[ad_1]
The National Health Surveillance Agency (Anvisa), Brazil’s regulatory agency, today authorized the resumption of tests for Coronavac, a possible Chinese vaccine against covid-19, after the death of a volunteer in the country.
“Anvisa reports that it has just authorized the resumption of the clinical study related to the Coronavac vaccine, which is sponsored by the Butantan Institute,” the Brazilian regulator said in a statement.
“After evaluating the new data submitted by the sponsor after the suspension of the study, Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination and continues to monitor the investigation of the outcome of the case, so that the possible causal relationship between the unexpected serious adverse event and the vaccine is defined “, added.
The agency also said it would not disclose the nature of the adverse event that occurred “out of respect for the privacy and integrity of the research volunteers.”
The suspension of Coronavac tests in Brazil was announced on Monday by Anvisa, after being notified of the death of a volunteer, without having confirmed the cause of death, despite the fact that the local press reported that it was a suicide.
The president of Anvisa, António Barra Torres, said at a press conference on Tuesday that the agency stopped testing Coronavac because it was the “only decision to make” at that time, highlighting that it was a “technical decision.” “.
The authorities have not officially confirmed the causes of the death of a 33-year-old volunteer on October 29, who was participating in the third phase of the Coronavac trial, which led to the suspension.
Rede Globo and other local media showed a police report on the case of the alleged volunteer, who was not identified, which included suicide as a cause of death.
Anvisa thus decided to suspend the tests, a decision it maintained until receiving recommendations from an international committee of independent researchers that analyzes the development of the immunizer.
On Tuesday night, the regulator said it had received the document from the international committee, which resulted in the decision to resume testing.
The suspension of the immunization studies led to a confrontation between Anvisa and the Butantan Institute, in São Paulo, which has an alliance with the Chinese pharmaceutical company Sinovac to manufacture the vaccine and carry out phase three trials in Brazil.
Shortly after the announcement of the strike, the institute’s director, Dimas Covas, said he was surprised by the agency’s decision, because the adverse event was a “death not related to the vaccine.”
The reaction of the president of Brazil, Jair Bolsonaro, to the suspension of the tests also caused controversy, after he declared “victory”, which generated several criticisms, either from politicians or health professionals, who accused him of politicize the immunizing government.
Last month, Bolsonaro had already opposed the acquisition of the Chinese vaccine, having forced his Ministry of Health to retract its intention to buy the immunizer.
Brazil is the Portuguese-speaking country most affected by the pandemic and one of the most affected in the world, accounting for the second number of deaths (more than 5.7 million cases and 162,829 deaths), after the United States of America.
The covid-19 pandemic caused at least 1,275,113 deaths in more than 51.5 million cases of infection worldwide, according to a report by the French agency AFP.
