The pause in the trials conducted by J&J’s Janssen Pharmaceuticals subsidiary follows an unexplained illness arising in a study participant, according to a news release. Under the company’s guidelines, the illness is being reviewed and evaluated by internal and independent investigators.
Johnson & Johnson said that adverse events are expected in clinical studies, especially large studies like the multi-country Phase 3 trial that began in September.
The company said it is respecting the privacy of the affected participant while also learning more about the illness before sharing additional information with the public.
Speaking last week during the virtual MedTech Conference by AdvaMed, J&J chief scientific officer Dr. Paul Stoffels said the first doses of Janssen’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it.
The U.S. Dept. of Health and Human Services and Defense Dept. agreed to a $1 billion deal for the vaccine candidate from Johnson & Johnson in August, while last week the European Commission, on behalf of the European Union, approved an advance purchase agreement for 200 million doses of the J&J vaccine.
Johnson & Johnson’s trial pause makes it the second company with a high-profile COVID-19 vaccine candidate study to be put on hold after AstraZeneca last month stopped its trial to conduct a review after an unexplained patient illness.