Ebola Vaccine Components Do Not Cause Ebola Disease!

Wed, 8 Jul 2015 Source: Sodzi-Tettey, Sodzi

Ebola never left Guinea and Sierra Leone, and already, is back in Liberia! And there is still no vaccine to protect the population from disease and death! In Ghana, our Parliamentarians have banned Ebola vaccine trials out of panic that trials amount to importing the disease. As is the practice when anyone makes critical comments of Ghanaian Parliamentarians, they have promptly summoned a professor of clinical pharmacology, Alex Dodoo, before their Privileges Committee for interrogating the scientific basis of their decision.

As it turns out, world class Ghanaian scientists –Prof. Fred Binka, Prof. Kwadwo Koram, Dr. Kwaku Poku Asante and the investigating team – from the University of Health and Allied Sciences (UHAS), the Noguchi Memorial Institute for Medical Research (NMIMR) and the Kintampo Health Research Institute (KHSI) have teamed up in a multi country effort to develop an effective Ebola vaccine.

It would be recalled that the Ghana Academy of Arts and Sciences (GAAS) recently issued a public statement raising a number of concerns about the Ghana Ebola vaccine trials. Last week, the Ghanaian scientists provided a factual response to each issue raised by GAAS.

In general, vaccines are used to immunize populations without infection nor disease as a protective measure against the development of a full blown disease. These trials therefore intend to recruit healthy Ghanaians to determine the safety of the vaccines and to assess how the body tolerates the proposed vaccines in the first instance.

GAAS asked for the circumstances surrounding the appearance of the virus in Guinea, Sierra Leone and Liberia. The investigation team declined to speculate on these circumstances, and rightfully so since they did not know. Indeed, this is the subject of other research work.

GAAS then raised a series of questions relating to why Ghanaian scientists were testing a vaccine against the Zaire strain of the Ebola virus when it was the Makona strain that was the culprit in mainly Guinea. Here too, the scientists patiently pointed out that Makona is a variant of the Zaire strain of the virus apart from the latter being the main strain responsible for the West African epidemic. Infact "The type of protein used in the construct of the vaccine against Ebola has 97% similarity with all the known Ebola virus strains including the Makona strain" they explained. Necessary preclinical studies evaluating safety, immunogenicity and protection having been carried out on the Zaire strain.

Perhaps, given that the Ghana vaccine trial is on the Zaire strain, if GAAS has more specific questions pertaining to Zaire, it would be useful to put those on the table rather than appearing to draw the scientists into a Makona debate when the Zaire strain is the major culprit in the West African Ebola tragedy.

As part of these pre-clinical studies of the Ebola virus strain, 100% efficacy has been demonstrated in chimpanzees hit with a very dose, higher than the doses believed to be responsible for the current outbreak. Having successfully done this, the next phase is to evaluate the safety, tolerability, immunogenicity and efficacy in humans which is the reason for this trial in Ghana and other Africa countries.

The GAAS also noted that the application for the GSK Ebola vaccine Phase II trial in Ghana includes children, even though the Phase I trial in the US, UK, Mali and Switzerland was limited to adults. Do we know the correct dosages to be used in children in the Ghana phase II trial? Addressing this concern, the scientists referenced best practices in vaccine development, namely that adults would be immunized and subsequently monitored for safety events. The safety data of the adult population will then be reviewed by an independent external data safety committee, the Ghana Food and Drug Authority and Ethics committees before any approval is given for continuation of trials in children.

Are Ghanaian scientists strictly complying with the International Committee on Harmonization Protocol Guidelines for Clinical Trials, including fully informing participants of the risks, benefits and intent of the study prior to their voluntary involvement i.e. Informed consent?

The Ghanaian team of scientists systematically explained the various processes they had gone through to ensure the strictest compliance with safety and ethical standards. First of all, "This protocol was reviewed at country level by the Ghana FDA and the Ghana Health Service Ethics Committee and at the international level through a joint review by the African Vaccine Regulatory Forum AVAREF. Other participating countries concerns raised by their regulatory authorities were also factored in before the final protocol was sent to Ghana regulatory authorities for review and final approval."

Secondly, the sites for the trials in Hohoe and Kintampo were assessed by authorities for human resource and infrastructural capacity, track record in clinical trials meeting international standards, ability to recruit and follow up participants, and existence of standard operating procedures in line with the International Protocols referenced by the GAAS.

Thirdly, interim visits will be conducted by Ghanaian regulatory authorities at various points during the study in addition to the study having certified independent external clinical safety monitors responsible for onsite and remote tracking to ensure compliance with approved protocols.

Fourthly, a team of independent data monitors review all data in real time and report any adverse events within 24 hours. Should there be serious concerns about safety at any point, the independent data monitors, composed of experts from different backgrounds, have power to recommend stoppage of the trial.

Finally, the Ghana Academy of Arts and Sciences stated emphatically that the study conducted in Europe produced "prolonged bleeding in 10-15%" of the population. This turned out to be factually erroneous information put out by the Academy, as per the explanation of the Ghanaian scientists. What was actually reported was that the human cells that prevent bleeding were reduced briefly and this was managed professionally "but there was NO bleeding"!

For a country that can approach near lynching of citizens on the basis of rumors of said citizen's ability to cause other people's genitals to disappear, circumspection in raising concerns is called for, especially by bodies like the GAAS which prior to raising these questions in a public statement, could actually have independently visited the sites to verify the existence of the protocols and confirmed compliance with all the approval processes referenced above.

Given Ghana's physical proximity to Ebola, our established ethical review and regulatory processes, the existence of a group of competent and experienced Ghanaian scientists with a sterling track record in the conduct of several clinical trials, Ghana can join the global search for an effective vaccine with USA, UK, Switzerland and NINE other Africa countries— Mali, Gabon, Kenya, Tanzania, Uganda, Nigeria, Cote d'Ivoire, Senegal and Burkina Faso, where these important trials are taking place.

Sodzi Sodzi-Tettey



3rd July, 2015

Columnist: Sodzi-Tettey, Sodzi

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