{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T20:14:08Z","timestamp":1790108048994,"version":"4.0.1"},"reference-count":29,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,5,6]],"date-time":"2025-05-06T00:00:00Z","timestamp":1746489600000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Active monitoring of health outcomes after COVID\u201019 vaccination provides early detection of rare outcomes post\u2010licensure. We evaluated health outcomes following bivalent COVID\u201019 Pfizer\u2010BioNTech (BNT162b2) and Moderna (mRNA\u20101273.222) vaccination in the United States.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Multiple health outcomes were monitored monthly from August 2022 to July 2023 in four administrative claims databases (CVS Health, Carelon Research, Optum, and Medicare). The study included individuals 6\u2009months and older who received a bivalent COVID\u201019 BNT162b2 or mRNA\u20101273.222 vaccination during the study period and met a minimum continuous enrollment requirement in a medical insurance plan prior to COVID\u201019 vaccination. Descriptive analyses monitored counts of vaccinations, outcomes, and concomitant COVID\u201019 and influenza vaccination. Maximized Sequential Probability Ratio Testing (MaxSPRT) tested for elevations in the observed incidence rate of outcomes post\u2010vaccination compared to annual historical rates estimated from 2019 or 2020, adjusted for claims delay in the observed rate. Where case counts permitted, historical rates were standardized by age and\/or sex for all persons, and race and\/or nursing home residency status for Medicare persons only.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 13.9 million individuals 6\u2009months and older received a bivalent COVID\u201019 vaccine. A statistical signal occurred for two outcomes in one database (significance level of 1%): anaphylaxis following both bivalent COVID\u201019 vaccines in persons 18\u201364\u2009years and myocarditis\/pericarditis following bivalent BNT162b2 vaccines in individuals 18\u201335\u2009years. Among 642\u2009142 vaccinated children 6\u2009months\u201317\u2009years, no signals were identified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Results were consistent with published COVID\u201019 vaccine safety studies and support the safety profile of bivalent COVID\u201019 mRNA vaccines.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70151","type":"journal-article","created":{"date-parts":[[2025,5,20]],"date-time":"2025-05-20T05:12:51Z","timestamp":1747717971000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Safety Monitoring of Bivalent\n                    <scp>COVID<\/scp>\n                    \u201019\n                    <scp>mRNA<\/scp>\n                    Vaccines Among Recipients 6\u2009Months and Older in the United States"],"prefix":"10.1002","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-1489-0438","authenticated-orcid":false,"given":"Patricia C.","family":"Lloyd","sequence":"first","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth R.","family":"Smith","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joann F.","family":"Gruber","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Ondari","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui Lee","family":"Wong","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5491-8392","authenticated-orcid":false,"given":"Mao","family":"Hu","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tainya C.","family":"Clarke","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rowan","family":"McEvoy","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8329-1522","authenticated-orcid":false,"given":"Kandace L.","family":"Amend","sequence":"additional","affiliation":[{"name":"Optum Epidemiology  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2788-3061","authenticated-orcid":false,"given":"Daniel C.","family":"Beachler","sequence":"additional","affiliation":[{"name":"Carelon Research  Wilmington Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl N.","family":"McMahill\u2010Walraven","sequence":"additional","affiliation":[{"name":"CVS Health  Blue Bell Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8020-3144","authenticated-orcid":false,"given":"John D.","family":"Seeger","sequence":"additional","affiliation":[{"name":"Optum Epidemiology  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Secora","sequence":"additional","affiliation":[{"name":"IQVIA  Falls Church Virginia 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