Loss of 800,000 Mpox Vaccine Doses in Africa Due to Policy and Logistics
Nearly 800,000 doses of the JYNNEOS® mpox vaccine, pledged by the United States under the Biden administration, are now unusable due to delayed shipment and insufficient shelf life. This article explores the technical, regulatory, and policy factors that contributed to this shortfall and outlines strategies to prevent similar outcomes in future global health campaigns.
Background of the Mpox Vaccine Pledge
In mid-2024, the U.S., the EU, and Japan collectively committed 5 million doses of mpox vaccine to support nearly a dozen African nations facing sustained transmission. The U.S. portion—over 1 million doses—was intended to be delivered by early 2025. To date, only 91,000 doses have been shipped, and just 220,000 still meet the World Health Organization’s minimum six-month expiration requirement for international dispatch.
Regulatory and Shelf-Life Requirements
- Minimum Shelf Life: WHO policy mandates a minimum of six months remaining before expiration to ensure cold-chain stability and allow for national rollout.
- Prequalification: Vaccines must receive WHO prequalification or emergency use listing (EUL) to enter partner countries’ regulatory systems.
- National Licensure: Some African regulators require local bridging studies or expedited reviews, adding 4–8 weeks to the import timeline.
Technical and Logistical Challenges
The JYNNEOS® vaccine, produced by Bavarian Nordic, uses a non-replicating Modified Vaccinia Ankara (MVA) vector and requires storage between -30°C and -15°C. This cryogenic requirement strains cold-chain logistics, especially in regions with intermittent power.
Cold-Chain Infrastructure
Shipment in 10-dose vials demands ultra-low-temperature freezers or dry ice shippers. Many peripheral health centers rely on solar-powered refrigerators rated for 2–8°C, insufficient for MVA-based vaccines. Transport from port to district hubs can take 5–10 days, during which temperature excursions risk potency loss.
Fill–Finish and Bottleneck Analysis
- Global Manufacturing Capacity: Bavarian Nordic’s fill–finish lines operate at ~2 million doses/month but must also supply U.S. domestic stockpiles.
- Export Licensing: U.S. export controls and the Defense Production Act prioritization delayed foreign shipments by 6–12 weeks.
- Container Availability: Dry ice–cooled containers were prioritized for COVID-19 mRNA vaccines, creating competition and shipping slot constraints.
Impact of Wasted Doses on Outbreak Control
Since mid-2022, Africa CDC reports ~160,000 suspected mpox cases and ~46,000 laboratory-confirmed infections. Modeling by the London School of Hygiene & Tropical Medicine indicates that vaccinating high-risk groups and health workers can reduce incidence by up to 70% within three months. Losing 800,000 doses represents a lost opportunity to avert an estimated 20,000 additional cases.
Policy and Funding Cuts Under Prior Administrations
Politico analysis attributes significant shipment delays to budgetary and structural cuts implemented during the Trump administration (2017–2021). Key changes included:
- USAID Restructuring: A 20% reduction in staff handling global health procurement.
- Foreign Aid Budget Cuts: Annual development assistance decreased from $60 billion (2016) to $45 billion (2020).
- Supply Chain Consolidation: Merging of logistics units increased lead time by an average of 4 weeks per shipment.
“To ship a vaccine to an African partner, we need six months of remaining shelf life to accommodate export review, customs clearance, and cold-chain distribution,” said Africa CDC deputy incident manager Yap Boum.
Expert Opinions
Dr. Matshidiso Moeti, WHO Regional Director for Africa, warns that delayed or canceled shipments prolong outbreaks and increase the risk of viral adaptation. “Every delayed dose is a missed chance to break transmission chains,” she stated at the May 2025 International Vaccine Summit.
Supply Chain Innovations and Next-Generation Vaccines
Efforts are underway to improve thermostability and decentralized production:
- mRNA Vaccine Platforms: Trials are testing mRNA-based mpox vaccines with 2–8°C storage, leveraging fill–finish capacity at the Afrigen Biologics mRNA hub in South Africa.
- Lyophilized Formulations: Research on freeze-dried MVA vaccines could reduce dependence on ultra-cold storage.
- Blockchain Tracking: Pilot projects with UNICEF are deploying blockchain-based shipment tracking to minimize diversion and reduce customs delays.
Recommendations and Future Outlook
To prevent future wastage, stakeholders should:
- Negotiate rolling-shipment agreements with manufacturers to align production runs with partner country readiness.
- Expand local fill–finish capacity in Africa through technology transfers and public–private partnerships.
- Implement real-time cold-chain monitoring using IoT sensors to ensure temperature compliance.
- Secure multi-year funding commitments for USAID and global health security programs.
With these measures, global health agencies can reduce the risk of large-scale vaccine wastage and enhance epidemic preparedness across Africa and beyond.