Brazil grants definitive registration to Pfizer vaccine

This is the first vaccine to be registered definitively in the country

Published in 23/02/2021 - 14:57 By Luciano Nascimento* - Brasília

Brazil’s national sanitary regulator Anvisa today (Feb. 23) granted definitive registration to the vaccine against COVID-19 developed by US pharmaceutical company Pfizer in partnership with German biotech firm BioNTech. The decision was announced by Anvisa Director-President Antônio Barra Torres, who mentioned that the assessment for the approval lasted 17 days.

“The vaccine of laboratory Pfizer/BioNTech had its safety, quality, and efficiency gauged and certified by the technical team of officials of Anvisa, which continues to work to protect the health of Brazilian citizens,” Barra Torres said while making the announcement. “We hope that other vaccines are assessed and approved soon,” he added.

The inoculation is the first to get definitive registration in Brazil. The shot is called Cominarty. The company filed the request for the definitive registration of the vaccine on February 6. The vaccine, however, is yet to be made available in the country.

In December, Pfizer had reported it would not make the request for the emergency use of the vaccine in Brazil, and that it would go ahead with the submission process for a definitive registration directly. At the time, the company said it considered the procedure to be “quicker” and more comprehensive.

Approximately 2.9 thousand volunteers are reported to have taken part in clinical trials of the Pfizer inoculation in Brazil. Throughout the world, participants add up to 44 thousand, at 150 centers across six countries, including South Africa, Germany, Argentina, the US, and Turkey. The results of the third and last phase of the tests, released in November, indicate 95 percent efficiency against the novel coronavirus (COVID-19).

The registration, Anvisa stated, “paves the way for the market introduction of a vaccine with all safeguards, control measures, and obligations stemming from this concession.” Until then, the vaccines approved in Brazil are for emergency use only: CoronaVac, produced by Butantan Institute in partnership with Chinese pharmaceutical Sinovac, and the vaccine produced by the Oswaldo Cruz Foundation (Fiocruz) in cooperation with Oxford University and UK laboratory AstraZeneca.

Among the authorities listed by the Pan-American Health Organization (PAHO), Anvisa declared, the Brazilian watchdog is the first to grant registration to a shot against COVID-19.

The application for definitive registration is the second Anvisa has received for a vaccine against COVID-19. The first was submitted on January 29 for the vaccine developed by AstraZeneca and Oxford University, which has already had its authorization granted for emergency use.

*Andreia Verdélio contributed to this article.

Translation: Fabrício Ferreira -  Edition: Fernando Fraga

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