The United States Food and Drug Administration (FDA) authorized this Tuesday the emergency use of Pfizer Inc. and BioNTech SE vaccines for children aged 5 to 11 years to receive the vaccine booster against covid-19.
The authorization allows all children in that age group who completed the first vaccination schedule at least five months ago to be eligible to receive a third dose of the Pfizer-BioNTech vaccine.. Until now, only children over the age of 12 and adults were eligible for the booster.
The drugmakers applied for authorization based on a study submitted to the agency in late April showing that a third dose is safe and can significantly increase antibody levels, counteract declining immunity and provide additional protection against the virus, including the omicron variant in this age group.
The authorization was disclosed in a press release issued by FDA Commissioner Dr. Robert Califf:
While it has largely been the case that Covid-19 tends to be less severe in children than adults, the omicron wave has led to more children getting sick and being hospitalized. And children can also experience longer-term effects, even after initially having mild illness. The FDA authorizes the use of a single booster dose of the Pfizer-BioNTech vaccine against covid-19 for children 5 to 11 years of age, in order to provide continuous protection against the virus.
– Dr. Robert Califf, FDA Commissioner
The FDA said it did not seek input from its outside advisers on the decision, as the agency said the committee had previously discussed the issues and no new questions were raised.
According to data compiled by the Centers for Disease Control and Prevention, only 28 percent of children ages 5 to 11 have received the first two doses. Between 0.1 and 1.5 percent of childhood coronavirus cases resulted in hospitalization, according to data from the American Academy of Pediatrics.
Advisors on vaccine practices from the Centers for Disease Control and Prevention will meet this Thursday to discuss the implementation of vaccine boosters for this age group. The agency director has the final word on the administration of vaccines.