From Tekmira and Biocryst Pharmaceuticals, to GSK , Johnson & Johnson Profectus BioSciences and Crucell Biopharmaceutical are all now working on the research and development of the Ebola vaccines.
The Ebola affected patients were administered ZMapp an experimental drug that is developed by Mapp Biopharmaceutical Inc. However, it has not yet been tested in humans for safety and efficacy. The product is a combination of three different monoclonal antibodies that bind to the protein of the Ebola virus, according to a media report.
Although there is no FDA approved vaccines for Ebola, the US-based National Institute of Health’s Institute of Allergy and Infectious Diseases is working on developing an Ebola vaccine. NIH in August this year announced the acceleration of the research to go in for a phase 1 clinical trials of an Ebola vaccine.
Recently the UK-based GlaxoSmithKline (GSK), a British pharmaceuticals firm, received the consent from the Swiss regulatory authority, Swissmedic for a trial with its experimental Ebola vaccine at the Lausanne University Hospital (CHUV). This is the latest step towards bringing safe and effective Ebola vaccines for testing and implementation as quickly as possible. GSK has said it might be able to make about one million doses of its vaccine per month by the end of 2015.
Swissmedic said the trial will be conducted among 120 volunteer participants with support from the U.N. World Health Organization. The experimental vaccine is to be initially administered on healthy volunteers who will be sent as medical staff to fight the Ebola epidemic in West Africa.
In a statement, the Bern-based Swiss government agency said the trial continues a series that began in the United States, Britain and Mali, using a vaccine based on a genetically modified chimpanzee adenovirus. The World Health Organization (WHO) has welcomed the approval.
There are no proven drugs or vaccines for Ebola, mainly because the disease is so rare it's been hard to attract research funding. But with governments and businesses now rapidly shifting millions of dollars to fight the Ebola epidemic centred in West Africa, WHO says two leading candidates for a vaccine have emerged.
It is also gathered that GSK vaccine is co-developed by NIAID too and the testing will take place at the NIH Clinical Center in Bethesda, Maryland.
It also reported in a section of the media that “the study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The others are to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.”
In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.
NIH is also supporting the Crucell biopharmaceutical company in its development of an Ebola/Marburg vaccine as well as Profectus Biosciences in its development of an Ebola vaccine. Additionally, NIH and the Thomas Jefferson University are collaborating to develop a candidate Ebola vaccine based on the established rabies vaccine.
Two other companies, Tekmira and Biocryst Pharmaceuticals, receive funding from the Department of Defense's Defense Threat Reduction Agency and have therapeutic candidates for Ebola in early development. The Department of Defense is working with a company called Newlink to develop an Ebola vaccine candidate. BioCryst, with NIH support, is working to develop an antiviral drug to treat Ebola virus that is expected to begin Phase 1 testing later this year.
The other front-runner vaccine is licensed by a small U.S. drug maker, NewLink Genetics, and was initially developed by the Public Health Agency of Canada. It has been sent to the U.S. Walter Reed Army Institute of Research for testing on healthy volunteers, with preliminary safety results expected by December.
The vaccine is based on a genetically modified chimpanzee adenovirus . The trial will test the safety of the vaccine and its capacity to induce an immune response. Results from the CHUV trial will – together with the results of other centres involved – provide the basis for planning subsequent trials involving several thousand participants, and for choosing vaccine dose-level for efficacy trials.
The trial is one of two in Switzerland coordinated by WHO. A second vaccine, rVSV-ZEBOV, is to be tested at the Geneva University Hospitals, concurrent to the Lausanne trial.
“These are dosing and safety trials being held in advance of to Phase II and III trials currently scheduled for late 2014-early 2015. If shown to be safe and effective, either of the vaccines could be scaled up for production during the first quarter of next year, with millions of doses produced for wide distribution in high-risk countries,”said Marie-Paule Kieny, Assistant Director-General for Health Systems and Innovation at WHO.
GSK acquired this Ebola vaccine candidate through the acquisition of a biotechnology company, Okairos, in May 2013 and has since been working with the US National Institutes of Health to develop this vaccine candidate in response to the threat of Ebola.
Government sops vital
Experts say drug makers are wagering that international groups and wealthier governments like the US will buy Ebola vaccines and drugs in mass quantities to stockpile them for future use once they're deemed safe.
According to an analyst with research and consulting firm GlobalData, in the battle against Ebola, incentives from governments and healthcare policy-makers have been and will continue to be vital for advancing the current treatment pipeline, by mitigating the risk and up-front costs from pharmaceutical companies.
Despite a clear need for novel therapeutic approaches to combat Ebola, the infection has not represented an attractive investment for pharmaceutical companies due to its low incidence and the occurrence of outbreaks in countries that cannot afford expensive medicines, he added.
“These two factors drastically reduce the ability of drug developers to recoup their research and development (R&D) costs", he adds.
“So far, clinical-stage experimental treatments for Ebola have all been advanced, at least in part, with the financial support of public entities, and the contribution of public resources to R&D has only increased as fears of the virus have spread.”
He notes that the most advanced Ebola pipeline candidate is GlaxoSmithKline’s (GSK) therapeutic vaccine, cAd3-ZEBOV. This treatment was originally developed jointly by the US National Institute of Allergy and Infectious Diseases and Okairos, which was acquired by GSK in 2013.
The analyst adds that experts are hopeful for data on cAd3-ZEBOV’s safety and dosing in healthy volunteers to be available by the end of this year. Other pharmaceutical companies with promising Ebola treatments that are partially supported by public funding include Johnson & Johnson, Mapp Biopharmaceutical, and NewLink Genetics.
“Ultimately, more partnerships between public entities and pharmaceutical companies are needed to bring to market novel therapies that combat neglected diseases, particularly those which, like Ebola, affect resource-deprived regions of the world,” he concludes.
Disease spreading fast
More than 10,000 people have been infected with Ebola and nearly half of them have died, according to the WHO. Ebola has now reached every district in Sierra Leone and all but one district in Liberia, with "intense transmission" in these countries' capital cities, according to the WHO.
West Africa today is nowhere near goals set by the United Nations to get the outbreak under control, according to the WHO.
Even with the modest goal of meeting 70 per cent of the region's needs by Dec. 1, affected countries would need at least 16 more labs to help medical staff quickly diagnose patients, 230 more "dead body management teams" to bury or cremate bodies in ways that don't spread Ebola; 4,388 more hospital beds; and 20,000 contract tracers to find and isolate potential cases.
Today, Liberia has enough beds for only 23 per cent of patients, according to the WHO. That means 77% of Ebola patients are languishing and dying at home or, worse, in the street.
Infectious disease expert Michael Osterholm said he's concerned that Ebola is poised to spill over the borders to other African countries, such as Ivory Coast. Of the eight districts in Guinea and Liberia that border Ivory Coast, all but one have reported Ebola cases, the WHO said.
In August, Ivory Coast closed its borders with Ebola-affected countries and temporarily suspended flights.
Asian countries ramping up response plans
In the meanwhile governments in Asian countries are ramping up response plans, stepping up surveillance at airports and considering quarantine measures. Still, health experts in the region's less developed countries fear any outbreak would be deadly and hard to contain.
Asia, home to 60 per cent of the world's population, scores higher than West Africa on most development indexes and includes emerging or developed countries like Singapore, Malaysia, South Korea and Japan. But countries like India, China, the Philippines and Indonesia have vast numbers of poor, many of whom live in crowded slums, and underfunded health systems.
The Philippine government estimates there are up to 1,700 Filipino workers in Liberia, Sierra Leone and Guinea, plus more than 100 peacekeeping troops in Liberia. The Department of Health is suggesting a 21-day quarantine period before its citizens leave those three countries, but doesn't know how it will pay for that, said spokesman Lyndon Lee Suy.
Indonesia has put 100 hospitals that have experience of treating patients suffering from bird flu on standby for Ebola, said Tjandra Yoga Aditama, head of the Health Ministry's research and development board.
The only way of ensuring that the virus doesn't spread into a country is enforced quarantine for people coming from countries with an outbreak or -- even more effective -- a total travel ban. But those measures would mean that doctors and other experts trying to beat the virus at its source in West Africa would be less willing or unable to help, making the outbreak worse.
Airports in Asia have stepped up their defences: screening passengers who have travelled from affected countries, taking any with high temperature for observation and trying to keep contact them with for 21 days -- the incubation period. Even assuming these measures are carried out effectively, people can and do lie about their travel history, and common drugs like Paracetamol are effective in reducing fever.
Authorities in China say 8,672 people have entered southern Guangdong province from Ebola-ridden areas since Aug. 23.
There are more than 160 direct flights per month from Africa to the region's capital, Guangzhou, a reflection of the booming economic ties between China and Africa. All arrivals are subject to medical observation, which, according to guidelines from the Health Ministry, involves medical staff visiting or calling them morning and evening for 21 days to ask them about their temperature. People whose temperature is above normal should be immediately quarantined for three weeks.
In Hong Kong, around 15 passengers a day arrive from the affected region. Prior to the Ebola outbreak, Singapore had an average of about 30 people arriving a month collectively from Guinea, Liberia and Sierra Leone, the government says.
Dale Fisher, the head of the infectious diseases' division at the Singapore National University Hospital, said governments in the region should be educating health workers about the disease and the need to ask anyone presenting with a fever at a medical facility about their travel history.
He said that an outbreak could be brought under control with quick isolation and effective tracing of anyone who might have been in contact with the patient, citing the example of Nigeria, African's most populous country. It was declared Ebola free after confirming 19 cases, seven of them fatal.
Asian health systems and workers have experience in countering infectious diseases, including severe acute respiratory syndrome, or SARS, which first appeared in Hong Kong in 2003, infecting more than 8,000 people and killing about 800. The region grappled a highly pathogenic strain of bird flu around the same time that killed about 800 people in 12 countries, and new strains continue to crop up.
Avoidable crisis
The Ebola crisis in west Africa could have been averted if governments and health agencies had acted on the recommendations of a 2011 WHO Commission on global health emergencies, according to a new comment, published in The Lancet.
The comment, written by Professor Lawrence Gostin, Faculty Director of the O’Neill Institute for National & Global Health Law at Georgetown University, USA, calls for renewed international commitment to a health systems contingency fund to prevent another infectious disease crisis, together with long-term funding for enduring health systems development.
Although WHO has now implemented a plan for dealing with Ebola five months after the virus first began to spread internationally implementation will be further delayed while US$490 million are raised to meet the cost of tackling the epidemic. In the meantime, Ebola continues to spread amongst health workers and the general population, in countries where health resources were already strained before the outbreak.
The 2011 WHO Review Committee proposed a Global Health Emergency Workforce, backed by a US$100 million contingency fund, which would have enabled the rapid initial response needed to contain the Ebola outbreak, but the Commission was not acted upon by WHO, lacking sufficient financial commitment from governments in high-income countries.
According to Professor Gostin, “How could this Ebola outbreak have been averted and what could states and the international community do to prevent the next epidemic? The answer is not untested drugs, mass quarantines, or even humanitarian relief. If the real reasons the outbreak turned into a tragedy of these proportions are human resource shortages and fragile health systems, the solution is to fix these inherent structural deficiencies.”
“A dedicated International Health Systems Fund at WHO would rebuild broken trust, with the returns of longer, healthier lives and economic development far exceeding the costs. This fund would encompass both emergency response capabilities and enduring health-system development.”
“The west African Ebola epidemic could spark a badly needed global course correction that would favour strong health infrastructure. Sustainable funding scalable to needs for enduring health systems is a wise and affordable investment. It is in all states’ interests to contain health hazards that may eventually travel to their shores. But beyond self-interest are the imperatives of health and social justice—a humanitarian response that would work, now and for the future.”