13,000 Brazilians participated in the country’s phase three vaccination experiment while the government hides safety data.
The government of São Paulo, which has tested the Chinese Coronavac vaccine on 13,000 Brazilians over five months – said today that the drug has exceeded the efficacy threshold that allows access to emergency use by the World Organization for Health (WHO), 50% protection, but has not shown the data to back up such claims.
The Chinese pharmaceutical company Sinovac, which created the vaccine, has requested a period of up to 15 days from the Brazilian institution to unify data from studies carried out in other countries, such as Indonesia and Turkey. The goal would be to avoid revealing different efficacy rates. This attempt to hide or mix up results is typical of vaccine companies whose own numbers are not positive so they hope that their mix and match malpractices.
“We have reached the threshold of effectiveness that allows access to emergency use,” said the president of the Butantan Institute, Dimas Covas, last Wednesday.
According to Covas, the study has basically observed mild adverse effects and in a small percentage of cases, such as pain at the injection site.
“This demonstration has not been different between the groups that have received vaccine and placebo,” he added at a press conference. Efficacy data, however, has not been released in hopes that when mixing results obtained with Brazil with those of other countries, their pie charts will show better outcomes.
Sinovac has requested to have time to evaluate results from other countries before requesting registration from the Chinese health agency. “This request from Sinovac is supported by the contract. We can only share the data together. We hope it will be as soon as possible,” said Covas.
The Coronavac clinical trial was carried out with 13,000 volunteers in Brazil. Phase three of the tests began in the country in July. In earlier stages of the China study, the vaccine has supposedly shown to be safe and capable of eliciting an immune response in up to 97% of participants.
In November, the Coronavac trial reached the minimum number of infected volunteers for the presentation of preliminary results in Brazil.
It exceeded the minimum of 151 infected among the groups that received the placebo or the immunizer and reached 170 infected volunteers, which is supposed to be more robust to the results.
The data was supposed to be published last December 12, but the Government of São Paulo changed its strategy to request the green light from Anvisa to use the vaccine to mass inoculate the population.
Covas said he would submit consolidated data to request final registration and not authorization for emergency use.
In the days that followed, however, he took a step back and said he would apply for both authorizations. Now, again the announcement of the data has been postponed, by the request of Sinovac.
The Butantan Institute is linked to the Government of São Paulo, which still maintains January 25 as the scheduled date to start the vaccination campaign in the State.
The Coronavac was also the target of political polarization that was established in the country.
Coronavac tests in Brazil were halted in November after the death of a volunteer. The circumstances, according to those responsible for the tests, had nothing to do with the immunization and experiments on Brazilians were resumed the following day.
President Bolsonaro even celebrated the stoppage of the vaccine purchased by the governor of São Paulo, João Doria. The two, once allies, became political enemies.
At the end of October, Bolsonaro said that he would not buy the vaccine developed by China. “With China, unfortunately, there is already a lot of discredit on the part of the population, especially because, as many say, this virus was born there,” he said, emulating Donald Trump, who refers to covid-19 as the “Chinese virus”.
After a long political crisis, and all scientifically-based data, Coronavac has finally been included in the national vaccination plan against covid-19 on December 16. The Government has the intention of purchasing 46 million doses with the Butantan Institute and is trying to expand it to acquire 100 million doses.
There is still no date to start vaccination across the country. The Minister of Health, Eduardo Pazuello, hopes to start in February, although he admits that in the best scenario it is possible to start vaccinating against the covid on January 20.