What it takes to produce Ebola Vaccines in Nigeria - Dr Agwale
A vaccinologist and viriologist, Dr Simon Agwale is the Chief Executive of Innovative Vaccines Limited, Abuja. In the heat of the Ebola virus scare in the country, he spoke with journalists in Abuja at the weekend, on Nigeria’s chances of developing vaccines for the virus.
It is apparent that the United States may not be in a position to give experimental drugs to Ebola-endemic countries. What hopes are there for us? The American government will not give any country vaccines or therapies that have not gone through clinical trials and licensed except for clinical trials purposes. These are products that showed promises in animal models. The good thing about the Ebola virus is that there are already existing animal models that develop the same symptoms as humans. It is a perfect platform to develop quick vaccines and drugs. One must be guided by science in asking the US for such products based on two patients recorded in Nigeria. Again, the products should be approved by the US regulatory authority, which is the FDA. For Nigeria to use products that come from our decisions, such products should be manufactured locally. This is not a rocket science. We know how these products are produced. The least we can do is to go into licensing agreements with the manufacturers with a defined territory. This means that when the products are licensed, Nigeria will be the territory for sales, and the royalties paid to the manufacturers. This is the standard practice. It is not a political decision but business decision. However, for outbreaks like the current Ebola and because of the public health interest, decisions may be taken on compassionate grounds.
What is the immediate way out in the case of Nigeria?
We have to segment this. We have to have a short-term solution because people are already infected; then medium and long-term solutions. It boils down to capacity development. There is no magic bullet as far as this is concerned. The main thing now unfortunately is to quickly build our own structure where we will be in the position to determine our tempo. If we have a local vaccine factory, various claims such as the woman in the US advocating for Nano Silver could be verified. Other people talk about electro-static ways of handling the virus, but all these claims must be scientifically verified. So there is need for a local vaccine factory or local capacity to be able to verify these claims. Without it, where will the claims be tested?
Do you think Nigeria is battle ready for Ebola virus?
The commitment has been fantastic in terms of creating awareness to reduce the spread. There is also information on how to isolate people who are infected; some telephone numbers have been stipulated for emergency cases. In that regard, the government has done well. But there is no disease that can be eradicated without a vaccine. So it
A vaccinologist and viriologist, Dr Simon Agwale, is the Chief Executive of Innovative Vaccines Limited, Abuja. He is in charge of Innovative Biotech USA Inc, and Keffi, Nasarawa state. In the heat of the Ebola virus scare in the country, he spoke with journalists in Abuja at the weekend, on Nigeria’s chances of developing vaccines for the virus.
points to building our local capacity. Currently we have what is called candidate vaccines; unfortunately these vaccine candidates were developed by scientists in the USA and Canada where no Ebola case exists. The place where we are in the vaccine industry is that we know the protective protein, which is called the glycoprotein (GP) of the Ebola virus. What we need to do is to take that protein and clone it into a system and then develop the process, and conduct the test. It has been shown to protect animals from Ebola virus challenge. Vaccine development is from animals to humans. There is no Ebola in Canada and the US; that is why they cannot do efficacy trials in humans. That is why they have just done the phase one of the trial. The result of the one done by the US National Institute of Health is promising. But they can’t go beyond that because there is no Ebola outbreak there. The ideal thing would have been to move to phase 2, and phase 3 clinical trials requiring the people that are exposed to receive the treatment; some will not. It is controlled clinical trials. This experimental candidate vaccine does exist; we know that they protect monkeys and other animal models, but it requires building the local capacity to enable the local production of the vaccine. Nigeria is in a fantastic position to develop Ebola vaccine for the world. The US and Canada have the technology but do not have Ebola. They won’t give their trial vaccines out because any product that is developed must be tested in the country of production first. However and like I said previously, based on licensing agreement or public health interest, these vaccines could be available only in the context of clinical trials.
Is there any effort you are making as an individual to locally have a vaccine manufacturing company in Nigeria?
When we talk about vaccine manufacturing, we are talking about manufacturing vaccines that are already in existence to make them available in Nigeria. When you talk about vaccine development, you are developing something that has not been known. In terms of Ebola virus, it is the second scenario because the vaccine has not been developed yet for us to manufacture, but even if vaccines for Ebola are developed for clinical trials, there must be a vaccine manufacturing plant to produce them for clinical testing. Currently the capacity to develop vaccines in Nigeria is very rudimental. It will take us time to build, but we have the capacity to build that within months, then train local scientists on vaccine development. But the fastest we can is to take advantage of our lab in the US. We are working on HIV vaccine and new generation cervical cancer vaccine. It is the same platform that was used to develop the cervical cancer vaccine (i.e. viral like particles or VLP displaying the protective proteins) that will be used on Ebola. What we need to do is to change the HIV antigen and put the Ebola antigen and quickly scale up the process and manufacture the clinical grade of the product and then begin to test. If we are serious about this, within months, we should have an experimental vaccine that we can test locally and see if we can control the disease. If there is vaccine, everybody will get Ebola vaccine, then the epidemic will end. It is urgent because we don’t know the next epidemic that will come after Ebola. That has been the history of infectious diseases. The good thing about building the capacity is that when we experience another epidemic, we already have a platform. It requires studying the new organism and checking whatever that can be taken and clone it into the platform. This is the only way to avoid jumping here and there to take care of epidemic emergencies. We have to be proactive.
Are there products which your agency has in Nigeria that can mitigate the epidemic?
Yes. There are many products that have been tested in vitro. An example is the Nano Silver. It has been tested against viruses, bacteria and parasites, and based on in vitro data, no organism survived the presence of Nano Silver above six minutes. Whether that will translate into treatment of Ebola is what needs to be investigated. There are many articles published on Nano Silver to inhibit the growth of these organisms. If we have the right platform, these products need to be tested immediately. The safety aspects of these products are well documented. These are the kind of products we are talking about for the short term. They have been well tested to show that they have anti-viral properties. This is a fantastic opportunity for us to test many products based on science. The issue of having the products does not rise because we can quickly get them. Getting them to Ebola patients is a decision that will go through the normal procedures.
You have been campaigning for the eradication of typhoid in Africa. How has the journey been?
Typhoid is a major problem in Nigeria. If it is kicked out, hospitalisation will be reduced drastically. Over the years we have had two types of typhoid vaccines: the oral typhoid vaccine is one. Its limitation is that it is attenuated. It does not protect people that live in countries where typhoid is endemic because of pre-existing immunity thereby reducing its effectiveness. Also it does not protect children less than five years old. Thirdly it must be taken three to four times and every three years. Because of these limitations, the second generation typhoid vaccine was developed which is called the Vi Polysaccharide typhoid Vaccine. Again it has its own limitations. It does not protect children less than two years. The antibodies also wane after three years, so one has to be revaccinated. The third is that the efficacy is just between 60 and 70 percent. The newest vaccine is the Typhoid Conjugate, which provides long lasting immunity that could potentially protect for life. The conjugate vaccine was licensed last year and currently undergoing registration here in Nigeria by NAFDAC exclusively to Innovative Vaccines, Abuja. It is produced by only one company in the world and our company partners with it in the process.