June 17, 2022 – The FDA authorized Pfizer’s and Moderna’s vaccines for children as young as 6 months, two days after an advisory panel recommended the agency to authorize both options with a 21-0 vote.
Before hospitals, pop-up clinics and pediatrician offices across the nation can inoculate children under 5 with the 10 million doses the federal government has distributed, the CDC has to back the FDA’s authorization. The CDC is poised to decide June 18.
Moderna’s two-dose vaccine is for 6-month- to 5-year-olds and is 25 micrograms each. Pfizer’s three-shot option is geared for 6-month- to 4-year-olds. Both company’s trials reported side effects similar to other populations.
“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 Califf, MD, said in a statement. “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.”
The Moderna vaccine has a 50.6 percent efficacy rate in preventing infection for children 6 to 23 months old, and a 36.8 percent efficacy rate for 2- to 5-year-olds. Pfizer’s showed about an 80 percent efficacy rate in early trials.