Study confirms efficacy of NewLink Genetics ebola vaccine
Monday, December 26, 2016
A study published last Thursday in The Lancet found the rVSV-ZEVOB ebola vaccine can provide up to 100% protection against onset of Zaire ebolavirus, one of the two most common strains of ebola, responsible for most of the cases observed in humans. Iowa-based NewLink Genetics, which owns the rights to rVSV-ZEVOB, on Friday announced hope the US Food and Drug Administration (FDA) would award them a priority review voucher in recognition of their work with the vaccine.
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Image: NIAID.
The study's findings also show the vaccine is effective post-exposure, which makes it suitable for ring vaccination, the anti-outbreak strategy used in the study, in which everyone who has come into contact with a confirmed case is vaccinated to prevent the illness from spreading.
NewLink's chief scientific officer for infectious diseases, Thomas Monath, said the FDA would likely approve the vaccine quickly, with large-scale production as early as 2018.
This might not be the only NewLink project to be waved to the front of the line. Priority review vouchers are awarded by the FDA as a means of providing an incentive for private industry to focus on tropical diseases and rare conditions. Any company that sees an eligible vaccine or treatment formally licensed can receive a voucher for fast-track FDA review on a future project. They can either keep the voucher for their own use or sell it. According to Monath, they can sell for US$100–300 million, and NewLink would share the money from any such sale with Merck, which currently holds the license on the vaccine.
rVSV-ZEVOB was initially developed by the Public Health Agency of Canada and the United States Army. It is a recombinant live replication-competent virus based on vesicular stomatitis virus. Although it is harmless to humans, it has been engineered to express one of the same surface marker proteins as the Zaire ebolavirus, which trains the host's immune system to recognize both the vaccine and the true virus.
US President Barack Obama added ebola to the priority review voucher program in December 2014 during the outbreak in West Africa.
Sources
- Tony Leys. "Ebola vaccine's triumph will lead to reward for Ames company" — The Des Moines Register, December 23, 2016
- David Nield. "It's official: We finally have an Ebola vaccine that's up to 100% effective" — ScienceAlert.com, December 23, 2016,
- Donald C. McNiell Jr.. "New Ebola Vaccine Gives 100 Percent Protection" — The New York Times, December 22, 2016
- Ana Maria Henao-Restrepo, MD; Anton Camacho, PhD; Prof Ira M Longini, PhD; Conall H Watson, MFPH; Prof W John Edmunds, PhD; Prof Matthias Egger, PhD; Miles W Carroll, PhD; Natalie E Dean, PhD; Ibrahima Diatta, MSc; Moussa Doumbia, MD; Bertrand Draguez, MD; Sophie Duraffour, PhD; Godwin Enwere, FWACP; Rebecca Grais, PhD; Stephan Gunther, MD; Pierre-Stéphane Gsell, PhD; Stefanie Hossmann, MSc; Sara Viksmoen Watle, MD; Prof Mandy Kader Kondé, PhD; Sakoba Kéïta, MD; Souleymane Kone, MSc; Eewa Kuisma, PhD; Prof Myron M Levine, MD; Sema Mandal, MD; Thomas Mauget, MBA; Gunnstein Norheim, PhD; Ximena Riveros, MSc; Aboubacar Soumah, MD; Sven Trelle, MD; Andrea S Vicari, PhD; Prof John-Arne Røttingen, MD; Marie-Paule Kieny, PhD. "Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!)" — The Lancet, December 22, 2016
- Alexander Gaffney. "Obama Signs Special Ebola Incentive Program Into Law" — Regulatory Affairs Professional Society, December 18, 2014
