The ivermectin wars intensify in Africa as, on the one hand, more nations embrace the drug at least for compassionate use targeting COVD-19 if not for the clinical research as a care option; while on the one hand, the latest COVID-19 wave intensifies on the continent—creating a sense of urgency and fear—while a mass vaccination campaigns appears to be an ambitious goal in the short run. But recently, the Africa Union and a spinoff health agency known as the Africa CDC issued a joint “Statement on the Use of Ivermectin for COVID-19” not embracing mounting data exhibiting efficacy. Unlike the U.S. National Institutes of Health (NIH), which has declared it doesn’t recommend for or against—and in fact suggests more clinical trial data is needed above and beyond the current studies—this African group takes a rigid Merck-like stance, declaring that there is no evidence period. That’s right: not any evidence from preclinical work nor evidence from any clinical trials, despite the many dozen studies nicely delineated by @CovidAnalysis. The group then acknowledges that there are some studies investigating the drug but rather than embrace a pragmatic approach such as governments in places like Zimbabwe, Zambia and even South Africa now establishing compassionate use status, the continent-wide body attacks the underlying basis for the positive ivermectin findings (lack of quality, limited number of patients, varied dosage, etc.). Either ignoring or dismissing outright the hard work of many scientists and researchers around the world—and ignoring prominent meta-analyses that even the World Health Organization publicly disclosed they are tracking carefully—this group, in the midst of a deadly pandemic, simply calls for more “well-designed, randomized, controlled trials.” But as TrialSite will share below, AU and Africa’s CDC’s real mission represents imminent mass vaccination, that is 60% of the African population, so that they can achieve inoculated numbers leading to so-called “herd immunity.” But Africa finds itself not at the front of the line for most vaccine products due to the predictable market forces at work. While the World Health Organization (WHO) COVAX facility would only subsidize 20% of the purchase price of the necessary $9.1 billion deal, the 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.” Russian or Chinese forces could also exploit this situation to drive momentum in their favor. As has been apparent, major pandemics lead to serious wealth accumulation opportunity in addition to health contagion, suffering and economic malaise.
Who are these groups?
Africa Union positions itself as a “continental body” involving 55 member states of the continent. Launched formally in 2002, this body was the successor to the Organization of African Unity. With ambitious initiatives across a myriad of topics, the groups’ funding comes from two sources, including 1) contributions from member states, and 2) donors.
With a broad and ambitious agenda (think ultimately like an EU), the group is overly dependent on the latter (donors from abroad) and that had led to financial challenges and attempts to overcome such dependencies as overwhelmingly failed, according to a report “Financing the African Union On Mindsets and Money.”
A group set up by the Africa Union (again referred herein as “AU”), the Africa Centers for Disease Control (CDC) is a public health agency of AU, organized to support the public health efforts of member states while strengthening the capacity of the health institutions to confront health threats. Formed in January 2016, the group launched right at the start of 2017.
COVID-19 is a ‘A Grave Crisis’
Recently, the AU’s outgoing chairperson, South African President Cyril Ramaphosa, gave an opening address on COVID-19 declaring the pandemic “is not only a severe health emergency, it is also a grave economic and social crisis,” reported the Mail & Guardian.
Because of the growing concern associated with the far more severe second wave of the pandemic here in Africa, some countries are starting to embrace the low cost, generic drug ivermectin as a possible treatment, such as in Zimbabwe, Zambia, South Africa (article 21) and even prominent principal investigators in Nigeria with the support from that nation’s vice president. Although, it turned out the lead researcher, a prominent ophthalmologist interviewed by TrialSite, has funded the entire IVERCOVID study on his own dime thus far, exhibiting the maddening nature of Nigerian bureaucratic politics.
AU: Mass Vaccination the Answer
Interesting and perhaps telling, the AU representation recently declared at the just held AU assembly that “the only way in which we can prevent COVID-19 transmission and deaths while at the same time protecting African economies and societies is to successfully immunize a critical mass of the African population with safe and efficacious COVID-19 vaccines.”
This, despite much of the rest of the world acknowledging that, in addition to mass vaccination effective therapeutic treatments, will be necessary especially for early onset COVID-19 (majority of cases) but also advanced therapies for when the disease progresses.
So, despite African physicians and health authorities on the ground, at the national and local level (think Zimbabwe, Zambia South Africa, Nigeria, etc.), warning of a dangerous gap between the point in time when vaccines will arrive en masse and the need to treat people now (especially early onset mild to moderate cases to stop disease progression), the AU’s position comes down simply to the foundational rationale for the purchase of 1.5 billion doses from major vaccine producers—more than likely from either the Chinese and/or Russians or perhaps AstraZeneca in a bid to vaccinate 60% of the population—that level that this group’s scientists tells them is needed for so called “herd immunity.”
Africa Left Behind Again?
The AU rightly doesn’t want Africa left at the end of the COVID-19 vaccination line. After all, the AU was really set up, based on the premise of the OAU, to “rid the continent of the remaining vestiges of colonization and apartheid…” as well as a number of other important noble goals for the peoples of Africa.
But a confluence of recognizable forces converge, including those of the marketplace itself and the realities of economics, leaving richer developed parts of the world (e.g. North America, Europe, East Asia) at the front of the vaccine line and reaffirming what some have called “artificial scarcity” associated with vaccine products leaving Africa “…once again at the tail end of the queue, this time for access to the vaccine.” But perhaps a plan is in the works?
Thus, AU and their public health affiliate and other author of the generally anti-Ivermectin edict, Africa Centers for Disease Control (CDC), combined forces recently to develop a strategy involving not only a vaccine development vision but also an access strategy endorsed by an internal committee in August of 2020. Apparently limited, the strategy covers 1) accelerate African involvement in the clinical development of the vaccine, 2) access a sufficient share of the global supply, and 3) remove barriers to widespread delivery and update of the vaccine.
While the first two appear more theoretical in nature, at least in the short run—like how will the continent accelerate clinical trials for vaccines so deep into the pandemic in time to make a difference, mindful that the organization, and mobilization of such trials would take considerable time, expense, mobilized human capital and political capital—while also factoring in market forces, the prospects for Africa somehow skipping places toward the front of the vaccination line look challenging to say the least. The bottom line: this would require a lot of money upfront and perhaps that vaccine queue gets shorter.
The $9 billion Challenge
So the AU leadership, in partnership with CDC, seeks to make itself on even footing with rich buyers in other parts of the world. This means that the AU must put a lot of money together to make a massive vaccine purchase.
Hence the formation of the COVID-19 African Vaccine Acquisition Task Team (AVATT) by Nov. 7 2020 in an effort to “accelerate funds for procurement and delivery of the vaccine doses.” Needing an estimated total of $9.1 billion to procure the 1.5 billion doses, while the AU buyer could only secure 20% of the funding via the COVAX facility, this leaves $6.1 billion that the AU leadership must find to give to vaccine makers to implement their mass vaccination strategy leading to 60% inoculate population and thus the desired “herd immunity.” To date, they have been able to secure 270 million doses.
But where will AU go to find $6.1 billion in the middle of such a crisis? Well, the leadership identified two sources—first a $5 billion load from the World Bank and the remainder from two sources, including the African Export-Import Bank (Afrexim Bank) as well as the capital makers in a proposed “vaccine bond” for up to $3 billion.
The so called “vaccine bonds” are the brain child of the International Finance Facility for Immunization (IFFIm), a key component of the GAVI capital structure. Again, GAVI stands for the Global Alliance for Vaccines and Immunization, a public-private partnership involving the World Health Organization, UNICEF, the World Bank, pharmaceutical companies producing vaccines as well as the Bill and Melinda Gates Foundation and private philanthropists.
Perhaps competing with Western investment banking interests to underwrite such large bundle debt securities are Chinese and Russian agents perhaps making their own moves in a quest to cover such a finance gap, suggests S&P Global.
More on ‘Vaccine Bonds’
So how would this work? Well, the AU would need to organize a deal based on the concepts developed by the IFFIm, where private investors and government donors would collaborate in a large debt financing where such bonds would represent debt to be repaid over a period of time with interest of course and a coupon leading to either fixed or variable rate of return.
Involving well-placed, connected and undoubtedly highly compensated intermediaries, AU would organize itself to entertain, entice and engage international bond markets to finance the undertaking. Apparently, about $6 billion of such vaccine bond deals have already been executed thus far for various diseases and conditions. Dr. Alan Gillespie was a key player in initiating these deals as “Founding Chair.” For a list of top donor countries to the IFFIm, see the link.
The Brookings Institute, a free-market focused think tank, has suggested that such bonds can be an instrumental tool for the funding of the necessary development and manufacturing of COVID-19 vaccine product for low to middle-income countries (LMICs).
But what about Therapies?
The adoption of low cost, widely available therapies to treat early onset COVID-19 is of paramount importance in combating this virus; and this critically important element is strangely minimized in the AU/CDC vision of COVID-19 conquest.
After all, a great majority of the cases worldwide fall into this category (that is early onset, mild cases). Many physicians and researchers acknowledge the importance of treating the coronavirus early on at onset of the virus infection, to inhibit progression. Ongoing studies in the West (more on that below) as well as Africa hammer home this point. Again, the AU and CDC discuss little about this critically important approach highlighted by prominent groups such as the World Health Organization, Doctors without Borders, and even major pharmaceutical firms that are developing more advanced, branded, and more than likely, expensive treatments.
An example in Africa would be the ANTICOV trial, which represents a major effort involving prominent research experts from around the world. Why wouldn’t the AU and CDC consider early onset COVID-19 treatment as a fundamental part of a holistic, comprehensive strategy to take on COVID-19 in Africa?
Could it be that the sole focus on securing the full $9 billion and accelerating mass vaccination is working to preclude other important strategic facets of a comprehensive plan? Well, one can’t be sure, but the groups behind ANTICOV do understand that pragmatic, economical treatments coupled with a broader vaccination strategy represents a fundamental underpinning of taking on COVID-19.
What is ANTICOV?
Not discussed much in Western press, ANTICOV is a major clinical trial conducted in Africa that looks at a number of therapies to treat COVID-19. Pragmatically, the organizers of this multinational trial know that actual mass vaccination won’t probably happen in the short run.
TrialSite shared in “Major Clinical Trial in Sub-Saharan Africa (ANTICOV) to Study Hydroxychloroquine & other Repurposed Treatments Targeting Early Onset COVID-19” that an international network of research institutions and thirteen African nations formed this alliance to conduct the largest COVID-19 clinical trial of its kind in the continent with an emphasis on investigating treatment options for mild to moderate cases at onset of SARS-Cov-2 infection. Again, this infection status represents the great majority of cases around the world, especially in African with its younger population.
Led by an organization known as Drugs for Neglected Diseases Initiative or “DNDi,” a non-profit organization made possible first by funds derived from the 1999 Nobel Peace Prize award granted to Médecins Sans Frontières (MSF)—known as Doctors without Borders in North America—ANTICOV’s sponsors acknowledge the pragmatic realities on the ground in Africa. Mass vaccination is a long way off.
By 2003, MSF, the World Health Organization and five international research institutions founded this group. Governance members include an impressive array of research and health personalities.
Of interest, although some physicians and researchers still claim that hydroxychloroquine shows promise as an early onset treatment targeting COVID-19, the majority of evidence now indicates the opposite—that it is not useful. Yet ANTICOV acknowledges that hydroxychloroquine remains the standard of care in Africa. They declare that other medications they will consider for the trial includes antiparasitic medicine—could that be ivermectin?
Therapeutic Trials Continue in USA—despite Vaccines
While mass vaccination against COVID-19 is obviously a target for all regions of the world, biotech and pharmaceutical companies continue to receive large amounts of funding from the U.S. government in America, for instance, to develop novel therapeutics to treat COVID-19. That is even despite the fact that two highly efficacious vaccine candidates (Pfizer/BioNTech & Moderna) have received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).
But why would this type of major financing and clinical activity continue ongoing if highly effective vaccines are already authorized, at least on an emergency basis? That’s because all recognize the need for a range of therapeutics targeting COVID-19 to augment vaccine efforts. Ideally, a healthy market forms with a variety of safe and effective products that can treat all stages of the disease lifecycle. Critically important are therapies targeting the early onset of COVID-19: that is those mostly mild to moderate cases that a great majority of the population infected actually experience. This market demands a range of products, from branded more pricey treatments to generic economical ones.
As TrialSite has chronicled, billions of public dollars are allocated into various companies’ research and development efforts involving COVID-19 therapeutics, including clinical trials sponsored by the National Institute of Health (NIH) ACTIV research program.
In “NIH’s Therapeutic Management of Patients with COVID-91 Some Unanswered Questions About Disturbing Chasm,” TrialSite shares the amounts of money involved. While not opposed to funding advanced COVID-19 therapeutics at all, TrialSite emphasizes that in fact these advanced investigational therapies represent part of a credible, comprehensive and holistic market response to the pandemic. The TrialSite critique centers on the overwhelming emphasis of such allocation of public financial support on novel, advanced (and expensive) approaches, favoring only future branded drugs, while no or de minimis consideration is given to low cost treatments evidencing potential, such as ivermectin.
A great example of a promising investigational product is a potentially compelling, investigational, long-acting monoclonal antibody therapy initially invented by some brilliant scientists at Vanderbilt and licensed by Anglo-Swede AstraZeneca, a prominent multinational pharmaceutical company. Of course, they are known to have licensed the Oxford vaccine but their AZD7442 investigational product shows considerable promise. So much so that the company, in partnership with the U.S. government, is testing the candidate both as a pre-Exposure prophylaxis (PrEP) and Post-exposure prophylaxis (PEP). This deal involved $486 million from the U.S. DOD to the company and two major clinical trials. That the government is supporting such an effort is good. After all, a health market response to such a pandemic should include safe and efficacious vaccines as well as therapeutics, including both branded and generics.
Of course, many know of the TrialSite perspective on Merck—we received the emails and comments—including the praise and the lectures.
The company announced a $425 million purchase of a biotech with a promising COVID-19 drug in November and just a month later received $356 million to subsidize clinical research. Also, recently the NIH just announced support for another monoclonal antibody producer originating out of both China and Research Triangle Park (RTP). Just proclaimed, the National Institutes of Allergy and Infectious Diseases (NIAID), part of the NIH, continues to heavily fund COVID-19 therapy research for the obvious reasons.
Theory vs. Reality
With skewed income distribution across much of the world (and even growing income inequality in many developing nations), much of the world may need to wait in line for their turn, to some extent directed by marketplace forces, for mass vaccination. Although sophisticated financial instruments could accelerate large purchases, it’s not clear if that would accelerate fulfillment.
In the meanwhile, those in the know are aware of the importance of safe and effective therapies to treat all stages of COVID-19. A sound, comprehensive treatment strategy addresses the fact that the great majority of COVID-19 cases represent early onset mild to moderate infections. Rapid treatment with appropriate therapies are a high priority. However, much of the world’s population may not be able to afford a therapeutics costing $2,500 to $5,000 per treatment, and this is particularly the case in most African nations.
A well thought-out generics strategy involving possible treatments such as ivermectin represents potentially game-changing dynamics, should they ultimately be proven safe and effective. The economic costs of not treating the pandemic this way in much of the world will make the benefits of short-term pharmaceutical profits not worth the heavy costs of longer term health, social and economic malaise resulting from not treating the condition early on, should an approach actually work. Hence the importance of publicly-funded investigations into ivermectin and other generic approaches in addition to branded investigational products.
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