The World Health Organization (WHO) has teamed up with the Ugandan Ministry of Health to support Ebola vaccine trials as the country is experiencing an outbreak of the disease.
The Ministry of Health has appointed the Makerere University Pulmonary Institute to conduct clinical trials of vaccines and therapies. A principal investigator from the Makerere University Pulmonary Institute will lead the vaccine trial.
The Coalition for Epidemic Preparedness Innovations (CEPI) and the Vaccine Alliance (Gavi) are providing support to ensure that sufficient doses of candidate vaccines are available for the trial. If sufficient doses can be made available, the goal of the vaccine trial would be to establish the efficacy of the candidate vaccines in various populations.
Vaccine developers and funders that will make the candidate vaccines available include Oxford University and the Serum Institute of India, the Sabin Vaccine Institute and the U.S. government institutions Biomedical Advanced Research and Development Authority (BARDA) and National Institutes of Health (NIH), as well as the International AIDS Vaccine Initiative (IAVI) and MSD.
In addition, other organizations are committed to supporting the global response, such as the African Centers for Disease Control and Prevention (CDC Africa), UNICEF, non-governmental organizations, donors and regulatory bodies, such as the African Vaccine Regulatory Forum (AVAREF).
A number of objectives have been identified for the organizations. In the short term, the aim is to support the Ugandan Ministry of Health’s outbreak response efforts as needed to control the outbreak and, under their leadership, to support a randomized clinical trial to evaluate one or more candidate vaccines as part of the response.
In the medium term, the intent is to allocate resources to plan and reserve sufficient manufacturing capacity to scale up production of candidate vaccines (even before they are licensed), potentially through the establishment of a risk-sharing mechanism.
This may also involve manufacturing additional at-risk vaccines during the trial to ensure that doses of a vaccine deemed effective can be made available to end the outbreak as soon as possible.
In the longer term, the aim is to explore ways to ensure that licensed vaccines are available through the Ebola vaccine stockpile, which is enabled and funded by Gavi and managed by UNICEF, on behalf of the International Coordinating Group (ICG) mechanism on vaccine supply coordinated by WHO, potentially using innovative market shaping mechanisms.
In addition, they also seek to commit to developing a mechanism to ensure equitable access and funding for vaccine research, outbreak response and preventive vaccination; in addition to providing support for the development and evaluation of next generation vaccines.
In this regard, the signatories commit to be guided by a number of principles: leveraging organizational strengths to achieve a common goal; committing to support Ministries of Health experiencing outbreaks and ensuring that any engagement with countries is coordinated and aligned with the Ministry of Health and responds to locally identified needs; evidence-based, access-sensitive decision making; and a comprehensive approach based on access and equity; efficient resource allocation and research ethics.
The actions taken by the Ugandan Ministry of Health and its partners are based on collaboration and past experiences in responding to Zaire ebolavirus (another Ebola virus species) outbreaks, lessons learned with COVAX, and work on other vaccine stockpile mechanisms.
