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 an announcement quoted by The Hill, 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 on submitting this same data to other regulatory agencies around the world, including the European Medicines Agency.
In September, the FDA authorized a booster dose of the Pfizer and BioNTech vaccine for older adults and some Americans at high-risk of illness.
To date, more than 100 million people have already received an additional shot, according to the Centers for Disease Control and Prevention (CDC). Around half of the people who are eligible for a booster half not gotten one yet.
Pfizer’s COVID-19 booster doses for children as young as 12 have been authorized by the FDA since January.
The company’s application to authorize boosters for children comes about a month after the FDA authorized a second booster dose of the company’s vaccine for people over 50 and immunocompromised individuals as young as 12.
Pfizer and BioNTech have also recently begun enrollment for a clinical trial to test the safety and immune response of their Omicron-specific COVID-19 vaccine in adults aged up to 55.
Pfizer CEO Albert Bourla said in January that the vaccine that targets the Omicron variant of COVID-19 will be ready in March, and the company has already begun manufacturing the doses.