FDA Delays Approval of Pfizer's COVID-19 Vaccine for Children Under The Age of 5

‘We’re parents as well,’ said FDA’s vaccine chief

Federal regulators delayed Pfizer and BioNTech’s authorization request for their COVID-19 vaccine for children pending more information regarding the effectiveness of a third dose.

The pharmaceutical company had previously asked the Food and Drug Administration to authorize the vaccine for children under the age of 5. 

The FDA postponed a Feb. 15 meeting where experts would have reviewed the company’s data regarding the impact of the vaccine on children.

“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.

“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 added.

Pfizer said in a statement on Feb. 11 that it needed to collect more data as “rates of infection and illness remain high in children of this age” because of the Omicron variant.

Pfizer and BioNTech announced on Dec. 21, 2021 that they would evaluate the effects of a third dose on children under the age of five as part of an ongoing clinical study.

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” Pfizer said.

The company reported that it expects to have the necessary data by early April.

According to CNBC, “Pfizer amended its clinical trial for younger kids in December to study the third shot after the first two doses did not produce an adequate immune response in children 2- to 4-years-old. Younger kids will receive a smaller, three microgram dose compared with the 30 microgram shots that are approved for adults.”

Speaking with the media via teleconference, the FDA’s vaccine chief Dr. Peter Marks said the delay was necessary to ensure a careful review.

“We take our responsibility for reviewing these vaccines very seriously because we’re parents as well,” said Marks.

There are approximately 18 million children under the age of 5 in the United States.

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