COVID Vaccine for Young Children Clears FDA Committee

Rollout could begin as early as next week pending further regulatory review

June 15, 2022

The much-anticipated authorization of COVID-19 vaccines for young children cleared a key hurdle today.

This afternoon, the FDA’s Vaccines and Related Biological Products Advisory Committee agreed that the Pfizer-BioNTech and Moderna COVID-19 vaccines should be available for emergency use in children 6 months and older. The committee voted unanimously that the benefits outweigh the risks for both vaccines.

During a daylong hearing, the FDA committee reviewed data and heard from company and public health officials about the safety and efficacy of the COVID-19 vaccines for young children.

Moderna has asked for authorization of its COVID-19 vaccine for children between 6 months through age 5, while Pfizer-BioNTech has requested authorization for use in children between 6 months through age 4.

Here’s what you need to know from today’s hearing:

• The next steps:  The FDA will make its final ruling following today’s advisory committee vote. The CDC’s Advisory Committee on Immunization Practices will meet on Friday and Saturday to discuss the vaccines for young children. CDC Director Rochelle Walensky will make the final recommendation following Saturday’s meeting, marking the final step before the COVID-19 vaccines can be administered to children 6 months and older.
• Topics of discussion:  Much of today’s discussion centered around the differences between Moderna and Pfizer-BioNTech’s vaccines for young children, the relative risks from COVID-19 infection, and the latest clinical trial data.
• Last remaining age group:  Children under 5 are the last group for which the COVID-19 vaccine is not available. In the under-5 demographic, the burden of severe disease for COVID-19 was comparable to influenza, the panelists said.
• Dosage for young children:  Pfizer-BioNTech’s three-shot vaccine uses a dosage that’s one-tenth the size of the adult dosage. Moderna’s two-dose vaccine for young children under 6 is 25 micrograms. That’s compared to the 100-microgram dose for adults.
• Slow demand:  COVID-19 vaccine uptake among younger children has lagged behind other age groups, with less than 30 percent of children between 5 and 11 completing the vaccine series. 

Yesterday, the FDA advisory committee recommended Moderna’s COVID-19 vaccine should be available for children between 6 and 17 years old. The dosages would be smaller for children between 6 and 11 (50 micrograms) than for children between 12 and 17 (100 micrograms). Following further regulatory review and approval, the two-dose Moderna vaccine would join Pfizer-BioNTech’s as an option for children in these age groups.

HAP will continue to monitor COVID-19 public health developments and provide updates to members and the general public. In addition, HAP encourages everyone to learn more about the safety and efficacy of the COVID-19 vaccines and make an appointment in your community if you are not up to date on your vaccines.

A replay of today’s meeting, as well as the presentations, is available online.