BRIEF—EU and US regulators consider Comirnaty booster for children

Pfizer and BioNTech have completed a submission to the European Medicines Agency to broaden the label for Comirnaty, to include a booster dose for children aged five to eleven.

The bivalent booster is designed to target the Omicron BA.4 and BA.5 strains of the novel coronavirus.

The firms have also recently submitted for Emergency Use Authorization (EUA) for the booster in this age group in the USA.

Pfizer and BioNTech have also initiated a Phase I/II/III study exploring different doses and regimens of the booster, in children from six months old.

In the second quarter of 2022, Pfizer reported $8.8 billion in global revenues for Comirnaty, a 13% increase from the same period of last year.