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Legal rights and coronavirus: The vaccine race and the safety of clinical trial participants

Product safety lawyer Sarah Moore discusses the race for a safe vaccine against Covid-19 and the dangers for participants involved in trials testing

Trials testing for Covid-19 treatment
Sarah Moore specialises in product liability and claims for groups of people who have suffered an injury because of unsafe products. She has written a number of articles on topics such as drug regulation, cigarette packaging and food safety.
In the midst of the global COVID-19 pandemic, scientists and politicians across the world agree that the only conclusive way out of this crisis is through the production of an effective COVID-19 vaccine.

On 10 January 2020 China shared the genetic sequence of a newly identified virus that appears to have originated in Wuhan province. Publication of that key data has been likened to firing the starter’s gun in the race to produce a vaccine.

Traditionally it can take many years to develop a safe vaccine: However, recent reports indicate that a COVID-19 vaccine may be available as early as June this year; or according to the UK’s chief scientific adviser, Sir Patrick Vallance, within 12-18 months.

Scientists will be working within an accelerated framework for testing and production which will need to balance the twin aims of developing an effective vaccine as quickly, but also as safely, as possible. History is full of examples of epidemics that have eventually been quelled by the development of effective drugs and vaccination programmes, from smallpox in the 16th century, to the Ebola Virus in West Africa and the Zika Virus in South America more recently.

But history is also redolent with examples of drugs ‘gone wrong’, some, such as the case of the anti-emetic drug Thalidomide back in the 1950s after they have been cleared by drug regulators and others, such as the (then novel) monoclonal antibody drug that allegedly led to the serious injuries caused to healthy participants involved in the Northwick Park Clinical Trials in 2006.

So all scientific teams engaged in the production of an effective COVID-19 vaccine will be acutely aware of the need for speed but also crucially of ensuring the safety of all trial participants.

Home-grown science teams at Imperial College London, and Oxford University, are already making use of accelerated testing frameworks to develop COVID-19 vaccines for clinical trials.

To support UK efforts, at the end of last week (17.4.20), the government announced a new Vaccine Taskforce to help the development of a vaccine for COVID-19 and to accelerate production and roll-out as soon as one arrives.

Last month Oxford University announced that it had been granted MHRA approval to begin clinical trials of an Oxford COVID-19 vaccine that to date has only been tested in ‘mice and other animals’.

The group has started screening healthy volunteers ahead of a COVID-19 vaccine trial and has recruited up to 510 volunteers aged 18-55 who will be injected with a newly developed vaccine or a control injection for comparison.

Updated reports show that, at this stage, no further volunteers are required for the Oxford trial.

However, for anyone considering becoming involved with COVID-19, or other clinical trials in the UK, the NHS and MHRA, provide useful online advice for all potential participants: Key points for participants to consider include the following:
  • Ensure that the trial is official and approved by the MHRA: The MHRA explains that all official trials will be registered via on the following websites:
EU Clinical Trials Register
National Institute for Health Research
  • Read all safety data provided by the Research Team very carefully, making a list of follow up questions
  • Talk to the Research Team, ask questions (even if they seem obvious) and do not feel rushed to confirm participation
  • Talk to your family/friends about your participation
  • Be clear about the time commitment that participation will involve, and how realistic this is for you to be able to provide
  • If possible discuss participation in the trial with your GP before entering the trial, particularly if you have any doubt about your clinical suitability
  • Retain all documentation and ideally keep a note of all discussions with researchers
  • Keep a ‘trial diary’, documenting details of participation in the trial on a day to day basis, what they have been told, what drugs were administered, how they feel – noting changes in symptoms etc.

From a legal point of view, in the event that participants do suffer adverse events as a result of participation in an approved clinical trial, there is existing legislation - including the Consumer Protection Act 1987, and the Clinical Trials Directive - that may provide protection. In addition the Association of British and Pharmaceutical Industry (ABPI) has published detailed guidelines on compensation in clinical trials.

Anyone who does decide to participate in clinical trials for development of a COVID-19 vaccine will be making an important contribution to the global effort to control, and ultimately extinguish the current pandemic.

That contribution is to be applauded, however, all trial participants must ensure that they are fully informed about the risks of the trial, even if those risks are stated to be low, and what recourse they will have to legal protection in the unlikely event that things do go wrong.

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