Vaccines and Global Health: The Week in Review 24 June 2017

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

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 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_24 June 2017

– blog edition: comprised of the approx. 35+ entries posted below.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Milestones :: Perspectives

Milestones :: Perspectives

Editor’s Note
Some observers suggest we are already in a “post-truth era.”  We observe that the judgement by the Court of Justice of the European Union suggests it might better be termed the “post-evidence era.” I was reminded of an undergraduate logic course [from many decades ago before the post-truth era] and one of the first fallacies we engaged: “post hoc, ergo propter hoc” [after this, therefore because of this]. We will monitor and report on any balanced legal/policy analysis of this judgement and its implications for vaccine injury litigation.

Court of Justice of the European Union
PRESS RELEASE No 66/2017
Luxembourg, 21 June 2017 Judgment in Case C-621/15
>W and Others v Sanofi Pasteur MSD and Others

Where there is a lack of scientific consensus, the proof of the defect of the vaccine and of a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence
[Full text, Editor’s text bolding]
 
The temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered may, where applicable, constitute sufficient evidence to make out such proof

Between the end of 1998 and the middle of 1999 Mr J. W was vaccinated against hepatitis B using a vaccine produced by Sanofi Pasteur. In August 1999, Mr W began to present with various troubles, which led to a diagnosis of multiple sclerosis in November 2000. Mr W died in 2011. Earlier, in 2006, he and his family had brought legal proceedings against Sanofi Pasteur to obtain compensation for the damage they claim Mr W suffered due to the vaccine.

The case was sent before the cour d’appel de Paris (Court of Appeal, Paris, France), which observed, inter alia, that there was no scientific consensus supporting a causal relationship between the vaccination against hepatitis B and the occurrence of multiple sclerosis. It held that no such causal link had been demonstrated and dismissed the action.

The French Cour de cassation (Court of Cassation), before which an appeal against the judgment of the Cour d’appel de Paris was brought, asks the Court of Justice whether, despite there being no scientific consensus and given that, under the EU directive on liability for defective products, [1] the injured person is required to prove the damage, the defect and the causal relationship, the court may base itself on serious, specific and consistent evidence enabling it to conclude that there is a causal link between the defect in a vaccine and that there is a causal link between the vaccine and the disease. Reference has been made in particular to Mr W’s previous excellent state of health, the lack of family antecedents and the close temporal connection between the vaccination and the appearance of the disease.

In today’s judgment, the Court holds that evidentiary rules allowing the court, where there is not certain and irrefutable evidence, to conclude that there is a defect in a vaccine and a causal link between the defect and a disease on the basis of a set of evidence the seriousness, specificity and consistency of which allows it to consider, with a sufficiently high degree of probability, that such a conclusion corresponds to the reality of the situation, are compatible with the Directive.

Such evidentiary rules do not bring about a reversal of the burden of proof which it is for the victim to discharge, since that system places the burden on the victim to prove the various elements of his case which, taken together, will provide the court hearing the case with a basis for its conclusion as to the existence of a defect in the vaccine and a causal link between that defect and the damage suffered.

Moreover, excluding any method of proof other than certain proof based on medical research, could make it excessively difficult in many situations or, where it is common ground that medical research neither confirms nor rules out the existence of a causal link, impossible to establish producer liability, thereby undermining the effectiveness of the Directive and its objectives, which are to protect consumer health and safety and ensure a fair apportionment between the injured person and the producer of the risks inherent in modern technological production.

The Court nevertheless adds that national courts must ensure that the evidence adduced is sufficiently serious, specific and consistent to warrant the conclusion that, having regard also to the evidence produced and the arguments put forward by the producer, a defect in the product appears to be the most plausible explanation for the occurrence of the damage. National courts must also safeguard their own freedom of assessment in determining whether such proof has been made out to the requisite legal standard, until such time as they consider themselves in a position to draw a definitive conclusion on the matter.

In the present case, the Court considers that the temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered, appears on the face of it to constitute evidence which, taken together, may lead a national court to consider that a victim has discharged his burden of proof. That could be the case inter alia where that evidence leads the court to consider, first, that the administering of the vaccine is the most plausible explanation for the occurrence of the disease and, second, that the vaccine therefore does not offer the safety that one is entitled to expect.

The Court adds that it is not possible for the national legislature or the national courts to introduce a method of proof under which the existence of a causal link between the defect attributed to a vaccine and the damage suffered by the victim will automatically be established when certain predetermined causation-related factual evidence is presented, as that would have the consequence of the burden of proof provided for in the Directive being undermined.

 1 Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ 1985, L 210, p. 29). 

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Vaccination in acute humanitarian emergencies: a framework for decision making

World Health Organization, Geneva
June, 2017 :: 96 pages
PDF: http://apps.who.int/iris/bitstream/10665/255575/1/WHO-IVB-17.03-eng.pdf
EXECUTIVE SUMMARY
Humanitarian emergencies, regardless of type and cause, have a number of common risk factors for communicable diseases inextricably linked to excess risk of morbidity and mortality which can come from vaccine–preventable diseases (VPDs). The reduction of VPDs is a significant aim of public-health interventions during crises.

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization carried out a comprehensive review of evidence on vaccination decision-making processes and considerations in humanitarian emergencies. This review resulted with decision-making framework which provides a transparent, evidence-based, and rigorous methodology for deciding on vaccination options in acute humanitarian emergencies. It consists of three essential steps: 1) assessing the local epidemiological risks of VPDs among the affected population, 2) vaccine selection and characteristics to consider, and 3) local contextual constraints that further assist in effective and timely decisions. The diagram below provides a schematic representation of this three-step approach in decision-making process.

This framework is intended to guide decision making on vaccination interventions immediately after the onset or during planning in anticipation of a possible or likely acute emergency. It may be applied in emerging humanitarian emergencies, or crisis of short duration, and in long-standing crisis and conflicts resulting in protracted humanitarian emergencies. The concept of “acute” emergency does not imply that the emergency in itself is short-lived, as in a protracted crisis situations can emerge and be considered as “acute”. An acute emergency signifies a situation meeting one or more of the following conditions: sudden unplanned displacement of a large proportion of the population, direct exposure of the civilian population to new or exacerbated and sustained episodes of armed conflict, impending or already occurred sudden deterioration of nutritional status, natural or industrial disasters, and/or sudden breakdown of critical administrative and management functions which result in large-scale disruption of public health and related services.

This decision-making framework is intended for senior-level government and partner organization officials who are expected to work together to reach a decision regarding the need of vaccine antigen(s) in a given humanitarian emergency. It makes part of a package which also includes “Vaccination in Humanitarian Emergencies Implementation Guide”. Both documents are supported with electronic versions to ensure that the most up-to-date vaccine and disease-specific data, and references to additional information and guidance are provided.
 
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POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 21 June 2017 [GPEI]
:: In Syria, 15 new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in the past week, bringing the total number of cVDPV2 cases in the country to 17.  Sixteen of the 17 cases are from Mayadeen district, Deir-Al-Zour governorate, and one case is from Raqua district, Raqua governorate.  All cases had onset of paralysis between 3 March and 23 May.

:: The 14th report of the Independent Monitoring Board (IMB) has been published, following the group’s meeting in May.[see below]

:: Summary of newly-reported viruses this week:  Syria – 15 new circulating vaccine-derived poliovirus type 2 (cVDPV2) were isolated from acute flaccid paralysis (AFP) cases, and four new cVDPV2 isolated from healthy community contacts.  Pakistan – one new wild poliovirus type 1 (WPV1) isolated from an environmental sample

Weekly country updates as of 21 June 2017
:: Syrian Arab Republic

In Syria, 15 new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in the past week, bringing the total number of cVDPV2 cases to 17.  Sixteen of the 17 cases are from Mayadeen district, Deir-Al-Zour governorate, and one case is from Raqua district, Raqua governorate.  All cases had onset of paralysis between 3 March and 23 May.  Additionally, four cVDPV2s were also isolated from healthy community contacts, all from Mayadeen (collected in April and May).

Of a total of 65 acute flaccid paralysis (AFP) cases detected in Deir-Al-Zour since the start of 2017, 16 have now tested positive for cVDPV2 (with the 17th case from Raqua), 22 have tested negative, 5 are pending for final laboratory results and 22 specimens are en route to a laboratory for processing.

Confirmation of these latest cases is not unexpected at this time and does not change the operational situation, as outbreak response plans are being finalized, in line with internationally-agreed outbreak response protocols.  Although access to Deir-Al-Zour is compromised due to insecurity, the Governorate has been partially reached by several vaccination campaigns against polio and other vaccine-preventable diseases since the beginning of 2016. Most recently, two campaigns have been conducted in March and April 2017 using the bivalent oral polio vaccine (OPV). However, only limited coverage was possible through these campaigns.

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EVERY LAST VIRUS
INDEPENDENT MONITORING BOARD OF THE GLOBAL POLIO ERADICATION INITIATIVE – FOURTEENTH REPORT: JUNE 2017 :: 34 pages
PDF: http://polioeradication.org/wp-content/uploads/2017/06/14th-IMB-Report-FINAL.pdf
The Independent Monitoring Board provides an independent assessment of the progress being made by the Global Polio Eradication Initiative in the detection and interruption of polio transmission globally. This report follows the IMB’s meeting held in London on 2 and 3 May
2017.

[Excerpt]
CONCLUSIONS AND RECOMMENDATIONS [p.20]
The Polio Programme has reached a level of performance where there is room for optimism that 2017 will be the year when poliovirus transmission globally is permanently interrupted. Nigeria has a strong programme that pioneered the use of an Emergency Operations Centre to integrate a diverse range of partners to drive up the level of performance. Pakistan has benefitted from the exceptional leadership of the Health Minister and the Prime Minister’s Focal Person on Polio Eradication. The transformation of the Polio Programme in that country from being judged “a disaster” in a previous IMB report is quite remarkable. The Afghanistan Programme has done well to achieve what it has despite serious problems of access due to conflict.

All this is commendable, but the Polio Programme in the three endemic countries and globally is not there yet. The optimism must be tempered with a realism about the risks and challenges that remain. Only if the appropriate balance is struck can the programme succeed soon.

If the narrative and statistical analysis in this IMB Report is read carefully, five major priorities for action jump out:
:: An innovative and transformational solution must be found to vaccinate the large numbers of so-called “Guest children” who are within the large high-risk mobile population in Pakistan; continuing with the current approach will not reduce the numbers of “still missed” children from hundreds of thousands to hundreds in less than six months.

:: A dramatic and immediate turnaround is needed in the low level of routine immunisation coverage in the polio reservoirs in Pakistan and Afghanistan; the current position is a stain on the Programme’s record of improved performance.

:: The Nigeria Programme has not yet realised that it must become an exemplar in how to operate as a high resilience enterprise; all its efforts should be directed to strengthening the defenses against any poliovirus breaking through.

:: The whole region around northern Nigeria, Lake Chad and surrounding countries has become a red zone in which there is a high-risk of the re-emergence of circulating poliovirus; leaders at the highest political level should be on full alert and completely engaged.

:: The quality and integrity of surveillance data across the Polio Programme, particularly in northern Nigeria and other parts of Africa, which may harbour another unwelcome, long-unrecognised outbreak, is not what it should be. This is compromising the ability of the Polio
Programme to be sure that transmission has ended.

These are major problems threatening the successful completion of polio eradication. They are problems awaiting solutions. The tried and trusted methods that are being used are still necessary but matching these problems with solutions that bring transformation is the missing ingredient….
[10 action recommendations follow]

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Emergencies

Emergencies

WHO Grade 3 Emergencies  [to 24 June 2017]
Iraq 
:: Iraq: Special health health situation report on Mosul crisis
17 June 2017 — WHO in coordination with Erbil and Ninewa Directorates of Health (DOH) on 13 June 2017 rapidly responded to suspected food borne illness outbreak in Hassan Sham U2 camp by conducting an investigation with the aim to identify the source and cause of the outbreak, treat those ill as well as contain and prevent any spread. WHO delivered 500 rapid diagnostic test kits (RDT) to Ninewa DoH and primary health care facilities in Qayyarah, Hammam al’Alil and Salamiyah, to support the response to any future cholera outbreaks in the Governorate of Ninewa including camps and host communities. WHO donated to health partners emergency medical supplies enough to serve the needs of more than 20500 persons in Al Salamiyah camp.

The Syrian Arab Republic 
:: More than 12 000 treatments delivered to Ein Issa and Karameh camps in Al-Raqqa governorate
22 June 2017 – The World Health Organization (WHO) has responded to an acute shortage of life saving medicines by dispatching a shipment of more than 12 000 treatments to the 2 main camps for internally displaced persons in rural Al-Raqqa. This shipment will support treatment of patients with chronic conditions, infectious diseases and diarrhoeal diseases who lack adequate access to medical care.

Nigeria
:: Overview of WHO operations in north eastern Nigeria
June 2017 —WHO has decided to adopt a sub-regional approach across the four Lake Chad basin affected countries, to increase its interventions, which will address the health needs of the displaced populations and host communities alike.

South SudanNo new announcements identified.
YemenNo new announcements identified.
 

WHO Grade 2 Emergencies  [to 24 June 2017]
Democratic Republic of the Congo
:: Ebola Situation report: 20 June 2017
…On 19 June 2017, no new confirmed, probable cases or suspected have been reported since the last situa­tion update on 15 June. Seven alerts have been reported and investigated and none fulfilled the suspected case definition…

Cameroon  No new announcements identified
Central African Republic  – No new announcements identified. 
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified
 
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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Hundreds of civilians are being killed and injured as fighting intensifies in Mosul’s old city
(Baghdad, 24 June 2017) – The United Nations strongly condemns recent incidents resulting in the terrible loss of civilian life including the 23 June attacks in eastern Mosul and in Mushahada in the old city of Mosul where as many as 12 civilians were killed and possibly hundreds injured.
“Killing and wounding civilians violates every humanitarian principle and is contrary in every way to international humanitarian law,” said Lise Grande, Humanitarian Coordinator for Iraq.
“We are shocked and deeply saddened by the tragic loss of life that has occurred during the fighting in Mosul and we extend our heartfelt condolences to the families of all the victims,” said Ms. Grande, the Humanitarian Coordinator for Iraq…

Syrian Arab Republic
:: 23 Jun 2017  Syria – Regional: Emergency Dashboard, June 2017

YemenNo new announcements identified

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
Somalia
:: Somalia: Drought Response – Situation Report No. 13 (as of 20 June 2017)

Ethiopia
:: 20 Jun 2017  Ethiopia Weekly Humanitarian Bulletin, 19 June 2017

DRC (Kasai crisis)No new announcements identified.
NigeriaNo new announcements identified.

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War-Torn Yemen to Get Cholera Vaccines as Death Toll Mounts
New York Times/ASSOCIATED PRESS
JUNE 21, 2017
GENEVA — The U.N. health agency and some major partners have agreed to send 1 million doses of cholera vaccine to Yemen to help stanch a spiraling and increasingly deadly caseload in the impoverished country, which is already facing war and the risk of famine.
A spokesman for the World Health Organization said Wednesday that it didn’t initially want to publicize last week’s decision because questions remain about when and how the doses could reach the neediest people in a country sliced up along front lines and grappling with a nearly-collapsed health system.
WHO said the 1 million doses for Yemen were approved on June 15 by the International Coordinating Group, which manages vaccine stocks and includes the Red Cross, Doctors Without Borders, UNICEF, and Gavi, the Vaccine Alliance along with WHO. Such a shipment would be the largest since 1 million doses were sent to Haiti after Hurricane Matthew last fall — and would amount to about half of the usual world stockpile, which would then be replenished.
…Now, in just over two months, the cholera outbreak has taken over 1,100 lives and the caseload is rising, with peak levels unpredictable, WHO says…
…”The fact that over a thousand people have died during this rapidly spreading cholera outbreak is shocking,” said Dr. Seth Berkley, CEO of Gavi, in an e-mail. “We cannot underestimate the huge logistical challenges of delivering vaccines in a warzone where the health system, as well as basic infrastructure, has been all but destroyed.”
Berkley said the doses could help slow the spread of the disease as part of a broader strategy to contain it…

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UNICEF  [to 24 June 2017]
https://www.unicef.org/media/media_94367.html
23 June 2017
5.6 million children at risk of waterborne diseases as rainy season hits communities affected by Lake Chad crisis
DAKAR/ GENEVA/ABUJA, 23 June 2017 – More than 5.6 million children are at increased risk of contracting waterborne diseases, such as cholera and diarrheal infections, as the rainy season begins in conflict-affected areas of countries around Lake Chad, UNICEF warned today. The threat of disease outbreaks in Cameroon, Chad, Niger and Nigeria coincides with growing regional insecurity and increased population movements particularly in Nigeria’s northeast.

Crisis ‘far from over’ as malnutrition, thirst and disease threaten lives of millions of children in north-east Nigeria, Somalia, South Sudan and Yemen
NEW YORK/DAKAR/NAIROBI/AMMAN, 23 June 2017 – The welcome announcement of an end to famine conditions in South Sudan this week should not distract from the fact that severe food insecurity continues to put the lives of millions of children at risk in north-east Nigeria, Somalia, South Sudan and Yemen, UNICEF warned today.

Nowhere To Go: Children in Iraq trapped in cycles of violence and poverty as conflict reaches unprecedented levels
BAGHDAD/NEW YORK, 22 June 2017 – Three years since the intensification of violence in Iraq, children are trapped in an endless cycle of violence and increasing poverty, according to a UNICEF assessment, Nowhere to Go.

South Sudan famine ebbs, but situation still desperate as hunger spreads
ROME/JUBA, South Sudan, 21 June 2017 – Famine has eased in South Sudan after a significant scale up in the humanitarian response, according to new analysis released today. However, the situation remains dire across the country as the number of people struggling to find enough food each day has grown to six million – up from 4.9 million in February – and is the highest level of food insecurity ever experienced in South Sudan.

South Sudan refugee crisis: Over 1,000 children fleeing violence and instability every day
KAMPALA/NAIROBI/NEW YORK, 20 June 2017 – As more than 1,000 children continue to flee South Sudan, on average every day in search of safety, the region’s refugee crisis has become a children’s crisis, UNICEF said today, on World Refugee Day.

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Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO webpages for updates and key developments.

EBOLA/EVD  [to 24 June 2017]
http://www.who.int/ebola/en/
WHO AFRO
Ebola Situation report: 20 June 2017 
…On 19 June 2017, no new confirmed, probable cases or suspected have been reported since the last situa­tion update on 15 June. Seven alerts have been reported and investigated and none fulfilled the suspected case definition…

MERS-CoV [to 24 June 2017]
http://www.who.int/emergencies/mers-cov/en/
DONs- Disease Outbreak News
Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia
19 June 2017
Between 11 and 15 June 2017, the national IHR Focal Point of Saudi Arabia reported 14 additional cases of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection including one fatal case among previously reported cases…
 
 
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WHO & Regional Offices [to 24 June 2017]

WHO & Regional Offices [to 24 June 2017]

New WHO advisory group launched in Almaty to shape the future of primary health care
20-06-2017
Experts convened in Almaty, Kazakhstan, on 20–21 June 2017 for the inaugural meeting of the Primary Health Care Advisory Group. The WHO Regional Director for Europe launched the Advisory Group to advance primary health care in the WHO European Region.
At its first meeting, the Advisory Group engaged in discussions on the readiness and responsiveness of primary health care to embrace future health and social needs…

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Highlights
Inaugural Africa Health Forum in Kigali, Rwanda
June 2017 – For the first time, WHO’s Regional Office for Africa is convening global leaders and thinkers to explore Africa’s healthcare priorities and challenges and find new ways to achieve better health for all.

More can be done to restrict sunbeds to prevent increasing rates of skin cancer
   June 2017 – WHO underscores national actions to limit the use of artificial tanning devices (sunbeds) in a bid to reduce the associated health risks, such as melanoma and non-melanoma skin cancers. For more than three decades, the deliberate sunbed exposure to ultraviolent radiation (UVR) for cosmetic purposes has been driving up the incidence of skin cancers and driving down the age of their first appearance.

WHO toolkit for the care and support of people affected by complications associated with Zika virus
June 2017 – Zika virus is associated with severe neurological complications, particularly congenital Zika virus syndrome and Guillain Barré syndrome. The associated complications have a marked impact on the people affected and their communities, including both physical and mental health. The toolkit has been developed to serve as a model guide, with the goal of enhancing country preparedness for Zika virus outbreaks.

Paris is 500th member of WHO Global Network for Age-friendly Cities and Communities
June 2017 – Today, 19 June, WHO’s Global Network for Age-friendly Cities and Communities (GNAFCC) welcomed Paris, France, as its 500th member. The Mayor of Paris, Anne Hidalgo and her deputy Dominique Versini – responsible for early childhood, the protection of children and the fight against exclusion and the elderly – formalised their commitment to become an age-friendly city during a presentation of the plan “2017-2021 Seniors in Paris”.

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Weekly Epidemiological Record, 23 June 2017, vol. 92, 25 (pp. 345–356)
:: Yellow fever vaccine: WHO position on the use of fractional doses – June 2017
:: Global polio eradication: progress towards containment of poliovirus type 2, worldwide
2017

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO AFRO to host the inaugural Africa Health Forum in Kigali, Rwanda  Brazzaville, 21 June 2017

WHO Region of the Americas PAHO
No new digest content identified.

WHO South-East Asia Region SEARO
:: International Day of Yoga   20 June 2017
 
WHO European Region EURO
:: New WHO advisory group launched in Almaty to shape the future of primary health care 20-06-2017
:: World Refugee Day: WHO training enables Syrian doctors and nurses to provide health care in Turkey 19-06-2017
:: European countries promote #SlowDown campaign for UN Global Road Safety Week 19-06-2017

WHO Eastern Mediterranean Region EMRO
:: WHO expresses thanks and appreciation to His Royal Highness, Crown Prince of Saudi Arabia, for his generous initiative to fund cholera response activities in Yemen  23 June 2017
:: World Refugee Day: WHO training enables Syrian doctors and nurses to provide health care in Turkey  19 June 2017

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CDC/ACIP [to 24 June 2017]

CDC/ACIP [to 24 June 2017]
http://www.cdc.gov/media/index.html
Media Advisory
Thursday, June 22, 2017
CDC Hosts Media Availability for New Ebola Exhibition

Media Statement
Tuesday, June 20, 2017
CDC surveys find increase in the number of U.S. counties with Aedes aegypti and Aedes albopictus mosquitoes that can spread Zika
The Southern United States shows a substantial increase in the number of counties that reported evidence of the mosquitoes that can spread chikungunya, dengue, and Zika viruses, according to new research by the Centers for Disease Control and Prevention (CDC) published in the Journal of Medical Entomology June 19.

MMWR – June 22, 2017
:: Evaluation of Placental and Fetal Tissue Specimens for Zika Virus Infection — 50 States and District of Columbia, January–December, 2016
:: Screening for Syphilis and Other Sexually Transmitted Infections in Pregnant Women — Guam, 2014
:: Global Polio Eradication: Progress Toward Containment of Poliovirus Type 2 — Worldwide 2017

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Announcements

Announcements
 
NIH  [to 24 June 2017]
http://www.nih.gov/news-events/news-releases
June 19, 2017
Study to examine effects of Zika infection in Guatemalan infants and children
— NIH-funded study will characterize outcomes of infection acquired after birth.
A large natural history study examining the neurologic, neurodevelopmental and other clinical outcomes of Zika virus infection in infants and young children has begun in rural Guatemala. It will focus on those infected with Zika virus after birth rather than those infected congenitally. The study is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, in partnership with FUNSALUD (Fundacion para la Salud Integral de los Guatemaltecos) Center for Human Development in Coatepeque, Guatemala, a nonprofit foundation dedicated to improving the health and human development of families and communities in the southwest region of Guatemala. Researchers in Guatemala and the United States, including NIAID scientists, designed the study; NIAID is funding the research….

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European Medicines Agency  [to 24 June 2017]
http://www.ema.europa.eu/ema/
23/06/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017
Eight medicines recommended for approval, including two medicines for chronic hepatitis C virus (HCV) infection
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval at its June meeting.
The CHMP recommended granting marketing authorisations for Maviret (glecaprevir / pibrentasvir) and Vosevi (sofosbuvir / velpatasvir / voxilaprevir) for the treatment of chronic hepatitis C virus (HCV) infection. Both medicines were reviewed under the EU’s accelerated assessment mechanism…
 
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EDCTP    [to 24 June 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
19 June 2017
Professor Alimuddin Zumla honoured for services to public health
Professor Alimuddin Zumla, Professor of Infectious Diseases and International Health at University College London was honoured in the United Kingdom for services to public health and protection from infectious disease with a Knighthood (KBE) in Her Majesty The Queen’s 2017 Birthday Honours List…

19 June 2017
Mundo Sano joins forces with EDCTP to fund research on neglected infectious diseases
On 16 June 2017, the Mundo Sano Foundation and the European & Developing Countries Clinical Trials Partnership (EDCTP) created a partnership to leverage research funding for neglected infectious diseases (NIDs). They agreed that Mundo Sano would contribute to clinical and product-focused implementation research in neglected diseases and soil-transmitted helminthiases.
 
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UNAIDS  [to 24 June 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Feature story – 22 June 2017
New survey finds high levels of HIV discrimination in Republic of Korea
…A new survey conducted by the Korean Network of People Living with HIV/AIDS (KNP+) finds that Mr Cho’s experience is far too common for people living with HIV in the Republic of Korea. The Korean People Living with HIV Stigma Index, which is the first peer-led survey in the country to detect and measure how HIV-positive people experience stigma and discrimination, was released on 22 June. Its development was supported by the Global Network of People Living with HIV, the International Community of Women Living with HIV and UNAIDS.
The survey, which was conducted from March to June 2016, found that 62% of people questioned reported that they were tested for HIV without their knowledge. This is high compared to other countries in Asia that have conducted similar peer-led surveys. In Viet Nam, 13% of people living with HIV reported similar experiences and in Nepal the figure was 9%. In addition, 17% of people surveyed in the Republic of Korea said their status was disclosed by medical staff to others without their consent.
“For too long, the voices of people living with HIV have been absent in policy-making,” said Son Mun Soo of KNP+. “This study documents their experiences and shows that the government, employers, health-care workers and communities must do much more to guarantee the rights of people living with HIV. A comprehensive anti-discrimination law must be enacted to protect their rights.”
UNAIDS and the World Health Organization strongly recommend that HIV testing only be undertaken with a person’s informed consent…
 
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MSF/Médecins Sans Frontières  [to 24 June 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Addition of Snakebite to WHO’s Neglected Tropical Diseases List Could Spur New, More Effective Treatments
June 23, 2017
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) welcomed the addition of snakebite to the World Health Organization’s (WHO) Neglected Tropical Diseases (NTD) list. Despite the fact that snakebite is estimated to kill over 100,000 people every year—more than any other disease on the list— there are hardly any resources to prevent and treat it and very few lifesaving anti-venoms available.
 
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Wellcome Trust  [to 24 June 2017]
https://wellcome.ac.uk/news
Opinion / Published: 20 June 2017
Director’s update: our priorities for the Brexit negotiations
As the formal negotiations on the UK’s exit from the European Union begin in Brussels, Wellcome’s Director Jeremy Farrar outlines what science needs to thrive post-Brexit.
In an article in today’s Times, he sets out three key things that the government should prioritise during the negotiations to sustain Britain’s status as a world-leading centre for science:
:: harmonised regulation between the UK and the EU on issues such as medicines and data protection, to create the right conditions for innovative industries to thrive
:: continued access to EU research funding schemes for UK scientists
: an immigration policy that is welcoming to foreign researchers, technicians, innovators and their families, at every stage of their career, and to students.

News / Published: 19 June 2017
Awards for the Wellcome community in the Queen’s Birthday Honours
Several members of the Wellcome community have been named in the Queen’s Birthday Honours list. The list, which was announced over the weekend, includes over 1,000 people who are recognised for their achievements and contributions to society…
 
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Industry Watch
:: Pfizer Begins Phase 1 Clinical Trial to Evaluate Investigational Group B Streptococcus Vaccine
An estimated 10 to 30 percent of pregnant women carry the GBS bacteria;1 the vaccine candidate is being studied to help protect newborns from infection via maternal immunization
June 19, 2017
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1 trial in healthy volunteers of PF-06760805, an investigational vaccine designed to help protect against Group B Streptococcus (GBS) infection. In newborns, GBS manifests as sepsis, pneumonia, and meningitis,2 with potentially fatal outcomes for some, and long-lasting neurological damage in 46 to 50 percent of those infected.3
“Because their immune systems are still immature, GBS can have potentially devastating effects on newborns,” said Carol J. Baker, M.D., Professor of Pediatrics-Infectious Disease at the Baylor College of Medicine in Houston, Texas. “The global health community would welcome a vaccine that could help reduce the impact of GBS everywhere, particularly in areas where the routine administration of antibiotics is not common practice.”
Women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. The U.S. and certain developed countries have established recommendations for women to be screened for GBS during their third trimester of pregnancy, and administered prophylactic antibiotics during labor to prevent transmission to their newborns at delivery.4,5 However, this requires a robust health delivery infrastructure that is not widely available globally.
“Pfizer is proud to take this important first step to support our efforts to ultimately develop a GBS vaccine with the potential to immunize a mother to help protect her infant against a devastating disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. …
 
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Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

 
Integrating Clinical Research into Epidemic Response: The Ebola Experience (2017)
Consensus Study Report
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Global Health; Board on Health Sciences Policy; Committee on Clinical Trials During the 2014-2015 Ebola Outbreak; Gerald Keusch, Keith McAdam, Patricia Cuff, Michelle Mancher, and Emily R. Busta, Editors
June 2017 :: 310 pages
PDF: https://www.nap.edu/login.php?record_id=24739&page=https%3A%2F%2Fwww.nap.edu%2Fdownload%2F24739
Description
The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014–2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak.

Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014–2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

The Lancet
Jun 24, 2017 Volume 389 Number 10088 p2443-2586  e16
http://www.thelancet.com/journals/lancet/issue/current
Comment
Clinical trials during epidemics
Gerald T Keusch, Keith P W J McAdam
The consensus report of the US National Academies of Sciences, Engineering and Medicine for the first time evaluates the clinical trials on Ebola therapeutics and vaccines in Guinea, Sierra Leone, and Liberia during 2014–15.1 The report presents seven recommendations for both interepidemic and epidemic periods to improve the likelihood that important new information on therapeutics and vaccines can be obtained during future epidemics. This information is especially critical for infections such as Ebola virus disease because the only time efficacy and safety of drugs or vaccines can be studied in infected or at-risk human beings is during an outbreak. The recommendations are based on analysis of what happened in west Africa, and fall into three main categories: capacity strengthening, engaging communities, and international coordination and collaboration.

Strengthening capacity in countries at risk of emerging epidemics to respond more effectively to outbreaks and evaluate unproven new drugs and vaccines seems obvious. Planning of trials should begin when effective outbreak surveillance and reporting identify an outbreak in progress, as mandated by the International Health Regulations of 2005.2 Although WHO is responsible for assuring the latter core competencies are achieved, without international experts and sufficient available donor funding WHO cannot meet its obligations. To be both effective and efficient, clinical trials research expertise must involve not only training researchers, but also integrating research within a health-care system, improving infrastructure for competent scientific and ethical review of human subject research, and establishing the capability to negotiate legal documents with trial sponsors.

The local health-care system in Guinea recognised and reported an unusual cluster of rapidly fatal illness in the Forestière region by mid-January, 2014, but the Ministry of Health was unable to identify the actual cause. Another 8 weeks elapsed before Ebola was confirmed, during which time the outbreak grew and spread to two additional countries and multiple urban centres.3 In the scramble to respond to meet basic care needs and halt transmission, the possibility to assess experimental drugs and vaccines received little attention until 5 months later when WHO declared a public health emergency of international concern.4 Despite herculean efforts to build necessary infrastructure and launch trials in record time, limited local experience with clinical research and poor capacity for timely scientific and ethical review or negotiation of research contracts, together with differing views of trial design and probable community reaction among local and international stakeholders, slowed the process.5

Unfortunately, record time was not fast enough: the nine formal clinical trials the committee evaluated all began as the outbreak was waning. The report describes the consequence as a “thin scientific harvest”,1 and 2 years later no licenced product is available. Strengthening the many areas of expertise required for clinical trials takes sustained effort, time, and funding before an outbreak strikes. The report concludes that the choice is to “pay now and prepare in advance, or to pay later when an outbreak occurs, with the likelihood that the cost will be multiple times greater”.1

Engaging local communities emerged as a complementary concern. Clinical trials require volunteers to participate, but in the context of an uncontrolled outbreak patients may not only be ill and inadequately informed, but also fearful, vulnerable, stigmatised, and confused about goals, benefits, and risks of trials. The relationship between researcher and participant, which depends on mutual trust, was difficult to achieve in west Africa, a region haunted by the memory of civil wars and ongoing distrust of authority, compounded by limited understanding among international researchers of local culture and social traditions.6 In the absence of trust, misunderstanding was the norm and resistance was the early response in affected communities. Building trusting relationships requires time and expertise in social science and communication.7 Despite early controversies about the ethics of doing trials during an emergency and assumptions that randomised controlled trials were unacceptable, and therefore nobody would volunteer,8 once community leaders and the community itself were effectively engaged, randomised controlled trials were successfully implemented.6, 9 The research community must learn how to accomplish this engagement more efficiently in the future.

International coordination and cooperation are essential to avoid the conflict and competition that will inevitably arise again when the next outbreak occurs. This coordination requires pre-emptive joint efforts among international and national stakeholders, including the humanitarian response, research and development, and clinical trials communities, to integrate research into response, have therapeutic and vaccine candidates ready to go, and agree on principles and processes to speed priority setting, and design, approval, and implementation of clinical trials. The report recommends such efforts be led by a Coalition of International Stakeholders, which is purpose-built, independent, free of conflicts of interest, possesses expertise in many disciplines, and includes representation from governments, WHO, academia, the private sector, humanitarian response organisations, and the countries and communities at risk. The coalition would need secure financial resources to lead the effort to establish necessary global mechanisms and commitments. It should have the responsibility and resources to convene an expert, independent Rapid Research Response Workgroup at the outset of a new outbreak, including national and community participants from affected countries, to prioritise which candidates to study, determine appropriate trial design, and facilitate implementation. The report concludes: “If national and international researchers can work together on a collaborative and coordinated research agenda, and include input from the population at risk, the global community has the best chance at being prepared for the next outbreak.”1 The time to act on these recommendations is now.

The next step is to engage the many stakeholders across continents, including WHO, the World Bank, UN system, governments, research-funding agencies and foundations, academic institutions, humanitarian and civil society organisations, and others, in thoughtful discussion to determine the best way forward.

The US National Academies of Sciences, Engineering and Medicine and former members of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak are reaching out to key stakeholders to stimulate these efforts through presentations, publications, and personal contacts. Major questions remain to be resolved. How can we systematically integrate clinical and social science research expertise with emergency response? Can we create a tool box with model study designs for different outbreak scenarios, pathways for community engagement, tutorials on ethical guidelines, and more, and provide training for future leaders in countries at particular risk for emerging infections in their use, and so speed action when an epidemic begins? What is the best governance model and the particular role of WHO? Who will take leadership and where will the funds and political will come from? The answers to these questions will guide these efforts to refresh the necessary collaborative global leadership, help it to thrive, and ensure it is held to account.

We were Co-Chairs of the US National Academies of Sciences, Engineering, and Medicine’s Committee on Clinical Trials During the 2014–2015 Ebola Outbreak. We declare no other competing interests.

The other members of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak were: Abdel Babiker, Mohamed Bailor Barrie, Janice Cooper, Sheila Davis, Kathryn Edwards, Susan Ellenberg, Roger Lewis, Alex John London, Jens Lundgren, Michelle Mello, Olayemi Omotade, David Peters, Fred Wabwire-Mangen, and Charles Wells. National Academies of Sciences, Engineering, and Medicine study staff were: Patricia Cuff, Michelle Mancher, Emily Busta, Michael Berrios, Anne Claiborne, Julie Pavlin, and Andrew Pope.

References
US National Academies of Sciences, Engineering and Medicine. ((accessed June 12, 2017).)Committee on Clinical Trials During the 2014–2015 Ebola Outbreak. Integrating clinical research into epidemic response: the Ebola experience. The National Academies Press, Washington, DC; 2017
https://www.nap.edu/catalog/24739/integrating-clinical-research-into-epidemic-response-the-ebola-experience