FDA Authorizes Pfizer And Moderna COVID Vaccines For Children Under 5

The Food and Drug Administration on Friday approved Pfizer and Moderna COVID-19 vaccines for emergency use in children under the age of 5, a monumental step for parents who have spent the past two years buffeted by day care and school closures while taking strict precautions for the health of their kids.

Shots could be in toddlers’ arms before the end of June, pending approval from the Centers for Disease Control and Prevention.

Moderna’s vaccine was also authorized for school-aged children and teens, adding another option alongside Pfizer for those age groups, The Associated Press reported.

Children under 5 remain the only people in the U.S. who aren’t eligible for a COVID-19 vaccine, leaving them especially vulnerable to the virus amid a nationwide surge in the omicron variant, which infected children in record numbers.

Moderna applied for FDA approval for its 25-microgram, two-dose regimen in late April. Data from a vaccine study of 6,700 children under the age of 6 showed that its effectiveness against omicron was similar for children and adults, the company said.

The Pfizer-BioNTech vaccine will be administered via three shots of a much smaller, 3-microgram dose for younger children, compared to the pediatric formulation of 10 micrograms approved for children ages 5 to 12. (Teens and adults, meanwhile, get 30 micrograms per shot.)

In a rare move, and at the urging of federal regulators, Pfizer initially sought approval in early February for a two-dose regimen ― even as data from a 2021 trial suggested three doses would likely be required for a strong immune response.

“We know that two doses isn’t enough, and we get that,” a source familiar with the FDA’s thinking told The Washington Post at the time. “The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”

But Pfizer withdrew the application a week later, saying it would prefer to wait and request approval for all three doses at once.

In addition to vaccinating the youngest Americans, we need to do a better job of vaccinating older children. According to the CDC, just 20% of children ages 5 to 11 have received two doses of the vaccine, while 55% of children 12 to 17 have.

This is a developing story. Please check back for updates.

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