When COVID-19 vaccines come onto the market, poorer countries will have to compete with wealthier ones, who can pay more, for access. Will it help if lower and middle-income countries pool their funds and order vaccines in bulk?
The race to find a COVID-19 vaccine is on — but so is the rivalry among countries around the world for who will have access to such products. Although several manufacturing deals have been signed with pharmaceutical companies to produce large quantities of eventual vaccines, experts agree that, at least initially, manufacturers will be unable to produce enough inoculations for the world’s almost 8 billion people.
Middle-income countries, including South Africa, will therefore have to compete for access to COVID-19 vaccines with much wealthier countries that can not only pay more for such goods, but that have also already clinched deals with drug companies to get vaccines first.
In June, the European Commission, for instance, pre-ordered 400 million doses of a vaccine candidate being tested by Oxford University, and through its Operation Warp Speed project, the United States signed a $2 billion contract in July with Pfizer and a German biotechnology company for 600 million doses of the vaccine the multinationals are testing.
This leaves poorer countries in a precarious position: if they can’t afford to buy COVID-19 vaccines at profitable prices directly from the companies that produce them, they may end up without this life-saving intervention — or wait years for it, until there is less competition for it.
Even in South Africa, where the country is hosting local legs of two international COVID-19 vaccine trials — Oxford’s ChAdOx1 nCoV-19, that will be produced by drug company AstraZeneca, and the US vaccine development company, Novavax’s NVX-CoV2373v (local testing of two other candidates will follow later this year) — access to affordable versions of these vaccines is not necessarily guaranteed, the trials’ chief investigator, Shabir Madhi, told Health24.
How can countries secure access to affordable COVID-19 vaccines?
One way around this, is for developing economies to sign up for deals known as advanced market commitments (AMCs), which pool the bargaining power of smaller, less wealthy countries to enable them to negotiate quicker access and cheaper prices to a product under development.
For instance, in 2007 the international vaccine advocacy and access organisation Gavi, the Vaccine Alliance created an advanced market commitment for a pneumococcal vaccine and used it to speed up poorer countries’ access to the pneumococcal conjugate vaccine (PCV). Ordinarily, children in the most under-resourced countries would receive newly developed vaccines more than a decade after kids in the richest countries, Gavi explains on its website.
But through this AMC, the alliance was able to roll out the pneumococcal vaccine in many developing countries within a year after it was first made available, at a price more 90% cheaper than what it would cost the US. By 2019, the AMC had enabled 60 countries in Africa and Asia to introduce PCV — as a result, the deaths of 700 million children had been prevented by the end of that year, according to Gavi’s latest projections.
For COVID-19, an AMC that is part of the COVAX mechanism — led by Gavi, the Vaccine Alliance, along with the World Health Organisation (WHO) and the Coalition for Epidemic Preparedness Innovation, an alliance that finances vaccine development — has been established. The COVAX commitment is modelled on the pneumococcal vaccine’s AMC and Gavi is using some of the unused funds to finance COVAX.
So far, 172 economies — comprising more than 70% of the world’s population — are engaged in discussions to potentially participate in COVAX, which has negotiated deals with the manufacturers of nine vaccine candidates under evaluation. COVAX has, for instance, secured 100 million doses of the AstraZeneca vaccine candidate, that will be produced by the Serum Institute of India under a license agreement with AstraZeneca, at $3 per shot — if the candidate turns out to be effective. Through the AMC, Novavax’s vaccine candidate, if successful, will also be available at $3 per dose to countries who are part of the AMC.
South Africa has expressed interest to join COVAX as well. But is this financial mechanism the answer to affordable COVID-19 vaccines for the country?
To answer this question a number of issues need to be considered.
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‘Not poor enough’: Who qualifies for COVAX?
Firstly, South Africa doesn’t qualify to be subsidised to get COVID-19 vaccines through COVAX for free — the country is simply not poor enough. Gavi’s board has approved 92 low- and lower-middle income countries to support financially; some will be fully funded while others only partially, depending on how poor the country is. Southern African countries such as Angola, Eswatini, Lesotho, Zambia, Zimbabwe and Mozambique are included on this list.
In addition to these countries, 80 higher-income economies, which will pay for the vaccines from their own public finance budgets, have submitted expressions of interest. South Africa falls into this category, along with other emerging economies such as Botswana, Brazil, Chile and Mauritius. But there are also much wealthier countries — such as Finland, Canada, Norway, the United Arab Emirates and New Zealand — who have indicated they would like to sign up.
High-income nations can, however, only be part of COVAX if their participation is approved by Gavi’s board — accepted countries will receive their contracts 18 September.
So, if COVAX won’t help South Africa to pay for COVID-19 vaccines, what would the country get from the deal?
Mainly, South Africa would be able to use the mechanism to buy and procure COVID-19 vaccines — but the country would have to allow COVAX to procure and buy the vaccines on its behalf. COVAX requires self-financing participants to enter into binding commitments that require them to make upfront payments, the first of which would be due by 9 October.
But this may pose a problem for South Africa particularly, as the government cannot procure — and pay — for vaccines that have not been approved by the country’s regulatory authority, the South African Health Products Regulatory Authority (Sahpra). Getting around this requirement may require an amendment of laws. Although the Disaster Management Act has allowances for emergency procurement, these can only be used while the country is under a declared state of disaster. Our current state of disaster is set to end on 15 September meaning we may not be able to use this route for October or payments — if the state of disaster is not extended.
What’s the catch?
South Africa would also not be able to dictate the number of vaccines it wants, or who should receive them. Rather, COVAX will offer vaccines “equally to all participating countries, proportional to their populations” and based on “country need, vulnerability and COVID-19 threat”. COVAX’s preferred allocation is for countries to prioritise vaccines for healthcare workers and then expand it to other vulnerable groups, such as the elderly and those with comorbidities like diabetes or heart conditions. However, allocation and prioritisation is context-specific and, in a country such as South Africa, with high HIV infection rates and groups who do not have access to clean water, who the country would want to prioritise, may be different from the groups COVAX has identified.
Another matter to consider is that although COVAX is a collaborative effort, it is ultimately managed by Gavi, and there will be few opportunities to challenge decisions. If South Africa is, for instance, denied the opportunity to join COVAX, the country will be unable to challenge the Gavi board’s decision as there is no appeal process.
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More importantly, the board or two-thirds of its donors — which are wealthy countries like Italy and the UK, as well as large philanthropic organisations such as the Bill & Melinda Gates Foundation – can choose to terminate COVAX without the agreement or input of the low- and middle-income countries joining and benefitting from the commitment, according to COVAX AMC contractual terms.
If Gavi is, for instance, unable to raise the funds needed for the commitment to work, it can unilaterally decide to end the AMC and not procure any doses. By late August, Gavi had only managed to raise about $700 million of the $2 billion in seed funding that it needs by the end of 2020 to successfully operate.
And, even if COVAX is successful, it may not be able to source enough vaccines for all who will need them. Though the COVAX AMC aims to provide vaccines to cover 20% of the populations of participating countries, only 100 million doses of either the Novovax or Oxford candidates “whichever vaccine is licensed first and approved by regulatory authorities” have been committed so far, according to Gavi spokesperson, James Fulker. This commitment covers less than 2% of the citizens of the 172 interested countries. But Fulker does point out that a further 300 million doses will be available to all AMC-supported countries through the COVAX Facility, a larger body of which the COVAX AMC forms part of.
The goal of COVAX is to deliver two billion doses of effective COVID-19 vaccines by the end of 2021.
How long will it take to get access to a vaccine?
There is a further challenge that could seriously delay access to vaccines through COVAX. In order to ensure that the vaccines it procures are safe and effective, COVAX will only fund products that receive WHO prequalification, are licensed through a regulatory system or both.
WHO prequalification is a process whereby the WHO verifies that a vaccine or drug is safe and works well. Prequalification is useful in countries with weaker regulatory approval systems, but it can also cause serious delays — the median time to obtain prequalification is 200 days, according to the WHO. But it can take even longer, as the WHO process can only begin once the vaccine has been approved by a stringent regulation authority, such as the US Food and Drug and Drug Administration. After prequalification, the vaccine must also be approved by the regulatory authority of each recipient country. In South Africa’s case, that would mean approval by Sahpra.
The WHO has reported that prequalification processes have experienced delays due to COVID-19. Going through COVAX, and the requirement of WHO prequalification, could therefore mean an almost seven-month delay in getting a COVID-19 vaccine rolled out in countries that are part of the AMC, a delay that could be avoided if South Africa procured a vaccine directly from a manufacturer.
Advance market commitments like COVAX are crucial to ensuring vaccine access at an affordable price, particularly in countries such as South Africa that have not been producing their own vaccines. Currently, there are few mechanisms that will ensure low and middle-income countries are able to get quick and affordable access to vaccines. In this context, joining the COVAX mechanism may be an important way for South Africa to ensure we are not left behind in the vaccine race. But the agreement is not without its difficulties and the country should be mindful that this is only the first step in the long road to rolling out a COVID-19 vaccine.
The Bhekisisa Centre for Health Journalism receives funding from the Bill & Melinda Gates Foundation, which is also a donor of COVAX. Bhekisisa guards its editorial independence and the BMGF played no role in the publication of this article and has no editorial input in Bhekisisa’s content.
Safura Abdool Karim is a senior researcher and health lawyer at PRICELESS SA, the South African Medical Research Council Centre for Health Economics and Decision Science. She is a 2020 Aspen Institute New Voices Fellow. Follow her on Twitter @AkSafs.