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SÃO PAULO – O Butantã Institute decided to delay the dissemination of the results of the efficacy of the Coronavac vaccine, National Health Surveillance Agency (Anvisa), in up to ten days, the data of the final analysis of the study and not of the so-called intermediate analysis, carried out with information from fewer volunteers. THE Coronavac It is developed by the Chinese pharmaceutical company Sinovac and produced in association with Butantã.
OR Status found that the decision was made after the researchers realized that the total number of infected in the group of participants had grown and exceeded the contamination mark of 151, the minimum number established in the study protocol for the final analysis efficiency. Previously, the analysis would have been carried out with data from just over 70 contaminated.
The information was anticipated by the column of Lauro Jardim, of the newspaper Or Balloon, and confirmed by the director of Butantã, Dimas Covas, in an online event promoted by the University of São Paulo (USP) on the morning of this Monday 14.
“We changed our strategy, which until last week was to request an emergency use with partial analysis data. Given the situation and a possible difficulty in relation to Anvisa’s own speed, we changed our strategy and we will request the definitive use in China and Brazil at the same time ”, he declared.
Dimas noted that Anvisa’s good practices certificate is also missing at the Sinovac plant, which is expected to be issued in late December or early January. We are awaiting the final analysis of effectiveness. This will allow the study to be concluded, it will happen in the next few days. We hope that registration can move very quickly in China and before the end of this year we will have the vaccine registration in China. As the vaccine is registered in one of the large agencies, such as European, Chinese, Japanese or American, Anvisa may authorize the exceptional use of the product. It was a strategy that we discussed with Sinovac and I think this will, in fact, emit greater agility, although it can put pressure on Anvisa, ”he declared.
The increase in infections among volunteers that made the final analysis possible occurred faster than expected by Butantã due to the increase in cases of the disease in the state of São Paulo and throughout the country. Coronavac is tested on 13 thousand volunteers distributed in 16 research centers in all regions.
With data from more volunteers, the results will be statistically stronger, increasing the chance that Butantã will get a quick record from Anvisa. There is an expectation in the government of São Paulo that this file will be delivered to Anvisa before December 23.
The agency has already been informed, in a meeting with researchers from Butantã, about the institute’s change in strategy. Butantã researchers do not rule out the possibility of sending the data in two possible ways: regular registration and emergency use.
As Covas mentioned, the Sinovac You must simultaneously file a registration request with the Chinese regulatory agency, which can decide on the matter in a few days, since, in the Asian country, the vaccine is already authorized for emergency use in specific audiences, such as essential services workers.
If the Chinese agency gives the registration to Coronavac before the Brazilian, Anvisa will have 72 hours after approval in China to comment on the registration in Brazil, as determined by the federal law that authorizes the use of health products without registration in Brazil as long as it has obtained approval from agencies in the United States, the European Union, Japan, or China.
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