[Skip to Content]
[Skip to Content Landing]

Detection of Messenger RNA COVID-19 Vaccines in Human Breast Milk

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

Vaccination is a cornerstone in fighting the COVID-19 pandemic. However, the initial messenger RNA (mRNA) vaccine clinical trials excluded several vulnerable groups, including young children and lactating individuals.1 The US Food and Drug Administration deferred the decision to authorize COVID-19 mRNA vaccines for infants younger than 6 months until more data are available because of the potential priming of the children’s immune responses that may alter their immunity.2 The Centers for Disease Control and Prevention recommends offering the COVID-19 mRNA vaccines to breastfeeding individuals,3 although the possible passage of vaccine mRNAs in breast milk resulting in infants’ exposure at younger than 6 months was not investigated. This study investigated whether the COVID-19 vaccine mRNA can be detected in the expressed breast milk (EBM) of lactating individuals receiving the vaccination within 6 months after delivery.

Sign in to take quiz and track your certificates

Buy This Activity

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 Credit(s)™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: July 25, 2022.

Published Online: September 26, 2022. doi:10.1001/jamapediatrics.2022.3581

Correction: This article was corrected on September 30, 2022, to fix the year of the study period and other minor typographical errors in the eMethods in the Supplement.

Corresponding Author: Nazeeh Hanna, MD, Division of Neonatology, Department of Pediatrics, NYU Langone Hospital–Long Island, NYU Long Island School of Medicine, 259 First St, Mineola, NY 11501 (nazeehhanna@gmail.com).

Author Contributions: Dr Hanna had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Hanna, Heffes-Doon, Lin, Nayak.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Hanna, Lin.

Obtained funding: Hanna.

Administrative, technical, or material support: Hanna, Lin, Manzano De Mejia, Botros, Gurzenda, Nayak.

Supervision: Hanna.

Conflict of Interest Disclosures: Dr Hanna reported grants from the National Institute of Child Health and Human Development, National Institute of Environmental Health Sciences, American Lung Association, March of Dimes, New York State Department of Health, and Robert Wood Johnson Foundation. No other disclosures were reported.

Funding/Support: All financial and material support for this work was provided by the Department of Pediatrics, NYU Langone Hospital–Long Island, New York University Long Island School of Medicine.

Role of the Funder/Sponsor: The supporting organization had a 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 acknowledge the participants who volunteered for this study. We are thankful to Christie Clauss, PharmD (Department of Pharmacy, NYU Langone Hospital–Long Island), for voluntarily providing unused vaccines for this study and for her critical revision of the manuscript. We are also thankful to the following individuals for their voluntary help in recruitment: Regina Cafferty, RN (Department of Pediatrics, NYU Langone Hospital–Long Island), and Elisabeth Sulger, MD, and Hollisa Rosa, MD (Department of Obstetrics and Gynecology, NYU Langone Hospital–Long Island). None of these individuals received compensation for their contribution.

References
1.
Van Spall  HGC .  Exclusion of pregnant and lactating women from COVID-19 vaccine trials: a missed opportunity.   Eur Heart J. 2021;42(28):2724-2726. doi:10.1093/eurheartj/ehab103PubMedGoogle ScholarCrossref
2.
US Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age. Released June 17, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children
3.
Centers for Disease Control and Prevention. COVID-19 vaccines while pregnant or breastfeeding. Accessed March 8, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html.
4.
European Medicines Agency. Assessment report: COVID-19 vaccine Moderna. Published March 11, 2021. http://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf.
5.
Pardi  N , Tuyishime  S , Muramatsu  H ,  et al.  Expression kinetics of nucleoside-modified mRNA delivered in lipid nanoparticles to mice by various routes.   J Control Release. 2015;217:345-351. doi:10.1016/j.jconrel.2015.08.007PubMedGoogle ScholarCrossref
6.
Bansal  S , Perincheri  S , Fleming  T ,  et al.  Cutting edge: circulating exosomes with COVID spike protein are induced by BNT162b2 (Pfizer-BioNTech) vaccination prior to development of antibodies: a novel mechanism for immune activation by mRNA vaccines.   J Immunol. 2021;207(10):2405-2410. doi:10.4049/jimmunol.2100637PubMedGoogle ScholarCrossref
Close
Want full access to the AMA Ed Hub?
After you sign up for AMA Membership, make sure you sign in or create a Physician account with the AMA in order to access all learning activities on the AMA Ed Hub
Buy this activity
Close
Want full access to the AMA Ed Hub?
After you sign up for AMA Membership, make sure you sign in or create a Physician account with the AMA in order to access all learning activities on the AMA Ed Hub
Buy this activity
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Close
Close

Lookup An Activity

or

My Saved Searches

You currently have no searches saved.

Close

My Saved Courses

You currently have no courses saved.

Close