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The National Health Surveillance Agency (Anvisa) of Brazil reported this Monday that it determined the temporary suspension of clinical trials in the country of the coronavirus vaccine developed by the Chinese laboratory Sinovac, after being notified of the occurrence of a “serious adverse event”.
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Anvisa “decided to interrupt the study to evaluate the data observed so far and to judge the risk / benefit of continuing the study” after it was notified of a serious adverse event on October 29.
“This kind of interruption is foreseen by the regulations of Anvisa and It is part of the Good Clinical Practice procedures, expected for clinical studies conducted in Brazil“, said the entity in a statement.
With the discontinuation of clinical trials, which include 9,000 volunteers in Brazil, no new individual can be vaccinated.
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Anvisa did not release further details about the suspension of the Coronavac tests, which are being tested in phase 3 clinical trials in Brazil, Turkey, Bangladesh and Indonesia, in addition to China, to respect the “principles of confidentiality, dignity human rights and protection of participants “.
The regulator did not specify the serious event that led to the decision, but explained that death, a potentially fatal adverse event, persistent or significant disability or disability, or hospitalization of the patient are considered a “serious adverse effect”.
Congenital anomalies or birth defects, suspected transmission of infectious agent by a medical device, or “clinically significant event” they also configure serious collateral reactions, he added.
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“Anvisa maintains the commitment with the Brazilian State to act in the interests of public health,” the entity completed.
The vaccine developed by Sinovac was being tested in Brazil in association with the Butantan Institute, one of the main medical research centers in South America located in Sao Paulo, the most populated and industrialized state in the country.
This Monday, the governor of São Paulo, Joao Doria, reported in a press conference that The first batch of 120,000 imported doses from Coronavac is expected to arrive in Sao Paulo on November 20 from China.
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Likewise, it foresees the arrival of supplies until the end of the month so that the Butantan Institute can start the production of 40 million doses in the country itself.
After learning of the regulator’s decision, the Butantan Institute stated in a note that it was “surprised” by the announcement and that it is finding out “in detail what happened during the Coronavac studies” and is available to “provide all clarifications necessary “.
EFE
