Research toolkit for use of vaccines in pregnant and lactating women
Toolkit sections
Introduction and Purpose
A key principle of vaccination in pregnancy is ensuring protection against vaccine-preventable diseases early in pregnancy, when the risks to mother and fetus are greatest and passive antibody transfer to the infant is most effective. For lactating women, the principle is to ensure protection against vaccine-preventable diseases while also ensuring that vaccines pose no risk to either the mother or the infant (1). Yet, pregnant and lactating women have historically been excluded from clinical trials of new vaccines, including those targeting pathogens with a high burden in these populations (2). This exclusion has created critical gaps in safety, immune response, and effectiveness data on the use of new vaccines in these populations, delaying approval for use, policy recommendations, and access to new vaccines. These delays are especially harmful in low- and middle-income countries, where timely access to preventive interventions is essential.
This module is part of a larger toolkit on the inclusion of pregnant and lactating women in clinical trials. It focuses specifically on vaccines, highlighting issues that are different from other medicines. It builds on World Health Organization (WHO) frameworks, the Safety Platform for Emergency Vaccines (SPEAC) (3), PREVENT guidelines (4), regulatory guidance updates (5), and ethical principles on equitable inclusion of pregnant and lactating women in clinical trials (6, 7). The aim is to make research fair, ethical, and practical, so that vaccines can be made available safely and quickly to women during pregnancy and breastfeeding, especially in countries where the need is greatest.
References
- Etti M, Calvert A, Galiza E, Lim S, Khalil A, Le Doare K, et al. Maternal vaccination: a review of current evidence and recommendations. Am J Obstet Gynecol. 2022;226(4):459–74. doi: 10.1016/j.ajog.2021.10.041
- Sewell CA, Sheehan SM, Gill MS, Henry LM, Bucci-Rechtweg C, Gyamfi-Bannerman C, et al. Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials. Am J Obstet Gynecol. 2022;227(6):805–11. doi: 10.1016/j.ajog.2022.07.037
- Safety Platform for Emergency vACcines (SPEAC) [website]. Brighton Collaboration; 2023. (https://brightoncollaboration.org/speac accessed 13 March 2026).
- Krubiner CB, Faden RR, Karron RA, Little MO, Lyerly AD, Abramson JS, et al. Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response. Vaccine. 2021;39(1):85–120. doi: 10.1016/j.vaccine.2019.01.011
- Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry DRAFT GUIDANCE. U.S. Food and Drug Administration; 2018 (https://www.fda.gov/media/112195/download accessed 13 March 2026).
- Hunt A, Banner N, Littler K. The global forum on bioethics in research meeting, “ethics of research in pregnancy”: Emerging consensus themes and outputs. Reprod Health. 2017;14(S3):158. doi: 10.1186/s12978-017-0431-1
- Lyerly AD, Little MO, Faden R. The second wave: Toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008;1(2):5-22.
- Kochhar S, Bauwens J, Bonhoeffer J. Safety assessment of immunization in pregnancy Vaccine. 2017;35(48Part A):6469–6471. doi: 10.1016/j.vaccine.2017.09.033