EBOLA/EVD [to 30 January 2016]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)
.
WHO Director-General addresses the Executive Board
Report by the Director-General to the Executive Board at its 138th Session
Geneva, Switzerland
25 January 2016
[Initial text]
Madam Chair, distinguished members of the Executive Board, Excellencies, colleagues in the UN system, ladies and gentlemen,
Fifteen months ago, Guinea, Liberia, and Sierra Leone were together reporting more than 950 cases of Ebola every week. Today, the three countries have interrupted all chains of transmission from the original outbreak that began more than two years ago.
This is a monumental achievement that needs to be acknowledged. Please join me in honouring the leadership of the three governments, the heroic sacrifices of health care workers and communities, and the unwavering support from a host of partners.
However, WHO has not yet declared the outbreak in West Africa over. As we now know, the virus can hide in the bodies of fully recovered survivors for as long as a year.
Since March of last year, WHO has documented 11 small flare-ups of infection following reintroduction of the virus from survivors. All were rapidly detected and quickly contained.
On 14 January, WHO declared that the outbreak in Liberia, the last country reporting cases, was over, but warned that the risk of further flare-ups would persist. The warning was well-founded. The next day, Sierra Leone confirmed its first new case since September of last year.
Let me put this setback in perspective.
First, these countries promptly report new cases. Vigilance is intense. Our view of the situation is sharp and transparent.
Second, these countries have the world’s largest pool of expertise in responding to Ebola. They know exactly what to do.
Third, I still have more than 1000 staff in West Africa to assist in detecting and responding to flare-ups like this one. I thank them for their skill and dedication.
Finally, thanks to a WHO-led clinical trial, we have a vaccine that can be used to confer a back-up ring of protection.
The Ebola virus is stubborn. I have no doubt that further flare-ups will occur. I have no doubt that all will be quickly contained.
The outbreak lingers in a second sense as well. Well over 10,000 survivors face persistent health problems together with continuing stigmatization. They need care.
Ebola delivered an extremely severe and shattering blow to societies and economies. Recovery will take some time.
While the job is by no means finished, no one anticipates that the situation will return to what we were seeing 15 months ago.
The determination is fierce. International solidarity has been extraordinary. The many steps taken at national and international levels have had a decisive impact.
No one will let this virus take off and run away again….
.
Report – Science in emergencies: UK lessons from Ebola
Second Report of Session 2015–16 HC 469
UK House of Commons
Science and Technology Committee
Published on 25 January 2016 :: 50 pages
Introduction
Ebola is a rare and deadly disease. It is spread through direct contact with the bodily fluids of infected people and with objects and materials contaminated with these fluids. Since late 2013, West Africa has experienced the largest Ebola outbreak ever recorded. It was, first and foremost, a human tragedy. We pay tribute to all those who worked tirelessly to tackle this outbreak, some of whom gave evidence to this inquiry, and many of whom continue working to avert similar crises in the future. We also commend the Government on its leading contribution to the fight against Ebola, and the financial, and personnel, commitments that it made, from constructing and staffing Ebola treatment centres in Sierra Leone to deploying troops, helicopters, aircrew and an aviation support ship to provide much needed logistical support.
Examples of UK successes in tackling Ebola, however, must not allow complacency to set in. Despite this impressive deployment of resources to combat Ebola in Sierra Leone, the UK response—like the international response—was undermined by systemic delay. The biggest lesson that must be learnt from this outbreak of Ebola is that even minor delays in responding cost lives. Rapid reaction is essential for any hope of success in containing an outbreak. Yet delays were evident at every stage of our response, from escalating Public Health England’s disease surveillance data to those with the capacity to act, to convening a Scientific Advisory Group for Emergencies—the main mechanism for channelling scientific advice to Government in an emergency—which failed to be established until October 2014, three months after ‘Cobra’, the Government’s emergency response committee, first met. In the absence of established mechanisms, ad hoc approaches emerged to fill the gaps. Inevitably, these were not as effective, or as targeted, as they should have been.
We recognise the enormous efforts made by governments, universities, regulatory bodies, humanitarian agencies, pharmaceutical companies and others to ensure that clinical trials for Ebola vaccines, treatments and diagnostics were launched in record time. But such efforts do not obscure the fact that the UK and other countries were not ‘research ready’ when the outbreak began, prompting a less than optimal and uncoordinated research response. The failure to conduct therapeutic trials earlier in the outbreak was a serious missed opportunity that will not only have cost lives in this epidemic but will impact our ability to respond to similar events in the future.
Research during an outbreak must be initiated rapidly, while still being designed and conducted to the highest possible standards. While we recognise the difficulties that arose in this outbreak, they are inherent to all epidemics; therefore, if we want to improve our response, we must address the weaknesses in our research readiness that this epidemic exposed. We are not convinced, however, that the Government has looked ahead and considered how a more timely, co-ordinated and robust response could be achieved when the next epidemic emerges.
Rapid and reliable communication is integral to delivering an effective response to a disease emergency. And yet, throughout the Ebola outbreak, we saw that systems to share advice, expertise, epidemiological and clinical data—particularly between the UK and Sierra Leone—were inadequate. We were concerned that this had harmful repercussions including a failure to undertake basic, yet important, research about the efficacy of Ebola treatments, as well as undermining the robustness of transmission modelling work. We recommend that the Chief Medical Officer urgently establishes new processes and protocols to ensure that knowledge and data are communicated effectively throughout an outbreak and that research is embedded into an emergency response from the outset.
The Government’s communications on Ebola with the UK public were accurate and balanced, making it all the more disappointing that the Government failed to explain why it went against guidance from the World Health Organization and Public Health England and introduced screening for Ebola at UK ports of entry. We recommend that when interventions like screening are instigated during an emergency, the Government makes the evidential basis for the intervention explicit.
Ebola also highlighted structural weaknesses in the UK’s capacity to absorb and withstand shocks to the system arising from emergencies. Despite hosting world-leading experts in immunology, epidemiology and tropical medicine in the UK, there are currently no licenced treatments for, and vaccinations against, Ebola. This situation has arisen, in part, due to a long-term market failure to invest in interventions for rare but potentially catastrophic epidemics. While we welcome the Government’s recent announcements of much needed research funds in this area, we recommend that it works with leading experts to publish an emerging infectious disease strategy, setting out the ‘priority threats’ the UK wishes to address, so that these funds can be effectively targeted and their benefits maximised.
We are also concerned that, in the unlikely but possible event of a domestic outbreak, the UK lacks the capability to go further and manufacture enough vaccines to vaccinate UK citizens in an emergency. Existing facilities are degraded and new plant will take years to build, leaving the UK in a vulnerable position. There is a need for the Government to do more than simply encourage inward investment in advanced manufacturing. We recommend that it acts now and negotiates with vaccine manufacturers to establish pre-agreed access to manufacturing capabilities that can be called upon quickly in an emergency.
The willingness of Government agencies, third sector organisations, health and aid workers, universities, and pharmaceutical companies to go above and beyond to help tackle the outbreak was phenomenal. The swift pace at which clinical trials were approved and conducted particularly stood out. The Defence Science and Technology Laboratory’s rapid diagnostic test for Ebola—which was developed, manufactured and latterly trialled on patients in Sierra Leone by January 2015—exemplifies the game-changing innovations that can be achieved by Government research and development facilities collaborating with private partners and clinicians. We were therefore dismayed to learn that, despite the promise shown by this test, and the production of 10,000 testing kits, it was not released for general use by the Government. Instead, we received different explanations, from different Government departments and agencies, about why the test was not operationalised. We are concerned that this is indicative of a worrying lack of cross-Government co-ordination, as well as an accountability deficit, for key aspects of the UK Ebola response. We ask the Government to clarify urgently why the rapid diagnostic test for Ebola was not released for use.
Prior to the Ebola outbreak, the Government had remained largely silent on its policy towards global health since it published its Health is Global framework in 2011. While we hope that the world will never experience an Ebola outbreak of this magnitude again, it would be naïve to assume that epidemics with the potential to cause death and devastation, and cross national borders, can be consigned to the past. Our global health policy will have a profound impact on the lives of people in the UK and beyond. It is therefore vital that the Government clearly sets out what would trigger an in-country response to a disease emergency and what capability the UK should be able to deploy readily overseas.
European Medicines Agency [to 30 January 2016]
http://www.ema.europa.eu/
29/01/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 2016
…Update on Ebola
The CHMP has adopted a final scientific opinion following its review of experimental Ebola treatments. The final report includes information on nine experimental medicines intended for the treatment of people infected with the Ebola virus: BCX4430, Brincidofovir, Favipiravir, TKM-Ebola, AVI-7537, ZMapp, Anti-Ebola F(ab’)2, GS-5734 and Ebotab. The assessment report for this review will be published shortly…
vaccines and global health :: ethics and policy 