through age 4.

On Tuesday, the U.S. Food and Drug Administration (FDA) announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on February 15 to discuss emergency use authorization (EUA) for Pfizer-BioNTech’s vaccine for children under 5.

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge,” said Acting FDA Commissioner Janet Woodcock, MD.  “Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials.”

Here are five things to know ahead of the FDA review.

  • The process:  The FDA’s committee meeting is a step in the process and would be followed by a review by the Centers for Disease Control and Prevention’s advisory committee. These groups review the available safety and efficacy data before determining whether to authorize the vaccines for emergency use
  • Parental perspectives:  About 31 percent of parents of children under 5 say they would get their child vaccinated “right away,” according to a recent Kaiser Family Foundation Vaccine Monitor. About a quarter said they would “definitely not,” get their child vaccinated and 12 percent would do so “only if required"
  • Two or three doses?:  Pfizer officials said they believe three doses of the vaccine will be needed for children between 6 months through 4 years of age to achieve high levels of protection. Authorization of the two-dose vaccine series will give parents “the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” officials said
  • By the numbers:  About 558,000 doses of the COVID-19 vaccine have been administered in children between 5 and 11, statistics from Philadelphia and the Pennsylvania Department of Health show
  • Quotable:  “As we have done for other COVID-19 vaccine authorizations, this meeting will help ensure that the public has a clear understanding of the data and information the FDA will evaluate as it considers whether to authorize the vaccine,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research

The FDA authorized the Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 during October 2021. The agency recently authorized the use of a single booster dose for those between 12 and 15.

HAP strongly urges those who have not received the COVID-19 vaccine or who are eligible for a booster dose to make an appointment in their community.

HAP will continue to monitor the latest regulatory developments about the COVID-19 vaccine and provide updates to members and the general public.

Additional information about the upcoming meeting is available online.