FDA expands authorization of COVID-19 vaccines to kids as young as 6 months

By Jonna Lorenz
The U.S. Food and Drug Administration on Friday authorized COVID-19 vaccines for children as young as 6 months. File Photo by Debbie Hill/UPI
The U.S. Food and Drug Administration on Friday authorized COVID-19 vaccines for children as young as 6 months. File Photo by Debbie Hill/UPI | License Photo

June 17 (UPI) -- The U.S. Food and Drug Administration on Friday expanded the emergency use authorization of Pfizer-BioNTech and Moderna COVID-19 vaccines to include children as young as 6 months.

The U.S. Centers for Disease Control and Prevention is to vote Saturday on whether to recommend the shots, which could become available for kids under 5 as early as next week, pending CDC Director Rochelle Walensky's approval.


"We know that many parents, caregivers and clinicians have been anxiously awaiting today's authorizations," FDA Commissioner Dr. Robert M. Califf said during a virtual news conference.

"We're acutely aware of the importance of having vaccines available for our youngest children. And as we've seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes of COVID-19 such as hospitalization and death."

The Moderna vaccine was authorized for children ages 6 months through 17 years. It includes a two-dose series at 25 micrograms for children 6 months to 5 years, 50 mcg for ages 6-11 and 100 mcg for ages 12 and older.


The Pfizer-BioNTech vaccine was authorized for a three-dose primary series for children ages 6 months through 4 years.

"Parents and caregivers can have confidence that these vaccines have been thoroughly evaluated and meet the FDA standards for safety and effectiveness," Califf said.

The Moderna vaccine was shown to be 50.6% effective in preventing COVID-19 among children ages 6 months to 2 years and 36.8% effective for kids ages 2 to 5. The Pfizer-BioNTech vaccine was found to be about 28% effective in preventing disease after two doses, but could be as high as 80% after three doses.

The FDA also said both vaccines were evaluated to be safe. The most common side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes, nausea, vomiting and fever.

Califf and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said slight differences exist between the two vaccines, but they would give children in their families whichever vaccine is available.

"I would say parents should feel comfortable getting either one of these vaccines to their children," Marks said. "They each have their own nuanced benefits and risks compared to each other.

"It may be that the Moderna vaccine brings an immune response slightly more rapidly. On the other hand, the three-dose Pfizer regimen may also bring a greater immune response after the third dose, and there are some subtle differences in the safety profile. But again these are relatively subtle."


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