As the confirmed cases of the COVID-19 continue to rise across the world, many African countries, including Nigeria, are not taking anything to chance to check its impact.
Of course, it is not surprising that humanity is waging a serious war against this virus. Globally, no fewer than 102 million persons have contracted the virus even as it has killed over two million persons. Nigeria particularly has recorded over 126, 160 confirmed cases of the virus just as it has killed over 1,544 persons.
With these statistics, it is no wonder that Nigeria has joined the league of nations seeking vaccines to save their populace from the deadly virus. But as they do this, findings by ThisNigeria show that many stakeholders, including the World Health Organisation, are concerned about the functionality and efficacy of these vaccines, especially in a hot climate. In fact, the WHO says it is deeply worried that getting the vaccines to Africa is one thing and the assurance for their efficacy in the African climate is another kettle of fish.
WHO said, “Global COVID-19 vaccine trials are being conducted in all continents, representing all diverse human populations in the world. In Africa, Egypt and South Africa are participating in these trials. Many other countries are also preparing to participate.
“Till date, discovery has shown that there are 260 COVID-19 vaccine candidates at different stages of development. Sixty of these are undergoing clinical testing (human trials) in different phases. This includes phase III trials – the point at which scientists aim to determine how well a vaccine protects (efficacy) trial participants from infection or severe COVID-19 symptoms.
COVID-19: Africa records 3.3m cases, 82,000 deaths
“November 2020 has been a celebratory month. Preliminary phase III data of three different COVID-19 vaccine candidates showed impressively high efficacy ranging from 70 per cent to 95 per cent. All three – Pfizer/BioNTech, Moderna mRNA-1273 and Oxford ChAdOx1-S vaccines – are in the late stage of phase III clinical trials. Pfizer/BioNTech and Oxford ChAdOx1-S are being tested in Africa too to ensure efficacy.
“After investigations of an initial safety concern in phase III trial, the Oxford ChAdOx1-S vaccine testing has proceeded well.
“The ground-breaking developments offer hope and optimism. But there are still major obstacles ahead, particularly for developing countries. Chief among these are the fact that at least one of the vaccines showing promise needs to be kept at extremely low temperatures prior to use. This will be difficult for most African countries.
“In addition, there are concerns about access to the vaccines once manufacturing starts. Among the key concerns is the availability of sufficient vaccine doses to meet the high demand. And then there’s the question of affordability. Resources will be urgently needed to procure and distribute COVID-19 vaccines at a rapid pace.
“A great deal of focus is being placed on the COVAX Facility, a GAVI co-led global risk sharing plan. This is overseeing the pooling of procurement and equitable distribution of eventual COVID-19 vaccines”.
NAFDAC rules out clinical trial
However, Nigeria says it is investing about N400bn for the expected COVID-19 vaccines due to arrive in country this month. The huge investment is coming on the heels of some stakeholders’ concerns over the workability of the drugs in the country. While some spoke on the need for a clinical trial of the drugs, others questioned the level of preparedness in terms of infrastructure, and climate. For instance, the National Agency for Food and Drug Administration and Control has ruled out the possibility of conducting a local clinical trial on the vaccines before administering them on the citizenry.
The agency said since the WHO had approved the vaccines, there might not be need to conduct another clinical trial on the vaccines. NAFDAC’s Media Consultant, Sayo Akintola, in an interview with our correspondent, noted that due to the exigencies of COVID-19, there would be no reason to conduct a trial before administering the vaccines. He said, “Once the vaccine arrives, a sample will be taken to the lab for a test. Once its safety and efficacy are certified by NAFDAC, it will be administered on Nigerians. We do not expect anything to be different though.
“The truth is that once a vaccine is approved by the WHO, it is assumed that it has passed through some preliminary stage of the trial. It is a known fact that for the WHO to approve a vaccine, it must have gone through a series of trial here and there.” Akinola, however, said there was the need for ratification to ensure the drugs’ efficacy and safety.
He stated, “It is just for ratification. There is nothing on drugs or vaccines you will do without the consent of WHO. It is also expected that the regulatory body in each country would do its work in tandem with the WHO standard.”
Reservations/concerns
Interestingly, some virologists and infectious disease experts have disagreed with NAFDAC, insisting that there is necessary to conduct a clinical trial on the vaccines in the country before administering them on Nigerians.
A clinical trial, according to the WHO, is a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. It notes that people volunteer to take part in clinical trials to test medical interventions including drugs, cells, biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.
For a medical virologist at the Ahmadu Bello University, Zaria, Kaduna State, Prof. Umaru Hassan Bako, it would be safer to conduct a mini clinical trial to determine the efficacy of the vaccine before rushing to administer it on a population of over 206 million.
Bako, who spoke to ThisNigeria noted, “This is because there is no evidence to show the earlier trial conducted in Europe had African volunteers. There is something we need to understand. In terms of human genetics, African Americans are different and cannot be used to represent Africans in a trial.
“They could be similar, but they cannot be regarded as a proper representation of Africans. That is why you see a lot of differences in the way we respond to treatments based on our genetic make-up.”
Also, a medical microbiologist at the Lagos State University, Ojo, Prof. Bola Oyefolu, said there was the need to conduct a clinical trial before administering the vaccines on Nigerians. “Before any vaccine is given, there is a standard procedure for it. Before you can inject people with any vaccine, it must have gone through serious clinical trials, and when you look at the duration for that, it will take an average of three years.
“The clinical trial will prevent mortality. There is the need for more time to do a more open clinical trial to be sure that what we are giving to the people is safe” Oyefolu also cautioned the Federal Government against procuring COVID-19 vaccines from abroad.
He said, “From the virologic point of view, I don’t think Nigeria should go for the vaccines because everything is shrouded. It is not open. I am just wondering why they are not doing clinical trials with their own people over there. Why must it be Africans? Are we guinea pigs? Unfortunately, most African leaders will not investigate the core of it; they will just go for the vaccines, maybe for the monetary gain.
“Once this vaccine is administered and it gives us a negative result, it can’t be reversed and that will be an indictment on the scientists in Africa.”
Recall that the Director-General, Nigerian Institute of Medical Research, Prof, Babatunde Salako, told News Agency of Nigeria that although there was a need for a clinical trial, NAFDAC had the responsibility to determine if that was necessary or not.
He said, “The fear of those calling for a clinical trial is understandable. That the vaccines work for Caucasians does not mean it will work the same way for Africans. Therefore, there is a need to determine whether the vaccine is also efficacious here and safe for use on Nigerians.
“Having said that, the owners of the vaccines are the ones who will decide if they want the clinical trial. For us, we have a regulatory body like NAFDAC that may insist that efficacy and safety tests be done before Nigeria accepts to try it. If they don’t have that already, they may have to do it.”
The researcher, however, expressed reservation that the pressure being mounted on manufacturers of the vaccines in other countries may not make them agree to such demand.
“I doubt if they will agree because there are countries who are ready to buy and use them willingly without that kind of conditionality.
“For instance, when we met with the Russian representatives for their COVID-19 vaccine last year, we did ask if we can run a clinical trial on it in Nigeria. They were not willing to agree. According to them, it has been conducted in one or two African countries and they thought that Nigeria is unlikely to be different. They believed that the efficacy of the data they got (from the other African countries) should be extrapolated to the Nigerian situation.
“Again, if the country decides to grant an emergency use of the vaccine, it will only review the data they have for other populations. But under normal circumstances, countries’ regulatory agencies will request a clinical trial on efficacy and safety of the vaccine,” he added.
‘No vaccine clinical trial site’
Contributing, a renowned Professor of Virology and former Vice-Chancellor, Redeemer’s University Nigeria, Oyewale Tomori, puts a question mark on NAFDAC’s claims.
He said, “The country does not have a site for vaccine clinical trial. To the best of my knowledge, I don’t think we have any. What we usually do is to insist that any product, drug or vaccines should obtain WHO approval for full and emergency use as well as NAFDAC authorisation before it is approved for human use in Nigeria.
“I’m not aware of any vaccine that was subjected to local clinical trials after WHO approval and NAFDAC authorisation.” He explained that what was usually carried out after inoculation with such approved vaccines was to conduct pharmacovigilance and meticulously monitor any adverse events among recipients.
He added, “I’m sure NAFDAC has plans for such studies. The Pfizer/BioNTech Covid-19 vaccine received emergency use validation from the WHO. I assume our NAFDAC will call for and review all the documentation submitted for the WHO approval.
“Again, I do not think it is feasible to do a local Nigerian clinical trial for a vaccine that has received WHO validation. We currently do not have the resources to conduct clinical trials for vaccines.” But toeing a different path, a consultant virologist at the University of Ibadan, Oyo State, Prof Olufemi Olaleye, said there was no need for another clinical trial of the vaccines.
He explained that there might be little difference in response of people to vaccines/antigens, adding that vaccines were supposed to be universal. He noted, “There is no vaccine for Africans that is different from the one for Caucasians or Chinese or any other race for that matter. Even within the same race, people respond to antigens or vaccines differently. I will be surprised if anyone is calling for clinical trial during a threatening pandemic like COVID-19. It is not when a house is on fire that you want to start testing your fire truck.”
The virologist disclosed that clinical trial was a long process, hence the reason for emergency use authorisation in the United States, the United Kingdom and the European Union countries.
He also stated that he was unaware of any institution with trained personnel and facilities for a proper clinical trial in Nigeria. Olaleye added, “I think what the minister of health requires is full information on the vaccines under considerations such as safety, immunogenicity and the logistics of handling to make an informed decision on which brand to procure. Be that as it may, an important question to ask based on the pattern of the disease in Nigeria thus far is whether we require vaccine now or not?”
He, therefore, recommended that the country should seek ways to ensure adherence to the non-pharmaceutical intervention approaches to more prevention and monitor outcomes of the ongoing vaccination in other countries as may be required.
NMA recants
Nonetheless, as these controversies go on, the President, Nigerian Medical Association, Prof. Innocent Ujah, has made a U-turn on the need for a clinical trial. According to him, since Nigeria is in an emergency, the COVID-19 vaccine will no longer need to pass through a clinical trial.
Ujah, who had earlier said the vaccine should be subjected to a clinical trial before being administered on Nigerians, noted that the efficacy of the vaccine had been established by scientific process. He explained that since Nigeria and Africa were not involved in the clinical trial, “it is good to revalidate so that we can also report some likely untoward effects – side effects.”
He said, “When we have that we can tell our people that it (the vaccine) cannot kill our people, but we can tell the people the likely reactions some people may likely get. That is revalidation. It is not that we are to go through a barrage of clinical trials because to do clinical trial particularly in an emergency will take some time.”
Ujah, who is also the Vice-Chancellor of Federal University of Health Sciences, Otukpo, Benue State, said though there had yet to be any vaccine for HIV all, scientists got a vaccine for COVID-19 within nine months and it was approved by the Food and Drug Administration in the United States because it required an “emergency authorisation.”
Meanwhile, the WHO has approved the Pfizer/BioNTech vaccine for emergency use, paving the way for lower and middle-income countries to begin immunising their population against COVID-19.
The vaccine was first approved in the United Kingdom last December 8, for emergency use in the country, with the United States, Canada and the European Union taking the same decision afterwards. All have begun their own vaccination drive.
The WHO approval implies that countries without their own regulatory bodies, or the means to rigorously assess the efficacy and safety of vaccines, can now expedite their own approval processes and begin rolling out vaccination programmes.
According to the WHO Assistant-Director General for Access to Medicines and Health Products, Dr. Mariângela Simão, the Emergency Use Listing has opened the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.
He added, “This is a positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasise the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere. “WHO and our partners are working day and night to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It is important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.”
Scientist cautions FG
In a related development, a professor of Immunology at the University of Ibadan, Ganiyu Arinola, has cautioned the Federal Government against the mass vaccination plan.
According to him, though no amount of investment on health is a waste, such nationwide vaccination programme might not be the best use of the nation’s scarce resources.
Arinola, who spoke to the News Agency of Nigeria noted, “The mere availability of COVID-19 vaccine is insufficient to give broad immunological protection. As of now, it will be advisable to be cautious in the use of current COVID-19 vaccines because so many facts are still emerging on the vaccines.”
He added, “Among other concerns about COVID-19 vaccination in low resource countries is a question; do their benefits outweigh the risks or how safe are the existing COVID-19 vaccines?”
Hope on the horizon
Meanwhile, ThisNigeria reports even as these fears exist, there is still hope on the horizon. For instance, according to WHO, there are already three vaccines at phase III stage with a similar choice of an antigen – the SARS-CoV-2 spike protein. But they work differently in the way they teach the immune system to protect human bodies from COVID-19.
Pfizer/BioNTech is a mRNA vaccine. Such vaccines work by instructing the human cells to make a small part of the virus surface protein and induce the appropriate type of immune response that is thought to confer protection. In this case, it is an immune response to the SARS-CoV-2 spike protein. This protein plays a key role in enabling coronaviruses to infect human cells and replicate.
According to the WHO, some infected people, COVID-19 disease develops, whereas others remain asymptomatic, without any signs or symptoms of the disease. Preliminary data show no major safety concerns are associated with a two-dose administration of the vaccine. This mRNA-based COVID-19 vaccine induces T-cell and strong neutralising antibody immune responses. Both T-cell and antibody immune responses are thought to be critical in protecting against COVID-19. A similar mRNA vaccine, made by Moderna, has shown comparable results.
Efficacy of 95 per cent has been reported for the Pfizer/BioNTech (mRNA) vaccine, far exceeding the expectations. This type of vaccine can be rapidly manufactured and scaled to capacity to meet the high demand for millions of doses. If licensed, it will be the first mRNA vaccine approved for human use by the regulatory authorities.
Oxford ChAdOx1-S is a non-replicating viral vector vaccine. The viral vector, or backbone, used in this vaccine is based on the chimpanzee adenovirus (ChAd). The choice of this type of vector is to circumvent common pre-existing immunity to human adenoviruses (HAdV) that would blunt the ability of such a vaccine to engage the human immune system.
Already, scientists have experience with clinical testing (safety and immunological profiles) of the ChAd viral vectored vaccines. The Oxford ChAdOx1-S works by using a replication-deficient adenovirus vector to conveniently deliver the spike protein to immune cells or tissues, thereby inducing the desired immune response against SARS-CoV-2. The vaccine-induced immunity comprises T-cell and strong neutralising (infection-blocking) antibody immune responses.
Novavax NVX-CoV2373 is a protein subunit vaccine. Subunit vaccines work by presenting a specific antigen that stimulates the immune system to mount a response. Importantly, these types of vaccines require combination with adjuvants (a compound that enhances an immune response), as the antigens alone are not enough to induce optimal and long-term immunity.
The antigen (spike protein) in NVX-CoV2373 vaccine is made and purified from cell culture, then formulated – along with Novavax’s saponin-based Matrix-M adjuvant – to a nanoparticle. There is vast clinical experience of this type of vaccine platform in terms of safety and immunogenicity, such as the seasonal influenza vaccine.
Preliminary data shows NVX-CoV2373 vaccine-induced immunity comprises T-cell and strong neutralising antibody immune responses. It is likely this two-dose schedule vaccine candidate will show high efficacy.
More challenges
ThisNigeria findings indicate there is a big challenge for the Pfizer/BioNTec vaccine, especially as it needs the cold chain requirements. It needs to be transported and stored at unusually low temperature (-70°C, on dry ice) prior to use. Immunisation programmes – particularly those on the continent – don’t have the vaccine supply and cold chain infrastructure that can optimally handle this vaccine. This is especially true at the level-one healthcare facilities where immunisations routinely take place.
This means that significant investments will have to be made prior to rollout to communities in remote areas. This could cause massive delays in the use of the vaccine, especially in low- and middle-income countries. The good news is that innovative approaches, such as design and development of appropriate transport containers, may address these challenges.
The other two vaccines can be handled within the current immunisation cold chain infrastructure that keeps temperature at a range of 2°C to 8°C prior to use.
Another potential challenge is that the use of any of these vaccines by national immunisation programmes will need to be informed by high quality and timely evidence that takes local context into consideration. This means that national policy makers must urgently and meticulously consider the merits and demerits of each of the vaccines prior to deciding which one to use.
On cost and access, a great deal of effort is being put into the COVAX Facility. This seems to be Africa’s only insurance policy against being the last in the queue.
Nigeria, for example, will receive 100,000 doses of the Pfizer vaccine by early February, according to official but they have to be stored in cold temperatures and getting them to rural areas will prove difficult.
In reply to WHO expectations, Nigeria, through its National Primary Healthcare Development Agency, says it has found a way though through its ultra-cold chain equipment. The NPHDA’s Director-General, Dr. Faisal Shuaib said, “What we do have coming to the country is the Pfizer vaccines that require about -70 degrees Celsius. This is why we are actively making sure that we have those vaccines and also bearing in mind that additional vaccines might be brought from the Covax facility that will require these types of temperatures.”
According to Shuaib, the NPHDA already has three Ultra Cold Chain (UCC) equipment on the ground.
He added, “Three of them have a total capacity of 2,100 litres. So, we have more than enough space for the 100,000 doses of the vaccine that will be brought in the first instance. But the country is also looking for easier alternatives. We will be focusing more on those vaccines that do not require these kinds of complicated cold chain mechanisms. So, the Oxford-Astrazeneca types of vaccine that require +2 to +8 degrees Celsius are what we are going to be focusing on.”
But a medic, who works with the health secretariat of the Federal Capital Administration, has raised doubts about the success of the planned vaccination. The medic, who craved anonymity said, “I know that such infrastructure does not exist in Nigeria but if they are, it is grossly inadequate to help in the upcoming vaccination exercise. And in a situation where we can’t respond to the cold chain mechanisms, then the vaccines will lose its potency. And if we don’t preserve them at the right temperature, we will not get the right result.
“So, we would be running the risk of administering vaccines that have lost their efficacy and you know the effect is that you will likely have millions of people you have wrongly vaccinated and not protected. The scenario is similar to that of a man who has a fake bullet proof. The man incidentally has this impression that he is protected, only for a bullet to hit and kill him. That is where we are heading for now and that is if the status quo remains the same.
“Except if these drugs they are bringing do not require such preservation, but I know that they do. All vaccines require some level of cold preservation and some we put them in refrigerators till we use. But for this COVID-19 vaccine, it requires extremely low temperature to enable it to work well and counter the virus.”
On the citizenry’s fear and apathy, he called for more public awareness.
He added, “You see we need public enlightenment because one thing is to bring in the vaccine and the other is for people coming forward to take it more especially when others say the virus does not exist. We have to adopt this strategy to make people accept the vaccines. “So, educating the people is important. Let them know the root of what they are about to take. The need for it and the methods it will take. These things must be applied, or the exercise is bound to fail.”
41 million more vaccines
Meanwhile, the Minister of Health, Dr. Osagie Ehanire, says the country has secured an additional 41 million doses of the COVID-19 vaccine.
Ehanire, who explained that the previously scheduled period for delivery of the 100,000 doses was January 2021, confirmed that the date shifted to this February because of the “challenges of getting the supplies”. He noted that the additional 41 million doses of the vaccines would come through the African Vaccine Acquisition Task Team (AVATT), a vaccine strategy organised by the African Union, which is chaired by the South African President Cyril Ramaphosa. He noted, “A mechanism for the African Vaccine Acquisition Task Team (AVATT), of which the minister of health of Nigeria is a member, and the chair is the president of South Africa, was inaugurated in November 2020.
“At the meeting we had on the January 6, it was announced that they had a mix of 270 million doses of COVID-19 vaccines going to be ready, because they are on order. “Now, we immediately applied for 10 million doses, but at the meeting we had two days ago, the AVATT team announced that they actually had now done allocation according to population. Nigeria is allocated 41 million doses of vaccines of three types.” He explained that the procurement of the vaccines for African countries is being financed by the Afrexim bank, and countries are expected to make a refund on a later date.
sked when in February the vaccines would be available in Nigeria, the minister said he did not have an exact date. “We do not have an exact date. The date it comes out depends on when the manufacturers are able to deliver, and that is not something any country can enforce,” he said. On the availability of funds for the procurement of the vaccines, he noted that the COVAX facility doses are free for the first 20 per cent of the population, while the country will pay for logistics on delivery and administration.
“Nigeria is mobilising resources. We have some funds ready. We will make a substantial deposit when it is time,” he added.
