Drug maker Johnson & Johnson on Monday informed that they have temporarily paused the trial of its covid-19 vaccine after one of its volunteers showed adverse effects.
“We have temporarily paused further dosing in all our Covid-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company said in a statement.
Currently, the volunteer’s sickness is being reviewed by an independent data and safety monitoring board.
The pause has stopped online enrollment system for the 60,000 patients clinical trial.
Meanwhile, J & J said that adverse effects are an “expected part of any clinical study, especially large studies.”
The study will be resumed once the company re-evaluates if the serious adverse events were related to the drug in question.
Earlier this month, Johnson & Johnson had joined the list of vaccine makers to conduct late-stage trials of their potential vaccine against the novel coronavirus. The company has since begun dosing up to 60,000 volunteers and underlined that the vaccine might be effective after just one dose.
Last month, J&J said that its vaccine has shown strong immune response against the coronavirus in early-to-mid trials.
Prior to J&J, drug maker AstraZeneca also halted their vaccine trials after ill effects shown in one of the participants. The vaccine developed by AstraZeneca in collaboration with Oxford University reportedly developed some neurological disorder in the said participant.
While trials in the UK, India and South Africa have resumed, the US is still waiting for a regulatory review from the authorities.
Meanwhile, Johnson & Johnson has declined to explain the nature of illness due to the privacy concerns.
The J&J’s Phase 3 trial had started in September across more than 200 sites around the world. The countries where trials are taking place are — US, Brazil, Chile, Argentina, Colombia, Mexico, Peru and South Africa.
