A volunteer is vaccinated on September 24, 2020, at a research center in Florida, USA, at a research center for coronavirus disease (COVID-19).
Marco Bello | Reuters
Healthy, young people in the UK may soon be asked to volunteer for exposure to COVID-19 as part of a group of human challenge studies aimed at speeding up the vaccine development process.
The study, which is controversial in medical circles, essentially calls for “challenging” volunteers with infectious disease organisms. The idea behind them is to recruit healthy, young people, inoculate them and then bring them against the virus to determine if the vaccine is effective. Proponents say such studies could accelerate vaccine development, while others say the tests raise ethical questions.
The UK government has taken an early step this week by signing an agreement with a pharmaceutical services company called Open Orphan for a so-called characteristic study, which includes identifying the most appropriate amount of virus for use in future human challenge studies. In practice, this means that researchers will determine the lowest dose of virus that will still look positive on a standard polymerase chain reaction, or PCR, test.
The characteristic study is expected to be completed in 2021 and is still subject to ethical and regulatory approval. Sponsored by Imperial College Ledge in the UK, the study will be conducted by Open Phanfran’s HVVO unit at the London-based research site.
The government has also secured the first three slots for vaccine testing using human challenge studies. It remains to be seen whether this study will proceed.
“In conventional vaccine testing, all subjects are vaccinated and sent to live their normal lives,” said Andrew Ketchpol, HVO’s chief scientific officer. “But the result is that most don’t come out naturally, so you’ll see on how much disease has spread in that community.”
Ketchpol said HVVO conducts a study of a more humane challenge to other diseases globally than any other company.
Volunteers participating in the study model should be between 18 and 30 years old, Ketchpol said. His general health will be checked for any risk factors, he said. The study is not open to pregnant women or nursing mothers.
It is not clear how many people will raise their hands, but in other countries, such as the US, large numbers have already shown a willingness to take part in such tests.
Medical experts from around the world have mixed ideas about the study of the human challenge.
“I think they can speed up the process and between epidemics, so it’s worth considering even though it’s dangerous and morally controversial,” said Arthur Caplan, a professor of biothics at New York University.
A person infected with the virus violates the “Do No Harmful Rule” which can have consequences for his health.
But, for the most serious, healthy people, the risk can be reduced as low as possible by starting with a very low probability of serious illness. Participants are usually given antiviral therapy, such as a remediator of Gilead Sciences, in the following exposure. It is worth noting, however, that recent studies have questioned the effectiveness of these drugs.
Others say the study may not be necessary given the potential damage.
Boston-based Emergency Medicine Physician Dr. “We may get the approval vaccine in the coming months, I don’t know how much the challenging study will speed up the process,” Jeremy Fost said. “People here are more likely to be put at risk without taking risks.”
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