The Coronavirus vaccine that Johnson & Johnson subsidiary Janssen Pharmaceutical developed is now under a lens as a pause in late-stage human trials was announced by the company.
The Coronavirus vaccine that Johnson & Johnson subsidiary Janssen Pharmaceutical developed is now under a lens as a pause in late-stage human trials was announced by the company. The announcement came as there was a potential safety concern after a trial participant developed an illness which the company said was “unexplained.” It is to note the J&J’s vaccine candidate uses the same approach as the one used for Oxford-AstraZeneca’s. Infact, the Oxford-AstraZeneca vaccine trial was also put on hold globally last month on the back of a similar concern. A report by The IE said that the Janssen’s vaccine candidate was used on 60,000 participants including phase 3 trials and one participant developed an “unexplained illness”.
The pause has not been decided by the regulators implying that the company has temporarily halted the trial. Right now, an independent Data Safety Monitoring Board along with J&J’s internal clinical and safety physicians are reviewing the illness of the patient. It is likely that the trial may resume after the review is done.
Is it a major concern?
The halt in trial decided by the company has put the product in limelight where the concern regarding the developed illness is questioned. However, there is no clarity as to what led to the “unexplained” illness in the participant who was a part of the trial. The report highlighted that at this stage, it would not be right to assume that the illness is a vaccine-related issue. The pause is being taken by the company as per protocols. Moreover, adverse events during a clinical trial are not uncommon and are considered as a part of experiment, the report added.
According to vaccine expert Dr Davinder Gill, a diverse population has been recruited into the last phase of human clinical trials for COVID-19 vaccine. He said that people in trials have all kinds of medical backgrounds as well as genetic predispositions. Therefore, something like this can come up during a clinical trial.
Meanwhile, the vaccine candidate by Janssen has not been tested in India so far. A Hyderabad-headquartered company Biological E in had signed an agreement with Janssen in August to produce the vaccine. The agreement was to make around 400-500 million doses in a year. Biological E, as of now, has said anything regarding the agreement since the vaccine trials are on a halt. It is likely that the outcome of J&J’s investigations regarding the illness may impact this agreement’s future course and its testing/ production in India.