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FDA authorizes Covid-19 vaccines for younger kids

FDA authorizes Covid-19 vaccines for younger kids

The Moderna and Pfizer/BioNTech Covid-19 vaccines are now authorized for emergency use in young children. The U.S. Food and Drug Administration expanded the authorizations for the vaccines Friday (Jun 17) to include children as young as 6 months.

However, shots can't be given until the U.S. Centers for Disease Control and Prevention's vaccine advisers have voted on whether to recommend them – a vote is scheduled for Saturday – and CDC Director Dr. Rochelle Walensky has signed off on that recommendation. The White House has said vaccinations for younger children may begin next week.

Moderna's vaccine is now authorized for use in children 6 months through 17 years and Pfizer/BioNTech's for children 6 months through 4 years. About 17 million kids under the age of 5 are now are eligible for Covid-19 vaccines.

"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. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of Covid-19, such as hospitalization and death," FDA Commissioner Dr. Robert M. Califf said in a news release. "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."

Previously, the Pfizer/BioNTech vaccine was authorized for people 5 and older and approved for 16 and up, and Moderna's vaccine was authorized only for adults.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, called Covid-19 vaccines for younger age groups a "milestone."

"It is a bit of a milestone to bring down the age range for these vaccines as we work through this," Marks said Wednesday in a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee.

In that meeting, the committee members voted unanimously in favor of expanding the authorizations to include children as young as 6 months.

"To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly disease is a very important thing," said committee member Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University.

She compared the day to December 2020, when the first Covid-19 vaccines were authorized for adults and older teens.

"I'm really pleased that we've reached this kind of milestone," said committee member Dr. Ofer Levy, of the Precision Vaccines Program at Boston Children's Hospital, who also likened the moment to when Covid-19 vaccines previously were authorized for other age groups.

"I recall our first vote a year ago or more on the first Pfizer authorization," Levy said. "I was one of the 17 votes in favor. I remember those early discussions – even then, should the 16- and 17-year-olds be included? At that point, that was a controversial topic that was being discussed. And here we are now, as a committee unanimously recommending authorization down to 6 months of age. So we've come a long way."