9 July 2021
The availability of vaccines, which have now proven their effectiveness in controlled clinical trials and on many millions of people, raises new ethical issues in the implementation of phase 3 clinical trial protocols regarding the new vaccines, necessary for approval by the Regulatory authorities. The Declaration of Helsinki is very clear in requiring that, when active drugs do already exist for a given indication, the best medicinal product available should be used as a control, not a placebo. Therefore, even in the case of vaccines, the question arises as to whether it is right to use a placebo.
The Italian Committee for Bioethics (ICB) intervened on the issue expressing the following recommendations:
- that the testing of new vaccines in phase 3 of trials is to be carried out not using a placebo as a control, but a vaccine that is already available. Ethics Committees are invited to monitor and ensure that this recommendation is respected in trials;
- regarding placebo-controlled studies that are nearing completion the Committee believes that they should not be routinely prolonged; their extension may be acceptable on obtaining a new informed consent, subject to approval by the relevant Ethics Committee for modification of the experimental protocol and based on scientific relevance;
- that in the locations where new vaccines are being studied, the most effective existing treatments to stop contagion and counteract the infection are to be made available.