As the coronavirus pandemic continues to wreak havoc in all nooks of the world, Johnson & Johnson, that was on the verge of successfully completing the clinical trial of the virus has halted the process temporarily after one of their participants developed a mysterious illness.
The company, in a statement issued on Monday, confirmed this news and revealed that the online enrollment system is now closed for the 60,000-patient clinical trial.
According to reports, the participant’s illness will be reviewed by a safety monitoring board, and further trials will be carried out only after completing this process. The company also revealed that serious adverse events during human trials of vaccines are not uncommon, as there are a large number of participants involved.
“The number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo,” read the company’s statement.
Last month, J&J had said its experimental Covid-19 vaccine had produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial, following which the pharma giant kicked off a final 60,000-person clinical trial. Results of the coronavirus vaccine trial are expected by the end of this year or early 2021.
The J&J Phase 3 trial had started recruiting participants in late September, with a goal of enrolling upto 60,000 volunteers across more than 200 sites in US and around the world.
The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
