So, 2020 is almost over, the Covid-19 pandemic is not. Worse, socioeconomic inequality, hunger and health colonialism have been aggravated.
Vaccine research has accelerated on an unprecedented, although welcomed, basis, with over 200 vaccine candidates in various stages of clinical research. Early results from among a handful of vaccine candidates show some promise that in the medium term we could exit this pandemic, but perhaps not its devastating consequences. Global health leaders have agreed that potential future Covid-19 vaccines must be considered a global public good and become the People’s Vaccine. And last week, the UK government even issued emergency regulatory approval for one such vaccine candidate.
But it is one thing to have an approved vaccine, quite another to afford and have access to it, in an equitable fashion. This is because rich countries have pre-ordered enough doses to cover their populations several times over, leaving us in the global south with insufficient supplies for our populations in greatest need and at high risk. In South Africa, this is exacerbated by our two-tiered health system which often benefits those with private health insurance, unless of course, the government steps in to develop an equitable access and allocation plan or framework.
Also, it is important to note that despite the pace of global developments and research, there is no clinically approved vaccine candidate for the South African market yet. And any commitment to purchase one or more vaccine/s will be speculative, even if necessary. This is because from among the range of potential vaccine products being investigated in many parts of the world, including South Africa, no one knows which candidate will work in the long term and for our context and health burden.
Nor do we know the full details of the cost of production and pricing determinations. There is only limited information, largely being pieced together by activists and journalists on the level of public funding and other forms of non-commercial investment in vaccine research, most notably the US government’s Operation Warp Speed.
The South African government has spent public funds on vaccine clinical research (approximately R10-million) and has committed to “sign up” to COVAX. For example, to give a sense of scale: MSF reports that vaccine candidates are benefiting from more than $4.4-billion of public and philanthropic funding including nearly $1-billion from the US Biomedical Advanced Research and Development Authority (BARDA) to just two companies, Johnson & Johnson and Moderna.
Mariana Mazzucato, Henry Lishi and Els Torreele in Project Syndicate wrote that BioNTech received $445-million from the German government, while Moderna was also given $1-million by the Coalition for Epidemic Preparedness Innovations. The AstraZeneca-Oxford University vaccine research has been reported to have received more than £1-billion (about $1.3-billion) of public funding.
In addition, while governments, philanthropists, multilateral institutions and drug companies have been working on researching vaccines, richer countries have also been “buying up” potential vaccine candidates. In other words, committing to advance purchase agreements, via bilateral agreements with drug companies, the terms of which are often secret. Recent estimates suggest that rich countries representing 13% of the world population including the US, UK, Canada and countries in the EU have bought up at least half of the world’s global potential vaccine supply before these vaccine candidates have even been approved for use.
Like most poor countries around the world that did not have the resources and funds to behave in a nationalistic way, the South African government to our knowledge has not committed to any advanced purchase of any vaccine candidate with any drug company, yet. Richer countries, on the other hand, are buying hope and effectively have “VIP vaccine access”. In some cases, by being guaranteed access, they have committed to a price, independently of their country’s medicine price regulatory framework, and agreed to patent rights or even monopolies in advance by precluding the possibility of accessing a generic version over time either through public health crisis licensing negotiation or by issuing a compulsory license as sovereign state actors.
High-income countries have already bought close to 80% of the Pfizer/BioNTech and Moderna vaccine doses that will be available within the first year.
Mariana Mazzucato, Henry Lishi and Els Torreele pointed out that “high-income countries have already bought close to 80% of the Pfizer/BioNTech and Moderna vaccine doses that will be available within the first year”. And they state that wealthy countries have bought 3.8 billion doses from different vaccine makers, compared with 3.2 billion (which includes about 700 million doses via COVAX) for the rest of the world combined.
Even though there are at least four Covid-19 vaccine clinical trials being conducted in South Africa with potentially two vaccine manufacturing agreements (still being negotiated) to produce just two of the many vaccine candidates being researched globally and here, if they are eventually approved for use in South Africa, there is no guarantee of access, preferential pricing or supplies for South Africans and other global south countries or populations in need either. No one has seen these agreements (or drafts) and we have not been assured as a nation, that if we manufacture certain vaccines in East London, that East London and other parts of South Africa will benefit too – in terms of supplies and no profit pricing.
Alongside the bilateral contracting taking place between richer countries and drug companies, COVAX (the Covid-19 Vaccine Global Access Facility), a new global financing mechanism that is being coordinated by Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) was established in the context of the WHO’s Access to Covid-19 Tools (ACT) Accelerator Initiative.
About two weeks ago, it was reported that South Africa missed the deadline for signing up to the voluntary COVAX facility. Last week much was made (in error, in my view) of the COVAX imposed “payment deadline” being missed by our government – following on from a public commitment by the South African Minister of Finance to contribute at least R500-million to COVAX, presumably to secure some supplies of a potential vaccine, one day.
Because COVAX is a pooled negotiating mechanism, not a company, or supplier, it is incapable of being subject to public tender and procurement rules or PFMA norms – not just for South Africa, but for many countries with strict public procurement rules.
Not all countries have signed on to COVAX yet, and not all drug companies are participating in COVAX exclusively either (in other words, in a global pandemic, countries and companies are hedging their bets, by pursuing bilateral pre-purchases). It is also unclear whether COVAX will continue beyond 2021, whether low, or no profit price agreements are temporary or if they terminate mid-2021 or December 2021 or rather when each individual drug company “deems” the pandemic being “over”. This has opened-up an important debate about COVAX itself – where however well-intentioned it may be, it now yields extraordinary global power, and only recently agreed to civil society representation on its structures after organisations such as MSF and others advocated for this.
In respect of South Africa and COVAX, media reports last week suggested that the Solidarity Fund will pay the “COVAX commitment fee” because of PFMA and other considerations that led to a delay in the payment. COVAX limitations aside, the Solidarity Fund, which is being treated as a private funder, may now be involving itself in highly complex vaccine selection and procurement acquisition processes with COVAX – itself an imperfect voluntary structure.
Because we live in a time of great anxiety, it is understandable that people around the world want their governments to be part of initiatives such as COVAX. But countries such as South Africa, regarded (wrongly, I believe) as “middle income” countries (MICs) do not qualify for subsidised support in COVAX and have to self-finance their participation. Low-income countries (LICs) are eligible for support mainly by virtue of ODA and philanthropic support to COVAX, but only for limited dosages and supplies that many reports indicate is likely to only vaccinate up to 20% of their respective populations, when herd immunity requires much greater population coverage. MICs are also being asked to self-finance their participation as the full-funding target for the entire negotiating facility has not yet been reached either (note: there are approximately 92 MICs and LICs combined).
If we wish to achieve global equity in access and allocation, then unfortunately, COVAX may not alone lend itself to that. Because everyone, everywhere will not be guaranteed vaccine access as things stand. While we advocate that vaccines and other interventions that could save lives in this pandemic be regarded as “global public goods” and while our president promotes “the people’s vaccine”, even with COVAX, the public does not own the intellectual property yet, nor have governments around the world retained the rights to “determine adequate production, supply and allocation”, or compel it. Without that, drug companies can determine which country gets supplies and when, at what price as well as the quantities.
COVAX is not the only solution to the global vaccine access and equity problem, nor will it assist with patent and pricing transparency or citizen oversight, issues that have been on the public health transparency and activism agenda for many years.
Instead, what we need is a global equitable allocation process and plan – and for states to reassert their authority and mainly, exercise powers that could guarantee equitable access and allocation in a public health crisis. This includes restrictions on patent monopolies.
Interestingly, because of the concern about the undue exercise of monopoly rights in a pandemic, in October, South Africa and India submitted a joint formal request for a waiver from certain provisions of the TRIPS agreement (agreement on Trade-Related Aspects of Intellectual Property Rights) for the prevention, containment and treatment of Covid-19 for the duration of the pandemic. Support for the request is growing including from several developing countries. Unsurprisingly this request is being opposed by a handful of wealthier nations, which, ironically, have already prepurchased vaccines.
Other shortcomings of COVAX and the set of bilateral vaccine access and pricing negotiations is that companies are rarely fully transparent about their costs, including total research and development (R&D) investment, publicly funded R&D and, as MSF points out, “cost investments into manufacturing scale-up/capacity, cost of goods, or the cost of manufacturing future Covid-19 vaccines”. It is also unclear whether licences will be opened to all available manufacturers to ensure life-saving vaccines are supplied to everyone who needs it, in a pandemic.
COVAX is not the only solution to the global vaccine access and equity problem, nor will it assist with patent and pricing transparency or citizen oversight, issues that have been on the public health transparency and activism agenda for many years. The COVAX tiered pricing model for differently resourced countries is also a concern. In many cases this model is worsening our global equity struggles – unrealistic deadlines, unfair economic classifications, lack of pricing transparency, deference to patent claims, unchecked negotiating power, unenforceable guarantees and unclear governance frameworks make it hard for citizens of individual countries to hold it to account. Its residual power is with big pharmaceutical companies and wealthier nations whose vaccine nationalism is now regrettably so obvious, and which is determining our future. Unsurprisingly, global south countries – those classified as LICs and MICs – are grappling with whether to hedge “vaccine access bets” on COVAX.
When Covid-19 hit, many warned of vaccine nationalism and excessive profiteering due to patent monopolies and bilateral deal-making that excludes sovereign state decision making on vaccine supplies and pricing. Sadly, we have arrived at this junction. MC
Fatima Hassan is the head of the Health Justice Initiative. Note: The HJI has requested the South African government to make relevant details available on the Development of a Plan to Ensure Affordable Access to and Equitable Allocation of Covid-19 Vaccines
COVAX is one of three pillars of the Access to Covid-19 Tools (ACT) Accelerator, which was launched in April by the World Health Organization (WHO), the European Commission and France.
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