COVID-19 vaccine development: New guidelines for ethical approach to infecting trial volunteers

May 27, 2020

Allowing consenting volunteers to be deliberately infected with COVID-19 for the purposes of developing a vaccine could be done ethically and potentially speed up its development, a University of Warwick researcher has argued in new research.

Dr Adair Richards at the University of Warwick has developed a set of ethical guidelines to guide researchers on an ethical approach to deliberately infecting volunteers who have been given a vaccine candidate with COVID-19.

He argues that this may significantly speed up the process of vaccine development and potentially save many lives. The work has been externally double-blind peer-reviewed and is published today (28 May) in the Journal of Medical Ethics.

Dr Adair Richards is an Associate Professor in the University of Warwick's Department of Chemistry and leads on research ethics training for postgraduate researchers in science and medicine. He said: "Currently there are several vaccine candidates that are undergoing human safety testing, but to find out whether they work we need to discover what happens when a vaccinated person is exposed to COVID-19. With new infections dropping in the countries where research is taking place, it may be a long time before many of the volunteers in these experiments naturally come into contact with the disease.

"Deliberately infecting volunteers with a disease as dangerous as COVID-19 has previously been considered to be unethical by the research community. However I believe that the current global situation is so different to those previously faced, that it is ethical in this case.

"In other areas of life it is not unusual for society to allow individuals to do things that put them at personal risk, such as to be a fire fighter or a health professional treating COVID-19 patients. Speeding up vaccine development even by a few weeks or months could result in saving many lives."

The research analyses each of the common arguments against these types of experiments: the risk of harm to volunteers; the risk of no useable vaccine; the validity of a volunteer's informed consent; the reputational risk to research; and that this could be a slippery slope to increasingly unethical research.

Dr Richards demonstrates that these arguments can be overcome and in fact we do not need to lower our ethical standards to permit these types of experiment, and that it is possible to put sufficient ethical safeguards in place.

The article provides guidance for regulators and researchers and poses three key questions for those planning vaccine development studies:Dr Richards adds: "My research shows that it is incorrect to rule out human challenge experiments as unethical in relation to COVID-19 vaccine development. I argue that you can apply the same standards of ethics, but that they lead us now to a different conclusion because the facts are different.

"Very large numbers of people globally are affected both directly and indirectly from COVID-19, and the saving of a few weeks or months of time in vaccine development can be expected to result in saving a large number of lives. There are also good ways to minimise the risk of harm to volunteers, and it is ethical, and I argue, admirable to allow a volunteer to choose to take a personal health risk to help serve a greater benefit to humanity."
-end-
'Ethical Guidelines for Deliberately Infecting Volunteers with COVID-19' has been peer-reviewed and will be published in the Journal of Medical Ethics at http://dx.doi.org/10.1136/medethics-2020-106322 .

Notes to editors:

Images of Dr Adair Richards available to download at:

https://warwick.ac.uk/services/communications/medialibrary/images/april2020/adair_richards-headshot_large.jpeg

https://warwick.ac.uk/services/communications/medialibrary/images/april2020/adair_richards-landscape_large.jpeg

For interviews or a copy of the paper contact:

Peter Thorley
Media Relations Manager (Warwick Medical School and Department of Physics) | Press & Media Relations | University of Warwick
Email: peter.thorley@warwick.ac.uk
Mob: +44 (0) 7824 540863

University of Warwick

Related Vaccine Articles from Brightsurf:

Who should get the COVID-19 vaccine first?
Nineteen global health experts from around the world have proposed a new, three-phase plan for vaccine distribution -- called the Fair Priority Model -- which aims to reduce premature deaths and other irreversible health consequences from COVID-19.

Breakthrough with cancer vaccine
Scientists have developed a new cancer vaccine with the potential to activate the body's immune system to fight a range of cancers, including leukaemia, breast cancer, lung cancer and pancreatic cancers.

How to improve the pneumococcus vaccine
Pneumococcus kills 1 million children annually according to the World Health Organization.

US inroads to better Ebola vaccine
As the world focuses on finding a COVID-19 vaccine, research continues on other potentially catastrophic pandemic diseases, including Ebola and Marburg viruses.

Successful MERS vaccine in mice may hold promise for COVID-19 vaccine
In a new study, published April 7 in mBio, researchers from the University of Iowa and the University of Georgia demonstrate that a new vaccine fully protects mice against a lethal dose of MERS, a close cousin of COVID-19.

Coronavirus Vaccine: Where are we and what's next? (video)
You might have heard that COVID-19 vaccine trials are underway in Seattle.

Why isn't there a vaccine for staph?
A study from Washington University School of Medicine in St.

Exposing vaccine hesitant to real-life pain of diseases makes them more pro-vaccine
New research from Brigham Young University professors finds there is a better way to help increase support for vaccinations: Expose people to the pain and suffering caused by vaccine-preventable diseases instead of trying to combat people with vaccine facts.

Lifetime flu vaccine?
Another year, another flu vaccine because so far scientists haven't managed to make a vaccine that protects against all strains of flu.

On the horizon: An acne vaccine
A new study published in the Journal of Investigative Dermatology reports important steps that have been taken towards the development of an acne vaccine.

Read More: Vaccine News and Vaccine Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.