Sao Paulo, Nov 10 (efe-epa).- Brazilian regulators’ suspension of clinical trials of a Chinese-made coronavirus vaccine was seized upon Tuesday by right-wing President Jair Bolsonaro to claim victory over a state governor expected to challenge him in 2022.
The federal regulatory agency, Anvisa, ordered the trials of Sinovac Biotech’s CoronaVac halted on Monday after an “unexpected serious adverse event.”
But Instituto Butantan, the world-renowned epidemiological center affiliated with the Sao Paulo state health department that is conducting the Phase 3 clinical tests, said Tuesday that the adverse event was unrelated to any effect of the vaccine.
“Jair Bolsonaro wins again,” the president wrote on Facebook a few weeks after overruling Health Minister Eduardo Pazuello to block an agreement to purchase millions of doses of CoronaVac.
Citing a police report, media outlets reported that the adverse event was the death by suicide of a 32-year-old man who volunteered for the vaccine trials.
Sao Paulo Gov. Joao Doria told Efe in an interview two months ago that his administration will be able to begin inoculating the state’s 46 million residents in January thanks to the accord between Sinovac Biotech and Instituto Butantan, the largest manufacturer of vaccines in the Southern Hemisphere.
“The distribution will be free of charge and we already have 60 million doses, but we would like to reach 100 (million) for Brazilians in other regions. We are talking with the federal government about financing it,” the center-right governor said then.
Bolsonaro, who sees Doria as a threat to his hopes of winning a second term, has signed a pact with AstraZeneca to obtain 100 million doses of the vaccine the UK-based pharmaceutical giant is developing in partnership with the University of Oxford, which is likewise in clinical trials in Brazil.
The 65-year-old president and Doria, 62, are both coronavirus survivors, but they have been at odds over how to deal with the public health crisis since Brazil’s first Covid-19 case was detected eight months ago in Sao Paulo city, the state capital.
While Doria implemented fairly stringent measures to slow the spread of the virus, Bolsonaro, who famously dismissed Covid-19 as “a measly flu,” remains cavalier about a disease that has claimed 163,000 lives in Brazil, which is second only to the United States in coronavirus deaths.
“What the Brazilian citizen doesn’t need today is an Anvisa contaminated by a political war. Is there a political war? Clearly it exists, but it must remain outside these walls,” agency director Antonio Barra told a press conference Tuesday.
He said that Anvisa’s decision to suspend CoronaVac trials was strictly “technical,” adding that the information provided to the agency so far regarding the adverse event was “insufficient and incomplete.”
“With what we had, we had no other alternative. Anvisa is not a partner of any developed, laboratory or institute,” Barra said, stressing the agency’s independence.
Last month, Anvisa decided not to suspend the Brazilian trials of the AstraZeneca/Oxford vaccine after a participant who received a placebo died of Covid-19.
Barra emphasized Tuesday that the two cases were different because the death of a test subject who did not receive the vaccine was not an “unexpected” adverse event.
In Sao Paulo, Instituto Butantan director Dimas Covas told reporters it was “impossible” that the CoronaVac trial subject’s death was caused by the vaccine.
The volunteer died on Oct. 29 and Butantan notified Anvisa on Nov. 6, in line with the relevant protocols, but the agency said it did not receive the notice until Monday due to a “cyber attack.”
Covas said that he learned through press reports of Anvisa’s decision to halt the trial, complaining that the agency did not contact him or anyone else connected with the program.
“Would it not be fairer, more ethical and more comprehensible to schedule a meeting to discuss that?” the Butantan director wondered. EFE