Pfizer is asking the FDA to approve the third dose for children ages 5 to 11 years

Dr. Sandra Hughes is preparing to administer a first dose of the Pfizer-BioNTech coronavirus vaccine (COVID-19) to Elise Langevina, 6, of Storrs, Connecticut, USA, on November 3, 2021.

Michelle McLoughlin | Reuters

Pfizer on Tuesday asked the Food and Drug Administration to approve a third dose of its Covid vaccine for children ages 5 to 11 years.

The application comes after Pfizer earlier this month released data from a small laboratory study of blood samples from 30 children in the age group, which showed a 36-fold increase in antibody levels to the omicron variant compared to two doses of the vaccine.

The booster shot is a dose of 10 micrograms, the same level as the primary vaccination series. The third shot did not show any new security issues in the attempt, according to Pfizer.

The FDA previously approved Pfizer booster doses for teens ages 12 to 15 in January when the omicron variant swept into the country. The protection that vaccines provide against infection has decreased over time, especially with omicron, which is able to avoid the antibodies that block the virus from infecting human cells. However, the vaccines still provide strong protection against serious illness.

It is unclear whether the FDA’s advisory committee will meet to discuss the data and make a recommendation. The FDA did not convene meetings of the external expert panel until they approved third shots for children ages 12 to 15 in January and fourth shots for people ages 50 and older last month.

Several members of the FDA panel as well as the Centers for Disease Control and Prevention’s advisory committee have criticized the agencies for repeatedly going ahead with extended booster eligibility without consulting them.

This is breaking news. Please come back for updates.

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