Pfizer and its partner BioNTech submitted on Monday a request to the US Food and Drug Administration (FDA) seeking emergency use authorization (EUA) of its bivalent COVID-19 booster shot for children between the ages of 5 and 11.
Pfizer’s 10 microgram dose of its omicron-specific booster – one-third of the 30 microgram dose that was authorized for adults in August- is currently authorized only for use in those 12 and older.
The company supported its EUA request with safety and immunogenicity data as well as non-clinical and pre-clinical data.
Just days before, Moderna, whose booster shots are currently authorized for adults only, also requested FDA authorization for its updated dose to be used in children as young as 6.
The FDA gave the bivalent boosters the green light without waiting for full human clinical trials to be completed, unlike previously authorized doses, going instead off of animal data as is the case with annual flu shots.
According to health experts and researchers, the updated doses should still be considered safe based on the numerous findings that have demonstrated the vaccine’s safety.
Pfizer noted in its announcement that it has begun a Phase 1/2/3 trial to determine the safety, tolerability, and immunogenicity of different doses of its omicron booster shot while looking into the vaccine’s administration in children as young as six months – including those that have not yet been immunized – through numerous substudies.
Hoping to avoid another surge in COVID cases during the fall and winter, the Biden administration has pushed for people to get updated boosters this season unless they’re recently vaccinated or have been recently infected with the coronavirus. They have been advised to wait a few months, at least two, before getting an updated booster.