Pfizer Seeks FDA Approval of COVID Boosters for Children Ages 5-11

Pfizer Inc. announced Tuesday that it has asked the U.S. Food and Drug Administration to approve emergency use of its booster shot for children ages 5 to 11.

The application hinges on a study of 140 children with no evidence of prior coronavirus infection. Their antibody levels against the original strain of the virus were six times higher a month after a booster dose than a month after a second dose, the company said in a news release.

A third dose boosted antibodies against the Omicron variant by 36 times in children ages 5-11, the companies reported earlier this month..

An initial two-dose series of the Pfizer vaccine was authorized for that age group in October.

First boosters of the vaccine are authorized for adults and certain immunocompromised youngsters aged 12 and older. Second boosters are authorized for anyone 50 and older.

The effectiveness of two doses of the Pfizer vaccine in preventing infection in children ages 5-12 fell from 68% to about 12% during the Omicron surge, but still provided protection against severe illness, according to studies by the U.S. Centers for Disease Control and Prevention and the New York State Department of Health.

Children younger than 5 are the only age group in the United States for which a COVID-19 shot is not authorized, but Pfizer is conducting worldwide clinical trials with more than 100,000 children ages 6 months to 12 years, and plans to submit data to a number of regulatory agencies for authorization in the coming weeks, CNN reported.

More information

Visit the U.S. Centers for Disease Control and Prevention for more on COVID vaccines for kids.

SOURCE: Pfizer, news release, April 26, 2022; The New York Times

Source: HealthDay