Johnson & Johnson which has been undergoing clinical trials for a Covid-19 vaccine announces its temporary pause in its clinical trials.
A study participant has caught an unknown illness which caused the pause, but the company did not disclose the illness.
The enrollment system for willing participants are also closed as they are still figuring out the details of the said illness. They were targeting 60,000 participants from around the world with the funding supported by the company and US National Institutes for Health (NIH). It was reported that US had given $1.45 billion to fund the vaccine candidate under Operation Warp Speed by the US government.
The company released a statement saying that the patient is being treated by internal physicians to determine what caused the illness of the patient.
The 60,000 person trial single shot by J&J for the covid-19 vaccine was supposed to be a game changer when compared to its rivals that presented a two-dose vaccine.
It is mandatory for huge clinical studied such as this to halt its current progress whenever a problem arises. The safety is also important as well as the effectivity of the vaccine.
J&J also emphasized that they prioritize the safety of their users and promises to give updates on the vaccine candidate they are developing. They revealed that they also paused their phase 3 ENSEMBLE trial and will be following all guidelines from Data Safety Monitoring board (DSMB) concerning their patient. They explained that they couldn’t disclose any information about the illness the participant caught since they are still gathering information about it. They also mentioned in their statement their respect for the participant’s privacy.
Their concept for the vaccine candidate was a single dose of cold-causing adenovirus which was modified so it cannot replicate itself when it enters the body. Together with a part of the novel coronavirus, it about sums up their developing vaccine.
The company had became the tenth company to conduct phase 3 trials for a COVID-19 vaccine candidate.
In late September, AstraZeneca has also paused its study for a COVID-19 vaccine after a participant incidentaly developed an unknown illness as well.