Immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating women
Open accessAbstract
Importance: Pregnant women are at increased risk of morbidity and mortality from COVID-19 but have been excluded from the phase 3 COVID-19 vaccine trials. Data on vaccine safety and immunogenicity in these populations are therefore limited. Objective: To evaluate the immunogenicity of COVID-19 messenger RNA (mRNA) vaccines in pregnant and lactating women, including against emerging SARS-CoV-2 variants of concern. Design, Setting, and Participants: An exploratory, descriptive, prospective cohort study enrolled 103 women who received a COVID-19 vaccine from December 2020 through March 2021 and 28 women who had confirmed SARS-CoV-2 infection from April 2020 through March 2021 (the last follow-up date was March 26, 2021). This study enrolled 30 pregnant, 16 lactating, and 57 neither pregnant nor lactating women who received either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines and 22 pregnant and 6 nonpregnant unvaccinated women with SARS-CoV-2 infection. Main Outcomes and Measures: SARS-CoV-2 receptor binding domain binding, neutralizing, and functional nonneutralizing antibody responses from pregnant, lactating, and nonpregnant women were assessed following vaccination. Spike-specific T-cell responses were evaluated using IFN-γ enzyme-linked immunospot and multiparameter intracellular cytokine-staining assays. Humoral and cellular immune responses were determined against the original SARS-CoV-2 USA-WA1/2020 strain as well as against the B.1.1.7 and B.1.351 variants. Results: This study enrolled 103 women aged 18 to 45 years (66% non-Hispanic White) who received a COVID-19 mRNA vaccine. After the second vaccine dose, fever was reported in 4 pregnant women (14%; SD, 6%), 7 lactating women (44%; SD, 12%), and 27 nonpregnant women (52%; SD, 7%). Binding, neutralizing, and functional nonneutralizing antibody responses as well as CD4 and CD8 T-cell responses were present in pregnant, lactating, and nonpregnant women following vaccination. Binding and neutralizing antibodies were also observed in infant cord blood and breast milk. Binding and neutralizing antibody titers against the SARS-CoV-2 B.1.1.7 and B.1.351 variants of concern were reduced, but T-cell responses were preserved against viral variants. Conclusion and Relevance: In this exploratory analysis of a convenience sample, receipt of a COVID-19 mRNA vaccine was immunogenic in pregnant women, and vaccine-elicited antibodies were transported to infant cord blood and breast milk. Pregnant and nonpregnant women who were vaccinated developed cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants of concern.
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The presence of functional neutralizing antibodies in infant cord blood and breast milk suggests a protective effect for newborns.
“suggesting that there is a protective effect for newborns.116, 117, 118”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [117]
Functional neutralizing antibodies against SARS-CoV-2 were found in infant cord blood and in the breast milk of vaccinated pregnant women.
“Importantly, functional neutralizing antibodies against SARS-CoV-2 were found in infant cord blood and in the breast milk of vaccinated pregnant women”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [117]
Neutralizing antibodies have been detected in cord blood and human milk after mRNA SARS-CoV-2 vaccination.
“mRNA vaccines against SARS-CoV-2 have also been shown to be immunogenic in pregnant and lactating people, and neutralizing antibodies have been detected in cord blood and human milk230.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [230]
mRNA vaccines against SARS-CoV-2 have been shown to be immunogenic in pregnant and lactating people.
“mRNA vaccines against SARS-CoV-2 have also been shown to be immunogenic in pregnant and lactating people, and neutralizing antibodies have been detected in cord blood and human milk230.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [230]
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References 26 · Cited by 397
Research works printed but not linked: 1
- Pace RM, Williams JE, Jarvinen KM, et al. COVID-19 and human milk: SARS-CoV-2, antibodies, and neutralizing capacity. MedRxiv. Preprint posted online September 18, 2020. doi:10.1101/2020.09.16. 20196071 · DOI
- Authors
- Collier, A.-R. Y., McMahan, K., Yu, J., Tostanoski, L. H., Aguayo, R., Ansel, J., Chandrashekar, A., Patel, S., Apraku Bondzie, E., Sellers, D., Barrett, J., Sanborn, O., Wan, H., Chang, A., Anioke, T., Nkolola, J., Bradshaw, C., Jacob-Dolan, C., Feldman, J., Gebre, M., Borducchi, E. N., Liu, J., Schmidt, A. G., Suscovich, T., Linde, C., Alter, G., Hacker, M. R., & Barouch, D. H.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- Harvard University (US)
- SeromYx Systems Inc, Cambridge, Massachusetts
- Corresponding author
- Barouch, Dan H.
- ORCID
- Collier, Ai-ris Y.
- McMahan, Katherine
- Yu, Jingyou
- Tostanoski, Lisa H.
- Chandrashekar, Abishek
- Patel, Shivani
- Sellers, Daniel
- Barrett, Julia
- Wan, Huahua
- Chang, Aiquan
- Anioke, Tochi
- Nkolola, Joseph
- Jacob-Dolan, Catherine
- Feldman, Jared
- Gebre, Makda
- Liu, Jinyan
- Schmidt, Aaron G.
- Suscovich, Todd
- Linde, Caitlyn
- Alter, Galit
- Hacker, Michele R.
- Barouch, Dan H.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2021-06-15
- Volume
- 325
- Issue
- 23
- Pages
- 2370
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC8120446
- OpenAlex
- W3163739433
- Cited by
- 397
- References
- 26
- Citations by year
- 2026: 16 · 2025: 21 · 2024: 46 · 2023: 90 · 2022: 134 · 2021: 89 · 2020: 1
- FWCI
- 28.51
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- ImmPort
- Funders
- Musk Foundation
- Massachusetts Consortium on Pathogen Readiness
- National Institutes of Health (UL1TR002541)
- National Cancer Institute (U01CA260476)
- National Institute of Allergy and Infectious Diseases (R01AI146779, T32AI007387)
- National Center for Advancing Translational Sciences
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12HD000849)
- 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
- COVID-19 mRNA vaccine, immunogenicity, pregnancy, lactation, SARS-CoV-2, spike protein antibodies, neutralizing antibodies, non-neutralizing antibodies, T cell response, vaccine safety, mRNA-1273, BNT162b2, variants of concern, Alpha variant, Beta variant, breast milk antibodies
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, mRNA Vaccines, BNT162 Vaccine, 2019-nCoV Vaccine mRNA-1273, Adult, Antibodies, Viral, Cross Reactions, Female, Fetal Blood, Humans, Immunoassay, Lactation, Leukocytes, Mononuclear, Middle Aged, Milk, Human, Pregnancy, Prospective Studies, T-Lymphocytes, Vaccines, Synthetic, Young Adult, Antibodies, Neutralizing
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