By Kemo Cham
If all go as planned, trial of the much talked about Ebola vaccine will soon become a reality in Sierra Leone.
Officials spearheading it hope to inject the first vial into the first of 6000 participants involved by the first week of March as part of an elaborate process designed to cover four districts – Bombabli, Port Loko, Tonkolili and the Western Area. These happen to be the hardest hit areas of the country by the epidemic.
The 2014 West African Ebola outbreak is the 19th, in terms of major outbreaks, since 1976 when the disease was first discovered in the Democratic Republic of Congo. There have been about 13 minor or single outbreaks in UK, US, Italy, the Philippines and elsewhere in Africa, bringing the total outbreak to 32, according to records by the United States Centers for Diseases Control (CDC).
According to figures from the World Health Organization (WHO), as of 11 February, 9162 people have died out of 22, 859 cases, since March 2014 when the first case in the current outbreak was confirmed in Guinea.
This outbreak is unmatched by all the previous ones in many respects, most notably for its high fatality rate and the fact that it transcended international borders.
Based on experience, say experts, once an epidemic broke out in a country recurrence is only a matter of time. They predict the next ten years from now in West Africa, justifying calls for urgent development of vaccines.
A vaccine is an antigenic substance prepared to provide immunity against one or several diseases. It usually contains an agent that resembles a disease-causing microorganism, often made from weakened or killed forms of the microbes - either their toxins or one of their surface proteins. Vaccines basically stimulate the body's own immune system to protect the person against future infection or disease.
Antibodies
Every living being is susceptible to ill health. At some point in time we fall sick due to some infection caused by foreign particles or microorganisms which invade our system. And the body of every living being has been designed so that it naturally fights off any such foreign particle, doing so with the help of agents called antibodies found in the blood. But sometimes the foreign particles outnumber the antibodies.
Vaccines are therefore designed to induce the formation of more antibodies so that they can overpower the foreign particles. Vaccines, therefore, are created only to prevent sickness and not to treat.
Vaccines have been developed for a number of diseases which has helped to eradicate some while putting many under check. Examples include the polio, small pox and measles vaccines. This is the reason why suckling mothers report to clinic at specific intervals after giving birth for immunization of the young kids against certain of these disease children are prone to.
There has been no approved vaccine for Ebola yet. But some scientists had been working on few when this outbreak erupted. And because they have not been fully tested and approved, these are called candidate vaccines.
The rVSV-EBOV, which is to be deployed in Sierra Leone, is just one. It was developed by the Public Health Agency of Canada and licensed to the pharmaceutical firms Newlink Genetics and Merck.
Every vaccine goes through a process of verification to not only ensure its efficacy, but also to prove that it is safe for humans. This is the reason for the Sierra Leone Ebola Vaccine Evaluation Study (SLEVES).
Controversies
SLEVES is funded by the United States government through its CDC, which is working in collaboration with the Ministry of Health and Sanitation (MoHS) and the University of Sierra Leone`s College of Medicine and Allied Health Sciences (COMAHS) to conduct the trials.
“We have seen how this epidemic has hit us hard and so we have been working with the international community to see how we can stop it,” said Professor Radcliff Lisk, Vice Principle, COMAHS.
Health professionals and those particularly at the front line of the fight against the epidemic will be targeted, he said at a special press briefing he chaired, which was convened to formally introduce the programme.
Sierra Leone has lost 11 doctors, among several hundred other health workers. Dr Lisk said health workers` exposure to the virus by virtue of their work makes them perfect choice.
“We think that they deserve to be the first people to benefits, that`s why they will be the first to receive the vaccine,” he said.
Dr Mohamed Samai, Provost of COMAHS and head of the Pharmacology department, is coordinating the study locally. In a power point presentation he took press men and officials gathered at a lecture hall in the Connaught Hospital through some of the intricacies of developing vaccines, their relevance and administration.
Vaccines have always attracted controversies. Ebola vaccines have proving no less controversial. Currently, the only available seeming remedy for the disease is supportive treatment.
At the height of the outbreak last August, WHO convened an emergency meeting of experts to discuss the possibility of fast tracking the development of the most potent candidate vaccines and experimental drugs.
Vaccines usually take six to 10 years to develop under normal circumstances. However, WHO, citing the scale of this epidemic and the urgency it demands, gave drug and vaccine makers the approval to fast tracked the development of their products within six to eight months, but on the condition that all ethical considerations are followed strictly.
But the WHO approval doesn’t negate the questions raised by this very limited time frame.
Dr Daniel Feikin, the CDC`s point man in the SLEVES project, assured that there would be no “short cuts.”
“What we are trying to do here is to take a terrible piece of history in West Africa and turn it into a piece of monumental history,” he said.
Another concern, which is common with all drugs and vaccine, is the issue of side effect.
The rVSV-EBOV vaccine has already been trialed in Kenya, Gabon, US, Canada, Germany and Switzerland. During the Switzerland trial, the process was temporarily halted when volunteers complained joints pain.
But SLEVES officials insisted that so far only joints pains and fever have been associated with this vaccine. Besides, argued Dr Samai, there is no drug that`s devoid of side effects.
“We are involved in this because we believe in the science we are doing,” he said.
Yet none of these officials could categorically rule out adverse side effect.
Vulnerable health workers
Even though there has been no major adverse effect other than “minor fevers,” said Dr SAS Kargbo, Director of Health System Planning at MoHS, talks were on with the CDC on liability issues for possible compensation in case of any eventuality.
Regardless of all these assurances, public skepticism remains a major issue. Memories are fresh of how denial syndrome, fuelled by ignorance, led to the epidemic getting out of control in the first place.
But it’s not just the layman that needs enlightenment and convincing.
Minister of Health and Sanitation, Dr Abubakarr Fofana, has in the past expressed skepticism about the efficacy and safety of both experimental drugs and vaccines. And a parliamentarian has also kicked against using Sierra Leoneans as ‘guinea pigs’.
The SLEVES has so far only been approved by the Sierra Leone Ethics and Scientific Review Committee, while other relevant offices, including parliament, have been informed about it.
Approval is pending from the Sierra Leone Pharmacy Board, the US Food and Drug Administration (FDA), and the CDC Institutional Review Board. These approvals, said Dr Samai, are expected in the next few weeks.
For the University of Sierra Leone, this will be the largest ever research studies the college of medicine is involved in, said Vice Chancellor Professor Ekundayo Thompson. He said the study was crucial especially given that it could serve as protection for the country`s highly vulnerable health workers.
Many of the 12 medical doctors who died from the virus are from COMAHS, he said, noting that the situation occasioned by the epidemic had compelled the university to think on how to bring in foreign doctors to fill in the vacuum.
© Politico 19/02/15
