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Home Coronavirus Anvisa approves definitive registration of the immunizer

Anvisa approves definitive registration of the immunizer

Anvisa (National Health Surveillance Agency) today approved the application for the definitive registration of the vaccine against covid-19 produced by Pfizer and Biontech. It is the first authorization of this nature for a coronavirus immunizer in Brazil and throughout Latin America.

This type of authorization allows the pharmaceutical company to sell doses for mass application in the entire Brazilian population. For now, however, the laboratory has not yet signed a sales contract with the Ministry of Health and there are no doses available for application (read more below).

Until now, Anvisa had only approved the emergency use of the CoronaVac vaccines – from the Butantan Institute and the Sinovac laboratory – and Oxford / AstraZeneca. Fiocruz, which produces this second one in Brazil, has also requested the definitive registration, but has not yet been authorized.

As Chief Executive Officer of the National Health Surveillance Agency, I inform you with great satisfaction that, after a seventeen-day review period, the General Management of Medicines, of the Second Board, granted the first registration of vaccine against covid-19, for use in the Americas.
Antonio Barra Torres, president of Anvisa

“The Pfizer / Biontech Laboratory immunizer had its safety, quality and efficacy, assessed and certified by Anvisa’s technical team of servers that continues in its work to protect the health of the Brazilian citizen,” said Anvisa’s president, Antonio Barra Torres, in a collegiate meeting this Tuesday.

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“We hope that other vaccines are soon being evaluated and approved,” he added.

According to Anvisa, registration is not a decision of the collegiate board and only needs publication in the Official Gazette, which should happen in an extra edition today.

“The registration is an act of the general manager of medicines, so his team and he promoted this benefit in this fight against covid-19,” said Barra Torres in reference to director Gustavo Mendes, who coordinated the analyzes at the General Management of Medicines and Biological Products from Anvisa.

Approval announcement was not expected

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Barra Torres’ statement took place at the opening of the 3rd Anvisa ordinary meeting, on the agenda of which the disclosure of Pfizer’s analyzes was not expected.

Before announcing approval, Torres compared Anvisa’s “victory” with the arrival of the Brazilian Army in Italy, during World War II.

“It was on February 21, in 1945, when a group of brave and gallant Brazilians, initially discredited, set foot in Italy in what would today be the greatest armed conflict of all time,” said Torres, who is a Rear Admiral. of the Navy.

“We arrived today, on a Tuesday, which begins under this victorious blessing of February 21 [de 1945]. May others like that come today “, he said.

Negotiation between Pfizer and government is stuck

Brazil has been negotiating with Pfizer since the first half of last year, but the agreement is stuck. The Minister of Health, Eduardo Pazuello, considers that the laboratory imposes “Leonine clauses” on the Brazilian government.

Yesterday, representatives of the pharmaceutical company participated in a session in Congress, and senators volunteered to mediate negotiations with the ministry. During the meeting, the pharmacists indicated that they will not give up the conditions they negotiate with the paste. One of them, for example, is that the government is responsible for eventual legal demands for adverse reactions.

In a statement released, Pfizer said it could not comment on the negotiations with the Brazilian government, but that “the clauses being negotiated are in line with the agreements we closed in other countries in the world including in Latin America”.


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