The clinical trials of CoronaVac, the Chinese vaccine against Covid-19, are concluded in Brazil and vaccination will start in January, according to the governor of the State of São Paulo, João Doria.
After the ideal level of 154 volunteers immunized for the coronavirus has been surpassed, the Butantan Institute and the Chinese company Sinovac decided to conclude this week the final phase of the clinical study in the country, the institute’s director-president, Dimas Covas said Monday.
The institution, Covas said, will now apply for the registration of CoronaVac with the Brazilian regulator ANVISA (National Health Surveillance Agency) and the Chinese drug regulation agency, for permanent use.
“The clinical study we conducted is what will allow registration of the vaccine in Brazil, China and the world,” said Covas. “The vaccine is worldwide,” he said
Initially, the institute had planned to announce preliminary data on the effectiveness of CoronaVac in preventing Covid-19, to allow emergency use of the vaccine, but after two postponements it now plans to present the definitive results of Phase 3 of the clinical trial.
The Butantan vaccine is developed based on a technology transfer agreement with the Chinese pharmaceutical company Sinovac. The registration request will be made next week, on the 23rd, conclusively.
According to Doria, the State of São Paulo expects to register the vaccine by the end of this year to start immunization against Covid-19 on January 25th.
A federal law signed this year at the beginning of the pandemic, states that ANVISA has 72 hours to express whether or not the registration of a vaccine against Covid-19 granted by one of the national health agencies in the United States, the European Union, Japan and China.
CoronaVac studies involve 13,000 volunteers in Brazil, already in the final phase of clinical trials, to verify the safety and the ability to generate an immune system response, in addition to the vaccine’s effectiveness.
A scientific study published last month by the British scientific journal Lancet confirmed the safety and immune response of CoronaVac, and the first doses of these have already reached the largest country in Latin America.
CoronaVac is in the third phase of testing in the South American country, through a partnership between the Chinese pharmaceutical company Sinovac and the authorities of the state of São Paulo, whose governor, João Doria, has become one of the President’s most staunch opponents. Brazil, Jair Bolsonaro, motivating a strong political dispute over the vaccine.
On October 20, Health Minister Eduardo Pazuello announced the central government’s intention to buy 46 million doses of the Chinese formula, but a few hours after the announcement, Bolsonaro disallowed his minister through social media, announcing the opposition the purchase of CoronaVac, arguing that the immunizer had not even passed the clinical testing phase.
The Bolsonaro government has an agreement with the University of Oxford and the AstraZeneca laboratory to purchase 100 million doses of this vaccine, which is in the same phase of studies as the Sinovac immunizer.
In the last week, ANVISA carried out an ‘on-site’ assessment of Sinovac’s laboratories in China. In a note released on Monday, it warned that the Chinese criteria for authorization of commercial use of the vaccine “are not public and are not available on the agency’s portal in that country”.