Statement from the RVMC Executive Committee

The Regionalized Vaccine Manufacturing Collaborative (RVMC) is gravely concerned about the evolving mpox outbreak. Despite the existence of effective vaccines, access to doses is severely limited. Scaling production faces a number of roadblocks and will be delayed by months. The outbreak highlights the need for regional vaccine manufacturing facilities that are ready to respond in a time of crisis.

The RVMC is committed to working with partners to develop regional vaccine manufacturing networks, leveraging lessons from the current outbreak to address challenges in vaccine manufacturing. We must not allow shortage of vaccines due to a lack of manufacturing capacity to hamper future responses to emerging regional and global health threats. 

We welcome positive developments:

• Coordination: We commend the Africa CDC’s Mpox Continental Preparedness and Response Plan and WHO’s Global Strategic Preparedness and Response Plan. A swift, coordinated response is essential and requires enhanced surveillance, point-of-care diagnostics, equitable access to medical countermeasures and community empowerment.
• Vaccine Donations: Partners are identifying doses from existing stockpiles for donation, addressing legal and regulatory challenges. Close collaboration between WHO, Gavi, Africa CDC, regulators and governments is vital. Donated vaccines will be key in the early response, given current delays.
• Emergency Use Listing: The WHO is presently expediting Emergency Use Listings (EUL) for existing vaccines.
• Research Progress on the MVA-BN vaccine in children will provide important data about its potential wider use in this most affected and vulnerable group. 

We note critical challenges and important lessons to be learned:

Demand and Financing:

• Predictable long-term demand will be crucial to scaling up manufacturing and transferring technology to regional producers. Africa CDC and Gavi aim to establish mpox vaccine stockpiles by 2026, but it remains to be seen whether this is sufficient to trigger manufacturers to scale up production and reduce prices. 
• Demand pooling and funding mechanisms must urgently be developed, balancing regional and global systems.
• Financing for immediate mpox vaccine procurement requires immediate clarity. Gavi’s First Response Fund, presently contingent on WHO EUL, may cover only a fraction of vaccine needs at current prices.
• The significant investments in African manufacturing made by Team Europe and others are critical to reinforce and build on.
• Development Finance Institutions (DFIs) must play a key role in de-risking investments to expand vaccine manufacturing and support long-term sustainability. We welcome the G7 DFI-led Surge Financing Initiative for rapid manufacturing scale-up and urge acceleration of its process. 

Regional Manufacturing Needs:

• Regional manufacturing will not, at this time, meet immediate demands, but it is vital for medium and long-term regional health security.
• Processes for selecting regional partners for technology transfer are presently being developed and need to be in place for the future. 
• Ensuring future access to affordable mpox vaccines suitable for use in low-income settings will require simplified, scalable technology platforms.

Regulatory Pathways:

• Streamlining the WHO EUL process should be considered, enabling pre-approval assessments for vaccines that can be used in future potential Public Health Emergencies of International Concern.
• A recalibration of risk-benefit assessments based on local authorities’ assessments during regulatory reviews seems necessary, especially when substantial safety data exists, and the risks from slow approval are substantial.
• Support to strengthen regional and national regulatory agencies is critical to regional production.

Procurement:

• Gavi and UNICEF should in the future act on approvals from stringent regulatory authorities without relying solely on WHO PQ or EUL.
• Other triggers to enable procurement should be identified in the event of local outbreaks before they get to the level of a PHEIC, driven by local need and local regulators with support as needed from WHO listed authorities. 

RVMC is doubling down on securing a future with equitable access to vaccines through the accelerated establishment of a regional vaccine manufacturing, for the benefit of all.

Dr. Jarbas Barbosa (PAHO), Dr. Shyam Bishen,(WEF) Dr. Victor Dzau (US NAM), Farid Fezoua (IFC), Dr. Richard Hatchett (CEPI), Dr. Jean Kaseya (AfCDC), Dr. Frederik Kristensen (RVMC)