FDA Approves Pfizer and Modern COVID Vaccines for Children Under 5

FDA Approves Pfizer and Modern COVID Vaccines for Children Under 5

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

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

Moderna’s vaccine has also been approved for school-going children and teens, adding another option along with Pfizer for those age groups, The Associated Press reported.

Children under 5 remain the only people in the U.S. who are not eligible for a COVID-19 vaccine, making them particularly vulnerable to the virus amid a nationwide boom in the omicron variant, which kills children in record numbers infected it.

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

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

In a rare move, and at the urging of federal regulators, Pfizer initially sought approval for a two-dose regimen in early February – even though data from a 2021 trial suggested that three doses would probably be needed for ‘ a strong immune response.

“We know that two doses are not enough, and we get it,” a source familiar with the FDA’s thinking told The Washington Post at the time. “The idea is, let’s go ahead and start reviewing two doses. If the data sticks to the submission, you can start children on their primary baseline months earlier than when you do nothing until the third dose of data arrives. ”

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

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

This is an evolving story. Please come back for updates.

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