Pfizer completes application to FDA for vaccine for children under 5 - Upsmag - Magazine News

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 five years old.

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’s emergency use authorization to include children under the age of five years old, and Pfizer said that their clinical data would be reviewed during that meeting.

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

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

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 US has seen rising cases in recent weeks, though still well below levels seen in previous COVID waves, such as last winter’s omicron spike.

Peter Sullivan contributed to this report.

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 five years old.

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’s emergency use authorization to include children under the age of five years old, and Pfizer said that their clinical data would be reviewed during that meeting.

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

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

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 US has seen rising cases in recent weeks, though still well below levels seen in previous COVID waves, such as last winter’s omicron spike.

Peter Sullivan contributed to this report.

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