Friday, May 7, 2021

World’s first coronavirus human challenge study gets green light in UK – POLITICO

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The U.K. is set to begin the world’s first trial of healthy volunteers being intentionally infected with coronavirus, after the study received ethics approval. 

The so-called human challenge study will begin within a month, said the U.K. Department for Business, Energy and Industrial Strategy in a statement Wednesday, with up to 90 people being exposed to a very small amount of coronavirus in a safe and controlled environment. These kinds of trials are controversial as they expose healthy volunteers to diseases that may be deadly. 

The next stage of the study, which has not yet been approved, will involve giving a coronavirus vaccine to different volunteers and then exposing them to coronavirus. Only vaccines that “have proven to be safe in clinical trials” will be used. However, researchers are still a “long way” from this stage of the study, according to Terence Stephenson, chair of the Health Research Authority, which gave ethics approval.

Proponents say these studies provide the fastest way to evaluate new vaccines, especially when the world emerges from an active pandemic, said Robert Read, head of clinical and experimental sciences within medicine at the University of Southampton, who belongs to this camp and is part of the team involved in the study.

This initial part of the study will help doctors understand how the immune system reacts to the virus and identify what affects transmission. The drug Remdesivir will be used as soon as volunteers start developing symptoms.

The volunteers, who are being encouraged to come forward for the study, will be between 18 and 30 and will be exposed to the variant circulating in the U.K. since March 2020.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.

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