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The National Health Surveillance Agency (Anvisa) officially spoke yesterday (26), through a clarifying note published on its website, about the statement of the governor of São Paulo João Dória on the possibility of applying the CoronaVac vaccine, even without the Brazilian agency registration, provided the drug has been approved in other countries.
According to the regulatory agency, the vaccine registration is intended to meet the technical requirements necessary for the manufacture and use of the immunizer on a large scale. In the note, Anvisa clarifies that, “even after registration in some other country”, the evaluation of the agency is necessary to verify points not evaluated by other international agencies.
As for the points to be analyzed, Anvisa cites: efficacy and safety of the vaccine in Brazilians, technical-operational conditions of the factory that will arrive in Brazil, expiration dates and conditions to preserve the vaccine in view of the Brazilian climate, and measures of accompaniment and treatment. possible side effects of the medicine.
The Governor’s Reply
There is confusion regarding my statement regarding the validation of Coronavac with Anvisa. There is a difference between validating a vaccine outside the country and authorizing its application in national territory.
– João Doria (@jdoriajr) November 26, 2020
In response to Governor Dória’s statements during an interview with the newspaper Metropolis, Anvisa states that since there is no material available yet for the evaluation of the effectiveness and safety of CoronaVac, this would not be the right time to discuss the issue.
After the publication of Anvisa’s note, Governor João Dória used his Twitter account at night, saying that “there is confusion regarding my statement about the validation of CoronaVac with Anvisa. There is a difference between validating a vaccine outside the country and authorize its application in national territory “.
The São Paulo State Secretariat of Health also intervened, noting in a note “that the CoronaVac vaccine will only be available for use in the population with prior authorization from Anvisa.”
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