Pfizer asks FDA to authorize new COVID booster for children

Pfizer on Monday announced it has submitted an application to the Food and Drug Administration (FDA) seeking authorization of its bivalent COVID-19 booster shot for children between the ages of 5 and 11.

In a press release, Pfizer said it has requested authorization of a 10 microgram dose of its omicron-specific booster for that age group. Pfizer’s bivalent boosters are currently only authorized for use in those 12 and older.

The dosage that Pfizer is asking to be authorized for children is one-third of the 30 microgram dose that was authorized for adults in August.

Pfizer said its decision to request authorization was supported by “safety and immunogenicity data” as well as “non-clinical” and “pre-clinical” data.

Unlike previously authorized doses, the FDA did not wait for full human clinical trials to be completed on the bivalent boosters before giving them the green light, instead going off of animal data, as is the case with annual flu shots. Health experts and researchers have largely said the shot should still be considered safe, owing to the numerous findings from throughout the pandemic that have demonstrated the vaccine’s safety.

In its announcement on Monday, Pfizer noted that it has begun a Phase 1/2/3 trial to determine the “safety, tolerability, and immunogenicity” of different doses of its omicron booster. The numerous substudies that are part of Pfizer’s effort are looking into the vaccine’s administration in children as young as six months, including those who are “vaccine naive” and have not yet been immunized.

Pfizer’s request for authorization of a bivalent booster for children comes just days after Moderna also requested FDA authorization to administer its updated dose to children as young as 6. Moderna’s booster shots are currently authorized for adults only.

The White House has pushed for people to get updated boosters this season in hopes of avoiding another surge in COVID-19 cases during the fall and winter. Recently vaccinated people and those who have been recently infected with the coronavirus have been advised to wait a few months, at least two, before getting an updated booster.