FDA authorizes COVID vaccines for children as young as 6 months

FDA authorizes COVID vaccines for children as young as 6 months

The Food and Drug Administration on Friday authorized both Pfizer-BioNTech and Moderna’s COVID-19 shots for children as young as 6 months.

Why it matters: Some of the youngest Americans are now one step closer to being eligible to receive their vaccinations. Children under 5 are the last group without access to COVID vaccines.

Driving the news: “Today’s decision will help build on this progress, giving parents much-needed relief and peace of mind and helping our nation continue to move forward safely,” President Biden said in a statement on Friday.

  • Pfizer and Moderna shots could start being administered to children younger than 5 years old as early as next week if the CDC signs off in the coming days.
  • “The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine,” the FDA said.
  • The Pfizer vaccine was authorized for children ages 6 months to 4 years, while the Moderna vaccine was authorized for children ages 6 months to 5 years, the FDA said.

What they’re saying: “Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age,” FDA commissioner Robert M. Califf said in a statement.

  • “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data,” Califf said.

What’s next: The CDC’s vaccine advisers are scheduled to vote in the coming days on whether they will recommend the Moderna and Pfizer shots for this age group.

  • If the panel votes on recommending shots, CDC director Rochelle Walensky is likely to sign off on the authorization.
  • Biden said that with the FDA authorization, the administration “will begin shipping millions of vaccine doses for kids to thousands of locations parents know and trust — including pediatricians’ offices, children’s hospitals, and pharmacies.”
  • “As doses are delivered, parents will be able to start scheduling vaccinations for their youngest kids as early as next week, with appointments ramping up over the coming days and weeks,” he said.

Go deeper… FDA committee recommends COVID shots for kids as young as 6 months

Editor’s note: This story has been updated with a statement from President Biden.

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