Authorization of Pfizer-BioNTech’s Comirnaty vaccine in the 12- to 16-yearold age group


In May 2021, Chile's Institute of Public Health (ISP), together with a group of experts of the National Immunization Program (NIP) and the Ministry of Health's National Advisory Committee on Vaccines and Immunizations (CAVEI) approved use of the Pfizer-BioNTech COVID-19 vaccine in a new age group, namely, 12- to 16-year-olds. This vaccine had been approved in Chile by the ISP on 16 December 2020 for emergency use. 


On 11 June 2021 the National Health Surveillance Agency (ANVISA) reported that it had authorized Pfizer-BioNTech's Comirnaty vaccine for use in children ages 12 and older. The authorization occurred after reviewing studies submitted by the manufacturing laboratory on the vaccine's safety and efficacy in this age group. The Comirnaty vaccine had initially been licensed for ages 16 and older.


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