Brazil authorizes resumption of COVID vaccine trials after its suspension due to the suicide of a volunteer

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The National Agency for Sanitary Surveillance (Anvisa), dependent on the Brazilian Ministry of Health, has authorized this Wednesday resume rehearsals carried out in the country with a Chinese vaccine against COVID-19, which had been suspended on Monday after the suicide of a volunteer.

Anvisa has reported in a statement that it has approved the resumption of the tests and has indicated that the temporary suspension, which caused a huge political upheaval in the country, was lifted after analyzing new “technical” data sent by the Butantan Institute, responsible for the experiments in Brazil.

“Suspension and Resumption of Clinical Trials they are common events in a clinical investigation and all the studies destined to the registry of medicines that are authorized in the country are previously evaluated with the aim of preserving the safety of all the volunteers of the study “, explains the note.

The suspension came after the death of a volunteer, who, according to local press, he committed suicide for unclear reasons. The decision was received almost with indignation by the Butantan Institute, which time and again declared that the death was not related to the vaccine, developed by the Chinese laboratory Sinovac.

Political controversy

The controversy was fed by the Brazilian president, Jair Bolsonaro, leader of an ultra-right denier, who upon learning of the suspension brought her to the political level and her differences with the governor of Sao Paulo, Joao Doria, who sponsors the experiment and disputes her leadership in conservatism.

“One more that Jair Bolsonaro wins”, the president wrote on his Facebook account, in response to a follower who asked him if the Government would buy the Sinovac vaccine if its effectiveness was proven.

And has added: “Death, disability, anomaly. That is the vaccine that Doria wanted to force the people of São Paulo to take. “In addition, in his publication on the social network, he reiterated that immunization” could never be mandatory “in the country, as the São Paulo governor defends.

Last month, Bolsonaro had affirmed that “the Brazilian people will not be anyone’s guinea pig” and that “a billionaire financial contribution is not justified in a medicine that did not even pass the testing phase”, alluding to what he already described of “Doria’s vaccine” and about which he warned that “will not be bought” by your government.

In the middle of the second wave of coronavirus, the central government no longer rules out any legal measure to stop the spread of the pandemic. Including the curfew, in communities where they have already been raised as an idea, such as Catalonia or Madrid, which should be decreed by declaring a state of alarm. Although still "there is no decision made". The Minister of Health, Salvador Illa, has called for the support of the PP to ensure that it would have sufficient support in Congress in the event that it was necessary to extend it after 15 days.

Bolsonaro’s reaction was criticized, both in scientific and political circles, and it came to be described as a sign of its “insensitivity” to the pandemic, which in Brazil already leaves almost 163,000 dead and 5.7 million infections.

Suspicions about suspension

Anvisa is an organism of the Brazilian State whose direction is appointed by the Government, which further fed the suspicions in relation to the possible relationship between Bolsonaro’s denial and the suspension of the experiment with which the president disparagingly qualifies as “Doria’s vaccine” or “Chinese vaccine.”

The agency, however, has insisted this Wednesday on the technical nature of the decision that caused the temporary interruption, adopted, according to the statement, by the lack of data on death of the volunteer.

“The measure, of an exclusively technical nature, has considered the data that Anvisa knew at that time and the scientific and legal precepts, especially the precautionary principle, which foresees prudence and caution in decisions“, says the note.



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