It has been nearly four days now since international media outlets announced that at least two Ebola trial vaccines were expected to arrive in the country on Friday, January 23. It seems no one higher up in government or those managing the nation’s Ebola crisis knows anything about the ChAd-3 and Vesicular Stomatitis Virus (VSV) vaccines, whether they have been shipped to, or are now in Liberia, by GlaxoSmithKline, a British national pharmaceutical, biologics vaccines and consumer healthcare company.
The company said the trial drugs have already been “shipped” to Liberia. It developed the vaccines in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health (NIH).
The NIAID/GSK Ebola vaccine is based on a type of chimpanzee cold virus, called chimp adenovirus type 3 (ChAd-3). The manufacturers said the adenovirus is used as a carrier, or vector, to deliver segments of genetic material derived from two Ebola virus species: Zaire Ebola and Sudan Ebola. Hence, this vaccine is referred to as a bivalent vaccine. “The Zaire species of the virus is responsible for the current Ebola outbreak in West Africa.”
“The vaccine candidate delivers one part of Ebola’s genetic material to human cells, but the adenovirus vector does not replicate. Rather, the Ebola gene that it carries allows the cells of the vaccine recipient to express a single Ebola protein, and that protein prompts an immune response in the individual.
It is important to know that the Ebola genetic material contained in the investigational vaccine cannot cause a vaccinated individual to become infected with Ebola.”
The Daily Observer contacted several highly placed officials over the weekend and Sunday, who confirmed that they have heard about the vaccines but could not say whether they were now on the ground in Liberia or otherwise. Most promised to get back sometime this Monday afternoon with answers after finding out the status of the vaccines.
One eminent Liberian, who asked not to be named, described the “I don’t know” attitude of these officials, who should know everything about the running of the state especially the vaccines that have been widely publicized, as “lackadaisical.” This person added: “These are the kind of people we have running the state of affairs and playing with the lives of ordinary Liberians.”
However, Mr. David Sumo, Managing Director, Liberia Medicines and Health Products Regulatory Authority (LMHRA), confirmed that he had received an application from the United States Government’s National Institutes of Health (NIH), asking his entity to grant approval for the trial of both vaccines to be carried out in Liberia.
Mr. Sumo’s LMHRA is tasked with the statutory mandate of ensuring that every medical supply that comes to the country is safe, effective and of good quality before it reaches the Liberian public. It is also tasked with protecting Liberians from the harmful effects of substandard and counterfeit medicines and health products.
“We are aware because the sponsors [NIH] did apply in accordance with our guidelines,” Mr. Sumo told our Health Correspondent Saturday.
He said two separate ethical committees — one at his entity and another at the Ministry of Health — have been meeting separately, looking into documents sent in by the sponsors.
“For us, we are going to respond officially to them by Monday (today) latest. From our side, there are still some outstanding issues that we have noticed with their document which need to be addressed,” he stated. He, however, clarified that some of the issues won’t stand in the way of the trial process.
Mr. Sumo disclosed that this is going to be the “phase 2 trial” of the vaccines, which, according to him, have already undergone phase 1 trial in a few countries, including Mali, USA and Switzerland.
“With the information obtained from the first trial, we can now go into the phase 2 trial if our outstanding issues are resolved.”
He stated that at least 600 participants, who are going to be mostly health workers, have been earmarked for phase 2. The third phase, will target at least 9,000 persons at an unknown date.
“All the participants are going to agree voluntarily to undergo the trial. They will be told all the side effects and that the drugs are trial. They would have to agree and sign before being allowed to undergo the trial,” he emphasized.
Mr. Sumo, however, clarified that every participant will be followed and monitored for at least a year in order to make sure that they remain healthy and don’t develop any sickness as a result of the trial.
He stated that the vaccines will be administered to healthy Liberians, who will be thoroughly screened.
He told our health correspondent that once participants come out of the trial well, it means that they have now been vaccinated against the Ebola virus disease and can’t contract the deadly virus even if they came in contact with an infected person or object.
He disclosed that the vaccines will be stored below minus 30 degrees Celsius at the US Embassy. This is probably because there is no public facility equipped with such a cooling system.
A US Embassy official, who asked anonymity, didn’t confirm or deny this report, but said, “As far as we have been told, the vaccines have not yet landed in Liberia.”
GlaxoSmithKline, Vaccine Manufacturers
Authorities of GlaxoSmithKline have stressed that the vaccine is still in development and the World Health Organization (WHO), and other regulators, would have to be satisfied the vaccine is both safe and effective before any mass immunization campaigns could be considered.
According to the BBC, field trials of other promising vaccines – for example one involving the company Merck – are planned in Guinea, Liberia and Sierra Leone in the months to come.
These three countries are the hardest hit nations.
However, experts say with the number of Ebola cases falling opportunities to test vaccines and drugs could be limited.