Saturday, 31 October, 2020

Johnson & Johnson places COVID-19 trial on pause after ‘unexplained illness’

Pfizer may seek emergency use for COVID vaccine in November Second COVID-19 vaccine trial paused over unexplained illness
Gustavo Carr | 17 October, 2020, 19:41

USA pharmaceutical company Johnson & Johnson has announced a pause in its clinical trials for a COVID-19 vaccine candidate.

The decision taken by the US-based company means that it has closed the online enrollment system for the 60,000-patient clinical trial and will now convene an independent patient safety committee. The company declined to provide further details.

"We must respect this participant's privacy", the Johnson & Johnson statement said.

Johnson & Johnson said that in large trials where tens of thousands of volunteers, it was to be expected that some may become unwell during the study period.

The letter said Pfizer and its partner BioNTech hope to apply for Emergency Authorization Use of their vaccine in the third week of November. "These are some of the ways we're trying to be creative about safely vaccinating people during the pandemic", she says. "In a small village, there are a lot of medical events that happen". Pfizer is one of four companies conducting Phase 3 clinical trials in the United States and the only one that is testing the vaccine in children.

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The company confirmed on its website it has approval from the US Food and Drug Administration to enroll children as young as 12 in its trial.

The FDA noted that a vaccine candidate must be at least 50% effective to receive emergency use authorization.

Coronavirus vaccines should be rolled out in four phases, with initial supply going to front-line health workers and first responders, an independent expert panel tapped by top USA health officials recommended earlier this month.

"That's why we are urging more people to support our incredible scientists and join the 270,000 people who have already signed up so we can speed up efforts to find a vaccine to defeat this virus once and for all", he added. The CDC said so far early clinical trials have only included non-pregnant adults, noting the recommended groups could change in the future as clinical trials expand to recruit more people.