The vaccine race: Johnson & Johnson resumes trials

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One of the participants in the trial developed an unexplained side effect – and the trial was stopped earlier this month • The study was stopped in advanced stage 3, but the control committee found no evidence that there was a link between the medical complication and the vaccine.






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Illustration: Juliya Shangarey, shutterstock


The pharmaceutical company Johnson & Johnson announced about a week and a half ago that it is suspending the trial to develop the vaccine against the corona it was working on. Over the weekend, the company announced that it would return to testing the vaccine it had developed. It is one of six vaccines against the virus being tested in the United States, and one of four in the third and most advanced phase.

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The trial was stopped this month following a medical incident by one of the experimenters. According to the Washington Post publication, it was a stroke in which one of the experimenters contracted after receiving the vaccine, but a control committee that discussed the case found no evidence that there was a connection between the two. AstraZeneca is also expected to return to testing in the United States, after receiving official approval from the U.S. Drug Administration under similar circumstances.

Phase 3 of Johnson’s experiment began in September. The vaccine requires only one dose so federal officials said they hope the trial will end slightly faster than trials of other vaccines, including those manufactured by Modern and Pfizer, which require two doses.

Corona virus (Photo: HQuality, shutterstock)
צילום:
HQuality, shutterstock

On October 13, the company announced an “unexplained response” among one of the experimenters. “The phenomenon that appeared in the participant is being investigated by both an independent team and an internal team of doctors from the company,” the company said in a statement on the matter. “Illnesses and mistakes – even serious ones – are an expected part of a clinical trial, especially in large studies.” Indeed, the Johnson & Johnson experiment is one of the largest in the world, if not the largest of them, with 60,000 experimenters. One of the goals of a clinical trial of a vaccine is to detect dangerous side effects. When such a phenomenon does occur, studies usually stop while doctors check if it is related to the vaccine, or if it is a coincidence.

“Given our high commitment to safety, all clinical trials conducted by the company have guidelines,” the company added at the time. “Our research may stop if a physical phenomenon occurs that may be caused by the vaccine or drug. We must respect the participant’s privacy. We also learn about the phenomenon and it is important to know all the facts before sharing more information.”

This is the second phase 3 vaccine trial in the US, after the Astrazenka trial was also suspended last month – due to a neurological complication in a UK volunteer.

Corona vaccine, illustration (Photo: Reuters)
Another experiment was stopped | Photo: Reuters







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