By: Olivia Estes
Infectious respiratory diseases, such as COVID-19, put pregnant people at an elevated risk for negative health outcomes, including morbidity. However, the data collected from clinical research in vaccine development is not representative of this elevated risk because pregnant people are, more often than not, excluded from clinical research.
DISCLAIMER: I will be using the term “pregnant people” throughout this blog post. This term applies to any pregnant-person, or person who is capable of becoming pregnant, regardless of gender-identity. However, in gender-specific case studies, the term “pregnant women” will be used to indicate specific participants in clinical trials, as defined by the parameters of the trials.
History of Inclusion
Clinical research settings have historically under-prioritized women’s health, and the representation of women in clinical trials did not begin until the early 1990s. The movement for clinical representation began with the National Institute of Health’s Revitalization Act of 1993. This act “established guidelines for the inclusion of women and underrepresented racial and ethnic minority populations in clinical research,” and it contributed to significant strides towards inclusion in clinical research. Now, women make up over half of the participants in clinical trials funded by the National Institutes of Health (NIH).[1]
Although women are more adequately represented in current-day clinical research settings, pregnant people remain a small portion of clinical study participants, which puts their health at a disadvantage. When pregnant people are excluded from the initial stages of vaccine development, this creates a “cycle of exclusion.” Not only are pregnant persons excluded from clinical research that generates data surrounding vaccine development, but these systematic barriers also exclude them from receiving vaccines with the support of sufficient clinical research. Without evidence from clinical trials that is applicable to this population, pregnant people must decide whether to receive or refuse vaccination for infectious diseases without access to research in support of their decision. [2]
COVID-19: A Case Study
Vaccinations for pregnant people against COVID-19 can be examined as a case study for how clinical research must shift to include pregnant people. As with other respiratory infectious diseases, pregnant people are at a higher risk for health risks and morbidity if they contract pathogens, such as COVID-19. [2] However, a study published in May of 2020 uncovered that less than 2% of COVID-19 trials registered through the World Health Organization (WHO) included pregnant women. [3] Additionally, during the time of this study, hydroxychloroquine and azithromycin were front-liners for promising combatants against COVID-19. [3] Despite both of these medications having strong safety profiles for use during pregnancy, of the 42 trials evaluating the efficacy of these drugs at the time, 36 intentionally excluded pregnant people and 6 did not address pregnancy at all in their criteria for participants in the study. [3] For perspective, over 1.3 million cases of COVID-19 had been recorded across the globe during the time this study was conducted. [3]
Conflicting Advice from Renowned Health Organizations
The underrepresentation of pregnant people in COVID-19 vaccination trials is directly reflected in the conflicting advice that was available to pregnant people during the COVID-19 pandemic in terms of vaccination status. Two major public health organizations, the U.S. Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) offered differing advice following the distribution of COVID-19 vaccines in January of 2021. The CDC issued a recommendation on January 7, 2021, stating, “‘Based on how…[mRNA] vaccines work, experts believe they are unlikely to pose a specific risk for people who are pregnant…[however, vaccination] is a personal choice for people who are pregnant.”’[4] Shortly after, the WHO issued a statement on January 8, 2021 in which they recommended that vaccines be withheld from pregnant people unless the vaccine resulted in more benefits than potential risks. [4] The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) responded to the WHO’s recommendation by collaborating on their own recommendation, which essentially stated that the decision to be vaccinated should be decided by pregnant people themselves.[4] The disparities in advice given by these renowned public health organizations can be traced to their common origin: early COVID-19 trials did not produce sufficient data in vaccination research that was applicable to pregnant people.
References:
1. Clayton JA. Reflecting on Past Accomplishments to Make History Moving Forward: The NIH Revitalization Act of 1933 and the New Office of Autoimmune Disease Research. National Institutes of Health. June 2023. https://orwh.od.nih.gov/about/director/messages/June_2023. Accessed April 17, 2024.
2. Beigi RH, Krubiner C, Jamieson DJ, et al. The need for inclusion of pregnant women in COVID-19 vaccine trials. Vaccine. 2021;39(6):868-870. DOI:10.1016/j.vaccine.2020.12.074. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7798437/. Accessed April 17, 2024.
3. Smith DD, Pippen JL, Adesomo AA, et al. Exclusion of pregnant women from clinical trials during the coronavirus disease 2019 pandemic: a review of international registries. Am J Perinatol. 2020;37(8):792-799. DOI:10.1055/s-0040-1712103. https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0040-1712103. Accessed April 17, 2024.
4. Rubin R. Pregnant people’s paradox—excluded from vaccine trials despite having a higher risk of covid-19 complications. JAMA. 2021;325(11):1027-1028. DOI:10.1001/jama.2021.2264. https://jamanetwork.com/journals/jama/fullarticle/2777024. Accessed April 17, 2024.
5. Hazlett A. Pregnant during Covid, women struggle to reconcile conflicting advice. NBC News. https://www.nbcnews.com/health/womens-health/pregnant-covid-women-struggle-reconcile-conflicting-advice-rcna16455. Published February 16, 2022. Accessed April 24, 2024.
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