According to Anvisa, Janssen vaccine data are the most complete in terms of efficacy, safety and quality.
Approved for emergency use in March 2021, Janssen’s vaccine has now received definitive authorization for its use in Brazil, by the National Health Surveillance Agency (Anvisa). “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”said the head of the Agency’s General Management of Medicines and Biological Inputs, Gustavo Mendes.
JANSSEN VACCINE PRESENTED THE BEST DATA FOR THE DEFINITIVE REGISTRATION
Applied in a single dose to people over 18 years of age, Mendes explains that the Janssen vaccine presented the most complete data for the official record to be determined. “It is the consolidation of the analysis of the best available and complete data, with more robust information from quality, efficacy and safety studies, as well as the risk mitigation plan and the adoption of monitoring measures“.
For a definitive record, Anvisa considers this analysis as the gold standard. Janssen is produced by a serotype 26 adenovirus vector (Ad26.COV2.S). “A 0.5 ml booster dose of the (recombinant) covid-19 vaccine can be given at least two months after the first dose”said the agency, in a note released this Tuesday, 05.
With 75.03% of the Brazilian population completely vaccinated by two doses or a single dose, the agency’s record also applies to the booster dose of applications already carried out with other pharmaceutical companies.. “The vaccine can also be given as a heterologous booster dose (from a different vaccine) to people who have completed their primary vaccination with an mRNA technology vaccine”.
Source: Recreio
