{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T08:35:08Z","timestamp":1768552508186,"version":"3.49.0"},"posted":{"date-parts":[[2021,6,6]]},"group-title":"Obstetrics and Gynecology","reference-count":85,"publisher":"openRxiv","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2021,6,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Pregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a rapid systematic review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO-CRD42021234185).<\/jats:p>\n                  <jats:p>We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period.<\/jats:p>\n                  <jats:p>Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included.<\/jats:p>\n                  <jats:p>Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures during the three trimesters of pregnancy.<\/jats:p>\n                  <jats:p>The most frequent exposure was to AS03 adjuvant in the context of A\/H1N1 pandemic influenza vaccines (n=24), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) COVID-19 vaccines that also used lipid nanoparticles. Except for one preliminary report about A\/H1N1 influenza vaccination (adjuvant AS03) - corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted given their novelty. Our findings support current WHO guidelines recommending that pregnant women may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.<\/jats:p>\n                <\/jats:sec>","DOI":"10.1101\/2021.06.03.21258283","type":"posted-content","created":{"date-parts":[[2021,6,7]],"date-time":"2021-06-07T00:00:37Z","timestamp":1623024037000},"source":"Crossref","is-referenced-by-count":4,"title":["Safety of COVID-19 vaccines, their components or their platforms for pregnant women: A rapid review"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5142-6122","authenticated-orcid":false,"given":"Agust\u00edn","family":"Ciapponi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4437-0073","authenticated-orcid":false,"given":"Ariel","family":"Bardach","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Agustina","family":"Mazzoni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tom\u00e1s","family":"Alconada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"Anderson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2492-8933","authenticated-orcid":false,"given":"Fernando J.","family":"Argento","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2495-8040","authenticated-orcid":false,"given":"Jamile","family":"Ballivian","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"Bok","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7111-5169","authenticated-orcid":false,"given":"Daniel","family":"Comand\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily","family":"Erbelding","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5730-023X","authenticated-orcid":false,"given":"Erin","family":"Goucher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6546-4709","authenticated-orcid":false,"given":"Beate","family":"Kampmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruth","family":"Karron","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0457-7689","authenticated-orcid":false,"given":"Flor M.","family":"Munoz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda Carolina","family":"Palermo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5847-109X","authenticated-orcid":false,"given":"Edward P. K.","family":"Parker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3029-4439","authenticated-orcid":false,"given":"Federico","family":"Rodriguez Cairoli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda Victoria","family":"Santa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0057-6627","authenticated-orcid":false,"given":"Andy","family":"Stergachis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerald","family":"Voss","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9292-5059","authenticated-orcid":false,"given":"Xu","family":"Xiong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalia","family":"Zamora","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabra","family":"Zaraa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7915-5643","authenticated-orcid":false,"given":"Mabel","family":"Berrueta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4294-8559","authenticated-orcid":false,"given":"Pierre M.","family":"Buekens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"54368","reference":[{"key":"2021060821150984000_2021.06.03.21258283v1.1","doi-asserted-by":"crossref","unstructured":"Eccleston-Turner M , Upton H. International Collaboration to Ensure Equitable Access to Vaccines for COVID-19: The ACT-Accelerator and the COVAX Facility. Milbank Q. 2021.","DOI":"10.1111\/1468-0009.12503"},{"key":"2021060821150984000_2021.06.03.21258283v1.2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m4853"},{"key":"2021060821150984000_2021.06.03.21258283v1.3","doi-asserted-by":"crossref","first-page":"941","DOI":"10.1016\/S0140-6736(21)00617-6","article-title":"Access to COVID-19 vaccines: looking beyond COVAX","volume":"397","year":"2021","journal-title":"Lancet"},{"key":"2021060821150984000_2021.06.03.21258283v1.4","doi-asserted-by":"crossref","unstructured":"Gray KJ , Bordt EA , Atyeo C , Deriso E , Akinwunmi B , Young N , et al. COVID-19 vaccine response in pregnant and lactating women: a cohort study. medRxiv : the preprint server for health sciences. 2021.","DOI":"10.1101\/2021.03.07.21253094"},{"key":"2021060821150984000_2021.06.03.21258283v1.5","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m3320"},{"key":"2021060821150984000_2021.06.03.21258283v1.6","doi-asserted-by":"crossref","unstructured":"Figueiro-Filho EA , Yudin M , Farine D. COVID-19 during pregnancy: an overview of maternal characteristics, clinical symptoms, maternal and neonatal outcomes of 10,996 cases described in 15 countries. J Perinat Med. 2020.","DOI":"10.1515\/jpm-2020-0364"},{"key":"2021060821150984000_2021.06.03.21258283v1.7","doi-asserted-by":"crossref","unstructured":"Vergara-Merino L , Meza N , Couve-Perez C , Carrasco C , Ortiz-Munoz L , Madrid E , et al. Maternal and perinatal outcomes related to COVID-19 and pregnancy: overview of systematic reviews. Acta Obstet Gynecol Scand. 2021.","DOI":"10.1111\/aogs.14118"},{"key":"2021060821150984000_2021.06.03.21258283v1.8","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6944e3"},{"key":"2021060821150984000_2021.06.03.21258283v1.9","doi-asserted-by":"crossref","unstructured":"Ciapponi A , Bardach A , Comand\u00e9 D , Berrueta M , Argento FJ , Cairoli FR , et al. COVID-19 and pregnancy: An umbrella review of clinical presentation, vertical transmission, and maternal and perinatal outcomes. medRxiv. 2021.2021.04.29.21256327.","DOI":"10.1101\/2021.04.29.21256327"},{"key":"2021060821150984000_2021.06.03.21258283v1.10","doi-asserted-by":"crossref","unstructured":"Higgins J , Thomas J , Chandler J, MS. C , Li T , Page M , et al. Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated August 2019). Cochrane, 2019. In: Cochrane, editor.2019.","DOI":"10.1002\/9781119536604"},{"key":"2021060821150984000_2021.06.03.21258283v1.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2020.10.007"},{"key":"2021060821150984000_2021.06.03.21258283v1.12","doi-asserted-by":"crossref","first-page":"e1003583","DOI":"10.1371\/journal.pmed.1003583","article-title":"The PRISMA 2020 statement: An updated guideline for reporting systematic reviews","volume":"18","year":"2021","journal-title":"PLoS Med"},{"key":"2021060821150984000_2021.06.03.21258283v1.13","doi-asserted-by":"publisher","DOI":"10.1002\/pds.851"},{"key":"2021060821150984000_2021.06.03.21258283v1.14","unstructured":"CBER-FDA. Guidance for Industry -Toxicity Grading Scale or Healthy Adult and Adolescent-Volunteers Enrolled in Preventive Vaccine Clinical Trials. In: Services USDoHaH, Administration F-FaD, Research C-CfBEa, editors. 2007."},{"key":"2021060821150984000_2021.06.03.21258283v1.15","unstructured":"EMA. ICH Topic E 2 A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting EMA - European Medical Agency; 1995."},{"key":"2021060821150984000_2021.06.03.21258283v1.16","doi-asserted-by":"crossref","first-page":"259","DOI":"10.2165\/00124363-200418050-00001","article-title":"Medical Dictionary for Regulatory Activities (MedDRA)","volume":"18","year":"2004","journal-title":"International Journal of Pharmaceutical Medicine"},{"key":"2021060821150984000_2021.06.03.21258283v1.17","unstructured":"Covidence systematic review software. Melbourne, Australia: Veritas Health Innovation."},{"key":"2021060821150984000_2021.06.03.21258283v1.18","unstructured":"Higgins J , Green S , (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. In: Cochrane, editor. 2011."},{"key":"2021060821150984000_2021.06.03.21258283v1.19","unstructured":"EPOC EPOoCCG. What study designs should be included in an EPOC review? EPOC Resources for review authors, 2017. 2017."},{"key":"2021060821150984000_2021.06.03.21258283v1.20","unstructured":"NIH. Study Quality Assessment Tools In: NIH National Heart L, and Blood Institute (NHLBI), editor.2020."},{"key":"2021060821150984000_2021.06.03.21258283v1.21","unstructured":"Jan Brozek AO , Holger Sch\u00fcnemann. The GRADE Working Group GRADEpro. 3.2.2 for Windows. Updated March 2009. 2009."},{"key":"2021060821150984000_2021.06.03.21258283v1.22","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2015.07.061"},{"key":"2021060821150984000_2021.06.03.21258283v1.23","doi-asserted-by":"crossref","first-page":"6215","DOI":"10.1016\/j.vaccine.2020.07.041","article-title":"Safety evaluation of adverse events following vaccination with Havrix, Engerix-B or Twinrix during pregnancy","volume":"38","year":"2020","journal-title":"Vaccine"},{"key":"2021060821150984000_2021.06.03.21258283v1.24","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1007\/s40264-013-0030-1","article-title":"The PREGVAXGRIP study: a cohort study to assess foetal and neonatal consequences of in utero exposure to vaccination against A(H1N1)v2009 influenza","volume":"36","year":"2013","journal-title":"Drug safety"},{"key":"2021060821150984000_2021.06.03.21258283v1.25","doi-asserted-by":"crossref","first-page":"e33","DOI":"10.2105\/AJPH.2011.300606","article-title":"H1N1 influenza vaccination during pregnancy and fetal and neonatal outcomes","volume":"102","year":"2012","journal-title":"American journal of public health"},{"key":"2021060821150984000_2021.06.03.21258283v1.26","doi-asserted-by":"crossref","first-page":"1180","DOI":"10.1016\/j.vaccine.2010.12.008","article-title":"Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November 2009-March 2010","volume":"29","year":"2011","journal-title":"Vaccine"},{"key":"2021060821150984000_2021.06.03.21258283v1.27","first-page":"231","article-title":"Active surveillance of adverse effects of Pandemrix vaccine to prevent influenza A(H1N1) in Cuba","volume":"63","year":"2011","journal-title":"Vigilancia activa de eventos adversos a la vacuna Pandemrixpara prevenir la influenza AH1N1 en Cuba"},{"key":"2021060821150984000_2021.06.03.21258283v1.28","first-page":"6488","article-title":"Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs","volume":"33","year":"2015","journal-title":"Special Issue: Advancing maternal immunization programs through research in low and medium income countries"},{"key":"2021060821150984000_2021.06.03.21258283v1.29","doi-asserted-by":"crossref","first-page":"6111","DOI":"10.1016\/j.vaccine.2018.08.074","article-title":"Uptake and safety of Hepatitis B vaccination during pregnancy: a Vaccine Safety Datalink study","volume":"36","year":"2018","journal-title":"Vaccine"},{"key":"2021060821150984000_2021.06.03.21258283v1.30","first-page":"209","article-title":"Efficacy and safety of pandemic influenza vaccine in pregnancy","volume":"21","year":"2010","journal-title":"Canadian Journal of Infectious Diseases and Medical Microbiology"},{"key":"2021060821150984000_2021.06.03.21258283v1.31","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1207210"},{"key":"2021060821150984000_2021.06.03.21258283v1.32","doi-asserted-by":"crossref","first-page":"5530","DOI":"10.1016\/j.vaccine.2009.06.085","article-title":"The first safe inactivated equine influenza vaccine formulation adjuvanted with ISCOM-Matrix that closes the immunity gap","volume":"27","year":"2009","journal-title":"Vaccine"},{"key":"2021060821150984000_2021.06.03.21258283v1.33","doi-asserted-by":"crossref","unstructured":"Jonas F , Peter S , Cecilia L , Sven C , Anders E , \u00d6rtqvist \u00c5 , et al. Maternal vaccination against H1N1 influenza and offspring mortality: Population based cohort study and sibling design. BMJ (Online). 2015;351.","DOI":"10.1136\/bmj.h5585"},{"key":"2021060821150984000_2021.06.03.21258283v1.34","doi-asserted-by":"crossref","first-page":"1583","DOI":"10.1111\/j.1471-0528.2012.03470.x","article-title":"Vaccination against H1N1 influenza with Pandemrix\u00ae during pregnancy and delivery outcome: A Swedish register study","volume":"119","year":"2012","journal-title":"BJOG: An International Journal of Obstetrics and Gynaecology"},{"key":"2021060821150984000_2021.06.03.21258283v1.35","doi-asserted-by":"crossref","unstructured":"Katz N , Neyro S , Carrega MEP , Del Valle Juarez M , Ranca\u00f1o C , Pasinovich M , et al. Maternal immunization in argentina: The importance of a safety profile analysis. Open Forum Infectious Diseases. 2016;3.","DOI":"10.1093\/ofid\/ofw172.598"},{"key":"2021060821150984000_2021.06.03.21258283v1.36","first-page":"469A","article-title":"Safety and immunogenicity of Heplisav-B in pregnancy","volume":"72","year":"2020","journal-title":"Hepatology"},{"key":"2021060821150984000_2021.06.03.21258283v1.37","first-page":"908","article-title":"H1N1 influenza vaccine in pregnant women: French pharmacovigilance survey","volume":"33","year":"2010","journal-title":"Drug Safety"},{"key":"2021060821150984000_2021.06.03.21258283v1.38","unstructured":"L\u00e4kemedelsverket. L\u00e4kemedelsverket. Final summary of adverse drug reaction reports in Sweden with Pandemrix through October 2009-mid April 2010. June 2, 2010. Accessed 23 May 2011 from www.lakemedelsverket.se. 2010."},{"key":"2021060821150984000_2021.06.03.21258283v1.39","first-page":"889","article-title":"Pilot swine flu vaccination active surveillance study: Final results","volume":"34","year":"2011","journal-title":"Drug Safety"},{"key":"2021060821150984000_2021.06.03.21258283v1.40","unstructured":"Levi M. Vaccination against influenza A(H1N1) virus is also safe during pregnancy. Nederlands Tijdschrift voor Geneeskunde. 2012;156."},{"key":"2021060821150984000_2021.06.03.21258283v1.41","doi-asserted-by":"crossref","first-page":"848","DOI":"10.7326\/M16-0139","article-title":"Risk for congenital malformation with H1N1 influenza vaccine: a cohort study with sibling analysis","volume":"165","year":"2016","journal-title":"Annals of Internal Medicine"},{"key":"2021060821150984000_2021.06.03.21258283v1.42","doi-asserted-by":"publisher","DOI":"10.1007\/s10654-013-9813-z"},{"key":"2021060821150984000_2021.06.03.21258283v1.43","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2011.04142.x"},{"key":"2021060821150984000_2021.06.03.21258283v1.44","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1908380"},{"key":"2021060821150984000_2021.06.03.21258283v1.45","doi-asserted-by":"crossref","first-page":"402","DOI":"10.1093\/cid\/ciy517","article-title":"The safety of influenza and pertussis vaccination in pregnancy in a cohort of Australian mother-infant pairs, 2012-2015: the FluMum study","volume":"68","year":"2019","journal-title":"Clinical Infectious Diseases"},{"key":"2021060821150984000_2021.06.03.21258283v1.46","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2013.08.033"},{"key":"2021060821150984000_2021.06.03.21258283v1.47","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1016\/j.vaccine.2017.11.039","article-title":"Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016","volume":"36","year":"2018","journal-title":"Vaccine"},{"key":"2021060821150984000_2021.06.03.21258283v1.48","doi-asserted-by":"crossref","first-page":"1802","DOI":"10.1093\/infdis\/jiz390","article-title":"Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants","volume":"220","year":"2019","journal-title":"J Infect Dis"},{"key":"2021060821150984000_2021.06.03.21258283v1.49","first-page":"209","article-title":"Vaccination against influenza a H1N1 and the risk of birth defects","volume":"19","year":"2010","journal-title":"VacciMonitor"},{"key":"2021060821150984000_2021.06.03.21258283v1.50","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2012.04.081"},{"key":"2021060821150984000_2021.06.03.21258283v1.51","doi-asserted-by":"crossref","unstructured":"Pasternak B , Svanstrom H , Molgaard-Nielsen D , Krause TG , Emborg HD , Melbye M , et al. Vaccination against pandemic A\/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark. BMJ. 2012;344.","DOI":"10.1136\/bmj.e2794"},{"key":"2021060821150984000_2021.06.03.21258283v1.52","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.6131"},{"key":"2021060821150984000_2021.06.03.21258283v1.53","first-page":"137","article-title":"Peripartum outcomes: non-adjuvanted v. adjuvanted H1N1 vaccination","volume":"186","year":"2014","journal-title":"CMAJ : Canadian Medical Association journal = journal de l\u2019Association medicale canadienne"},{"key":"2021060821150984000_2021.06.03.21258283v1.54","first-page":"13","article-title":"Maternal vaccinations in Australia-uptake, safety and impact","volume":"56","year":"2016","journal-title":"Australian and New Zealand Journal of Obstetrics and Gynaecology"},{"key":"2021060821150984000_2021.06.03.21258283v1.55","first-page":"S58","article-title":"Swine flu vaccination in pregnancy and associated miscarriage risk","volume":"20","year":"2011","journal-title":"Pharmacoepidemiology and Drug Safety"},{"key":"2021060821150984000_2021.06.03.21258283v1.56","doi-asserted-by":"crossref","unstructured":"Sammon CJ , Snowball J , McGrogan A , de Vries CS . Evaluating the Hazard of Foetal Death following H1N1 Influenza Vaccination; A Population Based Cohort Study in the UK GPRD. PLoS ONE. 2012;7.","DOI":"10.1371\/journal.pone.0051734"},{"key":"2021060821150984000_2021.06.03.21258283v1.57","doi-asserted-by":"crossref","unstructured":"Stedman A , Wright D , Schreur PJW , Clark MHA , Hill AVS , Gilbert SC , et al. Safety and efficacy of ChAdOx1 RVF vaccine against Rift Valley fever in pregnant sheep and goats. npj Vaccines. 2019;4.","DOI":"10.1038\/s41541-019-0138-0"},{"key":"2021060821150984000_2021.06.03.21258283v1.58","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.04.114"},{"key":"2021060821150984000_2021.06.03.21258283v1.59","unstructured":"COVID-19 vaccine tracker. In: https:\/\/vac-lshtm.shinyapps.io\/ncov_vaccine_landscape\/. Accesed May 20th 2021. Vaccine Centre at the London School of Hygiene & Tropical Medicine; 2021."},{"key":"2021060821150984000_2021.06.03.21258283v1.60","unstructured":"A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19). https:\/\/ClinicalTrials.gov\/show\/NCT04765384; 2021."},{"key":"2021060821150984000_2021.06.03.21258283v1.61","unstructured":"Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older. https:\/\/ClinicalTrials.gov\/show\/NCT04754594; 2021."},{"key":"2021060821150984000_2021.06.03.21258283v1.62","unstructured":"COVID-19: study to detect transfer of SARS-Cov-2 antibodies in breastmilk. https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2021-000893-27\/BE; 2021."},{"key":"2021060821150984000_2021.06.03.21258283v1.63","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciu915"},{"key":"2021060821150984000_2021.06.03.21258283v1.64","first-page":"CD001269","article-title":"Vaccines for preventing influenza in healthy adults","volume":"2","year":"2018","journal-title":"Cochrane Database Syst Rev"},{"key":"2021060821150984000_2021.06.03.21258283v1.65","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.12977"},{"key":"2021060821150984000_2021.06.03.21258283v1.66","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2018.1540807"},{"key":"2021060821150984000_2021.06.03.21258283v1.67","doi-asserted-by":"crossref","first-page":"e0220910","DOI":"10.1371\/journal.pone.0220910","article-title":"Effects of maternal influenza vaccination on adverse birth outcomes: A systematic review and Bayesian meta-analysis","volume":"14","year":"2019","journal-title":"PLoS One"},{"key":"2021060821150984000_2021.06.03.21258283v1.68","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.08.008"},{"key":"2021060821150984000_2021.06.03.21258283v1.69","doi-asserted-by":"publisher","DOI":"10.1055\/s-0036-1586101"},{"key":"2021060821150984000_2021.06.03.21258283v1.70","doi-asserted-by":"crossref","first-page":"1075","DOI":"10.1097\/AOG.0000000000001068","article-title":"Maternal Influenza Vaccination and Risk for Congenital Malformations: A Systematic Review and Meta-analysis","volume":"126","year":"2015","journal-title":"Obstet Gynecol"},{"key":"2021060821150984000_2021.06.03.21258283v1.71","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1002\/ijgo.12394","article-title":"A systematic review and meta-analysis of fetal outcomes following the administration of influenza A\/H1N1 vaccination during pregnancy","volume":"141","year":"2018","journal-title":"Int J Gynaecol Obstet"},{"key":"2021060821150984000_2021.06.03.21258283v1.72","doi-asserted-by":"crossref","first-page":"1","DOI":"10.2165\/11595670-000000000-00000","article-title":"Safety of hepatitis B, pneumococcal polysaccharide and meningococcal polysaccharide vaccines in pregnancy: a systematic review","volume":"35","year":"2012","journal-title":"Drug Saf"},{"key":"2021060821150984000_2021.06.03.21258283v1.73","doi-asserted-by":"crossref","unstructured":"Nasser R , Rakedzon S , Dickstein Y , Mousa A , Solt I , Peterisel N , et al. Are all vaccines safe for the pregnant traveller? A systematic review and meta-analysis. J Travel Med. 2020;27.","DOI":"10.1093\/jtm\/taz074"},{"key":"2021060821150984000_2021.06.03.21258283v1.74","doi-asserted-by":"crossref","unstructured":"Prabhu M , Murphy EA , Sukhu AC , Yee J , Singh S , Eng D , et al. Antibody Response to Coronavirus Disease 2019 (COVID-19) Messenger RNA Vaccination in Pregnant Women and Transplacental Passage Into Cord Blood. Obstet Gynecol. 2021.","DOI":"10.1097\/AOG.0000000000004438"},{"key":"2021060821150984000_2021.06.03.21258283v1.75","doi-asserted-by":"crossref","unstructured":"Shimabukuro TT , Kim SY , Myers TR , Moro PL , Oduyebo T , Panagiotakopoulos L , et al. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med. 2021.","DOI":"10.1097\/01.aoa.0000796052.11696.42"},{"key":"2021060821150984000_2021.06.03.21258283v1.76","doi-asserted-by":"crossref","unstructured":"Rottenstreich A , Zarbiv G , Oiknine-Djian E , Zigron R , Wolf DG , Porat S. Efficient maternofetal transplacental transfer of anti-SARS-CoV-2 spike antibodies after antenatal SARS-CoV-2 BNT162b2 mRNA vaccination. Clin Infect Dis. 2021.","DOI":"10.1101\/2021.03.11.21253352"},{"key":"2021060821150984000_2021.06.03.21258283v1.77","doi-asserted-by":"crossref","unstructured":"Magnus MC , Wilcox AJ , Morken NH , Weinberg CR , Haberg SE . Role of maternal age and pregnancy history in risk of miscarriage: prospective register based study. BMJ. 2019;364:869.","DOI":"10.1136\/bmj.l869"},{"key":"2021060821150984000_2021.06.03.21258283v1.78","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(64)80188-8"},{"key":"2021060821150984000_2021.06.03.21258283v1.79","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(87)80543-7"},{"key":"2021060821150984000_2021.06.03.21258283v1.80","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM197607222950406"},{"key":"2021060821150984000_2021.06.03.21258283v1.81","doi-asserted-by":"crossref","first-page":"1420","DOI":"10.1002\/bdr2.1589","article-title":"National population-based estimates for major birth defects, 2010-2014","volume":"111","year":"2019","journal-title":"Birth Defects Res"},{"key":"2021060821150984000_2021.06.03.21258283v1.82","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j2249"},{"key":"2021060821150984000_2021.06.03.21258283v1.83","first-page":"1725","article-title":"Child Mortality Collaborators. Global, regional, national, and selectedsubnational levels of stillbirths, neonatal, infant, and under-5 mortality, 1980-2015: asystematic analysis for the Global Burden of Disease Study 2015","volume":"388","author":"GBD","year":"2015","journal-title":"Lancet"},{"key":"2021060821150984000_2021.06.03.21258283v1.84","unstructured":"WHO. Status of COVID-19 Vaccines within WHO EUL\/PQ evaluation process. Accessed 12 May 2011 from: https:\/\/extranet.who.int\/pqweb\/sites\/default\/files\/documents\/Status_COVID_VAX_04May2021.pdf. 2021."},{"key":"2021060821150984000_2021.06.03.21258283v1.85","doi-asserted-by":"crossref","first-page":"1725","DOI":"10.1016\/S0140-6736(16)31575-6","article-title":"Global, regional, national, and selected subnational levels of stillbirths, neonatal, infant, and under-5 mortality, 1980&#x2013;2015: a systematic analysis for the Global Burden of Disease Study 2015","volume":"388","year":"2016","journal-title":"The Lancet"}],"container-title":[],"original-title":[],"link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1101\/2021.06.03.21258283","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T14:17:21Z","timestamp":1768486641000},"score":1,"resource":{"primary":{"URL":"http:\/\/medrxiv.org\/lookup\/doi\/10.1101\/2021.06.03.21258283"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6,6]]},"references-count":85,"URL":"https:\/\/doi.org\/10.1101\/2021.06.03.21258283","relation":{"is-preprint-of":[{"id-type":"doi","id":"10.1016\/j.vaccine.2021.08.034","asserted-by":"subject"}]},"subject":[],"published":{"date-parts":[[2021,6,6]]},"subtype":"preprint"}}