Anvisa (National Health Surveillance Agency) informed that today it ended the inspection process in China, at Sinovac, manufacturer of inputs used by the Butantan Institute in the production of CoronaVac, vaccine against the new coronavirus.
The trip to the site had the objective of verifying the “good manufacturing practices” of the company and the forecast is that the final decision on certification will be given between the last week of December and the first week of January next year.
The agency explained that the conclusion of the process will occur with the issuance of an inspection report made by the team, after presenting additional information resulting from the inspection to be sent by Butantan.
“The forecast is that the final decision regarding Certification in Good Manufacturing Practices will be made between the last week of December and the first week of January,” said the agency, in a statement released.
Next week, a team of agency employees will carry out the inspection process at Wuxi Biologics Co., producer of the inputs used by Fiocruz Bio-Manguinhos in the production of the AstraZeneca vaccine.
Butantan is a government agency in the state of São Paulo. Yesterday, the São Paulo governor, João Doria, (PSDB) said that the forecast is that CoronaVac will have an emergency use authorization by Anvisa in the first month of next year.
If it is not distributed by SUS (Unified Health System), Doria said that she already has an elaborated state immunization plan – which has not yet been released.
It is not the first time that Doria has given a date for the start of vaccination against covid-19 in the state. In September, when he signed the contract to purchase 46 million doses of CoronaVac, he said the intention was to start the vaccination campaign for health professionals in the state on December 15.
The vaccine, however, continues to be tested and needs to be authorized by Anvisa before being distributed and applied.
*The article has been translated based on the content of Source link by https://noticias.uol.com.br/saude/ultimas-noticias/redacao/2020/12/04/anvisa-encerra-processo-de-inspecao-na-sinovac.htm
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