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Antônio Barra Torres, general director of Anvisa (National Health Surveillance Agency), said today that the federal agency will not participate in the discussions about which vaccine against covid-19 the Ministry of Health can distribute. Currently, both CoronaVac and the Oxford vaccine are candidates for the position, but the lack of definition has even been the subject of a political dispute between President Jair Bolsonaro (without a party) and the governor of São Paulo, João Doria (PSDB).
“The purchase decision is a decision that will be made by whoever signs the check, and it will not come from us,” said the president of Anvisa in an interview with the columnist of the Twitter Carla Araújo and UOL reporter Wanderley Preite Sobrinho.
Last week, Bolsonaro even repudiated Minister Eduardo Pazuello, who had pledged to buy 46 million doses of CoronaVac, the vaccine developed and tested by the Butantan Institute in partnership with the Chinese laboratory Sinovac.
The vaccine, which is developed by the University of Oxford and will be produced by Fiocruz (Fundação Oswaldo Cruz), if approved, will already receive more than R $ 1 billion from the federal government for its development.
For Barra Torres, the definition between vaccines does not go through Anvisa. Last Friday (23), the Agency was responsible for allowing the import of the first 6 million doses of CoronaVac, which will already be ready from China. The other 40 million doses must be produced locally by Butantan, which is linked to the São Paulo government. “I do not comment on the decisions of the politicians,” he replied about the president’s decision not to buy the vaccine despite the fact that Anvisa registered it.
Anvisa’s decision continues until registration is granted. It can affect a ministerial decision, which is who buys and builds the national program.
“Anvisa’s decision was made a long time ago to register or not to register, so it has no impact on us. And what society certainly doesn’t want is to see a regulatory agency meddle with issues that concern you, like a political discussion. So we stay out of the political discussion, whoever comes. “
Political pressure
Regarding the political pressures within the agency, the president responded that they are matters that remain “at the door” of the agency. “There is no political mandate of any kind in our agency, as it should be. Our agency must be guided by ethical and scientific conduct.”
He said he does not see how the political dispute between Bolsonaro and João Doria could affect the approval processes for a vaccine. “I cannot understand why two people who do not work at Anvisa can hinder Anvisa’s work. They are authorities on the political and national management scene who are having national discussions.”
Barra Torres stated that Anvisa is a state body, not a government body. “We have a mandate, we are not like, for example, ministers. The ministers are replaced and the directors of agencies have a mandate signed by the Federal Senate. They are completely different things. So the decisions at the government level are government decisions. decisions at the state level are state decisions. “
Whether or not this drug, in this case the registered vaccine, will be included in the National Immunization Program is a decision of the Ministry of Health, in which we do not participate, we are not called upon to give an opinion.
Release delay
Regarding the accusation made by the Butantan Institute that there was a delay in the delivery of supplies to CoronaVac, Barra Torres denied that this was the case. “It is a position that cannot be sustained. We are not talking about a market list: we are talking about a product that will be injected into people to generate immunity against a dead viral disease.”
When asked about the Ministry of Health’s guidance for doctors to recommend chloroquine for the treatment of COVID-19, he said that it is not for the agency to interfere with the recommendations. “It is not the responsibility of Anvisa to speak absolutely nothing about the policies of the Ministry of Health, nor to speak about the use outside the package.”
This use of chloroquine and others are medications that are used at the discretion of physicians. What I’m saying is just my location as a doctor. As a regulator, Anvisa has no regulation in this regard.
