The Democratic Republic of the Congo’s Health Minister, Samuel-Roger Kamba, was cautiously optimistic on August 19, when he told his fellow citizens they could expect a much-needed shipment of vaccines against the mpox virus to arrive the following week. But a fortnight later, not a single shot has landed in the DRC. The reason is not a lack of urgency on the part of Dr Kamba and his government – a novel strain of the virus, known as Clade 1b, has ravaged the country all year. Nor is it a lack of supplies – <a href="https://www.thenationalnews.com/business/markets/2024/09/01/big-pharma-mpox/" target="_blank">mpox vaccines exist and have already been used</a> to quell previous outbreaks in rich countries. Instead, the problem appears to be a combination of bureaucracy and <a href="https://www.thenationalnews.com/opinion/editorial/2024/08/16/mpox-outbreak-health-disease-who-virus-infection/" target="_blank">indifference</a>. The DRC has been waiting for the World Health Organisation either to approve the available vaccines or issue an emergency licence that would enable use without such approval. One of these is necessary for organisations like Unicef and Gavi, the global vaccine alliance, to buy and distribute immunisations in developing countries. Mpox has plagued the world since the 1970s. The last global outbreak began just as the Covid-19 pandemic was receding. Since then, strains of the virus have reached <a href="https://www.thenationalnews.com/news/uae/2024/08/18/mpox-monkeypox-health-emergency-why-pakistan-sweden/" target="_blank">at least 119 countries</a>. But the DRC has been hit especially hard. Mpox is considered endemic there. Clade 1b has infected at least 15,000 Congolese this year, and killed at least 550. Most of the dead are children, including some who succumbed not to the virus itself, but to starvation because of painful lesions in their mouths and throats preventing them from eating. Authorities in Kinshasa first requested vaccines from the World Health Organisation and the international community two years ago, when US and EU regulators approved a vaccine developed by Danish company Bavarian Nordic and marketed under the name Jynneos to prevent the spread of mpox among their populations. Nonetheless, poorer nations like the DRC rely on approval from the WHO – not the US Food and Drug Administration or the European Medicines Agency. Bavarian Nordic submitted its research to the WHO in May of last year, but the WHO only began the process of formally considering that research in mid-August, when it declared mpox a “<a href="https://www.thenationalnews.com/health/2024/08/15/mpox-monkeypox-health-emergency-why/" target="_blank">public health emergency of international concern</a>” following Clade 1b’s spread to the DRC’s neighbours. Part of the reason for the delay is the WHO’s onerous expectations for research data. The FDA and EMA set a relatively low bar for approval – Jynneos was given the green light without human trials – because of the fears around mpox at the time. The WHO has been far more cautious – too cautious, critics say. Some experts, however, say the hesitation is warranted. No one knows how effective Jynneos and other vaccine candidates would be against the Clade 1b variant; the outbreaks in the West dealt with a different strain. Data released last month by the US National Institute of Allergy and Infectious Diseases was not promising. But a lack of attention and funding has been a major issue, too. The urgency that enabled 1.2 million Jynneos doses to be distributed in the US during the last outbreak quickly waned when the virus receded to Africa. The Africa Centres for Disease Control and Prevention says that of the $245 million it has requested to fight mpox, only 10 per cent has been funded. Under growing pressure, the WHO has eased its rules to allow partners to purchase vaccines in advance of any approval. As a result, the organisation said on Friday that a shipment of 230,000 mpox vaccines will arrive in the DRC sometime this week, donated by the European Commission and Bavarian Nordic. But that is just a first step; the road from securing a quarter of a million vaccines to getting millions more delivered in the field is very long. Mpox is a relatively slow-spreading virus, but so far it is outpacing our will to fight it.