Monrovia – The deadly Ebola Virus Epidemic of 2014 ravaged the West Africa nations of Guinea, Liberia and Sierra Leone, killing nearly 11,000 people and affecting 28,000 others before the World Health Organization (WHO) declared the outbreak over.
At the time there was no known cure or vaccines for Ebola and the world was doing everything humanly possible to find a rightful, clinically proven, tested and evidence-based solution.
Zmapp Trial in Liberia
Mr. Tolbert Nyenswah, former Director of the National Public Health Institute(NPHIL) and now a Senior Research Associate and Expert with the International Health Department, Bloomberg School of Public Health at the Johns Hopkins University, recalls how Liberia began the push for what, at the time was the only available drug still undergoing clinical trials.
“History knows how to repeat itself and experience is the best teacher,” Nyenswah says: “Ebola struck 2014, no drugs, no vaccines, nothing. The Minister of Health then, Dr. Gwenigale wrote his counterpart the Secretary of Health and Human Services of the United States to help Liberia with any medication or drugs. Then Foreign Minister, Augustine Ngafuan. was leaving the US on one of his resource mobilization and diplomatic missions he was given a box that contained doses of ZMAPP drug.”
Later, Dr. Gwenigale requested support from the US Government for a partnership to develop vaccines and therapeutics, thus establishing a partnership named and styled “The Partnership for Research on Ebola Virus in Liberia (PREVAIL) which began in October 2014.
At the request of Minister Gwenigale, Liberia developed a partnership between the Department of Health and Human Services (DHHS) and the government of Liberia (GoL) to conduct clinical research on promising therapeutics for Ebola and vaccines for its prevention.
The PREVAIL partnership was established between the governments of Liberia and the United States. The GoL represented through the Ministry of Health (MOH) previously through the Liberia Institute for Biomedical Research (LIBR) during its first year of implementation, and through the National Public Health Institute of Liberia (NPHIL), and Government of Liberia institutions including the University of Liberia and the JFK, thereafter.
The US was represented through the Department of Health and Human Services (DHHS), specifically through the National Institutes of Health (NIH) and the US Centers for Disease Control (CDC).
PREVAIL worked toward an unprecedented pace for clinical research. By February 2, 2015 the first participant enrolled in PREVAIL I: A Phase II/III randomized, double-blind, placebo-controlled study, trumpeting the trial as the highest and goal standard for research in the scientific world.
PREVAIL was also a part of a multicenter, multinational, randomized safety and efficacy study of putative investigational therapeutics in the treatment of patients with known Ebola infection (MCM RCT in EBOV) that studied ZMapp. The study was known in Liberia as PREVAIL II.
ZMapp is an experimental biopharmaceutical drug comprising three chimeric monoclonal antibodies still under development as a treatment for Ebola. But because there was no cure for Ebola, it was the closest to the next best thing.
Two of the three components for Zmapp were originally developed at the Public Health Agency of Canada’s National Microbiology Laboratory (NML), and the third at the U.S. Army Medical Research Institute of Infectious Diseases.
The cocktail was optimized by Gary Kobinger, a research scientist at the NML and underwent further development under license by Mapp Biopharmaceutical. ZMapp was first used on humans during the 2014 West Africa outbreak, having only been previously tested on animals and not yet subjected to a randomized controlled trial.
In February 2015, the NIH ran a clinical trial starting in January 2015 with subjects from Sierra Leone, Guinea, and Liberia aiming to enroll 200 people, but the epidemic waned and the trial closed early, leaving it too statistically underpowered to give a meaningful result about whether ZMapp worked.
The first clinical trial of ZMapp was launched in Liberia the same month.
The first phase was a randomized controlled trial of adults and children to compare ZMapp, made by Mapp Biopharmaceutical, with standard care, which typically includes intravenous fluids, correcting electrolyte imbalances, maintaining oxygen levels and blood pressure, and treating any secondary infections.
At the time, Dr. Fauci, said in the statement that although ZMapp had been used to treat several patients over the past few months, it was difficult to tell if the drug truly worked, because it wasn’t administered in a controlled trial setting. “This clinical trial will help us determine if ZMapp and other treatments are safe and effective for use in the current devastating outbreak in West Africa as well as in future outbreaks.”
In 2019, a clinical study determined that ZMapp was ineffective against Ebola compared to two other treatments.
Dr. Anthony Fauci, as Director of the National Institute of Allergy and Infectious Diseases (NIAID) was in Liberia to support Liberia’s quest to establish a national public health institute. He attended one of the insertion workshops and stakeholder’s meetings and second visited the research sites for PREVAIL
Scientific Remdesivir vs. Herbal CVO
Fast-forward to now, Liberia, like the rest of the world is faced with another killer virus, COVID-19.
Like Ebola, there is no known cure for the Coronavirus, only prevention at least until recently when strong signs pointed toward Remdesivir, an antiviral medicine which is being investigated for the treatment of COVID-19.
Remdesivir is a ‘viral RNA polymerase inhibitor’ (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying). It has shown broad in vitro activity against different RNA viruses, including SARS-CoV-2 and was originally developed for the treatment of Ebola virus disease.
Remdesivir is being developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein.
Despite the hopeful sign for Remdesivir, skeptical Africans appear to be content with the emergence of an herbal tea being trumpeted by Madagascar as a cure for COVID-19.
Over the past few days, Madagascar sent COVID-19 herbal tea to 15 African countries in the Economic Community of West African States (ECOWAS).
On Monday, April 20, 2020, President Andry Rajoelina launched the herbal tea, named COVID-Organics (CVO), claiming the concoction cured COVID-19 patients.
On his Instagram page on Friday, May 1, Rajoelina said the “herbal medicine” would be availed to all coronavirus patients in all friendly countries across the African continent and around the world.
While many appear to be impressed with the tea, some have reservations.
On Wednesday, ECOWAS and the West African Health Organization (WAHO), the specialized institution of ECOWAS responsible for health issues, issued a stinging rebuke of the CVO. “We wish to dissociate ECOWAS and its health Institution, West Africa Health Organization (WAHO), from this claim and to inform the general public that we have not ordered the said CVO medication,” the regional body said in a statement.
“The drug was approved by the US FDA only for compassionate use-meaning it was not approved fully but could be used base on the patient’s expressed consent. Why this long story? “Experience is the best teacher”. During outbreaks like Ebola, COVID-19 where there is no known cure, even black baggers can pretend and lie to get a cure. Governments have to be extremely careful about what to accept as quick solutions.
Mr. Tolbert Nyenswah, former Director of the National Public Health Institute(NPHIL) and now a Senior Research Associate and Expert with the International Health Department, Bloomberg School of Public Health
As part of its mandate to safeguard and improve the health of the region’s population, WAHO, the statement said, remains committed to promoting rational traditional medicine practices and products in the ECOWAS region, and over the years has worked consistently with the Member States to scientifically investigate plant medicines of proven efficacy. “These products are documented in our ECOWAS Pharmacopoeia of Traditional Medicines, the second edition of which will be published in the next few weeks. WAHO has also in the recent past identified, nurtured and supported centers of excellence in traditional medicine across the ECOWAS region.”
Caution Amid Skepticism
The statement added: “We are aware that several claims of a Covid-19 cure have been made in different parts of the world, but we can only support and endorse products that have been shown to be effective through scientific study. For this reason, WAHO is collaborating with relevant partners including WHO, Africa CDC, national, regional and international research consortia to promote the scientific search for a cure. We are working with Member States on some of the medications available for clinical trials and for use on a compassionate basis in selected severe cases. Some of the traditional medicine centers of excellence in the ECOWAS region are also currently investigating products of potential efficacy.
Instead, the ECOWAS Commission and WAHO say, they will continue to focus on delivering on the decisions made by ECOWAS Heads of State and Government at their recent Extraordinary Summit on the fight against Covid-19, one of which is to strengthen cooperation among Member States in research, training and experience sharing in health matters in general, and in the fight against Covid-19 in particular.
With so much attention now on Madagascar’s CVO, many like Mr. Nyenswah are urging caution. In the case of the Zmapp, he says: “The drug was approved by the US FDA only for compassionate use-meaning it was not approved fully but could be used base on the patient’s expressed consent. Why this long story? “Experience is the best teacher”. During outbreaks like Ebola, COVID-19 where there is no known cure, even black baggers can pretend and lie to get a cure. Governments have to be extremely careful about what to accept as quick solutions. My experience, this is what we did on the Incident Management System (IMS) then. I set up and appointed a research committee chaired by Dr. Stephen Kennedy, a Liberian.”
Tolbert adds: “For any drugs to be used it has to be prequalified by either WHO or US FDA either fully or on compassionate grounds. If drugs or vaccines are approved on compassionate grounds it has to meet the patients expressed consent before it can be administered by a physician, meaning the patients is assuming the risks of any adverse effects from that medication. ECOWAS does not certified vaccines or medications.”