Canada's Ebola vaccine development on fast track or slow boat?

Xinhua

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The Ebola conundrum continues as country after country speeds towards the "Holy Grail" for an effective vaccine. The 800 vials of Canadian experimental vaccine are expected to reach the World Health Organization headquarters in Switzerland on Wednesday.

The WHO declared in August that "West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history." That led to the WHO convening to "consider and assess the ethical implications for clinical decision-making of use of unregistered interventions that have shown promising results in the laboratory and in animal models but that have not yet been evaluated for safety and efficacy in humans."

This is the crux in all recent reports on the evolution and development of the vaccine either from Canada, the UK or the USA. The world hastens to establish, design, and implement trial after trail of the so far elusive vaccine. The WHO predicts a staggering 10,000 cases per week by December, a number so high as to instill a fever into mankind's previously complacent attitude to this current Ebola outbreak.

Health officials with the Public Health Organization in Canada are dispensing "soundbites of hope" to be the first in establishing the vaccine.

Dr. Lindsay Elmgren, Director of Center for Biologics Evaluation, Health Canada and Head of the WHO Collaborating Center for Standardization and Evaluation of Biologics, affirmed that " the Ebola disease is very serious and cases will very likely reach the numbers that WHO predicts.

"There are currently no licensed or approved Ebola vaccines. There are 2 candidate vaccines that are currently undergoing Phase 1 clinical trials in the U.S., Britain, and Germany. All further use of these vaccines will depend on the results of these trials. One of these possible vaccines was developed by scientists working for the Public Health Agency of Canada," Elmgren told Xinhua in an interview.

Elmgren clarified that the proverbial race was to gain momentum against the viral contamination. "Experts around the world are working together in an unprecedented manner to deal with the Ebola crisis. The race to get a vaccine is against the disease, not the experts working together."

Canada has pledged 65 million Canadian dollars thus far to the Ebola campaign as run by the WHO, and the need to establish groundbreaking protocols and procedure goes beyond the development of the vaccine. In the past few days, Canada has approved the implementation of Ebola screening and frontline protection in five hospitals across the country. Yet, Hedy Fry, a Canadian politician and physician, stated in regards to fighting Ebola, "Canada is not doing enough."

The question begs itself, what precisely is enough? Once again, Dr. Elmgren elaborates on the prototype vaccine, "This experimental vaccine was developed in Canada. A vaccine cannot be licensed anywhere until clinical trials have been completed that show the product is safe and effective."

This may be the beginning of establishing. The Public Health Agency of Canada has only developed one Ebola vaccine, which is a VSV-EBOV recombinant. The marketing rights for this experimental vaccine have been sold to NewLink, Iowa-based U.S. company.

In Europe, Dr. Stefan Becker has been waiting on the Canadian vaccine for several months. Becker is a professor at the Institute for Virology at Philipps University of Marburg, Germany. His research focuses on filoviridae that comprise Marburg and Ebola viruses. These related viruses cause hemorrhagic fever and bats are carriers of filoviruses that potentially spread the virus to humans in endemic regions of Central Africa.

Ebola, a filovirus, is categorized as a bio-safety level 4 virus and there are no vaccines and specific therapeutics available. This specific Ebola information was recently introduced to the global public by scientists like the Becker Group.

Responding to a Xinhua request for interview, Dr. Becker wrote, "unfortunately I am not able to answer your questions because I am drowning in requests by national media which I hardly can satisfy. "

The WHO acknowledged that vaccine development is often lengthy and costly and as Dr. Elmgren said, "Yes, this is normally up to a 10 year process." The WHO went on to stipulate that "even under the best conditions and with the massive efforts of many partners, a significant number of doses will not be available until late in the first quarter of 2015."

"This vaccine is not simple to produce and takes time to do. This vaccine is produced in a biological system and involves a very complex production process and hence the delay in getting any more vaccine produced," Dr. Elmgren said.

So the full steam ahead fast track may indeed be a slow boat, as though there is a theory of a 6-month compression time, vaccine production reality is dictated at this time by uncertain forces related to the spread of the deadly virus, procedures of vaccine protocols and "lady-luck". Serendipity will play a role of the right place, right time and all counter measures coming together to contain Ebola and stop it spreading to the Americas including Canada and to Europe and Asia.

In the interim, the WHO said it may allow health-care workers working on the frontlines of the epidemic to receive the Ebola vaccines even before their effectiveness has been fully studied. Dr. Elmgren confirmed, "This would be part of a controlled clinical trial and actually part of the safety and effectiveness studies. Anyone receiving the vaccine would get it only after having given informed consent."

A misdirection qualifier may apply to the oft quoted, there are no direct flights from West Africa to Canada, but there are many connecting flights as the routing of these flights fly through several G8 countries. Connecting flights are available via Dubai, Spain, France, Germany and the UK, to name a few.

Canadian Health Minister Rona Ambrose may be professing wishful thinking in her previous comments that ricocheted worldwide, NO DIRECT FLIGHTS TO CANADA. U.S. President Obama was more disambiguous in his reports. Dr. Elmgren commented upon this scenario,"There are never any guarantees that a therapeutic intervention will work ... that's why clinical trials are carried out. As President Obama continues to say, there is no reason to restrict world travel," But the WHO is now thinking differently.

The World Health Organization's emergency committee in Geneva is holding talks to discuss the Ebola epidemic. On the table are extended screening measures at borders and if stricter travel regulations will be implemented. The United States now requires travelers from the worst affected countries to arrive at one of five airports. This is the beginning of the global environmental impact of Ebola on all world economies. Such previous epidemic scares affected the travel and tourism industry, dramatically.

Toronto has spent 2.4 billion dollars on bringing the Pan Am games to Canada in 2015. With Ebola seen as a long term environmental threat, can this be perceived as a game of Russian roulette?

The containment for Ebola is a sophisticated multifaceted response that took international intervention combined with nationalistic pride more accepting of a joint survival than Canada may be capable of. Canada's multicultural society may prove harder to harness due to the many possible reactions of its vastly differentiated citizenry.

With this said, stated and advised by numerous international sources, the fast track versus the slow boat approaches to the development of the Ebola vaccine from all its phases and trails remains an undefined grey area. Much has to be discovered and all sources are working towards a solution regardless of the pace of established protocols. Who the winner is and what route they take is not the issue per se, as all safe guidelines will eventually be discovered and implemented.

Advisors continue to emphasize a fully tested and approved vaccine is not expected to become available for months or possibly years. The slow boat approach may be the winner as the efficacy of the Canadian virus, with rabid fragments of Ebola notwithstanding is unlikely to be effective at this time. "Ebola-Time" will tell.