FFrom its epicentre in the Democratic Republic of Congo, the MERS epidemic in Africa is spreading rapidly, reaching dozen other African countries still. The single most important tool for putting out the fire is the mpox vaccination, which prevents Infection and disease. Until yesterday, there had been no doses of the mpox vaccine in Congo. Only a few shots are available on the continent.
Congolese Health Minister Samuel-Roger Kamba speaks his country urgently needs 3.5 million doses to stop the outbreak, while 10 million doses necessary for the entire African continent. Without these vaccinations, mpox will continue to spread.
And here's the rub. While adults and children in 13 African countries are getting infected, sick, and in some cases dying, several rich countries are sitting on large stockpiles. The U.S., for example, is believed to have stockpiled 7 million doses by mid-2023, while Spain 2.5 million doses. If a rich country got sick, it could immediately launch a vaccination campaign to protect its citizens, as we saw during the mpox outbreak in the US in 2022, when the government launched a massive vaccination campaign, spreading more than a million images by the end of the year.
The Return of 'Vaccine Apartheid'
It's painful to watch history repeat itself. During the COVID-19 pandemic, we witnessed what Winnie Byanyima, Executive Director of the Joint United Nations Programme on HIV/AIDS, said it's called “global vaccine apartheid” – a profound injustice in which rich countries got vaccines and boosters first, leaving low- and middle-income countries behind. Now we are witnessing mpox vaccine apartheid.
Beyond being unfair and causing preventable illness and death in the 13 countries affected and counting, this vaccination disparity also hurts rich countries in two important ways. First, the public health adage is that an outbreak anywhere can become an outbreak everywhere. In other words, if an outbreak is not contained, it will continue to spread, including to rich countries.
Read more: What is it like to react to Mpox in Africa right now?
We are already seeing this happening. The outbreak centered in Congo is caused by a strain of mpox that affects adults and children, called clade I, which is thought to cause more severe disease than clade II, the strain that caused the mpox outbreak in several countries in 2022-2023. Clade I mpox cases have recently been identified in places as far away as Sweden And Thailandin people who have visited African countries.
Second, when vaccine apartheid allows a pandemic to fester, it wreaks havoc on the entire global economy, disrupting supply chains, imports, and exports. It’s not just low- and middle-income countries that suffer from this economic pain. During the COVID-19 pandemic, for example, one study It is estimated that about half of the global economic losses caused by vaccine apartheid have fallen on rich countries, largely due to suppressed exports.
It is in the world’s interest to urgently implement a mpox vaccination campaign in the affected countries of the African region. Why hasn’t this happened yet? Understanding the reasons is critical – not only to controlling the current mpox epidemic in Africa, but also to prevent the same serious mistakes from happening again.
Mpox vaccines are made in rich countries and should be trickled down to low-income countries
Essentially, the reason for the inequality regarding the mpox vaccine is that the shots are produced by companies from rich countries – Denmark’s Bavarian Nordic and Japan’s KM Biologics – and their high cost (around $200-400 per course)) means they are largely unaffordable for low-income countries like Congo. Affected countries in the African region that cannot afford the high prices are therefore forced to rely on charitable donations of shots from the current stockpiles of rich countries. Even if an affected African country now had enough cash, vaccine makers would likely sell doses to the highest bidder first. That is exactly what is happening: rich countries are now buy-up doses of mpox, with low-income countries at the back of the queue.
This is turned on its head. In the midst of a devastating epidemic in Africa, why is the region dependent on mpox vaccines “leaking” from the rich world? Instead, the region should build capacity to produce mpox injections locally and bring them closer to those most affected. Affected countries in Africa should also invest in being better prepared to respond to future mpox outbreaks with a well-trained workforce and the right tools: vaccines, drugs, and diagnostic tests.
Read more: What You Need to Know About Mpox in 2024
Since the World Health Organization (WHO) stated If an mpox epidemic in Africa were to become a global emergency (what it calls a “public health emergency of international concern”), there is a strong case for waiving intellectual property rights to mpox vaccines to allow any company around the world to make shots. Unfortunately, there is no sign that a waiver is being considered. But at the very least, Bavarian Nordic and KM Biologics should share the technology with African manufacturers and support them in scaling up production as quickly as possible. Even if these manufacturers do not start producing doses of mpox vaccine immediately, such a technology transfer would ensure that the continent has a robust capacity for this endemic disease.
In the long term, as we discuss in our recent published a roadmap to improve drug, vaccine and diagnostic development worldwide, a concerted global effort is needed to scale up vaccine manufacturing capacity in All regions of the world. If a new infectious disease outbreak breaks out in Africa, Latin America, the Asia-Pacific region, or any other region, the fastest and most affordable way to get vaccinated is to get doses on the spot. No more begging rich countries for doses.
The pandemic vaccine approval system is not fit for mpox
With the mpox vaccine unlikely to be rolled out in the African region for days, weeks, or perhaps even months, the only short-term option to defeat the epidemic is a well-structured donation program. However, even on this front, the international community is struggling to muster the strength.
The only real path for a large-scale vaccination campaign is one led by Gavi, the Vaccine Alliance And UNICEF. Because of their existing relationships with manufacturers and their position as the two main agencies that purchase and deliver vaccines on a large scale to low- and middle-income countries, they are in the best position to close a deal as quickly as possible. But now they are paralyzed.
UNICEF and Gavi's rules mean they are only allowed to buy vaccines that have been approved by the WHO, but while the US, Europe and several African countries have approved them, the WHO has yet to approve the mpox vaccines. Sania Nishtar, Gavi's CEO, said Lancet in late August that “it will still be several weeks before the WHO approves a vaccine for emergency use, and even then it will take time for manufacturers to supply doses in large quantities.”
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It's hard to believe we're in this situation. FDA approved mpox vaccine in September 2019. European Medicines Agency approved mpox vaccine in july 2022. bavarian north speaks In August 2022, it met with the WHO to discuss approval of its Jynneos vaccine. But two years later, the WHO has yet to give the green light through its approval system known as prequalification.
While WHO prequalification is important to ensure the safety and effectiveness of medicines and vaccines, the delay in approving mpox vaccines suggests the system is too slow, risk-averse and inflexible.
As UNICEF and Gavi have faced bureaucratic hurdles, several rich-country governments have stepped in to promise doses, though others will not give out any of their stockpiles. Last week, for example, the U.S. donated 10,000 doses to Nigeria — the first shots come anywhere on the continent – and yesterday 100,000 doses arrived in Congo, donated by the European Union, but other rich countries have made no commitment to release any of their stockpiles.
But there’s another sad twist to this story. Regulators in Congo and Nigeria have approved the mpox vaccine, so those countries can start vaccinating as soon as doses become available. But many of the affected African countries have not yet approved it, so even if the shots are donated, they won’t be able to immediately go into arms. In a situation where a country hasn’t approved it, it relies on WHO approval, which, as we’ve seen, comes with its own set of challenges. Regulators in low-income countries need to work together to jointly evaluate not just mpox vaccines, but all drugs and vaccines, reducing reliance on WHO approval as the only route.
History will repeat itself unless we act now.
Whenever a new epidemic or pandemic arises, the international community promises “make it the last.” But that’s a pipe dream unless we see a concerted, coordinated effort to invest in building a global system for developing, producing, and distributing vaccines that benefits everyone.
Beyond urgently streamlining the WHO prequalification process, in the longer term, regulatory authorities in low- and middle-income countries that assess and approve vaccines and other medicines must continue to build local capacity and expertise. Richer countries should provide technical and financial support to national and regional regulatory authorities, such as the newly created African Medicines Agency, to ensure that these authorities can effectively carry out essential regulatory functions. Equally, African countries must invest in strengthening health systems and ensure that national budgets meet annual financial commitments made in declarations such as Abuja Declaration allocation of 15% of annual budgets to health. Cross-collaboration between regulatory bodies in the region, as well as with those abroad, will also be crucial to building this capacity.
With stronger national and regional regulation, expanded research and development, and increased local manufacturing, we can see significant progress towards ending vaccine apartheid.