Ethics and anti-COVID vaccine trials, the ISS online Report

ISS, March 6 th 2021

The ISS COVID-19 Report titled “Ethical Aspects of the experimentation of anti-COVID-19 vaccines”, drafted by the “COVID-19 Bioethics” Working Group of the Istituto Superiore di Sanità -ISS (Italian National Institute of Health) has just been published. The document presents, analyses and debates the principal ethical aspects of the experimentation of anti-COVID-19 vaccines.

The response to the compelling request for a large-scale availability of vaccines has determined the shortening of the experimentation of anti-COVID-19 vaccinesalbeit still complying with the requirements of conventional studies. This was made possible by the application of safety protection strategies that succeeded to overcome most of the intrinsic limits of the acceleration and support the scientific evidence of their safety. In a pandemic, it is necessary to avoid delays in the authorization procedures, but it is equally dutiful not to loosen the rigour of scientific method: it is important to work quickly but it is even more important to work well.

The text opens with an overview on the technical and scientific aspects of the experimentation of candidate anti-COVID-19 vaccines.

It then goes on to describe and analyse the legal and regulatory aspectsof the experimentation of anti-COVID-19 vaccines, both at international level and those specific to our Country.

In delving into the ethical aspects, it should be noted that the experimentation of anti-COVID-19 vaccines must conform with the ethical criteria applied to any clinical trial. However, in pandemic emergencies, applying said criteria may turn out to be difficult. It is necessary to place particular attention on balancing the need for rigour in the scientific method with the respect for ethical criteria: no exception is allowed, either in the scientific rigour or in the ethical aspects. A particularly critical issue is the use of placebos. The general rule that excludes the use of placebos when an effective product is available should here apply. Exceptions to this rule are admissible only within the limits set in the documents of reference, including the Helsinki Declaration. The analysis also includes the issue of the so-called “challenge studies”, in which the participating healthy volunteers are deliberately infected. Although studies of this type could be admissible in exceptional cases, the very design of the method raises some perplexity and, from the ethical point of view, does not seem to be acceptable in theexperimentation of anti-COVID-19 vaccines.

The Working Group is coordinated by Carlo Petrini (Director of the Bioethics Unit and Chairman of the ISS Ethics Committee) and includes experts, both in-house and external to the ISS, who cover a multitude of disciplines in addition to bioethics: public health, epidemiology, clinical medicine, law, biolaw, nursing science, philosophy, paediatrics, palliative care, and others. Thanks to these multiple competences, the “COVID-19 Bioethics” Working Group has produced documents on various themes with ethical implications that have been raised by the pandemic.

In drafting the Report, the Working Group relied on the collaboration of various ISS departments: the National Centre for Drug Research and Evaluation, the Infectious Disease Department, and the Research Coordination and Support Service.

We hope that the Report may be of help to those in charge of planning, evaluating, implementing or participating in the experimentation of anti-COVID-19 vaccines.

We have used a jargon-free language with a view to offering non-expert citizens an understandable text containing an in-depth analysis of the issue.

The Report was published while the first tested vaccines were being made available in the first months immediately after the onset of the pandemic. This however does not make the Report untimely: numerous experimentations of anti-COVID-19 vaccines will continue and new ones will be expedited with the aim of not only making available a larger number of vaccines but also of combating new variants that might appear and spread over time.