The pause includes late-stage stage trials for the group’s single dose Covid-19 vaccine.
Key Facts
The U.S. company said it was not immediately clear what had caused the adverse reaction in the participant, whether it was linked to the vaccine or even if the participant had received the vaccine, as opposed to a placebo. An independent data safety monitoring board, in addition to the company’s own physicians, is monitoring the participant’s illness, the company said, adding that it is important to “have all the facts” and respect the participant’s privacy before sharing further information.
Though serious adverse events are not uncommon in clinical trials, the pause to Johnson & Johnson’s research might add to existing concerns over the safety of Covid-19 vaccines being at a much faster pace than is usual. “Adverse events – illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies,” the companyJohnson & Johnson is a frontrunner in the race to develop a Covid-19 vaccine, launching a large, 60,000-person phase 3 trial for its single dose vaccine last month. Without further information from the company, it’s impossible to tell which study this participant might be linked to or whether they had even received the vaccine.
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