Aiming to make potential Ebola therapies and vaccines available as quickly as possible, the ninth African Vaccine Regulatory Forum (AVAREF), taking place in Pretoria, South Africa Nov. 3-7, 2014 will devote the first two days to agree on a collaborative mechanism for fast tracking approvals for clinical trials and registration of these products in the affected countries.
“As the President of Liberia has aptly put, the best cure for Ebola is stronger health systems,” says Kees De Joncheere, World Health Organization (WHO) director for essential medicines and health products.
“It is crucial that we match the speed with which Ebola vaccines are being developed and tested with equal haste in making them available to populations once they are judged safe and effective,” says Sarah Barber, WHO representative in South Africa. “To do that, we need to agree on the design of clinical trials, and we need to collaborate across borders to fast-track scientific assessment, regulatory approval and roll-out.”
The mechaism would cover:
- Clear pathways and timelines for expedited ethical and regulatory review of clinical trial applications and approval of products
- Agreement on timelines and joint safety and efficacy assessments of the new products to fast-track national registration
- Endorsement of a panel of safety experts for expedited review of safety data of new products with relevant communication to National Regulatory Authorities (NRAs)
- Technical assistance from the World Health Organization (WHO) to facilitate these processes
Ebola, which has killed close to 5,000 people so far and crushed the already weakened health systems of Guinea, Liberia and Sierra Leone, had until recently received little attention from the pharmaceutical sector. The current outbreak, unprecedented in geographical scope and severity, has mobilised numerous private and public stakeholders to accelerate the development of vaccines to contain the outbreak and prevent other such crises in the future.
Three vaccines are currently undergoing human safety trials outside Africa. Once they are judged safe, further trials will take place in the countries affected by Ebola. The vaccines are being developed respectively by Glaxo-Smith-Kline with the U.S. government, Johnson & Johnson, and the Canadian Public Health Agency.
At the same time, partnerships between WHO and some member states are looking to the plasma of Ebola survivors, who have built antibodies to the virus, as a possible therapeutic option for people who are already infected. The plasma clinical trials will also need expedited review by ethics committees and regulators. If judged safe and effective, this therapy can be rolled out rapidly.
The Pretoria meeting will bring together public health officials, regulatory and industry experts from 25 African countries and international health stakeholders. The meeting has awakened broad interest among African governments because the accelerated mechanism fast track process it will put in place could be used as a model for other countries to accelerate access to potentially useful therapies in emergency situations.