{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T17:52:05Z","timestamp":1785779525046,"version":"3.56.0"},"reference-count":25,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T00:00:00Z","timestamp":1783814400000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","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":[[2026,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Within one\u2009week of the Food and Drug Administration granting the COVID\u201019 vaccine Emergency Use Authorization, the HERO\u2010Together study launched. We describe how the study utilized novel methods for streamlined enrollment and longitudinal data collection to efficiently monitor early and long\u2010term safety of the COVID\u201019 vaccine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>HERO\u2010Together is a fully remote, prospective observational cohort study, conducted through an online portal. Participants were recruited from an existing online community of healthcare workers that expanded to family and community members as vaccine eligibility expanded, as well as through marketing and point\u2010of\u2010vaccination efforts. Individuals received notifications to submit data at scheduled intervals for two\u2009years, and automated reminders prompted participants with missed check\u2010ins, with centralized call center outreach for non\u2010responders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Multiple recruitment approaches were adopted, including direct outreach, national and local media campaigns, downloadable enrollment toolkits (e.g., social media), social media influencer partnerships, and pharmacy referrals. A study population of\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200919,\u2009858 was enrolled within nine\u2009months of emergency use authorization, most self\u2010reporting as white, female, working in healthcare, and all for whom variable survey completion was observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Collectively, diverse recruitment strategies, data collection through the online portal, and electronic consent enabled rapid, decentralized enrollment of study participants in order to remotely monitor COVID\u201019 vaccine safety during the early days of the pandemic.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      EUPAS38671.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70431","type":"journal-article","created":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T01:08:36Z","timestamp":1783904916000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Novel Recruitment, Data Collection, and Safety Reporting Methods in the Era of\n                    <scp>COVID<\/scp>\n                    \u201019: Design of a Post\u2010Emergency Use Authorization\n                    <scp>COVID<\/scp>\n                    \u201019 Vaccination Safety\u2010Surveillance Study"],"prefix":"10.1002","volume":"35","author":[{"given":"Cherise","family":"Wong","sequence":"first","affiliation":[{"name":"Pfizer Inc., Worldwide Safety  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1794-2670","authenticated-orcid":false,"given":"Katherine","family":"Kendrick","sequence":"additional","affiliation":[{"name":"Pfizer Inc., Worldwide Safety  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Webb","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Cohen","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Patricia","family":"McAdams","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Rubino","sequence":"additional","affiliation":[{"name":"Pfizer Inc., Worldwide Safety  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Caubel","sequence":"additional","affiliation":[{"name":"Pfizer Inc., Worldwide Safety  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"O'Brien","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute  Durham North Carolina USA"},{"name":"Duke University School of Medicine  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,12]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"World Health Organization \u201cNovel Coronavirus\u2014China \u201daccessed July 3 2025 https:\/\/www.who.int\/emergencies\/disease\u2010outbreak\u2010news\/item\/2020\u2010DON233."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41423\u2010020\u20100372\u20104"},{"key":"e_1_2_11_4_1","unstructured":"World Health Organization \u201cNaming the Coronavirus Disease (COVID\u201019) and the Virus that Causes It \u201daccessed July 3 2025 https:\/\/www.who.int\/emergencies\/diseases\/novel\u2010coronavirus\u20102019\/technical\u2010guidance\/naming\u2010the\u2010coronavirus\u2010disease\u2010(covid\u20102019)\u2010and\u2010the\u2010virus\u2010that\u2010causes\u2010it."},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6915e4"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6949e2"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6950e2"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2027906"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/wmh3.350"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.12190"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591\u2010022\u201001945\u20106"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473\u20103099(22)00054\u20108"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2022.106740"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2026.108844"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11606\u2010020\u201006529\u2010z"},{"key":"e_1_2_11_16_1","volume-title":"The HERO Research Program\u2014A PCORnet Project to Support Studies on COVID\u201019","author":"O'Brien E.","year":"2024"},{"key":"e_1_2_11_17_1","unstructured":"J.Snare \u201cHERO\u2010TOGETHER: A Safety Surveillance Study of Post\u2010 Vaccination Events of Interest among People Vaccinated Against COVID\u201019 \u201dPCORnet March 5 2024 accessed April 29 2026 https:\/\/pcornet.org\/news\/studies\u2010hero\u2010together\u2010a\u2010safety\u2010surveillance\u2010study\u2010of\u2010post\u2010vaccination\u2010events\u2010of\u2010interest\u2010among\u2010people\u2010vaccinated\u2010against\u2010covid\u201019\/."},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746\u2010020\u20100290\u2010y"},{"key":"e_1_2_11_19_1","first-page":"319","article-title":"Real\u2010World Application of Racial and Ethnic Imputation and Cohort Balancing Techniques to Deliver Equitable Clinical Trial Recruitment","volume":"2023","author":"Craig K. 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