Human Challenge Trials: Healthy Volunteers Should Be Purposely Infected With Coronavirus To Speed Up Vaccine Race, Say Experts

Human challenge trials are trials in which participants are intentionally challenged (whether or not they have been vaccinated) with an infectious disease organism.

Healthy people should be purposely infected with the coronavirus to speed up the development of a vaccine, according to a group of 100 leading experts that includes Nobel Prize-winning scientists.

These experts have written an open letter  to the US National Institutes of Health saying the benefits of bringing a vaccine to the masses outweighs the risk to trialists’ health.

The group behind the letter, called 1 Day Sooner, is made up of more than 100 prominent scientists and 15 Nobel laureates.

Among the signatories is Professor Adrian Hill, the director of Oxford University’s Jenner Institute, which has one of the leading prototype coronavirus vaccines.

The group say the risk to the health of volunteers would be low, and could speed up vaccine development by many months, saving countless lives.

Writing in the letter, they say: ‘If challenge trials can safely and effectively speed the vaccine development process, then there is a formidable presumption in favour of their use, which would require a very compelling ethical justification to overcome.’

Dr Collins said the challenge trials are ‘on the table for discussion — not on the table to start designing a plan’.

Two projects in Britain are using this method, Oxford and Imperial College London.

However, waiting for enough people to be exposed to the coronavirus can take months, particularly as Covid-19 infections fall globally.

Human challenge trials

Human challenge trials are trials in which participants are intentionally challenged (whether or not they have been vaccinated) with an infectious disease organism. This challenge organism may be close to wild-type and pathogenic, adapted and/or attenuated from wild-type with less or no pathogenicity, or genetically modified in some manner.

In July 2014, WHO held a consultation on Clinical evaluation of vaccines: regulatory expectations (1). One area that was considered as an important issue for facilitating vaccine development was related to human challenge trials. It was recognized that regulation of these trials need to be well defined by the NRAs and vaccine developers and manufacturers need to be aware of regulatory expectations.

The practice of deliberately infecting people with disease, termed “human challenge trials,” has a long history. It is embedded in the origin of the very first vaccine in 1796, when Edward Jenner, an English physician, purposely infected his gardener’s 8-year-old son with cowpox after observing that people previously infected with cowpox, a relatively mild disease, seemed protected from smallpox, one of the deadliest scourges of the time.

In the June 1 issue of the Journal of Infectious Diseases, Nir Eyal, Marc Lipsitch, and Peter G. Smith argue that this approach could accelerate the development and approval of a Covid-19 vaccine by many months.

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