Building resilience: Strengthen epidemic preparedness with flexible pharma manufacturing
On 3 February 2025, the World Health Organisation (WHO), the Ministry of Health of Uganda, and other partners launched a clinical efficacy trial for a vaccine against the Sudan strain of the Ebola virus.
Why is this a big deal? Well, this is the first-ever trial to assess the clinical efficacy of a vaccine against the Sudan Ebola virus. It is the first clinical trial of the vaccine during an outbreak. Most impressive is the speed at which this trial was rolled out, that too in an emergency situation – only a mere four days passed between the confirmation of the outbreak and the trial to be ready for rollout. All thanks to advanced research preparedness. This is all the more important because, while there are many promising medical countermeasures in clinical development, there aren’t any licensed vaccines or approved treatments for this strain of the virus.
With financial support from the WHO, CEPI and other international partners, the candidate vaccine was donated by IAVI. Meanwhile, principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI) led preparedness efforts and the implementation of the trial. This quick commencement of the trial was also due to the efforts and involvement of Uganda’s health workers and communities.
Setting the stage for clinical efficacy trials during outbreaks.
Though the final stages of the trial preparation – including refresher training for research teams – were completed within four days, preparations for this moment truly began as far back as 2022.
In 2022, there was an outbreak of the Sudan strain of the Ebola virus in Uganda. At this time, a randomised protocol for candidate vaccines was developed, principal investigators were designated, and research teams were trained in good clinical practice (GCP) and standard operating procedures (SOPs) for a trial during an active outbreak. Vaccine doses were pre-positioned in Uganda. Cold chain documentation was also reviewed by the WHO to ensure proper storage in the years leading up to the outbreak. These prescient actions set the stage for such a quick trial rollout in 2025.
If this trial is successful and the candidate vaccine is deemed effective, this intervention will not only play an important role in controlling this outbreak but it will also generate critical data for vaccine licensure.
The way forward for this trial.
As part of the agreements signed by the WHO, Uganda’s Ministry of Health and IAVI, in addition to the pre-positioned vaccine doses, the IAVI will also supply additional doses of the candidate vaccine, as needed in the ring trial, on an accelerated timeline. These additional doses will be crucial to ensuring an uninterrupted supply for the successful completion of this trial.
The agility with which all the organisations, institutions and communities involved commenced this trial is commendable. It is a testament to the major advancements that are possible when effective preparedness measures are put in place. It is a reminder of why we must have immediately available doses of approved and experimental medical countermeasures. It is a reminder that speed can save lives.
Epidemic preparedness: Learning from Uganda and IAVI.
The rapid response to the Sudan Ebola outbreak in Uganda demonstrates the importance of preparedness in public health and medical research. The ability to quickly produce medicines, vaccines, and diagnostics during an outbreak is critical, not only for containing the immediate crisis but for mitigating the impact of future health emergencies. In the case of Sudan Ebola, the swift rollout of the clinical trial was made possible by years of groundwork, including vaccine pre-positioning, training, and coordination among research institutions, health agencies, and the community. Such preparedness is crucial in saving lives and preventing further transmission of the virus.
However, as the world faces increasing risks of epidemics and pandemics, it is becoming clear that preparedness also requires the ability to scale up production rapidly to meet the demands of a global health emergency. Existing pharmaceutical manufacturing facilities often struggle to respond quickly enough to the sudden spike in demand for vaccines or drugs, especially when dealing with diseases that are unpredictable or novel. To address this challenge, there is a growing need for flexible, scalable, and adaptable manufacturing systems that can respond swiftly to any crisis, whether it’s a local outbreak or a worldwide pandemic.
PodTech™’s prefabricated pharma factory systems — we call them podule™ clusters — are designed to meet this very need. These modular, containerized facilities can be rapidly deployed in regions where they are needed most, allowing for the on-site production of vaccines, medicines, and diagnostics. The podule™ clusters are built with a focus on scalability, so they can grow with demand and produce large quantities of critical medical countermeasures in a matter of weeks, not months. This ensures that the necessary products are available on the ground during health emergencies, without the long delays that often occur when relying on traditional manufacturing infrastructures.
In addition to being scalable, PodTech™’s podules™ can also be relocated if necessary, offering the agility to address health crises in different geographical locations. Whether it’s setting up an emergency vaccine production facility in a remote area or ensuring that essential medicines are distributed globally, the relocatability of these clusters makes them an invaluable asset in the fight against infectious disease outbreaks.
By using cutting-edge technology to build flexible manufacturing solutions and robust supply chains, PodTech™’s podule™ technology could play a pivotal role in the future of epidemic preparedness, ensuring that we can act quickly and efficiently in the face of health crises, just as was done in Uganda in early 2025.
As we reflect on the lessons from Uganda’s swift response to the Sudan Ebola outbreak, it becomes clear that the future of epidemic preparedness relies on collaboration and innovation. Pharmaceutical manufacturers, governments, and entrepreneurs — particularly those in low- and middle-income countries (LMICs) — must come together to build resilient, adaptable systems that can meet the challenges of unexpected health crises.
If you’re one of these stakeholders, you can partner with PodTech™ to leverage the power of scalable, relocatable, and rapid-response manufacturing solutions to strengthen your outbreak response capabilities. Together, we can ensure that no region is left behind when it comes to protecting public health. Together, we can make the world better prepared for the next health emergency.