Pfizer seeks FDA approval of COVID-19 boosters for children ages 5 to 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 years.
The application hinges on a study of 140 children with no evidence of prior COVID-19 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 to 11 years, 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 years and older. Second boosters are authorized for anyone 50 years and older.
The effectiveness of two doses of the Pfizer vaccine in preventing infection in children ages 5 to 12 years fell from 68 percent to about 12 percent 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.
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