The National Health Surveillance Agency (Anvisa) authorized the resumption of CoronaVac tests on Wednesday (11). The release comes two days after the study was suspended in Brazil, due to the death of one of the participating volunteers.
“Seeking to meet the principle of transparency, Anvisa informs that it has just authorized the resumption of the clinical study related to the CoronaVac vaccine, which is sponsored by the Butantan Institute”, says the note from the agency, published on its official website.
In the statement, the municipality linked to the Ministry of Health also said it had analyzed the new data presented by Butantan, a partner of the Chinese laboratory Sinovac in the production of the immunizer against covid-19, after the suspension of the clinical trial. Thereafter, it obtained “sufficient subsidies” to allow testing to resume.
Anvisa also commented that it will continue to follow the investigations on the case, until the definition of a “possible causal relationship between the unexpected serious adverse event (AGE) and the vaccine”. The text also points out that the temporary suspension does not necessarily indicate the lack of quality, safety or efficacy of the immunization.
The suspension of the CoronaVac test led to an intense dispute between Butantan and the agency linked to the federal government. On the one hand, the director of the Dimas Covas institute claimed to have informed Anvisa that the death was unrelated to the vaccine.
On the other hand, the agency director Antônio Barra Torres said that he had not received the details of the case and that, given the lack of information, he decided to interrupt the study, based on “technical reasons”.