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A week after Covid-19 vaccine trial goes on pause, Johnson & Johnson and FDA won't reveal critical details

October 19, 2020. Summarized by summa-bot.

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Despite repeated claims they're committed to transparency, Johnson & Johnson and the US Food and Drug Administration still aren't revealing crucial details one week after the pharmaceutical giant's Covid-19 vaccine trial went on pause.

(CNN)Despite repeated claims they're committed to transparency, Johnson & Johnson and the US Food and Drug Administration still aren't revealing crucial details one week after the pharmaceutical giant's Covid-19 vaccine trial went on pause.

The Johnson & Johnson trial was put on hold October 12 due to a study participant's "unexplained illness," according to a company statement last week.

The company and the FDA declined to answer two questions from CNN: One, whether the study volunteer who became ill received the vaccine or the placebo, and two, if this is the first pause for the trial.

The pharmaceutical company has also said it's committed to transparency, including transparency about its Covid-19 vaccine trial.

Only the trial's Data Safety and Monitoring Board, a group of independent scientists, can unblind the status of the ill participant and find out if he or she received a vaccine or placebo.

When CNN asked whether the volunteer received the vaccine or the treatment, the Johnson & Johnson spokesman pointed to the company's October 12 statement, which notes that "as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo. "

Offit said it's clear to him that the participant received the vaccine -- otherwise the trial wouldn't have been put on hold and stayed on hold for a week.

Johnson & Johnson and the FDA also declined to answer whether this was the first pause for its Covid-19 vaccine trial.

Offit said the pharmaceutical companies should inform the public of pauses, and if the trial is allowed to proceed, explain why the illnesses were coincidental and not due to the vaccine.

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