Pfizer asked the Food and Drug Administration (FDA) on Tuesday to authorize a third dose of its COVID-19 vaccine for children ages 5 to 11.
The request comes after Pfizer released clinical trial data earlier this month showing blood samples from 30 children in the age group had a 36-fold increase in antibody levels against the Omicron variant compared with two doses of the vaccine.
The booster vaccine is a 10 microgram dose, the same level as the primary vaccination series. The third dose did not show any new safety concerns in the trial, according to Pfizer.
The FDA authorized Pfizer’s booster doses for children ages 12 to 15 in January, when the Omicron variant swept the country.
The protection provided by vaccines against infection has diminished over time, particularly in the context of Omicron, which evades antibodies that prevent the virus from infecting human cells. However, vaccines still provide strong protection against serious diseases.
It is unclear whether the FDA advisory committee will meet to discuss the data and make a recommendation.
The FDA did not convene outside expert panel meetings before authorizing the third injection for children ages 12 to 15 in January and the fourth injection for people 50 and older last month.
Several members of the FDA panel, as well as the advisory committee of the Centers for Disease Control and Prevention (CDC), have criticized government agencies for repeatedly scaling up booster doses without consulting them .
–
