COVID-19 vaccination: Cases of side effects aiding skepticism

• Bottlenecks As States Begin Vaccination
• Medical Guild Decries Vaccine Nationalism By West

After several months of waiting, Nigeria eventually began nationwide COVID-19 vaccination last week Friday, in Abuja. But despite the excitement that greeted the occasion, there are several concerns and unanswered questions over the vaccination.

Besides, accessing COVID-19 vaccines has become an issue, especially with Western countries trying to ‘own’ them.

Also, it has been alleged that the West wants to ‘fleece’ developing nations, particularly African countries of their foreign reserves domiciled in Europe through the vaccines, coupled with the politics involved in accessing the vaccines, as the West buys up more than they need, leaving other countries struggling to access them.

But just as the exercise spread to states across the country, the issue of safety of the vaccine has reared its head again. Before now, many Nigerians, including Kogi State Governor Yahaya Bello, were skeptical of the efficacy and real intent of the vaccination and had refused to take the jab.

A European Medicines Agency (EMA) statement on Thursday that about 30 cases of the side effects were reported among five million Europeans that had been vaccinated reinforced that belief.

Although no African country has reported any side effect of the AstraZeneca vaccine, though South Africa recently stopped its use, this has further heightened anxiety among the populace as the vaccination exercise soon spreads to the grassroots.

The batch of the vaccine delivered to 17 European countries traceable to the few cases of a blood clot is reported to be ABV5300, which the federal government assured was not the same delivered to Nigeria.

While some countries have stopped its administration, others suspended its use. Among countries that have placed total suspension of its use are Denmark, Iceland, and Norway, while Italy; Austria; Estonia; Latvia; Lithuania, and Luxemburg have suspended the use of the particular batch, just as Thailand, which had not begun its administration, suspended its use.

Joint pioneer of In Vitro Fertilisation (IVF) and Medical Director, Medical Art Centre (MART) in Maryland, Lagos, Prof. Oladapo Ashiru, said: “This is the problem we have in Nigeria. In most countries, medical science is driving the initiative, but in Nigeria, strategy, coordination, and cooperation is lacking.

“There are some side effects, but we need to do a critical evaluation to determine the best solution regarding the vaccination. In most countries, it is easier for the public to take the vaccine once the medical science experts give a go-ahead.

“That is why the Academy of Medicine Specialties has assembled a team of experts to assess and advise government on the way forward. It wants to take a lead in advising the public on the way forward in the current pandemic.

“Like other national academies of medicine, we need to launch a rapid-response initiative committee of the academy to explore the current state of the art and provide recommendations to improve the country-wide strategy for preparedness, border control in cases of new pandemics, regulatory approval, distribution of vaccines and post-approval surveillance for adverse events.

“The expert committee would head this rapid initiative group and would give advice to the Academy regularly to be published and given to the government and in the newsletter to the Academy and the Public. The group is expected to be active immediately.”

A public health physician and Executive Director, Enugu State Agency for the Control of AIDS (ENSACA), Dr. Chinedu Idoko, told The Guardian: “There is still a lot to unravel/learn about this novel COVID-19. Could the stated reactions/side effects, following vaccination, be race-linked? What percentage of the general populace that received the vaccine was affected? Have the said reactions been confirmed to have only been experienced with the particular vaccine make? A lot of questions to attend to before even making a hypothesis of it.

“Having said that, I don’t see Nigeria suspending the use of the vaccine. We have to look more to the general populace gain and the targeted ultimate herd immunity to be derived from good immunisation coverage and then, of course, a follow up on associated factors to vaccination, these possible side effects not being an exemption.”

Following apprehension over the vaccination, the Head, Public Relations Unit of NPHCDA, Mohammed Ohitoto, in a statement, said the agency was awaiting the outcome of the investigations and would go ahead with the exercise.

The statement read: “We understand that investigations are being conducted to determine if the batch is in any way linked to an observed side effect. While we await the outcome of the investigations, it is important to clearly state that Nigeria did not receive any doses from the batch of vaccines, which is at issue.

“Vaccinations in Nigeria started earlier this month and we have not observed any similar adverse reactions. All side effects reported by those who have been administered the vaccine have been mild.

“We are satisfied that the clinical evidence indicates the Oxford-AstraZeneca vaccine to be safe and effective. Our assessment is in line with countries, such as Spain and the UK, which have indicated that they will continue to administer the vaccine because it remains an important tool to protect against COVID-19.

“…We are continuing to monitor the developments regarding ABV5300 batch and will share further information as it becomes available.

“In the meantime, we encourage Nigerians who are among those being prioritised in the current phase to continue their confidence and enthusiasm for our vitally important national vaccine programme. Together, we can save lives.”

On access to vaccines, Director General/Chief Executive Officer of Nigeria Centre for Disease Control (NCDC), Dr. Chikwe Ihekweazu, told The Guardian: “A unique challenge with accessing COVID-19 vaccines that the world has not faced in decades is that every single country in the world needs vaccines for their entire population. This means we need vaccines for the over seven billion people in the world. Unfortunately, the demand at this time greatly exceeds the supply.

“However, for this pandemic, we have structures, such as COVAX, established by World Health Organisation (WHO), Coalition for Epidemic Preparedness Innovations (CEPI) and Global Alliance for Vaccine Initiative (GAVI), as well as the African Vaccine Acquisition Task Team (AVATT), established by the Africa Centres for Disease Control (CDC).

“These structures have begun to enable equitable access to vaccines so that countries that cannot strongly compete economically for these vaccines can still access them. Through COVAX, over 20 countries have now received vaccines, including Nigeria.

“During the H1N1 pandemic, we had to wait for nearly 100 days after high-income countries started vaccinating to receive vaccines. This has been cut down to 38 days with COVID-19, thanks to COVAX.”

COVID-19 Vaccines Global Access, abbreviated as COVAX, is a global initiative aimed at equitable access to COVID-19 vaccines, led by United Nations Children Fund (UNICEF), Gavi, Vaccine Alliance (formerly the Global Alliance for Vaccines and Immunisation, or GAVI), the WHO, CEPI, and others.

It is one of the three pillars of the Access to COVID-19 Tools Accelerator, an initiative begun in April last year by the WHO, the European Commission, and the Government of France as a response to the COVID-19 pandemic.

COVAX aims to coordinate international resources to enable the equitable access of COVID-19 diagnostics, treatments, and COVID-19 vaccines.

Ihekweazu, who is also an epidemiologist, added: “We are still not in an ideal position, with respect to vaccine equity, but there is a lot of progress that should be recognised. The Africa CDC is working through AVATT to complement the efforts of the COVAX Facility and acquire additional doses for African countries.”

Ihekweazu said the Nigerian Government, through National Primary Health Care Development Agency (NPHCDA), continues to work very hard to identify avenues to increase access to vaccines for Nigerians, adding: “Globally, there is increasing advocacy for technology transfer and other processes to increase the global manufacturing capacity for COVID-19 vaccines.

“This is a challenge that cannot be solved as soon as we would like, but one that requires continuous engagement and strategic processes towards success.”

President of the Guild of Medical Directors, Prof. Olufemi Dokun-Babalola, decried the hoarding of COVID-19 vaccines and vaccine nationalism being experienced globally. 

He lamented that countries that have invested in vaccine research and production are in the driver’s seat, while countries that have not invested in research are at the receiving end. 

He told The Guardian yesterday in Abuja that it is natural for countries to want to take care of their own citizens first, before they “help” other countries, adding: “It is unfortunate that vaccine nationalism is now being experienced in the world. We cannot blame them for that.

“The so-called ‘vaccine nationalism’ entails that advanced nations will look to their own interests before considering the interest of the developing nations.”

Dokun-Babalola, who observed that Africa is not in the front of the line for vaccine products due to the predictable market forces at work, said: “The World Health Organisation (WHO) COVAX facility (in conjunction with CEPI  (the Coalition for Epidemic Preparedness Innovations) and GAVI (the Vaccine Alliance) would only subsidize 20 per cent of the purchase price of the necessary $9.1billion deal.

“The African group is actively working to borrow over $6 billion from a combination of the World Bank and global bond investors via so-called “vaccine bonds. Since the bulk of the pandemic has in fact passed Africa by, it is questionable if this potential indebtedness will be in the interest of Africa.” 

He added: “Nigeria is willing to spend over N300billion to purchase the AstraZeneca vaccine, which is a huge sum compared with the GDP and our previous expenditure on the health sector. 

“If that amount had been put into our hospitals, research, and training, modernising our ailing health sector, by now we will be the leading destination country for medical tourism in Africa.” 

He said there is a high cost of vaccines, relative to the earning power of the various African countries, saying it has been estimated that it would cost Nigeria no less than N400billion to vaccinate a sizeable portion of the 200 million population in the country. 

President, Nigerian Association of Resident Doctors (NARD), Dr. Uyilawa Okhuaihesuyi, said: “While coronavirus vaccine programmes are underway in most developed economies, many African countries are facing a long wait. So far, of Africa’s 54 nations, only Egypt, Morocco, Guinea, and Seychelles have started rolling out vaccines to their populations, and recently Nigeria and some West African countries.

“As of February 1, only 0.02 doses per 100 people had been administered on the African continent. In comparison, this number was 5.77 for North America and 3.39 for Europe, according to data collated by Our World in Data.

“The highest number in Africa was recorded in the Seychelles, which has a population of fewer than 100,000 people. Note that at that time, not a single vaccine had been given within the confines of Nigeria.

“On the day that the first consignment of COVID-19 vaccines arrived in a rainy South Africa, the United Kingdom (UK) jabbed around 280,000 people to take its total number of vaccinations to nine million.”

Okhuaihesuyi said since February 1, Britain and other high-income countries, such as Israel and the United Arab Emirates (UAE) have continued their vaccination programmes apace, while even relatively rich African countries, such as South Africa, continue to lag.

He stated that this stark divide in access to vaccines to combat the pandemic underscores structural problems in the developing world and in Africa in particular, where there are significant barriers to financing the procurement of life-saving inoculations, according to industry players.

The physician said shortfalls in both funding and supply are also creating opportunities for China and Russia to export their vaccines to Africa, as they seek to strengthen commercial and political relations with the continent.

Okhuaihesuyi said, according to Bloomberg News, Africa CDC has estimated that the continent would need to vaccinate almost two-thirds of its population to achieve herd immunity, which would require 1.5 billion doses, if a double shot regime is used, and cost between $10billion and $15 billion.

He stated that the perceived unfair and undue occurrence of owning of vaccines by some western countries is one of immense humanitarian concern, noting: “In this time of a worldwide pandemic, especially involving a novel pathogen that appears to occasionally mutate into newer and more vicious entities, considering the towering numbers of people deceased worldwide since its onset, the WHO seems to have a lot of work cut out for it to do, with ensuring beneficence and justice.”

The physician said the speculated fleecing of African countries of their foreign reserves domiciled in Europe is also now a topic of immense concern, saying: “While still being speculated, the onus once more lies on the world health bodies to see to it that maleficence does not become the order of the day. This is a situation where advocacy is required by all African countries, with the hope of ensuring that their foreign reserves do not tamper.”

The NARD president further explained: “The world continues to fight COVID-19. This, most nations of the world have been able to do individually, with collaboration with close sister countries and across continents.

“Albeit, many questions are being asked about the allocation and access to vaccines. As they become available from vaccine-producing nations, will they want to own these vaccines, as many feel? The simple answer is no.

“As a preamble, the WHO started work on COVID-19 vaccine research and development in February last year after consultations with multiple international scientists and public health experts. This, they have done in concert with the CEPI and Gavi. The sub-department of the WHO in charge of this is the COVAX Facility.

“COVAX is bringing nations together, regardless of their income level, to ensure the procurement and equitable distribution of COVID-19 vaccines. Member countries of the COVAX Facility will have access to enough vaccines to immunise their population’s priority groups.

“In the first phase of allocation, doses will be made available to participating countries simultaneously until they can cover approximately 20 per cent of the population of every country. And the NPHCDA has actually stuck to the guidelines given by the COVAX facility.”

Reacting to allegations that the West wants to ‘fleece’ developing, particularly African, countries of their foreign reserves domiciled in Europe through the vaccines, coupled with the politics involved in accessing the vaccines, as the West buys up more than they need, leaving other countries running here and there to access the drugs, Okhuaihesuyi said: “Again, to put the records straight, no one is fleecing anyone. Should producers of vaccines make profit? Answer is yes! However, there are checks and balances put by the WHO to guide and guard producers and producing nations.

“Recall I talked about the first phase to achieve 20 per cent, in the second phase, the rate at which countries would receive additional doses of vaccine would be determined by an assessment of their risk at any given time if there remain substantial supply limitations.

“Consideration will be based on an evaluation of threat (the potential impact of COVID-19 on a country, assessed, using epidemiological data and vulnerability, that of a country based on health systems and population factors.

“Using these indices, the analysis will identify nations with the highest risk, which will receive vaccines quicker than those considered at lower risk. Special consideration will be given to nations that may suddenly face major outbreaks or national disasters throughout the allocation process.

“So, with these, I think clarity has been given to the perception of producing countries dictating the spread of vaccines and attempts at ripping off poor/low-income nations.”

A consultant pharmacist and Medical Director of Merit Healthcare, Dr. Lolu Ojo, told The Guardian that accessing the vaccines could become an issue because of factors such as availability, cost, logistics, and politics.

Ojo explained: “Right now, there are not enough doses to go round for the population in need. This is a source of stress, which will be difficult to manage. The supply may not increase very soon because of the special, sensitive, and complicated production process.

“This is certainly an additional burden to the poor countries of the world. The vaccines are not cheap; the least costly is about $3/dose and for citizens of some countries who are living on less than $1/day, this is a lot of money to part with. Will the governments of such countries be able to bear the responsibility? Only time will tell.

“The vaccines are not ordinary drugs; there is a special handling procedure to be followed. The Pfizer vaccine requires storage at 70 degrees Celsius and meeting this condition will present challenges for nations like Nigeria. Our worlds keep on evolving and shaped by politics of interest.

“It will, therefore, not be surprising that the western nations may take advantage of the situation to get some advantages. What the seemingly weaker nations need to do is to take the lessons and move on to higher level of preparedness for emergencies.”

Ojo said nothing is free in absolute term and we should expect that we would pay a price for our inability to grow beyond our immediate reach and concerns, saying: “Rather than cry on the antics of the Western nations, we should do honest introspection and resolve that we will never be found on the weaker side of the negotiation table again.

“Let us get our universities and research institutes working. Let us stop stealing from the common patrimony. Let corruption stop. Let us concentrate on growth and development, with an eye on future occurrences.”

A consultant obstetrician, gynaecologist, and Medical Director of Optimal Specialist Hospital in Surulere, Lagos, Dr. Celestine Chukwunenye, stated: “The health authorities are not saying enough, doing enough, researching enough, and collaborating with the private health sector enough to bring this pandemic under control.

“In many countries in the Far East, no one is talking about COVID-19 anymore; they have put it practically behind them. There are a series of measures they put in place in their countries to achieve this. Why can we not adopt such measures? We are always looking at the West and America.

“We lack proper governance or are being governed indirectly by those who want us dead for reasons best known to them. The same way we lack academic discipline or many who should not have been their village school’s headteachers are leading our Ivory Towers. I am choosing my words carefully so that we may all wake up from this deep slumber. Total lockdown of the country will not have any positive effect at this stage.

“Nigeria and Nigerians are doing a lot to keep the country and themselves safe from the devastation that COVID-19 induces. I personally believe that we need to intensify the public health preventive measures that were rolled out last and to use the treatment protocols that researches in several countries, including Nigeria, have shown to be effective, with rapid recovery and no loss of lives, for early mild and moderate cases.

“The vaccines that have been rolled out in many countries have not shown much promise in curtailing the effects of COVID-19 on their populace. While vaccinating 70 per cent and above of their population is feasible and could help achieve substantial herd immunity, for us here in Nigeria, that is a herculean task. The resources are virtually none existent in our over-polluted political environment that cannot assure our children, grandchildren, and possibly great-grandchildren of safety in their school.

“While the free donation of vaccines to us is a welcome development, considering the poor state of our healthcare infrastructure, obviously, it is like drop water in the mighty ocean. It is not likely to achieve anything for us, except we can muster the resources to achieve 70 per cent coverage of the populace in the next one year.

“Even where the vaccines are being rapidly deployed, the people are still being told to wear their facemasks, do social distancing, avoid crowded places and wash their hands frequently or use hand sanitisers.

“We still need to work out the modalities for the distribution and administration of the vaccines to a population that is highly skeptical. We also need to start fast-tracking the process of developing our healthcare infrastructure.

“Like I have said before, instead of spending the hundreds of billions of naira on acquiring the vaccines, it is better for us to invest the money in developing our healthcare infrastructure and protects our future better that way. No one knows the next virus that is about to launch another horrific attack on the human race.”

A virologist and vaccinologist, Dr. Simon Agwale, added: “As NPHCDA officials plan for nationwide distribution of the long-awaited vaccines, ensuring that vaccines are authentic could emerge as an important issue. To the naked eye, there is no discernible difference between the potentially life-saving liquid inside a COVID-19 vaccine vial and any other clear liquid.

“Also, not even the professionals tasked with administering the vaccine will be able to test on the spot if the liquid contains the authentic COVID-19 vaccine. There should, therefore, be a clear message that any COVID-19 vaccine that is not through the government channels, at least for now, should be considered counterfeit. Tracking transactions will be a good strategy the regulators can employ to disrupt chains of counterfeit COVID-19 vaccines.

“My understanding is that the NPHCDA has developed a portal that will enable citizens to be registered and the portal should be made available in addition to vaccine certificates. This should be similar to our international passports.

“From available information, the National Agency for Food and Drug Administration and Control (NAFDAC) is using a tracking system to monitor COVID-19 distribution nationwide that is one of the safeguards in place to prevent counterfeit vaccines from coming into the country.

“Furthermore, people should be educated to know that there is serious vaccine shortage globally and no organisation has access to COVID-19 vaccines outside the well-established channels. This will certainly change after the pandemic is over and when more vaccines become available.

“I will always emphasise the need to build our capabilities to develop and manufacture vaccines locally, as this will certainly make the work of NAFDAC and others a lot easier since the regulation of locally-manufactured products is easier than those that are imported.”

President, Pharmaceutical Society of Nigeria (PSN), Mazi Sam Ohuabunwa, noted: “The PSN is ready and willing to assist government efforts in this regard. Many logistics and supply chain challenges must be surmounted if we are going to have an agile system of vaccination.

“Pharmacovigilance must be on top gear to eliminate possible medication therapy issues and interactions, especially in the vulnerable groups with co-morbidities and multiple medications. The implication is that any compromise in the cold chain system will affect the quality of the vaccines, which will ultimately affect effectiveness.”

PSN recommended, among other things, that vaccination should be seen as public health good to be delivered to all nooks and crannies of the country, stressing that collaboration among stakeholders, including the public and private sector and faith-based organisations must be effectively implemented, while participation of pharmacists, be it community or research or hospital, must be secured to ensure the effectiveness of the vaccinations and generation of data for much needed local vaccine research, Ohuabunwa said.

He said community pharmacies should be considered as vaccination centres to reach a larger number of Nigerians within the shortest time possible, saying this has been the practice in the United States (US) and employed even now for the COVID-19 vaccine.