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_26 May 2018

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

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
– 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.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

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

Milestones :: Perspectives

Editor’s Note:
The WHA closes today. We will provide a more detailed analysis of outcomes in next week’s edition.

World Health Assembly
21–26 May 2018
Geneva

Seventy-first World Health Assembly update, 26 May
26 May 2018 – News Release, Geneva
The Director-General of WHO, Dr Tedros Adhanom Ghebreyesus, told delegates to the World Health Assembly today that they had charted a new course for the Organization.

Closing the Assembly, he said that everything WHO did going forward would be evaluated in the light of the “triple billion” targets which were approved this week in WHO’s new five-year strategic plan. By 2023 the targets aim to achieve:
1 billion more people benefitting from universal health coverage
1 billion more people better protected from health emergencies
1 billion more people enjoying better health and wellbeing.

On the final day of the Assembly, delegates also came to agreement on maternal, infant and young child nutrition and on poliovirus containment.

Nutrition
Delegates unanimously renewed their commitment to invest and scale up nutrition policies and programmes to improve infant and young child feeding.

Member States discussed efforts to achieve the World Health Assembly Global Nutrition Targets, concluding progress has been slow and uneven, but noted a small step forward in the reduction of stunting, with the number of stunted children under 5 years falling from 169 million in 2010 to 151 million in 2017. WHO is leading global action to improve nutrition, including a global initiative to make all hospitals baby friendly, scaling up prevention of anaemia in adolescent girls, and preventing overweight in children through counselling on complementary feeding. A new report was launched on the implementation of the Code of Marketing Breastmilk Substitutes, highlighting that 6 more countries had adopted or strengthened legislation in 2017 to regulate marketing of breastmilk substitutes.

Polio
With wild poliovirus transmission levels lower than ever before, and the world closer than ever to being polio-free, discussions focused on securing a lasting polio-free world. As at May 2018, only 9 cases due to wild poliovirus had been reported globally, from just 2 countries: Afghanistan and Pakistan. Delegates reviewed emergency plans to interrupt the last remaining strains of the virus.

To prepare for a polio-free world, global poliovirus containment activities continue to be intensified, and Member States adopted a landmark resolution on poliovirus containment. In a limited number of facilities, poliovirus will continue to be retained, post-eradication, to serve critical national and international functions such as the production of polio vaccine or research. It is crucial that poliovirus materials are appropriately contained under strict biosafety and biosecurity handling and storage conditions to ensure that the virus is not released into the environment, either accidentally or intentionally, to again cause outbreaks of the disease in susceptible populations.

Member States expressed overwhelming commitment to fully implement and finance all strategies to secure a lasting polio-free world in the very near term. Rotary International, speaking on behalf of the Global Polio Eradication Initiative (which consists of WHO, Rotary, CDC, UNICEF and the Bill & Melinda Gates Foundation) offered an impassioned plea to the global community to eradicate a human disease for only the second time in history, and ensure that no child will ever again be paralysed by any form of poliovirus anywhere.

Closing remarks
In his final speech to this year’s Assembly, Dr Tedros said that everywhere he went, he had the same message: health as a bridge to peace. “Health has the power to transform an individual’s life, but it also has the power to transform families, communities and nations,” he told delegates.

The Organization’s new 5-year strategic plan, he said, called on WHO to measure its success not by its outputs, but by outcomes – by the measurable impact it delivers where it matters most – in countries.

“Ultimately, the people we serve are not the people with power; they’re the people with no power,” the Director-General said. He told delegates the true test of whether the discussions held in the Assembly this week were successful would be whether they resulted in real change on the ground and he urged them to go back to their countries with renewed determination to work every day for the health of their people.

“The commitment I have witnessed this week gives me great hope and confidence that together we can promote health, keep the world safe, and serve the vulnerable,” he concluded.

Milestones :: Perspectives

EBOLA/EVD  [to 26 May 2018]
http://www.who.int/ebola/en/

WHO supports Ebola vaccination of high risk populations in the Democratic Republic of the Congo
News Release – Geneva  21 May 2018
[Editor’s text bolding]
The Government of the Democratic Republic of Congo, with the support of WHO and partners, is preparing to vaccinate high risk populations against Ebola virus disease (EVD) in affected health zones.

Health workers operating in affected areas are being vaccinated today and community outreach has started to prepare for the ring vaccination.

More than 7,500 doses of the rVSV-ZEBOV Ebola vaccine have been deployed to the Democratic Republic of the Congo to conduct vaccination in the northwestern Equator Province where 46 suspected, probable and confirmed Ebola cases and 26 deaths have been reported (as of May 18). Most of the cases are in Bikoro, a remote rural town, while four confirmed cases are in Mbandaka, the provincial capital with a population of over 1 million people.

The vaccines are donated by Merck, while Gavi, the Vaccine Alliance is contributing US$1 million towards operational costs. The Wellcome Trust and DFID have also pledge funds to support research activities.

“Vaccination will be key to controlling this outbreak,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “We are grateful for the support of our partners in making this possible.”

The Ministry of Health with WHO, Medecins Sans Frontieres (MSF), UNICEF and other key partners are implementing a ring vaccination with the yet to be licensed rVSV-ZEBOV Ebola vaccine, whereby the contacts of confirmed cases and the contacts of contacts are offered vaccination. Frontline healthcare workers and other persons with potential exposure to EVD – including but not limited to laboratory workers, surveillance teams and people responsible for safe and dignified burials – will also receive the vaccine.

“We need to act fast to stop the spread of Ebola by protecting people at risk of being infected with the Ebola virus, identifying and ending all transmission chains and ensuring that all patients have rapid access to safe, high-quality care,” said Dr Peter Salama, WHO Deputy Director-General for Emergency Preparedness and Response.

A ring vaccination strategy relies on tracing all the contacts and contacts of contacts of a recently confirmed case as soon as possible. Teams on the ground have stepped up the active search and follow up of all contacts. More than 600 have been identified to date.

“Implementing the Ebola ring vaccination is a complex procedure,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “The vaccines need to be stored at a temperature of minus 60 to minus 80 degrees centigrade and so transporting them to and storing them in affected areas is a major challenge.”

WHO has sent special vaccine carriers, which can keep their contents in sub-zero temperatures for up to a week and has set up freezers to store the vaccines in Mbandaka and Bikoro. The Organization is deploying both Congolese and Guinean experts to build the capacities of local health workers. The Ministry of Health, WHO, UNICEF and partners are engaging communities to inform people about Ebola, including the vaccine.

The vaccine was shown to be highly protective against Ebola in a major trial in 2015 in Guinea. Among the 5,837 people who received the vaccine, no Ebola cases were recorded nine days or more after vaccination. While the vaccine is awaiting review by relevant regulatory authorities, WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has recommended the use of the rVSV-ZEBOV Ebola vaccine under an expanded access/compassionate use protocol during Ebola outbreaks linked to the Zaire strain such as the one ongoing in the DRC.

WHO and partners need US$26 million for the Ebola Response in the Democratic Republic of the Congo over the next three months. Funding has been received from Italy, UN CERF, Gavi – the Vaccine Alliance, USAID, the Wellcome Trust and UK DFID. WHO has also released US$2 million from its Contingency Fund for Emergencies

WHO partners in the DRC Ebola response include:
The International Federation of Red Cross and Red Crescent Societies (IFRC), the Red Cross of the Democratic Republic of the Congo (DR Congo Red Cross), Médecins Sans Frontières (MSF), the Disaster Relief Emergency Fund (DREF), the Africa Centers for Disease Control and Prevention (Africa-CDC), the US Centers for Disease Control and Prevention (US-CDC), the World Food Programme (WFP), UNICEF, UNOCHA, MONUSCO, International Organization for Migration (IOM), the FAO Emergency Management Centre – Animal Health (EMC-AH), the International Humanitarian Partnership (IHP), Gavi – the Vaccine Alliance, the African Field Epidemiology Network (AFENET), the UK Public Health Rapid Support team, the EPIET Alumni Network (EAN), the International Organisation for Animal Health (OIE), the Emerging Diseases Clinical Assessment and Response Network (EDCARN), the World Bank and PATH. Additional coordination and technical support is forthcoming through the Global Outbreak Alert and Response Network (GOARN) and Emergency Medical Teams (EMT).
 
 

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 22 May 2018 [GPEI]
This week, the World Health Assembly is meeting in Geneva, Switzerland, and will be presented with a Strategic Action Plan on Polio Transition (including the Post-Certification Strategy), a status report on polio eradication, and a proposed resolution on containment of polioviruses.

Summary of newly-reported viruses this week:
Pakistan: Three new WPV1 positive environmental samples have been reported, Two in Sindh province, and one in Balochistan province.
Nigeria: One new case of cVDPV2 has been reported, in Jigawa state. Somalia: One new cVDPV3 positive environmental sample has been reported, in Banadir province. Two new cVDPV2 positive environmental samples have been reported, also in Banadir province.

[See WHA above for Polio action summary]

::::::
::::::

WHO Grade 3 Emergencies  [to 26 May 2018]
::::::
 
WHO Grade 2 Emergencies  [to 26 May 2018]
[Several emergency pages were not available at inquiry]

::::::
::::::
 
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. 
Yemen 
:: Yemen Humanitarian Update Covering 15 – 21 May 2018 | Issue 16

::::::

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
:: OCHA Somalia Flash Update #6 – Humanitarian impact of heavy rains | 25 May 2018
:: OCHA Flash Update #3 – Tropical Cyclone Sagar | 23 May 2018

Ethiopia
:: Ethiopia Humanitarian Bulletin Issue 53 | 07-20 May 2018
 
::::::
::::::
 
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 26 May 2018]
http://www.who.int/ebola/en/
[See Milestones above for detail]

WHO & Regional Offices [to 26 May 2018]

See Milestones above for coverage of WHA and Ebola.
 
Weekly Epidemiological Record, 25 May 2018, vol. 93, 21 (pp. 305–320)
Dracunculiasis eradication: global surveillance summary, 2017
 
::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
Selected Featured News
:: WHO Launches Business Case for Immunization in Africa at the World Health Assembly
23 May 2018
:: South Sudan launches an Ebola sensitization and awareness campaign to enhance preparedness in the country  23 May 2018
:: With another Ebola Containment Effort Underway, New Report Tracks Progress Made by the WHO in the African Region in its Transformation Agenda  23 May 2018
:: Africa Vaccination Week comes to an end with calls for civil servants to become immunization champions  21 May 2018
:: Zambia Charts the Way forward for Cholera Elimination  21 May 2018
 
WHO European Region EURO
:: Strategic country mission to Libya advances health of migrants and displaced people 25-05-2018
:: Latest data shows southern European countries have highest rate of childhood obesity 24-05-2018
:: World Cup 2018: reaching out to football fans to promote healthier and more active lives 23-05-2018
 

CDC/ACIP [to 26 May 2018]

http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for May 24, 2018
HIV Preexposure Prophylaxis in the U.S. Military Services – 2014-2016
The U.S. military is implementing strategies to reduce barriers to receiving HIV prevention and care services. These strategies include patient self-referrals for HIV pre-exposure prophylaxis (PrEP) evaluations, increasing the number and quality of provider education efforts, and developing of a new health policy to provide universal access to the provider, laboratory, and pharmacy service elements required for an effective PrEP program. This report describes HIV PrEP in the U.S. military. The findings indicate that more than 2000 beneficiaries have accessed PrEP in the U.S. military healthcare system. However, current estimates indicate that approximately 10,000 more service members are eligible. Currently, the availability of PrEP services varies widely based on the individual patient’s geographic location. New DoD policy is being developed to address identified gaps through initiatives to improve provider education, to ensure universal access to PrEP at the primary care level, and to standardize pharmacy and laboratory service delivery at all military treatment facilities.

Vaccination Coverage Among Children Aged 2 Years – U.S. Affiliated Pacific Islands, April-October, 2016
While CDC found vaccination coverage was low and varied widely among children age 2 years in five United States Affiliated Pacific Islands (USAPI), CDC and USAPI now have the information they need to improve vaccination coverage in the region and to reduce the occurrence of vaccine-preventable diseases. It is an important first step in overcoming the challenges of geographic remoteness and difficulty tracking highly mobile populations across the USAPI. CDC conducted the first region-wide assessment of vaccination coverage in the United States Affiliated Pacific Islands (USAPI). Vaccination coverage was low and varied widely among children age 2 years in the five USAPI assessed. Coverage for the recommended six-vaccine series did not meet the 85% coverage target in any jurisdiction. The results serve as a baseline for coordinated USAPI and CDC efforts to improve vaccination coverage. By using medical records, CDC is able to overcome the challenges of geographic remoteness and difficulty tracking highly mobile populations to conduct rapid vaccination coverage assessment to support timely programmatic decision-making. Effectively monitoring vaccination coverage, coupled with implementation of data-driven interventions, is essential to maintain protection from VPD outbreaks.

Notes from the Field:
Vaccine Administration Errors Involving Recombinant Zoster Vaccine – United States, 2017-2018

Register for upcoming June ACIP meeting
June 20-21, 2018
Deadline for registration:
Non-US Citizens: May 16, 2018
US Citizens: June 11, 2018
Registration is NOT required to watch the live meeting webcast or to listen via telephone.

::::::
 

ECDC – European Centre for Disease Prevention and Control  [to 26 May 2018]

https://ecdc.europa.eu/en/home
Publication
Communicable disease threats report, 20-26 May 2018, week 21
publication – 25 May 2018

Data
Yellow fever distribution and areas of risk in Brazil, as of 25 May 2018
map – 25 May 2018

Publication
Rapid risk assessment: Ebola virus disease outbreak in Equateur Province, Democratic Republic of the Congo, First update
risk assessment – 25 May 2018

Announcements

CARB-X   [to 26 May 2018]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
05.22.2018
UK Government and Bill & Melinda Gates Foundation join CARB-X partnership in fight against superbugs
…The UK Government is committing up to £20 million, and the Bill & Melinda Gates Foundation up to US$25 million, to CARB-X over the next three years. Combined with existing funding commitments from Wellcome Trust and the US Government (BARDA and NIAID), CARB-X now has more than $500 million to invest in antibacterial development. CARB-X is the world’s leading non-profit partnership focused on accelerating the early development of antibiotics, vaccines, diagnostics and other products needed to save lives and to address the rising threat of superbugs. There are currently 33 projects in the CARB-X portfolio from 7 countries…
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 26 May 2018]
http://cepi.net/
Latest News
CEPI Awards $25 Million Contract to Profectus BioSciences and Emergent BioSolutions to Develop Nipah Virus Vaccine
OSLO, Norway, BALTIMORE and GAITHERSBURG, Md., May 24, 2018
CEPI—the Coalition for Epidemic Preparedness Innovations—today announced a collaboration with Profectus BioSciences, Inc. and Emergent BioSolutions Inc. (NYSE: EBS) under which Profectus and Emergent will receive up to $25 million to advance the development and manufacture of a vaccine against the Nipah virus, a bat-borne virus that can spread to both humans and livestock.
Under the terms of the Framework Partnering Agreement for the collaboration among the three parties, Profectus will receive development funding from CEPI for advancing its Nipah virus vaccine and Emergent will provide technical and manufacturing support for the CEPI-funded program. Emergent, through a separate agreement with Profectus, has an exclusive option to license and to assume control of development activities for the Nipah virus vaccine from Profectus. The international nonprofit organization PATH will also be working with the consortium under a separate agreement with CEPI to work on clinical development…

Strong Clinical Research Capacity in At-Risk Countries Key to Global Epidemic Prevention
May 22, 2018   New report outlines urgent need and opportunities in low- and middle-income countries where disease outbreaks most often strike
[See Research/Reports below for more detail]

CEPI Partners with the International AIDS Vaccine Initiative to Advance Lassa Fever Vaccine Development
NEW YORK and OSLO – May 21, 2018
Organizations aim to tackle WHO priority disease and to stockpile emergency vaccines

European Medicines Agency  [to 26 May 2018]
http://www.ema.europa.eu/ema/
24/05/2018
Development of antibiotics for children – towards a global approach
Workshop with regulators from EU, Japan and US open for registration …
 
 
Gavi [to 26 May 2018]
http://www.gavi.org/library/news/press-releases/
23 May 2018
Gavi’s response to the DRC Ebola outbreak
Statement to the 71st World Health Assembly
Gavi, the Vaccine Alliance, would like to congratulate the Government of DRC and particularly,    the leadership shown by the Minister of Health and the support of international partners in the very quick response to the Ebola outbreak.
Ring vaccination started Monday based on a very prompt reaction from the Government. Gavi was instrumental in making 300,000 investigational doses of the rVSV-ZEBOV Ebola vaccine available, some of which will be used in the current Ebola response. Without Gavi’s agreement with the manufacturer making sure that the doses are available immediately for outbreak response, we would be in a much worse position to respond to this outbreak.
Moreover, Gavi is providing US$1 million towards the vaccination drive. Gavi’s funding will support the deployment of health workers, transport, critical supplies and other operations. The vaccination will be implemented by the Government of DRC and partners including WHO, which is leading and coordinating the international health response, and Medecins Sans Frontieres (MSF). Guinea and Niger sent experts in DRC to support implementation that reflects a great solidarity effort in the continent.
Next 10 days are going to be critical. We will have a better sense of how the epidemic is going to evolve…

21 May 2018
Ebola vaccine to help tackle DRC outbreak
Vaccination begins in the Democratic Republic of the Congo.
 
 
IAVI  [to 26 May 2018]
https://www.iavi.org/
May 21, 2018
CEPI Partners with the International AIDS Vaccine Initiative to Advance Lassa Fever Vaccine Development
Organizations aim to tackle WHO priority disease and to stockpile emergency vaccines.
The Coalition for Epidemic Preparedness Innovations (CEPI) and the International AIDS Vaccine Initiative (IAVI) announced a partnership today to develop a new vaccine candidate against Lassa fever virus with the goal of creating a stockpile to address future outbreaks.
IAVI CEO Mark Feinberg and CEPI CEO Richard Hatchett sign an agreement to advance vaccines against Lassa fever on May 18 in London. Photo/CEPI
The partnership will support the development of IAVI’s replicating viral vector-based Lassa vaccine candidate, rVSVΔG-LASV-GPC. CEPI will provide US$10.4 million to support the first phase of the project, with options to invest up to a total of US$54.9 million over five years (including stockpile). CEPI is providing support to IAVI to develop the vaccine based on previous findings that the vaccine induced strong immune responses and was highly efficacious in animal models…
 
 
MSF/Médecins Sans Frontières  [to 26 May 2018]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
MSF Welcomes Adoption of World Health Assembly Resolution to Tackle Snakebite Crisis
May 24, 2018
Doctors Without Borders/Médecins Sans Frontières (MSF) made the following statement after the adoption of a resolution on “Addressing the burden of snakebite envenoming” during the 71st World Health Assembly today.

Press release
MSF Response on Launch of Global Hub to Combat Antimicrobial Resistance
May 22, 2018
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) welcomes the launch of the Global Research & Development (R&D) collaboration hub on antimicrobial resistance (AMR) announced at the World Health Assembly today.

 
NIH  [to 26 May 2018]
http://www.nih.gov/news-events/news-releases
May 23, 2018
NIH begins testing Ebola treatment in early-stage trial
— Scientists developed monoclonal antibody from Ebola survivor.
A first-in-human trial evaluating an experimental treatment for Ebola virus disease has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland. The Phase 1 clinical trial is examining the safety and tolerability of a single monoclonal antibody called mAb114, which was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and their collaborators. Investigators aim to enroll between 18 and 30 healthy volunteers aged 18 to 60. The trial will not expose participants to Ebola virus.
Ebola virus disease is a serious and often fatal illness that can cause fever, headache, muscle pain, weakness, fatigue, diarrhea, vomiting, stomach pain and hemorrhage (severe bleeding). It was first discovered in humans in 1976 in the Democratic Republic of the Congo (DRC) and has caused periodic cases and outbreaks in several African countries since then. The largest outbreak, which occurred in West Africa from 2014 to 2016, caused more than 28,600 infections and more than 11,300 deaths, according to the World Health Organization. In May 2018, the DRC reported an Ebola outbreak, located in Équateur Province in the northwest of the country. As of May 20, health officials have reported 51 probable or confirmed cases and 27 deaths. There are currently no licensed treatments available for Ebola virus disease, although multiple experimental therapies are being developed.
“We hope this trial will establish the safety of this experimental treatment for Ebola virus disease — an important first step in a larger evaluation process,” said NIAID Director Anthony S. Fauci, M.D. “Ebola is highly lethal, and reports of another outbreak in the DRC remind us that we urgently need Ebola treatments.”…
 
NIH-funded researchers identify target for chikungunya treatment
May 21, 2018 — Chikungunya is transmitted to humans by the bite of an infected mosquito.

PATH  [to 26 May 2018]
http://www.path.org/news/index.php
Announcement | May 23, 2018
Ebola returns to Democratic Republic of Congo
… What PATH is doing
:: Jointly with the MOH, PATH deployed the first wave of 12 MOH investigators on May 10, and on May 23 an additional 10 epidemiologists and 6 communication experts to Mbandaka.
:: PATH’s Dr. Ousmane Ly has been designated as interim Coordinator for the national Emergency Operations Center (EOC) in Kinshasa, and is advising Minister of Health Dr. Oly Ilunga on implementing a strategy for data collection—including using satellite imagery to refine maps to help track the outbreak.
:: This week, PATH will work with the WHO to install and support a provincial EOC in Mbandaka Equateur Province to coordinate response efforts with officials in the national EOC.
:: PATH’s Dr. Leon Kapenga and Dr. Robert Burume are working to support the Ministry on a daily basis for the surveillance and communication commissions.
:: PATH is reestablishing “VSATs” (satellite communications systems) in Equateur, thus reconnecting vital telecommunications capabilities in the remote Bikoro health zone where the outbreak began.
:: PATH delivered Chlorine Makers made by Seattle-based MSR Global Health for critical water treatment and disinfection of biohazard waste from healthcare facilities and trained local personnel on their use and maintenance…
 
 
UNAIDS [to 26 May 2018]
http://www.unaids.org/en
Feature story
Global HIV Prevention Coalition accelerates action to reduce new HIV infections
23 May 2018
The Global HIV Prevention Coalition has launched its first progress report.
Taking stock of the progress made in strengthening political commitment for HIV prevention and reducing new HIV infections, the report shows that significant progress has been made since the launch of the Global HIV Prevention Coalition six months ago. National prevention coalitions have been established to accelerate and better coordinate responses, new and ambitious prevention programme targets have been set in many countries and HIV strategies that focus on prevention have been launched…
 
Vaccine Confidence Project  [to 26 May 2018]
http://www.vaccineconfidence.org/
Confidence Commentary
Ebola outbreak: Importance of gaining community trust during vaccine roll-out – expert comment
Heidi Larson | 24 May, 2018
The experimental Ebola vaccine rVSV-ZEBOV is being deployed in the Democratic Republic of Congo to help stop the spread of the disease.
At this crucial time Dr Heidi Larson, Director of The Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine, comments on the importance of gaining the trust of the local population.
“In the context of uncertainty, fear, a known deadly virus and an unknown foreign vaccine, it is not surprising that some particularly remote or marginalized communities might turn to their faith-based groups and religious leaders.
“We have come a long way since the 2014 West Africa Ebola outbreak in terms of having vaccine candidates that have shown to be effective, albeit it yet-to-be registered for population-wide use outside of emergencies, but they are still very new and we need to build trust.
“As long as there are Ebola reservoirs in animals we will continue to have outbreaks. Our immediate task is to build community trust to help contain the current outbreak, and we must continue with building vaccine awareness and confidence in order to be ready for the next one.”
“The new vaccine is an important additional measure which we hope will help control the outbreak, but equally important are the tried and tested methods of Ebola outbreak response, such as increased hygiene methods and safe burials of those affected by Ebola to prevent spread to family and community.”
Dr Larson leads the Vaccine Confidence Project which in 2016 found that the European region is the most sceptical about vaccine safety, with France the country least confident with 41% of those surveyed disagreeing that vaccines are safe.

Wellcome Trust  [to 26 May 2018]
https://wellcome.ac.uk/news
News / Published: 23 May 2018
Wellcome pledges £2m after new Ebola outbreak confirmed
Wellcome is making an initial fund of up to £2 million available to support a rapid response to the new Ebola outbreak in the Democratic Republic of Congo (DRC).
The pledge comes after the DRC government announced the latest outbreak following tests that confirmed two cases of Ebola in the Bikoro area, near the north-west border. It’s the ninth Ebola outbreak in DRC.
The funding will be available to the government of the DRC and the World Health Organization (WHO) for the critical research needed to support the operational response now underway in the country.

News / Published: 23 May 2018
Second global call to action against drug-resistant infections
Wellcome is to co-host a second global conference, in Ghana, to help drive pioneering action to stop the rise and spread of superbugs.
The two-day Call to Action, taking place in Accra this November, is co-hosted with the governments of Ghana and Thailand, and the United Nations Foundation, and is organised in partnership with the Inter-Agency Coordination Group (IACG) on Antimicrobial Resistance.
Health representatives from national governments and agencies, civil society, the private sector and global philanthropies will be invited to come together at the Call to Action to focus on how to address the most critical gaps in tackling the development and spread of drug-resistant infections.

World Organisation for Animal Health (OIE)   [to 26 May 2018]
http://www.oie.int/en/for-the-media/press releases/2018/
24/05/18
State of play of the global animal health situation
The 86th OIE General Session was the occasion to give OIE Member Countries, an overview of the global animal health situation, as well as to analyse trends in the evolution of priority terrestrial and aquatic animal diseases. In addition, new disease status were officially recognised for 10 countries.

22/05/18
OIE International Standards implementation, a path to more efficient national animal health systems
The 86th General Session of the OIE is the occasion to present a report on the state of play on the implementation and capacity building needs in respect to OIE International Standards. Topics cover the challenges faced to implement these standards, the role that the new OIE Observatory will play in this regard and the perspective from International Organisations on creating greater transparency for improved animal health, welfare and safe trade.

::::::
 
BIO    [to 26 May 2018]
https://www.bio.org/insights/press-release
access to the medicines they need …”

DCVMN – Developing Country Vaccine Manufacturers Network  [to 26 May 2018]
http://www.dcvmn.org/
access to the medicines they need …”
 
IFPMA   [to 26 May 2018]
http://www.ifpma.org/resources/news-releases/
25 May 2018
IFPMA Welcomes Set-Up of New African Medicines Agency
Geneva, 25 May 2018 – To mark Africa Day, soon after African health ministers of 55-country African Union, all gathered at the 71st World Health Assembly, unanimously adopted a treaty to establish the African Medicines Agency, IFPMA seizes this momentum to welcome this important milestone. The new African Medicines Agency (AMA) will support the varying regulatory capacities of its member states and will help set-up a comprehensive, regional system of regulatory supervision that serves to harmonize regulations across national boundaries, make efficient use of its limited resources, and deepen its capacity building. It is a vital step that will help improve timely access to effective, quality therapies, and vaccines for all patients, in every corner of Africa…

News Release: International Alliance of Patients’ Organizations joins Fight the Fakes as 36th partner
24 May 2018

News Release: The pharmaceutical industry advocates for even greater collaboration as critical to future global health progress
Geneva, 22 May 2018 – IFPMA launches today “50 Years of Global Health Progress”. The report traces global health progress over the past 50 years and the pioneering collaborative role the research-based biopharmaceutical industry has played not only to deliver prevention and treatment, but to strengthen health systems around the world. The report reviews some of the research-based biopharmaceutical industry’s major scientific advances, as well as acknowledging challenges the industry faces and areas of unfinished business. The industry’s track record of partnerships over recent decades demonstrates what can be achieved by uniting governments, civil society and business. The report concludes with a commitment to continue to innovate and partner with a shared goal to deliver better health for everyone, everywhere…
 
PhRMA    [to 26 May 2018]
http://www.phrma.org/press-room
access to the medicines they need …”

Industry Watch    [to 26 May 2018]
:: A Study Analyzing Observational Data Shows Real-World Effectiveness of Prevnar® 13 in Adults Age 65+
   Study Finds Prevnar 13 was Associated With Reduced Risk of Hospitalization From Vaccine-Type Community-Acquired Pneumonia in Older Adults1
May 22, 2018

:: Pfizer Begins a Phase 1/2 Study to Evaluate Respiratory Syncytial Virus (RSV) Vaccine
May 22, 2018
   RSV affects 33 million children globally and leads to approximately 120,000 childhood deaths every year1
   In the United States approximately 177,000 older adults are hospitalized annually because of RSV2
   The clinical program aims to develop a vaccine for populations at highest risk of infection: infants through maternal immunization, and older adults through direct vaccination

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
 
 
Full Report: Money and Microbes: Strengthening Research Capacity to Prevent Epidemics
The International Vaccines Task Force (IVTF)
Supported by the International Vaccines Task Force was supported by the World Bank Group and the [CEPI] Coalition for Epidemic Preparedness Innovations.
World Bank – Working Paper  2018/05/01:: 75 pages
PDF: http://documents.worldbank.org/curated/en/120551526675250202/pdf/126338-REVISED-27231-IVTF-Report-reduced.pdf
Abstract
In the last 5 years alone, the world has been tested with serious challenges from two viral diseases. The Ebola outbreak that unfolded between 2014 and 2016 devastated West Africa, and while its health and economic impacts beyond the continent were limited, it sent a loud message to the rest of the world about how vulnerable it was to the next epidemic. This was followed by the Zika Virus outbreak that began in early 2016, which also remained confined largely to Latin America, and served to remind the rest of the world that there was no room for complacency. Further warnings were not needed—but they nevertheless came in quick succession. In May 2017, the Democratic Republic of the Congo notified international public health agencies of a cluster of suspected cases of Ebola virus disease in the Likati health zone of the province of Bas Uélé. In October 2017, Madagascar reported an outbreak of the deadliest form of plague, pneumonic, which had hit its major cities and towns and was spreading fast. Around the same time, a Marburg virus disease outbreak was detected in the Kween district of eastern Uganda. And a few months later, Nigeria begun experiencing what would turn out to be its worst Lassa fever outbreak ever, recording more cases in January 2018 alone than during all of 2017.

Press Release
Strong Clinical Research Capacity in At-Risk Countries Key to Global Epidemic Prevention
New report outlines urgent need and opportunities in low- and middle-income countries where disease outbreaks most often strike
GENEVA, May 22, 2018 – Robust clinical research capacity in low- and middle-income countries is key to stemming the spread of epidemics, according to a new report from the International Vaccines Task Force (IVTF). The report, entitled Money and Microbes: Strengthening Research Capacity to Prevent Epidemics, lays out how to develop the political support, financing and coordination required to build this capacity as a crucial component of global epidemic preparedness. The IVTF was convened by the World Bank Group (WBG) and the Coalition for Epidemic Preparedness Innovations (CEPI) in October 2017.
There have been many global and country-level efforts to strengthen pandemic preparedness and response since the deadly West African Ebola outbreak in 2014-2015 that killed 11,000 people—and the last few weeks have provided evidence of this. During the current Ebola outbreak in the Democratic Republic of Congo (DRC) with 49 total cases and 26 deaths so far, the government of DRC has approved the use for trials starting this week of a new, as-yet unlicensed Ebola vaccine, the rVSV-ZEBOV. The vaccine has proven highly effective in a clinical trial conducted in Guinea in 2015. Nigeria had its worst Lassa Fever outbreak on record earlier this year, and also pushed forward with conducting clinical trials as the outbreak unfolded.
“Times of crisis present the opportunity to focus capabilities and energy on solving important problems,” said Marie-Paule Kieny, Director of Research at INSERM and co-chair of IVTF. “Robust clinical research capacity is the only way to ensure that we don’t face future outbreaks with the same knowledge gaps over and over again.”
Of the 96 countries that have conducted vaccine trials in the past 20 years, 56 have conducted only between 1 and 10 trials, according to a registry maintained by the World Health Organization (WHO). This is insufficient to advance promising new vaccines, therapeutics and diagnostics for epidemic infectious diseases at the scale that is needed. The report recommends building capacity at a national or regional level that can flexibly scale up to run clinical trials during outbreaks, and focus on ongoing high-priority disease research based on local needs in between outbreaks…

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

American Journal of Public Health
June 2018  108(6)
http://ajph.aphapublications.org/toc/ajph/current

VACCINES
Humanitarian Goals, Financial Constraints, and Residual Questions of America’s First Vaccine Institute
Andrea Rusnock
108(6), pp. 715–717

American Journal of Public Health
June 2018  108(6)
http://ajph.aphapublications.org/toc/ajph/current

VACCINES
Mistrust in Medicine: The Rise and Fall of America’s First Vaccine Institute
Tess Lanzarotta and Marco A. Ramos
108(6), pp. 741–747

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 26 May 2018)

Research article
Prediction of mortality in severe dengue cases
Increasing incidence of dengue cases in Malaysia over the last few years has been paralleled by increased deaths. Mortality prediction models will therefore be useful in clinical management.
Authors: Saiful Safuan Md-Sani, Julina Md-Noor, Winn-Hui Han, Syang-Pyang Gan, Nor-Salina Rani, Hui-Loo Tan, Kanimoli Rathakrishnan, Mohd Azizuddin A-Shariffuddin and Marzilawati Abd-Rahman
Citation: BMC Infectious Diseases 2018 18:232
Published on: 21 May 2018

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 26 May 2018)

Commentary
Informing real-world practice with real-world evidence: the value of PRECIS-2
Authors: Gila Neta and Karin E. Johnson
Citation: BMC Medicine 2018 16:76
Published on: 21 May 2018
Abstract
Real-world evidence is needed to inform real-world practice. Pragmatic controlled trials are intended to provide such evidence by assessing the effectiveness of medicines and other interventions in real-world settings, as opposed to explanatory trials that assess efficacy in highly controlled settings. Dal-Ré and colleagues (BMC Med 16:49, 2018) recently performed a literature review of studies published between 2014 and 2017 to assess the degree to which studies that self-identified as pragmatic were truly so. The authors found that over one-third of randomized controlled trials of drugs and biologics that were self-labeled as pragmatic used placebo controls (as opposed to usual care), tested medicines before licensing, or were conducted in a single site. Further, they proposed that, in order to improve the reliability of the ‘pragmatic’ label, investigators should assess their trials using the PRECIS-2 tool upon submission to funders, ethics boards, or journals. We appreciate the value of PRECIS-2 as an indicator to assess the pragmatic versus explanatory features in a trial, and we herein highlight the potential challenges and opportunities that may arise with its systematic and widespread use.

Emerging Infectious Diseases
Volume 24, Number 6—June 2018
http://wwwnc.cdc.gov/eid/

Perspective
Ferrets as Models for Influenza Virus Transmission Studies and Pandemic Risk Assessments PDF Version [PDF – 424 KB – 7 pages]
A. Belser et al.

The European Journal of Public Health
Volume 28, Issue 3, 1 June 2018
https://academic.oup.com/eurpub/issue/28/3

Editorials
Investing in public health—driving prosperity for the present and future generations
M Dyakova; C Hamelmann
Extract
Countries across Europe and the World are faced with growing health, inequity, social security, economic and environmental challenges. We need urgent, innovative and priority-focused investment to ensure sustainable development for the present and future generations. Doing business as usual is unsustainable with high costs for individuals, families, communities, society, the economy and the planet. Governments can have a major impact on all factors influencing health and wellbeing, on the way people live and on their everyday choices. The interconnected nature of current challenges and possible solutions needs strong leadership, strategic and political commitment, and coherent action. It also requires new approaches and financing mechanisms building on cross-sector collaboration and…

The European Journal of Public Health
Volume 28, Issue 3, 1 June 2018
https://academic.oup.com/eurpub/issue/28/3

Migration and health
Vaccination policies of immigrants in the EU/EEA Member States–the measles immunization example
Mihai A Bica; Ralf Clemens
Abstract
Background
In 2015–16, the European Union/European Economic Area Member States (EU/EEA MSs) experienced an unprecedented volume and rate of migration, posing serious challenges to existing national immunization systems and strategies and raising the questions of where, when and who to vaccinate. We assessed existing strategies for vaccinating immigrant populations in the EU/EEA using measles as an example of the most important vaccine-preventable diseases.
Methods
In this cross-sectional study, conducted from March to May 2016, an electronic questionnaire was sent to the Heads of National Immunization Technical Advisory Groups (NITAGs) or equivalent policy-making bodies in each of the 31 EU/EEA Member States. Responses were entered into a structured database and validated by survey responders for final analysis.
Results
Validated responses from all 31 EU/EEA NITAGs or equivalents showed that there is no common measles immunization policy for European immigrants. Policies vary widely from no policy at all (9 of 31, 29%) to vaccination of all comers (2 of 31, 6%), or vaccination of selected cohorts based on vaccination history (17 of 31, 55%) or serum antibody analysis (2 of 31, 6%). Further, the operational responsibilities for immigrant vaccination and documentation methods are not unified within the EU/EEA region.
Conclusions
With some notable exceptions immunization policies to contain spread of infectious diseases through migration are either non-existent or vary widely between countries in the EU/EEA. With freedom of movement within the EU/EEA there ought to be harmonization and a common EU/EEA vaccination strategy to replace national policies for immigrant populations.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 26 May 2018]

Research
24 May 2018
Analyzing the impacts of global trade and investment on non-communicable diseases and risk factors: a critical review of methodological approaches used in quantitative analyses
Authors: Krycia Cowling, Anne Marie Thow and Keshia Pollack Porter

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 26 May 2018]

Research
24 May 2018
Translating research into action: an international study of the role of research funders
Authors: Robert K. D. McLean, Ian D. Graham, Jacqueline M. Tetroe and Jimmy A. Volmink
Abstract
Background
It is widely accepted that research can lead to improved health outcomes. However, translating research into meaningful impacts in peoples’ lives requires actions that stretch well beyond those traditionally associated with knowledge creation. The research reported in this manuscript provides an international review of health research funders’ efforts to encourage this process of research uptake, application and scaling, often referred to as knowledge translation.
Methods
We conducted web-site review, document review and key informant interviews to investigate knowledge translation at 26 research funding agencies. The sample comprises the regions of Australia, Europe and North America, and a diverse range of funder types, including biomedical, clinical, multi-health domain, philanthropic, public and private organisations. The data builds on a 2008 study by the authors with the same international sample, which permitted longitudinal trend analysis.
Results
Knowledge translation is an objective of growing significance for funders across each region studied. However, there is no clear international consensus or standard on how funders might support knowledge translation. We found that approaches and mechanisms vary across region and funder type. Strategically tailored funding opportunities (grants) are the most prevalent modality of support. The most common funder-driven strategy for knowledge translation within these grants is the linking of researchers to research users. Funders could not to provide empirical evidence to support the majority of the knowledge translation activities they encourage or undertake.
Conclusions
Knowledge translation at a research funder relies on context. Accordingly, we suggest that the diversity of approaches uncovered in our research is fitting. We argue that evaluation of funding agency efforts to promote and/or support knowledge translation should be prioritised and actioned. It is paradoxical that funders’ efforts to get evidence into practice are not themselves evidence based.

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 26 May 2018]

Commentary
23 May 2018
The evolution of the field of Health Policy and Systems Research and outstanding challenges
Authors: Sara Bennett, Julio Frenk and Anne Mills

Humanitarian Exchange Magazine
Number 71  March 2018
https://odihpn.org/magazine/humanitarian-response-urban-areas/

Humanitarian response in urban areas
Humanitarian crises are increasingly affecting urban areas either directly, through civil conflict, hazards such as flooding or earthquakes, urban violence or outbreaks of disease, or indirectly, through hosting people fleeing these threats. The humanitarian sector has been slow to understand how the challenges and opportunities of working in urban spaces necessitate changes in how they operate. For agencies used to working in rural contexts, the dynamism of the city, with its reliance on markets, complex systems and intricate logistics, can be a daunting challenge. Huge, diverse and mobile populations complicate needs assessments, and close coordination with other, often unfamiliar, actors is necessary.

[Reviewed earlier]

JAMA
May 22/29, 2018, Vol 319, No. 20, Pages 2057-2146
http://jama.jamanetwork.com/issue.aspx

Research Letter
Sources of Funding for Research in Evidence Reviews That Inform Recommendations of the US Preventive Services Task Force
Jennifer Villani, PhD, MPH; Quyen Ngo-Metzger, MD, MPH; Isaah S. Vincent, PhD; et al.
JAMA. 2018;319(20):2132-2133. doi:10.1001/jama.2018.5404
The US Preventive Services Task Force (USPSTF) is an independent panel of national experts in disease prevention and evidence-based medicine that develops recommendations for the delivery of clinical preventive services including screening tests, preventive medications, and behavioral counseling.1 To develop recommendations, the USPSTF evaluates the quantity, quality, and strength of evidence from systematic reviews of published studies.2

JBI Database of Systematic Review and Implementation Reports
May 2018 – Volume 16 – Issue 5
http://journals.lww.com/jbisrir/Pages/currenttoc.aspx

Editorial
Systematic review: the first step in developing a complex intervention
Bannigan, Katrina
JBI Database of Systematic Reviews and Implementation Reports. 16(5):1079-1080, May 2018.

Journal of Adolescent Health
June 2018 Volume 62, Issue 6, p633-754
https://www.jahonline.org/issue/S1054-139X(17)X0021-9

Editorials
Is Tdap the Best Prevention We Have Against Pertussis Disease?
Malini B. DeSilva, Elyse O. Kharbanda
p639–640
Published in issue: June 2018

Journal of Adolescent Health
June 2018 Volume 62, Issue 6, p633-754
https://www.jahonline.org/issue/S1054-139X(17)X0021-9

Original Articles
Assessment of Tdap Vaccination Effectiveness in Adolescents in Integrated Health-Care Systems
Elizabeth C. Briere, Tracy Pondo, Mark Schmidt, Tami Skoff, Nong Shang, Alison Naleway, Stacey Martin, Michael L. Jackson
p661–666
Published online: March 15, 2018

Journal of Medical Ethics
June 2018 – Volume 44 – 6
http://jme.bmj.com/content/current

Political philosophy & medical ethics
Paper: Content analysis of requests for religious exemptions from a mandatory influenza vaccination program for healthcare personnel
(24 May, 2018)
Armand H Antommaria, Cynthia A Prows

Journal of Medical Ethics
June 2018 – Volume 44 – 6
http://jme.bmj.com/content/current

Research ethics
Paper: Consent and the ethical duty to participate in health data research
(24 May, 2018)
Angela Ballantyne, G Owen Schaefer

Journal of Medical Ethics
June 2018 – Volume 44 – 6
http://jme.bmj.com/content/current

Paper: Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project
(24 May, 2018)
Sandi Dheensa, Gabrielle Samuel, Anneke M Lucassen, Bobbie Farsides
 

Journal of Public Health Policy
Volume 39, Issue 2, May 2018
https://link.springer.com/journal/41271/39/2/page/1

Original Article
“It just forces hardship”: impacts of government financial penalties on non-vaccinating parents
Catherine Helps, Julie Leask, Lesley Barclay

Journal of Public Health Policy
Volume 39, Issue 2, May 2018
https://link.springer.com/journal/41271/39/2/page/1

Commentary
Vaccine mandates, public trust, and vaccine confidence: understanding perceptions is important
Roy Widdus, Heidi Larson

The Lancet
May 26, 2018 Volume 391 Number 10135 p2079-2184 e20
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Health care in conflict: war still has rules
The Lancet
Denouncing attacks on health-care facilities and personnel in conflict situations, the UN Security Council unanimously adopted resolution 2286 in May, 2016. Addressing the Council, then UN Secretary-General Ban Ki-moon, condemned military actions leading to destruction of health-care facilities as war crimes, and called on Member States to honour their obligations to protect health-care workers and patients in conflict saying “even war has rules”.

But 2 years later, on May 21, a new report from the Safeguarding Health in Conflict Coalition, Violence on the front line: attacks on healthcare in 2017, shows a grim reality of continued attacks on health infrastructures coming from all sides, and which persist with impunity.
In 2017, at least 188 hospitals and clinics were damaged or destroyed, 50 ambulances attacked or stolen, and there were 57 reports of armed groups violently assaulting staff and patients in hospitals—101 health-care workers were killed and 64 kidnapped, 203 patients were killed, and 141 injured. Denial or obstruction of access to health-care facilities was reported 74 times. 57 of these events were in the occupied Palestinian territory. In Turkey, a physician was arrested for providing impartial medical care, and in Afghanistan, female health workers have been threatened for actions deemed inappropriate for a woman. Health facilities in Afghanistan, Burkina Faso, the Central African Republic, Egypt, and Turkey have been forced to close.

When resolution 2286 was adopted, Peter Maurer, President of the International Committee of the Red Cross, urged Member States that “after outrage must come action, not complacency”. But the sheer number of attacks in 2017 demonstrates the international community’s catastrophic failure to uphold its commitment to the resolution. The Coalition makes specific recommendations to the UN High Commission for Human Rights, Security Council, and Secretary-General to ensure that the lives and rights of health-care workers and patients are protected in conflict areas. António Guterres, UN Secretary-General, must continue to condemn these attacks, work proactively to stop them, and hold the perpetrators accountable for their war crimes.

The Lancet
May 26, 2018 Volume 391 Number 10135 p2079-2184 e20
http://www.thelancet.com/journals/lancet/issue/current

Articles
Inactivated varicella zoster vaccine in autologous haemopoietic stem-cell transplant recipients: an international, multicentre, randomised, double-blind, placebo-controlled trial
Drew J Winston, Kathleen M Mullane, Oliver A Cornely, Michael J Boeckh, Janice Wes Brown, Steven A Pergam, Igoris Trociukas, Pavel Žák, Michael D Craig, Genovefa A Papanicolaou, Juan D Velez, Jens Panse, Kimberly Hurtado, Doreen A Fernsler, Jon E Stek, Lei Pang, Shu-Chih Su, Yanli Zhao, Ivan S F Chan, Susan S Kaplan, Janie Parrino, Ingi Lee, Zoran Popmihajlov, Paula W Annunziato, Ann Arvin on behalf of the V212 Protocol 001 Trial Team

Lancet Global Health
Jun 2018 Volume 6 Number 6 e593-e702
http://www.thelancet.com/journals/langlo/issue/current

Comment
Untangling the causes of the 2016–18 Cholera epidemic in Yemen
Michael Gormley
As war continues to rage in Yemen into its third year, the disruption to civil society has been immense. An estimated 22·2 million Yemenis are in need of humanitarian assistance and 2 million people have been displaced by the conflict and live in desperate conditions in Yemen itself or have sought refuge elsewhere in the region.

Amid this deepening crisis sits the largest documented cholera epidemic of modern times. In The Lancet Global Health, Anton Camacho and colleagues1 address this epidemic from an epidemiological perspective and have sought to explain the key triggers for the massive surge in cases in May 2017. The publication of these results is very timely since one of the key triggers identified in the study links the surge in cases to the advent of the rainy season in May, with the concern that a resurge in transmission of the disease could occur in 2018 when the rains start. The research addresses the causal factors of the epidemic and investigates the size, spatial extent, and key populations affected by both waves of the epidemic. A key driver for the research was to identify public health interventions to try to mitigate the effects of a possible third wave in 2018. The mapping of the epidemic has shown the full extent of the problem and is key to implementing the intervention. The research maps the transmission and incidence of cholera in over 1 million suspected cases in Yemen, and the methods used are applicable to conflict zones and humanitarian situations globally.

The paper highlights the difficulties associated with carrying out research in war zones. When civil society is stretched to its limits, data gathering can be near impossible. The close working between the research team, the Health Authorities in Yemen, and WHO facilitated the production of a well kept line list database of cases, which formed the basis for the outbreak data.

Gathering environmental data poses similar difficulty in a conflict zone. The hypothesis that water sources were contaminated by rainfall in the second wave of the outbreak in May 2017 requires more than anecdotal evidence to be proven. The use of the Climate Hazards Group InfraRed Precipitation with Station data (CHIRPS) system was a novel approach to estimating precipitation levels during the period in question. It is recognised that the use of more localised data would have produced a more robust correlation; however, given the conflict in Yemen, the installation and maintenance of local weather stations would have been impractical. The research team have recognised the level of detail available and some inherent biases of the CHIRPS product used. Because of the aerial averages from satellite data used in the production of localised data by CHIRPS, it is likely that precipitation was underestimated. While accuracy is important, it is useful to note that an underestimation of precipitation levels does not invalidate the hypothesis in this research that the second wave was caused by the start of the rainy season.

The methods used for the assessment of precipitation levels follows recent trends in the use of earth observation data from recognised sources. The level of detail possible is increasing and it may be worth exploring the possibilities of using real time (RT) or Near Real Time (NRT) data from these satellite data sources to assess the extent and quality of local water resources.2 The challenges of implementing these earth observation data into a study such as the cholera outbreak in Yemen are not to be underestimated; however, given the difficulty in obtaining real time local data, the effort may be worthwhile, particularly if algorithms can be developed to manipulate the Big Data available in a meaningful way. An increase in local accuracy might also contribute to a greater understanding of the different impacts of spring rainfall to summer rainfall and their relative impact on water quality.

The paper also highlights the possible effect that local cultural practices had on the transmission of the disease, particularly during Ramadan. The research concluded that the risk of being reported as a suspected cholera case during Ramadan was 1·19 times (1·14–1·25) higher than that of the preceding month and that this risk varied substantially across districts. This hypothesis is supported by the data, but more research would be required to show why Ramadan had an effect on transmission. The variability across districts would also merit further investigation. A social survey of the areas involved might illuminate the reason for these correlations, but the transient nature of populations in these times of conflict could make this an overly onerous task.

In conclusion, the paper represents a timely investigation of the plausible causes for the two waves of cholera outbreak in Yemen between 2016 and 2018. More social research on the influence of Ramadan on transmission of the disease would further add to the quantitative analysis presented in the paper. There is a real opportunity to develop remote methods of assessing water quality using earth observation satellite data in RT or NRT, which would create a generalised methodology for assessing the likelihood of disease spread in conflict zones. The methods would also be applicable to other areas of humanitarian need such as post-disaster refugee camps.

With this work, and future planned work, Camacho and colleagues1 are helping to implement a public health strategy to mitigate against a possible third wave of the outbreak following the rains due in May 2018. It is hoped that further data will be collected in 2018 to further the models developed in this research.
I declare no competing interests.
 

Lancet Global Health
Jun 2018 Volume 6 Number 6 e593-e702
http://www.thelancet.com/journals/langlo/issue/current

Articles
Cholera epidemic in Yemen, 2016–18: an analysis of surveillance data
Anton Camacho, Malika Bouhenia, Reema Alyusfi, Abdulhakeem Alkohlani, Munna Abdulla Mohammed Naji, Xavier de Radiguès, Abdinasir M Abubakar, Abdulkareem Almoalmi, Caroline Seguin, Maria Jose Sagrado, Marc Poncin, Melissa McRae, Mohammed Musoke, Ankur Rakesh, Klaudia Porten, Christopher Haskew, Katherine E Atkins, Rosalind M Eggo, Andrew S Azman, Marije Broekhuijsen, Mehmet Akif Saatcioglu, Lorenzo Pezzoli, Marie-Laure Quilici, Abdul Rahman Al-Mesbahy, Nevio Zagaria, Francisco J Luquero
Summary
Background
In war-torn Yemen, reports of confirmed cholera started in late September, 2016. The disease continues to plague Yemen today in what has become the largest documented cholera epidemic of modern times. We aimed to describe the key epidemiological features of this epidemic, including the drivers of cholera transmission during the outbreak.
Methods
The Yemen Health Authorities set up a national cholera surveillance system to collect information on suspected cholera cases presenting at health facilities. Individual variables included symptom onset date, age, severity of dehydration, and rapid diagnostic test result. Suspected cholera cases were confirmed by culture, and a subset of samples had additional phenotypic and genotypic analysis. We first conducted descriptive analyses at national and governorate levels. We divided the epidemic into three time periods: the first wave (Sept 28, 2016, to April 23, 2017), the increasing phase of the second wave (April 24, 2017, to July 2, 2017), and the decreasing phase of the second wave (July 3, 2017, to March 12, 2018). We reconstructed the changes in cholera transmission over time by estimating the instantaneous reproduction number, Rt. Finally, we estimated the association between rainfall and the daily cholera incidence during the increasing phase of the second epidemic wave by fitting a spatiotemporal regression model.
Findings
From Sept 28, 2016, to March 12, 2018, 1 103 683 suspected cholera cases (attack rate 3·69%) and 2385 deaths (case fatality risk 0·22%) were reported countrywide. The epidemic consisted of two distinct waves with a surge in transmission in May, 2017, corresponding to a median Rt of more than 2 in 13 of 23 governorates. Microbiological analyses suggested that the same Vibrio cholerae O1 Ogawa strain circulated in both waves. We found a positive, non-linear, association between weekly rainfall and suspected cholera incidence in the following 10 days; the relative risk of cholera after a weekly rainfall of 25 mm was 1·42 (95% CI 1·31–1·55) compared with a week without rain.
Interpretation
Our analysis suggests that the small first cholera epidemic wave seeded cholera across Yemen during the dry season. When the rains returned in April, 2017, they triggered widespread cholera transmission that led to the large second wave. These results suggest that cholera could resurge during the ongoing 2018 rainy season if transmission remains active. Therefore, health authorities and partners should immediately enhance current control efforts to mitigate the risk of a new cholera epidemic wave in Yemen.
Funding
Health Authorities of Yemen, WHO, and Médecins Sans Frontières.

Lancet Global Health
Jun 2018 Volume 6 Number 6 e593-e702
http://www.thelancet.com/journals/langlo/issue/current

Cost-effectiveness of the controlled temperature chain for the hepatitis B virus birth dose vaccine in various global settings: a modelling study
Nick Scott, Anna Palmer, Christopher Morgan, Olufunmilayo Lesi, C Wendy Spearman, Mark Sonderup, Margaret Hellard

Lancet Infectious Diseases
Jun 2018 Volume 18 Number 6 p583-696 183-e220
http://www.thelancet.com/journals/laninf/issue/current

Comment
Eradicating polio with a vaccine we must stop using
Nicholas C Grassly

Lancet Infectious Diseases
Jun 2018 Volume 18 Number 6 p583-696 183-e220
http://www.thelancet.com/journals/laninf/issue/current

Cholera control: one dose at a time
Louise C Ivers
Cholera continues to harm the most vulnerable people worldwide.1 As an indicator of human progress, the sustained or new presence of the disease in any region is a stark reminder of how far we, as a society, have to go to reach Sustainable Development Goal 6: ensuring availability and sustainable management of water and sanitation for all.2 Diarrhoeal diseases are a major source of preventable morbidity and mortality, and in 2015 claimed the lives of more than 1·3 million people, of whom 499 000 were children younger than 5 years.3

As a contributor to the global burden of diarrhoeal disease, Vibrio cholerae is a particularly harsh pathogen, causing rapid onset of severe nausea, vomiting, and profuse watery diarrhoea that can lead to death within hours—even of the healthiest young adults. Whole communities can be rapidly affected in epidemics, causing both physical harm and psychological distress. The pervasive social determinant of the problem—poor or no access to safe water, sanitation, and hygiene—means that displaced people, refugee populations, and those in conflict zones are at risk of major outbreaks of the illness. Cholera also continues to occur routinely, regularly, and with great impact (although often with less media attention) in endemic countries, such as Bangladesh and now Haiti, where children and the poorest people are the most at risk of being harmed. In both epidemic and endemic circumstances, the public health role of cholera vaccination has been re-emerging with interest from policy makers over the past 8 years.

In The Lancet Infectious Diseases, Firdausi Qadri and colleagues4 describe results of 2 years of follow-up of a large, randomised, double-blind, placebo-controlled efficacy trial of a single dose of an inactivated whole-cell oral cholera vaccine (OCV) in Bangladesh. They found that a single dose provided protection for at least 2 years when given to adults (vaccine protective efficacy against all cholera episodes 59%, 95% CI 42–71) and to children aged 5 years or older (52%, 8–75). The findings make an important contribution to cholera control around the world, and could help to take us one step closer to WHO’s ambitious goal of reducing deaths from the disease by 90% by 2030.5

Increasing practical experiences with large-scale public health use of OCV—initially including reactive vaccination campaigns in Guinea and Haiti in 2012,6, 7 revitalised WHO’s support of cholera-affected countries,8 and investment by GAVI, the vaccine alliance, in a global stockpile of vaccine—have resulted in millions of doses of OCV being used each year since 2014. The vaccine has most often been given in two doses, 14 days apart, as recommended by the manufacturers.9 Yet giving a second dose of OCV on schedule can be challenging during crisis situations. Furthermore, multiple competing demands on the global stockpile mean that, at times, officials might have to decide if they should vaccinate a population without guarantee of the availability of the second tranche of doses.

Qadri and colleagues’ trial complements findings from other important studies on the use of a single-dose OCV, which were largely secondary analyses and shorter-term prospective observational studies.10, 11 Together, the evidence shows that single-dose OCV campaigns can be effective both in the short term in outbreaks and for up to 2 years in endemic settings. With these data to further support decision making on who to vaccinate against cholera and when to vaccinate them, government agencies, multilateral organisations, and non-governmental organisations should continue to invest in cholera vaccines as a part of the toolkit to control and prevent the disease.

However, a single dose of OCV did not protect children younger than 5 years compared with placebo (vaccine protective efficacy against all cholera episodes −13%, 95% CI −68 to 25),4 consistent with the 6-month results of the same study.12 Other studies show some, but reduced, protection of two doses of OCV in this age group as well, which has implications for strategies on the use of OCV in highly endemic regions where young children are an important risk group.13 Further studies are needed to determine how best to protect the youngest individuals, and to identify the ideal dosing schedule of the vaccine.

Still more evidence is needed on how to integrate vaccination strategies into evidence-based water, sanitation, and hygiene interventions to interrupt diarrhoeal disease—a subject in which evidence of impact is surprisingly scarce.14 What is notable about the discourse on OCV in 2018 are the burning questions not associated with whether vaccines should be used in endemic countries or whether they should be used during epidemics for cholera control, but rather how best to use them in a way that maximises effectiveness and efficiency in saving the lives of the most vulnerable people from this entirely preventable disease.

Lancet Infectious Diseases
Jun 2018 Volume 18 Number 6 p583-696 183-e220
http://www.thelancet.com/journals/laninf/issue/current

Articles
Immunogenicity of type 2 monovalent oral and inactivated poliovirus vaccines for type 2 poliovirus outbreak response: an open-label, randomised controlled trial
Khalequ Zaman, Concepción F Estívariz, Michelle Morales, Mohammad Yunus, Cynthia J Snider, Howard E Gary Jr, William C Weldon, M Steven Oberste, Steven G Wassilak, Mark A Pallansch, Abhijeet Anand

Lancet Infectious Diseases
Jun 2018 Volume 18 Number 6 p583-696 183-e220
http://www.thelancet.com/journals/laninf/issue/current

Articles
Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial
Firdausi Qadri, Mohammad Ali, Julia Lynch, Fahima Chowdhury, Ashraful Islam Khan, Thomas F Wierzba, Jean-Louis Excler, Amit Saha, Md Taufiqul Islam, Yasmin A Begum, Taufiqur R Bhuiyan, Farhana Khanam, Mohiul I Chowdhury, Iqbal Ansary Khan, Alamgir Kabir, Baizid Khoorshid Riaz, Afroza Akter, Arifuzzaman Khan, Muhammad Asaduzzaman, Deok Ryun Kim, Ashraf U Siddik, Nirod C Saha, Alejandro Cravioto, Ajit P Singh, John D Clemens
Summary
Background
A single-dose regimen of inactivated whole-cell oral cholera vaccine (OCV) is attractive because it reduces logistical challenges for vaccination and could enable more people to be vaccinated. Previously, we reported the efficacy of a single dose of an OCV vaccine during the 6 months following dosing. Herein, we report the results of 2 years of follow-up.
Methods
In this placebo-controlled, double-blind trial done in Dhaka, Bangladesh, individuals aged 1 year or older with no history of receipt of OCV were randomly assigned to receive a single dose of inactivated OCV or oral placebo. The primary endpoint was a confirmed episode of non-bloody diarrhoea for which the onset was at least 7 days after dosing and a faecal culture was positive for Vibrio cholerae O1 or O139. Passive surveillance for diarrhoea was done in 13 hospitals or major clinics located in or near the study area for 2 years after the last administered dose. We assessed the protective efficacy of the OCV against culture-confirmed cholera occurring 7–730 days after dosing with both crude and multivariable per-protocol analyses. This trial is registered at ClinicalTrials.gov, number NCT02027207.

Findings

Between Jan 10, 2014, and Feb 4, 2014, 205 513 people were randomly assigned to receive either vaccine or placebo, of whom 204 700 (102 552 vaccine recipients and 102 148 placebo recipients) were included in the per-protocol analysis. 287 first episodes of cholera (109 among vaccine recipients and 178 among placebo recipients) were detected during the 2-year follow-up; 138 of these episodes (46 in vaccine recipients and 92 in placebo recipients) were associated with severe dehydration. The overall incidence rates of initial cholera episodes were 0·22 (95% CI 0·18 to 0·27) per 100 000 person-days in vaccine recipients versus 0·36 (0·31 to 0·42) per 100 000 person-days in placebo recipients (adjusted protective efficacy 39%, 95% CI 23 to 52). The overall incidence of severe cholera was 0·09 (0·07 to 0·12) per 100,000 person-days versus 0·19 (0·15 to 0·23; adjusted protective efficacy 50%, 29 to 65). Vaccine protective efficacy was 52% (8 to 75) against all cholera episodes and 71% (27 to 88) against severe cholera episodes in participants aged 5 years to younger than 15 years. For participants aged 15 years or older, vaccine protective efficacy was 59% (42 to 71) against all cholera episodes and 59% (35 to 74) against severe cholera. The protection in the older age groups was sustained throughout the 2-year follow-up. In participants younger than 5 years, the vaccine did not show protection against either all cholera episodes (protective efficacy −13%, −68 to 25) or severe cholera episodes (−44%, −220 to 35).
Interpretation
A single dose of the inactivated whole-cell OCV offered protection to older children and adults that was sustained for at least 2 years. The absence of protection of young children might reflect a lesser degree of pre-existing natural immunity in this age group.
Funding
Bill & Melinda Gates Foundation to the International Vaccine Institute.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 26 May 2018)

Viewpoints
“Rapid impact” 10 years after: The first “decade” (2006–2016) of integrated neglected tropical disease control
Peter J. Hotez, Alan Fenwick, Sarah E. Ray, Simon I. Hay, David H. Molyneux
Viewpoints | published 24 May 2018 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006137

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 26 May 2018)

Research Article
Cost-effectiveness of dog rabies vaccination programs in East Africa
Rebekah H. Borse, Charisma Y. Atkins, Manoj Gambhir, Eduardo A. Undurraga, Jesse D. Blanton, Emily B. Kahn, Jessie L. Dyer, Charles E. Rupprecht, Martin I. Meltzer
| published 23 May 2018 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006490

PLoS One
http://www.plosone.org/
[Accessed 26 May 2018]

Research Article
Estimating the cost-effectiveness of a sequential pneumococcal vaccination program for adults in Germany
Ulrike Kuchenbecker, Daniela Chase, Anika Reichert, Julia Schiffner-Rohe, Mark Atwood
Research Article | published 24 May 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0197905

PNAS – Proceedings of the National Academy of Sciences of the United States
of America
http://www.pnas.org/content/early/
[Accessed 26 May 2018]

Stabilized single-injection inactivated polio vaccine elicits a strong neutralizing immune response
Stephany Y. Tzeng, Kevin J. McHugh, Adam M. Behrens, Sviatlana Rose, James L. Sugarman, Shiran Ferber, Robert Langer, and Ana Jaklenec
PNAS May 21, 2018. 201720970; published ahead of print May 21, 2018. https://doi.org/10.1073/pnas.1720970115

Qualitative Health Research
Volume 28, Issue 7, June 2018
http://qhr.sagepub.com/content/current

Research Articles
Innovating for Transformation in First Nations Health Using Community-Based Participatory Research
Grace Kyoon-Achan, Josée Lavoie, Kathi Avery Kinew, Wanda Phillips-Beck, Naser Ibrahim, Stephanie Sinclair, Alan Katz
First Published February 27, 2018; pp. 1036–1049
Preview
Community-based participatory research (CBPR) provides the opportunity to engage communities for sustainable change. We share a journey to transformation in our work with eight Manitoba First Nations seeking to improve the health of their communities and discuss lessons learned. The study used community-based participatory research approach for the conceptualization of the study, data collection, analysis, and knowledge translation. It was accomplished through a variety of methods, including qualitative interviews, administrative health data analyses, surveys, and case studies. Research relationships built on strong ethics and protocols to enhance mutual commitment to support community-driven transformation. Collaborative and respectful relationships are platforms for defining and strengthening community health care priorities. We further discuss how partnerships were forged to own and sustain innovations. This article contributes a blueprint for respectful CBPR. The outcome is a community-owned, widely recognized process that is sustainable while fulfilling researcher and funding obligations.

Science        
25 May 2018 Vol 360, Issue 6391
http://www.sciencemag.org/current.dtl

Policy Forum
Disparities in science literacy
By Nick Allum, John Besley, Louis Gomez, Ian Brunton-Smith
Science25 May 2018 : 861-862 Full Access
Cognitive and socioeconomic factors don’t fully explain gaps
Summary
Much is known about how adult science literacy varies internationally and over time, and about its association with attitudes and beliefs. However, less is known about disparities in science literacy across racial and ethnic groups (1). This is particularly surprising in light of substantial research on racial and ethnic disparities in related areas such as educational achievement, math and reading ability (2), representation in science, technology, engineering, and math (STEM) occupations (3), and health literacy (4). Given the importance of science literacy to securing and sustaining many jobs, to understanding key health concepts to enhance quality of life, and to increasing public engagement in societal decision-making (5), it is concerning if the distribution of science literacy is unequally stratified, particularly if this stratification reflects broader patterns of disadvantage and cultural dominance as experienced by minorities and educationally underserved populations. We describe here such disparities in science literacy in the United States and attempt to explain underlying drivers, concluding that the science literacy disadvantage among black and Hispanic adults relative to whites is only partially explained by measures of broader, foundational literacies and socioeconomic status (SES).

Social Science & Medicine
Volume 206 Pages 1-122 (June 2018)
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/206/suppl/

The social network of international health aid
Original research article
Pages 67-74
Lu Han, Mathias Koenig-Archibugi, Tore Opsahl
Abstract
International development assistance for health generates an emergent social network in which policy makers in recipient countries are connected to numerous bilateral and multilateral aid agencies and to other aid recipients. Ties in this global network are channels for the transmission of knowledge, norms and influence in addition to material resources, and policy makers in centrally situated governments receive information faster and are exposed to a more diverse range of sources and perspectives. Since diversity of perspectives improves problem-solving capacity, the structural position of aid-receiving governments in the health aid network can affect the health outcomes that those governments are able to attain. We apply a recently developed Social Network Analysis measure to health aid data for 1990–2010 to investigate the relationship between country centrality in the health aid network and improvements in child health. A generalized method of moments (GMM) analysis indicates that, controlling for the volume of health aid and other factors, higher centrality in the health aid network is associated with better child survival rates in a sample of 110 low and middle income countries.

Social Science & Medicine
Volume 206 Pages 1-122 (June 2018)
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/206/suppl/C

The geography of smallpox in England before vaccination: A conundrum resolved
Open access – Original research article
Pages 75-85
Romola Jane Davenport, Max Satchell, Leigh Matthew William Shaw-Taylor

Vaccine
Volume 36, Issue 24 Pages 3389-3568 (7 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/24

Meeting reports
Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes
Open access
Pages 3389-3396
Nora Dellepiane, Sonia Pagliusi, Registration Experts Working Group
Abstract
The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines’ registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10 countries were compared. Modules 2–5 of the CTDs of two regions and three countries were compared to the CTD of the US FDA. The application forms of eight countries were compared and the registration procedures of 134 importing countries were compared as well. The analysis indicates a high degree of divergence in numbering structure and content requirements. Possible interventions that would lead to significant improvements in registration efficiency include alignment in CTD numbering structure, a standardised model-application form, and better convergence of evaluation procedures.

Vaccine
Volume 36, Issue 24 Pages 3389-3568 (7 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/24

WHO articles
Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines
Open access
Pages 3411-3417
Kirsten S. Vannice, Annelies Wilder-Smith, Alan D.T. Barrett, Kalinka Carrijo, … Joachim Hombach
Abstract
Licensing and decisions on public health use of a vaccine rely on a robust clinical development program that permits a risk-benefit assessment of the product in the target population. Studies undertaken early in clinical development, as well as well-designed pivotal trials, allow for this robust characterization. In 2012, WHO published guidelines on the quality, safety and efficacy of live attenuated dengue tetravalent vaccines. Subsequently, efficacy and longer-term follow-up data have become available from two Phase 3 trials of a dengue vaccine, conducted in parallel, and the vaccine was licensed in December 2015. The findings and interpretation of the results from these trials released both before and after licensure have highlighted key complexities for tetravalent dengue vaccines, including concerns vaccination could increase the incidence of dengue disease in certain subpopulations. This report summarizes clinical and regulatory points for consideration that may guide vaccine developers on some aspects of trial design and facilitate regulatory review to enable broader public health recommendations for second-generation dengue vaccines.

Vaccine
Volume 36, Issue 24 Pages 3389-3568 (7 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/24

Pharmacies versus doctors’ offices for adolescent vaccination
Original research article
Pages 3453-3459
Parth D. Shah, Macary W. Marciniak, Shelley D. Golden, Justin G. Trogdon, … Noel T. Brewer