Pfizer and BioNTech on Tuesday submitted an application to the Food and Drug Administration (FDA) requesting authorization to administer a booster dose of their COVID-19 vaccine to children aged 5-11.
In its announcement, Pfizer cited data from a Phase 2/3 trial which it says indicated a “strong immune response” in the younger age group after a booster dose was administered six months after primary immunization with its COVID-19 vaccine.
The companies intend to submit the same data to other regulatory agencies around the world, including the European Medicines Agency.
A booster dose of Pfizer’s COVID-19 shot has been authorized for adults since September, with over 100 million people since receiving an additional shot, according to the Centers for Disease Control and Prevention. However, about half of the people who are eligible for a booster half not gotten one yet.
Pfizer-BioNTech COVID-19 booster doses for children as young as 12 have been authorized by the FDA since January
According to the most recent data from the CDC, 28.4 percent of children 5-11 are considered to be fully vaccinated in the U.S., while another 35 percent have received their first dose of a vaccine. Nearly 60 percent of children 12-17 are fully vaccinated.
Pfizer’s application to authorize boosters for children comes about a month after the FDA approved a second booster dose of the company’s vaccine for adults over 50 and immunocompromised individuals as young as 12.
COVID-19 vaccines are still not authorized for children under the age of five in the U.S. The Biden administration has recently indicated the FDA will consider both Pfizer’s and Moderna’s requests for coronavirus vaccine administration for this age group later in the summer, possibly in June.