The slow Mpox response is another pandemic wake-up call

NEW YORK : It feels like a movie we have already seen. A new viral strain is killing people in some of the world’s poorest countries, and although vaccines against the pathogen exist, production shortages and regulatory barriers are preventing them from reaching those in need.

The response to the mpox outbreak in Central Africa suggests that we have not learned the lessons of COVID-19, when inequitable access to vaccines prolonged the pandemic and worsened its economic consequences. Even more alarmingly, it demonstrates how unprepared we are for a new global health crisis.

There are two silver linings, however. The first is a matter of luck. While the coronavirus was transmitted very easily because it was airborne, mpox spreads much more slowly via close contact, which has limited its toll. The World Health Organization (WHO) counts around 100,000 confirmed mpox cases since January 2022, and the Africa Centres for Disease Control and Prevention reports 724 mpox deaths in 2024.

Second, this crisis presents an opportunity. By working together to clear the roadblocks to the mpox response, governments, international organisations, and the biopharmaceutical sector can better prepare for future pathogens. The easiest roadblocks to dismantle are regulations that make it harder for vaccines to be manufactured and distributed across borders.

Mpox vaccines received regulatory approval in the European Union, Japan, the United States, and Canada after an outbreak in 2022. Yet in the Democratic Republic of the Congo (DRC), the country hit hardest by the outbreak that started last year, regulatory authorities didn’t approve mpox vaccines until June, placing an additional hurdle in the way of incoming donated shots.

Many low-income countries rely on the WHO to assess vaccine safety and efficacy, and WHO approval is also necessary for Gavi and UNICEF to start large-scale vaccine orders and distribution. Despite the WHO’s hard work, its rules prevented it from declaring mpox to be an emergency and authorising emergency use of mpox vaccines until mid-August, when the disease’s spread had made it a public-health problem of international concern.

The WHO’s declaration paved the way for UNICEF to launch a tender for up to 12 million doses through 2025. In parallel, the WHO worked with manufacturers and regulators to gather the data necessary for full “pre-qualification” of mpox vaccines (which also covers non-emergency use). The first of these was granted on September 13, and a few days later, Gavi reached an agreement with the manufacturer, Denmark’s Bavarian Nordic, to purchase 500,000 doses for delivery this year.

To avoid such delays in future emergencies, countries must be better prepared to receive vaccines. Governments could start recognising regulatory approvals by other countries, and they can use the negotiations on a proposed WHO Pandemic Agreement to give national and regional regulators and the WHO new tools to speed up approvals.

Smooth cross-border trade is vital in health emergencies. During the COVID-19 pandemic, multi-country supply chains helped ramp up production and distribution of desperately needed personal protective equipment, test kits, and billions of vaccine doses. By 2021, global trade in medical products was worth $1.5 trillion, up 29% from 2019, according to World Trade Organization data. But there were disruptions along the way, with several governments restricting exports and cutting off vaccine access for many import-dependent countries.

Another issue is evident in the fact that, until US President Joe Biden’s recent donation of one million mpox vaccine doses, the DRC had received only a few hundred thousand, even though its population is above 100 million. Here, we see a problem that goes beyond trade barriers: there has been far too little headway toward diversifying vaccine manufacturing and building extra production capacity.

Before the COVID-19 pandemic, 80% of world vaccine exports came from only ten countries, which meant that export restrictions in just a few of them were sufficient to disrupt global supplies. Decentralising vaccine and diagnostics production to more developing countries would help to shock-proof supplies. But doing so requires action across multiple fronts by governments, international organisations, and the private sector.

Intellectual property is one front. During the pandemic, WTO members reached a hard-fought decision on COVID-19 vaccine IP that provides tools to diversify production capacity. For mpox and future health threats, pharmaceutical companies have a responsibility to be proactive. By preparing to reach voluntary agreements with potential partners, they can rapidly scale up production around the world as needed. Given that the Medicines Patent Pool has a proven track record of facilitating such agreements, we should focus on making this approach work even better.

Developing countries, for their part, should ensure that their legislative and regulatory frameworks are ready to support local or regional manufacturing, whether through voluntary licenses from patent holders or by taking advantage of flexibilities in WTO IP rules. The WTO, the WHO, and the World Intellectual Property Organization can help governments in this area.

But IP is not the only issue. Governments also must agree on where to locate regional production hubs to enable economies of scale. Here, the Regionalized Vaccine Manufacturing Collaborative’s efforts to organise and scale vaccine manufacturing on a regional basis can help governments. New production facilities in Africa and elsewhere will need sustained demand to continue operating. The pooled procurement approach put in place by the African Vaccine Acquisition Trust during the COVID-19 pandemic represents a step in the right direction. Looking ahead, the World Bank’s Pandemic Fund could help finance long-term purchasing commitments, as this would be an investment in a global public good.

During the COVID-19 pandemic, the WTO Secretariat worked with vaccine manufacturers and member-state governments to identify and address trade-related bottlenecks that were holding back vaccine production and distribution. We stand ready to do our part for mpox and whatever other threats lie in the future. Governments, civil society, and the private sector should stop talking past each other on these issues and start working together.

Ngozi Okonjo-Iweala, Director-General of the World Trade Organization, is a former board chair of Gavi, the Vaccine Alliance.

Copyright: Project Syndicate, 2024.

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