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• Safe, effective, proportional and necessary?
  Oliver Muller
  Published on: 22 August 2020

• Published on: 22 August 2020

  Safe, effective, proportional and necessary?

  • Oliver Muller, Trustee Consent CIO

  While the authors are right to conclude that any compulsory medical intervention/vaccination could only be justified if the intervention is safe, effective, proportional and necessary, the moral dilemma really only starts here.

  Who should have the right to determine what is proportional and necessary? Furthermore, the safety and efficacy in themselves will be disputed. We know this from existing vaccine controversies that lead parents to decline vaccines for their children. They do not trust the data produced by the manufacturers and they do not trust anyone who has industry funding or other potential conflicts of interest. Clearly the only reason why a parent would decline a medical intervention is because they fear that it could harm their child.

  Although a Covid19 vaccine would not mainly be aimed at children, as in routine childhood immunisations, but at everyone, the question of safety and efficacy remains and invariably determines the question of proportionality as well. In fact it will be even more difficult, due to the shorter development times, shorter trial lengths and shorter follow-ups we can expect, as well as the limited time the virus is expected to be around in sufficient parts of the population that would allow for meaningful field trials.

  Safety and efficacy have always been at the heart of the debate. We know from our work with parents at Consent (https://consent-charity.org.uk) that any...

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  While the authors are right to conclude that any compulsory medical intervention/vaccination could only be justified if the intervention is safe, effective, proportional and necessary, the moral dilemma really only starts here.

  Who should have the right to determine what is proportional and necessary? Furthermore, the safety and efficacy in themselves will be disputed. We know this from existing vaccine controversies that lead parents to decline vaccines for their children. They do not trust the data produced by the manufacturers and they do not trust anyone who has industry funding or other potential conflicts of interest. Clearly the only reason why a parent would decline a medical intervention is because they fear that it could harm their child.

  Although a Covid19 vaccine would not mainly be aimed at children, as in routine childhood immunisations, but at everyone, the question of safety and efficacy remains and invariably determines the question of proportionality as well. In fact it will be even more difficult, due to the shorter development times, shorter trial lengths and shorter follow-ups we can expect, as well as the limited time the virus is expected to be around in sufficient parts of the population that would allow for meaningful field trials.

  Safety and efficacy have always been at the heart of the debate. We know from our work with parents at Consent (https://consent-charity.org.uk) that any medical intervention to which they do not give their voluntary and informed consent comprises a huge emotional conflict; one which can become almost an existential threat, psychologically, if they feel forced into allowing or accepting a medical intervention which they have, rightly or wrongly, come to believe to be dangerous. One can imagine the resistance this will induce. People will consider deregistering children from schools and giving up their careers in order to avoid the perceived threat.

  How do we address this questions of safety? How can people be made to trust the data? Do we have a moral right to mandate, if we have made no effort to convince? Are we willing to do what it takes? In the long term the answer may well have to be a completely independent body to conduct trials, independent both of industry and politics.

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  Conflict of Interest:
  None declared.

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