Consumer and pharmaceutical conglomerate Johnson & Johnson said on Monday it would pause its COVID-19 vaccine clinical trials due to one participant’s unexplained illness. It added that the case is now being studied by both an independent panel and the company’s own team of physicians.
last month became the fourth company to sign on to the U.S. government’s “Operation Warp Speed,” aiming at producing 300 million doses of safe and effective vaccines, the first to be delivered by January 21.
It is also the second major pharmaceutical group to pause its so-called Phase 3 trial, after U.K.-based AstraZeneca
last month paused its late-stage trials because a participant became sick. The trials have since resumed in the U.K. but remain on hold in the U.S., pending a regulatory review.
- J&J pointed out in its release that the “study pause” that it decided is different from a “regulatory hold” that can be required by health authorities. It added that so-called serious adverse events aren’t “uncommon in clinical trials,” notably those involving a large number of participants.
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The outlook: The news is a reminder that the road to a safe vaccine may be longer and bumpier than hoped by some, even though the number of adverse cases so far isn’t unusual in final trials of that size. The public’s perception of a vaccine’s safety will be a key condition of its broad adoption. That largely explains why pharmaceutical companies aren’t eager to rush to market, and will resist pressure from politicians such as U.S. President Donald Trump to speed up the trial and approval process.
It is worth noting, however, that most vaccine developers remain confident that there will be a breakthrough in the coming months.
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