{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T22:59:24Z","timestamp":1791932364487,"version":"4.3.4"},"reference-count":94,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2020,12,19]],"date-time":"2020-12-19T00:00:00Z","timestamp":1608336000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004334","name":"Merck","doi-asserted-by":"publisher","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}],"id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>rVSV\u0394G-ZEBOV-GP is a live, attenuated, recombinant vesicular stomatitis virus (rVSV)-based vaccine for the prevention of Ebola virus disease caused by Zaire ebolavirus. As a replication-competent genetically modified organism, rVSV\u0394G-ZEBOV-GP underwent various environmental evaluations prior to approval, the most in-depth being the environmental risk assessment (ERA) required by the European Medicines Agency. This ERA, as well as the underlying methodology used to arrive at a sound conclusion about the environmental risks of rVSV\u0394G-ZEBOV-GP, are described in this review. Clinical data from vaccinated adults demonstrated only infrequent, low-level shedding and transient, low-level viremia, indicating a low person-to-person infection risk. Animal data suggest that it is highly unlikely that vaccinated individuals would infect animals with recombinant virus vaccine or that rVSV\u0394G-ZEBOV-GP would spread within animal populations. Preclinical studies in various hematophagous insect vectors showed that these species were unable to transmit rVSV\u0394G-ZEBOV-GP. Pathogenicity risk in humans and animals was found to be low, based on clinical and preclinical data. The overall risk for non-vaccinated individuals and the environment is thus negligible and can be minimized further through defined mitigation strategies. This ERA and the experience gained are relevant to developing other rVSV-based vaccines, including candidates under investigation for prevention of COVID-19.<\/jats:p>","DOI":"10.3390\/vaccines8040779","type":"journal-article","created":{"date-parts":[[2020,12,21]],"date-time":"2020-12-21T01:01:08Z","timestamp":1608512468000},"page":"779","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Environmental Risk Assessment for rVSV\u0394G-ZEBOV-GP, a Genetically Modified Live Vaccine for Ebola Virus Disease"],"prefix":"10.3390","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0558-1986","authenticated-orcid":false,"given":"Joan G.","family":"Tell","sequence":"first","affiliation":[{"name":"Merck &amp; Co., Inc., Kenilworth, NJ 07033, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beth-Ann G.","family":"Coller","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc., Kenilworth, NJ 07033, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheri A.","family":"Dubey","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc., Kenilworth, NJ 07033, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ursula","family":"Jenal","sequence":"additional","affiliation":[{"name":"Jenal &amp; Partners Biosafety Consulting, 4310 Rheinfelden, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Lapps","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc., Kenilworth, NJ 07033, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liman","family":"Wang","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc., Kenilworth, NJ 07033, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2837-8262","authenticated-orcid":false,"given":"Jayanthi","family":"Wolf","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc., Kenilworth, NJ 07033, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2020,12,19]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1038\/s41572-020-0147-3","article-title":"Ebola Virus Disease","volume":"6","author":"Jacob","year":"2020","journal-title":"Nat. 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