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The National Health Surveillance Agency (Anvisa) of Brazil confirmed this Monday the start of the work of a team of Brazilian inspectors, charged with verifying the good manufacturing practices of the CoronaVac vaccine, in China.
In a note, the body linked to the Ministry of Health of Brazil pointed out that, on the first day of the inspection, its team verified the points of the CoronaVac pharmaceutical quality management system, immunized against covid-19 in phase 3 of development, created by Chinese Sinovac Laboratory.
According to the Brazilian health surveillance agency, risk management procedures, documents and the “master plan” for validating the immunizer have been verified.
Furthermore, the technical requirements of the so-called “Seed and Cellular Banks”, viral particles and host cells used in the production of the vaccine were verified.
The Brazilian inspectors have also begun to verify the technical requirements applicable to the sampling procedures of the raw materials used in the formulation of CoronaVac.
Anvisa clarified that the inspectors sent to China follow a work program, which will extend until next Friday (4/12), at the Sinovac company.
“The program includes different technical requirements every day to be checked for evaluation, if the vaccine is manufactured according to the Agency’s Good Practices regulation, which is in line with the standards used by the main international health agencies.” of the health surveillance agency.
The Butantan Institute, a scientific organization linked to the regional government of the Brazilian state of Sao Paulo, partnered with Sinovac to test CoronaVac in Brazil, in an agreement that included the purchase of 46 million doses of the immunizer, as well as the transfer of technology for its production if the effectiveness of the drug is proven.
However, to be applied in the South American country, CoronaVac will need the approval of Anvisa.
Brazil is the Portuguese-speaking country most affected by the pandemic and one of the most affected in the world, with the second highest number of deaths (over 6.3 million cases and 172,833 deaths), after the United States.
The covid-19 pandemic has caused at least 1,460,018 deaths resulting from more than 62.7 million cases of the infection worldwide, according to a report made by the French agency AFP.
The disease is transmitted by a new coronavirus detected in late December 2019 in Wuhan, a city in central China.
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