Pfizer on Thursday formally applied for emergency use authorization with the Food and Drug Administration for a smaller dose of its COVID-19 vaccine for use in children aged between 5 and 11.
Thursday's announcement was expected, as just over a week ago, the company submitted Phase 2/3 trial data to the FDA that showed children developed virus-fighting antibodies about as well as adults who received two typical shots of the vaccine.
The FDA and the Centers for Disease Control and Prevention will continue to review Pfizer's data. The shots will eventually need approval from the FDA's Vaccines and Related Biological Products Advisory Committee and the CDC's Advisory Committee on Immunization Practices, as well as both agencies as a whole before emergency use authorization is approved.
Pfizer's COVID-19 vaccine already has full approval for people aged 16 and up — the only vaccine thus far to receive full approval in the U.S. The vaccine is currently approved for emergency use authorization for people aged between 12 and 15.
Pfizer said last week that it planned to release data on studies of its COVID-19 vaccine in young children and babies by the end of 2021.
