Equity in coronavirus disease 2019 vaccine development and deployment.
Published on Jan 15, 2021in American Journal of Obstetrics and Gynecology6.502
· DOI :10.1016/J.AJOG.2021.01.006
The COVID-19 pandemic exposed weaknesses in multiple domains and widened gender-based inequalities across the world. It also stimulated extraordinary scientific achievement, bringing vaccines to the public in under a year. In this article, we discuss the implications of current vaccination guidance for pregnant and lactating women, whether their exclusion from the first wave of vaccine trials was justified, and if a change in the current vaccine development pathway is necessary. Pregnant and lactating women were not included in initial SARS-CoV-2 vaccine trials. Perhaps unsurprisingly therefore, the first vaccine regulatory approvals have been accompanied by inconsistent advice from public health, governmental, and professional authorities around the world. Denying vaccination to women who though pregnant or breastfeeding are fully capable of autonomous decision-making is a throwback to a paternalistic era. Conversely, lack of evidence upon which to make an informed decision generated in a timely manner, shifts responsibility from research sponsors and regulators, and places the burden of decision-making upon a woman and her healthcare advisor. The World Health Organization (WHO), the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), and others have highlighted the long-standing disadvantage experienced by women in relation to the development of vaccines and medicines. It is uncertain whether there was sufficient justification for excluding pregnant and lactating women from initial SARS-CoV-2 vaccine trials. In future, we recommend regulators mandate plans that describe the development pathway for new vaccines and medicines that address the needs of women who are pregnant or lactating. These should incorporate at the outset, careful consideration of the balance of risks of exclusion or inclusion from initial studies, patient and public perspectives, details of “Developmental and Reproductive Toxicity” studies, and approaches to collect data systematically from participants who are unknowingly pregnant at the time of exposure. This requires careful consideration of any prior knowledge of the mode of action of the vaccine and the likelihood of toxicity or teratogenicity. We also support the view that the default position should be a “presumption of inclusion”, with exclusion of women who are pregnant or lactating only if justified on specific, not generic, grounds. Finally, we recommend closer coordination across countries with the aim of issuing consistent public health advice.