In Brazil, Pfizer begins process to register COVID-19 vaccine

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In Brazil, Pfizer begins process to register COVID-19 vaccine

Wednesday, November 25, 2020

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SÃO PAULO, Brazil (AFP) - Pfizer gave the office of Brazil's health regulators results of the tests of their COVID-19 vaccine, a necessary step to approve and register the vaccine, the US-based pharmaceutical said Wednesday.

"This is an important step so that the vaccine can be available in Brazil," Pfizer said in a statement in Portuguese.

Brazil, with a population of 212 million, has the highest COVID-19 death rate in the world after the United States. It has recorded more than six million novel coronavirus cases since the pandemic began.

The clinical results of the Phase 3 study of the BNT162b2 vaccine, developed by Pfizer and the German pharmaceutical BioNTech, began in July and involved 43,661 participants in 150 places around the world. In Brazil there were 2,900 volunteers, the companies said.

Representatives of Pfizer and Brazil's National Health Oversight Agency (ANVISA) met Wednesday to begin the process of presenting the results.

To streamline the process, ANVISA said that the labs developing the vaccines can present the results as they become available.

Pfizer said it expects to present information related to the vaccine in stages, including data showing its "95 percent efficiency rate seven days after taking the second dose, as demonstrated in the Phase 2 clinical trial," the statement read.

"Pfizer will make available all of the necessary data for evaluation, and will collaborate with ANVISA so that the process moves smoothly and as quickly as possible," Marjori Dulcine, Pfizer's medical director in Brazil, said in the statement.

The vaccine has been under evaluation for weeks in the European Union, Australia, Canada, Japan and the United Kingdom, the companies said earlier.

Brazil's health ministry also agreed to buy 100 million doses of a different vaccine developed by AstraZeneca and Oxford University.

The health ministry said that over the past week officials have met with representatives of five pharmaceutical labs -- Pfizer, Janssen, Bharat Biotech, Moderna and the Russian Direct Investment Fund (RDIF) -- "with the goal of diversifying actions" to help handle the COVID-19 pandemic.

The regional government of Sao Paulo -- home to the country's most populous city -- has signed an agreement with the Chinese laboratory SinoVac to purchase six million doses of the CoronaVac vaccine, and to buy material to produce another 40 million doses locally.

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