Vaccine regulation should require and enforce the inclusion of pregnant and breastfeeding women in prelicensure clinical trials

References

• Department for Business, Energy & Industrial Strategy, The Rt Hon Alok Sharma MP. Press release: funding and manufacturing boost for UK vaccine programme. 2020 [accessed 2022 Mar 24]. https://www.gov.uk/government/news/funding-and-manufacturing-boost-for-uk-vaccine-programme.
   Google Scholar
• U.S. Department of Health and Human Services. Explaining operation warp speed. 2020 [accessed 2022 Mar 24]. https://www.nihb.org/covid-19/wp-content/uploads/2020/08/Fact-sheet-operation-warp-speed.pdf.
   Google Scholar
• Beigi RH, Krubiner C, Jamieson DJ, Lyerly AD, Hughes B, Riley L, Faden R, Karron R. The need for inclusion of pregnant women in COVID-19 vaccine trials. Vaccine. 2021;39(6):1–6. doi:10.1016/j.vaccine.2020.12.074.
   PubMed Web of Science ®Google Scholar
• Farrell R, Michie M, Pope R. Pregnant women in trials of Covid-19: a critical time to consider ethical frameworks of inclusion in clinical trials. Ethics Hum Res. 2020;42(de):17–23. doi:10.1002/eahr.500060.
   PubMedGoogle Scholar
• Krubiner CB, Faden RR, Karron RA, Little MO, Lyerly AD, Abramson JS, Beigi RH, Cravioto AR, Durbin AP, Gellin BG, etal. Pregnant women and vaccines against emerging epidemic threats: ethics guidance for preparedness, research, and response. Vaccine. 2019;31(1):85–120. doi:10.1016/j.vaccine.2019.01.011.
   Google Scholar
• COVAX Maternal Immunization Working Group. Considerations for the evaluation of COVID-19 vaccines in pregnant and lactating women. 2021. p. 1–38. https://epi.tghn.org/covax-overview/clinical-science/maternal-immunization/reports-mi/.
   Google Scholar
• Kweder S, Thor S, Vasisht K, Yao L, Everett D. Global regulators envision paradigm shift toward inclusion of pregnant and breastfeeding women in clinical research for medicines and vaccines. US Food and Drug Administration Newsroom. 2021 July 19 [accessed 2021 Aug 19]. https://www.fda.gov/news-events/fda-voices/global-regulators-envision-paradigm-shift-toward-inclusion-pregnant-and-breastfeeding-women-clinical.
   Google Scholar
• Lyerly AD, Little MO, Faden RR. Toward responsible inclusion of pregnant women in research. Int J Fem App Bioeth. 2008;1(2):5–22. doi:10.3138/ijfab.1.2.5.
   PubMedGoogle Scholar
• COVAX Maternal Immunization Working Group. Advances in maternal immunization science and implementation in times of COVID-19 - How has the COVID-19 pandemic impacted the future of maternal immunization? 2021. p. 1–26. https://media.tghn.org/medialibrary/2022/01/COVAX_MIWG_Webinar_Report_NOV2021_Final.pdf.
   Google Scholar
• Einav S, Ippolito M, Cortegiani A. Inclusion of pregnant women in clinical trials of COVID-19 therapies: what have we learned? Brit J Anaesth. 2020;125(3):e326–e328. doi:10.1016/j.bja.2020.05.020.
   PubMed Web of Science ®Google Scholar
• Taylor MM, Kobeissi L, Kim C, Amin A, Thorson AE, Bellare NB, Brizuela V, Bonet M, Kara E, Thwin SS, etal. Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action. Lancet Glob Health. 2021;9(3):e366–e371. doi:10.1016/S2214-109X(20)30484-8.
   PubMed Web of Science ®Google Scholar
• SOGC (The Society of Obstetricians and Gynaecologists of Canada). SOGC statement on COVID-19 vaccination in pregnancy. 2021 [accessed 2021 Sept 14]. https://www.sogc.org/common/Uploaded%20files/Latest%20News/SOGC_Statement_COVID-19_Vaccination_in_Pregnancy.pdf.
   Google Scholar
• Rasmussen SA, Kelley CF, Horton JP, Jamieson DJ. Coronavirus disease 2019 (COVID-19) vaccines and pregnancy: what obstetricians need to know. Obstet Gynecol. 2021;137(3):408–414. doi:10.1097/AOG.0000000000004290.
   PubMed Web of Science ®Google Scholar
• BioNTech SE, Pfizer. Study to evaluate the safety, tolerability, and immunogenicity of SARS CoV-2 RNA vaccine candidate (Bnt162b2) against COVID-19 in healthy pregnant women 18 years of age and older. United States: NIH US National Library of Medicine; 2021. Report No: NCT04754594. https://clinicaltrials.gov/ct2/show/NCT04754594?term=pfizer&cond=Covid19&draw=2&rank=18.
   Google Scholar
• Pfizer Canada ULC, BioNTech Manufacturing GmbH. COMIRNATY(TM) COVID-19 vaccine, mRNA. 2021 Sept 16 [accessed 2022 Mar 30]. https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf.
   Google Scholar
• Ellington S, Strid P, Tong VT, Woodworth K, Galang RR, Zambrano LD, Nahabedian J, Anderson K, Gilboa SM. Characteristics of women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status — United States , January 22–June 7, 2020. Morb Mortal Wkly Rep. 2020;69(25):769–775. doi:10.15585/mmwr.mm6925a1.
   PubMed Web of Science ®Google Scholar
• Money D, Global Research in Pregnancy and the Newborn Collaboration, Public Health Agency of Canada, Canadian Perinatal Surveillance System. Canadian surveillance of COVID-19 in pregnancy: epidemiology, maternal and infant outcomes, report #4. Vancouver (BC): University of British Columbia; 2021. p. 1–15. Early release: Maternal and infant outcomes (March 1, 2020 to September 30, 2020) from three Canadian provinces 2020. https://med-fom-ridprogram.sites.olt.ubc.ca/files/2021/10/CANCOVID_Preg-report-4-19oct2021.pdf.
   Google Scholar
• Wei SQ, Bilodeau-Bertrand M, Liu S, Auger N. The impact of COVID-19 on pregnancy outcomes: a systematic review and meta-analysis. Can Med Assoc J. 2021;193(16):E540–E548. doi:10.1503/cmaj.202604.
   PubMed Web of Science ®Google Scholar
• DeSisto CL, Wallace B, Simeone RM, Polen K, Ko JY, Meaney-Delman D, Ellington SR. Risk for stillbirth among women with and without COVID-19 at delivery hospitalization — United States, March 2020–September 2021. Morb Mortal Wkly Rep. 2021;70:1–7. doi:10.15585/mmwr.mm7047e1externalicon.
   PubMed Web of Science ®Google Scholar
• Kasehagen L, Byers P, Taylor K, Kittle T, Roberts C, Collier C, Ricaldi JN, Green J, Zapata LB, Beauregard J, et al. COVID-19–associated deaths after SARS-CoV-2 infection during pregnancy — Mississippi, March 1, 2020–October 6, 2021. Morbidity Mortality Weekly Rep. 2021;70(47):1646–1648. doi:10.15585/mmwr.mm7047e2.
   PubMed Web of Science ®Google Scholar
• SMFM (Society for Maternal-Fetal Medicine). Society for Maternal-Fetal Medicine (SMFM) Statement: SARS-CoV-2 vaccination in pregnancy. 2020 [accessed 2020 Dec 3]. https://www.smfm.org/covidclinical.
   Google Scholar
• RCOG (Royal College of Obstetricians & Gynaecologists). COVID-19 vaccines, pregnancy and breastfeeding. United Kingdom; 2021. https://www.rcog.org.uk/en/guidelines-research-services/coronavirus-covid-19-pregnancy-and-womens-health/covid-19-vaccines-and-pregnancy/covid-19-vaccines-pregnancy-and-breastfeeding/.
   Google Scholar
• BIB (Berman Institute of Bioethics), CIR (Center for Immunization Research), JHU (Johns Hopkins University). COVID-19 maternal immunization tracker (COMIT). 2021. http://www.comitglobal.org.
   Google Scholar
• Zavala E, Krubiner CB, Jaffe EF, Nicklin A, Gur-Arie R, Wonodi C, Faden RR, Karron RA. Global disparities in public health guidance for the use of COVID-19 vaccines in pregnancy. Brit Med J Glob Health. 2022;7(2):e007730. doi:10.1136/bmjgh-2021-007730.
   PubMedGoogle Scholar
• Giles ML, Gunatilaka A, Palmer K, Sharma K, Roach V. Alignment of national COVID-19 vaccine recommendations for pregnant and lactating women. Bull World Health Organ. 2021;99(10):739–746. doi:10.2471/BLT.21.286644.
   PubMed Web of Science ®Google Scholar
• Skirrow H, Barnett S, Bell S, Riaposova L, Mounier-Jack S, Kampmann B, Holder B. Women’s views on accepting COVID-19 vaccination during and after pregnancy, and for their babies: a multi-methods study in the UK. BioMed Cen Pregnancy Childbirth. 2022;22(1):33. doi:10.1186/s12884-021-04321-3.
   PubMed Web of Science ®Google Scholar
• Geoghegan S, Stephens LC, Feemster KA, Drew RJ, Eogan M, Butler KM. “This choice does not just affect me.” Attitudes of pregnant women toward COVID-19 vaccines: a mixed-methods study. Hum Vaccines Immunother. 2021;17(10):3371–3376. doi:10.1080/21645515.2021.1924018.
   PubMed Web of Science ®Google Scholar
• Huddleston HG, Jaswa EG, Lindquist KJ, Kaing A, Morris JR, Hariton E, Corley J, Hoskin E, Gaw SL, Cedars MI. COVID-19 vaccination patterns and attitudes among American pregnant individuals. Am J Obstet Gynecol MFM. 2022;4(1):100507. doi:10.1016/j.ajogmf.2021.100507.
   PubMed Web of Science ®Google Scholar
• Heath PT, Le Doare K, Khalil A. Inclusion of pregnant women in COVID-19 vaccine development. Lancet Infect Dis. 2020;20(9):1007–1008. doi:10.1016/S1473-3099(20)30638-1.
   PubMed Web of Science ®Google Scholar
• Mandavalli A. Pregnant women may receive covid vaccines safely, W.H.O. says. New York Times; 2021 Jan 29 [accessed 2021 Jan 30]. https://www.nytimes.com/2021/01/29/health/covid-vaccine-pregnancy.html.
   Google Scholar
• Krubiner CB, Faden RR. In the race for coronavirus vaccines, don’t leave pregnant women behind. STAT; [2020 Feb 25]. https://www.statnews.com/2020/02/25/coronavirus-vaccine-covid-19-pregnant-women/.
   Google Scholar
• ICMRA (International Coalition of Medicines and Regulatory Authorities). ICMRA pregnancy and lactation workshop. International Coalition of Medicines Regulatory Authorities; 2021 Feb 9 [accessed 2021 Nov 22]. https://www.icmra.info/drupal/en/covid-19/9february2021.
   Google Scholar
• Dashraath P, Nielsen-Saines K, Madhi SA, Baud D. COVID-19 vaccines and neglected pregnancy. The Lancet. 2020;396(10252):e22. doi:10.1016/S0140-6736(20)31822-5.
   PubMed Web of Science ®Google Scholar
• Mertens M. Protect pregnant women “through research,” not “from research,” OB-GYNs urge. NPR (National Public Radio); 2021 Jan 25 [accessed 2021 Jan 26]. https://www.npr.org/sections/health-shots/2021/01/25/958862775/protect-pregnant-women-through-research-not-from-research-ob-gyns-urge?fbclid=IwAR20c_94tYVmuopoTf55RQEy6WI9W3-SVPDZJHTVIwLdki6vnWmWf1LnfWw.
   Google Scholar
• ModernaTx, Inc. Product monograph including patient medication information: spikevax(TM). 2021 [accessed 2021 Oct 28]. https://covid-vaccine.canada.ca/info/pdf/covid-19-vaccine-moderna-pm-en.pdf.
   Google Scholar
• Wild V. How are pregnant women vulnerable research participants? Int J of Fem App Bioeth. 2012;5(2):82–104. doi:10.2979/intjfemappbio.5.2.82.
   Web of Science ®Google Scholar
• Gomes MF, de la Fuente-Núñez V, Saxena A, Kuesel AC, de la Fuente-Núñez V. Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials. Reprod Health. 2017;14(3):172. doi:10.1186/s12978-017-0430-2.
   PubMedGoogle Scholar
• 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 editors. Clinical research involving pregnant women. Vol. 3. Switzerland: Springer; 2016. p. 65–94.
   Google Scholar
• Jorgensen SCJ, Miljanic S, Tabbara N, Somanader D, Tse CLY, De Castro C, Malhamé I, Lapinsky SE, Burry L. Characterizing the inclusion of pregnant and breastfeeding people in infectious diseases randomized controlled trials: a targeted literature review. Clin Microbiol Infect. [accessed 2022 May 20];28(6):801–811. doi:10.1016/j.cmi.2021.10.024.
   PubMed Web of Science ®Google Scholar
• Palmer-Ross A, Ovseiko PV, Heidari S. Inadequate reporting of COVID-19 clinical studies: a renewed rationale for the Sex and Gender Equity in Research (SAGER) guidelines. Br Med J Glob Health. 2021;6(4):e004997. doi:10.1136/bmjgh-2021-004997.
   PubMedGoogle Scholar
• Baylis F, Halperin S. Research involving pregnant women: trials and tribulations. Clin Investiga. 2012;2(2):139–146. doi:10.4155/cli.11.178.
   Google Scholar
• Anderson PO. Maternal vaccination and breastfeeding. Breastfeed Med. 2019;14(4):215–217. doi:10.1089/bfm.2019.0045.
   PubMed Web of Science ®Google Scholar
• Madhi SA, Polack FP, Piedra PA, Munoz FM, Trenholme AA, Simões EAF, Swamy GK, Agrawal S, Ahmed K, August A, et al. Respiratory syncytial virus vaccination during pregnancy and effects in infants. N Eng J Med. 2020;383(5):426–439. doi:10.1056/NEJMoa1908380.
   PubMed Web of Science ®Google Scholar
• Jaffe E, Lyerly AD, Goldfarb IT. Pregnant women’s perceptions of risks and benefits when considering participation in vaccine trials. Vaccine. 2020;38(44):6922–6929. doi:10.1016/j.vaccine.2020.08.059.
   PubMed Web of Science ®Google Scholar
• Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and gender equity in research: rationale for the SAGER guidelines and recommended use. Res Integr Peer R. 2016;1(1):2. doi:10.1186/s41073-016-0007-6.
   PubMedGoogle Scholar
• Bischof E, Oertelt-Prigione S, Morgan R, Klein SL. Sex and Gender in COVID19 Clinical Trials Working Group (SGC), Gender and COVID-19 Working Group. Towards precision medicine: inclusion of sex and gender aspects in COVID-19 clinical studies—acting now before it’s too late—a joint call for action. Environ Res Public Health. 2020;17(10):4. doi:10.3390/ijerph17103715.
   Web of Science ®Google Scholar
• Razzaghi H, Meghani M, Pingali C, Cane B, Naleway A, Weintraub E, Kenigsberg TA, Lamias MJ, Irving SA, Kauffman TL, 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. 70. doi:10.15585/mmwr.mm7024e2.
   Web of Science ®Google Scholar
• Bradfield Z, Wynter K, Hauck Y, Sweet L, Wilson AN, Szabo RA, Vasilevski V, Kuliukas L, Homer CSE. COVID-19 vaccination perceptions and intentions of maternity care consumers and providers in Australia. Plos One. 2021;16(11):e0260049. doi:10.1371/journal.pone.0260049.
   PubMed Web of Science ®Google Scholar
• Manca TA. Deferring risk: the COVID-19 pandemic and vaccination during pregnancy. 2021 Canadian society for the sociology of health; [accessed 2021 July 8]. https://www.cssh-scss.ca/webinars.
   Google Scholar
• Manca TA, Baylis F, Munoz FM, Top KA. Prioritise research on vaccines for pregnant and breastfeeding women. The Lancet. 2022;399(10328):890–893. doi:10.1016/S0140-6736(22)00379-8.
   PubMed Web of Science ®Google Scholar