The Food and Drug Administration announced on Friday that it would postpone authorization of the Pfizer-BioNTech Covid vaccine for children under the age of five, and instead wait for results from Pfizer’s clinical trials to include a third vaccine dose for young children.
The FDA said in a statement that it is delaying a vaccine advisory-panel meeting, initially scheduled for Tuesday, meant to debate authorization of the Pfizer vaccine for the age group.
“Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” read the statement.
Children in Pfizer’s clinical trials have received one-tenth the Covid vaccine dosage given to adults. The vaccine did not produce the desired amount of antibodies in children ages two to four but did in those younger than two, while no safety concerns were identified, multiple officials told the New York Times.
Pfizer and BioNTech said results from clinical trials regarding a third dose for young children will be available in April.
“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said in a statement. “The companies expect to have three-dose protection data available in early April.”
Children under age five, about 18 million Americans, are the only age group for which a Covid vaccine is not authorized. Children are at much lower risk of complications from Covid than adults and especially seniors, although close to 300 young children have died of Covid since the pandemic began, according to the CDC.