RIO DE JANEIRO — Brazil’s health regulatory agency on Wednesday allowed a Chinese vaccine trial that was halted earlier in the week to resume, saying its experts were convinced that the death of a volunteer last month did not raise concerns about the trial’s safety.
The agency, Anvisa, startled health experts and triggered a political outcry after it announced on Monday night the suspension of the CoronaVac trial in Brazil, citing an unspecified “serious” event. The vaccine, which was developed by the Chinese company Sinovac, is among 11 experimental vaccines around the world that have shown enough promise to move into a late stage of research known as Phase 3 trials.
It’s not unusual for a large vaccine trial to be paused to investigate possible safety concerns, and several others have been paused and restarted as well.
Sinovac’s Brazilian partner, Instituto Butantan, called the decision to halt the study unwarranted and found itself in the middle of a political clash that dominated headlines in Brazil on Tuesday. President Jair Bolsonaro, who had previously spoken dismissively about the Chinese vaccine, hailed the trial’s suspension as a political victory.
Instituto Butantan is run by the government of the state of São Paulo, which is governed by one of Mr. Bolsonaro’s political rivals, João Doria.
“This is the vaccine Doria wanted everyone in São Paulo to take,” the president wrote on Facebook. “Yet another victory for Bolsonaro.”
Mr. Bolsonaro chided his health ministry last month after learning that it planned to purchase millions of doses of the Chinese vaccine.
Officials at Anvisa struggled to explain their decision on Tuesday after it became clear that the trial volunteer whose death prompted the suspension was being investigated as a suicide. Health officials overseeing the study reported the death to Anvisa as a routine matter, but did not regard it as problematic for the trial.
In a statement issued Wednesday morning, Anvisa said its experts had concluded the trial may resume and that the brief suspension should not cast aspersions about the “quality, safety or efficacy” of CoronaVac.
Source : Nytimes
