Health
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The African Vaccine Regulatory forum has ended its meeting in Pretoria, South Africa November 7, on how to expedite approval of vaccines and therapies for Ebola
EBOLA, which has killed close to 5000 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. But this is changing with the current outbreak, unprecedented in geographical scope and severity, as numerous private and public stakeholders have been mobilized 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 US 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 idea of making potential Ebola therapies and vaccines available as quickly as possible is one of the basic aims of the just concluded meeting of the ninth African Vaccine Regulatory Forum, AVAREF, which took place in Pretoria, South Africa, from November 3 to 7. The meeting devoted 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.
One of the attendees to the meeting Kees De Joncheere, WHO director for Essential Medicines and Health products, who quoted the President of Liberia as aptly saying that the best cure for Ebola is stronger health systems. “That wake-up call could turn things around for Africa and represent another step towards increasing access to and better regulation of health products,” he said.
Also, Sarah Barber, WHO representative in South Africa, said: “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. 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 mechanism 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 and technical assistance from the World Health Organisation, WHO, to facilitate these processes.
The Pretoria meeting brought 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.
AVAREF was founded in 2006 by WHO to support NRAs in making informed decisions concerning authorisation of clinical trials, evaluation of product registration dossiers, and any other challenging issues related to vaccines evaluation. AVAREF provides African regulatory authorities charged with ensuring the safety of medical products and related research with expertise and opportunities for information sharing and capacity building. It also offers product developers the opportunity for joint review by regulatory authorities from multiple countries of clinical trial and marketing authorisation applications for high priority vaccines to be used in African countries. While initially focused on vaccines, AVAREF is beginning to expand to cover medicines and diagnostics as well.
— Nov. 17, 2014 @ 01:00 GMT
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Tags: AVAREF Kees De Joncheere Sarah Barber WHO World Health Organisation
