China is willing to provide the necessary convenience for the Brazilian delegation sent to the country to inspect the research and development of COVID-19 vaccines, in accordance with relevant laws and international practices, the Chinese Foreign Ministry said Friday, as Brazil plans to send a delegation to China before potentially approving the vaccine for Brazilian use.
China's independent R&D of COVID-19 vaccines is in a leading position in the world. "We are cooperating with many countries, including Brazil, which all parties speak highly of," Foreign Ministry spokesperson Wang Wenbin told a media briefing.
Brazilian health regulator National Health Surveillance Agency (Anvisa) will visit Chinese firm Sinovac Biotech's (Sinovac) manufacturing site, including vaccine production lines and the whole factory, to assess if its process meets with Brazil's Good Manufacturing Practice (GMP) conditions, a Sinovac source told the Global Times on Friday.
The visit is part of Brazil's drug and vaccine regulatory framework, and a necessary step before it is made available to the public. "When we import vaccines from another supplier, we will also go to its factory to inspect," said the source, who asked to remain anonymous.
The inspection team is scheduled to visit Sinovac between November 30 and December 4, after their 14-day quarantine period requested upon their arrival on November 15. The team is mainly composed of inspectors of Anvisa, while the researchers of Sao Paulo's Butantan Institute that partnered with Sinovac in late-stage clinical trials may not be part of it, according to the source.
"The team will also inspect the production records to see if the personnel responsible for operations understand, master and implement relevant requirements," he added.
Anvisa announced on Wednesday local time the resumption of trials of a vaccine candidate developed by Sinovac, following the suspension on Monday after the death of a volunteer in Sao Paulo was reported. Media described the case as a "severe adverse" case, but broadcaster TV Cultura said on Tuesday that the death was a suicide unrelated to the vaccine.
"We are glad to see the resumption of Phase-III clinical trials of the COVID-19 vaccine… Four Chinese vaccines are in Phase-III clinical trials in multiple countries, indicating preliminarily a good safety profile. China's vaccine R&D progress has been commended by many countries," the FM spokesperson said Thursday.
The Brazilian government agreed to buy 46 million doses of the Sinovac vaccine in early October.
According to Johns Hopkins University, global COVID-19 infections have reached 52,753,626, with 1,293,434 deaths as of 4 pm Friday. The US, India and Brazil have the highest number of infections.