Butantan Director finds Anvisa’s decision to suspend Coronavac test strange: ‘it is a death unrelated to the vaccine’ | Saint Paul

According to Dimas Covas, it is “a death unrelated to the vaccine” and, therefore, “there is no moment [ou motivo] due to interruption of the clinical study “of the vaccine in Brazil.

“Anvisa was first notified of a death, not of an adverse effect. This is different. This decision by Anvisa even seems a bit strange to us, because it is a death not related to the vaccine. That is, since there are more than 10,000 volunteers at that time, deaths can occur. [o voluntário] you can get in a car accident and die. In other words, it is a death other than the vaccine. This is the case here. One death occurred, which is not related to the vaccine. Then there is no time [ou motivo] to interrupt the clinical study, “said Dimas Covas on TV Cultura this Monday (9).

Coronavac is one of the candidates for the coronavirus vaccine and is developed by the Chinese laboratory Sinovac Biotech, in association with the Butantan Institute in São Paulo. With the study discontinued, no new volunteers can be vaccinated.

Anvisa said, through a statement, that it was notified of a serious adverse effect on October 29. However, the agency did not say the specific cause for this suspension. They are considered “serious adverse events”.

Dimas Covas affirmed that the Butantã Institute has already asked Anvisa for clarification about the interruption and that he expects to have more details this Tuesday morning (10).

“These questions were asked by Anvisa tonight, clarification has not yet been requested. We are already requesting and, publicly, I request here so that tomorrow [terça], in the first hour, this data is provided. Because, in reality, this death is not related to the vaccine, ”said Dimas Covas.

In a note, the Government of São Paulo said that it “regrets having been informed by the press and not directly by Anvisa” about the suspension, “as is often the case in clinical procedures of this nature.”

Palácio dos Bandeirantes said on Monday (9) that “more detailed information is expected from the clinical staff of the National Health Surveillance Agency on the real reasons that determined the strike.”

“The Government of São Paulo, through the Butantan Institute, regrets having been informed by the press and not directly by Anvisa, as is often the case in clinical procedures of this nature, about the interruption of the Coronavac vaccine tests. Butantan awaits information more detailed information about the organization Clinical report from the National Health Surveillance Agency on the real reasons that determined the strike ”, said the note from Palácio dos Bandeirantes.

The Butantan Institute also expressed itself through a note and stated that it is “requesting further clarification from Anvisa.” The institute scheduled a press conference for 11 am this Tuesday (10) to clarify the reasons for the interruption of studies on Coronavac in Brazil.

The Butantan Institute clarifies that it was surprised, on Monday night, with the decision of the National Health Surveillance Agency (Anvisa) and that it is investigating in detail what happened with the progress of the Coronavac clinical studies. Butantan also informs that it is at the disposal of the Brazilian regulatory agency to provide all the necessary clarifications on the adverse events that the clinical studies have presented so far ”, the note says.

The National Health Surveillance Agency (Anvisa) temporarily suspended human testing of the Coronavac vaccine. According to the agency, the outage was determined on Monday (9) due to a “serious adverse event” on October 29.

However, the agency did not say the specific cause of the suspension.

According to a list published by the federal agency, serious adverse events are considered: “death, potentially fatal adverse event, persistent disability or disability, hospitalization of the patient, congenital anomaly or birth defect, any suspicion of transmission of an infectious agent through a clinically significant medical device and event “.

CBN radio reported that the hiatus in clinical trials came after the death of a volunteer. The information was not confirmed by the agency.

This is the third experimental vaccine against Covid-19 that has had its clinical trials suspended due to serious adverse events.

• The Oxford candidate was stopped testing after a volunteer showed symptoms of a neurological disease.
• The Johnson & Johnson vaccine also stopped testing after an “unexplained illness” in one of the participants.

Coronavac tests are in the third and final phase. Volunteers who have already been injected will continue to be monitored by the research team.

It takes time to produce a vaccine. The most rapidly developed vaccine to date was the mumps vaccine, which took about four years to be licensed and distributed to the public.

Before testing in volunteers begins, immunization goes through several phases of preclinical experimentation (in the laboratory and with guinea pigs). Only after its safety and efficacy have been evaluated do human trials begin, the so-called clinical phase, which are three:

• Phase 1: is a preliminary evaluation of the safety of the immunizer, performed with a small number of healthy adult volunteers who are closely monitored. It is at this time that the type of response that the immunizer produces in the body is understood. It is applied to dozens of participants in the experiment.
• Phase 2: In the second phase, the clinical study is expanded and has hundreds of volunteers. The vaccine is given to people with characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In this phase, the safety of the vaccine, immunogenicity (or protection capacity), dosage and how it should be administered are evaluated.
• Phase 3: Large-scale trial (with thousands of people) that needs to provide a definitive evaluation of its efficacy and safety in larger populations. In addition, designed to predict adverse events and ensure the durability of protection. Only after this phase can a medical history be taken.

According to the National Health Surveillance Agency (Anvisa) to carry out a clinical trial in Brazil, the approval of the National Research Ethics Commission (Conep) is required, a body linked to the Ministry of Health. Volunteers are recruited by research centers.

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