The authority also approved the import of the “Covaxin” vaccine, which is produced by the private Indian company “Bharat Biotech”.
Although the leadership of “Anvisa” voted by a majority of votes in favor of the decision on “Sputnik V”, which was sought by the governors of six Brazilian states, the Brazilian Interregional Development Federation and the Brazilian laboratory “União Química”, the Director-General of “Anvisa” Gustavo Mendes Lima Santos, said that the authority, Based on the available data, it was unable to confirm the quality, efficacy and safety of the vaccine and required the six states that intend to use it, to “widely inform the public of this fact”.
Among the conditions put forward by Anvisa are the supply of vaccines only from production facilities that have been verified by the regulator, and it also recommended that the vaccine be given to healthy adults only.
Thus, Brazil becomes the 67th country to approve the use of “Sputnik V”, and Kirill Dmitriev, head of the Russian Direct Investments Fund, which is responsible for marketing the vaccine abroad, said that “Sputnik V will arrive in Brazil next July.”
The decision comes after the authority, in late April, refused to import the Russian vaccine based on the recommendation of the technical staff, who at the time indicated “serious” defects and the lack of data guaranteeing its safety and quality.
“From the very beginning, Anvisa was provided with all the necessary documents, and after the decision to postpone the approval of Sputnik V, we did not leave any of the questions raised by the regulator unanswered,” Dmitriev stressed.
Brazil managed to immunize more than 47 million people with at least one dose of vaccines against the virus, which is equal to 22.6% of the population.
The country has recorded about 17 million confirmed cases of coronavirus and more than 470,000 deaths.
