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- Rafael Barifouse
- BBC News Brazil in São Paulo
Credit, reproduction
‘Sinovac cannot have three efficacies for the same vaccine,’ said the director of Butanta
Butantan announced on Wednesday (12/23) that CoronaVac reached the effectiveness threshold that allows it to request authorization for emergency use of the immunizer in Brazil, but has not released the data.
This means that the vaccine had a rate above 50%, which the World Health Organization (WHO) has said is sufficient for approval and useful in fighting the pandemic.
The National Health Surveillance Agency (Anvisa) has also stated that it will grant the registration for an immunizer that is at least 50% effective, that is, that protects 50 of the 100 people who take it.
The Brazilian agency follows the criteria adopted by the Food and Drug Administration (FDA), an agency equivalent to Anvisa in the United States.
Butantan director Dimas Covas explained that Sinovac, a Chinese pharmaceutical company that develops the vaccine, asked that the effectiveness rate not be disclosed at this time.
The company requested the sending of data from the study carried out by Butantan and a period of 15 days to analyze them.
The objective would be to standardize the results of the phase 3 tests, which investigate whether CoronaVac really protects against covid-19, which are being done in other countries, such as China, Turkey, Indonesia and, more recently, in Chile.
The effectiveness verified in Brazil was different from that obtained in other countries and “deserves a re-evaluation,” explained the Secretary of Health of São Paulo, Jean Gorinchteyn.
“For a company to be able to say that an immunization has been established, it must have the same percentage of effectiveness in any part of the world,” said the secretary.
Covas reinforced that “Sinovac cannot have three efficacies for the same vaccine.” “This does not imply that the data is higher or lower than expected,” said the director of Butantan.
The postponement does not compromise the start of vaccination, says the SP government
Credit, fake images
The results of the vaccine efficacy in Brazil were different from those obtained in other countries
This is the second postponement of data on the effectiveness of CoronaVac. Initially, the preliminary results would be released on the 15th, but the government of São Paulo and Butantan argued that, at that time, the criteria for a complete analysis had already been met, that is, 170 volunteers had already contracted the coronavirus. – and that he preferred to hold on to the disclosure to await the conclusive study.
In both cases, in both the preliminary and final results, an independent committee has access to the confidential information of the tests so that they can check if the people who fell ill are part of the group of research participants who received the vaccine or the vaccine. placebo.
João Gabardo, executive coordinator of the covid-19 contingency center in São Paulo, said that the new postponement does not change the plans to start immunization in the state on January 25, because the data obtained so far give the certainty that the vaccine will meet the efficacy criteria of Anvisa.
He stressed that Sinovac can finish the analysis before the 15 days that were requested by the company.
Even if the full term is used, Gabbardo said, it will still be possible to start vaccination on January 25, because Anvisa has a period of ten days to analyze an emergency use request.
“Meanwhile, Anvisa will have the time necessary to carry out the analysis of the definitive registry. By the 25th, we are sure that we will obtain this (emergency) authorization to start the vaccination,” Gabbardo said.
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