15 May 2023

Vaxing

'Learning from five bad arguments against mandatory vaccination' by Maxwell J Smith and Ezekiel J Emanuel in (2023) 41(21) Vaccine 3301-3304 comments 

The suboptimal uptake of COVID-19 vaccines in many parts of the world has prompted unprecedented public debate concerning the ethics of mandatory vaccination. It is imperative we learn lessons from this debate so we are better positioned to navigate policy proposals for mandatory vaccination in the future. Specifically, we should aim to dispense with unsophisticated ethical claims that distract from or otherwise parody more nuanced and forceful arguments and which overshadow other important ethical concerns that have by comparison received little attention. To this end, we identify five ethical objections to mandatory vaccination that are of poor quality but have been frequently raised during the COVID-19 pandemic, including that mandatory vaccination violates the Nuremberg Code, that it is coercive, that it violates informed consent, that it is discriminatory, and that it infringes civil liberties. We argue that, presented as such, each ought to be rejected, allowing future consideration of mandatory vaccination to be focused on concerns more worthy of ethical scrutiny.

In dealing with pseudolaw claims that mandatory vaccination violates the Nuremberg code the authors note 

The Nuremberg Code is a set of principles for the ethics of human experimentation delineated in the 1947 Nazi doctor case of United States v. Brandt et al.. Principle one emphasizes that voluntary consent is essential for human participation in research. Vaccination mandates violate the Nuremberg Code because COVID-19 vaccines are ‘experimental’ and because mandates undermine the voluntariness of informed consent. ... 

Response 

COVID-19 vaccines used in practice and involved in vaccination mandates are either authorized or fully approved by national regulatory authorities. Hence, they are not experimental and not part of research, and thus not covered by the Nuremberg Code. Taking approved medicines prescribed or used as a matter of regular medical or public health practice does not constitute an experiment or research in any common understandings of the terms. 

But what of the fact that COVID-19 vaccines are still being studied? All medicines undergo on-going study without being considered experimental. The study of medicines does not cease once evidence regarding their safety and efficacy has met the standards of regulatory approval and are used in regular clinical and public health practice. For instance, a drug’s effectiveness is often compared to other interventions. But this does not render those medicines ‘experimental’ and subject to regulations for human subjects research. 

Ultimately, whether something is called ‘experimental’ is arguably irrelevant and unhelpful when evaluating the ethics of vaccination mandates because this is a term that could include everything from first-in-human use to off-label use to medicines authorized for emergency use. Each of these has different evidentiary standards, requiring different forms of ethical scrutiny, and so should be assessed accordingly. The mere charge of being ‘experimental’ is therefore of little or no moral importance; instead, what should matter from a moral perspective is whether there is sufficient causal evidence and a positive risk-benefit ratio to justify the use of the medicine in practice. In practical terms, approval or authorization by a national regulatory authority indicate when this condition has been satisfied. 

Finally, this objection seems to be confused because no country has in fact legally recognized the Nuremberg Code for the ethical conduct of research. Consequently, a ‘violation’ of the Nuremberg Code would represent a violation of principles of historical ethical importance, not a violation of a law or regulation (e.g., actual regulations governing research or laws concerning informed consent for vaccination).