Equity in coronavirus disease 2019 vaccine development and deployment

Neena Modi, Diogo Ayres-de-Campos, Eduardo Bancalari, Manon Benders, Despina Briana, Gian Carlo Di Renzo, Eduardo Borges Fonseca, Moshe Hod, Liona Poon, Magda Sanz Cortes, Umberto Simeoni, Charlotte Tscherning, Maximo Vento, Gerald H.A. Visser, Liliana Voto

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

The coronavirus disease 2019 pandemic exposed weaknesses in multiple domains and widened gender-based inequalities across the world. It also stimulated extraordinary scientific achievement by bringing vaccines to the public in less than a year. In this article, we discuss the implications of current vaccination guidance for pregnant and lactating women, if 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 the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. Therefore, perhaps unsurprisingly, 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, although pregnant or breastfeeding, are fully capable of autonomous decision making is a throwback to a paternalistic era. Conversely, lack of evidence generated in a timely manner, upon which to make an informed decision, shifts responsibility from research sponsors and regulators and places the burden of decision making upon the woman and her healthcare advisor. The World Health Organization, the Task Force on Research Specific to Pregnant Women and Lactating Women, 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 the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. In future, we recommend that 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, a careful consideration of the balance of the risks of exclusion from or inclusion in 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 previous knowledge about 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.

Original languageEnglish (US)
JournalAmerican journal of obstetrics and gynecology
DOIs
StateAccepted/In press - 2021
Externally publishedYes

Keywords

  • Task Force on Research Specific to Pregnant Women and Lactating Women
  • World Health Organization
  • antibody-dependent enhancement
  • clinical trials
  • coronavirus disease 2019
  • gender-equity
  • lactation
  • neonatal immunity
  • pregnancy
  • randomized trials
  • research-equity
  • safety and efficacy
  • severe acute respiratory syndrome coronavirus 2
  • vaccine development
  • women

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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