FDA authorizes vaccine for youngest children

The long-awaited COVID-19 vaccine for children as young as 6 months old is now one step away from being available, which could be as early as June 21. 

On June 17, 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.

 

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