Vaccines and Global Health: The Week in Review 19 December 2015

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

.Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

pdf version A pdf of the current issue is available here:  Vaccines and Global Health_The Week in Review_19 December 2015

blog edition: comprised of the approx. 35+ entries posted below on 6 December 2015.

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

EBOLA/EVD [to 19 December 2015]

EBOLA/EVD [to 19 December 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Ebola Situation Report – 16 December 2015
SUMMARY
No confirmed cases of Ebola virus disease (EVD) were reported in the week to 13 December. All contacts associated with the cluster of 3 confirmed cases of EVD reported from Liberia in the week to 22 November have now completed 21-day follow-up. The first-reported case in the cluster, a 15-year-old boy, died on 23 November. Two subsequent cases, the boy’s father and younger brother, tested negative twice for Ebola virus on 3 December and were discharged. As of 11 December, 210 eligible recipients associated with the cluster had received the rVSV-ZEBOV Ebola vaccine as part of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL study), which is administered by the Government of Liberia and the US National Institutes of Health.

Human-to-human transmission linked to the recent cluster of cases in Liberia will end on 14 January 2016, 42 days after the 2 most-recent cases received a second consecutive negative test for Ebola virus, if no further cases are reported. Human-to-human transmission linked to the primary outbreak in Guinea will end on 28 December 2015, 42 days after the country’s most recent case, reported on 29 October, received a second consecutive negative test for Ebola virus. In Sierra Leone, human-to-human transmission linked to the primary outbreak was declared to have ended on 7 November 2015. The country has now entered a 90-day period of enhanced surveillance scheduled to conclude on 5 February 2016…

POLIO [to 19 December 2015]

POLIO [to 19 December 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week as of 15 December 2015
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

:: The report on the September 2015 meeting of the Strategic Advisory Group of Experts on immunization (SAGE) was published this week, confirming that the globally coordinated withdrawal of the type 2 component in oral polio vaccine (OPV), also referred to as the ‘tOPV to bOPV switch’, should occur in April 2016.

:: Looking back at 2015 and ahead at 2016: a wrap-up of the year shows fewer cases in fewer places than ever before. The report on the status of polio eradication to WHO’s Executive Board also summarizes the progress on the Polio Endgame Plan, and on Resolution WHA68.3, adopted by the World Health Assembly (WHA) in May 2015.
[No new cases identified in Country-level reports in this week’s Update]

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Poliomyelitis – Report by the Secretariat
WHO Executive Board 138 Session Provisional Agenda item 8.6
EB138/25 11 December 2015
Excerpts – Editor’s text bolding
1. At the time of writing (November 2015), strong progress continues to be made towards each of the four objectives of the Polio Eradication and Endgame Strategic Plan 2013–2018 (the Endgame Plan). With only Afghanistan and Pakistan remaining endemic for poliomyelitis, wild poliovirus transmission is at the lowest levels in history, with the fewest-ever reported cases from the fewest-ever affected countries. In resolution WHA68.3 on poliomyelitis, adopted in May 2015, the World Health Assembly recognized progress made towards interrupting transmission and towards the phased removal of oral polio vaccines, and urged Member States to fully finance and implement the Endgame Plan.

2. The declaration of international spread of wild poliovirus as a Public Health Emergency of International Concern and the temporary recommendations promulgated under the International Health Regulations (2005) remain in effect. In September 2015, the Polio Oversight Board of the Global Polio Eradication Initiative reviewed progress and concluded that wild poliovirus transmission is more likely to be interrupted in 2016 than in 2015. This delay shifts the target date for certification of global polio eradication to 2019 and increases the cost of completing polio eradication by US$ 1500 million. In October 2015, WHO’s Strategic Advisory Group of Experts on immunization confirmed its recommendation that the withdrawal of oral polio vaccines containing the type 2 component should occur during the period 17 April–1 May 2016 in all countries that are using trivalent oral polio vaccine through a globally-coordinated replacement of this vaccine by the bivalent oral polio vaccine. The Group also reaffirmed that, in preparation for this global event, it is crucial that countries meet established deadlines to identify facilities holding wild or vaccine-derived poliovirus type 2, destroy all type 2 poliovirus materials and, only where necessary, appropriately contain type 2 poliovirus in essential poliovirus facilities…

Strengthening routine immunization
15. The Global Polio Eradication Programme initiated a joint programme of work with the GAVI Alliance and other partners to support efforts to strengthen routine immunization in 10 “focus” countries with significant polio resources. Six of these countries – Chad, Democratic Republic of the Congo, Ethiopia, India, Nigeria and Pakistan – have developed annual national immunization plans that build on polio assets to improve broader immunization goals, resulting in as much as a 22% reduction in unimmunized children in some areas, in 2014 compared to 2013.1 Polio staff in these countries spend as much as 50% of their time on broader immunization and public health issues.

CONTAINMENT
16. In 2015, pursuant to resolution WHA68.3, the Global Commission for the Certification of the Eradication of Poliomyelitis and the Strategic Advisory Group of Experts on immunization urged accelerated implementation of the WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use (GAP III). Specifically, all Member States should complete Phase I (Preparation for containment of poliovirus type 2) which includes establishing an inventory of facilities holding polioviruses, destroying all wild poliovirus materials by the end of 2015 and destroying all Sabin type 2 poliovirus materials by July 2016. Any type 2 poliovirus materials not destroyed should be securely contained in designated “poliovirus essential” facilities. For implementation of Phase II (Poliovirus type 2 containment period) Member States hosting essential poliovirus facilities (vaccine production, research and repositories) should designate a national containment authority, establish biorisk management regulations aligned with GAP III, and certify secure containment of poliovirus materials. The Secretariat is supporting Member States in implementing the global action plan…

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Circulating vaccine-derived poliovirus – Lao People’s Democratic Republic
Disease outbreak news
15 December 2015
On 8 December 2015, the National IHR Focal Point of Lao People’s Democratic Republic (PDR) notified WHO of 2 additional VDPV1 cases. These cases are from Xaisomboun, a previously unaffected province. To date, the total number of confirmed cVDPV1 cases in this outbreak is 5…

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IS Hinders Polio Eradication Efforts in Afghanistan
Noor Zahid, Zabihullah Ghazi
Voice of America December 11, 2015 4:40 PM
JALALABAD, AFGHANISTAN—
Polio vaccinations for tens of thousands of Afghan children are being delayed because health workers are unable to access remote regions controlled by Islamic militants including the Islamic State group.

Gula Khan Ayub, a Ministry of Public Health official, said around 100,000 children could not get vaccinated in a recent four-day polio vaccination campaign carried out in 14 eastern and southern provinces of Afghanistan due to militants’ threats.

The militants are blocking polio vaccination campaigns, saying the Afghan government and the West are using health workers for intelligence-gathering purposes, VOA correspondent Zabihullah Ghazi reports…

WHO & Regionals [to 19 December 2015]

WHO & Regionals [to 19 December 2015]

Health and human rights
Fact sheet N°323
December 2015
Key facts
:: The WHO Constitution enshrines “…the highest attainable standard of health as a fundamental right of every human being.”
:: The right to health includes access to timely, acceptable, and affordable health care of appropriate quality.
:: Yet, about 100 million people globally are pushed below the poverty line as a result of health care expenditure ever year.
:: Vulnerable and marginalized groups in societies tend to bear an undue proportion of health problems.
:: Universal health coverage is a means to promote the right to health.
Launch of WHO mobile phone application for nutrition
December 2015 — Access the latest WHO nutrition guidelines, recommendations and related information for nutrition interventions, wherever you are, with the eLENA (e-Library of Evidence for Nutrition Actions) mobile phone application.
Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: 17 December 2015 Human infection with avian influenza A(H7N9) virus – China
:: 15 December 2015 Circulating vaccine-derived poliovirus – Lao People’s Democratic Republic
:: 15 December 2015 Microcephaly – Brazil
:: 15 December 2015 Cholera – Democratic Republic of the Congo
Weekly Epidemiological Record (WER) 18 December 2015, vol. 90, 51/52 (pp. 701–712)
Contents
701 Index of countries/areas
701 Index, Volume 90, 2015, Nos. 1–52
IVB
:: 17 December 2015
WHO seeks expression of interest from sub-Saharan African countries for pilot implementation projects of the RTS,S/AS01 malaria vaccine.
Expression of interest – English pdf, 332kb
Expression of Interest – French pdf, 301kb
Deadline for application: 15 January 2016
:: 17 December 2015
Immunization Practices Advisory Committee (IPAC): CALL FOR NOMINATIONS
Information and submission of proposals pdf, 124kb
Closing date: 1 February 2016
:: WHO Regional Offices
WHO African Region AFRO
:: The African Programme for Onchocerciasis Control (APOC) closes and a new body set up to eliminate Neglected Tropical Diseases
KAMPALA, 17 December 2015:- The African Programme for Onchocerciasis Control (APOC) founded in 1995 has been formally closed and a new entity – the Expanded Special Project for the Elimination of Neglected Tropical Diseases (ESPEN), with an expanded mandate, proposed to replace it. ESPEN was formally introduced to delegates at the 21st session of the Joint Action Forum (JAF) of the African Programme for Onchocerciasis Control (APOC) that has concluded in Kampala, Uganda.

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

WHO South-East Asia Region SEARO
:: Make focused, accelerated efforts to prevent, reduce newborn deaths: WHO
SEAR/PR/1617
New Delhi, 14 December 2015: Nearly 7400 new-borns die every day in the WHO South-East Asia Region causing untold misery to mothers and families. Two-thirds of these deaths can be prevented by adopting proven and cost-effective measures, World Health Organization today said seeking focused efforts by governments and partners to prevent newborn deaths with a sense of urgency.
“Scaling up interventions with good quality care around the time of childbirth and during the first days after birth can substantially prevent complications and infections in new-borns, which are the main causes of newborn deaths,” Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia Region, said here as health partners signed a pledge to reduce newborn deaths.
Led by WHO; UNICEF, UNFPA, World Bank, UNAIDS and UNWOMEN pledged to jointly support the countries in the Region to prioritize accelerated reduction in newborn deaths by ensuring equitable access to essential life-saving interventions for mothers and babies across the Region…

WHO European Region EURO
:: Will there be sufficient health professionals to meet future needs? 18-12-2015
:: European health report available in French, German and Russian 16-12-2015

WHO Eastern Mediterranean Region EMRO
:: WHO: Urgent support needed to provide health services for 15 million people in Yemen
Geneva, 15 December 2015 – WHO and health partners are appealing for US$ 31 million to ensure the continuity of health services for nearly 15 million people in Yemen affected by the ongoing conflict. Funding is urgently needed as the Yemeni health system has collapsed, leaving millions of vulnerable people without the care and medications they urgently need. Conflict is making the delivery of health services and supplies extremely challenging, health facilities and ambulances have been damaged, and there is a shortage of health workers, limiting access to health care.

WHO Western Pacific Region
:: Universal Health Coverage – a Foundation for the Sustainable Development Goals
MANILA, 12 December 2015 – Held every year since 2012 on 12 December, Universal Health Coverage (UHC) day gathers partners globally to reaffirm the urgency for greater action and progress towards UHC. WHO Regional Office for the Western Pacific calls for countries to ensure good quality health services are accessible to all as it celebrates UHC Day. Dr. Shin Young-soo, WHO Regional Director for the Western Pacific said, “Every country – no matter how rich or poor – can do something now to improve access to good quality services, to improve financial protection and to improve efficiency.”

UNICEF [to 19 December 2015]

UNICEF [to 19 December 2015]
http://www.unicef.org/media/media_78364.html
Selected press releases

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On the Day of International Migration, UNICEF says children need urgent solutions, solidarity
GENEVA, 18 December 2015 – “The year, 2015, will be remembered for the heart-breaking image of a lifeless little boy on a beach – one of many who came before him; one of many who came after him. It was a year that saw hundreds of thousands of children and their families on the move leaving behind horrors, on an odyssey of hope through Europe. It was the year of mass displacement. And there is no end in sight.

More than 16 million babies born into conflict this year: UNICEF
NEW YORK, 17 December 2015 – More than 16 million babies were born in conflict zones in 2015 – 1 in 8 of all births worldwide this year – UNICEF said today, a figure that underscores the vulnerability faced by increasing numbers of children.

UNHCR and UNICEF highlight unrelenting children’s crisis
NAIROBI, Kenya, 15 December 2015 – The UN High Commissioner for Refugees (UNHCR) and the UN Children’s Fund (UNICEF) warned today that the children of South Sudan remain some of the most vulnerable in the world. Noting the second anniversary since violence erupted in South Sudan, the two UN agencies called for all parties to uphold their commitments to the Peace Agreement, so as to allow the almost 1.5 million South Sudanese children to return home and receive an education, and child soldiers to be released and reintegrated.

UNICEF: 500 children die every day from lack of safe water, sanitation in sub-Saharan Africa
DAKAR, Senegal, 15 December 2015 – Around 180,000 children under 5 years old die every year – roughly 500 a day – in sub-Saharan Africa due to diarrhoeal diseases linked to inadequate water, sanitation and hygiene (WASH), UNICEF said ahead of a conference in Dakar on financing for the sector.

FDA [to 19 December 2015]

FDA [to 19 December 2015]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

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Influenza Virus Vaccine for the 2015-2016 Season
Posted: 12/16/2015

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December 14, 2015 Approval Letter – GARDASIL 9 (PDF – 35KB)
Posted: 12/15/2015
…approved your request to supplement your biologics license application for Human Papillomavirus 9 – valent Vaccine, Recombinant to extend the indication by including Boys and men 16 through 26 years of age for the prevention of the followingg diseases:
:: Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
:: Genital warts (condyloma acuminata) caused by HPV types 6 and 11. And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
:: Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3…

Industry Watch [to 19 December 2015]

Industry Watch [to 19 December 2015]

:: FDA Approves Expanded Age Indication for GARDASIL® 9 in Males
December 15, 2015
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GARDASIL®9

:: Janssen Announces Collaboration with Bavarian Nordic to Develop Vaccine for Chronic Human Papillomavirus (HPV) Infections
Dec 18, 2015, 16:00 ET
New approach for early treatment and interception of HPV-induced cancers
Janssen Pharmaceuticals, Inc. (Janssen) announced today that the company has entered into a definitive collaboration and license agreement with Bavarian Nordic to leverage their MVA-BN® technology, jointly with Janssen’s own AdVac® technology, in the development and commercialization of a heterologous prime-boost vaccine for the treatment of Human Papillomavirus (HPV) chronic infections which can lead to cancer. Under this agreement, Janssen will conduct all clinical development and, subject to regulatory approval, will be responsible for registration, distribution and commercialization of the potential combination vaccine worldwide…