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Pfizer and BioNTech request vaccine authorization for children under 5 years of age

2/1/2022, 10:12:34 PM


Pfizer and BioNTech are seeking emergency use authorization for their two-dose COVID-19 vaccine for children 6 months to 5 years of age.

Pfizer advances with vaccine for 6-month-old babies 0:40

(CNN) --

Pfizer and BioNTech are seeking emergency use authorization for their two-dose COVID-19 vaccine for children ages 6 months to 5 years, the companies said Tuesday.

The Pfizer/BioNTech vaccine is already licensed for use in people 5 years of age and older and would be the first COVID-19 vaccine available for the little ones.

The companies continue to test a three-dose version of the vaccine in this younger age group.

In December, Pfizer expanded testing of its vaccine in younger children after two doses of the children's vaccine failed to produce the expected immunity in those 2 to 5 years old, though it did in infants as young as 2 years old.

For people over 12 years of age, the Pfizer/BioNTech vaccine dose is 30 micrograms of vaccine, and for children 5 to 11 years of age, it has been reduced to 10 micrograms.

The dose for younger children is even lower: 3 micrograms per dose.

CNN reported Tuesday that federal regulators have encouraged Pfizer to seek authorization for the two-dose vaccine, and they hope that authorization can be granted by the end of February.

Waiting for data on three doses could extend the wait into March.

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"If the goal of the vaccine is to get baseline immunity in children, to prevent really bad outcomes, and you're not using the vaccine as a tool to prevent infection in the first place, two doses might do it," Dr. Scott said. Gottlieb, a former FDA commissioner and current Pfizer board member, on CBS this Sunday.

"I think that may be why federal health officials are reconsidering this."


CNN's Carma Hassan and Amanda Sealy contributed to this report.

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