The stretch of the fatalities occasioned by the emergence of the global coronavirus pandemic remains humanity’s most pressing burden. Today, the virus has left in its trail deaths, economic downward spiral, a wasteland of impoverishment, dead dreams or deferred aspirations and a litany of global grievances. In this piece, KEHINDE OYETIMI reports the protracted journey to developing a vaccine, the weight of putting ethics before profit and the challenge in developing a vaccine during a pandemic.
As of July 18, 2020, the coronavirus has killed no fewer than 602,060 people globally since it started its spread in Wuhan, China, late 2019. Based on official sources, over 14 million people have contracted the virus. While Nigeria, Africa’s most populous demography has 36,107 cases out of Africa’s more than 700,000 infections with deaths numbering over 14,000, the fatalities in the United States of America, Brazil, Britain, Mexico and Italy make the race to create a vaccine urgent.
Today, the United States of America has recorded the most casualties numbering 139,266. In such morbid marathon, the United States of America is followed by Brazil with 77,851 deaths; Britain, 45,119; Mexico, 38,310 and Italy’s 35,028 casualties. The spike in deaths has not come as a surprise to many considering the overwhelming burden that the viral infection has had on health care infrastructure globally. Across many countries, there are concerns of second and third wave emergence of the virus. Countries like Spain which attempted to reopen their economies were forced to shut down following rise in new infections. In Barcelona, as well as in other places, about four million people have been urged to stay indoors.
The economic millstone and social drain of the pandemic have seen repeated efforts by world powers to provide stimulus packages. The European Union, for the first time in five months, met in person last Friday but failed to reach a consensus about a planned 750-billion-euro ($857 billion) stimulus package.
The finance ministers and central banks from the G20 countries are seeking global recovery. Amid increasing demands to widen debt relief for crisis-ridden poor countries, they met on a virtual platform hosted by Saudi Arabia as they sought comprehensive economic revitalisation imposed by a coronavirus-goaded recession.
The race for a vaccine
With such appallingly dismal realities and the seeming likelihood of a bleak future, the journey to getting a vaccine appears to be the global ambition aimed at halting the rising deaths and incapacitations by the spread of the virus.
As of a few days ago, the World Health Organisation (WHO) announced that 23 out of 163 COVID-19 vaccines being prepared around the world had commenced clinical tests on humans. When successfully developed, the serum would stimulate the immune system to produce antibodies against the coronavirus. However, only two have reportedly reached Phase 3 which is considered the last scientific stage before approval to be marketed. This, of course, would require large-scale trials with thousands of individuals to assess the efficacy and safety of the vaccine.
For both vaccine preparations which have reached Phase 3 trials, reports have established that at least 14,000 Brazilians would be involved in clinical trials. There are also advanced talks to launch three more vaccine trials in the country.
WHO also stated that there are encouraging early results from clinical tests which have raised expectations for an effective coronavirus vaccine.
Researches in the United States of America and the United Kingdom have reported several experimental vaccines producing a good immune response in volunteers without life threatening side-effects. Pharmaceutical giant Pfizer and biotech company Moderna have announced early successes in this regard.
On Tuesday, the United Kingdom announced that it had secured early access to 90 million vaccine doses through partnerships with some pharmaceutical companies. Included in the figure are 30 million doses of a vaccine being developed by BioNTech and Pfizer, the first agreement the two companies have signed with any government. This vaccine has reached Phase 2 trials.
The second deal is an agreement in principle for 60 million doses of a vaccine being developed by Valneva, with an option to acquire a further 40 million doses if this vaccine is proven to be safe, effective and suitable.
At the Oxford University, expectations were met when the United Kingdom announced on Tuesday that preliminary results from a coronavirus vaccine trial which involved over a thousand people in the UK suggest that it is safe and induces an immune response.
The vaccine from the Oxford University is reportedly designed to stimulate two parts of the immune system – producing neutralising antibodies and T-cells – both of which can play a key role in preventing viral infection.
Expectedly, the campaign to have a remarkable number of participant-volunteers has started to gather momentum.
Reports equally have it that the crusade has recorded the impressive support of more than 100 prominent figures, out of which are 15 Nobel Laureates. They claim that the success of the trials would of necessity involve healthy, young volunteers being deliberately infected with coronavirus after receiving the vaccine.
Why Brazil is global laboratory
Significantly, Brazil, where the number of infections has exceeded 2 million, has attracted major researchers and renowned pharmaceutical companies are bent on getting a vaccine.
The South American giant has been reported to offer a compelling and alluring assortment for study. Today, Brazil has a rapidly increasing rate of transmission, as well as globally prized research centres with a public health system skilled in creating and distributing vaccines.
Chinese biotech company Sinovac has commenced a Phase 3 trial in Brazil, in collaboration with Brazil’s Butantan Institute in Sao Paulo. Its CoronaVac trial vaccine uses inactivated virus cells to stimulate an immune response in patients. The tests will begin today with 9,000 volunteers in five Brazilian states plus the capital.
Like the Oxford vaccine, CoronaVac will be given mostly to health professionals. Ricardo Palacios, medical director of research at Butantan, in an interaction with CNN says that the institute is also in “very advanced conversations with two other vaccines under development» and in talks with dozens of pharmaceutical companies about COVID-19 research studies.
“All producers in the world will always look for a place where there is high transmission to attest to the effectiveness of the vaccine. But infection rate is not enough. A country needs to have institutions that work with international scientific, regulatory, and ethical protocols to carry out the tests,” he said.
The challenge of putting ethics before profit
However promising these vaccines appear in their various stages, leading health experts have advised caution. For some of them, the challenge which naturally arises is how to put ethics before profit. The fierce debate on human challenge trials has oscillated between ethical and practical considerations.
The World Health Organisation, in a report published a few weeks back, argued that challenge trials could provide important information, but that they would be difficult to administer because of the possibility of the coronavirus “to cause severe and fatal illness and its high transmissibility”.
The report by a 19-member advisory panel, provided detailed guidelines about the safest way to conduct challenge trials, recommending that they be limited to healthy people aged 18 to 25 because they have the least risk of severe illness or death from the virus.
But the panel also said its members were divided over whether trials should be carried out if no highly effective therapy had been identified to treat participants who got sick; over whether studies in healthy young adults could predict the efficacy of a vaccine in older people or other high-risk adults; and whether challenge trials could really speed vaccine development.
Also, while raising concerns about putting healthy people at risk, head of the United States’ National Institute for Allergy and Infectious Diseases, Dr. Anthony Fauci, in an interaction with New York Times, said any challenge trial would have to be conducted “with absolute intense examination by a group of independent ethicists and independent people who have nothing to do with the trial.”
Jeffrey Kahn, the director of the Johns Hopkins Berman Institute for Bioethics, also opposed challenge trials, stating that “there are too many uncertainties”.
However, in the journal, Vaccine, published in April and seen by the Nigerian Tribune, Dr. Arthur Caplan and Dr. Stanley Plotkin, argued that “Despite the danger, a challenge trial could take advantage of the lower death rate in people aged 18 to 29. We believe it is ethical to ask now for volunteers who would be informed about the known and unknown risks.” Also, a team led by Nir Eyal, a bioethicist at Rutgers, wrote in March, in an article in The Journal of Infectious Diseases that a human challenge trial is “not without risks”. The team, however, insists that “every week that vaccine rollout is delayed will be accompanied by many thousands of deaths globally.”
Why Africa lags behind in vaccine clinical trial
In Africa, only South Africa and Egypt appear to have announced the start of the continent’s first COVID-19 clinical trials. There have also been fears in many quarters at the attempt at running vaccine clinical trials in the midst of a pandemic particularly in third world nations with African countries leading this bunch. Healthcare infrastructure in many African countries have been in very terrible or non-existent state with little funding for research or clinical experiments.
Other pressing demands like terrorism, insurgency, poverty, banditry, decrepit leadership, corruption and weak economies are the traumatising traits of the African experience.
Nigeria doing nothing on vaccine —Tomori, chairman, Expert Committee on COVID-19
Virologist and chairman, Expert Committee on COVID-19, Professor Oyewale Tomori, tells Nigerian Tribune that Nigeria is nowhere when it comes to COVID-19 vaccine, adding that “we are doing nothing.”
He stated that the only way Nigeria could have gotten involved was to be part of the clinical trials of the vaccine at Egypt and South Africa.
Professor Tomori declared: “The clinical trials show that at least you are contributing to the body of knowledge. We should identify where we can contribute. We are not thinking about this. In a country where there are still a lot of people that believe there is no COVID-19, how can we contribute?”
He, however, said despite this, when the vaccine is ready Nigeria will not be left out, as the world would not want Nigeria to become a reservoir from which the virus spreads to other parts of the world. “So they are not saying we will not get, but it will be after they have satisfied their own needs,” he stated.
The renowned virologist, however, added that Nigeria has the human resources and that it needs to develop the appropriate vaccine but the environment is not favourable.
For Chairman, University College Hospital Committee Response on COVID-19 Pandemic, Professor Kayode Osungbade, vaccination remains a probable option for fighting the pandemic.
“There is no doubt that any infectious disease of this nature requires a vaccine to be taken to prevent or even to minimise the effects when anybody gets exposed. So if any is developed, it should be welcomed.
“Well, vaccine development is not a venture anybody can get into as an individual; standard laboratories are required and the government must be ready to fund them. It is capital intensive,” he said.
We can only wait —NAFDAC DG
In her reaction, Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Professor Moji Adeyeye, in a chat with Nigerian Tribune stated that “There are vaccines that are being developed in many countries all over the world and some of them are under clinical trials and there is nothing that Nigeria can do except to wait.”
Director of Research at the Nigerian Institute of Medical Research (NIMR), Professor Rosemary Audu, stated that COVID-19 vaccine is something that can be produced in Nigeria.
According to Audu, “We can do certain phases of the vaccine production here in Nigeria and collaborate with others outside Nigeria. So it is possible and we have a team working on it here in NIMR.”
For Professor Christian Happi, director of the African Centre of Excellence for Genomics of Infectious Diseases (ACEGID) at the Redeemer’s University, Ede, vaccine productions take time because of the steps involved and the need to verify their safety and potency.
He gave the assurance that when the vaccines are eventually ready, Nigeria would not be deprived of its use. “Even though we are not part of its clinical trial, the vaccine will be distributed equitably to all nations in the world,” he stated.
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