Vol VI, Issue 2 Date of Publication: April 22, 2021
DOI: https://doi.org/10.20529/IJME.2021.015

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Placebo-controlled trials of Covid-19 vaccines – Are they still ethical?

Gustavo Ortiz-Millán
Abstract:
A World Health Organization (WHO) Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation recently recommended placebo-controlled trials (PCT) of Covid-19 vaccines. PCTs are ethically acceptable when there is no proven effective and safe treatment for a certain condition. However, there are already some vaccines that have been approved and which have high levels of efficacy and safety. Any new vaccine under development must be tested against the most effective vaccines available. PCTs go against the participants’ best interests, by putting them in a position of disadvantage while taking part in a trial, compared with people who are not in the trial and who could get vaccinated. Particularly in high-income countries, many people are getting vaccinated. This means that, following a recent trend in clinical trials, PCTs would have to be conducted in low- and middle-income countries, where there a number of advantages for drug companies, but where fatality rates of Covid-19 are, in many cases, much higher. For this and other reasons having to do with equal rights, participants in control groups should be protected with the most effective vaccines available.


Copyright and license
©Indian Journal of Medical Ethics 2021: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0),
which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.

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Comments:
  1. Raffaela Schiavon Ermani, MD, Ob/Gyn
    Independent Consultant , Mexico
    10 March 2021

    Dear Gustavo, thanks for your very interesting article!

    You are rigth about questioning the ethics AND the scientific value of PCTs, when one (or more than one) vaccine has already been proven to be SAFE and EFFECTIVE. Actually, in PCTs, the “placebo” are often opt-out when they “discover” they are placebo, and ask for a vaccine.

    So, the model should be a NON-INFERIORITY TRIAL, where you compare a (golden) standard with a new vaccine. Both arms of the study may thus benefit of the standard vs.the new vaccine.

    This is actually the type of clinical study you should conduct with new drugs or treatments in general, not only vaccine.
    It must be said, however, that we probably do NOT havee, yet, a GOLDEN standard COVID vaccine….

    With my greatest respect and admiration

    • Affiliation: Independent Consultant
    • Country: Mexico
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