Janssen shot granted definitive registration in Brazil

Brazil’s national drug authority Anvisa has approved the definitive registration of Janssen’s vaccine against COVID-19. The inoculation, approved for emergency use since March 31, 2021, received the definitive registration today (Apr. 5).

Janssen is the last of the vaccines applied in Brazil to receive definitive registration. Pfizer/BioNTech, AstraZeneca/Oxford, and Coronavac already have their definitive registrations granted by Anvisa.

Janssen, a single-dose vaccine, may be applied either as the first dose or as booster.

Gustavo Mendes, head of Anvisa’s General Management of Drugs and Biological Supplies, explains that registration stands for high standards in drug assessment.

“It’s the result of the thorough analysis of the best data available—including more robust data from quality, efficacy, and safety studies—in addition to the risk mitigation plan and the adoption of monitoring measures. Registration assures people the product is guaranteed to meet requirements comparable to the world’s best regulatory agencies,” he noted.

The Janssen shot is indicated for people 18 years old or older and is applied in a single 0.5ml dose. A booster dose of 0.5ml can be administered at least two months after the first dose.