Johnson & Johnson pauses Covid-19 vaccine trial after participant suffers “unexplained illness”
The company said it is learning more about the participant’s illness before sharing additional information.
Johnson & Johnson, one of the world’s largest pharmaceutical companies, has announced that it is pausing all Covid-19 vaccine clinical trials due to an “unexplained illness” in a participant.
In a statement, the company said it is respecting the privacy of the participant in question, it is learning more about their illness and that it is important to have all the facts before additional information is shared.
In the meantime, there will be a “careful review” of all the medical information before it is decided whether to restart the study or not.
“At Johnson & Johnson, there is no greater priority than the safety and wellbeing of the people we serve every day around the world,” the statement read.
“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.
“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. Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.”
Johnson & Johnson said that adverse events such as illnesses or accidents, even those serious in nature, are an expected part of an clinical study, especially one of the scale of the Covid-19 vaccine trial.
Strong Adverse Events (SAEs), the company said, are not uncommon and that they can reasonably be expected to increase in trials involving large numbers of participants.
As many trials are placebo-controlled, Johnson & Johnson explained, it is not always immediately apparent whether a participant received a study treatment or a placebo.
The Phase 3 ENSEMBLE trial by Johnson & Johnson commenced in September and had aimed to recruit 60,000 volunteers in 200 sites in the United States and around the world.
It is one of four Phase 3 clinical trials taking place in the United States and 10 around the world, with trials also taking place in South Africa, Mexico, Peru, Chile, Argentina, Colombia and Brazil.
Director-General of the World Health Organisation (WHO), Tedros Adhanom Ghebreyesus, said last week that “there is hope that by the end of this year we may have a vaccine”.
Speaking recently on The Architects of Business on JOE, made in partnership with EY Entrepreneur Of The Year™, Philip Noone, CEO of Aalto Bio, a Dublin-based biotech company working on a Covid-19 vaccine, predicted a vaccine would be available by the end of this year.