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CoronaVac, the Covid-19 vaccine from the Chinese laboratory Sinovac that is being tested and packaged in Brazil by the Butantan Institute, should have similar effectiveness in preventing the disease in adults aged 18 to 59 and in the elderly over 60, he said. Butantan medical director of clinical research Ricardo Palacios told Reuters on Tuesday.
He explained that data from Phase 1 and 2 studies in China, which determine the safety and immune response generated by the vaccine, with elderly volunteers will soon be published in a scientific journal. According to Palacios, the results were similar to those found in adults between 18 and 59 years old at the same stage of the tests, which showed that 97% of the volunteers showed an immune response.
“This allows us to predict, or say that we can infer from that, that age is not such a relevant factor in relation to immunogenicity and it should not also be in relation to efficacy. This is what this data seems to suggest, ”he said.
Last week, Butantan postponed the release of CoronaVac efficacy data after Phase 3 clinical studies in Brazil, and the study data was sent to China, according to the institute, due to a contractual provision in the agreement. with Sinovac.
Palacios said the data was not sent to China so that the results could be standardized with those obtained in Phase 3 clinical studies conducted with CoronaVac in other countries, such as Turkey and Indonesia. He stated that it is impossible to unify the data as the studies have different criteria.
“You cannot make a uniform,” he guaranteed. “Our study works with health professionals. Health professionals are the most exposed of the entire population, they are actually the ones most at risk. The behavior that a vaccine can have in a population that has extremely high risk levels is very different with a study that was done in the community, like the one that was done in Turkey and Indonesia, ”he said.
“The results are not going to be the same, nobody expects them to be the same,” he added.
According to Butantan, the postponement of the announcement of the effectiveness of the vaccine and the sending of the data to China happened because the Chinese regulatory agency NMPA (in the acronym in English) has a different procedure than the National Sanitary Surveillance Agency (Anvisa) . The Chinese body requires a prior analysis of the study data before applying for registration.
“It is a regulatory procedure, nothing more,” he said. “Until NMPA declares that everything is in order, we cannot say that there is a way to carry out this analysis,” he said, adding that, for the CoronaVac registry in Brazil, only data from the clinical study carried out by Butantan will be used.
Palacios declined to detail the data from Phase 3 of the study. When asked if the statement given at a press conference last week by Butantan President Dimas Covas that no test volunteers who contracted Covid-19 developed the severe form of the disease indicates that CoronaVac is 100% effective in preventing severe cases, he said the vaccine is expected to prevent more acute cases of the disease.
“What (the study) tells us is that the vaccine is effective, it may have a more interesting efficacy for severe forms, it is what you would expect from a vaccine like this,” he said.
