Gavi Statement on the MPOX Emergency in Africa

Geneva, 15 August 2024 – GAVI, the Vaccine Alliance, remains deeply concerned by the unfolding epidemic disease emergency on the African continent. We welcome the measures recently announced by partners at the Africa Centers for Disease Control and Prevention (Africa CDC) and the World Health Organization (WHO). These measures will help create an enabling environment that supports a comprehensive, locally led response. We also join our partners in highlighting the importance of international cooperation following the African Union (AU) declaration of a continental security public health emergency. Africa CDC Public Health Emergency of International Concern Who.

Gavi, working with countries and partners, has been closely monitoring the MPOX situation since 2022. As a result, considerations for MPOX have been driven by the design of Gavi's new innovative health security mechanisms aimed at addressing systemic gaps identified during the COVID-19 vaccine response, as well as Gavi's Next Five-Year StrategyThe mpox vaccine was included for consideration when the evaluation process for Gavi's next five-year Vaccine Investment Strategy (VIS) was launched in 2023. A special meeting of the VIS Steering Committee was held in the first quarter of 2024 to ensure the approach took into account developments in the Democratic Republic of the Congo (DRC), where a rapidly spreading epidemic is primarily affecting children (both in morbidity and mortality) and resulting in high case fatality rates.

As a result, in June 2024 The Gavi Board approved the following measures related to MPOX::

• In its next five-year strategic period starting in 2026, Gavi will: Global MPOX vaccine stockpile – Similar to existing stockpiles of cholera, Ebola, meningitis and yellow fever vaccines. The establishment of the stockpile is pending availability of WHO emergency use listing or prequalification of recommended vaccines and will be subject to Gavi’s next strategic period funding. A key goal is to ensure that the design of the stockpile is based on a robust assessment of long-term public health needs.
• Meanwhile, Gavi Supporting response to the outbreak in the Democratic Republic of the Congo and neighboring countriesFor more details, please see below.
• In parallel, Gavi A significant investment in learning outcomes This will ensure that the current response helps inform and improve future vaccination efforts against the disease, including the design of the global stockpile.

Supporting ongoing emergency and response efforts

Gavi has been monitoring the MPOX situation daily over the past few weeks and is now working closely with countries, Africa CDC, WHO, UNICEF, donors and manufacturers to support the MPOX response. Our activities include:

• Rapid operational support: As an emergency measure, Gavi has formally declared the MPOX situation a regional emergency and has begun the process of expanding this to the region. This will unlock certain additional flexibilities and streamline processes, building on our no-regret approach to risk. Specifically, this will allow us to repurpose available funds to support the vaccine response (e.g., funding operational costs to support the use of vaccine donations) and waive formal independent review processes for new vaccine introductions and campaigns.
• Leverage new and innovative mechanisms to support a holistic response: In June 2024, the Gavi Board First Response FundThe Day Zero Financing Facility is the most immediate tool in a suite of instruments called the Day Zero Financing Facility, which aims to make resources immediately available for vaccine responses to urgent public health emergencies in response to key lessons learned from COVID-19. Gavi can leverage its First Response Fund, accessible if WHO declares a Grade 2 or Grade 3 emergency, or PHEIC, to support both the direct procurement of the mpox vaccine and other aspects of country preparedness and vaccine response.
• Direct Sourcing: Gavi is accelerating collaboration with manufacturers, including Bavarian Nordic, on the potential direct procurement of MPOX vaccine to support the outbreak response, and the WHO recently announced that two vaccines are under consideration for emergency use listing, an important interim step to enable partners to act now ahead of the longer period expected for WHO prequalification.
• Dose Donations and Emergency Response: Building on its unique experience in working with 33 donors to coordinate the donation of nearly 1 billion doses to 114 countries in response to COVID-19, Gavi will provide direct support and knowledge sharing to countries and partners as requested, and work with countries to develop national vaccination strategies. At a workshop last month, the Government of the Democratic Republic of the Congo, Africa CDC, Gavi, WHO, UNICEF and other partners worked together to develop a three-phase vaccine response strategy based on a common understanding of the supply of vaccines available for donation. At the same time, Gavi is sharing legal and process knowledge and providing operational support to Africa CDC and other partners involved in procuring donated vaccines. Building on its experience in working with donors, countries and partners to coordinate the global COVAX vaccine donation mechanism, this includes providing input on the complex technical, legal, regulatory and logistical considerations involved in conducting rapid vaccination campaigns with donated vaccines.
• Invest in your learning agenda: Following its June 2024 Executive Board decision, Gavi is committed to ensuring that any vaccine response against mpox also contributes to improving available data on disease burden and epidemiology, including through supporting surveillance and modelling studies on vaccine use and impact. Expanding available data will support the efforts of countries and partners, such as WHO and Africa CDC, to ensure that future global stockpiles accurately respond to long-term public health needs, and therefore help improve future vaccination efforts against the disease. Following recent developments, Gavi is working with partners to finalise the design of this agenda and aims to issue a request for proposals as soon as possible.