Brazil decided to stop Coronavac clinical trials was technical

The interruption was motivated by the absence of detailed information sent to Anvisa in relation to the study

The interruption was decided by the General Management of Medicines, an technical area of ​​Anvisa. - Photo: Fabio Rodrigues Pozzebom / Agência Brasil

Nov 11, Rio De Janeiro: The interruption of the clinical study of the Chinese vaccine Coronavac determined by the National Health Surveillance Agency (Anvisa), this Monday (9), was a technical decision because of the lack of detailed information about the research about a serious adverse event not expected. The information was provided by the agency's CEO, Antônio Barra Torres.

“The reason is that the information released yesterday was considered by the technical area to be insufficient, incomplete, so that yesterday it would be possible, in their possession, to continue allowing vaccine development. In the face of incomplete information, the technical area only has a decision to make when it is experiencing an unexpected serious adverse event ”, explains Antônio Barra, at a press conference this Tuesday (10).

Also, read- More than 5 million Brazilians have recovered from Covid-19

According to Barra, in the face of an unexpected serious adverse event in which, at first, it is not possible to establish a correlation, the indicated thing is to interrupt the study until everything is clarified so as not to work in a state of doubt.

“It is no joke to certify that a vaccine can be given to a person, this cannot occur in the presence of doubt. And a doubt, to be taken away, accurate and complete documents must be sent to us. And that didn't happen, ”he says.

Serious adverse events are considered: death; potentially fatal adverse event; persistent or significant disability/disability; requires hospitalization of the patient or prolongs hospitalization; congenital anomaly or birth defect; any suspicion of transmission of an infectious agent through a medical device; and clinically significant event.

Also, read- More than 5 million Brazilians have recovered from Covid-19

Technical decision

Barra explained that the interruption was decided by the General Management of Medicines, a technical area of ​​Anvisa. The measure is provided for by the agency's rules and is part of the Good Clinical Practice procedures expected for clinical studies conducted in Brazil. As of the decision, no new volunteers can be vaccinated.

According to Anvisa, during the clinical study, it is not uncommon for interruptions to occur as a safety measure to maintain the integrity of the volunteers.

At the news conference, the agency said that the position to stop clinical trials could be changed when the circumstances of the unexpected serious adverse event are clarified by official sources.

Also, read- More than 5 million Brazilians have recovered from Covid-19

“The decision made yesterday by the General Management of Medicines was the only one to be taken in doubt, so that, once the necessary information is obtained, it authorizes the proceeding or not. As simple as that, there is nothing more than that ”, points out the CEO of Anvisa.

Tests with Coronavac

In July, Anvisa authorized the Butantan Institute, in partnership with the Chinese pharmaceutical company Sinovac Biotech, to start phase three of the clinical trials to test the effectiveness and safety of the vaccine called CoronaVac. The volunteers are health professionals who work to care for patients with Covid-19.

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