BRASILIA (Reuters) – Pfizer Inc has asked Brazil’s health regulator Anvisa to approve the application of a third dose of its Comirnaty vaccine against COVID-19 and change the package insert to include the booster option, the agency said on Tuesday.
The booster request would apply to all age groups that the vaccine is currently used for, from 12 years and up.
The study Pfizer presented on the safety of the booster dose to back up its request included the participation of Brazilian volunteers, along with volunteers from the United States and South Africa, the regulator said.
Anvisa has 30 days to study Pfizer’s request.
(Reporting by Anthony Boadle; Editing by Aurora Ellis)
