Johnson & Johnson halts COVID-19 vaccine trial after participant falls sick

Grant Boone
October 17, 2020

A late-stage study of Johnson & Johnson's COVID-19 vaccine candidate has been paused while the company probes whether a study participant's unexplained illness is related to the shot. "Following our guidelines, the participant's illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board, as well as our internal clinical and safety physicians".

"We must respect this participant's privacy".

Developing countries must have "equal access" to future COVID-19 vaccines, Indonesia's foreign minister warned, as wealthy nations scoop up billions of doses.

The New Brunswick-based company announced in a statement Monday evening that illnesses, accidents and other so-called adverse events are an expected part of large clinical studies.

Given the size of the trial, it's not surprising that study pauses could occur, and another could happen if this one resolves, a source said.

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Supporters of human challenge trials say they are a good way to cut short the often lengthy process of testing potential vaccines on tens of thousands of volunteers in the real world who go about normal life and are monitored to see if they contract the disease or are protected from it. Johnson & Johnson said last month that its goal was to seek an emergency use authorization approval in early 2021.

Pfizer said that at least 90 people have responded to an ad looking for teens to participate in the trial, and they hope to enroll more adolescents in the coming weeks.

But before any drugmaker can apply for emergency use authorization of a Covid-19 vaccine candidate, the Food and Drug Administration will require two months of safety information following the final dose of vaccine.

The US is attempting to fast-track vaccine development too, after President Donald Trump authorised Operation Warp Speed in April to support companies with federal funding.

According to the FDA, a typical Phase 3 trial would take one to three years.

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