Updated: Nov 12
On Monday, Johnson & Johnson announced that it would be temporarily pausing their large-scale vaccine trial due to reports that a participant had experienced an unexplained illness.
According to Johnson & Johnson, the participant’s unexplained illness will be reviewed and evaluated by the ENSEMBLE independent Data Safety Board as well as the New Jersey based pharmaceutical companies’ internal clinical and safety physicians.
This illness comes just weeks after Johnson & Johnson announced that it would be launching the first phase three, large-scale, single-dose COVID-19 vaccine trial in the United States. In a press release posted on their website, the company claimed that illnesses and accidents, even those that could potentially be serious are an expected part of any study. They stated. “ Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.”
Dr. Mathai Mammen, global head of Janssen research and development at Johnson & Johnson, told investors on Tuesday that they still have limited information on the participant’s illness and have not yet discovered if the participant took the placebo or received the vaccine.
Johnson & Johnson said that it would not release the details of the participant’s illness due to privacy concerns. They also stated that they are still learning more about the illness and would not share any additional information until they have all of the facts.
This is not the first COVID-19 vaccine trial to be halted. On September 8, Astrazeneca announced that the trial for the vaccine would be paused due to a participant developing a spinal cord injury known as transverse myelitis. Although the trial continues to be halted in the United States, The United Kingdom and other countries have since resumed all trials.
The vaccines being developed by Johnson & Johnson and Astrazeneca are just two of several late-stage vaccines currently in development. On Friday, Pfizer announced that it could be ready to file for emergency use authorization for their vaccine in November making it available in the United States as early as the end of the year.