Officials of the Brazilian health agency, Anvisa, will inspect from November 30 plants of the Chinese laboratories Sinovac and Wuxi Biological, manufacturers of the biological supplies that will be imported to produce two vaccines against the coronavirus, in the testing phase in the South American country .
“The main objective of the inspection is to verify whether a production facility complies with Anvisa’s regulations” of “good manufacturing practices,” Ronaldo Gomes, Anvisa’s manager for sanitary inspections and controls, said in a virtual conference on Wednesday.
From November 30 to December 4, five Anvisa inspectors – already carrying out quarantine in China – will visit the Sinovac plant in Beijing, which develops the biological input that will be used in the Coronavac vaccine, to be manufactured together with the Butantan Institute of Sao Paulo , he detailed.
The same team will inspect, from December 7 to 12, the Wuxi Biological plant, 130 km from Shanghai, where the viral vector will be manufactured that will be imported to Brazil for the vaccine from the AstraZeneca laboratory and the University of Oxford, which will transfer technology to the Fiocruz institute.
Gomes highlighted “that Anvisa uses the most modern sanitary regulations in the world for this verification”, the international protocol PIC / s that is applied by the sanitary agencies of the United States, Europe, Canada, Japan, Singapore, among others.
Between the end of December and the beginning of January, Anvisa plans to issue the certificate of good manufacturing practices, necessary for laboratories to import into Brazil the components that will be used in vaccines against covid-19, said the official.
Neither of the two facilities were previously inspected by a member country of the PIC / s, so the report issued by Anvisa has already been requested by “other international health authorities,” Gomes added, without mentioning which ones.
Once the inspection is completed, “routine” according to Gomes, Anvisa technicians will try to issue their report in the “shortest time possible” considering the emergency situation due to the coronavirus pandemic.
Starting this week, the Brazilian government is holding a round of talks with the pharmaceutical companies Pfizer, which also carries out Phase 3 tests in Brazil, prior to the approval, as well as with Johnson & Johnson and Moderna, among others, for an eventual purchase of the vaccine.
With 212 million inhabitants, Brazil reports almost 170,000 deaths from covid, only behind the United States, and the South American giant is one of the three countries with the most infected (almost 6 million).
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