{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T16:04:38Z","timestamp":1793117078980,"version":"4.5.0"},"reference-count":32,"publisher":"American Medical Association (AMA)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2024,2,6]]},"abstract":"<jats:sec id=\"ab-joi230158-4\">\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>Better knowledge about neonatal adverse events after COVID-19 vaccination during pregnancy could help address concerns about vaccine safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-joi230158-5\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the risks of neonatal adverse events after exposure to COVID-19 vaccination during pregnancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-joi230158-6\">\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>Population-based cohort study including all infants in Sweden and Norway born from June 2021 to January 2023. Unique personal identity numbers were used to link individual information from different national registers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-joi230158-7\">\n                    <jats:title>Exposure<\/jats:title>\n                    <jats:p>Administration of any mRNA vaccine against COVID-19 during pregnancy, irrespective of previous vaccination, number of doses during pregnancy, or vaccine manufacturer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-joi230158-8\">\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>Outcomes were neonatal conditions with bleeding\/thrombosis or inflammation\/infection; disorders of the central nervous system; circulatory, respiratory, or gastrointestinal problems; and neonatal mortality. Statistical methods included logistic regression adjusted for characteristics of the pregnant individuals, with additional restricted and stratified analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-joi230158-9\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 196 470 newborn infants included (51.3% male, 93.8% born at term, 62.5% born in Sweden), 94 303 (48.0%) were exposed to COVID-19 vaccination during pregnancy. Exposed infants exhibited no increased odds of adverse neonatal outcomes, and they exhibited lower odds for neonatal nontraumatic intracranial hemorrhage (event rate, 1.7 vs 3.2\/1000; adjusted odds ratio [aOR], 0.78 [95% CI, 0.61-0.99]), hypoxic-ischemic encephalopathy (1.8 vs 2.7\/1000; aOR, 0.73 [95% CI, 0.55-0.96]), and neonatal mortality (0.9 vs 1.8\/1000; aOR, 0.68 [95% CI, 0.50-0.91]). Subgroup analyses found a similar association between vaccination during pregnancy and lower neonatal mortality; subgroups were restricted to infants delivered by individuals unvaccinated before pregnancy, individuals vaccinated before pregnancy, individuals vaccinated after a general recommendation of vaccination during pregnancy was issued, and individuals without COVID-19 infection during pregnancy. Analyses restricted to term infants, singleton births, or infants without birth defects yielded similar results. Stratifying the analysis by vaccine manufacturer did not attenuate the association between vaccination and low neonatal mortality.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-joi230158-10\">\n                    <jats:title>Conclusions and Relevance<\/jats:title>\n                    <jats:p>In this large population-based study, vaccination of pregnant individuals with mRNA COVID-19 vaccines was not associated with increased risks of neonatal adverse events in their infants.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jama.2023.26945","type":"journal-article","created":{"date-parts":[[2024,2,6]],"date-time":"2024-02-06T12:55:10Z","timestamp":1707224110000},"page":"396","source":"Crossref","is-referenced-by-count":49,"title":["Neonatal Outcomes After COVID-19 Vaccination in Pregnancy"],"prefix":"10.1001","volume":"331","author":[{"given":"Mikael","family":"Norman","sequence":"first","affiliation":[{"name":"Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Neonatal Medicine, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria C.","family":"Magnus","sequence":"additional","affiliation":[{"name":"Centre for Fertility and Health, Norwegian Institute of Public Health, Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonas","family":"S\u00f6derling","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petur B.","family":"Juliusson","sequence":"additional","affiliation":[{"name":"Department of Clinical Science, University of Bergen, Bergen, Norway"},{"name":"Department of Health Registry Research and Development, Norwegian Institute of Public Health, Bergen, Norway"},{"name":"Department of Paediatric and Adolescent Medicine, Haukeland University Hospital, Bergen, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Nav\u00e9r","sequence":"additional","affiliation":[{"name":"Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Neonatal Medicine, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne K.","family":"\u00d6rtqvist","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Obstetrics and Gynecology, Visby County Hospital, Visby, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siri","family":"H\u00e5berg","sequence":"additional","affiliation":[{"name":"Centre for Fertility and Health, Norwegian Institute of Public Health, Oslo, Norway"},{"name":"Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olof","family":"Stephansson","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Women\u2019s Health, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"3","key":"joi230158r1","doi-asserted-by":"publisher","DOI":"10.1002\/rmv.v33.3","article-title":"Effects of COVID-19 vaccination during pregnancy on SARS-CoV-2 infection and maternal and neonatal outcomes: a systematic review and meta-analysis.","volume":"33","author":"Rahmati","year":"2023","journal-title":"Rev Med Virol"},{"issue":"8","key":"joi230158r2","doi-asserted-by":"publisher","first-page":"825","DOI":"10.1001\/jamainternmed.2022.2442","article-title":"Association of COVID-19 vaccination during pregnancy with incidence of SARS-CoV-2 infection in infants.","volume":"182","author":"Carlsen","year":"2022","journal-title":"JAMA Intern Med"},{"issue":"20","key":"joi230158r5","doi-asserted-by":"publisher","first-page":"2076","DOI":"10.1001\/jama.2021.5775","article-title":"Association of maternal SARS-CoV-2 infection in pregnancy with neonatal outcomes.","volume":"325","author":"Norman","year":"2021","journal-title":"JAMA"},{"issue":"5","key":"joi230158r6","doi-asserted-by":"publisher","first-page":"619","DOI":"10.1159\/000526313","article-title":"Infants born to mothers who were SARS-CoV-2 positive during pregnancy and admitted to neonatal intensive care unit.","volume":"119","author":"Shah","year":"2022","journal-title":"Neonatology"},{"issue":"1","key":"joi230158r7","doi-asserted-by":"publisher","first-page":"894","DOI":"10.1038\/s41467-023-36547-4","article-title":"Maternal SARS-CoV-2 vaccination and infant protection against SARS-CoV-2 during the first six months of life.","volume":"14","author":"Zerbo","year":"2023","journal-title":"Nat Commun"},{"issue":"4","key":"joi230158r8","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.7430","article-title":"Attitudes and beliefs associated with COVID-19 vaccination during pregnancy.","volume":"5","author":"Cui","year":"2022","journal-title":"JAMA Netw Open"},{"issue":"1","key":"joi230158r9","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1186\/s12884-021-04321-3","article-title":"Women\u2019s views on accepting COVID-19 vaccination during and after pregnancy, and for their babies: a multi-methods study in the UK.","volume":"22","author":"Skirrow","year":"2022","journal-title":"BMC Pregnancy Childbirth"},{"issue":"15","key":"joi230158r10","doi-asserted-by":"publisher","first-page":"1469","DOI":"10.1001\/jama.2022.3271","article-title":"Association of SARS-CoV-2 vaccination during pregnancy with pregnancy outcomes.","volume":"327","author":"Magnus","year":"2022","journal-title":"JAMA"},{"issue":"5","key":"joi230158r11","doi-asserted-by":"publisher","first-page":"470","DOI":"10.1001\/jamapediatrics.2022.0001","article-title":"Association of BNT162b2 COVID-19 vaccination during pregnancy with neonatal and early infant outcomes.","volume":"176","author":"Goldshtein","year":"2022","journal-title":"JAMA Pediatr"},{"issue":"12","key":"joi230158r12","doi-asserted-by":"publisher","first-page":"1314","DOI":"10.1001\/jamapediatrics.2023.4499","article-title":"Newborn and early infant outcomes following maternal COVID-19 vaccination during pregnancy.","volume":"177","author":"Jorgensen","year":"2023","journal-title":"JAMA Pediatr"},{"issue":"1","key":"joi230158r13","doi-asserted-by":"publisher","first-page":"5275","DOI":"10.1038\/s41467-023-40965-9","article-title":"Neonatal and maternal outcomes following SARS-CoV-2 infection and COVID-19 vaccination: a population-based matched cohort study.","volume":"14","author":"Lindsay","year":"2023","journal-title":"Nat Commun"},{"issue":"1","key":"joi230158r14","doi-asserted-by":"publisher","first-page":"2414","DOI":"10.1038\/s41467-022-30052-w","article-title":"Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy.","volume":"13","author":"Prasad","year":"2022","journal-title":"Nat Commun"},{"issue":"4","key":"joi230158r16","doi-asserted-by":"publisher","first-page":"466","DOI":"10.1111\/aogs.2018.97.issue-4","article-title":"The Swedish Pregnancy Register: for quality of care improvement and research.","volume":"97","author":"Stephansson","year":"2018","journal-title":"Acta Obstet Gynecol Scand"},{"issue":"8","key":"joi230158r17","doi-asserted-by":"publisher","first-page":"1411","DOI":"10.1111\/apa.2019.108.issue-8","article-title":"The Swedish Neonatal Quality Register: contents, completeness and validity.","volume":"108","author":"Norman","year":"2019","journal-title":"Acta Paediatr"},{"key":"joi230158r20","doi-asserted-by":"publisher","first-page":"g6572","DOI":"10.1136\/bmj.g6572","article-title":"Maternal overweight and obesity in early pregnancy and risk of infant mortality: a population based cohort study in Sweden.","volume":"349","author":"Johansson","year":"2014","journal-title":"BMJ"},{"issue":"3","key":"joi230158r21","doi-asserted-by":"publisher","DOI":"10.1002\/rmv.v32.3","article-title":"Coronavirus disease 2019 (COVID-19) vaccination recommendations in special populations and patients with existing comorbidities.","volume":"32","author":"Mohseni Afshar","year":"2022","journal-title":"Rev Med Virol"},{"issue":"1","key":"joi230158r22","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1038\/s41541-022-00569-8","article-title":"Understanding thrombosis with thrombocytopenia syndrome after COVID-19 vaccination.","volume":"7","author":"Buoninfante","year":"2022","journal-title":"NPJ Vaccines"},{"issue":"12","key":"joi230158r23","doi-asserted-by":"publisher","first-page":"1169","DOI":"10.7326\/M22-2274","article-title":"Incidence of myocarditis\/pericarditis following mRNA COVID-19 vaccination among children and younger adults in the United States.","volume":"175","author":"Goddard","year":"2022","journal-title":"Ann Intern Med"},{"issue":"1","key":"joi230158r25","doi-asserted-by":"publisher","first-page":"4422","DOI":"10.1038\/s41467-022-32188-1","article-title":"Evaluation of transplacental transfer of mRNA vaccine products and functional antibodies during pregnancy and infancy.","volume":"13","author":"Prahl","year":"2022","journal-title":"Nat Commun"},{"issue":"9","key":"joi230158r26","doi-asserted-by":"publisher","DOI":"10.1016\/j.isci.2023.107549","article-title":"Minimal mRNA uptake and inflammatory response to COVID-19 mRNA vaccine exposure in human placental explants.","volume":"26","author":"Gonzalez","year":"2023","journal-title":"iScience"},{"issue":"21","key":"joi230158r27","doi-asserted-by":"publisher","first-page":"2008","DOI":"10.1056\/NEJMc2114466","article-title":"COVID-19 vaccination during pregnancy and first-trimester miscarriage.","volume":"385","author":"Magnus","year":"2021","journal-title":"N Engl J Med"},{"key":"joi230158r28","doi-asserted-by":"publisher","DOI":"10.1136\/bmjph-2023-000314","article-title":"Infection with SARS-CoV-2 during pregnancy and risk of stillbirth: a Scandinavian registry study.","volume":"1","author":"Magnus","year":"2023","journal-title":"BMJ Public Health"},{"key":"joi230158r29","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2022-071416","article-title":"Risk of preterm birth, small for gestational age at birth, and stillbirth after COVID-19 vaccination during pregnancy: population based retrospective cohort study.","volume":"378","author":"Fell","year":"2022","journal-title":"BMJ"},{"issue":"3","key":"joi230158r30","doi-asserted-by":"publisher","first-page":"406","DOI":"10.1002\/ijgo.v156.3","article-title":"Systematic review of the safety, immunogenicity, and effectiveness of COVID-19 vaccines in pregnant and lactating individuals and their infants.","volume":"156","author":"Fu","year":"2022","journal-title":"Int J Gynaecol Obstet"},{"issue":"2","key":"joi230158r31","doi-asserted-by":"publisher","first-page":"248","DOI":"10.1111\/bjo.v129.2","article-title":"COVID-19 vaccination during the third trimester of pregnancy: rate of vaccination and maternal and neonatal outcomes, a multicentre retrospective cohort study.","volume":"129","author":"Rottenstreich","year":"2022","journal-title":"BJOG"},{"issue":"6","key":"joi230158r32","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajogmf.2021.100467","article-title":"Pregnancy and birth outcomes after SARS-CoV-2 vaccination in pregnancy.","volume":"3","author":"Theiler","year":"2021","journal-title":"Am J Obstet Gynecol MFM"},{"key":"joi230158r3","unstructured":"European Medicines Agency. Safety of COVID-19 vaccines. Accessed July 25, 2023. https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/public-health-threats\/coronavirus-disease-covid-19\/covid-19-medicines\/safety-covid-19-vaccines#suspected-side-effects-section"},{"key":"joi230158r4","unstructured":"UK National Health Service. COVID-19 vaccines side effects and safety. Accessed July 25, 2023. https:\/\/www.nhs.uk\/conditions\/covid-19\/covid-19-vaccination\/covid-19-vaccines-side-effects-and-safety\/"},{"key":"joi230158r15","unstructured":"European Surveillance of Congenital Anomalies. EUROCAT subgroups of congenital anomalies (version 2014; implemented in EDMP December 2014, used for website prevalence tables from December 2014). Accessed July 26, 2023. https:\/\/eu-rd-platform.jrc.ec.europa.eu\/sites\/default\/files\/Section%203.3-%2027_Oct2016.pdf"},{"key":"joi230158r18","unstructured":"Norwegian Institute of Public Health. Emergency Preparedness Register for COVID-19 (Beredt C19). Accessed July 26, 2023. https:\/\/www.fhi.no\/en\/id\/corona\/coronavirus\/emergency-preparedness-register-for-covid-19\/"},{"key":"joi230158r19","unstructured":"Centers for Disease Control and Prevention. Possible side effects after getting a COVID-19 vaccine. Accessed July 25, 2023. https:\/\/archive.cdc.gov\/#\/details?url=https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/vaccines\/expect\/after.html"},{"key":"joi230158r24","unstructured":"EURO-PERISTAT. European Perinatal Health Report, 2015-2019. Accessed July 26, 2023. https:\/\/www.europeristat.com\/index.php\/reports\/ephr-2019.html"}],"container-title":["JAMA"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jama\/articlepdf\/2814537\/jama_norman_2024_oi_230158_1706898129.33303.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,6]],"date-time":"2024-02-06T12:55:15Z","timestamp":1707224115000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2814537"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,6]]},"references-count":32,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,2,6]]}},"URL":"https:\/\/doi.org\/10.1001\/jama.2023.26945","relation":{},"ISSN":["0098-7484"],"issn-type":[{"value":"0098-7484","type":"print"}],"subject":[],"published":{"date-parts":[[2024,2,6]]}}}