Doria wants to apply Coronavac without Anvisa registration, as long as it has the backing of other countries – Money Times



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João Doria, Governor of São Paulo
At the moment, CoronaVac has not yet received a request for regulatory approval in any country (Image: REUTERS / Amanda Perobelli)

A CoronaVac, vaccine against COVID-19 Chinese Sinovac which is being tested on Brazil skin Butantan Institute, it can be applied in the country even if the registration of the National Sanitary Surveillance Agency is not obtained (Anvisa), as long as it receives approval from regulatory agencies in other countries, the governor of São Paulo said Thursday, João Doria (PSDB), in an interview with the Metropoles portal.

He also said that Anvisa is under suspicion of political interference from the Planalto Palace and, although CoronaVac has not yet presented the preliminary results of its Phase 3 clinical study, it said there is no other avenue for the agency other than to register for the vaccine. , which has not yet been requested.

“There is no other way than to release (CoronaVac) within the criteria that Anvisa has, which are the same criteria as the international protocols of other health surveillance agencies that are also evaluating the CoronaVac vaccine, in the United States, in Europe, especially in Asia. These agencies, if they validate the vaccine, it will be valid independently of Anvisa itself ”, he said.

At the moment, CoronaVac has not yet received a request for regulatory approval in any country.

This week it was announced that the minimum number of study volunteers infected by Covid-19 was reached to perform a first reading on the effectiveness of the immunizer, which should occur in the first week of December, with the results evaluated by an independent international committee. .

Doria said, however, that CoronaVac will “certainly” have an efficiency of between 90% and 95%, although this data is not yet available.

Asked if the vaccine could be applied in Brazil, even without Anvisa registration, but with the approval of agencies in other countries, Doria told the portal that it could.

“It can (apply). There is an international understanding and acceptance, in fact, supported by the World Health Organization that in this case, in the face of a pandemic, in this case yes ”.

Doria criticized Anvisa’s decision this month to briefly stop testing CoronaVac, after reporting a serious adverse event in a volunteer, who later turned out to be a volunteer who committed suicide.

Butantan said the episode had nothing to do with the vaccine.

The governor said it was “a sad episode” in Anvisa’s history and that President Jair Bolsonaro, his political opponent, “influenced” Anvisa’s decision and said the episode put the agency under suspicion.

“The only thing we did not expect is that there could have been an intervention and, in fact, there was. There are clear suspicions that there was an intervention by the Planalto Palace with Anvisa. In fact, the best proof of this was a publication by President Bolsonaro celebrating: I won and Doria lost, ”he said.

“Today there is a suspicion that Anvisa may suffer political interference from the Planalto Palace and not be an independent agency as it should be, as it should be,” Doria told the portal.

Wanted, Anvisa did not immediately comment on Doria’s comments.

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