Krubiner CB, Faden RR, Karron RA Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response. Vaccine. 2019;

Macklin R. The art of medicine: Enrolling pregnant women in biomedical research. Lancet. 2010; 375:632-633

Verweij M, Lambach P, Ortiz JR, Reis A. Maternal immunisation: ethical issues. Lancet Infect Dis. 2016; e310-e314

Vaccines, pregnancy and ethics

02 June 2019
Volume 27 · Issue 6


History has shown the dangers posed by drugs that are untested in the pregnant population; yet these trials carry an inherent risk to women and vulnerable babies. George Winter debates the issue

In the late 1950s and early 1960s, the drug thalidomide was taken by pregnant women to counteract morning sickness —with the result that around 10 000 babies globally were born with limb deformities. Macklin (2010) not only observes that thalidomide had never been tested in pregnant women, but also suggests that: ‘Had the drug been tested in very few women in a phase I or phase II clinical trial, the mutagenic effect would most likely have been discovered and the number of babies born with deformities would have been much smaller’ (Macklin, 2010: 632).

This bold speculation exemplifies a utilitarian approach to ethics, which has at its core the intention of minimising the number of individuals exposed to a potential harm. But would it have been ethically right to have enrolled pregnant women in a clinical trial of thalidomide? If there is such a thing as ‘objective’ knowledge acquired through honest reasoning, it seems certain that if thalidomide had first been tested on ‘very few women’, as Macklin (2010) frames it, a public health catastrophe could have been prevented. Perhaps the unease that many of us would feel in adopting such a position is because of the difficulty in separating reason from innate values: in this case, an aversion to expose pregnant women to a possible mutagen.

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