Johnson & Johnson said it temporarily suspended clinical trials of the COVID-19 vaccine due to a study prticipant’s unexplained illness, delaying one of the most significant efforts to control the global pandemic.
The participant’s illness is monitored and evaluated by an independent data and safety monitoring board, as well as the company’s clinical and safety doctors, J&J said in the report.
J&J, which reports quarterly financial results on Tuesday morning, said such pauses are normal in large studies that may involve tens thousands of people. The company stated that the “pause of the study” is different from the “regulatory suspension” demanded by the health authorities. The current case is therefore a pause and not a regulatory suspension.
The J&J vaccine is based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins. “This could be the second case of an adenovirus vaccine that would raise safety concerns,” said Olga Smolentseva, Bryan Garnier analyst.
The final phase of testing was launched by the American company on September 22nd. According to information, it is attended by 60,000 volunteers from three continents. Johnson & Johnson hopes the vaccine could be available early next year. While most vaccine developers anticipate that COVID-19 vaccine will need to be applied in two doses, with Johnson & Johnson, only one dose should be sufficient.
Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University School of Medicine, said: “It would have to be a serious adverse event. If it was something like prostate cancer, uncontrolled diabetes or a heart attack – they wouldn’t stop testing for these reasons. It will probably be a neurological event. ”
J&J declined to give a further explanation of the patient’s health problems due to privacy concerns. Some study participants are said to have received a placebo effect and it was not always clear whether a person who had a serious adverse event in a clinical study was affected by the placebo effect or treatment with a new drug.
This negative event could serve as a source of speculation on the sale of Johnson & Johnson shares.
Source: Reuters.com, WebTrader