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Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy
Open accessPublished version of a preprint
Abstract
To evaluate the effectiveness of the BNT162b2 messenger RNA vaccine in pregnant women, we conducted an observational cohort study of pregnant women aged 16 years or older, with no history of SARS-CoV-2, who were vaccinated between 20 December 2020 and 3 June 2021. A total of 10,861 vaccinated pregnant women were matched to 10,861 unvaccinated pregnant controls using demographic and clinical characteristics. Study outcomes included documented infection with SARS-CoV-2, symptomatic COVID-19, COVID-19-related hospitalization, severe illness and death. Estimated vaccine effectiveness from 7 through to 56 d after the second dose was 96% (95% confidence interval 89-100%) for any documented infection, 97% (91-100%) for infections with documented symptoms and 89% (43-100%) for COVID-19-related hospitalization. Only one event of severe illness was observed in the unvaccinated group and no deaths were observed in either group. In summary, the BNT162b2 mRNA vaccine was estimated to have high vaccine effectiveness in pregnant women, which is similar to the effectiveness estimated in the general population.
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“A recent observational study in a cohort of 10,861 pregnant women showed that BNT162b2 had 96% effectiveness in the prevention of COVID-19.115”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [115]
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Cites
BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting
Dagan, N., Barda, N., Kepten, E., Miron, O., Perchik, S., Katz, M. A., Hernán, M. A., Lipsitch, M., Reis, B., & Balicer, R. D. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2101765 · Cited by 2,527 · cited 2×
“VE for women with chronic conditions may be somewhat lower than the average VE reported in this study, as previously reported for the general population (13).”
Self-citationZambrano, L. D., Ellington, S., Strid, P., Galang, R. R., Oduyebo, T., Tong, V. T., Woodworth, K. R., Nahabedian, J. F., Azziz-Baumgartner, E., Gilboa, S. M., et al. (2020) · MMWR Morbidity and Mortality Weekly Report · doi:10.15585/mmwr.mm6944e3 · Cited by 1,207
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Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
Shimabukuro, T. T., Kim, S. Y., Myers, T. R., Moro, P. L., Oduyebo, T., Panagiotakopoulos, L., Marquez, P. L., Olson, C. K., Liu, R., Chang, K. T., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2104983 · Cited by 927
The impact of COVID-19 on pregnancy outcomes: a systematic review and meta-analysis
Wei, S. Q., Bilodeau‐Bertrand, M., Liu, S., & Auger, N. (2021) · Canadian Medical Association Journal · doi:10.1503/cmaj.202604 · Cited by 912
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Immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating women
Collier, A.-R. Y., McMahan, K., Yu, J., Tostanoski, L. H., Aguayo, R., Ansel, J., Chandrashekar, A., Patel, S., Apraku Bondzie, E., Sellers, D., et al. (2021) · JAMA · doi:10.1001/jama.2021.7563 · Cited by 397
SARS-CoV-2–Specific Antibodies in Breast Milk After COVID-19 Vaccination of Breastfeeding Women
Perl, S. H., Uzan-Yulzari, A., Klainer, H., Asiskovich, L., Youngster, M., Rinott, E., & Youngster, I. (2021) · JAMA · doi:10.1001/jama.2021.5782 · Cited by 285
Coronavirus Disease 2019 (COVID-19) Vaccines and Pregnancy
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Research works printed but not linked: 1
- Barda, N., Dagan, N. & Balicer, R. D. BNT162b2 mRNA Covid-19 vaccine in a nationwide mass vaccination setting. Reply. N. Engl. J. Med. 384, 1970 (2021).
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Fiolet, T., Kherabi, Y., MacDonald, C.-J., Ghosn, J., & Peiffer-Smadja, N. (2022) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2021.10.005 · Cited by 911
mRNA-based therapeutics: powerful and versatile tools to combat diseases
Qin, S., Tang, X., Chen, Y., Chen, K., Fan, N., Xiao, W., Zheng, Q., Li, G., Teng, Y., Wu, M., et al. (2022) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-022-01007-w · Cited by 852
SARS-CoV-2 breakthrough infections in vaccinated individuals: measurement, causes and impact
Lipsitch, M., Krammer, F., Regev‐Yochay, G., Lustig, Y., & Balicer, R. D. (2021) · Nature reviews. Immunology · doi:10.1038/s41577-021-00662-4 · Cited by 345
Self-citationCOVID-19 mRNA vaccines: Platforms and current developments
Szabó, G. T., Mahiny, A. J., & Vlatkovic, I. (2022) · Molecular Therapy · doi:10.1016/j.ymthe.2022.02.016 · Cited by 308
Prasad, S., Kalafat, E., Blakeway, H., Townsend, R., O’Brien, P., Morris, E., Draycott, T. J., Thangaratinam, S., Doaré, K. L., Ladhani, S. N., et al. (2022) · Nature Communications · doi:10.1038/s41467-022-30052-w · Cited by 292
Metadata
- Authors
- Dagan, N., Barda, N., Biron-Shental, T., Makov-Assif, M., Key, C., Kohane, I. S., Hernán, M. A., Lipsitch, M., Hernandez-Diaz, S., Reis, B. Y., & Balicer, R. D.
- Affiliations
- Ben-Gurion University of the Negev (IL)
- Clalit Health Services (IL)
- Harvard University (US)
- Boston Children's Hospital (US)
- Corresponding author
- Balicer, Ran D.
- ORCID
- Venue
- Nature Medicine
- Published
- 2021-09-07
- Volume
- 27
- Issue
- 10
- Pages
- 1693-1695
- ISSN
- 1078-8956 (ISSN-L)
- 1546-170X
- OpenAlex
- W3180834485
- Cited by
- 312
- References
- 13
- Citations by year
- 2026: 12 · 2025: 27 · 2024: 38 · 2023: 86 · 2022: 130 · 2021: 19
- FWCI
- 21.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Nature Medicine (publishedVersion)
- Research Square (acceptedVersion, cc-by)
- PubMed (publishedVersion)
- Digital Access to Scholarship at Harvard (DASH) (Harvard University) (acceptedVersion)
- Funders
- Ivan and Francesca Berkowitz Family Living Laboratory at Harvard Medical School
- Morris-Singer Fund
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Obstetrics and Gynecology › COVID-19 Impact on Reproduction
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- BNT162b2 mRNA vaccine, COVID-19 vaccines, pregnancy, vaccine effectiveness, COVID-19 pandemic, COVID-19 hospitalization, maternal immunization
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, BNT162 Vaccine, Adolescent, Adult, Female, Humans, Pregnancy, Pregnancy Complications, Infectious, Cohort Studies, Incidence, Young Adult
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