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Pfizer Postpones Request for FDA Approval of Its Covid Vaccine for Children Under 5

Pfizer postponed its application seeking FDA authorization for its coronavirus vaccine for children five years old and under (Pictures: AFP)

Pfizer has pulled its application to the US Food and Drug Administration (FDA) to expand its two-dose coronavirus vaccine for children under five years old – postponing it for the time being.

The company on Friday said it will wait for its data on a three-dose series of its jab because it ‘may provide a higher level of protection in this age group’. Pfizer expects data on its third dose in early April.

‘The trial in children 6 months through 4 years of age is ongoing and data on the first two,’ Pfizer stated. ‘Doses in this age group are being shared with the FDA on an ongoing basis.’

In December, Pfizer had said that the two-dose series did not generate a strong enough immune response in its trial of kids aged two to four.

Nevertheless, the company in February asked the FDA to authorize the first two doses, and intended to provide additional data on the third dose in the following weeks. Federal regulators initially wanted to start reviewing data as Pfizer continued to study its three-dose series, believing that two doses would provide enough protection against the Omicron variant.

Outside experts had voiced concerns to the FDA that there was not sufficient data from Pfizer and felt their calls were ‘falling on deaf ears’, two sources told NBC News.

On Friday, Dr Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said that regulators reviewed Pfizer’s two-dose data and determined that they needed to see findings from the three-dose regimen before they could consider giving authorization.

Marks added that the FDA takes its ‘responsibility for reviewing these vaccines very seriously because we’re parents as well’.

The FDA was expected to publish an analysis of Pfizer’s data on Friday, before an advisory committee meets next week. But the FDA on Friday said the meeting was postponed.

Pfizer’s vaccine received FDA approval for use on children aged five to 11 in October.

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