Vaccines and Global Health: The Week in Review 25 March 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_25 March 2017

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

– 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

Milestones :: Perspectives :: Featured Journal Content

Milestones :: Perspectives :: Featured Journal Content

From coast to coast: Africa unites to tackle threat of polio
116 million children to be immunized from coast to coast across the continent, as regional emergency outbreak response intensifies
GENEVA/BRAZZAVILLE/NEW YORK/DAKAR, 24 March 2017 –  More than 190,000 polio vaccinators in 13 countries across west and central Africa will immunize more than 116 million children over the next week, to tackle the last remaining stronghold of polio on the continent.

The synchronized vaccination campaign, one of the largest of its kind ever implemented in Africa, is part of urgent measures to permanently stop polio on the continent. All children under five years of age in the 13 countries – Benin, Cameroon, Central African Republic, Chad, Côte d’Ivoire, Democratic Republic of Congo, Guinea, Liberia, Mali, Mauritania, Niger, Nigeria and Sierra Leone – will be simultaneously immunized in a coordinated effort to raise childhood immunity to polio across the continent. In August 2016, four children were paralysed by the disease in security-compromised areas in Borno state, north-eastern Nigeria, widely considered to be the only place on the continent where the virus maintains its grip.

“Twenty years ago, Nelson Mandela launched the pan-African ‘Kick Polio Out of Africa’ campaign,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “At that time, every single country on the continent was endemic to polio, and every year, more than 75,000 children were paralysed for life by this terrible disease. Thanks to the dedication of governments, communities, parents and health workers, this disease is now beaten back to this final reservoir.”

Dr Moeti cautioned, however, that progress was fragile, given the epidemic-prone nature of the virus. Although confined to a comparatively small region of the continent, experts warned that the virus could easily spread to under-protected areas of neighbouring countries. That is why regional public health ministers from five Lake Chad Basin countries – Cameroon, Central African Republic, Chad, Niger, and Nigeria – declared the outbreak a regional public health emergency and have committed to multiple synchronized immunization campaigns…

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New England Journal of Medicine
March 23, 2017  Vol. 376 No. 12
http://www.nejm.org/toc/nejm/medical-journal
Editorial
Rotavirus Vaccines — A New Hope
Mathuram Santosham, M.D., M.P.H., and Duncan Steele, Ph.D.
N Engl J Med 2017; 376:1170-1172 March 23, 2017 DOI: 10.1056/NEJMe1701347

Rotavirus gastroenteritis is the leading cause of diarrhea-associated hospitalization and death in children younger than 5 years of age,1 with more than 85% of the approximately 200,000 annual rotavirus deaths occurring in Africa and Asia.2 Since improvements in water, sanitation, and hygiene do not prevent rotavirus transmission, as they do with the spread of bacterial enteropathogens, the implementation of a rotavirus vaccine is essential to prevent death and complications from childhood diarrhea.

Two rotavirus vaccines — Rotarix (an attenuated G1P8 rotavirus manufactured by GlaxoSmithKline) and RotaTeq (containing five human–bovine reassortant rotaviruses, manufactured by Merck), attained prequalification by the World Health Organization (WHO) in 2008, which paved the way for UNICEF vaccine procurement through the financing mechanisms of the Gavi Alliance. These vaccines, which have been introduced in 42 Gavi-eligible countries and in 6 countries that have been designated as low-income and middle-income, have had a major effect on rotavirus deaths and hospitalizations in all settings.3

However, the uptake of rotavirus vaccines has slowed for various reasons, including supply constraints, high cost, and programmatic concerns for national immunization programs, particularly cold-chain capacity.4 Gavi countries have predominantly selected the attenuated G1P8 rotavirus vaccine,5 which has a smaller vaccine vial size and comes with a vaccine vial monitor for temperature monitoring. The two approved rotavirus vaccines have a liquid ready-to-use formulation. However, issues of cost of the vaccine and vaccine supply remain.
With Gavi support, low-income countries can procure rotavirus vaccines with a minimal copayment of 40 cents (in U.S. currency) per course, and Gavi cofinances the remainder of the UNICEF price (which ranges from $4.50 to $10.50). Low-income and middle-income countries, which are not Gavi-eligible, pay substantially higher costs for rotavirus vaccines.5 Gavi’s principles for vaccine-supply security emphasize the need for multiple manufacturers in the market to drive down prices while establishing sufficient vaccine supply. This protocol will become more critical as countries transition from Gavi support owing to socioeconomic development.

Fortunately, the situation is improving. In 2013, an indigenously developed rotavirus vaccine (ROTAVAC, Bharat Biotech International) was licensed in India and has been introduced in the routine childhood immunization program in four Indian states, with expanded rollout expected this year. This vaccine is under consideration for WHO prequalification, which would make it eligible for UNICEF procurement and Gavi subsidy. Bharat Biotech has committed to a cost of approximately $3.00 per course for global public markets.

In this issue of the Journal, Isanaka and colleagues6 document the safety and efficacy of an oral bovine rotavirus pentavalent vaccine (BRV-PV) developed by Serum Institute of India. The vaccine, which the investigators evaluated in an impoverished setting in Niger, had a reported efficacy of 66.7%,6 which is similar to that of other licensed rotavirus vaccines in similar settings. Efficacy data from an Indian study are pending. Despite this modest efficacy, the absolute public health benefits of vaccination are large, given the tremendous disease burden.

Estimates suggest that rotavirus vaccines have the potential to prevent 2.46 million childhood deaths and 83 million disability-adjusted life-years during the period from 2011 through 2030.7
The authors describe a rotavirus vaccine that is thermostable for 24 months at 37°C and for 6 months at 40°C, which may provide advantages for vaccine delivery in remote areas where cold-chain capacity is limited. However, this vaccine is freeze-dried, and practitioners in many countries may prefer other rotavirus vaccines that have liquid all-in-one formulations to simplify programmatic considerations. The projected cost of this heat-stable vaccine falls between the Gavi prices for the two currently used vaccines. The availability of vaccines from several manufacturers will increase global supply.

During the past three decades, remarkable progress has been made in reducing mortality from diarrheal disease, but the goal of ending such deaths cannot be achieved without aggressive implementation of a comprehensive approach to diarrhea prevention and treatment, including providing access of rotavirus vaccines to every child regardless of economic status. Increased availability of low-cost, programmatically suitable vaccines in abundant supply will be key to achieving this goal.

Original Article
Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger
Sheila Isanaka, Sc.D., Ousmane Guindo, M.D., Celine Langendorf, Pharm.D., M.P.H., Amadou Matar Seck, M.D., Brian D. Plikaytis, M.Sc., Nathan Sayinzoga-Makombe, M.P.H., Monica M. McNeal, M.Sc., Nicole Meyer, M.Sc., Eric Adehossi, M.D., Ali Djibo, M.D., Bruno Jochum, M.S., and Rebecca F. Grais, Ph.D.
N Engl J Med 2017; 376:1121-1130 March 23, 2017 DOI: 10.1056/NEJMoa1609462
Abstract
Background
Each year, rotavirus gastroenteritis is responsible for about 37% of deaths from diarrhea among children younger than 5 years of age worldwide, with a disproportionate effect in sub-Saharan Africa.
Methods
We conducted a randomized, placebo-controlled trial in Niger to evaluate the efficacy of a live, oral bovine rotavirus pentavalent vaccine (BRV-PV, Serum Institute of India) to prevent severe rotavirus gastroenteritis. Healthy infants received three doses of the vaccine or placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis were assessed through active and passive surveillance and were graded on the basis of the score on the Vesikari scale (which ranges from 0 to 20, with higher scores indicating more severe disease). The primary end point was the efficacy of three doses of vaccine as compared with placebo against a first episode of laboratory-confirmed severe rotavirus gastroenteritis (Vesikari score, ≥11) beginning 28 days after dose 3.
Results
Among the 3508 infants who were included in the per-protocol efficacy analysis, there were 31 cases of severe rotavirus gastroenteritis in the vaccine group and 87 cases in the placebo group (2.14 and 6.44 cases per 100 person-years, respectively), for a vaccine efficacy of 66.7% (95% confidence interval [CI], 49.9 to 77.9). Similar efficacy was seen in the intention-to-treat analyses, which showed a vaccine efficacy of 69.1% (95% CI, 55.0 to 78.7). There was no significant between-group difference in the risk of adverse events, which were reported in 68.7% of the infants in the vaccine group and in 67.2% of those in the placebo group, or in the risk of serious adverse events (in 8.3% in the vaccine group and in 9.1% in the placebo group); there were 27 deaths in the vaccine group and 22 in the placebo group. None of the infants had confirmed intussusception.
Conclusions
Three doses of BRV-PV, an oral rotavirus vaccine, had an efficacy of 66.7% against severe rotavirus gastroenteritis among infants in Niger. (Funded by Médecins sans Frontières Operational Center and the Kavli Foundation; ClinicalTrials.gov number, NCT02145000.)

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Editor’s Note:
Please note World TB Day announcements across this edition.

Emergencies

Emergencies

WHO Grade 3 Emergencies  [to 25 March 2017]
Iraq  –
WHO scales up disease surveillance reporting in East Mosul and Hamdaniya districts, Iraq
19 March 2017, Erbil, Iraq – The World Health Organization (WHO) and the United Nations Office for the Coordination of Humanitarian Affairs (UNOCHA) are scaling up disease surveillance activities in newly accessible areas of Ninewa governorate, Iraq, to reduce the risk of disease outbreaks. As a result of acute shortages of safe water, sanitation services, food, and electricity in East Mosul and Hamdaniya districts, current humanitarian conditions pose a high risk of communicable diseases among displaced persons, returnees, and host communities.

Nigeria No new announcements identified
South Sudan  – No new announcements identified
The Syrian Arab Republic No new announcements identified
YemenNo new announcements identified

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WHO Grade 2 Emergencies  [to 25 March 2017]
Cameroon  – No new announcements identified.
Central African Republic  – No new announcements identified.
Democratic Republic of the Congo No new announcements identified.
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
Myanmar No 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
:: UN Expresses Profound Concern about Terrible Loss of Life in Western Mosul
Published on 24 Mar 2017
The United Nations is profoundly concerned by reports yesterday of a high number of civilian casualties in Al Aghawat Al Jadidah, a densely populated neighborhood in Mosul. Initial reports indicate hundreds of causalities.

“We are stunned by this terrible loss of life and wish to express our deepest condolences to the many families who have reportedly been impacted by this tragedy,” said Ms. Lise Grande, the Humanitarian Coordinator for Iraq.

“Nothing in this conflict is more important than protecting civilians,” said Ms. Grande.    “International humanitarian law is clear. Parties to the conflict — all parties – are obliged to do everything possible to protect civilians. This means that combatants cannot use people as human shields and cannot imperil lives through indiscriminate use of fire-power.”

As the fighting to retake Mosul intensifies, civilians are being put at extreme risk. “We fear for the families who are caught in the conflict,” said Ms. Grande. “Everything must be done to avoid civilian casualties.

:: Iraq: Humanitarian Bulletin, February 2017 | Issued on 23 March
:: Iraq: Mosul Humanitarian Response Situation Report No. 25 (13-19 March 2017)

Syria  
:: 24 Mar 2017   Emergency Telecommunications Cluster (ETC) Syria Operation, March 2017

Yemen
:: 19 Mar 2017  Yemen Humanitarian Bulletin Issue 21 | As of 18 March 2017
HIGHLIGHTS
…Two years of conflict puts future of coming generations at great risk
..First UN cross-line medical aid delivery to Taizz city in months
…117,107 people migrate to Yemen from the Horn of Africa in 2016
…Cholera response gives promising results

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POLIO [to 25 March 2017]
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 22 March 2017
:: From 25 to 28 March, synchronised polio campaigns will take place across 13 counties in west and central Africa including Nigeria, Chad, Cameroon, Guinea, Mali and Niger. Over 190 000 vaccinators will immunize more than 116 million children over the course of the campaigns..

Country Updates [Selected Excerpts]
New cases or environmental samples reported across the monitored country/region settings: Afghanistan, Pakistan, Nigeria, Lake Chad Basin, Guinea and West Africa, Lao People’s Democratic Republic.
:: No new case activity reported

 [See report on story on polio immunization across Africa in Milestones above]

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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.

 Yellow Fever  [to 25 March 2017]
http://www.who.int/emergencies/yellow-fever/en/
Disease outbreak news
20 March 2017
Updates on yellow fever vaccination recommendations for international travellers related to the current situation in Brazil

As of 16 March 2017, yellow fever virus transmission continues to expand towards the Atlantic coast of Brazil in areas not deemed to be at risk for yellow fever transmission prior to the revised risk assessment, supported by the scientific and technical advisory group on geographical yellow fever risk mapping (GRYF), and published by WHO in the Disease Outbreak News of 27 January 2017 and 6 March 2017; as well as on the WHO International Travel and Health website on 31 January 2017,14 February 2017, and 6 March 2017.

As of 16 March 2017, confirmed cases of yellow fever virus infection in humans were reported in Rio de Janeiro State, and epizootics and human cases are under investigation for yellow fever virus infection in São Paulo State. These reports are consistent with the increased yellow fever activity observed in other States (Espírito Santo and Minas Gerais) that share the same ecosystem — tropical and sub-tropical broad leaved forests. As of 16 March 2017, there is no evidence of human cases of yellow fever virus infection transmitted by Aedes aegypti, the vector that could sustain urban transmission of yellow fever.

The WHO Secretariat has determined that the State of Rio de Janeiro, with the exception of the urban areas of Rio de Janeiro City and Niterói, and the State of São Paulo, with the exception of the urban areas of São Paulo City and Campinas, should also be considered at risk for yellow fever transmission.

Consequently, vaccination against yellow fever is recommended for international travellers visiting those areas in the States of Rio de Janeiro and São Paulo. The typology of activities that international travellers anticipate to undertake while visiting areas determined to be at risk for yellow fever transmission should be weighted in the risk-benefit analysis informing the individual decision to be immunized against yellow fever.

There are no other additional changes with respect to other areas of Brazil determined to be at risk for yellow fever transmission in 2013, as published by WHO in the Disease Outbreak News on 31 January 2017 and 6 March 2017…

 EBOLA/EVD  [to 25 March 2017]
http://www.who.int/ebola/en/
No new digest content identified for this edition.

 MERS-CoV [to 25 March 2017]
http://www.who.int/emergencies/mers-cov/en/
No new digest content identified for this edition.

 Zika virus  [to 25 March 2017]
http://www.who.int/emergencies/zika-virus/en/
No new digest content identified for this edition.

WHO & Regional Offices [to 25 March 2017]

WHO & Regional Offices [to 25 March 2017]

Highlights

10th meeting of the Strategic and Technical Advisory Group for Neglected Tropical Diseases
March 2017 – The meeting, taking place on 29–30 March 2017, will cover issues on Global Vector Control Response, examination of dossiers requesting the potential inclusion of diseases as NTDs, gaps in disease elimination, eradication of dracunculiasis, integrated data management, and the 2nd WHO NTD Global Partners’ Meeting.

Global Health Sector Strategy on Viral Hepatitis
March 2017 – Worldwide, approximately 240 million people have chronic hepatitis B infection and 80 million people have chronic hepatitis C infection. A dedicated portal has been developed for the first ever Global Health Sector Strategy on Viral Hepatitis 2016–2021.

Ad-hoc Interagency Coordination Group on antimicrobial resistance
March 2017 – At the UN General Assembly’s high-level meeting on antimicrobial resistance in September 2016, Member States requested the Secretary-General to establish, in consultation with WHO, the Food and Agriculture Organization, and the World Organisation for Animal Health, an ad-hoc interagency coordination group on antimicrobial resistance.

Weekly Epidemiological Record, 24 March 2017, vol. 92, 12 (pp. 129–144)
Zoonotic influenza viruses: antigenic and genetic characteristics and development of candidate vaccine viruses for pandemic preparedness

Disease outbreak news

:: Meningococcal disease – Nigeria  24 March 2017
:: Human infection with avian influenza A(H7N9) virus – China  23 March 2017
:: Yellow fever – Brazil  20 March 2017  [See Yellow Fever above]

:: WHO Regional Offices
Selected Press Releases, Announcements

WHO African Region AFRO
:: From coast to coast: Africa unites to tackle threat of polio – 23 March 2017
:: Dr Matshidiso Moeti on an official visit to Republic of Niger – 21 March 2017

WHO Region of the Americas PAHO
:: PAHO/WHO: “Let’s unite to end TB, leaving no one behind” (03/23/2017)

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
:: World TB Day: leave no one behind 23-03-2017
:: France becomes one of the first countries in Region to recommend colour-coded nutrition labelling system 22-03-2017
:: World Water Day: good health and managing wastewater go hand-in-hand 22-03-2017
:: TB/HIV co-infections up 40% across Europe over the last five years 20-03-2017

WHO Eastern Mediterranean Region EMRO
:: World TB Day: Unite to End TB and alleviate the suffering of millions  22 March 2017
:: WHO reinforces monitoring of health facilities, services and resources in Syria  22 March 2017
:: WHO scales up disease surveillance reporting in East Mosul and Hamdaniya districts, Iraq
19 March 2017

WHO Western Pacific Region
:: Unite to End TB, by properly financing care MANILA, 24 March 2017

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CDC/ACIP [to 25 March 2017]
http://www.cdc.gov/media/index.html

MMWR Weekly March 24, 2017 / No. 11
[Excerpts]
:: World TB Day — March 24, 2017
:: Tuberculosis — United States, 2016
:: Tuberculosis Among Foreign-Born Persons Diagnosed ≥10 Years After Arrival in the United States, 2010–2015
:: Establishing a Timeline to Discontinue Routine Testing of Asymptomatic Pregnant Women for Zika Virus Infection — American Samoa, 2016–2017
:: Notes from the Field: Obstetric Tetanus in an Unvaccinated Woman After a Home Birth Delivery — Kentucky, 2016

Announcements

Announcements

Gavi [to 25 March 2017]
http://www.gavi.org/library/news/press-releases/
21 March 2017
Gavi ‘effective and fit for purpose’
Network of 19 donor countries assesses Gavi, the Vaccine Alliance’s performance

Gavi is an effective, ‘fit for purpose’ organisation, scoring top ratings in a number key performance areas, according to the Multilateral Organisation Performance Assessment Network (MOPAN).

In its second institutional review of the organisation, MOPAN commends Gavi as being both “strategic and nimble in meeting new vaccine challenges and countries’ evolving needs, while keeping a clear focus on its mission goals.” Gavi is also recognised as being a “strong model for sustainability”.

MOPAN is a network of 19 donor countries, representing 95% of Overseas Development Assistance (ODA), which assesses the effectiveness of the multilateral organisations that receive development and humanitarian funding.

“Gavi has a clear long-term vision based on a distinct business and partnership model” states the report. “It plays a catalytic role in expanding immunisation coverage and shaping the global vaccine market.”

The review, covering the period from 2014 to mid-2016, notes that Gavi demonstrates transparency and accountability in its operations, with strong compliance with fiduciary and social requirements and safeguards. It has recently strengthened its internal audit and risk management functions to meet its increased organisational ambition, complexity and size.
As a performance and results orientated organisation, “Gavi has a clear framework of indicators, targets and metrics at the country level. Results-based management is integral to its planning and grant allocation.”…

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NIH [to 25 March 2017]
http://www.nih.gov/news-events/news-releases
March 24, 2017
NIH Statement on World Tuberculosis Day
Statement of Christine F. Sizemore, PhD., Richard Hafner, M.D., and Anthony S. Fauci, M.D. National Institute of Allergy and Infectious Diseases.
Tuberculosis (TB) is one of the world’s most devastating infectious diseases. March 24th marks the day in 1882 when German microbiologist Robert Koch announced he had discovered Mycobacterium tuberculosis, the bacterium that causes this ancient scourge. Today, in recognition of World TB Day, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), reasserts its commitment to improving our understanding of TB and how to prevent, diagnose and treat it. Around the globe, researchers and the public health community are united in working toward these goals.

TB is the world’s leading cause of death from an infectious disease, especially among women and children. The World Health Organization estimates that more than 1.8 million people worldwide died of TB in 2015. The symptoms of the disease, which is transmitted through the air and primarily affects the lungs, often begin with coughing, shortness of breath or swollen lymph nodes — but can end in death if left untreated. People with HIV are especially vulnerable: of deaths among people co-infected with HIV and TB, about one quarter are due to TB. In addition, the World Health Organization estimates that about one-third of the world’s population is infected with “latent” TB, in which people carry the bacterium while exhibiting no symptoms.  Five to 10 percent of these latent TB carriers risk developing active TB at some point in their lifetimes. For latent TB carriers who are infected with HIV, this risk is approximately 10 percent per year. Finally, it is important to note that smoking substantially increases TB disease occurrence and risk of death due to TB worldwide.

A safe and highly effective vaccine against TB will be a critical tool in ultimately controlling the infection. Currently, the only available vaccine against TB is bacille Calmette-Guerin (BCG), developed in 1921. While this vaccine offers protection against disseminated disease and death in children, it is much less effective against the transmissible pulmonary form of the disease in adults. NIAID supports research across the spectrum of basic, preclinical and clinical development to arrive at innovative new approaches toward the development of vaccines to prevent this disease…

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NIH achieves milestone to accelerate multisite clinical studies
March 23, 2017 — CTSA Program paves way for nationwide single IRB mode
Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

The National Institutes of Health is leading policy and programmatic initiatives to streamline this overly cumbersome process. NIH’s National Center for Advancing Translational Sciences (NCATS) announced today that all Clinical and Translational Science Awards (CTSA) Program sites have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement. This agreement — which now includes a total of more than 150 top medical research institutions — will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference.

The SMART IRB authorization agreement serves as a model to help investigators adhere to the NIH’s policy on single IRB use for multisite studies. This policy was designed to improve IRB efficiencies while ensuring the protection of research participants so that research can proceed expeditiously.

The authorization agreement effort was led by Harvard CatalystUniversity of Wisconsin-Madison Institute for Clinical and Translational Research, and Dartmouth Synergy. Through these institutions, a team of NCATS-supported SMART IRB ambassadors facilitated and provided critical guidance and support to assist institutions in joining and implementing the SMART IRB authorization agreement.

“This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly,” said NCATS Director Christopher P. Austin, M.D. “It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago.”…

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Global Fund [to 25 March 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund and Inter-Parliamentary Union Sign MOU
23 March 2017
The Global Fund and the Inter-Parliamentary Union (IPU) have signed a memorandum of understanding to promote mutual advocacy, engage in joint technical work and raise awareness in the fight against AIDS, TB and malaria and building resilient and sustainable systems for health.

News
Senegal and the Global Fund Extend Their Partnership
21 March 2017
The Honorable Macky Sall, President of the Republic of Senegal, today welcomed a delegation from the Global Fund to Fight AIDS, Tuberculosis and Malaria led by Dr. Mark Dybul, Executive Director. The meeting marked the official signing of the Agreement on the Privileges and Immunities of the Global Fund, a symbolic step in strengthening the partnership between the Global Fund and Senegal that has been in place for 15 years. Senegal is now the 15th country to sign the agreement; Côte d’Ivoire, Togo, Burkina Faso, Rwanda as well as some ten European and African states have already done so.

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PATH [to 25 March 2017]
http://www.path.org/news/index.php
Announcement | March 23, 2017
PATH welcomes new promising study results for rotavirus vaccine candidate
A new article published today in the New England Journal of Medicine provides the results of a recent Phase 3 clinical trial conducted in Niger with a rotavirus vaccine candidate from India. The study, conducted by Médecins Sans Frontières (MSF) and Epicentre, evaluated the efficacy and safety of the pentavalent bovine-human reassortant rotavirus vaccine (BRV-PV) manufactured by Serum Institute of India Pvt. Ltd. in infants in Niger. Data from the trial revealed the BRV-PV to be highly efficacious for the prevention of severe rotavirus gastroenteritis and to have an excellent safety profile. In addition, the vaccine was transported and stored at ambient temperature, thus bypassing the typically challenging cold-chain requirements that apply to most other vaccines…

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UNAIDS [to 25 March 2017]
http://www.unaids.org/
Press release
UNAIDS warns that countries will miss the 2020 target of reducing HIV-associated TB deaths by 75% unless urgent action is taken
GENEVA, 24 March 2017—On World Tuberculosis Day, 24 March, UNAIDS is urging countries to do much more to reduce the number of tuberculosis (TB) deaths among people living with HIV. TB is the most common cause of hospital admission and death among people living with HIV. In 2015, 1.1 million people died from an AIDS-related illness—around 400 000 of whom died from TB, including 40 000 children.
“It is unacceptable that so many people living with HIV die from tuberculosis, and that most are undiagnosed or untreated,” said Michel Sidibé, Executive Director of UNAIDS. “Only by stepping up collaboration between HIV and tuberculosis programmes to accelerate joint action can the world reach its critical HIV and tuberculosis targets.”
Eight countries—the Democratic Republic of the Congo, India, Indonesia, Mozambique, Nigeria, South Africa, the United Republic of Tanzania and Zambia—account for around 70% of all TB deaths among people living with HIV. Scaling up action in these eight countries would put the world on track to reach the ambitious target in the 2016 United Nations Political Declaration on Ending AIDS of reducing TB-related deaths among people living with HIV by 75% by 2020…

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Wellcome Trust [to 25 March 2017]
https://wellcome.ac.uk/news
Published: 24 March 2017
Breakthrough in battle against resistant TB
A cutting-edge technique developed by Wellcome-funded researchers in Oxford means that tuberculosis (TB) can now be diagnosed much faster and more accurately.
The researchers’ method uses whole genome sequencing to quickly assess which strains of TB a patient is infected with. Patients will receive their diagnosis in just over a week, rather than waiting up to a month.
This will improve treatments and help reduce the spread of drug-resistant infections.
It will also be possible to improve identification and treatment of other resistant pathogens.
The news comes as World TB Day marks global efforts to eliminate a disease that infects 10 million people and kills 1.5 million each year. The spread of resistant strains of TB are of particular concern. In 2015, an estimated 480,000 people worldwide developed multidrug-resistant TB…

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EDCTP [to 25 March 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
24 March 2017
World TB day 2017: closing the gaps to end tuberculosis
Ending the tuberculosis (TB) epidemic by 2030 is one of the health targets of the Sustainable Development Goals. Although TB incidence has fallen by an average of 1.5% per year since 2000, TB is still one of the top 10 causes of death worldwide. Over 95% of TB deaths occur in low- and middle-income countries. In 2015, an estimated 480,000 people globally developed multidrug-resistant TB (MDR-TB). This ambitious aim to end the TB epidemic by 2030 can only be achieved by uniting efforts to close the research gaps…

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Industry Watch [to 25 March 2017]
:: Pfizer Receives Positive CHMP Opinion for TRUMENBA® for Prevention of Meningococcal Group B Disease
TRUMENBA Has Been Studied in a Global Clinical Development Program Evaluating the Vaccine in Adolescents and Adults1
The Majority of Meningococcal Disease Cases in Europe are Caused by Meningococcal Group B (MenB), with Adolescents and Young Adults at Increased Risk2
March 24, 2017
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that TRUMENBA® (Meningococcal Group B Vaccine) be granted marketing authorization in the European Union (EU) for active immunization of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB).3 The CHMP’s opinion will now be sent to the European Commission (EC) for final decision.
“This positive opinion by the CHMP to recommend marketing authorization of TRUMENBA in the EU is an additional step toward the fight to help protect individuals over 10 years of age from meningococcal disease caused by serogroup B, an uncommon yet devastating and life-threatening disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “This decision further affirms the effectiveness and robust safety profile of TRUMENBA.”…

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AERAS [to 25 March 2017]
http://www.aeras.org/pressreleases
No new digest content identified.

BIO [to 25 March 2017]
http://www.bio.org/insights
No new digest content identified.

BMGF – Gates Foundation [to 25 March 2017]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 25 March 2017]
http://cepi.net/
No new digest content identified.

DCVMN [to 25 March 2017]
http://www.dcvmn.org/
No new digest content identified.

European Vaccine Initiative [to 25 March 2017]
http://www.euvaccine.eu/news-events
No new digest content identified.

FDA [to 25 March 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
No new digest content identified.

Fondation Merieux [to 25 March 2017]
http://www.fondation-merieux.org/news
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
No new digest content identified.

GHIT Fund [to 25 March 2017]
https://www.ghitfund.org/
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical companies, the Japanese Government and the Bill & Melinda Gates Foundation.
No new digest content identified.

Hilleman Laboratories [to 25 March 2017]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 25 March 2017]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.

IAVI – International AIDS Vaccine Initiative [to 25 March 2017]
http://www.iavi.org/
No new digest content identified.

IFPMA [to 25 March 2017]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.

IVI [to 25 March 2017]
http://www.ivi.int/
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PhRMA [to 25 March 2017]
http://www.phrma.org/press-room
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Sabin Vaccine Institute [to 25 March 2017]
http://www.sabin.org/updates/pressreleases
No new digest content identified.

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

WHO issues ethics guidance to protect rights of TB patients
World TB Day 2017 – Unite efforts to leave no one behind
News release
22 March 2017 | GENEVA – New tuberculosis (TB) ethics guidance, launched today by the World Health Organization (WHO), aims to help ensure that countries implementing the End TB Strategy adhere to sound ethical standards to protect the rights of all those affected.

TB, the world’s top infectious disease killer, claims 5 000 lives each day. The heaviest burden is carried by communities which already face socio-economic challenges: migrants, refugees, prisoners, ethnic minorities, miners and others working and living in risk-prone settings, and marginalized women, children and older people.

“TB strikes some of the world’s poorest people hardest,” said Dr Margaret Chan, WHO Director-General. “WHO is determined to overcome the stigma, discrimination, and other barriers that prevent so many of these people from obtaining the services they so badly need.”

Poverty, malnutrition, poor housing and sanitation, compounded by other risk factors such as HIV, tobacco, alcohol use and diabetes, can put people at heightened risk of TB and make it harder for them to access care. More than a third (4.3 million) of people with TB go undiagnosed or unreported, some receive no care at all and others access care of questionable quality.

The new WHO ethics guidance addresses contentious issues such as, the isolation of contagious patients, the rights of TB patients in prison, discriminatory policies against migrants affected by TB, among others. It emphasizes five key ethical obligations for governments, health workers, care providers, nongovernmental organizations, researchers and other stakeholders to:
:: provide patients with the social support they need to fulfil their responsibilities
:: refrain from isolating TB patients before exhausting all options to enable treatment adherence and only under very specific conditions
:: enable “key populations” to access same standard of care offered to other citizens
ensure all health workers operate in a safe environment
:: rapidly share evidence from research to inform national and global TB policy updates…

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Journal of Global Oncology
DOI: http://dx.doi.org/10.1200/JGO.2016.008151
Special Article
Primary Prevention of Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Guideline
Silvina Arrossi, Instituto Nacional del Cancer, Buenos Aires, Argentina; Sarah Temin, American Society of Clinical Oncology, Alexandria, VA; Suzanne Garland, University of Melbourne, Melbourne, Victoria, Australia; Linda O’Neal Eckert, University of Washington; Vivien Tsu, PATH, Seattle, WA; Neerja Bhatla, All India Institute of Medical Sciences, New Delhi, India; Xavier Castellsagué and Silvia de Sanjosé, Institut Català d’Oncologia, L’Hospitalet de Llobregat, Barcelona, Spain; Sharifa Ezat Alkaff, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia; Tamika Felder, Cervivor, Upper Marlboro, MD; Doudja Hammouda, Institut National de Santé Publique, Algiers, Algeria; Ryo Konno, Jichi Medical University, Saitama Medical Center, Saitama, Japan; Gilberto Lopes, Sylvester Comprehensive Cancer Center, Miami, FL; Emmanuel Mugisha, PATH, Kampala, Uganda; Rául Murillo, International Agency for Research on Cancer, Lyon, France; Isabel C. Scarinci, University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; Margaret Stanley, University of Cambridge, Cambridge, United Kingdom; Cosette M. Wheeler, University of New Mexico, Albuquerque, NM; and Isaac Folorunso Adewole, Ministry of Health, Abuja, Nigeria
Abstract
Purpose
To provide resource-stratified (four tiers), evidence-based recommendations on the primary prevention of cervical cancer globally.
Methods
The American Society of Clinical Oncology convened a multidisciplinary, multinational panel of oncology, obstetrics/gynecology, public health, cancer control, epidemiology/ biostatistics, health economics, behavioral/ implementation science, and patient advocacy experts. The Expert Panel reviewed existing guidelines and conducted a modified ADAPTE process and a formal consensus-based process with additional experts (consensus ratings group) for one round of formal ratings.
Results E
xisting sets of guidelines from five guideline developers were identified and reviewed; adapted recommendations formed the evidence base. Five systematic reviews, along with cost-effectiveness analyses, provided evidence to inform the formal consensus process, which resulted in agreement of >= 75%.
Recommendations
In all resource settings, two doses of human papillomavirus vaccine are recommended for girls age 9 to 14 years, with an interval of at least 6 months and possibly up to 12 to 15 months. Individuals with HIV positivity should receive three doses. Maximal and enhanced settings: if girls are age >= 15 years and received their first dose before age 15 years, they may complete the series; if no doses were received before age 15 years, three doses should be administered; in both scenarios, vaccination may be through age 26 years. Limited and basic settings: if sufficient resources remain after vaccinating girls age 9 to 14 years, girls who received one dose may receive additional doses between age 15 and 26 years. Maximal, enhanced, and limited settings: if >= 50% coverage in the priority female target population, sufficient resources, and cost effectiveness, boys may be vaccinated to prevent other noncervical human papillomavirus–related cancers and diseases. Basic settings: vaccinating boys is not recommended.

It is the view of the American Society of Clinical Oncology that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Journal Watch

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org