Creating a Global Strategy for Epidemic Preparedness

With more frequent travel, globalised trade and greater interconnectedness between countries, infectious disease outbreaks of international concern are becoming inevitable, and they remain unpredictable. When faced with diseases for which there are few or no medical countermeasures, massive chaos and loss of life can ensue.

The World Health Organization (WHO) is spearheading a global movement to avert full-blown epidemics by making Research and Development (R&D) outbreak-ready. Together, we can spot emerging epidemics and stop them before they spiral out of control. We can save lives.

While conventional surveillance, contact tracing and containment measures remain cornerstones of a health emergency response, better understanding of highly infectious pathogens, and a repertoire of effective health technologies could be the key to pre-empting full-blown epidemics, and limiting their human, social and economic losses.

The Ebola epidemic taught us that we can move faster to try to curb the spread of disease. By acting together based on a coordinated plan, we can accelerate the development of the vaccines, drugs, diagnostics and delivery systems needed to short-circuit emerging health threats.

It is essential that we collaborate to build the capacity to rapidly evaluate investigational drugs and vaccines that meet the highest scientific and ethical standards, protect patients’ welfare, and generate actionable results.

Dr Luciana Borio, Food and Drug Administration, USA
  • Ebola broke out of its rural seclusion and into West African cities in a matter of weeks.
    ➜ Explore

    WHO and partners are now in Phase 3 of the Ebola response, from August 2015 to mid-year 2016. The overarching goal is to interrupt all remaining chains of Ebola transmission, and to respond to the consequences of residual risks. To do this, several objectives have been outlined and we are working towards enhancing the rapid identification of all cases and contacts, improving Ebola survivor engagement and support, among others.

    Learn More ➜
  • The Middle East Respiratory Syndrome (MERS) virus spread to 26 countries in three years and is still on the move.
    ➜ Explore

    Middle East respiratory syndrome (MERS) is a viral respiratory disease caused by a novel coronavirus (MERS‐CoV) that was first identified in Saudi Arabia in 2012. Our understanding of the virus and the disease it causes is continuing to evolve.

    Learn More ➜
  • SARS travelled by plane across hemispheres to cause hundreds of deaths and cost billions of dollars in just six months.
    ➜ Explore

    SARS was recognized at the end of February 2003. WHO coordinated the international investigation with the assistance of the Global Outbreak Alert and Response Network and worked closely with health authorities in the affected countries to provide epidemiological, clinical and logistical support as required.

    Learn More ➜
  • Zika infections and related health conditions are arising as the next pandemic, possibly infecting as many as 4 million people by the end of 2016.
    ➜ Explore

    Zika virus is a mosquito-borne virus transmitted by Aedes mosquitoes. The same mosquito also transmits 3 other vector-borne diseases—dengue, chikungunya and yellow fever—across tropical and subtropical regions around the world.

    Learn More ➜

An R&D Blueprint for Action to Prevent Epidemics

At the request of its 194 Member States in May 2015, the World Health Organization (WHO) has convened a broad coalition of experts to develop an R&D Blueprint for Action to Prevent Epidemics.

The R&D Blueprint will present options to reduce the time lag between the identification of a nascent outbreak and approval of the most advanced products that can be used to save lives and stop larger crises.

The R&D Blueprint will map the knowledge already accrued through efforts of research and development stakeholders, as well as remaining gaps. It will identify the main activities needed to promote strategic research in advance of and during outbreaks. As we saw with Ebola, we can compress R&D timelines from a decade or longer, to less than a single year.

WHO expert teams, an international scientific advisory board, and partners engaged through global forums are collaborating to formulate this novel R&D model. Already, several consultations have been held among public health agencies, industry, researchers, social scientists and governments. They have identified major bottlenecks to international collaboration; agreed upon basic data-sharing principles; and explored innovative clinical trial models.

Intensive work will be carried out over the next 10 months to ensure an R&D preparedness plan is ready by the time the next unpredictable outbreak hits.

Learning from Ebola to Prepare for The Next Epidemic: Accelerated R&D

When the Ebola outbreak in West Africa erupted in the spring of 2014, the medical community was ill-prepared to cope. There were no vaccines, few diagnostics, no drugs for treatment, and few medical teams and trained responders. With no public education in place, fear raced ahead of the virus.

As the crisis quickly deepened, the international community responded with urgency. Over a period of 10 months, WHO-facilitated collaborations achieved unprecedented results:

  • The testing of multiple vaccines, leading to at least one that appears to be safe and effective against Ebola;
  • Release of 13 diagnostic tools that can detect Ebola virus in a matter of hours rather than days, and 24 testing laboratories;
  • Accelerated development of novel therapies and testing of existing drugs.

As convener, WHO enabled complex communication among many partners and facilitated the simultaneous testing of different vaccines, drugs and diagnostics. Emergency WHO review assured the quality of these new medical tools, and enabled those that were approved to quickly reach people suffering from Ebola.

If we are to take the lessons from Ebola to heart, we need to improve how we develop the full range of R&D tools to detect, treat and control these diseases, as well as to determine what new threats are inevitably lurking around the corner.

Dr Jeremy FARRAR, Wellcome Trust, UK

Gaps in R&D Practice

It is clear today that there is insufficient research on epidemic-prone diseases and gaps in R&D practice. During the Ebola epidemic, there was a need for the following:

  • Platforms that expedite vaccine clinical trials, drug testing and data sharing;
  • A broader R&D scope that encompassed, for example, better understanding of the disease, animal models and personal protective equipment;
  • Community engagement plans from the outset; and
  • Funding sources that could be quickly activated.

Even as WHO and its partners continue to learn from Ebola, we are applying these lessons to the R&D Blueprint so that next time, we can be better prepared.

We should never again experience a crisis like the West Africa Ebola epidemic.

To save lives we need to accelerate the development of drugs, vaccines and diagnostics in response to epidemics of emerging pathogens.

Pr Lucille BLUMBERG,
National Institute for Communicable Diseases, South Africa

Five Work Streams to Map Our Line of Defence

The R&D Blueprint builds on the efforts of international partners and communities through five work streams:

  1. 01Prioritise Global Infectious Disease Threats
    ➜ Explore
    • Identify the top global disease threats on which to focus initial R&D efforts;
    • Develop a review process to reassess priorities in light of changing circumstances; and
    • Plan for the transition from preparedness to action in the event of an outbreak.

    Severe, emerging epidemic-prone diseases lack the interventions necessary for disease control. The only opportunity to evaluate such interventions occurs during an outbreak—but such events are sporadic and unpredictable. This has resulted in slow progress in taking candidate interventions to field use, and in a dearth of approved countermeasures. In order to progress, we need to perform the prerequisite R&D in the inter-epidemic period, have interventions ready for evaluation when an event occurs, and be able to launch a coordinated research response within the short epidemic timeframe.

    Learn More ➜
  2. 02Identify Research Priorities
    ➜ Explore
    • Create a prototype R&D roadmap for MERS, identifying the basic and applied research, and health technologies needed to contain this emerging threat;
    • Based on this prototype, develop roadmaps for all priority diseases and for cross-cutting issues such as regulatory science and social science research; and
    • Agree on standard procedures to rapidly evaluate new health technologies in emergencies while maintaining the highest scientific and ethical standards.

    There are insufficient levels of research for epidemic-prone diseases mainly affecting low and middle-income countries (LMIC), and there are multiple challenges to conducting research during an outbreak. The research needs of LMICs span from proof of principle/preclinical studies through to the conduct and regulation of clinical studies (before and during health crises), innovative strategies for the production of health technologies, development of key enabling capacities, such as pathogenesis studies of the priority pathogens and surveillance methodologies, and regulatory science needed to enhance regulatory preparedness.

    Learn More ➜
  3. 03Global Coordination & Expansion of Capacity
    ➜ Explore
    • Develop organisational frameworks for the coordination of national and international actors and inclusion of scientists in low- and middle-income countries as equal partners;
    • Build the capability to conduct clinical trials for vaccines and therapeutics against emerging disease threats in low- and middle-income countries; and
    • Agree on the open sharing of data, the fair sharing of biological samples for research, and manufacturing plans for new health products.

    An R&D response during an epidemic relies on the existence of the right conditions—or an enabling environment—to facilitate timely and efficient action. This means that there must be, for example, a system in place for coordinated action, broad agreement on data and sample sharing, governance of R&D, and standards of care.

    Learn More ➜
  4. 04Continuous Assessment
    ➜ Explore
    • Develop a plan to evaluate the impact of the R&D Blueprint and continuously improve the Blueprint;
    • Create a high-level checklist to monitor preparedness and impact, using MERS as an example; and
    • Conduct the first assessment of the presence of supportive conditions for R&D in 2017, and evaluate the impact of the R&D Blueprint when the next outbreak occurs.

    R&D efforts during the Ebola emergency in West Africa offer the opportunity to distill precious information regarding successful activities and gaps. All this information will serve as a basis to evaluate the outcomes of the R&D Blueprint efforts. Assessment will focus on the Blueprint's ability to create an enabling environment for R&D preparedness in low- and middle-income countries, and on the impact that R&D plans will have in terms of availability of medical technologies for the next outbreak/epidemic. These may be difficult to measure before an outbreak actually occurs.

    Learn More ➜
  5. 05Mobilise Funding
    ➜ Explore
    • Explore funding models for R&D preparedness and response.

    Lack of funding for R&D was a serious issue during the Ebola outbreak and showed that emergency funding is something that needs to be pre-planned and quickly activated. Currently, there is insufficient investment into the development of treatments, vaccines, and diagnostics for the diseases included in the blueprint. Many different innovative funding models have been discussed in the past years, especially with respect to the funding of neglected diseases. Some funding and coordination mechanisms already exist that cover R&D for highly infectious pathogens at least in part. But none of these models is totally satisfactory. Work stream 5 explores other options to ensure that we can develop the necessary tools to counter the next outbreak.

    Learn More ➜

The WHO team has developed a comprehensive work schedule that includes a series of expert consultations and aggressive deadlines for deliverables related to each of the five work streams, with the final Blueprint due to the 69th World Health Assembly in May 2016.

We should never again experience a crisis like the West Africa Ebola Epidemic. The world needs a more dynamic approach to R&D for life-saving drugs, vaccines and diagnostics.

Dr Mimi DARKO, Food and Drugs Authority, Ghana

The Ebola R&D Response Awakens Hope

The Ebola R&D response awakens hope. There are many diseases with the potential to trigger chaos and human suffering, but we have learned how to jumpstart research and development to stem the tide of suffering from these diseases. Please join the global effort to develop an R&D Blueprint for Action to Prevent Epidemics.

Our ability to stand up to new global disease threats is crucial to achieving the Sustainable Development Goals. As we saw with Ebola, an uncontained epidemic can wipe out decades of progress in health and economic development. We cannot afford to let that happen.

Dr John-Arne ROTTINGEN, Norwegian Institute of Public Health, Norway