Immunogenicity of COVID-19 mRNA Vaccines in Pregnant and Lactating Women

Corresponding Author: Dan H. Barouch, MD, PhD, Center for Virology and Vaccine Research, 330 Brookline Ave, E/CLS-1043, Boston, MA 02115 (dbarouch@bidmc.harvard.edu).

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.