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Brazil’s health regulator announced that it had clinical trials of a Chinese vaccine against covid-19 suspended after a volunteer suffered “A serious incident”.
The Brazilian Health Surveillance Agency (Anvisa) “decided to interrupt the clinical trial of the CoronaVac vaccine after a serious incident” on October 29.
The agency did not provide details about what happened, but indicated that such incidents could include death, possibly fatal side effects, severe disability, hospitalization and other “clinically significant events.”
Waiting for more details on what happened, the Chinese laboratory Sinovac Biotech said on Tuesday “confident” in the safety of its vaccine.
“We are confident in the safety of the vaccine,” Sinovac said in a statement in which he stated that the incident in question was “not related” to the vaccine.
The public body that coordinates the trials of the vaccine in Brazil, the Butantan Institute, was “surprised” by the suspension of the trials.
The institute “is investigating in detail what happened” and “is at the disposal of the Brazilian regulatory agency to provide any necessary clarification on any incident that may have occurred in clinical trials,” he added. On Tuesday he will give a press conference on this subject at 11:00.
CoronaVac has been the center of a political battle in Brazil between one of its biggest defenders in the country, the governor of Sao Paulo, Joao Doria, and his main political rival, President Jair Bolsonaro.
The São Paulo state government said in a statement that “He regrets having learned of the decision from the press, instead of directly from Anvisa”, and was waiting together with the Butantan Institute for more information on “the real reasons for the suspension.”
Pandemic and politics
The far-right president has referred to the Sinovac model as the vaccine of “that other country” and has promoted instead the one being developed by the University of Oxford with the British pharmaceutical company AstraZeneca.
Last month, Bolsonaro canceled a purchase agreement for 46 million doses of the Chinese vaccine that his own Minister of Health had announced.
“The Brazilian people will not be anyone’s guinea pig,” said Bolsonaro, who referred to the project as “Joao Doria’s Chinese vaccine.”
Hours before the suspension of the trials was announced, Doria had indicated that the first 120,000 doses of CoronaVac were to arrive in Sao Paulo on November 20.
His state has an agreement with Sinovac to purchase 46 million doses, six million produced in China and the rest in Sao Paulo.
“State government officials fear that Bolsonaro will use technical decisions to delay the vaccine schedule for political reasons”reported the Folha de Sao Paulo newspaper, citing Doria’s allies.
The setback for CoronaVac came on the same day that US pharmaceutical giant Pfizer announced that its coronavirus vaccine is 90% effective.
The Pfizer and Sinovac vaccines are in phase 3 of the trials, the last one before they get the go-ahead or not from the regulatory authorities.
Both are being tested in Brazil, the country with the second highest number of deaths from covid-19 behind the United States, with more than 162,000 deaths.
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