Two Major COVID Trials Paused for Safety Issues

Johnson & Johnson’s COVID-19 vaccine trial is now on hold after a participant's unexplained illness. Courtesy of Johnson & Johnson

Johnson & Johnson’s COVID-19 vaccine trial is now on hold after a participant's unexplained illness. Courtesy of Johnson & Johnson

In August, Indonesia kicked off human trials of a vaccine candidate produced by China's Sinovac Biotech with some 1,600 volunteers taking part in the six-month study. So far more than 215,000 Americans have died of the deadly disease.

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At the time that it put a pause on its testing, Johnson & Johnson's drug was in Phase III of its clinical trial, meaning that the company was attempting to confirm the safety and effectiveness that it had seen in its first two trials.

It is not known-and "is not always immediately apparent", J&J added-if the ill participant was among participants randomized to JNJ-78436735, or to placebo.

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"SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants", J&J added.

J&J's trial is on a study pause as opposed to a regulatory hold - a regulatory hold of a clinical trial is a requirement by a regulatory health authority, such as the US Food and Drug Administration.

Johnson & Johnson's Covid-19 experimental vaccine is based on adenovirus vector Ad26. The pause comes just weeks after the company kicked off the 60,000-patient study and about a month after AstraZeneca suspended its own COVID-19 study for similar reasons. Elsewhere, Russia's government in August approved a vaccine called Sputnik V-named after the Soviet space satellite-after researchers completed only small-scale tests on 76 volunteers.

They are both also part of the US government's Operation Warp Speed programme to support vaccine development.

Others have said not to expect one until sometime between March and May.

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"We are extending and expanding our fast-track approach to address the COVID emergency so that developing countries have fair and equal access to vaccines", said the bank's president, David Malpass, said in the statement. The trial pause "is a good thing and a normal thing", she said.

The World Bank seeks to support the vaccination of up to a billion people, the statement said.

"Safety is the primary focus for vaccine clinical trials", the World Health Organization said.

Vardhan had earlier said a Covid-19 vaccine is likely to be available by the first quarter of 2021.

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