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The National Health Surveillance Agency (Anvisa) announced on Friday (23) the import of 6 million doses of CoronaVac, a Chinese vaccine that should be produced by the Butantan Institute, in São Paulo.
The decision does not respond to the request of the São Paulo government that it also be allowed to import the supplies necessary for the production of another 40 million doses in Brazil.
The vaccine is currently in the third phase of testing. Sinovac, the Chinese pharmacist responsible for the immunizer, has yet to obtain registration for the immunizer application.
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So far, the São Paulo government has only presented partial data on the safety of the vaccine, but they have not been sent to the agency or published in scientific journals.
Coronavac is the target of political dispute: on Tuesday, the Health Minister announced the negotiation to acquire the 46 million doses. Annoyed, President Jair Bolsonaro ordered the cancellation of the purchase; The ministry said “there is no intention to buy” and replaced the statement on the website.
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46 million doses expected
In total, the São Paulo government signed a contract with the Chinese company Sinovac to purchase 46 million doses of CoronaVac. These first 6 million will come ready from China and the other 40 million will be packaged and labeled at the Butantan Institute with material that will be imported.
Earlier, also on Friday, the director of Butantan, Dimas Covas, said that the schedule stipulated by the São Paulo government is being maintained, regardless of what the São Paulo authorities point to as an Anvisa delay in releasing the import. raw material. from China.
That same day, the agency denied the obstacle and announced the purchase of doses, but the issue of importing the raw material has not yet been clarified.
“At this moment what we care about is the raw material, precisely because the factory, our production line, is waiting for the arrival of this raw material,” said Dimas Covas, in an interview with Jornal Nacional this Thursday (23).
The government of São Paulo also announced on Friday (23) the creation of six new CoronaVac test centers in volunteers. As a result, the total number of places where research is carried out in the country amounts to 22.
CoronaVac is in the third phase of testing. The group of volunteers is made up exclusively of health professionals. So far, 15,000 vaccinations have been given to 9,000 volunteers. Each volunteer receives two doses. With the opening of the new centers, the objective is to expand the survey for a total of 13,000 volunteers.
In this final phase of the research, half of the participants are inoculated with the vaccine and the other half receive a placebo. To determine the effectiveness of CoronaVac, at least 61 participants must be infected with the coronavirus.
If the immunizing agent reaches the necessary levels of efficacy and safety, it can be evaluated by Anvisa (National Health Surveillance Agency) for its registration and subsequent use in the population.
To streamline the process of testing potential immunizers against coronavirus, Anvisa reduced the requirement for initial documentation and simplified the registration process so that study data is sent during work, and not just at the end.
