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Anvisa (National Health Surveillance Agency) announced tonight that it will send an “inspection mission” to China to evaluate the facilities of Sinovac, the company responsible for the development of the CoronaVac vaccine and the supplies for its production, in association with Instituto Butantan— , and the Wuxi Biological Co-producer of vaccine supplies AstraZeneca, used by Fiocruz Bio-Manquinhos.
Anvisa’s inspection mission to China will be carried out, in order to verify compliance with good manufacturing practices in the facilities of the Sinovac companies Lifetime Sciences Co. (manufacturer of the supplies used by the Butantan Institute in the production of the Coronavac vaccine) and Wuxi Biological Co. (producer of the inputs used by Fiocruz Bio-Manguinhos/ AstraZeneca Vaccine), “the federal government agency said on its website.
According to Anvisa, the visits to the factories will take place from November 30 to December 4, in the case of Sinovac (located in Beijing), and from December 7 to 11, in the case of Wuxi Biological (situated in Wuxi).
“The certification of good manufacturing practices is an essential requirement for the eventual registration of vaccines against Covid-19 that use inputs produced in these facilities,” says the note.
Anvisa stated that, due to the requirement to comply with the quarantine for all travelers arriving in China, the inspectors will leave Brazil on Friday (13), and the arrival in China is scheduled for November 15.
CoronaVac Testing Resumption
Yesterday, Anvisa announced authorization to resume testing with the CoronaVac vaccine. The agency suspended phase 3 studies on Monday night (9) after reporting a “serious adverse event” – the death of a volunteer who was testing the covid-19 immunizer. The São Paulo government affirms that the death is not related to the investigation.
“After evaluating the new data presented by the sponsor after the suspension of the study, Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination,” said a statement released yesterday.
* With Reuters
