FDA Delays Decision to Approve COVID Vaccine for Kids Under 5, Citing Need for More Data

An advisory panel to the FDA had been set to meet to discuss approving Pfizer’s vaccine for the youngest age group on Feb. 15

Pfizer-BioNTech vaccine against COVID-19
Pfizer-BioNTech's COVID-19 vaccine . Photo: LUIS ACOSTA/AFP via Getty

The decision on whether to approve a COVID-19 vaccine for use in kids under 5 years old will be further delayed, Pfizer-BioNTech and the Food and Drug Administration announced Friday in a surprise reversal.

Five days before an advisory panel to the FDA had planned to meet and discuss the possibility of approving two doses of Pfizer-BioNTech's vaccine for children 6 months to 4 years old, they decided to wait until there is more data from clinical trials.

Pfizer-BioNTech had announced in December that clinical trials found that two, smaller doses of their vaccine did not create enough of an immune response in the age group, and that they would continue their clinical trials with a third dose.

Despite the results, and amid concern that this youngest age group continues to be unprotected from COVID-19, the FDA encouraged Pfizer-BioNTech to submit that initial data for approval to begin the process of vaccinating kids with the first two doses, while they wait for the data on three doses. Pfizer-BioNTech went through with that plan on Feb. 1, and the FDA's advisory panel was expected to discuss it on Feb. 15.

In a press release, Pfizer-BioNTech said that the trials on three doses of the vaccine "are advancing at a rapid pace" and they and the FDA decided it was best to wait until the data is ready before making a decision.

Those results should be ready in early April, they said.

"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," the companies said.

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The FDA had hoped to approve the initial two-dose vaccine series now to begin the process of vaccinating this youngest age group with pediatric cases and hospitalizations at record highs during the omicron surge. The idea was that by the time kids are ready for a third dose, Pfizer-BioNTech will have completed their clinical trials and it will prove to be effective.

"In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available, including the data that it has recently collected during the omicron surge," the FDA told USA Today at the beginning of February.

One day after Pfizer-BioNTech formally submitted their data to the FDA for approval, Surgeon General Dr. Vivek Murthy reassured parents that it will be thoroughly analyzed.

"Please know that the FDA will not cut any corners in their review process. They know that they are the gold standard that all of us rely on," he said during a White House news briefing on Feb. 2.

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