Brazilian institute announces vaccine exceeds minimum efficacy, safety levels

Sao Paulo, Dec 23 (efe-epa).- The vaccine against Covid-19 developed by China’s Sinovac Biotech Ltd. laboratory, in cooperation with the Butantan Institute in Brazil’s Sao Paulo state, has exceeded the minimum levels of safety and efficiency demanded by Brazilian and international health authorities, government sources in Sao Paulo reported on Wednesday.

The Coronavac vaccine “reached the indices demanded both by Anvisa (the Brazilian medication regulator) and by the World Health Organization in the phase three studies. That will allow us to prevent the deaths of thousands of people,” said Sao Paulo state Health Secretary Jean Gorinchteyn at a press conference.

The state government had been scheduled on Wednesday to release the efficacy and safety data on the vaccine after the conclusion of the third and last phase of clinical trials being undertaken in Brazil, trials that included more than 13,000 volunteers.

However, because the vaccine is being tested in several other countries, Sinovac asked for an extension of up to two weeks to gather data, analyze it and assemble the figures obtained from the different testing nations and, thus, be able to publish the efficacy and safety data in a “uniform and analogous” manner.

“Sinovac wants to provide isonomic numbers for all the countries, and wants all the results to be equal without any disparity,” Gorinchteyn.

Meanwhile, Butantan Institute director Dimas Covas, said that besides exceeding the minimum required levels of efficacy, which is 50 percent, Coronavac also showed an “excellent safety profile,” which it had also displayed in the earlier testing phases.

“From the point of view of safety, the data that are available on all vaccines undergoing testing here in Brazil show that (Coronavac) is the safest, without any doubt,” the secretary said, adding that the absence of concrete data on the effectiveness of the vaccine “has no influence” on its development program in Brazil, which “is continuing normally and full speed ahead.”

In addition, the Sao Paulo state government said that it will maintain its immunization schedule, according to which authorities are slated to begin vaccinating the state’s entire population on Jan. 25.

Brazil, with its population of 210 million, is the No. 2 country in the world for Covid-19 deaths, following the United States, and the No. 3 country in terms of confirmed coronavirus cases, after the US and India.

Meanwhile, Brazilian President Jair Bolsonaro – one of the most skeptical world leaders regarding danger posed by the coronavirus – has expressed contempt for Sinovac’s product, saying his government will not buy it and even celebrating Brazilian regulators’ decision in early November to temporarily halt clinical trials of Coronavac following the death of a volunteer for reasons unrelated to any effect of that vaccine.

Bolsonaro has signed a pact with AstraZeneca to obtain 100 million doses of the vaccine that United Kingdom-based pharmaceutical giant is developing in partnership with the University of Oxford, which is likewise in clinical trials in Brazil.

The rightist head of state has frequently expressed mistrust of China even though the Asian giant is Brazil’s largest trade partner.

Bolsonaro said Wednesday that the “best vaccine” against Covid-19 is the virus itself.

“I had the best vaccine: it was the virus. And without any collateral effects,” Bolsonaro, who contracted the coronavirus and recovered, told a group of supporters, most of them not wearing facemasks, during his visit to the city of Sao Francisco do Sul, in the southern state of Santa Catarina.

Bolsonaro has called the coronavirus a “measly little flu,” although he did acknowledge last week that that remark might have been “an exaggeration.”

Just like several other nations, the South American giant is experiencing a second wave of the pandemic and, so far, has suffered almost 190,000 deaths and more than 7.3 million confirmed Covid-19 cases.

The state of Sao Paulo, Brazil’s most populous with 46 million residents, is also the one hardest hit by the pandemic so far, with 45,395 deaths and some 1.4 million cases, at latest count.