Johnson & Johnson’s announced that the covid-19 vaccine study was halted after a volunteer had “unexplained illness”. The test is the same that will be carried out in Mato Grosso do Sul.
According to a document sent to the researchers, who are testing 60,000 patients, a “regulatory break” will be followed.
In a statement, Johnson & Johnson’s states that “adverse events – illnesses, accidents etc. – even serious ones, are an expected part of any clinical study, especially large studies”.
It also points out that the patient’s illness is “being analyzed and evaluated by the independent Data Security Monitoring Council, as well as by our internal clinical and security doctors”.
Wanted by Campo Grande News, the State Secretary of Health, Geraldo Resende, said that he will wait for new information from the company to know what the immediate effect of the tests in Mato Grosso do Sul will be.
“Let’s wait. It is only one case, of course, that such a serious research has to verify the reaction in order to proceed or not. We will have 15 days to have an exact definition on. As it is an internationally renowned laboratory, the criteria in these researches are strict, we will wait for the manifestation ”.
The immunization was developed by the pharmaceutical company Janssen Pharmaceuticals, a member of the J&J group. Immunization was the fourth to obtain authorization for phase 3 tests in Brazil, in August.
In September, the company announced that it would start the third stage worldwide, with 60,000 volunteers. In Brazil, according to Anvisa, there are 7 thousand participants. The vaccines that will be tested in Mato Grosso do Sul, about 2 thousand, are already in São Paulo.
The expectation is to open the registration for candidates in the coming days. The volunteer cannot have comorbidities, such as hypertension and diabetes. Pregnant women will also not participate.