WHO Sets Priority for Emerging Diseases Research

Janis C. Kelly

December 22, 2015

The World Health Organization (WHO) has issued an initial list of diseases needing urgent research attention to prevent severe outbreaks. This list, which includes Crimean Congo hemorrhagic fever, Ebola and Marburg virus diseases, Lassa fever, Middle East respiratory syndrome and severe acute respiratory syndrome coronavirus diseases, Nipah, and Rift Valley fever, is expected to be a key element in the WHO Research and Development (R&D) Blueprint for infectious diseases with epidemic potential currently under development for presentation in May 2016 at the 69th World Health Assembly in Geneva, Switzerland.

Chikungunya, a severe fever with thrombocytopenia syndrome, and Zika were designated as "serious" problems requiring action by WHO to promote R&D as soon as possible. HIV/AIDS, tuberculosis, malaria, avian influenza, and dengue were not included in the list because these infections are already being addressed via major disease control and research networks.

The Blueprint is a successor project to the work WHO did during the recent Ebola virus disease outbreak in West Africa and was initiated at the WHO Ebola Research and Development Summit held in May 2015. In arguing for a new approach to R&D, WHO said that the Ebola epidemic demonstrated the inadequacy of current approaches to vaccine, drug, and diagnostics development. Specifically, WHO says that market-driven R&D models are not suited to controlling sporadic or unpredictable diseases, especially in less-developed countries.

"The challenge becomes even greater when faced with a wholly new disease such as [severe acute respiratory syndrome], [Middle East respiratory syndrome,] and Nipah virus infection, which are just three examples of diseases that have emerged at the human-animal interface in the last two decades," WHO writes in a statement about the blueprint.

"The international community needs to invest to improve our collective ability to respond to new threats and to prepare itself with a novel R&D paradigm to address future epidemics."

WHO made clear up front that it will not be paying for this multimillion dollar undertaking. The blueprint approach will request proposals for flexible development and production platform technologies for vaccines, therapeutics (drugs and blood products), and diagnostics against five to 10 top-priority pathogens/diseases. Platforms would manufacture candidate vaccines or drugs for use in phase 1 clinical trials in advance of a confirmed outbreak and for phase 2/3 clinical trials during a potential epidemic.

"[T]he most meritorious ideas emerging from the process — as assessed by the R&D Blueprint Scientific Advisory Group — will be invited to present in a dedicated workshop where WHO Member States and relevant R&D funders will be invited to participate," say the authors of the statement.

The initial list of target infections was selected by a panel of scientists and public health experts convened by WHO and tasked with prioritizing the top five to 10 emerging pathogens likely to cause severe outbreaks and for which few or no medical countermeasures exist. The working group included experts in virology, microbiology, immunology, public health, clinical medicine, mathematical and computational modeling, product development, and respiratory and severe emerging infections. The conclusions of the experts were reviewed by the Blueprint's independent Scientific Advisory Group. The initial list will be reviewed annually or when new diseases emerge.

"In general, I think that the respiratory infections are still the most nefarious, including [Middle East respiratory syndrome and severe acute respiratory syndrome coronavirus diseases]. Avian flu is a specific exclusion on this list, as they already deem it well-funded. Ditto, overall resistant [tuberculosis] and malaria, which remain threats. I find it strange that they didn't include cholera," David O. Freedman, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham, director of the University of Alabama at Birmingham Travelers Health Clinic, and founding director of the GeoSentinel Surveillance Network, told Medscape Medical News.

Dr Freedman, who was not involved in developing the list of target infections, said he found the whole thing a "bit strange, as it seems to have come out of the Essential Medicines Program and not out of WHO's Pandemic and Epidemic Response department."

The Essential Medicines Program produces and regularly updates the WHO Essential Medicines List and the WHO Essential Medicines List for Children.

Dr Freedman has disclosed no relevant financial relationships.

"WHO R&D Blueprint." WHO. Published online November 2015. Full text

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