Canada’s Ebola conundrum

Canada Ebola vaccine development Fast Track or Slow Boat

The Ebola conundrum continues as country after country, speeds towards the “Holy Grail” for “A” or “The” Ebola vaccine.

The World Health Organization 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 U.K or the U.S.A. While full-steam ahead and man the torpedoes may be the Hoorah! Which constitutes the Ebola War Cry and the world hastens to establish, design, and implement trial after trail of the so far elusive vaccine. Reality does bite. The WHO predicts a staggering 10,000 cases per week by December. A number so high has 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 sound bites of “Hope” the wish to be first in establishing the vaccine.

Dr. Lindsay Elmgren, Director, Centre for Biologics Evaluation /Health Canada / Santé Canada/ Head, WHO Collaborating Centre 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. Having said that, the risk to Canadians remains low. He continued, “There are currently no licensed or approved Ebola vaccines. There are 2 candidate vaccines that are currently undergoing Phase 1 clinical trials in the US, 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, 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 dollars thus far to the Ebola campaign as run by the WHO and the need to establish groundbreaking protocols and procedure go beyond the development of the Vaccine. In the past few days, Canada has approved the implementation of Ebola screening and Front line protection in 5 Hospitals across Canada.  Yet Hedy Fry, PC, MP a Canadian politician and physician, Stated, “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.  As you know, these trials have only just recently begun for the PHAC developed vaccine.”

This may be the beginning of establishing, what is enough.  “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”.  

The WHO has already established that this version of  Ebola was the largest, most severe, most complex outbreak of Ebola virus disease in history. This is a natural segue into this key point .The PHAOC, developed one Ebola vaccine, which is a VSV-EBOV recombinant leads us to Germany, to Dr. Stefan Becker, who has been waiting on the Canadian vaccine for several months. Dr. Stephan Becker Ph.D, is Professor at the Institute for Virology, Philipps University of Marburg, Marburg, Germany. His research plays an important role in the evolution of this vaccine and focuses on Filoviridae that comprises Marburg an Ebola viruses. Both cause severe hemorrhagic fever in humans and non-human primates. The natural reservoir of filoviruses seems to be fruit bats from which the virus can spread to humans in endemic regions in Central Africa. Since no vaccine and specific therapeutics are available, filoviruses are categorized as level 4 agents, which are investigated under highest safety precautions and categorised as a biosafety level 4. The Becker group contributed to the understanding of transcription replication strategies of filoviruses and is mainly interested in the interplay between viral replication and assembly.

The WHO acknowledged Wednesday that vaccine development is often lengthy and costly and as Dr. Elmgren, states, “Yes, this is normally up to a 10 year process.”

The Who went onto 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”.  Dr. Elmgren ,”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.”

So the Full steam ahead – Fast track may indeed a slow boat, as though there is the thought and a theory of a 6 month compression time, to produce any vaccine the reality is dictated by at this time ambiguous forces related to the spread of the deadly virus, protocols of vaccine protocols and “ Lady-luck”

In the interim, the WHO says 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. A misdirection that the US President Obama addressed, by not banning flights to the US, as the routing of this flights, does fly through many G8 countries from West Africa and though Direct flights do not exist, Flights are available via, Dubai, Spain, France, Germany and the UK to name a few routes. All those countries fly directly to Canada. Carrying passengers that could have begun their flights or been exposed to Ebola, enroute. Minister Ambrose may be professing Wishful thinking in her previous comments that ricocheted world-wide. Fortunately US President Obama was less obtuse in his reports. Dr. Elmgren commented upon this scenario. If flights or countries are placed in a state of high alert, will world travel be restricted?  “There are never any guarantees that a therapeutic intervention will work … that are why clinical trials are carried out.  As President Obama continues to say, there is no reason to restrict world travel”.

Toronto has spent 2.4 Billion dollars on bringing the Pan Am games to Canada. With Ebola seen as a long term environmental threat, can this be perceived as a game of Russian roulette? Bringing millions of people to Toronto at a time when Ebola vaccines are just being introduced into the world’s population, if all goes according to some plan?  And that plan is a global one, not per country. Yet Canada is bringing the world to Toronto, creating the perfect storm for Ebola infection, as per Ebola’s ability to infect, by close exposure. Dr.Elmgren, replies “Interesting scenario.  Ebola is not transmissible by being in the same room as someone.  It is only transmissible by direct contact with bodily fluids of an infected, symptomatic individual.”

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.

By Cristoph De Caermichael

 

EBOLA Q&A

 

How is it that Canada has 2 development vaccines – The (rVSV-ZEBOV) was developed by the Public Health Agency of Canada in Winnipeg. The license for commercialization of the Canadian vaccine is held by an American company, the NewLink Genetics company, located in Ames, Iowa.  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.  

Health Minister Ambrose- VSV-EBOV vaccine and the clinical trials: Human clinical trials of an experimental Canadian Ebola vaccine are underway.  This is correct.  See the link that I provided you with above.

Are these 2 the one and same virus? In 2 countries. The documents indicate that this was started in August but still no vaccine? And then why is Dr.Becker waiting for the vaccine?  If you are referring to rVSV-EBOV and VSV-EBOV, yes they are the same thing.

How is Dr. Stephan Becker Ph.D. Stephan Becker, Ph.D., Professor at the Institute for Virology, Philipps University of Marburg, Marburg, Germany, involved?  I do not know how Dr Becker is involved.

Is New Link Genetics company and Dr. Becker collaborating? Why is the Vaccine not being developed, licensed etc in Canada?  This experimental vaccine was developed in Canada.  A vaccine can not be licensed anywhere until clinical trials have been completed that show the product is safe and effective.  As you know, these trials have only just recently begun for the PHAC developed vaccine.

WHO acknowledged Wednesday that vaccine development is often lengthy and costly.  Yes, this is normally up to a 10 year process.

“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,” they stated.  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.

In the meantime, WHO says 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.  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.

Toronto’s Pan Am games as a game of Russian roulette. Bringing millions of people to Toronto at a time when Ebola vaccines are just being introduced into the world’s population, if all goes according to some plan?  And that plan is a global one, not per country. Yet Canada is bringing the world to Toronto, creating the perfect storm for Ebola infection, as per Ebola’s ability to infect, by close exposure. Interesting scenario.  Ebola is not transmissible by being in the same room as someone.  It is only transmissible by direct contact with bodily fluids of an infected, symptomatic individual.  

With 65 Million donated to prevent or protect??, what guarantees are there that this is going to work. If flights or countries are placed in a state of high alert, will world travel be restricted?  There are never any guarantees that a therapeutic intervention will work … that is why clinical trials are carried out.  As President Obama continues to say, there is no reason to restrict world travel.

What is a real time frame, involved in making a vaccine that works?  Under normal circumstances, up to 10 years.

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