TABLE 5.
Ethical principles guiding SARS‐CoV‐2 vaccination in pregnancy
Ethical principle | Application |
---|---|
Justice | Pregnant women, just as any other human subject, should have the right to be included in research trials and participate in vaccination campaigns where there are no compelling scientific or ethical reasons to exclude them. |
Non‐maleficence | The risks of mRNA vaccine in pregnancy are unknown with little precedent amongst the non‐pregnant population. As with any new drug class, the potential for teratogenicity should be balanced with the untapped potential for benefit to the mother, fetus and neonate. Limited animal Developmental and reproductive toxicity studies and observations in Phase 3 participants with inadvertent pregnancy suggest no harm. |
Beneficence | COVID‐19 in pregnancy has a greater risk of severe complications and there exists a potential to reduce morbidity and mortality amongst pregnant women by including them in vaccination. There is also a possibility of passive immunisation of the fetus or neonates through transplacental IgG transfer or through breastfeeding. |
Autonomy | Adult pregnant women regularly exercise autonomy by providing informed consent for clinical decision‐making. Similarly, they have the capacity to weigh the risks and benefits of vaccination and provide informed consent. |