Background: The gaps in clinical trial evidence about vaccination in pregnancy have serious implications for health care worker and public misunderstandings. Contradictions between National Immunization Technical Advisory Group (NITAG) recommendations and regulatory product labeling information contribute to misinformation about vaccine safety and effectiveness.
Methods: A mixed methods approach that included a stakeholder consensus decision-making workshop and a national survey of Canadian health care providers (HCPs).
Results: We identified knowledge gaps and serious limitations concerning the information in vaccine product labels. Stakeholders were troubled that some HCPs rely on regulatory product labels to inform their decisions without knowing their limitations in content. Our survey showed that HCPs were uncertain about the purpose of product labels and the evidence contained in them. Over a third of respondents incorrectly thought that product labels and NITAG recommendations are based on the same evidence and that the information they contain is regularly updated.
Conclusions: Applying social risk theories, we show how such gaps in information defer responsibility for decisions about disease risk and vaccine safety from regulatory agencies and vaccine manufacturers onto HCPs and their clients. This may be especially relevant for COVID-19 and other emerging vaccines that are initially authorized for conditional or emergency use, and especially in understudied populations such as pregnant people. More frequent updating and alignment of robust, unbiased, and independently reviewed clinical trial and postmarket safety and effectiveness evidence with NITAG recommendations would allay HCP and public misunderstandings.

Get full access to this article

View all available purchase options and get full access to this article.


1. Riley LE, Hughes BL. Pregnant and lactating women should not be excluded from Covid-19 drug, vaccine trials. STAT, 2020. Available at: https://www.statnews.com/2020/09/28/pregnancy-lactation-no-reason-exclude-women-covid-19-drug-vaccine-trials Accessed September 29, 2020.
2. Geampana A. Risky technologies: Systemic uncertainty in contraceptive risk assessment and management. Sci Technol Hum Values 2019;44:1116–1138.
3. Noh Y, Yoon D, Song I, et al. Discrepancies in the evidence and recommendation levels of pregnancy information in prescription drug labeling in the United States, United Kingdom, Japan, and Korea. J Womens Health 2018;27:1086–1092.
4. Top KA, Esteghamati A, Kervin M, et al. Governing off-label vaccine use: An environmental scan of the Global National Immunization Technical Advisory Group Network. Vaccine 2020;38:1089–1095.
5. Jarvis JR, Dorey RB, Warricker FDM, et al. The effectiveness of influenza vaccination in pregnancy in relation to child health outcomes: Systematic review and meta-analysis. Vaccine 2020;38:1601–1613.
6. McMillan M, Clarke M, Parrella A, et al. Safety of tetanus, diphtheria, and pertussis vaccination during pregnancy. Obstet Gynecol 2017;129:560–573.
7. Neels P, Southern J, Abramson J, et al. Off-label use of vaccines. Vaccine 2017;35:2329–2337.
8. McDonald K, Amir LH, Davey M-A. Maternal bodies and medicines: A commentary on risk and decision-making of pregnant and breastfeeding women and health professionals. BMC Public Health 2011;11(Suppl 5):1–8.
9. Lyerly AD, Mitchell LM, Armstrong EM, et al. Risk and the pregnant body. Hastings Cent Rep 2009;39:34–42.
10. Weir L. Pregnancy, risk and biopolitics: On the threshold of the living subject. New York: Routledge, 2006.
11. Dubé È, Gagnon D, Kaminsky K, et al. Vaccination against influenza in pregnancy: A survey of Canadian maternity care providers. J Obstet Gynaecol Can 2019;41:479–488.
12. Vishram B, Letley L, Jan Van Hoek A, et al. Vaccination in pregnancy: Attitudes of nurses, midwives and health visitors in England. Hum Vaccines Immunother 2018;14:179–188.
13. Morales KF, Menning L, Lambach P. The faces of influenza vaccine recommendation: A Literature review of the determinants and barriers to health providers' recommendation of influenza vaccine in pregnancy. Vaccine 2020;38:4805–4815.
14. Top KA, Arkell C, Scott H, et al. Effect of package insert language on health-care providers' perceptions of influenza vaccination safety during pregnancy. Lancet Glob Health 2016;4:e690–e691.
15. Lupton DA. ‘Precious cargo’: Foetal subjects, risk and reproductive citizenship. Crit Public Health 2012;22:329–340.
16. Manca TA, Graham JE, Dubé È, et al. Developing product label information to support evidence-informed use of vaccines in pregnancy. Vaccine 2019;37:7138–7146.
17. Manca TA, Graham JE, MacDonald NE, et al. Healthcare providers' interpretations of product labelling information developed through a consensus stakeholder approach. Vaccine 2021;39:2652–2659.
18. Hannah-Moffat K, O'Malley P. Gendered risks: An introduction. In: Hannah-Moffat K, O'Malley P, eds. Gendered risks. New York: Routledge, 2007:1–29.
19. Hays S. The cultural contradictions of motherhood. New Haven, CT: Yale University Press, 1996.
20. Reich JA. Neoliberal mothering and vaccine refusal: Imagined gated communities and the privilege of choice. Gend Soc 2014;28:679–704.
21. Douglas M. Risk and blame: Essays in cultural theory. New York: Routledge, 1994.
22. Jones M, Graham JE. Multiple institutional rationalities in the regulation of health technologies: An ethnographic examination. Sci Public Policy 2009;36:445–455.
23. Eren Vural I, Herder M, Graham JE. From sandbox to pandemic: Agile reform of Canadian drug regulation. Health Policy 2021;125:1115–1120.
24. ModernaTX, Inc. Product monograph including patient medication information: Spikevax™, 2021. Available at: https://covid-vaccine.canada.ca/info/pdf/covid-19-vaccine-moderna-pm-en.pdf Accessed October 28, 2021.
25. Pfizer Canada ULC, BioNTech Manufacturing GmbH. COMIRNATY® COVID-19 vaccine, mRNA, 2021. Available at: https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf Accessed March 30, 2022.
26. Foucault M. Two lectures. In: Gordon C, ed. Power/knowledge: Selected interviews and other writings 1972–1977. New York: Vintage Books, 1980:78–108.
27. Den hollander GC, Browne JI, Arhinful D, et al. Power difference and risk perception: Mapping vulnerability within the decision process of pregnant women towards clinical trial participation in an urban middle-income setting. Dev World Bioeth 2018;18:68–75.
28. Krubiner CB, Faden RR, Karron RA, et al. Pregnant women and vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response. Vaccine 2021;31:85–120.
29. Baylis F, Halperin S. Research involving pregnant women: Trials and tribulations. Clin Investig 2012;2:139–146.
30. Rubin R. Pregnant people's paradox—Excluded from vaccine trials despite having a higher risk of COVID-19 complications. JAMA 2021;325:1027–1028.
31. Bell CE, Shane A, Pickering LK. Discrepancies between US Food and Drug Administration Vaccine Licensure Indications and Advisory Committee on Immunization Practices Recommendations: Provider knowledge and attitudes. Clin Ther 2018;40:1308–1319.
32. World Health Organization. Table 1: Summary of WHO position papers—Recommendations for routine immunization. WHO recommendations for routine immunization—Summary tables, 2019. Available at: https://www.who.int/immunization/policy/immunization_tables/en Accessed January 1, 2020.
33. Boonyaratanakornkit J, Chu HY. Why should we advocate maternal immunization? Pediatr Infect Dis J 2019;38:S28–S32.
34. Kochhar S, Edwards KM, Ropero Alvarez AM, et al. Introduction of new vaccines for immunization in pregnancy—Programmatic, regulatory, safety and ethical considerations. Vaccine 2019;37:3267–3277.
35. Roberts JN, Gruber MF. Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy. Vaccine 2015;33:966–972.
36. Nesin M, Sparer O. Vaccine monitoring systems: A potential model for medications in pregnancy. Semin Perinatol 2015;39:524–529.
37. The Society of Obstetricians and Gynaecologists of Canada. SOGC statement on COVID-19 vaccination in pregnancy, 2021. Available at: https://sogc.org/common/Uploaded%20files/Latest%20News/SOGC_Statement_COVID-19_Vaccination_in_Pregnancy.pdf Accessed April 28, 2022.
38. The American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. ACOG and SMFM joint statement on WHO recommendations regarding COVID-19 vaccines and pregnant individuals, 2021. Available at: https://www.acog.org/news/news-releases/2021/01/acog-and-smfm-joint-statement-on-who-recommendations-regarding-covid-19-vaccines-and-pregnant-individuals Accessed April 28, 2022.
39. Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. N Engl J Med 2021;384:2273–2282.
40. Hillson K, Clemens SC, Madhi SA, et al. Fertility rates and birth outcomes after ChAdOx1 nCoV-19 (AZD1222) vaccination. Lancet 2021;398:6–12.
41. Gray KJ, Bordt EA, Atyeo C, et al. COVID-19 vaccine response in pregnant and lactating women: A cohort study. Am J Obstet Gynecol 2021;225:303.e1–303.e17.
42. Halasa N, Olson S, Staat M, et al. Effectiveness of maternal vaccination with mRNA COVID-19 vaccine during pregnancy against COVID-19–associated hospitalization in infants aged <6 months—17 states, July 2021–January 2022. Morb Mortal Wkly Rep 2022;71:264–270.
43. Hsieh H-F, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res 2005;15:1277–1288.
44. Charmaz K. Constructing grounded theory. Thousand Oaks, CA: Sage, 2014.
45. Lupton DA. Risk. New York, NY: Routledge, 1999.
46. Douglas M. Purity and danger: An analysis of concepts of pollution and taboo. London, UK: Taylor & Francis Group, 2002.
47. Foucault M. Security, territory, population: Lectures at the Collège de France 1977–1978. New York, NY: Palgrave Macmillan, 2004.
48. Kukla R. Pregnant bodies as public spaces. In: Hardy S, Wiedmer C, eds. Motherhood and space: Configurations of the maternal through politics, home, and the body. New York, NY: Palgrave Macmillan, 2005:283–305.
49. van Der Zande I, van der Graaf R, Browne JL, van Delden JJM. Fair inclusion of pregnant women in clinical research: A systematic review of reported reasons for exclusion. In: Baylis F, Ballantyne A. eds. Clinical research involving pregnant women. Switzerland: Springer, 2016:65–94.
50. Darville R. Literacy, experience, power. In: Campbell ML, Manicom A. eds. Knowledge, experience, and ruling relations. Toronto, ON: University of Toronto Press, 1993:249–262.
51. Jefferson T. Sponsorship bias in clinical trials: Growing menace or dawning realisation? J R Soc Med 2020;113:148–157.
52. Tanveer S, Rowhani-Farid A, Hong K, et al. Transparency of COVID-19 vaccine trials: Decisions without data. BMJ Evid Based Med 2021:1–7.
53. GVSB 2.0 Drafting Group (Global Vaccine Safety Blueprint). Global vaccine safety blueprint 2.0 (GVSB2.0)—Draft 1. 38, 2019. Available at: https://www.who.int/vaccine_safety/Draft_GVSB2.0_20190929.pdf?ua=1 Accessed July 7, 2020.
54. Lexchin J. Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: A retrospective cohort study. BMJ Open 2018;8:e020377.
55. Smith JA, Brindley DA. Conditional approval pathways: The ‘special’ case of global regenerative medicine regulation. Rejuvenation Res 2017;20:1–3.
56. Dubé È, Gagnon D, Vivion M. Optimizing communication material to address vaccine hesitancy. Can Commun Dis Rep 2020;46:48–52.
57. Money D, Global Research in Pregnancy and the Newborn Collaboration, Public Health Agency of Canada, et al. Canadian surveillance of COVID-19 in pregnancy: Epidemiology, maternal and infant outcomes, Report #4. 2021:1–15. Available at: https://med-fom-ridprogram.sites.olt.ubc.ca/files/2021/10/CANCOVID_Preg-report-4-19oct2021.pdf Accessed April 28, 2022.
58. Kasehagen L, Byers P, Taylor K, et al. COVID-19–associated deaths after SARS-CoV-2 infection during pregnancy—Mississippi, March 1, 2020–October 6, 2021. Morb Mortal Wkly Rep 2021;70:1646–1648.
59. Dagan N, Barda N, Biron-Shental T, et al. Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy. Nat Med 2021;27:1693–1695.
60. Iacobucci G. Covid-19 and pregnancy: Vaccine hesitancy and how to overcome it. BMJ 2021;375:n2862.
61. Razzaghi H, Mehreen M, Pingali C, et al. COVID-19 vaccination coverage among pregnant women during pregnancy—Eight integrated health care organizations, United States, December 14, 2020–May 8, 2021. Morb Mortal Wkly Rep 2021;70:895-899.
62. Huddleston HG, Jaswa EG, Lindquist, et al. COVID-19 vaccination patterns and attitudes among American pregnant individuals. Am J Obstet Gynecol MFM 2022;4:100507.
63. Kilich E, Dada S, Francis MR, et al. Factors that influence vaccination decision-making among pregnant women: A systematic review and meta-analysis. PLoS One 2020;15:e0234827.
64. Mohammed H, McMillan M, Roberts CT, et al. A systematic review of interventions to improve uptake of pertussis vaccination in pregnancy. PLoS One 2019;14:e0214538.
65. Wong VWY, Lok KYW, Tarrant M. Interventions to increase the uptake of seasonal influenza vaccination among pregnant women: A systematic review. Vaccine 2016;34:20–32.
66. Bradfield Z, Wynter K, Hauck Y, et al. COVID-19 vaccination perceptions and intentions of maternity care consumers and providers in Australia. PLoS One 2021;16:e0260049.
67. Top KA, Arkell C, Graham JE, et al. Do health care providers trust product monograph information regarding use of vaccines in pregnancy? A qualitative study. Can Commun Dis Rep 2018;44:134–138.

Information & Authors


Published In

cover image Journal of Women's Health
Journal of Women's Health
Volume 31Issue Number 8August 2022
Pages: 1103 - 1112
PubMed: 35730988


Published online: 17 August 2022
Published in print: August 2022
Published ahead of print: 22 June 2022


Request permissions for this article.




Department of Pediatrics (Infectious Diseases), Dalhousie University, Halifax, Canada.
Canadian Center for Vaccinology, IWK Health Centre, Halifax, Canada.
Technoscience & Regulation Research Unit, Faculty of Medicine, Dalhousie University, Halifax, Canada.
Department of Pediatrics (Infectious Diseases), Dalhousie University, Halifax, Canada.
Canadian Center for Vaccinology, IWK Health Centre, Halifax, Canada.
Kirsten Weagle
Department of Pediatrics (Infectious Diseases), Dalhousie University, Halifax, Canada.
Department of Pediatrics (Infectious Diseases), Dalhousie University, Halifax, Canada.
Canadian Center for Vaccinology, IWK Health Centre, Halifax, Canada.
Technoscience & Regulation Research Unit, Faculty of Medicine, Dalhousie University, Halifax, Canada.


Address correspondence to: Janice E. Graham, PhD, Department of Pediatrics (Infectious Diseases), Dalhousie University, 5849 University Avenue, C-302, P.O. Box 15000, Halifax, Nova Scotia B3H 4H7, Canada [email protected]

Authors' Contributions

T.A.M., K.A.T., and J.E.G. conceived of the idea, drafted, and revised the article. K.W. assisted with data analysis, interpretation, and writing of results.

Author Disclosure Statement

All authors report no conflicts of interest.

Funding Information

This study was supported by grants from the Department of Pediatrics, Dalhousie University and IWK Health, the Canadian Institutes of Health Research (PJT-148908), and by a contract with the Public Health Agency of Canada in collaboration with the SOGC. K.W. was supported by a Dalhousie Medical Research Foundation summer studentship.

Metrics & Citations



Export citation

Select the format you want to export the citations of this publication.

View Options

Get Access

Access content

To read the fulltext, please use one of the options below to sign in or purchase access.

Society Access

If you are a member of a society that has access to this content please log in via your society website and then return to this publication.

Restore your content access

Enter your email address to restore your content access:

Note: This functionality works only for purchases done as a guest. If you already have an account, log in to access the content to which you are entitled.

View options


View PDF/ePub

Full Text

View Full Text







Copy the content Link

Share on social media

Back to Top