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Lessons Learned from the Development and Roll-Out of the rVSVΔG-ZEBOV-GP Zaire ebolavirus Vaccine to Inform Marburg Virus and Sudan ebolavirus Vaccines.
Coller, Beth-Ann G; Lapps, William; Yunus, Mahum; Bruno, Samantha; Eichberg, Michael J; Lee, Andrew Wen-Tseng; Liu, Kenneth; Drury, Rosybel; Millogo, Jules; Macareo, Louis Robert; Armstrong, Thomas H; Blue, Jeffrey T; Isopi, Lynne A; Hughes, Melissa; VanRheenen, Susan M; Deutsch, Jonathan; Tell, Joan G; Dubey, Sheri A.
Affiliation
  • Coller BG; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Lapps W; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Yunus M; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Bruno S; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Eichberg MJ; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Lee AW; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Liu K; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Drury R; MSD, 69007 Lyon, France.
  • Millogo J; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Macareo LR; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Armstrong TH; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Blue JT; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Isopi LA; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Hughes M; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • VanRheenen SM; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Deutsch J; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Tell JG; Merck & Co., Inc., Rahway, NJ 07065, USA.
  • Dubey SA; Merck & Co., Inc., Rahway, NJ 07065, USA.
Vaccines (Basel) ; 10(9)2022 Sep 01.
Article in En | MEDLINE | ID: mdl-36146524
ABSTRACT
This review describes key aspects of the development of the rVSVΔG-ZEBOV-GP Ebola vaccine and key activities which are continuing to further expand our knowledge of the product. Extensive partnerships and innovative approaches were used to address the various challenges encountered during this process. The rVSVΔG-ZEBOV-GP Ebola vaccine was initially approved by the European Medicines Agency and prequalified by the World Health Organization in November 2019. It was approved by the United States Food and Drug Administration in December 2019 and approved in five African countries within 90 days of prequalification. The development resulted in the first stockpile of a registered Ebola vaccine that is available to support outbreak response. This also provides insights into how the example of rVSVΔG-ZEBOV-GP can inform the development of vaccines for Sudan ebolavirus, Marburg virus, and other emerging epidemic diseases in terms of the types of approaches and data needed to support product registration, availability, and the use of a filovirus vaccine.
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Vaccines (Basel) Year: 2022 Document type: Article Affiliation country: United States Publication country: CH / SUIZA / SUÍÇA / SWITZERLAND

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Vaccines (Basel) Year: 2022 Document type: Article Affiliation country: United States Publication country: CH / SUIZA / SUÍÇA / SWITZERLAND