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Pfizer Seeks FDA Emergency-Use Approval for Covid Vaccine for Kids 5 to 11

Pfizer and BioNTech have asked U.S. regulators to approve emergency use of their Covid-19 vaccine for children ages 5 to 11.

Shares of Pfizer  (PFE) - Get Pfizer Inc. Report and BioNTech  (BNTX) - Get BioNTech SE Sponsored ADR Report were higher after the health-care giant and its partner asked the U.S. Food and Drug Administration to approve emergency use of their Covid-19 vaccine for children aged 5 to 11.

The move comes at a time when children are heading back to school and infections among this age group have jumped.

At the end of September, nearly 5.9 million children in the U.S. had tested positive for Covid-19 since the pandemic started, according to data from the American Academy of Pediatrics.

Since the pandemic began, children represented 16.2% of total cases. For the week ending Sept. 30, children were 26.7% of reported weekly Covid-19 cases.

The FDA has set a date of Oct. 26 for outside advisers to meet and discuss the Pfizer application, making it possible for kids to begin receiving the vaccines shortly afterward.

Last month, Pfizer submitted data from a late-stage trial of its coronavirus vaccine on children between the ages of 5 and 11.

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Pfizer said the trial, which included 2,268 participants, showed a "favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses" of its vaccine. The vaccine is marketed under the brand name Comirnaty.

Since December of last year, the two-shot Pfizer/BioNTech Covid-19 vaccine has been available for emergency use in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10.

In August, the FDA gave the vaccine full clearance for people 16 and older.

In March, Moderna  (MRNA) - Get Moderna, Inc. Report begun studying its two-shot Covid-19 vaccine in children aged 6 months to 11 years in the U.S. and Canada.

42.74+0.72 (+1.71%)At close: 4:02PM EDT

Shares of Pfizer, rose 72 cents, or 1.7%, to $42.74. Shares of BioNTech ended up $10.43, or 4.4%, at $246.57.