The joint guidelines, issued by the African Medicines Agency (AMA) and the European Medicines Agency (EMA), are designed to reduce unnecessary delays in vaccine research and support the timely assessment of potential candidates, particularly during public health emergencies.
The initiative follows scientific consultations convened with the World Health Organization (WHO) on August 24, 2026. The resulting position paper was published by the EMA’s Emergency Task Force (ETF) in collaboration with AMA.
According to the agencies, the initiative comes amid a public health emergency in the Democratic Republic of the Congo (DRC), with cases also reported in Uganda, Kenya and Nigeria.
The regulators stressed that accelerating vaccine development must go hand in hand with rigorous scientific evaluation, appropriate safety assessments and safeguards for people participating in clinical trials.
Under the proposed framework, vaccine developers using established technologies, including messenger RNA (mRNA) and certain viral-vector platforms, may not need to repeat some toxicity studies if sufficient evidence already exists to demonstrate the safety of similar technologies.
The agencies explained that relevant safety data from previously developed vaccines could provide a scientific basis for advancing promising candidates into early-stage human trials more quickly.
The approach is intended to avoid unnecessary duplication of research while ensuring that regulatory decisions remain grounded in reliable scientific evidence.
African clinical trials to be prioritised
The guidelines recommend conducting initial clinical trials in Africa, where researchers can work towards advancing vaccine candidates and preparing for larger studies involving populations at risk of infection.
For later-stage evaluation, the agencies proposed Phase III clinical trials involving people who have had close contact with confirmed Ebola patients. This approach, commonly known as ring vaccination, focuses on populations connected to identified cases to assess vaccine effectiveness during an outbreak.
The framework also allows for multiple vaccine candidates to be evaluated under a common clinical trial structure, potentially improving coordination and reducing delays in assessing different products.
Another priority is the development of single-dose vaccines, which regulators said should be favoured because they would be easier to administer during outbreaks.
A single-dose regimen could simplify vaccination campaigns, reduce the logistical burden on healthcare workers and make it easier to reach people in affected communities, particularly where access to healthcare facilities is limited.
However, the suitability of individual vaccine candidates will still depend on evidence of their safety and effectiveness.
Safeguards for vulnerable groups
The joint guidance also addresses the inclusion of vulnerable populations in vaccine research, particularly children and pregnant women.
The agencies recommended that studies involving these groups should begin once sufficient preliminary safety data have been obtained from adult participants.
The approach is intended to balance the need to generate evidence for populations that may be affected by outbreaks with the responsibility to minimise risks to clinical trial participants.
Regulators emphasised that vaccine developers must maintain appropriate scientific and ethical standards throughout the research process, even where public health emergencies create pressure for faster results.
Regulators seek closer cooperation
The agencies have encouraged vaccine developers to engage with AMA and national regulatory authorities across Africa at an early stage of the development process.
Early consultations are expected to help researchers obtain scientific guidance, coordinate clinical trial assessments and facilitate regulatory decisions across participating countries.
Closer cooperation between African and European regulators could also improve the consistency of assessments and help prevent avoidable delays arising from fragmented regulatory processes.
The initiative reflects a broader effort to strengthen collaboration in the development of vaccines against emerging infectious disease threats, particularly those that disproportionately affect African populations.
By combining existing scientific evidence, coordinated clinical trials and closer regulatory engagement, AMA and EMA aim to support the development of safe and effective vaccines against Bundibugyo virus disease without compromising participant protection.
The effectiveness of the framework will ultimately depend on the availability of promising vaccine candidates, the quality of clinical evidence and the ability of researchers and regulators to coordinate trials efficiently during outbreaks.