Brazil Approves Pfizer & BioNTech’s Comirnaty

BRASILIA, Brazil – Pfizer and BioNTech’s Comirnaty has become the first COVID-19 vaccine to secure full approval from Brazil’s National Health Surveillance Agency (ANVISA), the agency announced.

Antonio Barra Tores, ANVISA’s CEO, announced, “I am pleased to inform you that, after a seventeen-day review period, the General Management of Medicines, of the Second Board, granted the first vaccine registration against COVID-19, for wide use in the Americas.”

Comirnaty was first registered for approval on February 5, 2021. The company did not seek EUA, but rather full approval, and Comirnaty underwent a complete safety, quality, and efficacy review by ANVISA’s technical team.

Gustavo Mendes, General Manager, Medicines and Biological Products, ANVISA, said, “The company decided to follow the registration path. That is why it became the first vaccine registered. This does not imply that it is safer than other vaccines. Not at all, because it is part of the assessment, both for emergency use authorization and registration, to establish an adequate safety profile for use.”

Results from the third phase of testing show Comirnaty has a 95% efficacy rate against the virus. According to ANVISA, the vaccine has not caused any long-term reactions.

The vaccines from Sinovac and AstraZeneca/University of Oxford have only been authorized for emergency use, allowing temporary use of the vaccine while studies are still in progress, said ANVISA.