The race to find effective vaccines for Covid-19 is being outstripped by the race to secure access to them. And with news headlines such as “Covid-19 vaccine could come in late October; White House says no pressure on timing,” the prospect of a vaccine being available “soon” seems tantalisingly close.
But “soon” means different things, depending on where in the world you live.
With the US, the UK and the European Union pre-buying around two billion doses of Covid-19 vaccines that are still in development, the looming question – particularly for countries such as South Africa, and almost 100 developing countries with even less economic muscle and limited vaccine manufacturing capability – is whether, despite much high-level talk about global solidarity, we will actually get our hands on vaccines as soon as they are proved successful. Globally limited vaccine manufacturing capabilities, located mostly in wealthy countries, mean that some kind of “rationing” will be necessary, even with production capacity ramp-ups underway across the world.
On 4 September 2020, the Director-General of the World Health Organisation, Dr Tedros Adhanom Ghebreyesus, said, “We want all people everywhere to have access to vaccines,” acknowledging that initially supplies will be limited. “The first priority must be to vaccinate some people in all countries, rather than all people in some countries,” he said.
Not all WHO member states feel the same. So how does the ideal of global solidarity square up against wealthy countries’ brazen “vaccine nationalism”?
COVAX, which is the vaccines “arm” of the WHO-led ACT Accelerator, aims to ensure that developing countries secure equal – or at least simultaneous – access to Covid-19 vaccines. It is the practical mechanism that translates the often-expressed ideal of “global solidarity” into concrete action – but its effectiveness will depend on the generosity of the world’s wealthiest nations to underwrite vaccine financing for developing ones that can’t afford it.
Three different organisations co-lead COVAX: the Coalition for Epidemic Preparedness (CEPI), the World Health Organisation (WHO), and Gavi, the vaccine alliance. CEPI’s role is to oversee vaccine development and manufacturing, intended to ensure that COVAX has “the largest and most diverse” Covid-19 vaccine portfolio in the world.
Gavi is leading the “pooled procurement” mechanism through which COVAX aims to ensure “fair and equitable” access. COVAX will do this by using an allocation framework being developed by WHO, which is also responsible for setting policy, such as Tedros’s statement on 4 September that “initially, when supply is limited, priority must be given to vaccinating essential workers and those most at risk – including older people and those with underlying conditions”.
“In the scramble for a vaccine, countries can act alone – creating a few winners, and many losers – or they can come together,” says CEPI CEO Richard Hatchett, describing COVAX as “an initiative which is built on enlightened self-interest but also equity”. Gavi CEO Seth Berkley said: “For high-income countries, it represents a win-win: not only will you be guaranteed access to the world’s largest portfolio of vaccines, you will also be negotiating as part of a consortium, bringing prices down and ensuring truly global access.”
In the meantime, countries with deep pockets are hedging their bets by spending billions on “pre-buying” across the range of different types of vaccines in development, knowing that some of those may not work (vaccine candidates historically have about a 90% failure rate), but banking on the likelihood that at least one of them will.
The UK has made deals to secure upwards of 340 million doses of six different vaccines (including the Oxford University/AstraZeneca vaccine that is currently in Phase III trials in South Africa, Brazil and the UK). By mid-August 2020, the US – as part of its “Operation Warp Speed” – had advance-bought a combined 800 million doses (with an option for another 1 billion), by investing $11-billion in seven different companies’ development efforts. These also include the vaccine candidates from Oxford/AstraZeneca, Moderna, Pfizer, Johnson & Johnson, GlaxoSmithkline, and Novavax (one of the two vaccines in Phase III trials also in South Africa).
The European Union, whose countries are buying as a bloc, and Japan have also allegedly bought hundreds of millions of doses for their entire populations (their gamble is based on multiple doses for each person), with the EU pre-buying 400 million doses of the Oxford vaccine, and seeking to invest in several others.
Professor Helen Rees, a global and regional vaccines expert who is Chair of the CEPI Scientific Advisory Committee, and (among other things) head of the regulatory body that will ultimately license a vaccine for use in South Africa, has said that it’s unlikely there will be enough vaccines for everyone globally until 2022. “It’s very likely that you’ll have a graduated approach,” she said, “and that’s going to be quite country specific.”
In an interview with Daily Maverick, Rees explained what that might look like, along the lines of WHO’s recent recommendation: “If you’ve got limited amounts of vaccine, and you’ve got efficacy data [only] from adult, healthy human subjects, it is likely that we would prioritise frontline health workers – but it is very much on the cards for discussion about how South Africa will do it.” (This would be a national Department of Health decision, which has not yet defined its future vaccine rollout policy.)
South Africa’s role in clinical trials
There are close to 200 Covid-19 vaccine “candidates” in development, 37 are in clinical trials in humans, and nine are in Phase III (final-phase) trials in humans. Two of the final nine – Oxford University/AstraZeneca’s “ChAdOx1 nCoV-19” and Novavax’s “NVX-CoV2373” – are being tested in South Africa, across several sites in different provinces, in addition to in their “home” markets (the UK and the US), and in a small number of other countries, including high-prevalence Brazil (the higher the rate of Covid-19 transmission in a country, the quicker vaccine trials might show if a vaccine works or not).
The South African arms of the trials are both being led by Wits vaccinologist Professor Shabir Madhi, who is the Executive Director of the SA Medical Research Council’s Vaccines and Infectious Diseases Analytics (VIDA) research unit, and who along with Rees is co-founder of the African Leadership in Vaccinology Expertise (ALIVE) consortium.
Access to vaccines, along with who to prioritise when supply is short, is one of Rees’s biggest Covid-19-related concerns for South Africa, she says. South Africa’s role in international trials doesn’t necessarily mean South Africa will have preferential access to those vaccines, if they are successful. But, Madhi says, South Africa is at least getting a headstart in generating data on how the vaccine performs locally, which will speed up our own regulatory process. “WHO doesn’t recommend the introduction of a vaccine into low- and middle-income countries (LMICs) until you are able to show in that context that a vaccine works.” (Vaccines can perform differently in different settings – and many vaccines’ introductions into LMICs have historically been delayed because of a lack of information as to how well they will perform.)
If the vaccine candidates being tested here are proven successful, South Africa’s Health Products Regulatory Authority (SAHPRA) will be able to act quickly to license the vaccines for local use.
How COVAX will work
Under COVAX, vaccines will be delivered equally to all participating countries (WHO’s allocations will be proportional to countries’ populations), starting with healthcare workers and expanding to cover the next-most vulnerable groups. Overall, 78 potentially self-financing countries have submitted “expressions of interest” to COVAX, along with 92 low- and middle-income countries that WHO defines as eligible to be supported by the financial commitments of the self-financing ones (South Africa is not one of them – by the time of publication, the Department of Health had not confirmed that we would be “self-financing”).
In addition, COVAX will keep a “buffer” of doses for emergency and humanitarian use, including dealing with severe outbreaks before they spiral out of control.
… and will COVAX work?
If COVAX works, it will buy and roll out vaccines in “sufficient volumes to end the acute phase of the pandemic by 2021”.
But countries’ participation in COVAX is voluntary, which means that this ideal model of how equitable vaccine distribution might work depends on the wealthiest countries’ deciding to support the vaccines for the poorest via an “advance market commitment” (AMC). This is designed to incentivise vaccine manufacturers to produce enough volumes for all countries, by sharing the financial risk with the wealthy ones. (No prizes for guessing that the US has refused to join this international initiative and will keep its politicised Operation Warp Speed to itself.)
Producing vaccines is an expensive business. COVAX’s success depends on rich countries assuring that poorer countries will be able to access the global “public good” of a vaccine for a global pandemic – so it will only work if the self-financing countries and other donors invest.
“Many pharmaceutical companies are investing a lot, and they’re doing it at risk, because if that product doesn’t work, that’s billions of dollars’ worth of investment that’s gone,” says Rees.
The deadline for countries to put their money where their mouths are – by turning “expressions of interest” into binding commitments – is 18 September, with their first upfront payments due no later than 9 October 2020.
If COVAX’s initial $2.4-billion target for research and development is reached, and the $2-billion target for the “advance market commitment” (AMC) is reached, COVAX will be able to distribute the first 2 billion doses of the future successful vaccines by mid to late 2021. Essentially, this will cover vaccines for 20% of all participating countries’ populations.
If contributions for both fall short, there doesn’t seem to be a contingency plan – or at least not one that is yet in the public domain. Together, the 172 countries participating in COVAX represent 70% of the world’s population – stakes are high.
“The vaccine manufacturers will come to the party, but the important thing is, they need money. So it’s really going to be highly dependent on countries putting money in,” says Rees.
What does this mean for South Africa?
“If the Oxford vaccine is successful, and given that we’ve contributed to the science of this, if we don’t get the vaccine [soon], it will be of great concern,” says Rees. “In terms of the principles of global equity and reciprocity, people who have put themselves at risk deserve to be recognised for it. But there’s no guarantee – so that’s why COVAX is so important.”
But, Rees emphasises the fact that there is already a global debate about “vaccine nationalism”, is critical. “This cannot be all for some and none for many others – there has to be an equitable distribution of vaccines. The important thing is that the debate hasn’t been left to the end… we’re having that debate now.” DM/MC
Adèle Sulcas writes about global health and food systems, is an adviser to Internews’ Pandemic Media Mentors, and is a consultant for the Foundation for Innovative New Diagnostics. She has previously worked in Geneva at the World Health Organisation and the Global Fund to Fight AIDS, TB and Malaria.
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