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Review

Development of Pandemic Vaccines: ERVEBO Case Study

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Regulatory Affairs, Merck & Co. Inc., Kenilworth, NJ 07033, USA
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Global Vaccines & Biologics Commercialization, Merck & Co. Inc., Kenilworth, NJ 07033, USA
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Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck & Co. Inc., Kenilworth, NJ 07033, USA
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Department of Safety Assessment and Laboratory Animal Resources, Merck & Co. Inc., Kenilworth, NJ 07033, USA
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Global Clinical Trial Operations, Vaccines, Merck & Co. Inc., Kenilworth, NJ 07033, USA
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Global Clinical Development, Vaccines, Merck & Co. Inc., Kenilworth, NJ 07033, USA
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Global Scientific & Medical Publications, Merck & Co. Inc., Kenilworth, NJ 07033, USA
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Author to whom correspondence should be addressed.
Academic Editor: Vita Golubovskaya
Vaccines 2021, 9(3), 190; https://doi.org/10.3390/vaccines9030190
Received: 21 January 2021 / Revised: 11 February 2021 / Accepted: 16 February 2021 / Published: 25 February 2021
(This article belongs to the Special Issue Advances in Vaccine Development and Immunotherapies)
Preventative vaccines are considered one of the most cost-effective and efficient means to contain outbreaks and prevent pandemics. However, the requirements to gain licensure and manufacture a vaccine for human use are complex, costly, and time-consuming. The 2013–2016 Ebola virus disease (EVD) outbreak was the largest EVD outbreak to date and the third Public Health Emergency of International Concern in history, so to prevent a pandemic, numerous partners from the public and private sectors combined efforts and resources to develop an investigational Zaire ebolavirus (EBOV) vaccine candidate (rVSVΔG-ZEBOV-GP) as quickly as possible. The rVSVΔG-ZEBOV-GP vaccine was approved as ERVEBOTM by the European Medicines Authority (EMA) and the United States Food and Drug Administration (FDA) in December 2019 after five years of development. This review describes the development program of this EBOV vaccine, summarizes what is known about safety, immunogenicity, and efficacy, describes ongoing work in the program, and highlights learnings applicable to the development of pandemic vaccines. View Full-Text
Keywords: Ebolavirus vaccine; rVSVΔG-ZEBOV-GP; vaccine development; regulatory strategy; vaccine manufacturing Ebolavirus vaccine; rVSVΔG-ZEBOV-GP; vaccine development; regulatory strategy; vaccine manufacturing
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MDPI and ACS Style

Wolf, J.; Jannat, R.; Dubey, S.; Troth, S.; Onorato, M.T.; Coller, B.-A.; Hanson, M.E.; Simon, J.K. Development of Pandemic Vaccines: ERVEBO Case Study. Vaccines 2021, 9, 190. https://doi.org/10.3390/vaccines9030190

AMA Style

Wolf J, Jannat R, Dubey S, Troth S, Onorato MT, Coller B-A, Hanson ME, Simon JK. Development of Pandemic Vaccines: ERVEBO Case Study. Vaccines. 2021; 9(3):190. https://doi.org/10.3390/vaccines9030190

Chicago/Turabian Style

Wolf, Jayanthi, Risat Jannat, Sheri Dubey, Sean Troth, Matthew T. Onorato, Beth-Ann Coller, Mary E. Hanson, and Jakub K. Simon. 2021. "Development of Pandemic Vaccines: ERVEBO Case Study" Vaccines 9, no. 3: 190. https://doi.org/10.3390/vaccines9030190

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