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: “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.
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: “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 will likely sign off on the authorization.Go deeper… FDA committee recommends COVID shots for kids as young as 6 months
Source : Axios