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The Upcoming Review of COVID-19 Vaccines and Young Children

Much-anticipated regulatory review of Pfizer-BioNTech and Moderna vaccines for young children scheduled for June

May 23, 2022

Next month, federal regulators will begin the review of Moderna’s and Pfizer-BioNTech’s COVID-19 vaccines for use in young children.

Today, Pfizer-BioNTech announced it was submitting new clinical trial data indicating its vaccine was more than 80 percent effective for children between 6 months and 5 years old during the Omicron wave. The announcement comes after Moderna said it was finalizing its submissions to the FDA last month.

“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” Albert Bourla, chairman and CEO of Pfizer said in a statement.

Here’s what you need to know:

  • The Process:  The advisory board for the FDA will review the safety and efficacy of the vaccines before they are authorized for use in young children. The CDC also will need to endorse the recommendations before the vaccines are publicly available in this age group.
  • Key dates:  Thus far, Moderna’s vaccine has only been authorized for use in adults. On June 14, the FDA’s advisory committee will review Moderna’s application for use in children between ages 6 and 17. On June 15, the committee will review requests from Moderna for use in children between 6 months through age 5, and from Pfizer-BioNTech for use in children between 6 months through age 4.
  • Smaller doses:  Pfizer-BioNTech’s three-dose regimen uses a 3-microgram dose that is one-tenth the size of the adult dosage. Moderna is seeking approval for a two-dose vaccine for children under 6 that is 25 micrograms. That’s compared to the 100-microgram dose for adults.
  • Vaccination in children lags: Nationally, fewer than 30 percent of children between 5 and 11 have completed the initial series.
  • Quotable:  “We know parents are anxious for us to determine if these vaccines are safe & effective. In light of the disclosure by Pfizer re: their data & anticipated dates for submission, we believe that we will complete review of both EUA requests within days of one another,” the FDA said in a statement today.

HAP will continue to monitor the latest COVID-19 public health developments and provide updates to members.

With COVID-19 subvariants leading to a new increase in cases, HAP encourages everyone who is eligible to make an appointment to receive the COVID-19 vaccine or a booster dose. Don’t hesitate to contact your health care provider for questions or for more information about the available vaccines.

More information about COVID-19 vaccines is available online.