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Friday, October 23, 2020

U.K. Government Reportedly In Advanced Talks To Initiate Human Challenge Vaccine Trials That Would See Volunteers Infected With Covid-19

Topline

A U.K.-based biotech firm is in advanced talks with the British government to create and provide strains of the Covid-19 virus which can be used for human challenge trials to test the efficacy of vaccines —  in which inoculated volunteers could be deliberately infected with the disease — a move that may face ethical and safety concerns.

Key Facts

Preliminary work for the trials is being carried out by hVIVO, a unit of pharmaceutical services group Open Orphan, Reuters reported.

Once an appropriate strain and dose of the virus is selected, volunteers who have received a vaccine shot will be deliberately infected, a move that could yield quicker results than a conventional vaccine trial.

If the U.K. government agrees, a human challenge study model for such a trial will need to be created.

Any such trial would still need to gain ethical and safety approval from regulators.

Crucial Quote

Prominent scientists including 15 Nobel laureates have written an open letter to the U.K. health secretary, Matt Hancock in support of human challenge trials arguing that its benefits far outweigh the risks. “If done properly, live Coronavirus human challenge trials can be an important way to accelerate vaccine development and, ideally, to save innumerable lives around the world as well as help rescue global economies,” the letter, published by 1DaySooner, a non-profit that advocates for Covid-19 challenge trial volunteers, read.

Big Number

38,659: That’s the total number of volunteers who have signed up to participate in human challenge trials across 166 countries, according to 1DaySooner.

Key Background

Human challenge studies have been successfully employed in the past and were a key process in establishing the efficacy of the first-ever vaccine. In the late 18th century, British physician Edward Jenner inoculated a young boy with cowpox virus and then exposed him to smallpox. The method has since been used to develop vaccines for typhoid, cholera and malaria. The U.S National Institute of Allergy and Infectious Diseases (NIAID) is working to create a strain of coronavirus that could be used in human challenge trials, Dr. Anthony Fauci told CNN in August but described this approach as “Plan D.” 

Chief Critic

However, Fauci, the U.S.’s top infectious disease official, has been critical of challenge experiments in the past, arguing that challenge they are likely to be slower, more ethically fraught and harder to scientifically interpret than many people appreciate. “You generally do [human challenge trials] if you don’t have enough infections in the community at any given time to get a signal from the vaccine,” Fauci said. “Unfortunately for us, we don’t have that problem — we have a lot of infections.”

Further Reading

Britain moves closer to COVID-19 vaccine trials that infect volunteers (Reuters)

U.S. will prepare coronavirus strain for potential human challenge trials (Washington Post)

Nobel laureates call on UK to back infecting volunteers with Covid for vaccine trials (Guardian)

Full coverage and live updates on the Coronavirus

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