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Coronavac, an immunizer against Covid-19 created by the Chinese Sinovac and that will be jointly produced in Brazil by the Butantan Institute, proved to be safe in its test of the so-called phase 3 in 50 thousand volunteers in China.
The study data will be presented this Thursday (23) by Governor João Doria (PSDB), the director of Butantan, Dimas Covas, and a representative of the Chinese pharmaceutical company.
The results on effectiveness, which in the previous phases were considered satisfactory, should be ready in November. If this calendar continues smoothly, the expectation in the São Paulo government is a launch for vaccination in December.
According to the Chinese study, there were only 5.36% side effects in the trial participants, all without severity: pain at the application site (3.08%), fatigue (1.53%) and mild fever (0.21%). The rest presented loss of appetite, headache and fever.
“Safety and efficacy are two of the main factors in testing whether a vaccine is ready for emergency use in the population. We are very optimistic with the results that Coronavac has presented so far, ”says Covas.
Sinovac tests your immunizer in 10 countries and has been approved for emergency vaccination in your home country. In Brazil, 5,600 of the 9,000 volunteers in 12 research centers in five states and the Federal District have already received at least one dose of the vaccine.
If Coronavac proves effective, São Paulo will present to Anvisa, the federal government’s health surveillance agency, a request for the emergency release of the vaccination campaign. The expectation is that this is possible in the last month of the year.
Although the vaccine is a political asset for Doria, an opponent of President Jair Bolsonaro and a potential rival in 2022, in the São Paulo government the assessment is that Anvisa will not stop the liberation process.
There are no details yet on the studies and which groups would be vaccinated initially; healthcare professionals are obvious candidates.
A batch of 5 million vaccines will arrive from China in October. By December, there will be 6 million imported doses ready and another 40 million formulated from Chinese supplies in Butantan, which covers the entire population of São Paulo.
Another 55 million doses are expected to be available in the first half of 2021. After the vaccination in São Paulo, if the immunizer is approved, the plan is to offer Coronavac to other states and even countries in the region.
Construction of the new vaccine factory in Butantan will begin next month, and will have the capacity to produce 100 million doses per year.
Distribution outside of São Paulo can occur under specific agreements or depend on an agreement with the Bolsonaro government.
It so happens that, in addition to the political dispute that could hinder the plan, the Ministry of Health has a contract for the English vaccine from the AstraZeneca company and the University of Oxford to be manufactured at the Oswaldo Cruz Foundation.
So the problem is of another nature. The English vaccine is also in phase 3 trials, but there have already been two trial stops due to localized serious side effects in two people.
The tests continue. Coronavac’s advantage over English is that it uses an old and proven technology to elicit the immune response, using the new inactivated coronavirus. This is how flu vaccines work, for example.
The Englishwoman has opted for a new technology, which transports genetic material from Sars-CoV-2 capable of stimulating immunity through an adenovirus that causes flu in monkeys.
This technique is considered risky by a competitor to both vaccines, the Gamaleya Institute in Russia. Maker of the Sputnik V vaccine, which is already in production at the same time as the tests, the laboratory uses a human adenovirus for transport in its product, something that has already been done in an immunizer against the Ebola virus and in treatments against cancer.
If all goes well, São Paulo will be one of the first places in the world to have a vaccination campaign. against Covid-19, which has killed 34,000 São Paulo so far, the largest contingent of 137,000 dead in the country. China and Russia intend to start their campaigns before the end of the year.
The WHO (World Health Organization) adopts caution, stating that it is necessary to be sure of the safety and efficacy of protudos with extensive studies. And he says a global immunization could take up to two years, if not longer.
