| アブストラクト | 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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| 投稿日 | 2021/4/22 |
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| 投稿者 | 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 |
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| ジャーナル名 | The New England journal of medicine |
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| 組織名 | 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.). |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33882218/ |
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