{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T05:45:12Z","timestamp":1791265512272,"version":"4.1.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2023,3,31]],"date-time":"2023-03-31T00:00:00Z","timestamp":1680220800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,11,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>YF-VAX\u00ae (Sanofi, Swiftwater, PA), a live, attenuated vaccine based on the yellow fever (YF) substrain 17D-204, is the only YF vaccine licensed in the USA. Manufacturing disruption of YF-VAX and anticipated depletion of the US supply by mid-2017 led to the importation of another YF vaccine, STAMARIL\u00ae (Sanofi, France), into the USA under an expanded access investigational new drug program (EAP) to fulfil the public health need for YF vaccination. As part of this program, Sanofi collected enhanced safety surveillance data following vaccination with STAMARIL. Here, we report the results of the enhanced safety surveillance.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>STAMARIL vaccine was offered to those aged \u22659\u00a0months at high risk of YF. Vaccine recipients (or parents\/guardians) were instructed to report suspected adverse reactions, any serious adverse events (SAEs) including adverse events of special interest [AESI] occurring after vaccination regardless of suspected relationship, and any inadvertent exposure in pregnancy or breastfeeding within 14\u00a0days of vaccination. The AESIs monitored were anaphylaxis, neurotropic disease (YEL-AND) and viscerotropic disease (YEL-AVD).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 627\u2009079 individuals received STAMARIL from May 2017 through June 2021; of these, 1308 (0.2%) reported at least one AE, of which 122 reported at least one SAE. There were seven cases of YEL-AND and three cases of YEL-AVD reported, for reporting rates of 1.1 and 0.5 per 100\u2009000 vaccine recipients, respectively. One vaccine recipient developed an anaphylactic reaction (reporting rate: 0.16 per 100\u2009000). No safety concerns were identified from inadvertent vaccine exposure during pregnancy (41 pregnant women) or potential neonatal exposure via breast milk (four exposed infants).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This study supports the utility of STAMARIL in the EAP as an alternative solution for the YF vaccine shortage in the USA. SAEs were very rare and consistent with the known safety profile of STAMARIL.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jtm\/taad037","type":"journal-article","created":{"date-parts":[[2023,3,30]],"date-time":"2023-03-30T17:13:54Z","timestamp":1680196434000},"source":"Crossref","is-referenced-by-count":18,"title":["Enhanced safety surveillance of STAMARIL\u00ae yellow fever vaccine provided under the expanded access investigational new drug program in the USA"],"prefix":"10.1093","volume":"30","author":[{"given":"Andrey","family":"Rojas","sequence":"first","affiliation":[{"name":"Global Pharmacovigilance Department, Sanofi , Bogota , Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wayne","family":"Hachey","sequence":"additional","affiliation":[{"name":"Department of Scientific & Medical Affairs, Sanofi , Swiftwater, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gurpreet","family":"Kaur","sequence":"additional","affiliation":[{"name":"Department of Scientific & Medical Affairs, Sanofi , Swiftwater, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Korejwo","sequence":"additional","affiliation":[{"name":"Global Pharmacovigilance Department, Sanofi , Lyon , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riyadh","family":"Muhammad","sequence":"additional","affiliation":[{"name":"Department of Scientific & Medical Affairs, Sanofi , Swiftwater, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,3,31]]},"reference":[{"key":"2023112012041184700_ref1","doi-asserted-by":"crossref","first-page":"457","DOI":"10.15585\/mmwr.mm6617e2","article-title":"Addressing a yellow fever vaccine shortage\u2014United States, 2016\u20132017","volume":"66","author":"Gershman","year":"2017","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2023112012041184700_ref2","article-title":"Yellow fever outbreak: Sanofi look to double vaccine production","author":"Stanton","year":"2016","journal-title":"Bio Pharma Reporter"},{"key":"2023112012041184700_ref3","volume-title":"YF-VAX\u00ae-Yellow Fever Vaccine","author":"Food and Drug Administration","year":"2019"},{"key":"2023112012041184700_ref4","volume-title":"United States. 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