Malabo, Equatorial Guinea, July 22, 2014 – The outbreak of Ebola virus disease in parts of West Africa was the largest, longest, most severe, and most complex in the nearly four-decade history ofthis disease. It is in this context that the African Union Commission (AUC) has organised the International Conference on Africa’s fight against Ebola under the theme “Africa helping Africans in the Ebola Recovery and Reconstruction”. The conference is currently ongoing in Malabo, Equatorial Guinea.
The search for vaccines and other therapies against the disease still continues as some candidate drugs are being tested for their efficacy. Currently there are clinical trials going on in the countries that were affected; seven clinical trials in Sierra Leone, two in Mali and several applications have been submitted for approval to the National Medicines Regulatory Agencies in these countries. Applications for 15 other therapies have also been submitted for clinical trials in the affected countries, of which nine have been approved while six are still pending. Meanwhile, one clinical trial on Ebola vaccine has been put on hold in Ghana pending a public awareness programme in order to clarify various misconceptions that are emerging from the general public about the trial.
Representatives from various institutions attending meeting on Clinical trials oversight on Ebola Therapies and Vaccines and other Neglected Tropical Diseases
To inform theEbola conference on how the African Union will address future public health threats, the NEPAD Agency jointly with AUC has organised a side event on innovative clinical trials to combat Ebola and other emerging health risks across Africa. The meeting titled “Clinical Trials Oversight on Ebola therapies and Vaccines and other Neglected Tropical Diseases” brought together experts from diverse disciplines to capture different experiences, recommendations for policy intervention, scientific undertaking and public participation and acceptance.
The side event was aimed at mobilising the African National Medicines Regulatory Agencies and Regional Economic Communities (RECs) to come up with strategies which will assist African Union Member States in facilitating development and regulation of new therapies and vaccines for prevention and treatment of diseases that disproportionately affect the African populations.
In his opening remarks, Prof. Aggrey Ambali, Head of NEPAD Science, Technology and Innovation Hub, highlighted that the AU Assembly January 2015 decision recognised the contributions of the African Medicines Regulatory Harmonisation (AMRH) Initiative in regulatory capacity development in Africa. The AU decision further directed the NEPAD Agency and AUC in collaboration with the World Health Organization (WHO) to support the speedy evaluation of promising treatment options and vaccine candidates against Ebola Virus Disease through the AMRHInitiative.
Prof Aggrey Ambali (left) addressing delegates and Dr Margaret Ndomondo-Sigonda presenting on Regulatory Harmonisation in Africa
“Indeed as we have moved into the post-Ebola epidemic era. There is a a need to mobilise scientists from all fields to continue with the task of finding approved vaccines and other therapies forEbola and other neglected tropical disease. I emphasise that this is a taskthat requires mobilisation of all disciplines, including strong public engagement.” he said
Echoing Prof Ambali’s statement, the AUC Director of Social Affairs, Ambassador Dr. Olawale Maiyegun reiterated that the conference on Ebola has strong propensity to provide an opportunity for Africa to take action and progress towards achieving robust national health systems that are adequately staffed and financed, resilient to shocks and health threats, and that are able to reach all people with good quality preventive and curative services.
“Sothis side event will address the issue of ensuring availability of medical products, vaccines and technologies which will be considered in the outcomes of the main conference,” he said.
The meeting also heard presentations from the countries that had experienced Ebola outbreaks. Representatives from the affected countries (Guinea, Liberia, Sierra Leone, Mali, Ghana andNigeria) had an opportunity to share the challenges and successes in the conduct of clinical trials in their respective countries in response to theoutbreak. The country experiences shared will be crucial input into the main conference to help advise the AU on how regulatory sciences and services should be deployed in the search for therapies and vaccines.
Discussing country shared experiences…
The representatives also underscored the critical role that the RECs play in facilitating joint reviews, strengthening regulatory capacity building, and the ethical clearance of vaccine clinical trials. They also discussed the challenges they faced in trying to combat the virus, such as the limited number of technical personnel, resources and infrastructure for the evaluation, monitoring and implementation of clinical trials.
These country experiences emphasised the importance of reinforcing the link between health research and intervention to better coordinate the response against Ebola and other major emerging endemic diseases in Africa. The regional Working Groups established under the AMRH programme are a viable route for building capacity of regulatory and ethics systems, considering that most of the countries are still building their regulatory systems. The NEPAD Agency and the World Health Organization (WHO) have committed to continue working together in order to support the RECs and Member States.
Mike Ward, WHO Coordinator for Regulatory Systems Strengthening spoke on various measures taken by the organisation in the fight against Ebola. These included the creation of a task team on Ebola, a sub-regional Ebola Operations and coordination Centre to help manage international responses, which acted as a platform for coordination of support to affected areas, facilitated research and development for advancement of therapies and vaccines component and supported the countries in mechanisms to be very prepared in tackling such challenges.
The outcomes and recommendations of the meeting will feed into the agenda of the two-day International Conference on Africa’s fight against Ebola.