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Pfizer completes application to FDA for vaccine for children under 5

Pfizer said on Wednesday that is has completed its emergency use application to the Food and Drug Administration (FDA) to administer its COVID-19 vaccine to children under the age of 5.

Pfizer said in a statement that its application for the vaccine, developed with BioNTech, “includes safety, immunogenicity and efficacy data” from previous clinical research on young children who received a third dose at least two months after their second shot.

The FDA’s vaccine advisory committee is slated to meet on June 15 to look at expanding the Pfizer-BioNTech emergency use authorization to include children under the age of 5, and Pfizer said its clinical data would be reviewed during that meeting.

A decision regarding authorizing the vaccine for children under 5 could be made soon after the meeting.

Last week, Pfizer offered promising signs on the efficacy of its children’s vaccine, saying research showed it was roughly 80 percent effective for those under 5.

Pfizer and BioNTech announced in February that they did not have enough data regarding the third dose’s efficacy for children, delaying their FDA authorization request.

The U.S. has seen rising cases in recent weeks, though they remain well below levels seen in previous COVID-19 waves, such as last winter’s omicron spike.

Peter Sullivan contributed to this report.


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