EBOLA UPDATE (38): VACCINES, FUNDING

Posted on 11TH OCT 2017
tagged Ebola, Worldwide

A ProMED-mail post
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International Society for Infectious Diseases
http://www.isid.org

In this update:
[1] Vaccines
- Ebola Vaccines, Drugs Added to U.S. Stockpile
- Ebola vaccine trial
[2] Funding: vaccines and antivirals
- Development of multi-component vaccine for Ebola, Marburg, and Lassa viruses
- Department of Health and Human Services Contracts
- Preparation for next Ebola-scale epidemic

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[1] Vaccines
2 Oct 2017: Ebola Vaccines, Drugs Added to U.S. Stockpile
https://ohsonline.com/articles/2017/10/02/ebola-treatments-added-to-stoc...
["Today [Mon 2 Oct 2017] we are prepared to add 4 Ebola countermeasures to the stockpile, whereas 3 years ago, very few products were even in early stages of development," BARDA Director Rick Bright, Ph.D., said. "This marks a pivotal moment in U.S. and global preparedness for future public health emergencies from viral hemorrhagic fevers like Ebola."
HHS on [Fri 29 Sep 2017] announced the 1st purchase of vaccines and therapeutic drugs for the Ebola virus by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response. These are 1st vaccines and drugs for Ebola to receive Project BioShield funding, which supports late-stage development toward licensing and stockpile purchases.
We reached this point at unprecedented speed, and that's a direct result of innovative approaches to product development and to partnering across the U.S. government, other nations, and private industry."
"The U.S. Department of Homeland Security considers [EVD] a potential bioterrorism threat, as well as a naturally occurring public health threat. Under the agreements announced [Fri 29 Sep 2017], BARDA will provide Project BioShield funding for each company to validate its manufacturing processes and undertake the final preparations needed to apply for approval through the U.S. Food and Drug Administration; as that work is completed, BARDA can purchase the vaccines and drugs for potential use in a public health emergency.
"The HHS agency could buy up to 1.13 million regimens of vaccine, including a single-dose vaccine from Merck Sharp and Dohme Corp of Whitehouse Station, N.J., and a 2-dose vaccine from Janssen Vaccines and Prevention B.V. of Leiden, The Netherlands. BARDA also will buy a therapeutic drug from Mapp Biopharmaceutical, Inc. of San Diego, Calif., and a therapeutic drug from Regeneron Pharmaceuticals, Inc. of Tarrytown, N.Y.
"The announcement said Merck Sharp and Dohme Corp's single-shot vaccine would be used to protect people at high risk of exposure to Ebola, and BARDA will provide USD39.2 million for late-stage development and purchase. Janssen Vaccines and Prevention B.V.'s vaccine is a 2-dose vaccine regimen that would be used to prevent illness in people who have not been exposed to Ebola but could be, such as health care workers and the general public; BARDA will provide USD44.7 million for late-stage development and purchase under Project BioShield. And for Mapp Biopharmaceutical, BARDA initially will provide USD45.9 million for late-stage development and initial purchase of the therapeutic drug ZMapp under Project BioShield."]

9 Oct 2017 Ebola vaccine trial (rVSV-[delta]GP-ZEBOV)
https://medicalxpress.com/news/2017-10-ebola-vaccine-hailed-success.html
[Experts at St George's, University of London, have reported that an Ebola vaccine is safe for children as well as adults and produces an immune response.
The worst Ebola virus disease outbreak in history ended in 2016 after infecting 28 600 people and killing about 11 300 worldwide.
The outbreak led to urgent action by medical experts across the world to combat this devastating disease; including the setting up of trials of vaccines to stop the disease taking hold.
This global commitment to develop a vaccine against the disease suggested 8 options, out of a starting pool of 15 candidates, should be evaluated in clinical trials worldwide by the end of 2015.
Professor Sanjeev Krishna, of St George's University of London's Institute for Infection and Immunity, said: "An unprecedented Ebola outbreak showed how it is possible for academics, non-governmental organisations, industry and funders to work effectively together very quickly in times of medical crisis. The results of the trial show how a vaccine could best be used to tackle this terrible disease effectively.
"We need a system of specialists, medical experts and organisers that maintains vigilance against outbreak diseases like Ebola.
"We should continue to improve ways to make, evaluate and deliver vaccines when they are needed, often in parts of the world lacking in infrastructure for diagnosing infections and providing treatments."
He explained that considering the persistent replication of the vaccine which is called rVSV-[delta] GP-ZEBOV in children and adolescents, further studies investigating lower doses in this population are warranted.
The vaccine contains a non-infectious portion of a gene from the Zaire Ebola virus. The St George's researchers worked with colleagues on a vaccine trial in Gabon.
In addition, lower vaccine doses should be considered when boosting individuals with pre-existing antibodies to Ebolavirus glycoprotein, a finding that has emerged after the vaccine was tested in a country that has experienced Ebola virus outbreaks in the past.
The vaccine was one of 2 being examined as a 'candidate' option by the World Health Organisation to identify urgently a vaccine to combat the Ebola virus outbreak in West Africa.
The clinical trial was led by colleagues at University of Tubingenin in Germany, coordinated by Professor Peter Kremsner with their partner institute CERMEL in Lambareanea, Gabon.
Professor Krishna was among a consortium of experts called VEBCON convened by the WHO in August 2014 in Geneva to discuss solutions and strategies for combatting the EVD crisis.
He acted as a scientific advisor to the new studies in Gabon, He is also affiliated with the Institute of Tropical Medicine in Tubingenin and has carried out collaborative work for many years in Lambareanea . ]

[More information: "Safety and immunogenicity of rVSVÎ"G-ZEBOVGP Ebola vaccine in adults and children in Lambareanea, Gabon: A phase I randomised trial," PLOS Medicine (2017) doi.org/10.1371/journal.pmed.1002402]

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[2] Funding: vaccines and antivirals
2 Oct 2017: Profectus BioSciences Awarded NIH Contract for up to USD22.25 Million to Develop Multi-Component Vaccine for Ebola, Marburg, and Lassa Viruses>
http://markets.businessinsider.com/news/stocks/Profectus-BioSciences-Awa...
[Profectus BioSciences, Inc. announced today [Mon 2 Oct 2017] that the company has received a contract for up to USD22.25 million from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. The base period of the contract, with a value of USD6.96 million, will support a proof-of-concept (POC) study in non-human primates (NHP) and preparations for manufacture under Good Manufacturing Processes (GMP) of a vaccine designed to protect against Zaire ebolavirus, Sudan ebolavirus, Marburgvirus, and Lassa viruses. The contract also includes USD15.29 million in options that may be exercised by the NIAID to support GMP manufacture and clinical evaluation of the multi-component vaccine. The vaccine is being developed in lyophilized form to allow distribution without a cold chain and enable routine mass immunization.
Ebola and Marburg viruses belong to the filovirus family of viruses, which cause periodic outbreaks of a highly contagious and lethal human infectious disease marked by a hemorrhagic fever, with a mortality rate that ranges between 25 percent and 90 percent. The infection typically affects multiple organs in the body and is often accompanied by severe bleeding (hemorrhage). The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission.
Lassa virus is endemic to West Africa, where it infects up to 300 000 individuals per year, resulting in 60 000 cases of severe multisystem disease and 5000 deaths. Among those who survive, about one in 8 suffers permanent deafness. The main reservoir of this virus is the multi-mammate rat, which lives in close proximity to humans and sheds the virus in its urine and feces.]

04 Oct 2017: Department of Health and Human Services Contracts
http://thehill.com/business-a-lobbying/lobbying-contracts/353960-under-c...
[...The Department of Health and Human Services is purchasing Ebola 'medical countermeasures' and vaccines that can be deployed in the event of an [Ebola virus disease (EVD)] outbreak. A USD46 million contract has been awarded to Mapp Pharmaceuticals, which is developing an [EVD] treatment drug. The contract seeks to advance [the drug] ZMapp to licensure by the Food and Drug Administration. It also received another multi-million contract to support Mapp's preclinical stage products for Sudan virus and pan-Marburg virus. Janssen Vaccines and Prevention, a Johnson and Johnson company, won a USD44.7 million contract to help further the development and approval of an Ebola vaccine. ...-more]

9 Oct 2017: GSK warns drug firms need more cash to prepare for next Ebola-scale epidemic
http://www.telegraph.co.uk/business/2017/10/09/gsk-warns-drug-firms-need...
[Britain's biggest drug maker, GSK, has warned world governments that they are not spending enough to prepare for future epidemics on the scale of [Ebola virus disease (EVD)] or zika [ZIKAV].
The FTSE 100 firm's chief medical officer for vaccines, Thomas Breuer, said the company had built a brand new lab outside Washington DC with capacity to work on vaccines for potential global outbreaks but was lacking public funds to press ahead.
Mr Breuer said: "We have created a completely new site in the US in Rockville near Washington DC and we have reserved space in case we get grants to do research on these diseases. We have to run a business so these new initiatives on potential vaccine candidates for future pandemics can only materialise if we get the funds."
In the wake of the Ebola and Zika epidemics - with the former claiming more than 11 000 lives, mainly in Africa, while the latter resulted in babies being born with congenital brain abnormalities in affected countries - there has been a coordinated response.
Mr Breuer said Cepi's launch was a welcome attempt to "at least to try to get ahead of the curve" but had to be backed with sufficient funding. ...-more]

[Compiled by: Celeste Whitlow ]

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Communicated by:
ProMED-mail

[[Multiple Ebola vaccine candidates are in various stages of development. See Sharma R, Jangid K, Anuradha. Ebola Vaccine: How Far are we? Journal of Clinical and Diagnostic Research  2017;11(5):DE01-DE04. doi:10.7860/JCDR/2017/22184.9863 for a review of the current vaccines under study.

[Maps of the West African countries affected by the 2014 Ebola outbreak can be accessed at
Liberia http://healthmap.org/promed/p/54
Guinea http://healthmap.org/promed/p/45
Sierra Leone http://healthmap.org/promed/p/46. - Mod.LK]]

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