Pfizer asks FDA to authorize third dose for children 5 to 11 years old

Dr. Sandra Hughes prepares to administer a first dose of the Pfizer-BioNTech coronavirus vaccine (COVID-19) to Elise Langevina, 6, in Storrs, Connecticut, U.S., November 3, 2021.

Pfizer asked the FDA to approve a third dose of its Covid vaccine for children.

Pfizer released clinical trial data earlier this month showing that blood samples from 30 kids in the age group had a 36-fold increase in antibody levels against the omicron variant compared to two doses of the vaccine.

The booster shot is the same level as the primary vaccine. Pfizer said that the third shot did not show any new safety concerns.

In January, the FDA gave Pfizer booster doses for teenagers as the omicron variant swept the nation. The protection against infections provided by the vaccines has declined over time, particularly in the case of omicron, which is able to evade the anti-viruses that block the virus from infecting human cells. The vaccines provide strong protection against illness.

It is not clear if the FDA's advisory committee will meet to discuss the data and make a recommendation. The FDA did not call meetings of the outside expert panel before authorizing third shots for kids ages 12 to 15 in January and fourth shots for people 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 moving forward with expanded booster eligibility without consulting them.

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