Pfizer Submits Emergency Vaccine Request to FDA for Children Under 5

Duncan Barnes, 1, is held by his mother, Jennifer Barnes, while receiving a vaccine for sw
John Amis/AP
Simon Kent

Pfizer announced Wednesday it has completed an emergency submission to the U.S. Food and Drug Administration (FDA) to administer its three-dose coronavirus vaccine to children under the age of five.

Pfizer said in a statement 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 Hill reports.

The request came just days after Pfizer/BioNTech published clinical trial results indicating three low-dose shots of their coronavirus vaccine produces a “strong immune response” among children under five.

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  five, and Pfizer said its clinical data would be reviewed during that meeting.

The U.S. has 18 million young children who would be eligible.

If the FDA decides to authorize vaccines for younger children after the hearing and the Centers for Disease Control and Prevention’s independent advisers agree, it could mean vaccines could be available for that cohort by July 1.

Pfizer’s shots are reportedly three micrograms each, one-tenth the dose offered to adults, while Moderna’s shots are 25 micrograms each, one-quarter of its adult-sized dose.

The FDA said it plans to review the application “as quickly as possible” but could not give a timeframe for when it would be done, ABC News reported.

Follow Simon Kent on Twitter: or e-mail to: skent@breitbart.com

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