FDA Asks Pfizer For More Data On 3rd COVID Shot For Kids Under 5

ACROSS AMERICA — Federal regulators have paused Pfizer-BioNTech’s emergency application to expand access to its COVID-19 vaccine for young children under 5, a setback for parents eager to get children vaccinated and for the Biden administration’s vaccine push to move the country past the pandemic.

The Food and Drug Administration postponed a meeting planned for next week to publicly debate the request to give Pfizer time to collect more data on the efficacy of a three-dose series of the vaccine for children ages 6 months to 4 years. A third dose “may provide a higher level of protection in this age group,” the company said in a statement.

The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. Dr. Peter Marks, the FDA’s vaccine chief, asked their parents to be patient and said the decision to delay approval was part of the agency’s circumspect review and high scientific standards.

“We take our responsibility for reviewing these vaccines very seriously because we’re parents as well,” Marks told reporters in a teleconference.

Pfizer anticipated a third dose would likely be needed based on early data that showed a two-dose course for children 5 and older was less effective at preventing COVID-19 in kids ages 2-5. Adding a third dose to the series is supported by findings that show booster shots significantly improve protection in other age groups, the company said.

Pfizer filed its application with the FDA earlier this month and, on Tuesday, CEO Albert Bourla told CNBC the chances the FDA would approve vaccines for young children were “very high.”

Pfizer said more data is generated daily because infection rates remain high in young children, especially due to the recent omicron surge.

That data is expected in early April.

The FDA didn’t elaborate on the data it is asking Pfizer to provide, except that it involved a third dose.

“We believe additional information regarding evaluation of a third dose should be considered as part of our decision-making,” the agency said in a statement.

The Associated Press contributed reporting.