Johnson and Johnson (J&J) announced on Monday that the company has paused the clinical trials of its covid19 vaccine only weeks after the phase 3 trials were started for the vaccine because a volunteer encountered an unknown illness. The company said that the illness of the volunteer is being evaluated and reviewed by the company’s internal safety and clinical physicians as well as by the ENSEMBLE independent Data Safety Monitoring Board (DSMB).
The company did not make it clear whether the illness was found in someone who received a placebo or the experimental vaccine. The company said in a statement that they are trying to learn more about the illness and it’s essential to have full facts before disclosing information.
Janssen’s Global Head of Research and Development Mathai Mammen said that the company is now waiting for further medical evaluation and information, which would be sent to the DSMB for further recommendations. She further said that many clinical trials involve the use of placebo so it is sometimes unclear whether the person got a placebo or study treatment.
Johnson and Johnson’s experimental covid19 vaccine is better in some ways than the other vaccines but in the race for a vaccine, it was behind its competitors. The benefit this vaccine has is that it could work in only one dose and it does not require to be frozen. The company started the phase 3 trials of its covid19 vaccine last month and the company is aiming to incorporate 60,000 adult people from multiple countries, which would make it the biggest trial.
This is not the first case of a pause in phase 3 trials of a covid19 vaccine as AstraZeneca, who also initiated the phase 3 trials of its vaccine last month, paused the trials in the United States because a volunteer in the United Kingdom encountered a neurological complication. The AstraZeneca trials were resumed in the UK and other countries, however, remain paused in the US as it is awaiting the approval of the Food and Drug Administration (FDA).
The dean of the Brown University School of Public Health Dr. Ashish Jha said that the pauses of such kind are completely normal and not concerning. She further said that this pause could be one of many as it is the largest trial in the world with 60,000 volunteers and this pause is also a reminder that it is ridiculous to even try to have a vaccine before the 3rd of November due to the artificial political deadline. Jha believes that it is reassuring that the companies are being responsible and pausing when there is a need.
Phase 3 trials of Johnson and Johnson’s covid19 vaccine initiated in the month of September and is 1 of the 6 vaccines that are being tested around the United States, and is also 1 of the 4 vaccines which are in the most advanced stage, that is the Phase 3 trials. The federal officials are hoping the testing of Johnson and Johnson’s vaccine may be done quicker than some of the other vaccines because it only requires one dose.