Anvisa says that ‘the approval of the vaccine by the Chinese regulatory authority’ does not release application in Brazil | Vaccine

“(…) it is important to clarify that the tacit recognition of the approval of other agencies to register vaccines here in Brazil is not foreseen by law and may represent a risk for the Brazilian population,” the agency said.

• 4 of the 11 vaccines in phase 3 trials have already shown satisfactory efficacy rates; see comparison

The note was released by Anvisa after an interview with João Doria (PSDB), governor of São Paulo, on the Metropoles portal on Thursday (26).

The governor affirmed that CoronaVac, a vaccine against Covid-19 from the Chinese Sinovac that is being tested in Brazil by the Butantan Institute, can be applied in the country even if it does not obtain the Anvisa registration, as long as it has the approval of regulatory agencies. from other countries .

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

Doria mentioned that there is an international understanding and acceptance by the World Health Organization (WHO) that the use would be released in a pandemic situation.

Governor of Agency Refunds

In the note released at 4:53 p.m., Anvisa also addresses other points raised by Doria in the interview, which was published early in the morning.

Anvisa denied that it has already received clinical study data from CoronaVac, contrary to one of Doria’s statements.

The agency says it had a meeting Thursday with the Butantan Institute and that it warned the agency that the “information package necessary for the evaluation of the vaccine has not yet been completed by the Institute.”

See the full Anvisa note below:

The National Health Surveillance Agency, through this note, comes to provide the following clarifications to Brazilian society:

The Butantan Institute did not release the results of any phase of the human clinical research to Anvisa.

So far, Anvisa has only received preclinical data, which is data prior to human testing, contrary to what was claimed that data related to phase 3 had already been released.

In a meeting held between the Agency and the Butantan Institute, this Thursday (11/26), Butantan stated that the Institute has not yet completed the information package necessary for the evaluation of the vaccine.

Anvisa reports that the eventual approval of a vaccine by the Chinese regulatory authority does NOT imply automatic approval for Brazil.

The CoronaVac vaccine is NOT being tested in the US or Europe.

The CoronaVac vaccine is being tested in China, Turkey, Indonesia, and Brazil.

The aim of registering vaccines by Anvisa is to guarantee the Brazilian population that the technical requirements necessary for the manufacture and massive use of the vaccine are met.

Even after registration in some other country, Anvisa’s evaluation is necessary to verify points that are not evaluated by other international agencies, such as:

1. Evidence that the vaccine is effective and safe in Brazilians.
2. Technical-operational conditions of the vaccine factory that will arrive in Brazil.
3. Terms of validity and quality measures for the conservation of vaccines, considering the climatic conditions of our country.
4. Measures to monitor and treat vaccine side effects that occurred in vaccinated people here in Brazil.

Anvisa has adopted a series of measures to avoid rework and unnecessary efforts and, therefore, it is possible to consider analyzes carried out by other agencies for its decision.

However, it is important to clarify that the tacit recognition of approval by other agencies to register vaccines here in Brazil is not foreseen by law and may represent a risk for the Brazilian population.

Anvisa plays an essential role in protecting Brazilians against threats such as emerging infectious diseases, including the Covid-19 pandemic. Thus, the evaluation of vaccines by the Agency goes through a rigorous analysis of laboratory, production, stability and clinical data to guarantee the safety and efficacy of these products. We clarify that, currently, there are no vaccines available for the prevention of Covid-19 registered in Brazil.

Finally, the National Health Surveillance Agency, an organ of the Brazilian State, remains committed to acting in the interest of public health. “

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