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Brazilian regulatory agency approves definitive use for Pfizer vaccine against COVID-19

Although the Pfizer vaccine is the first to obtain a definitive registration in the country, the Brazilian federal government has no acquisition agreement with the North-American company

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  • In the order filed with Anvisa on February 6, Pfizer called the immunizer now approved Cominarty;
  • In December last year, the company had already said that it would not place the order for emergency use because, among other issues, it considered the necessary information for this to be so complex that requesting the final registration could be a “faster” process.

The Brazilian health regulatory agency, Anvisa, granted this Tuesday the definitive registration to Pfizer‘s vaccine against COVID-19, developed in partnership with the German laboratory BioNTech. According to the director-president of the regulatory agency, Antônio Barra Torres, the analysis for the immunizer’s definitive approval took 17 days.

Although the Pfizer vaccine is the first to obtain a definitive registration in the country, the Brazilian federal government has no acquisition agreement with the North-American company.

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In the order filed with Anvisa on February 6, Pfizer called the immunizer now approved Cominarty. In December last year, the company had already said that it would not place the order for emergency use because, among other issues, it considered the necessary information for this to be so complex that requesting the final registration could be a “faster” process.

To date, two vaccines have been approved for emergency use in Brazil: CoronaVac, from Chinese Sinovac, tested and produced locally in partnership with the Butantan Institute; and Oxford/AstraZeneca, from the AstraZeneca laboratory, which also has a local partnership for testing and production, with the Oswaldo Cruz Foundation (FioCruz). The latter also has a definitive use request in progress at Anvisa.

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According to information provided by Pfizer to Agência Brasil, 2,900 volunteers participated in clinical trials of the vaccine in Brazil. The results of the third and final phase of testing for the immunizer, released in November, showed 95% effectiveness against the new coronavirus (COVID-19).

Among the authorities endorsed by the Pan American Health Organization (PAHO), Anvisa is the first to grant the definitive registration of a vaccine against COVID-19, which should also pave the way for other countries in Latin America and the Caribbean to do the same.

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