Healthcare Alerts | Infectious Diseases | MPox

Deliveries, approvals, and collaboration. Momentum builds in Africa’s Mpox fight

Time to read: 06:12 mins
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16 September 2024, 12:30 
Contributor: Linda Ravenhill, Editor

Last week, we reported on the lack of delivery of the promised mpox vaccine to the African countries most hard hit by the virus.

This week, we’re delighted to report not one but three good news stories related to the Mpox outbreak.

Up first, we can confirm that nearly 100,000 doses of Bavarian Nordic's MVA-BN mpox vaccine have been delivered to Kinshasa, DRC, through the European Union donation program, with another 100,000 doses expected to have arrived by the time this article reaches you.  

This is excellent news, in particular for the Democratic Republic of Congo (DRC), which has been hardest hit by the latest outbreak. According to health authorities in that country, the vaccination program is expected to commence in the first week of October to allow healthcare workers to be properly trained on key issues related to the vaccines, including administration and storage.  

This initial delivery accounts for 200,000 of the 3.6 million doses pledged globally so far, which includes 620,000 doses of the MVA-BN vaccine, to be contributed by the European Commission and countries like Austria, France, and the U.S., as well as contributions by the makers of the vaccine, Danish company Bavarian Nordic, and 3 million doses of the LC16 vaccine pledged by Japan, who have made the largest commitment to the outbreak efforts to date.

The situation on the ground

According to the latest Mpox: Multi-Country External Situation Report (WHO), for the period 1 January 2024 to September 8, 2024, a total of 5,759 laboratory-confirmed mpox cases have been recorded in Africa.  The number of suspected cases is obviously much higher: 25 093 suspected mpox cases, including both tested and untested cases, have been reported in this eight month period, with 723 deaths recorded.

The three countries reporting the most suspected mpox cases in 2024 are the Democratic Republic of the Congo (21 835 suspected cases, 717 deaths), Burundi (1489 suspected cases, no deaths), and Nigeria (935 suspected cases, no deaths). 




Here in South Africa, on September 9th, the Department of Health reported another case, bringing the total number of cases recorded in the country since the start of the outbreak to 25, with three fatalities. The case - a 38-year-old male - sought medical assistance at a private facility in the Western Cape after presenting with lesions, headache and muscle pain. He had no known history of international travel or contact with a confirmed mpox case, which once again highlights the potential for undetected local transmission.

The situation in South Africa illustrates another of the difficulties authorities have encountered in managing this outbreak, namely that there are two monkeypox virus (MPXV) clades - clades I and II - and their subclades circulating in different geographic areas in the region, affecting different populations. Each clade requires a tailored and locally adapted response, which is not always possible given the resource constraints in the affected countries.  

According to the External Situation Report, while genomic sequencing capacity is limited, it appears that clade 1b, a mutated strain of the virus, is driving the increase in cases in the DRC, Burundi, Rwanda, Kenya, and Uganda.  This strain has also been found in imported cases in Sweden and Thailand, which is of great concern for the global community. So far, the cases in South Africa have have not been the result of the clade 1b, which is of some relief to local authorities.

Good News Story Two

This brings us to the second of our good news story, and that is the WHO announced on September 13 that it was adding the MVA-BN vaccine to its pre-qualification list. 

The vaccine is the first mpox vaccine to be given such approval, although the WHO is progressing with applications for two other mpox vaccines – LC-16 and ACAM2000.

Pre-qualification (PQ) is a crucial tool in the WHO's outbreak management arsenal. It ensures that medical products—like vaccines, medicines, and diagnostics—meet international quality, safety, and efficacy standards and still reach the people who need them most. 

The goal is to provide a rigorous evaluation of products intended for use in low- and middle-income countries, where healthcare systems might not have the capacity to conduct such assessments.

With the MVA-BN vaccine now prequalified, international health organizations can purchase and distribute it, marking a critical milestone in global outbreak control efforts. Under the pre-qualification, the WHO's Strategic Advisory Group of Experts (SAGE) has recommended the use of the MVA-BN vaccine for individuals at high risk of mpox exposure. 

Available data shows that a single dose offers 76% effectiveness against the virus, while the full two-dose regimen achieves 82% effectiveness. On this basis, the pre-qualification allows for a single-dose approach where vaccine supplies are limited, which will extend the campaign's reach in the region.

Furthermore, the WHO has applied its Emergency Use Listing (EUL) mechanism to the vaccine. This is particularly significant for the current situation, as the MVA-BN vaccine is not currently licensed for use in patients younger than 18 years of age.

In this current outbreak, the highest burden of disease, including mortality rates, is in children aged 15 years and younger. In Bujumbura Nord, for example, the most affected district in Burundi, approximately half of the cases recorded have been children under five years of age. Under the EUL, the MVA-BN can now be used "off-label" in these younger children, which will go a long way to alleviating the burden of disease.


Looking Ahead

In addition to working towards the pre-qualification of additional vaccines, such as LC-16 and ACAM2000, the WHO has received six expressions of interest for mpox diagnostic products for licensing under the Emergency Use Listing mechanism, which will further support outbreak management efforts.

And that brings us to our final good news story, which was another announcement by the WHO on September 13 that, together with its partners and member states, it has established the Access and Allocation Mechanism (AAM) for mpox vaccines, treatments, and diagnostics. 

Created to address some of the key challenges posed by global health emergencies like the mpox outbreak, the primary focus of the AAM is to ensure equitable to tools such as vaccines and diagnostic kits, ensuring they are allocated based on risk rather than wealth or geography. This is a significant development as many regions in low- and middle-income countries, often face delays in receiving vital healthcare supplies due to logistical or financial constraints.

By working with a wide range of partners, the AAM aims to foster a collaborative approach, integrating the expertise and resources of various organizations to streamline the development, manufacturing, and delivery of medical countermeasures. This collaborative effort will not only make vaccines and treatments more accessible, but it will also speed up the response to outbreaks, ensuring that the tools needed to combat mpox are delivered quickly and fairly.

The creation of the AAM also signifies a broader shift toward global cooperation in pandemic preparedness and response. 

The interim Medical Countermeasures Network (i-MCM-Net), of which the AAM is a part, is designed to build a comprehensive ecosystem for developing, manufacturing, and distributing medical countermeasures for health emergencies.

The i-MCM-Net involves not only health agencies and international organizations but also civil society groups, industry stakeholders, and private-sector partners, creating a multi-faceted approach to tackling disease outbreaks.WHO member states have endorsed this network as an interim solution while negotiations continue toward a more permanent pandemic agreement, demonstrating the global commitment to improving outbreak readiness. 

As new tools and treatments for mpox become available, the AAM will play a pivotal role in ensuring that these resources are used efficiently and equitably, bringing relief to those hardest hit by the virus.

These three developments mark significant advancements in the global response to the crisis. While it has taken some time to get to this point, now that many of the roadblocks have been removed, there is reason to hope that we are one step closer to delivering relief to the people on the ground—both those suffering from the disease and the healthcare workers struggling to manage the situation. Most importantly, there is hope that the region can finally bring the outbreak under control.

The following sources were used to compile this article:

13 September 2024 | Interim Medical Countermeasures Network (i-MCM-Net)
13 September 2024 | Prequalified Vaccines | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
13 September 2024 | WHO and partners establish an access and allocation mechanism for mpox vaccines, treatments, tests
14 September 2024 | Multi-country External Situation Report n. 36, published 14 September 2024 (PDF) 
9 September 2024 | Health Department confirms one more positive mpox case (PDF)

Access more articles related to Mpox
 

9 September 2024 | Promised Mpox vaccines for Africa delayed as outbreak intensifies
27 August  2024 | WHO | First-ever delivery of mpox vaccines in Africa outside of clinical trials arrives in Nigeria
31 August 2024 | UNICEF Issues Emergency Tender for Mpox Vaccines as Global Response Intensifies



Access all Mpox articles & resources

 

 

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