The National Health Surveillance Agency (Anvisa) approved the definitive registration of Janssen’s vaccine against Covid-19. The vaccine, which was already approved for emergency use since March 31, 2021, received the definitive registration today (5).
Janssen is the last of the vaccines applied in Brazil to receive the definitive registration. Pfizer/BioNTech, AstraZeneca/Oxford and Coronavac already have their definitive records approved by Anvisa.
Janssen’s vaccine, which is a single dose, can be given either as a first dose or as a booster dose.
Responsible for the General Management of Medicines and Biological Inputs at Anvisa, Gustavo Mendes explains that the registration represents the gold standard for evaluating a medicine.
“It is the consolidation of the analysis of the best available data and in a complete way, with more robust information from quality, efficacy and safety studies, as well as the risk mitigation plan and the adoption of monitoring measures. With the registration, the population receives a certificate that the product has passed requirements comparable to those of the best regulatory agencies in the world”, says the specialist.
Janssen’s immunizer is indicated for people aged 18 years or older and is applied in a single dose of 0.5 ml. A booster dose of 0.5 ml can be given at least 2 months after the first dose.
