{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T23:14:49Z","timestamp":1780701289446,"version":"3.54.1"},"reference-count":23,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n SARS-CoV-2 vaccines are authorized for use in most age groups. The safety of SARS-CoV-2 vaccines is unknown in children younger than 5 years.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To retrospectively evaluate the safety of the BNT162b2 vaccine used off-label in children younger than 5 years compared with the safety of non\u2013SARS-CoV-2 vaccines in the same sample.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This investigator-initiated retrospective cohort study included parents or caregivers who registered children for SARS-CoV-2 vaccination in outpatient care facilities in Germany. The study was performed as an authenticated online survey. A total of 19\u202f000 email addresses were contacted from vaccination registration databases between April 14 and May 9, 2022. Inclusion criteria were child age younger than 5 years at the first BNT162b2 vaccination and use of a correct authentication code to prove invitation.<\/jats:p>\n <\/jats:sec>\n \n Exposures<\/jats:title>\n Off-label BNT162b2 vaccination and on-label non\u2013SARS-CoV-2 vaccinations.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Reported short-term safety data of 1 to 3 doses of 3 to 10 \u03bcg BNT162b2 in children from birth to younger than 60 months are presented. Coprimary outcomes were the frequencies of 11 categories of symptoms after vaccination with bivariate analyses and regression models adjusting for age, sex, weight, and height.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The study included 7806 children (median age, 3 years [IQR, 2-4 years]; 3824 [49.0%] female) who were followed up of for a mean (SD) of 91.4 (38.8) days since first BNT162b2 vaccination (survey response rate, 41.1%). A 10-\u03bcg dosage was more frequently associated with local injection-site symptoms compared with lower dosages. In the active-comparator analysis, the probability of any symptoms (odds ratio [OR], 1.62; 95% CI, 1.43-1.84), local symptoms (OR, 1.68; 95% CI, 1.38-2.05), musculoskeletal symptoms (OR, 2.55; 95% CI, 1.32-4.94), dermatologic symptoms (OR, 2.18; 95% CI, 10.7-4.45), or otolaryngologic symptoms (OR, 6.37; 95% CI, 1.50-27.09) were modestly elevated after BNT162b2 compared with non\u2013SARS-CoV-2 vaccines, whereas the probabilities of general symptoms (OR, 0.77; 95% CI, 0.63-0.95) and fever (OR, 0.42; 95% CI, 0.32-0.55) were lower after BNT162b2. Symptoms requiring hospitalization (n\u2009=\u200910) were reported only at BNT162b2 dosages above 3 \u03bcg.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this cohort study, the symptoms reported after BNT162b2 administration were comparable overall to those for on-label non\u2013SARS-CoV-2 vaccines in this cohort of children younger than 5 years. The present data may be used together with prospective licensure studies of BNT162b2 efficacy and safety and could help guide expert recommendations about BNT162b2 vaccinations in this age group.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2022.37140","type":"journal-article","created":{"date-parts":[[2022,10,18]],"date-time":"2022-10-18T11:28:29Z","timestamp":1666092509000},"page":"e2237140","source":"Crossref","is-referenced-by-count":17,"title":["Comparative Safety of the BNT162b2 Messenger RNA COVID-19 Vaccine vs Other Approved Vaccines in Children Younger Than 5 Years"],"prefix":"10.1001","volume":"5","author":[{"given":"Nicole","family":"Toepfner","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universit\u00e4t Dresden, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfgang C. G.","family":"von Mei\u00dfner","sequence":"additional","affiliation":[{"name":"Haus\u00e4rzte am Spritzenhaus, Family Practice, Baiersbronn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Strumann","sequence":"additional","affiliation":[{"name":"Institute of Family Medicine, University Hospital Schleswig-Holstein, Campus Luebeck, Luebeck, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denisa","family":"Drinka","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universit\u00e4t Dresden, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Stuppe","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University Medical Center Rostock, University of Rostock, Rostock, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian","family":"Jorczyk","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universit\u00e4t Dresden, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeanne","family":"Moor","sequence":"additional","affiliation":[{"name":"Department of General Internal Medicine, Inselspital University Hospital Bern, Bern, Switzerland"},{"name":"Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"P\u00fcschel","sequence":"additional","affiliation":[{"name":"Hausarztzentrum Greven, Family Practice, Greven, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Liss","sequence":"additional","affiliation":[{"name":"Praxis f\u00fcr Kinder- und Jugendmedizin, D\u00fcsseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilie","family":"von Poblotzki","sequence":"additional","affiliation":[{"name":"Praxis die Kinderaerzte, M\u00fcnchen, Deutschland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reinhard","family":"Berner","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universit\u00e4t Dresden, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias B.","family":"Moor","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Hypertension, Inselspital University Hospital Bern, Bern, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cho-Ming","family":"Chao","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University Medical Center Rostock, University of Rostock, Rostock, Germany"},{"name":"Cardio-Pulmonary Institute, Universities of Giessen and Marburg Lung Center, member of the German Center for Lung Research, Justus Liebig University Giessen, Giessen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2022,10,18]]},"reference":[{"issue":"6","key":"zoi221053r1","doi-asserted-by":"publisher","first-page":"604","DOI":"10.1056\/NEJMc2118775","article-title":"BNT162b2 Covid-19 vaccine in children 5 to 11 years of age.","volume":"386","author":"Fang","year":"2022","journal-title":"N Engl J Med"},{"issue":"1","key":"zoi221053r2","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1056\/NEJMoa2116298","article-title":"Evaluation of the BNT162b2 Covid-19 vaccine in children 5 to 11 years of age.","volume":"386","author":"Walter","year":"2022","journal-title":"N Engl J Med"},{"issue":"3","key":"zoi221053r3","doi-asserted-by":"publisher","first-page":"239","DOI":"10.1056\/NEJMoa2107456","article-title":"Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents.","volume":"385","author":"Frenck","year":"2021","journal-title":"N Engl J Med"},{"issue":"3","key":"zoi221053r4","doi-asserted-by":"publisher","first-page":"227","DOI":"10.1056\/NEJMoa2205011","article-title":"BNT162b2 vaccine effectiveness against omicron in children 5 to 11 years of age.","volume":"387","author":"Cohen-Stavi","year":"2022","journal-title":"N Engl J Med"},{"issue":"6","key":"zoi221053r5","doi-asserted-by":"publisher","first-page":"525","DOI":"10.1056\/NEJMoa2203209","article-title":"Effectiveness of BNT162b2 vaccine against omicron in children 5 to 11 years of age.","volume":"387","author":"Tan","year":"2022","journal-title":"N Engl J Med"},{"issue":"20","key":"zoi221053r17","doi-asserted-by":"publisher","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.","volume":"310","author":"World Medical Association","year":"2013","journal-title":"JAMA"},{"issue":"2","key":"zoi221053r18","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap): a metadata-driven methodology and workflow process for providing translational research informatics support.","volume":"42","author":"Harris","year":"2009","journal-title":"J Biomed Inform"},{"issue":"4","key":"zoi221053r19","doi-asserted-by":"publisher","first-page":"324","DOI":"10.1590\/S0100-879X2008000400011","article-title":"Defensive responses to threat scenarios in Brazilians reproduce the pattern of Hawaiian Americans and non-human mammals.","volume":"41","author":"Shuhama","year":"2008","journal-title":"Braz J Med Biol Res"},{"issue":"3","key":"zoi221053r23","doi-asserted-by":"publisher","first-page":"186","DOI":"10.1542\/hpeds.2018-0168","article-title":"Off-label medication prescribing patterns in pediatrics: an update.","volume":"9","author":"Yackey","year":"2019","journal-title":"Hosp Pediatr"},{"key":"zoi221053r6","unstructured":"Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY | Pfizer. Accessed August 20, 2022. https:\/\/www.pfizer.com\/news\/announcements\/pfizer-and-biontech-submit-variation-ema-vaccination-children-6-months-less-than-5-years"},{"key":"zoi221053r7","unstructured":"US Food and Drug Administration. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. Published July 13, 2022. Accessed August 20, 2022. https:\/\/www.fda.gov\/emergency-preparedness-and-response\/coronavirus-disease-2019-covid-19\/comirnaty-and-pfizer-biontech-covid-19-vaccine"},{"key":"zoi221053r8","unstructured":"Christmann? K. Neues Portal will Impfungen f\u00fcr unter Zw\u00f6lfj\u00e4hrige bef\u00f6rdern. Der Tagesspiegel Online. Published November 21, 2021. Accessed May 11, 2022. https:\/\/www.tagesspiegel.de\/wissen\/kontaktanbahnung-und-beratung-neues-portal-will-impfungen-fuer-unter-zwoelfjaehrige-befoerdern\/27819890.html"},{"key":"zoi221053r9","unstructured":"Heroisch, leichtsinnig oder einfach das Richtige?: Deshalb impfen \u00c4rzte schon jetzt Kinder unter zw\u00f6lf Jahren gegen Corona. Published July 31, 2021. Accessed May 11, 2022. https:\/\/plus.tagesspiegel.de\/wissen\/heroisch-oder-leichtsinnig-warum-manche-aerzte-jetzt-schon-kleine-kinder-gegen-corona-impfen-201203.html"},{"key":"zoi221053r10","unstructured":"Aktuell? SWR. \u00c4rzte in Baiersbronn haben schon 900 Kinder gegen Corona geimpft. swr.online. Accessed May 11, 2022. https:\/\/www.swr.de\/swraktuell\/baden-wuerttemberg\/tuebingen\/baiersbronner-aerzte-impfen-kinder-seit-langem-gegen-corona-100.html"},{"key":"zoi221053r11","unstructured":"Delay in COVID-19 vaccines for kids upset parents. Experts say it was the right thing to do. USA Today. Accessed May 11, 2022. https:\/\/www.usatoday.com\/story\/news\/2022\/02\/21\/pfizer-covid-vaccine-kids-under-5-fda-delay\/6789369001\/"},{"key":"zoi221053r12","unstructured":"Off-Label-Use \u2013 Verordnungsf\u00e4higkeit von Arzneimitteln in nicht zugelassenen Anwendungsbieten - Gemeinsamer Bundesausschuss. Accessed May 11, 2022. https:\/\/www.g-ba.de\/themen\/arzneimittel\/arzneimittel-richtlinie-anlagen\/off-label-use\/"},{"key":"zoi221053r13","unstructured":"Schutzimpfungen au\u00dferhalb der Zulassung (Off-Label-Use). Deutsches Gr\u00fcnes Kreuz f\u00fcr Gesundheit e.V. Accessed May 11, 2022. https:\/\/dgk.de\/fachleute\/dgk-fachnewsletter\/schutzimpfungen-ausserhalb-der-zulassung-off-label-use.html"},{"key":"zoi221053r14","unstructured":"Rodeck? B. 7. Stellungnahme des ExpertInnenrates der Bundesregierung zu COVID-19. Published February 17, 2022. Accessed September 10, 2022. https:\/\/www.bundesregierung.de\/resource\/blob\/974430\/2006266\/47d5893828bc9d1ab4d07ed41b7cb078\/2022-02-17-siebte-stellungnahme-expertenrat-data.pdf?download=1"},{"key":"zoi221053r15","unstructured":"Corona-ExpertInnenrat | Bundesregierung. Webseite der Bundesregierung | Startseite. Accessed May 5, 2022. https:\/\/www.bundesregierung.de\/breg-de\/bundesregierung\/bundeskanzleramt\/corona-expertinnenrat-der-bundesregierung"},{"key":"zoi221053r16","unstructured":"German Clinical Trials Register. Survey of side effects after vaccination (Comirnaty, BNT162b2) against COVID-19 in children below 5 Years in Germany. DRKS00028759. Accessed September 9, 2022. https:\/\/www.drks.de\/drks_web\/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00028759"},{"key":"zoi221053r20","unstructured":"DocCheck | Praxis COMIRNATY. Accessed May 13, 2022. https:\/\/praxis.comirnaty.de\/de\/public\/login.html?destination=\/content\/comirnaty\/de\/de\/auth\/chargennummern-abfrage"},{"key":"zoi221053r21","unstructured":"ClinicalTrials.gov. Phase 1, Open-Label Dose-Finding Study to Evaluate Safety, Tolerability, and Immunogenicity and Phase 2\/3 Placebo-Controlled, Observer-Blinded Safety, Tolerability, and Immunogenicity Study of a SARS-CoV-2 RNA Vaccine Candidate Against Covid-19 in Healthy Children and Young Adults. NCT04816643. Accessed April 19, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04816643"},{"key":"zoi221053r22","unstructured":"Paul-Ehrlich-Institut. Coronavirus und COVID-19 - Sicherheit von COVID-19-Impfstoffen. Accessed May 10, 2022. https:\/\/www.pei.de\/DE\/newsroom\/dossier\/coronavirus\/arzneimittelsicherheit.html"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2797451\/toepfner_2022_oi_221053_1665165481.06107.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,18]],"date-time":"2022-10-18T11:28:34Z","timestamp":1666092514000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2797451"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,10,18]]},"references-count":23,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2022,10,3]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2022.37140","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2022.05.17.22275005","asserted-by":"object"}]},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,18]]}}}