The Global System for Distributing Mpox Shots Is Broken. Here’s How to Fix It

From its epicenter in the Democratic Republic of the Congo, Africa’s mpox epidemic is spreading fast, reaching a dozen other African nations so far. The single most important tool for extinguishing the fire is mpox vaccination, which prevents infection and illness. Until yesterday, not a single dose of mpox vaccine was available in Congo. Few shots are available anywhere on the continent.

Congo’s health minister Samuel-Roger Kamba says his country urgently needs 3.5 million doses to stop its outbreak, while 10 million doses are needed for the whole African continent. Without these shots, mpox will continue to spread.

And here’s the kicker. While adults and children in 13 African nations are getting infected, sick, and in some cases dying, several rich nations are sitting on large stockpiles. The U.S., for example, is believed to have stockpiled 7 million doses by mid-2023, while Spain has 2.5 million doses. If a rich country were to become affected, it could immediately launch a vaccination campaign to protect its own citizens—as we saw during the 2022 U.S. mpox outbreak, when the government mounted a robust vaccine campaign, distributing more than one million shots by the end of the year.

The return of “vaccine apartheid”

It is painful to watch History repeating itself. During the COVID-19 pandemic, we witnessed what Winnie Byanyima, executive director of the Joint United Nations Programme on HIV and AIDS, called “a global vaccine apartheid”—a profound injustice in which rich countries were the first to get vaccines and boosters, while low- and middle-income nations were left behind. Now we are witnessing mpox vaccine apartheid.

Beyond being unfair and causing preventable illness and deaths in the 13 affected nations and counting, this vaccine inequity also hurts rich nations in two important ways. First, an adage in public Health is that an outbreak anywhere can become an outbreak everywhere. In other words, if the outbreak is not contained, it will continue to spread, including to rich nations.

Read More: What It’s Like to Respond to Mpox in Africa Right Now

We’re already seeing this happen. The outbreak centered in Congo is of an mpox strain targeting adults and children called clade I, which is thought to cause a more severe illness than clade II, the strain that caused a multi-country mpox outbreak in 2022-2023. Cases of clade I mpox have recently been identified as far away as Sweden and Thailand, in people who had traveled to African countries.

Second, when vaccine apartheid causes a pandemic to smolder, it hurts the entire global economy by disrupting supply chains, imports, and exports. It is not just low- and middle-income countries that suffer this economic pain. During the COVID-19 pandemic, for example, one study estimated that about half of the global economic losses caused by vaccine apartheid were borne by rich nations, mostly through suppressed exports.

Mounting an urgent mpox vaccination campaign in the countries affected in the African region is in the whole world’s interest. Why is it not yet happening? Understanding the reasons is critical—not just to control Africa’s current mpox epidemic, but to ensure we do not make the same grave mistakes again.

Mpox shots are made in rich nations and must “trickle down” to low-income countries

At its heart, the reason for mpox vaccine inequity is that the shots are made by companies in rich nations—Denmark’s Bavarian Nordic and Japan’s KM Biologics—and their high costs (around $200-$400 per course) means they are largely unaffordable to low-income nations like Congo. The affected countries in the African region that are unable to afford the high prices are therefore left to rely on charitable donations of shots from rich nations’ current stockpiles. Even if an affected African nation had enough cash in hand now, vaccine makers are likely to sell doses to the highest bidders first. That’s exactly what’s happening: rich countries are now buying up mpox doses, and low-income countries are at the back of the queue.

This is topsy turvy. In the middle of a devastating epidemic in Africa, why on earth is the region dependent on mpox vaccines “trickling down” from the rich world? Instead, there should be capacity built within the region to manufacture mpox shots locally and have them close to those most affected. Affected countries in Africa should also be making investments to ensure they are better prepared to respond to future mpox outbreaks with a well-trained workforce and the right tools: vaccines, medicines, and diagnostic tests.

Read More: What to Know About Mpox in 2024

Since the World Health Organization (WHO) has declared Africa’s mpox epidemic to be a global emergency (what it calls a “public Health emergency of international concern”), there’s a powerful case for waiving the intellectual property rights on mpox vaccines to allow any company worldwide to make the shots. Sadly, there is no indication that a waiver is on the table. But at the very least, Bavarian Nordic and KM Biologics should share the Technology with African manufacturers and support them to scale up manufacturing as soon as possible. Even if these manufacturers do not produce mpox vaccine doses immediately, such Technology transfer would ensure that lasting capacity is built on the continent for this endemic disease.

In the long run, as we discuss in our recently published “roadmap” on improving the development of medicines, vaccines, and diagnostics worldwide, a concerted global effort is needed to build vaccine manufacturing capacity in all regions of the world. If there’s a new infectious disease epidemic in Africa, Latin America, the Asia Pacific, or any other region, the fastest and most affordable way to get shots in arms is to make doses locally. No more going hat in hand begging for doses from the rich world.

The system for approving pandemic vaccines isn’t fit for mpox

Since it looks like mpox vaccine manufacturing won’t be up and running in the African region in the coming days, weeks, or perhaps even months, in the short term, the only feasible avenue for beating the epidemic is a well-structured donation program. Yet even on this front, the international community can’t get its act together.

The only realistic avenue for a large vaccination campaign is one led by Gavi, the Vaccine Alliance and UNICEF. Because of their existing relationships with manufacturers, and their positioning as the two major agencies that buy and deliver vaccine shots at large scale to low- and middle-income countries, they are best placed to strike a deal the quickest. But right now, they are paralyzed.

UNICEF and Gavi’s rules mean they are only allowed to buy vaccines that have been approved by WHO—yet while the U.S., Europe, and a few African nations have approved them, the WHO has still not approved mpox vaccines. Sania Nishtar, Gavi’s Chief Executive Officer, told The Lancet in late August that “we are still weeks away from any vaccine being approved for emergency use by WHO and even then, it will take time for manufacturers to supply doses in large quantities.”

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It is hard to believe we are in this situation. The U.S. Food and Drug Administration approved an mpox vaccine in September 2019. The European Medicines Agency approved an mpox vaccine in July 2022. Bavarian Nordic says it met with WHO in August 2022 to discuss approval of its vaccine, Jynneos. But here we are, two years on, and WHO still has not given the green light through its approval system known as pre-qualification.

While WHO pre-qualification is important in helping ensure the safety and effectiveness of medicines and vaccines, the delay in approving mpox vaccines indicates that the system is too slow, risk averse, and iNFLexible.

With UNICEF and Gavi hampered by these bureaucratic hurdles, a handful of rich-country governments have stepped in to pledge doses, although others won’t release any of their stockpile. For example, last week the U.S. donated 10,000 doses to Nigeria—the first shots to arrive anywhere on the continent—and yesterday 100,000 doses arrived in Congo, donated by the European Union, but other rich countries have not committed to release any of their stockpiles.

But there’s another sorry twist to the tale. The regulatory agencies in Congo and Nigeria have both approved the mpox vaccine, so these countries can start vaccination as soon as doses arrive. But many affected African nations have not yet approved it, so even if shots were to be donated, they can’t go into arms immediately. In a situation in which a country has not approved it, it relies on WHO approval, which, as we have seen, comes with its own challenges. Regulatory agencies in low-income nations must work together to jointly assess not just mpox vaccines but all medicines and vaccines, reducing dependence on WHO approval as the only avenue.

History will keep repeating itself unless we act now

Each time there’s a new epidemic or pandemic, the international community pledges to “make it the last.” But this is a pipe dream unless we see a concerted, coordinated effort to invest in building a global system of vaccine development, manufacturing, and distribution that benefits everyone.

In addition to urgently streamlining the WHO prequalification process, over the long run, the regulatory agencies in low- and middle-income countries that assess and approve vaccines and other medicines should continue to build local capacity and expertise. Richer countries should provide technical and financial support to national and regional regulatory agencies, such as the newly formed African Medicines Agency, to ensure that these agencies can effectively perform core regulatory functions. Equally, African nations should invest in Health systems strengthening and ensure that national budgets meet the annual financial commitments made in declarations such as the Abuja Declaration committing 15% of annual budgets to Health. Cross-collaboration between regulatory authorities within the region, as well as with those abroad, will also be critical to build this capacity.

With strengthened national and regional regulation, increased research and development, and scaled-up local manufacturing, we can start to see meaningful progress towards the end of vaccine apartheid.