The COVID-19 vaccine evidence gap: Decisions without data for pregnant and breastfeeding women
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Published:
Aug 26, 2021
Keywords:
Maternal health, COVID-19, vaccines
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References
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2. Cucinotta D, Vanelli M. WHO Declares COVID-19 a Pandemic. Acta Biomed. 2020;91(1):157-60. Epub 2020/03/20. doi: 10.23750/abm.v91i1.9397. PubMed PMID: 32191675; PubMed Central PMCID: PMCPMC7569573 stock ownership, equity interest, patent/licensing arrangement etc.) that might pose a conflict of interest in connection with the submitted article.
3. Klein SL, Dhakal S, Ursin RL, Deshpande S, Sandberg K, Mauvais-Jarvis F. Biological sex impacts COVID-19 outcomes. PLOS Pathogens. 2020;16(6):e1008570. doi: 10.1371/journal.ppat.1008570.
4. Chin T, Kahn R, Li R, Chen JT, Krieger N, Buckee CO, et al. U.S. county-level characteristics to inform equitable COVID-19 response. medRxiv : the preprint server for health sciences. 2020:2020.04.08.20058248. doi: 10.1101/2020.04.08.20058248. PubMed PMID: 32511610.
5. Hu J, Wang Y. The Clinical Characteristics and Risk Factors of Severe COVID-19. Gerontology. 2021. doi: 10.1159/000513400.
6. Wizemann T, Pardue M, editors. 6, The Future of Research on Biological Sex Differences: Challenges and Opportunities. Washington (DC): National Academies Press (US); 2001.
7. McCartney PR. Sex-Based Vaccine Response in the Context of COVID-19. J Obstet Gynecol Neonatal Nurs. 2020;49(5):405-8. Epub 2020/08/05. doi: 10.1016/j.jogn.2020.08.001. PubMed PMID: 32800743.
8. Van Spall HGC. Exclusion of pregnant and lactating women from COVID-19 vaccine trials: a missed opportunity. Eur Heart J. 2021. doi: 10.1093/eurheartj/ehab103.
9. Stafford IA, Parchem JG, Sibai BM. The COVID-19 vaccine in pregnancy: risks benefits and recommendations. American Journal of Obstetrics and Gynecology. 2021. doi: https://doi.org/10.1016/j.ajog.2021.01.022.
10. Foulkes M, Grady C, Spong C, Bates A, Clayton J. Clinical Research Enrolling Pregnant Women: A Workshop Summary. J Womens Health (Larchmt). 2011;20(10):1429-32. doi: 10.1089/jwh.2011.3118. PubMed PMID: 21819233.
11. Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Womens Health Issues. 2013;23(1):e39-e45. doi: 10.1016/j.whi.2012.10.003. PubMed PMID: 23312713.
12. Zipursky JS, Greenberg RA, Maxwell C, Bogler T. Pregnancy, breastfeeding and the SARS-CoV-2 vaccine: an ethics-based framework for shared decision-making. Canadian Medical Association Journal. 2021;193(9):E312. doi: 10.1503/cmaj.202833.
13. Fischinger S, Boudreau CM, Butler AL, Streeck H, Alter G. Sex differences in vaccine-induced humoral immunity. Semin Immunopathol. 2019;41(2):239-49. Epub 2018/12/13. doi: 10.1007/s00281-018-0726-5. PubMed PMID: 30547182.
14. 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: https://doi.org/10.1016/j.vaccine.2019.01.011.
15. Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT): PREVENT; [updated 2018; cited 2021 February 24]. Available from: http://vax.pregnancyethics.org/.
16. Whitehead CL, Walker SP. Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. The Lancet. 2020;395(10237):e92. doi: 10.1016/S0140-6736(20)31029-1.
17. COVID-19 Vaccination Recommendations for Special Populations. Toronto, Ontario: Ministry of Health, Government of Ontario, 2021.
18. Taylor MM, Kobeissi L, Kim C, Amin A, Thorson AE, Bellare NB, et al. Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action. Lancet Glob Health. 2021;9(3):e366-e71. doi: 10.1016/S2214-109X(20)30484-8.
19. Wastnedge EAN, Reynolds RM, Boeckel SRv, Stock SJ, Denison FC, Maybin JA, et al. Pregnancy and COVID-19. Physiological Reviews. 2021;101(1):303-18. doi: 10.1152/physrev.00024.2020. PubMed PMID: 32969772.
20. Rubin R. Pregnant People’s Paradox—Excluded From Vaccine Trials Despite Having a Higher Risk of COVID-19 Complications. Jama. 2021. doi: 10.1001/jama.2021.2264.
21. Cohen J. Zika rewrites maternal immunization ethics. Science. 2017;357(6348):241-. doi: 10.1126/science.357.6348.241.
22. Klein SL, Creisher PS, Burd I. COVID-19 vaccine testing in pregnant females is necessary. The Journal of Clinical Investigation. 2021. doi: 10.1172/JCI147553.
23. Craig AM, Hughes BL, Swamy GK. Coronavirus disease 2019 vaccines in pregnancy. American Journal of Obstetrics & Gynecology MFM. 2021;3(2):100295. doi: https://doi.org/10.1016/j.ajogmf.2020.100295.
24. Souza RT, Costa ML, Mayrink J, Feitosa FE, Rocha Filho EA, Leite DF, et al. Perinatal outcomes from preterm and early term births in a multicenter cohort of low risk nulliparous women. Sci. 2020;10(1):8508. doi: 10.1038/s41598-020-65022-z.
25. Chang W-H. A review of vaccine effects on women in light of the COVID-19 pandemic. Taiwanese Journal of Obstetrics and Gynecology. 2020;59(6):812-20. doi: https://doi.org/10.1016/j.tjog.2020.09.006.
26. COVID-19 vaccines: the pandemic will not end overnight. The Lancet Microbe. 2021;2(1):e1. doi: 10.1016/S2666-5247(20)30226-3.
27. Vaccines for COVID-19 Ottawa, ON: Government of Canada; 2021 [cited 2021 March 5]. Available from: https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19/vaccines.html?&utm_campaign=hc-sc-covidvaccine-20-21&utm_medium=sem&utm_source=ggl&utm_content=ad-text-en&utm_term=canada%20vaccine%20covid&adv=2021-0071&id_campaign=12088104441&id_source=116538480476&id_content=491971664630&gclid=Cj0KCQiAyoeCBhCTARIsAOfpKxiff5HgfiQUwHqaE9OX5MEOf2X1ykPyTt0bI4FVHX1ZkCY2HXO-RTQaAu2DEALw_wcB&gclsrc=aw.ds.
28. Yakerson A. Women in clinical trials: a review of policy development and health equity in the Canadian context. International Journal for Equity in Health. 2019;18(1):56. doi: 10.1186/s12939-019-0954-x.
29. Payne P. Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards. Ethics & Human Research. 2019;41(6):35-40. doi: https://doi.org/10.1002/eahr.500036.
30. Poliquin V, Castillo E, Boucoiran I, Watson H, Yudin M, Money D, et al. SOGC Statement on COVID-19 Vaccination in Pregnancy. SOGC 2021.
31. Madhi SA, Polack FP, Piedra PA, Munoz FM, Trenholme AA, Simões EAF, et al. Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants. N Engl J Med. 2020;383(5):426-39. doi: 10.1056/NEJMoa1908380.
32. Swamy GK, Metz TD, Edwards KM, Soper DE, Beigi RH, Campbell JD, et al. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial. Vaccine. 2020;38(44):6930-40. Epub 2020/09/05. doi: 10.1016/j.vaccine.2020.08.056. PubMed PMID: 32883555.
33. Jackson LA, Patel SM, Swamy GK, Frey SE, Creech CB, Munoz FM, et al. Immunogenicity of an Inactivated Monovalent 2009 H1N1 Influenza Vaccine in Pregnant Women. The Journal of Infectious Diseases. 2011;204(6):854-63. doi: 10.1093/infdis/jir440.
2. Cucinotta D, Vanelli M. WHO Declares COVID-19 a Pandemic. Acta Biomed. 2020;91(1):157-60. Epub 2020/03/20. doi: 10.23750/abm.v91i1.9397. PubMed PMID: 32191675; PubMed Central PMCID: PMCPMC7569573 stock ownership, equity interest, patent/licensing arrangement etc.) that might pose a conflict of interest in connection with the submitted article.
3. Klein SL, Dhakal S, Ursin RL, Deshpande S, Sandberg K, Mauvais-Jarvis F. Biological sex impacts COVID-19 outcomes. PLOS Pathogens. 2020;16(6):e1008570. doi: 10.1371/journal.ppat.1008570.
4. Chin T, Kahn R, Li R, Chen JT, Krieger N, Buckee CO, et al. U.S. county-level characteristics to inform equitable COVID-19 response. medRxiv : the preprint server for health sciences. 2020:2020.04.08.20058248. doi: 10.1101/2020.04.08.20058248. PubMed PMID: 32511610.
5. Hu J, Wang Y. The Clinical Characteristics and Risk Factors of Severe COVID-19. Gerontology. 2021. doi: 10.1159/000513400.
6. Wizemann T, Pardue M, editors. 6, The Future of Research on Biological Sex Differences: Challenges and Opportunities. Washington (DC): National Academies Press (US); 2001.
7. McCartney PR. Sex-Based Vaccine Response in the Context of COVID-19. J Obstet Gynecol Neonatal Nurs. 2020;49(5):405-8. Epub 2020/08/05. doi: 10.1016/j.jogn.2020.08.001. PubMed PMID: 32800743.
8. Van Spall HGC. Exclusion of pregnant and lactating women from COVID-19 vaccine trials: a missed opportunity. Eur Heart J. 2021. doi: 10.1093/eurheartj/ehab103.
9. Stafford IA, Parchem JG, Sibai BM. The COVID-19 vaccine in pregnancy: risks benefits and recommendations. American Journal of Obstetrics and Gynecology. 2021. doi: https://doi.org/10.1016/j.ajog.2021.01.022.
10. Foulkes M, Grady C, Spong C, Bates A, Clayton J. Clinical Research Enrolling Pregnant Women: A Workshop Summary. J Womens Health (Larchmt). 2011;20(10):1429-32. doi: 10.1089/jwh.2011.3118. PubMed PMID: 21819233.
11. Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Womens Health Issues. 2013;23(1):e39-e45. doi: 10.1016/j.whi.2012.10.003. PubMed PMID: 23312713.
12. Zipursky JS, Greenberg RA, Maxwell C, Bogler T. Pregnancy, breastfeeding and the SARS-CoV-2 vaccine: an ethics-based framework for shared decision-making. Canadian Medical Association Journal. 2021;193(9):E312. doi: 10.1503/cmaj.202833.
13. Fischinger S, Boudreau CM, Butler AL, Streeck H, Alter G. Sex differences in vaccine-induced humoral immunity. Semin Immunopathol. 2019;41(2):239-49. Epub 2018/12/13. doi: 10.1007/s00281-018-0726-5. PubMed PMID: 30547182.
14. 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: https://doi.org/10.1016/j.vaccine.2019.01.011.
15. Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT): PREVENT; [updated 2018; cited 2021 February 24]. Available from: http://vax.pregnancyethics.org/.
16. Whitehead CL, Walker SP. Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. The Lancet. 2020;395(10237):e92. doi: 10.1016/S0140-6736(20)31029-1.
17. COVID-19 Vaccination Recommendations for Special Populations. Toronto, Ontario: Ministry of Health, Government of Ontario, 2021.
18. Taylor MM, Kobeissi L, Kim C, Amin A, Thorson AE, Bellare NB, et al. Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action. Lancet Glob Health. 2021;9(3):e366-e71. doi: 10.1016/S2214-109X(20)30484-8.
19. Wastnedge EAN, Reynolds RM, Boeckel SRv, Stock SJ, Denison FC, Maybin JA, et al. Pregnancy and COVID-19. Physiological Reviews. 2021;101(1):303-18. doi: 10.1152/physrev.00024.2020. PubMed PMID: 32969772.
20. Rubin R. Pregnant People’s Paradox—Excluded From Vaccine Trials Despite Having a Higher Risk of COVID-19 Complications. Jama. 2021. doi: 10.1001/jama.2021.2264.
21. Cohen J. Zika rewrites maternal immunization ethics. Science. 2017;357(6348):241-. doi: 10.1126/science.357.6348.241.
22. Klein SL, Creisher PS, Burd I. COVID-19 vaccine testing in pregnant females is necessary. The Journal of Clinical Investigation. 2021. doi: 10.1172/JCI147553.
23. Craig AM, Hughes BL, Swamy GK. Coronavirus disease 2019 vaccines in pregnancy. American Journal of Obstetrics & Gynecology MFM. 2021;3(2):100295. doi: https://doi.org/10.1016/j.ajogmf.2020.100295.
24. Souza RT, Costa ML, Mayrink J, Feitosa FE, Rocha Filho EA, Leite DF, et al. Perinatal outcomes from preterm and early term births in a multicenter cohort of low risk nulliparous women. Sci. 2020;10(1):8508. doi: 10.1038/s41598-020-65022-z.
25. Chang W-H. A review of vaccine effects on women in light of the COVID-19 pandemic. Taiwanese Journal of Obstetrics and Gynecology. 2020;59(6):812-20. doi: https://doi.org/10.1016/j.tjog.2020.09.006.
26. COVID-19 vaccines: the pandemic will not end overnight. The Lancet Microbe. 2021;2(1):e1. doi: 10.1016/S2666-5247(20)30226-3.
27. Vaccines for COVID-19 Ottawa, ON: Government of Canada; 2021 [cited 2021 March 5]. Available from: https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19/vaccines.html?&utm_campaign=hc-sc-covidvaccine-20-21&utm_medium=sem&utm_source=ggl&utm_content=ad-text-en&utm_term=canada%20vaccine%20covid&adv=2021-0071&id_campaign=12088104441&id_source=116538480476&id_content=491971664630&gclid=Cj0KCQiAyoeCBhCTARIsAOfpKxiff5HgfiQUwHqaE9OX5MEOf2X1ykPyTt0bI4FVHX1ZkCY2HXO-RTQaAu2DEALw_wcB&gclsrc=aw.ds.
28. Yakerson A. Women in clinical trials: a review of policy development and health equity in the Canadian context. International Journal for Equity in Health. 2019;18(1):56. doi: 10.1186/s12939-019-0954-x.
29. Payne P. Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards. Ethics & Human Research. 2019;41(6):35-40. doi: https://doi.org/10.1002/eahr.500036.
30. Poliquin V, Castillo E, Boucoiran I, Watson H, Yudin M, Money D, et al. SOGC Statement on COVID-19 Vaccination in Pregnancy. SOGC 2021.
31. Madhi SA, Polack FP, Piedra PA, Munoz FM, Trenholme AA, Simões EAF, et al. Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants. N Engl J Med. 2020;383(5):426-39. doi: 10.1056/NEJMoa1908380.
32. Swamy GK, Metz TD, Edwards KM, Soper DE, Beigi RH, Campbell JD, et al. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial. Vaccine. 2020;38(44):6930-40. Epub 2020/09/05. doi: 10.1016/j.vaccine.2020.08.056. PubMed PMID: 32883555.
33. Jackson LA, Patel SM, Swamy GK, Frey SE, Creech CB, Munoz FM, et al. Immunogenicity of an Inactivated Monovalent 2009 H1N1 Influenza Vaccine in Pregnant Women. The Journal of Infectious Diseases. 2011;204(6):854-63. doi: 10.1093/infdis/jir440.