(CMR) The US Food and Drug Administration has authorized the Moderna and Pfizer/BioNTech COVID-19 vaccines for emergency use in children as young as 6 months.
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. However, shots can't be given until the US Centers for Disease Control and Prevention's vaccine advisers have voted on whether to recommend them, and CDC Director Dr. Rochelle Walensky has signed off on that recommendation. The vote is expected to take place on Saturday.
The White House has said vaccinations for younger children may begin next week, CNN reported.
“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.
“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,” he added.
Previously, the Pfizer/BioNTech vaccine was authorized for people 5 and older and approved for 16 and up, and Moderna's vaccine was allowed 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 to expand 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.