Cited by 937COVID-19 Impact on ReproductionSARS-CoV-2 and COVID-19 ResearchPharmacovigilance and Adverse Drug Reactions

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Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

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Shimabukuro, Tom T., Kim, Shin Y., Myers, Tanya R., Moro, Pedro L., Oduyebo, Titilope, Panagiotakopoulos, Lakshmi, Marquez, Paige L., Olson, Christine K., Liu, Ruiling, Chang, Karen T., Ellington, Sascha R., Burkel, Veronica K., Smoots, Ashley N., Green, Caitlin J., Licata, Charles, Zhang, Bicheng C., Alimchandani, Meghna, Mba-Jonas, Adamma, Martin, Stacey W., Gee, Julianne M., Meaney-Delman, Dana M.·2021·New England Journal of Medicine

DOI 10.1056/nejmoa2104983PMC PMC8117969

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Abstract

BACKGROUND: Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. METHODS: From December 14, 2020, to February 28, 2021, we used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. RESULTS: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). CONCLUSIONS: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.

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Authors: 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., Ellington, S. R., Burkel, V. K., Smoots, A. N., Green, C. J., Licata, C., Zhang, B. C., Alimchandani, M., Mba-Jonas, A., Martin, S. W., Gee, J. M., & Meaney-Delman, D. M.
Affiliations: National Center on Birth Defects and Developmental Disabilities (US)
From the Immunization Safety Office, Division of Healthcare Quality Promotion (T.T.S., T.R.M., P.L. Moro, L.P., P.L. Marquez, C.K.O., C.L., B.C.Z., J.M.G.), and the Arboviral Diseases Branch, Division of Vector-Borne Diseases (S.W.M.), National Center for Emerging and Zoonotic Infectious Diseases, the Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities (S.Y.K., V.K.B., C.J.G., D.M.M.-D.), the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion (T.O., K.T.C., S.R.E., A.N.S.), the World Trade Center Health Program, National Institute for Occupational Safety and Health (R.L.), and the Epidemic Intelligence Service (K.T.C.) — all at the Centers for Disease Control and Prevention, Atlanta; and the Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD (M.A., A.M.-J.).
Corresponding author: Shimabukuro, Tom T.
ORCID: Shimabukuro, Tom T.
Kim, Shin Y.
Myers, Tanya R.
Moro, Pedro L.
Panagiotakopoulos, Lakshmi
Olson, Christine K.
Liu, Ruiling
Chang, Karen T.
Ellington, Sascha R.
Burkel, Veronica K.
Green, Caitlin J.
Alimchandani, Meghna
Martin, Stacey W.
Gee, Julianne M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2021-06-17
Volume: 384
Issue: 24
Pages: 2273-2282
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa2104983
PMC: PMC8117969
OpenAlex: W3154888372
Cited by: 927
References: 23
Citations by year: 2026: 37 · 2025: 46 · 2024: 84 · 2023: 194 · 2022: 317 · 2021: 246
FWCI: 190.97
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: New England Journal of Medicine (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Centers for Disease Control and Prevention
Topics: Health Sciences › Medicine › Obstetrics and Gynecology › COVID-19 Impact on Reproduction
Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: COVID-19 mRNA vaccine, vaccine safety in pregnancy, pregnant women, injection site pain, miscarriage, preterm birth, small for gestational age, neonatal outcomes, live birth, adverse pregnancy outcomes, VAERS
MeSH terms: Abortion, Spontaneous, COVID-19 Vaccines, mRNA Vaccines, Adolescent, Adult, Female, Humans, Infant, Newborn, Infant, Small for Gestational Age, Middle Aged, Pregnancy, Registries, United States, Vaccines, Synthetic, Adverse Drug Reaction Reporting Systems, Premature Birth, Young Adult, Public Health Surveillance

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Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

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