Pharmaceutical giant Johnson & Johnson (J&J) just announced they are pausing all clinical Covid-19 vaccine trials after a study volunteer became sick with an unexplained illness.
According to The Wall Street Journal, this pause announced Monday affects all trials of J&J’s vaccine, including a large Phase 3 trial that began in September and aimed to enroll as many as 60,000 people in the U.S. and several other countries.
“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” says the company.
An independent data-safety monitoring board is currently reviewing the study subject’s mystery illness but that is the only information disclosed to the public at this time.
This is not the only occasion a Covid-19 vaccine trial has been paused for safety concerns. Last month, the Phase 3 trial of a vaccine candidate from AstraZeneca was paused after a British study participant developed a neurological illness. The AstraZeneca study resumed a few days later in the United Kingdom and elsewhere, though it remains on hold in the U.S., reports NPR.
Medical experts pointed out the importance of study pauses and the inability to keep a set timeline for a vaccine release because of these possible pauses.
“This is completely expected, and it’s just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3,” says Ashish Jha, dean of the Brown University School of Public Health.
As EcoWatch reports, J&J is the fourth pharmaceutical company receiving funding under Operation Warp Speed to enter late-stage testing of its vaccine candidate. Moderna, AstraZeneca, and Pfizer are all in the process of evaluating safety and efficacy data of their clinical trials.