The other day I wrote an article titled ‘FDA and the Secret Ebola Vaccine’. While some found it informative and insightful, others, though with no cogent rebuttal, felt it would discourage efforts at testing the Ebola Vaccine in Ghana. The point must be made that, a condemnation of the FDA’s approach to this trial is not a blanket attack on vaccination. Neither is it a hasty conclusion on the appropriateness, success or otherwise of the proposed vaccine trial.
Those who felt there is undue hue and cry about the Ebola trials put forward a number of arguments. Some of them say that the vaccine is safe because they have been tested in some other countries. Another group makes the argument that no form of Ebola virus will be introduced into the test subjects, while others are proclaiming loudly, especially on social media, that they are ready to take the vaccine test.
The question to ask those who are touting the safety of the vaccine is this; why would you need to test a vaccine which is already known to be clinically safe? I can only lend credence to this sort of position if it were post marketing studies being conducted. This usually helps to determine comparative effectiveness, optimal use, effects of widespread use etc. But once it remains a pre-market test, those concluding on the absolute safety of the vaccine should either stop being economical with the truth or simply hold their peace.
At this moment, what we should be interested in is the stages of trials that were conducted in other countries, if any, and the outcomes. What stage is proposed in Ghana? What is it meant to test for? Adverse effects, dosage, overall risk-benefit relationship, etc. What potential risks and short-term effects could there be in the stage of testing being proposed in Ghana? While some have voluntarily gone a step ahead to get information from some sources on purported trials in other countries, we are yet to get a thorough answer from the FDA on this aspect of the matter.
Those trumpeting the view that no form of Ebola virus will be introduced into the system of the test subjects should go tell their story to the marines. This claim conflicts the fundamental understanding of vaccination; which involves the introduction of a weakened form of the virus (pathogen) into the test subject. The test subject is expected to develop resistance to the virus so as to be able to fight the active form of the virus.
A way to determine that the vaccine actually works could be to subsequently introduce an active form of the virus into the vaccinated subject. The finer detail of how this is done depends on the stage of the trial. While some protest that this approach will not be used, others want to know how the researchers will determine that the immune response to be generated by the test vaccine in Ghanaians is strong enough to fight Ebola. Some now intend to go into jargons by claiming the vaccine only contains a ‘prototype’ of the Ebola virus or a recombinant antigen. I ask; prototype or recombinant antigen of which protein sequence? – That of the Ebola virus or a housefly? Why do we have to complicate issues instead of telling people the truth in simple terms?
While others claim they are willing to volunteer for the trial despite the little information available, they must know that the consequences of a botched test is not limited to them. A possible situation could arise where a test subject who is re-infected with an active dose of the virus would not develop symptoms within the benchmarked period and thus would be released back into his or her community. When this person subsequently comes down with symptoms, it is prior education and awareness that will compel him/her and their immediate community to report quickly, without remorse, to a physician – who would also have a fair appreciation of the situation and take appropriate action. However, if a few persons go to conduct the test in secrecy and an undesirable outcome surfaces, how are we expected to handle it as a nation in an organized manner?
To end, it is instructive to know that this is not a simple for or against matter. Vaccine trials can be prone to complications; as has been widely reported elsewhere and sited in my earlier article. As such, it is important that we ask the appropriate questions and get the necessary education. While doing this, we must be careful not to throw away the baby with the bathwater; that is, if the consensus is reached that the trials should go on.