scholarly journals Study on Environmental Risk Assessment for Potential Effect of Genetically Modified Nicotiana benthamiana Expressing ZGMMV Coat Protein Gene

2006 ◽  
Vol 22 (4) ◽  
pp. 353-359
Author(s):  
Tae-Sung Kim ◽  
Min-Su Yu ◽  
Kong-Suk Koh ◽  
Kyoung-Hee Oh ◽  
Hong-Il Ahn ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Coat Protein ◽  
Environmental Risk ◽  
Coat Protein Gene ◽  
Environmental Risk Assessment ◽  
Nicotiana Benthamiana ◽  
Protein Gene ◽  
Genetically Modified ◽  
Potential Effect

scholarly journals Environmental Risk Assessment for rVSVΔG-ZEBOV-GP, a Genetically Modified Live Vaccine for Ebola Virus Disease

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 779
Author(s):  
Joan G. Tell ◽  
Beth-Ann G. Coller ◽  
Sheri A. Dubey ◽  
Ursula Jenal ◽  
William Lapps ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Ebola Virus ◽  
Virus Disease ◽  
Genetically Modified ◽  
Ebola Virus Disease ◽  
European Medicines Agency ◽  
Low Level ◽  
Animal Populations

rVSVΔG-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, rVSVΔG-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 rVSVΔG-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 rVSVΔG-ZEBOV-GP would spread within animal populations. Preclinical studies in various hematophagous insect vectors showed that these species were unable to transmit rVSVΔG-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.

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