A research and development Blueprint for action to prevent epidemics
Public consultation on target product profile for a Nipah virus vaccine
Nipah virus (NiV) is one of the pathogens in the WHO R&D Blueprint list of epidemic threats needing urgent R&D attention. From 1998 to 2015, more than 600 cases of Nipah virus (NiV) human infections were reported. Later outbreaks, in India and Bangladesh, have caused death in 43% to 100% of infected patients. WHO has just published a draft NiV vaccine target product profile, which is now available for public consultation. Comments may be submitted by individuals or organizations through the form attached below and sent to firstname.lastname@example.org - with your name and affiliation. Deadline is COB 13 April 2017. Note that all comments may be made publicly available at a later stage. WHO will publish the finalized NiV vaccine target product profile after integrating the comments received.
WHO publishes revised Zika vaccine profile
Zika Virus remains an enduring public health challenge likely to cause future outbreaks that put susceptible populations at risk, thus requiring intense R&D action. A first Zika vaccine target product profile (TPP), describing the preferred product characteristics for vaccines, was published in July 2016. Due to rapidly evolving evidence, a robust review was done in November 2016 incorporating the latest emerging data. The revised Zika Vaccine TPP is now available.
Update on the R&D Blueprint Activities
Read the latest on Blueprint achievements and activities to improve R&D preparedness during public health emergencies. A list of anticipated benefits for the three areas of work is available here below.
Towards Better Zika Diagnostic Tests
There is a need to continue the global scientific effort to gain a better understanding of the Zika virus, its vectors, modes of transmission and the natural history of the disease. Key to this effort is having an accurate diagnosis of Zika virus infection, however, available tests are limited by several factors. WHO’s current R&D activities on Zika diagnostics are summarized in this publication in PLoS NTD. WHO will continue its R&D work on Zika under the WHO R&D Blueprint effort.
WHO publishes revised list of diseases likely to cause public health emergencies
WHO today publishes a revised list of priority diseases that need urgent R&D in order to prevent public health emergencies in the near future. The list includes nine disease categories for which few or no medical countermeasures exist due to market failures or lack of scientific knowledge. The diseases provide the basis for work on the WHO R&D Blueprint for emergency preparedness and response. The current list of diseases builds on the first such list developed by a coalition of international experts convened by WHO in November 2015.
Regulatory gaps during emergencies must be addressed
A public health emergency in a badly regulated environment leaves the door open to the production and commercialisation of poor quality and unsafe products. The 17th International Conference of Drug Regulatory Authorities (ICDRA) focused on the need for international collaboration between national regulatory authorities (NRAs) to expand patient access to safe and effective diagnostics, medicines, vaccines and medical devices that may be developed during a public health emergency. NRAs are still unprepared to face a public health emergency, they lack resources and support in large regions of the developing world, have limited experience of communicating with stakeholders, media and public, and lack of regulators early stage engagement in product development. Gaps and recommendations are now available.
About R&D Blueprint
ICDRA identifies regulatory gaps during emergencies
- Developing guidance tools for biological sample sharing in public health emergencies
- Taking the panic out of emergencies
- Progress in prioritizing diseases with epidemic potential
Information note on sample sharing, biobanking and material transfer agreements
Guidance For Managing Ethical Issues In Infectious Disease Outbreaks
- Platform technologies for R&D preparedness in epidemics