FDA Postpones Possible Authorization Of Vaccines For Kids Under 5

(Photo by Shawn Thew-Pool/Getty Images)

Dylan Housman Healthcare Reporter
Font Size:

The Food and Drug Administration (FDA) announced Friday it is postponing a meeting of its vaccine experts to consider authorizing Pfizer’s COVID-19 vaccine for kids under age five.

The FDA said it was notified by Pfizer that “new data recently emerged” and that this delay will give the agency more time to review the trial results on a three-dose vaccine series for children aged six months through four years. Pfizer’s initial trial results indicated that a two-dose COVID-19 vaccine did not generate a strong immune response in kids aged 2-4.

Pfizer submitted a request for Emergency Use Authorization (EUA) for its vaccine in young children in early February at the request of the FDA. That was despite the fact that its data showed the two-dose regimen lacked efficacy and that it would take until April for the company to have full data on a proposed three-dose series.

Still, the FDA decided to schedule a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for Feb. 15 to potentially give a green light to the two-dose series while trials were completed for data on the third dose. With today’s announcement, that meeting is now off the calendar.

“We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation,” the agency said in a statement. (RELATED: Study: COVID-19 Can Lead To Long-Term Heart Trouble, Especially In Severe Cases)

Children under age five remain the only group of Americans who are not authorized to get vaccinated against COVID-19. They also remain among the least likely Americans to face serious risks from the virus. Just 412 children under age five have died with COVID-19 during the pandemic in America, out of more than 900,000 total American deaths, according to the Centers for Disease Control and Prevention (CDC).