[ad_1]
The tests to measure the efficacy and safety of the candidate vaccine, which the company is carrying out through its pharmaceutical company Janssen, were suspended on Monday. The event occurs after one of the volunteers participating in the study registered “an unexplained disease.”
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the data security monitoring board, as well as our internal safety and clinical physicians,” Johnson & Johnson said in a statement.
The firm did not provide further details, arguing that they must “respect the privacy of this participant.”
“We are learning more about the disease from this participant and it is important to have all the data before sharing additional information,” he added.
In addition, the company stressed that “adverse events (illnesses, accidents, etc.), even those that are serious, are an expected part of any clinical trial, especially large studies.”
In the third phase of the development of this vaccine, the aim is to measure the efficacy and safety of the vaccine in 60,000 patients from different countries, including Colombia.
Also read: 18 Santander residents were given the COVID-19 vaccine in the trial stage.
In Santander, the first doses were applied to the first group of 18 people, last Wednesday at the Fundación Cardiovascular de Colombia. Some 13,000 people in the department were expected to participate in the study, which for now is suspended.
[ad_2]
