{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T04:42:44Z","timestamp":1781844164970,"version":"3.54.5"},"reference-count":20,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,2,15]],"date-time":"2023-02-15T00:00:00Z","timestamp":1676419200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>mRNA COVID\u201019 vaccines are used in pregnant populations whether advertently or inadvertently. However, evidence on the safety of these vaccines during pregnancy is limited. The objective of this study is to evaluate the effect of BNT162b2 (Pfizer\u2010BioNTech) and mRNA\u20101273 (Moderna) vaccination during the first 20\u2009weeks of gestation on the risk of spontaneous abortion (SAB).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>All pregnant women who received at least one dose of BNT162b2 or mRNA\u20101273 and enrolled in the COVID\u201019 Vaccines International Pregnancy Exposure Registry (C\u2010VIPER) were prospectively followed from enrollment until 20\u2009weeks of gestation, SAB, or loss to follow\u2010up. Baseline demographics, vaccination information, and pregnancy outcomes were collected via monthly online self\u2010administered questionnaires, vaccination certificates, and medical records. Life tables were used to calculate the cumulative risk of SAB. Cox regression was used to estimate the hazard ratio (HR) comparing the two vaccines groups stratified by country of residence and gestational age at enrollment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 6840 participants who received at least one dose of BNT162b2 or mRNA\u20101273 at any time in pregnancy between Jan\u2010Sep, 2021, 2129 met the inclusion criteria (1576 received BNT162b2 and 553 mRNA\u20101273). The two groups were balanced in terms of baseline characteristics. There were 37 SABs, with an overall 13.4% estimated cumulative risk by 20\u2009weeks of gestation, which is similar to the expected risk in the population. The HR of SAB comparing mRNA\u20101273 to BNT162b2 was 1.46 (95% CI: 0.66, 3.22).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The C\u2010VIPER data show no evidence that mRNA COVID\u201019 vaccines increase the risk of SAB.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5600","type":"journal-article","created":{"date-parts":[[2023,2,8]],"date-time":"2023-02-08T05:00:21Z","timestamp":1675832421000},"page":"685-693","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["<scp>mRNA COVID<\/scp>\u201019 vaccination early in pregnancy and the risk of spontaneous abortion in an international pregnancy registry"],"prefix":"10.1002","volume":"32","author":[{"given":"Omar","family":"Mansour","sequence":"first","affiliation":[{"name":"Department of Epidemiology Harvard T.H. Chan School of Public Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1458-7642","authenticated-orcid":false,"given":"Sonia","family":"Hernandez\u2010Diaz","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard T.H. Chan School of Public Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6293-3429","authenticated-orcid":false,"given":"Diego F.","family":"Wyszynski","sequence":"additional","affiliation":[{"name":"Pregistry  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,2,15]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41467\u2010022\u201033937\u2010y"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lanepe.2022.100410"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2104983"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm11061698"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471\u20100528.16969"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2021.08.054"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010021\u201092357\u2010y"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7047e1"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.33273"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2022.05.020"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.whi.2022.06.004"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10654\u2010021\u201000728\u20106"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2113891"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010022\u201001271\u20103"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kws393"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/00001648-199101000-00006"},{"key":"e_1_2_11_18_1","unstructured":"CDC.Pregnant and recently pregnant people. Centers for disease control and prevention. Published October 25 2022. Accessed November 7 2022.https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/need-extra-precautions\/pregnant-people.html"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.2459"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.13816"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwac011"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5600","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5600","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5600","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,18]],"date-time":"2023-08-18T01:08:28Z","timestamp":1692320908000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5600"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,15]]},"references-count":20,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,6]]}},"alternative-id":["10.1002\/pds.5600"],"URL":"https:\/\/doi.org\/10.1002\/pds.5600","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,15]]},"assertion":[{"value":"2022-11-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-02-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-02-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}