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What is the immunogenicity of COVID-19 messenger RNA (mRNA) vaccines in pregnant and lactating women?
In this cohort study involving 103 women who received a COVID-19 mRNA vaccine, 30 of whom were pregnant and 16 of whom were lactating, immunogenicity was demonstrated in all, and vaccine-elicited antibodies were found in infant cord blood and breast milk. Pregnant and nonpregnant vaccinated women developed cross-reactive immune responses against SARS-CoV-2 variants of concern.
In a small convenience sample, COVID-19 mRNA vaccines were immunogenic in pregnant and lactating women and induced immune responses against SARS-CoV-2 variants.
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.
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.
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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Corresponding Author: Dan H. Barouch, MD, PhD, Center for Virology and Vaccine Research, 330 Brookline Ave, E/CLS-1043, Boston, MA 02115 (firstname.lastname@example.org).
Accepted for Publication: April 27, 2021.
Published Online: May 13, 2021. doi:10.1001/jama.2021.7563
Author Contributions: Drs Collier and Barouch had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Collier, Alter, Barouch.
Acquisition, analysis, or interpretation of data: Collier, McMahan, Yu, Tostanoski, Aguayo, Ansel, Chandrashekar, Patel, Apraku Bondzie, Sellers, Barrett, Sanborn, Wan, Chang, Anioke, Nkolola, Bradshaw, Jacob-Dolan, Feldman, Gebre, Borducchi, Liu, Schmidt, Suscovich, Linde, Hacker, Barouch.
Drafting of the manuscript: Collier, McMahan, Yu, Chang, Anioke, Barouch.
Critical revision of the manuscript for important intellectual content: Collier, Tostanoski, Aguayo, Ansel, Chandrashekar, Patel, Apraku Bondzie, Sellers, Barrett, Sanborn, Wan, Chang, Nkolola, Bradshaw, Jacob-Dolan, Feldman, Gebre, Borducchi, Liu, Schmidt, Suscovich, Linde, Alter, Hacker, Barouch.
Statistical analysis: Collier, Yu, Tostanoski, Chang, Hacker.
Obtained funding: Schmidt, Barouch.
Administrative, technical, or material support: Collier, McMahan, Yu, Aguayo, Ansel, Chandrashekar, Patel, Apraku Bondzie, Sellers, Barrett, Sanborn, Chang, Anioke, Bradshaw, Feldman, Gebre, Liu, Suscovich, Linde, Barouch.
Supervision: Collier, McMahan, Ansel, Nkolola, Schmidt, Alter, Barouch.
Other - Performing assays: Wan.
Other - methodology, resources, data curation: Alter.
Conflict of Interest Disclosures: Dr Suscovich reported that he is an employee at and owns shares of SeromYx Systems Inc. Dr Linde reported that she is an employee of SeromYx Systems Inc. Dr Alter reported cofounding and serving as a consultant to, and having a patent pending through SeromYx Systems Inc. Dr Barouch reported receiving grants from National Institutes of Health (NIH), the Henry M. Jackson Foundation of the Walter Reed Army Institute of Research, the Bill and Melinda Gates Foundation, the Defense Advanced Research Projects Agency, Gilead, Intima, Alkermes, CureVac, South Africa Medical Research Council, amfAR, Ragon Institute, MassCPR, Sanofi, Legend, and Zentalis; receiving personal fees from SQZ Biotech; and having a patent for COVID-19 vaccines licensed to Janssen with no premarket royalties or payments of any kind. No other disclosures were reported.
Funding/Support: This study was funded by grant CA260476 from the National Institutes of Health (NIH), and grants from the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, Harvard, the Massachusetts Consortium for Pathogen Readiness, and the Musk Foundation (DHB); AI146779 from the NIH (AGS); HD000849 from the Reproductive Scientist Development Program from the Eunice Kennedy Shriver National Institute of Child Health & Human Development and from Burroughs Wellcome Fund (AYC), AI007387 from the Multidisciplinary AIDS Training Program (LHT), and TR002541 from the Harvard Clinical and Translational Science Center (MRH).
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank the participants and their families, the frontline health care providers, and the Center for Virology and Vaccine Research, the Harvard Catalyst Clinical Research Center, the office of the Beth Israel Deaconess Medical Center Chief Academic Officer, and the Department of Obstetrics and Gynecology for enrollment, collection, and processing samples for the Beth Israel Deaconess Medical Center COVID-19 Biorepository.
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