After evaluating the new data presented by the sponsor after the study was suspended, Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination, informs the agency on its official website
The National Health Surveillance Agency (Anvisa) authorized the resumption of clinical tests of the vaccine against the coronavirus Sars-CoV-2 CoronaVac, created by the Chinese laboratory Sinovac Biotech. The suspension had been imposed on Monday (9), after the registration of a “serious adverse event” with the death of a volunteer. (ANSA). It turns out that the cause of the volunteer’s death was suicide, and there is apparently no relationship with taking the vaccine.
On its website, Anvisa informs of the reasons for which it decided to suspend the tests on November 9: “the seriousness of the event, the precariousness of the data sent by the sponsor at that time; the need to protect research volunteers; and the absence of an opinion from the Independent Security Monitoring Committee ”.
