Covid-19 vaccine factory in China inspected by authorities – World

The National Health Surveillance Agency (Anvisa) of Brazil confirmed this Monday the beginning of the work of a team of Brazilian inspectors, who were assigned to verify the good manufacturing practices of the CoronaVac vaccine, in China.

In a statement, the body linked to the Ministry of Health of Brazil stressed that, on the first day of inspection, his team checked the points of CoronaVac’s 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, procedures on risk management, documents and the ‘master plan’ for validating the immunizer were verified.

In addition, the technical requirements of the so-called “Seed and Cellular Banks” were verified, which are viral particles and host cells used in the production of the vaccine.

Brazilian inspectors also began to verify 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 schedule, which will extend until next Friday (4/12), at the company Sinovac.

“The schedule includes each day different technical requirements to be verified for the evaluation, if the vaccine is manufactured according to the Agency’s Good Practices regulation, which is in step with the regulations used by the main international health agencies. “, says the statement from the health surveillance agency.

The Butantan Institute, a scientific organization linked to the regional government of the Brazilian state of São Paulo, entered into a partnership 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 drug’s effectiveness is proven.

However, in order to be applied in the South American country, CoronaVac will need Anvisa’s approval.

Brazil is the Portuguese-speaking country most affected by the pandemic and one of the hardest hit in the world, with the second highest number of deaths (more than 6.3 million cases and 172,833 deaths), after the United States.

The covid-19 pandemic caused at least 1,460,018 deaths resulting from more than 62.7 million cases of 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.

– .