Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy  

New England Journal of Medicine
July 26, 2018   Vol. 379 No. 4
http://www.nejm.org/toc/nejm/medical-journal

Original Articles
Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy  
Saranya Sridhar, M.B., B.S., D.Phil., Alexander Luedtke, Ph.D., Edith Langevin, M.Sc., Ming Zhu, Ph.D., Matthew Bonaparte, Ph.D., Tifany Machabert, M.Sc., Stephen Savarino, M.D., M.P.H., Betzana Zambrano, M.D., Annick Moureau, M.Sc., Alena Khromava, M.D., M.P.H., Zoe Moodie, Ph.D., Ted Westling, B.S., Cesar Mascareñas, M.D., Carina Frago, M.D., Margarita Cortés, M.D., Danaya Chansinghakul, M.D., Fernando Noriega, M.D., Alain Bouckenooghe, M.D., M.P.H., Josh Chen, Ph.D., Su-Peing Ng, M.B., B.S., Peter B. Gilbert, Ph.D., Sanjay Gurunathan, M.D., and Carlos A. DiazGranados, M.D.

Identifying Areas at Greatest Risk for Recent Zika Virus Importation — New York City, 2016

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 28 Jul 2018]

Identifying Areas at Greatest Risk for Recent Zika Virus Importation — New York City, 2016
July 25, 2018 · Research Article

Introduction: The New York City Department of Health and Mental Hygiene sought to detect and minimize the risk of local, mosquito-borne Zika virus (ZIKV) transmission. We modeled areas at greatest risk for recent ZIKV importation, in the context of spatially biased ZIKV case ascertainment and no data on the local spatial distribution of persons arriving from ZIKV-affected countries.

Methods: For each of 14 weeks during June-September 2016, we used logistic regression to model the census tract-level presence of any ZIKV cases in the prior month, using eight covariates from static sociodemographic census data and the latest surveillance data, restricting to census tracts with any ZIKV testing in the prior month. To assess whether the model discriminated better than random between census tracts with and without recent cases, we compared the area under the receiver operating characteristic (ROC) curve for each week’s fitted model versus an intercept-only model applied to cross-validated data. For weeks where the ROC contrast test was significant at P < 0.05, we output and mapped the model-predicted individual probabilities for all census tracts, including those with no recent testing.

Results: The ROC contrast test was significant for 8 of 14 weekly analyses. No covariates were consistently associated with the presence of recent cases. Modeled risk areas fluctuated across these 8 weeks, with Spearman correlation coefficients ranging from 0.30 to 0.93, all P < 0.0001. Areas in the Bronx and upper Manhattan were in the highest risk decile as of late June, while as of late August, the greatest risk shifted to eastern Brooklyn.

Conclusion: We used observable characteristics of areas with recent, known travel-associated ZIKV cases to identify similar areas with no observed cases that might also be at-risk each week. Findings were used to target public education and Aedes spp. mosquito surveillance and control. These methods are applicable to other conditions for which biased case ascertainment is suspected and knowledge of how cases are geographically distributed is important for targeting public health activities.

 

Sexual transmission of Zika virus and other flaviviruses: A living systematic review

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 28 Jul 2018)

Research Article
Sexual transmission of Zika virus and other flaviviruses: A living systematic review
Michel Jacques Counotte, Caron Rahn Kim, Jingying Wang, Kyle Bernstein, Carolyn D. Deal, Nathalie Jeanne Nicole Broutet, Nicola Low
| published 24 Jul 2018 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002611

One million dog vaccinations recorded on mHealth innovation used to direct teams in numerous rabies control campaigns

PLoS One
http://www.plosone.org/
[Accessed 28 Jul 2018]

Research Article
One million dog vaccinations recorded on mHealth innovation used to direct teams in numerous rabies control campaigns
Andrew D. Gibson, Stella Mazeri, Frederic Lohr, Dagmar Mayer, Jordana L. Burdon Bailey, Ryan M. Wallace, Ian G. Handel, Kate Shervell, Barend M.deC. Bronsvoort, Richard J. Mellanby, Luke Gamble
Research Article | published 26 Jul 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0200942

Estimating the cost-effectiveness of an infant 13-valent pneumococcal conjugate vaccine national immunization program in China

PLoS One
http://www.plosone.org/
[Accessed 28 Jul 2018]

Research Article
Estimating the cost-effectiveness of an infant 13-valent pneumococcal conjugate vaccine national immunization program in China
Kunling Shen, Matthew Wasserman, Dongdong Liu, Yong-Hong Yang, Junfeng Yang, Greg F. Guzauskas, Bruce C. M. Wang, Betsy Hilton, Raymond Farkouh
| published 25 Jul 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0201245
 

A renewed focus on preventing malaria in pregnancy

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 28 Jul 2018]

Commentary
|   27 July 2018
A renewed focus on preventing malaria in pregnancy
Authors: Erin K. Ferenchick, Elaine Roman, Katherine Wolf, Lia Florey, Susan Youll, Viviana Mangiaterra, Koki Agarwal and Julie Gutman
Abstract
While much progress has been achieved globally in the fight against malaria, the significant financial investments made to date have not translated into scaled-up malaria in pregnancy (MiP) prevention efforts. Mothers and newborns remain at risk, and now is the time to refocus efforts. Against the backdrop of a new global health architecture embodied by the principles of Every Women, Every Child and driven by the work of the H6 Partnership, Global Financing Facility, strong bilaterals and key financiers, there is a new and timely juncture to advocate for MiP. Recent updates in the WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience present an opportunity to strengthen MiP as a core maternal and child health issue and position MiP prevention as a priority.

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH) :: Thematic issue: Economics of NCDs

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)

http://www.paho.org/journal/index.php?option=com_content&view=featured&Itemid=101

Thematic issue: Economics of NCDs

The global health burden of noncommunicable diseases (NCDs) is large and growing, as this group of diseases already accounts for 70% of total deaths. Global evidence indicates that the high health burden of NCDs translates into significant economic and social costs that threaten to diminish the quality of life of millions of individuals, impoverish families, jeopardize universal health coverage, and increase health disparities within and between countries. Evidence consistently shows that the NCD epidemic cannot be tackled through interventions and policies in the health sector alone. In particular, prevention measures that address NCD risk factors involve a range of sectors including finance, trade, education, agriculture, and transportation. As economics has become the common language among decision makers across sectors, it is imperative that health authorities leverage economic information to more effectively communicate the urgency of tackling NCDs and related risk factors.

This thematic issue of the Pan American Journal of Public Health is part of a continued collaboration between the Public Health Agency of Canada (PHAC) and PAHO/WHO to fa­cilitate intragovernmental dialogue for a better understanding of NCD issues by making economic evidence available in the Americas, and to assist countries in integrating economic approaches into their NCD prevention and control policies.

[Reviewed earlier]

 

 

 

Marvelous models

Science         
27 July 2018  Vol 361, Issue 6400
http://www.sciencemag.org/current.dtl
Special Issue – Frontiers in computation

Introduction to special issue

Marvelous models
By Michael Funk, Colin Norman, Keith T. Smith, Jelena Stajic, Jake Yeston
Science27 Jul 2018 : 342-343
Scientists learn about the world by observing, manipulating, measuring, and abstracting. To make sure that they truly understand their system, and to gain insight beyond what experimental data can provide, many also turn to building mathematical models. Some models are based directly on fundamental physical laws, but most rely on approximations. The computational costs vary widely—from exactly solvable models to those that require all the computer power you can get. This power has become increasingly accessible; throw in the recent forays of artificial intelligence into scientific computing and the tantalizing promise of quantum computers, and it’s clear that exciting times are ahead.

In this special issue, we highlight several areas of scientific computing that have seen recent progress. A feature article by Science reporter Paul Voosen focuses on an ambitious and controversial project, backed by high-tech philanthropists, to leverage breakthroughs in artificial intelligence, satellite imaging, and high-resolution simulations to create a new climate model. Kent and Kotliar reflect on two complementary approaches to predicting the properties of materials in which electrons are inextricably correlated with one another. Bottaro and Lindorff-Larsen report on the simulation of biological molecules, where recent progress has been driven by advances in theory and methods and tighter integration of experimental constraints. Sanchez-Lengeling and Aspuru-Guzik review approaches that use machine learning to design chemical structures that bear a desired characteristic. Finally, Brügmann describes how to simulate the complex equations that govern four-dimensional spacetime in Einstein’s theory of general relativity, focusing on the example of gravitational waves produced by merging black holes.

 

 

 

 

Assessing imprecision in Cochrane systematic reviews: a comparison of GRADE and Trial Sequential Analysis

Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 28 Jul 2018]

Methodology
Assessing imprecision in Cochrane systematic reviews: a comparison of GRADE and Trial Sequential Analysis
The evaluation of imprecision is a key dimension of the grading of the confidence in the estimate. Grading of Recommendations Assessment, Development and Evaluation (GRADE) gives recommendations on how to down…
Authors: Greta Castellini, Matteo Bruschettini, Silvia Gianola, Christian Gluud and Lorenzo Moja
Citation: Systematic Reviews 2018 7:110
Published on: 28 July 2018

A report on the status of vaccination in Europe

Vaccine
Volume 36, Issue 33   Pages 4963-5106 (9 August 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/33

Review
A report on the status of vaccination in Europe
Open access – Review article
Pages 4979-4992
Shazia Sheikh, Eliana Biundo, Soizic Courcier, Oliver Damm, … Norman Begg
Abstract

Vaccine policy, decision processes and outcomes vary widely across Europe. The objective was to map these factors across 16 European countries by assessing (A) national vaccination strategy and implementation, (B) attributes of healthcare vaccination systems, and (C) outcomes of universal mass vaccination (UMV) as a measure of how successful the vaccination policy is.

  1. Eleven countries use standardised assessment frameworks to inform vaccine recommendations. Only Sweden horizon scans new technologies, uses standard assessments, systematic literature and health economic reviews, and publishes its decision rationale. Time from European marketing authorisation to UMV implementation varies despite these standard frameworks. Paediatric UMV recommendations (generally government-funded) are relatively comparable, however only influenza vaccine is widely recommended for adults.
  2. Fourteen countries aim to report annually on national vaccine coverage rates (VCRs), as well as have target VCRs per vaccine across different age groups. Ten countries use either electronic immunisation records or a centralised registry for childhood vaccinations, and seven for other age group vaccinations.
  3. National VCRs for infant (primary diphtheria tetanus pertussis (DTP)), adolescent (human papillomavirus (HPV)) and older adult (seasonal influenza) UMV programmes found ranges of: 89.1% to 98.2% for DTP-containing vaccines, 5% to 85.9% for HPV vaccination, and 4.3% to 71.6% for influenza vaccine. Regarding reported disease incidence, a wide range was found across countries for measles, mumps and rubella (in children), and hepatitis B and invasive pneumococcal disease (in all ages).

These findings reflect an individual approach to vaccination by country. High VCRs can be achieved, particularly for paediatric vaccinations, despite different approaches, targets and reporting systems; these are not replicated in vaccines for other age groups in the same country. Additional measures to improve VCRs across all age groups are needed and could benefit from greater harmonisation in target setting, vaccination data collection and sharing across EU countries.

 

 

Cost-effectiveness of an Adjuvanted Recombinant Zoster Vaccine in older adults in the United States

Vaccine
Volume 36, Issue 33   Pages 4963-5106 (9 August 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/33

Original research article
Cost-effectiveness of an Adjuvanted Recombinant Zoster Vaccine in older adults in the United States
Open access –
Pages 5037-5045
Curran, B. Patterson, L. Varghese, D. Van Oorschot, … B. Yawn

Parental predictors of HPV vaccine initiation among low-income Hispanic females aged 11–17 years

Vaccine
Volume 36, Issue 33   Pages 4963-5106 (9 August 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/33

Original research article
Parental predictors of HPV vaccine initiation among low-income Hispanic females aged 11–17 years
Pages 5084-5090
Serena A. Rodriguez, Lara S. Savas, Elizabeth Baumler, Alan G. Nyitray, … Maria E. Fernandez

 

Avian Influenza A Virus Pandemic Preparedness and Vaccine Development

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 28 Jul 2018)

Review  Open Access
Avian Influenza A Virus Pandemic Preparedness and Vaccine Development
by Rory D. de Vries, Sander Herfst and Mathilde Richard
Vaccines 2018, 6(3), 46; https://doi.org/10.3390/vaccines6030046 – 25 July 2018
Abstract
Influenza A viruses can infect a wide range of hosts, creating opportunities for zoonotic transmission, i.e., transmission from animals to humans, and placing the human population at constant risk of potential pandemics. In the last hundred years, four influenza A virus pandemics have had a devastating effect, especially the 1918 influenza pandemic that took the lives of at least 40 million people. There is a constant risk that currently circulating avian influenza A viruses (e.g., H5N1, H7N9) will cause a new pandemic. Vaccines are the cornerstone in preparing for and combating potential pandemics. Despite exceptional advances in the design and development of (pre-)pandemic vaccines, there are still serious challenges to overcome, mainly caused by intrinsic characteristics of influenza A viruses: Rapid evolution and a broad host range combined with maintenance in animal reservoirs, making it near impossible to predict the nature and source of the next pandemic virus. Here, recent advances in the development of vaccination strategies to prepare against a pandemic virus coming from the avian reservoir will be discussed. Furthermore, remaining challenges will be addressed, setting the agenda for future research in the development of new vaccination strategies against potentially pandemic influenza A viruses.

Why Is Eradicating Typhoid Fever So Challenging: Implications for Vaccine and Therapeutic Design

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 28 Jul 2018)

Review  Open Access
Why Is Eradicating Typhoid Fever So Challenging: Implications for Vaccine and Therapeutic Design
by Yi-An Yang, Alexander Chong and Jeongmin Song
Vaccines 2018, 6(3), 45; https://doi.org/10.3390/vaccines6030045 – 24 July 2018
Abstract
Salmonella enterica serovar Typhi (S. Typhi) and S. Paratyphi, namely typhoidal Salmonellae, are the cause of (para) typhoid fever, which is a devastating systemic infectious disease in humans. In addition, the spread of multidrug-resistant (MDR) and extensively drug-resistant (XDR) S. Typhi in many low and middle-income countries poses a significant risk to human health. While currently available typhoid vaccines and therapeutics are efficacious, they have some limitations. One important limitation is the lack of controlling individuals who chronically carry S. Typhi. However, due to the strict host specificity of S. Typhi to humans, S. Typhi research is hampered. As a result, our understanding of S. Typhi pathogenesis is incomplete, thereby delaying the development and improvement of prevention and treatment strategies. Nonetheless, to better combat and contain S. Typhi, it is vital to develop a vaccine and therapy for controlling both acutely and chronically infected individuals. This review discusses how scientists are trying to combat typhoid fever, why it is so challenging to do so, which approaches show promise, and what we know about the pathogenesis of S. Typhi chronic infection

 

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary
 
Oman Medical Journal
Volume 33 Issue 4 (Jul 2018)
Original Articles
A snapshot of Influenza surveillance, vaccine recommendations, and vaccine access, drivers, and barriers in selected middle Eastern and North African countries
S Al Awaidy, A Althaqafi, G Dbaibo – Oman Medical Journal, 2018
Abstract:
Objectives: Influenza is a vaccine-preventable acute respiratory viral infection that causes epidemics annually around the globe. A regional influenza stakeholder network (MENA-ISN) comprised of experts assessed the status of influenza prevention and control using a structured survey.
Methods: A survey questionnaire was used to obtain information from each participating country on surveillance system, the burden of disease, influenza vaccination programs, recommendations, funding and access for vaccine and vaccination, target rate, coverage rate monitoring, and drivers and barriers to influenza vaccination.
Results: Out of the 10 countries that participated, nine had an influenza surveillance system and vaccination policy, and seven had World Health Organization (WHO) accredited reference laboratory. Three countries had burden of disease data available and eight had a reimbursement vaccine policy. Influenza vaccine was available in five countries through the Ministry of Health whereas in others, pharmacies also dispensed for the private sector. In all countries, prescribers were physicians, and vaccinators, which could be physicians, nurses, and pharmacists. Eight countries had a set vaccination target rate and only three monitored the influenza coverage rates. Drivers and barriers of vaccination were similar in all countries.
Conclusions: Despite existing policies, influenza vaccination coverage remains far below the WHO recommendations. Increased awareness and effective implementation of policies with collaboration of stakeholders can help increase the rates to reach WHO targets.
 
 
Book: HIV Vaccines and Cure: The Path Towards Finding an Effective Cure and Vaccine
Linqi Zhang, Sharon R. Lewin
Springer, Jul 20, 2018 – 318 pages
This book provides a comprehensive review of the major barriers to HIV cure and vaccine. It covers the fundamental virology and immunology leading to HIV transmission, protection from infection and long term HIV persistence on antiretroviral therapy. In addition, strategies being tested to eliminate persistent HIV and the rational design of vaccines to induce protective immunity are covered. This book also discusses the challenges related to the design of clinical trials for testing the safety and efficacy of these innovative approaches. This book will provide a systematic overview and also discuss controversial issues for researchers in virology and immunology, as well as practicing physicians, and scientists in the pharmaceutical industry.

Media/Policy Watch

Media/Policy Watch

This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.
 
 
The Atlantic
http://www.theatlantic.com/magazine/
Accessed 28 Jul 2018
Science
The Deleted WeChat Post That Fueled China’s Vaccine Scandal
It alleged a complex web of corruption going back decades.
Sarah ZhangKaren Yuan
Jul 25, 2018
A vaccine scandal in China began building slowly and then suddenly, this weekend, it was everywhere at once.
The story began back in November, when a large vaccine manufacturer called Changsheng Biotechnology Co. was forced to recall 252,600 ineffective doses of vaccines for DPT (diphtheria, pertussis, and tetanus). Then earlier this July, a government investigation caught Changsheng falsifying data about its rabies vaccine, and a local food and drug administration fined the company 3.44 million yuan, or approximately $500,000, over the faulty DPT vaccines.
Over the weekend, an anonymous post recounting all this and more went viral on the Chinese social network WeChat. In addition to the recent developments, it alleged a complex web of corruption that went back decades, involving other vaccines for hepatitis B and chicken pox. The post was deleted the next day.

But by then, a full-blown national scandal had erupted. The Chinese government this week scrambled to put out statements assuring a prompt investigation. President Xi Jinping described the situation as “vile and shocking.” Police on Monday announced the swift arrest of four of the company’s executives, including its chairwoman.

Changsheng’s vaccines have not yet been tied to any deaths or illnesses, but the story caught on because it so perfectly echoed many scandals that have rocked China in recent years. In 2016, for example, a hospital pharmacist sold two million doses of vaccines improperly stored in an “overheated, dilapidated storeroom.” That came after scandals over tainted milk, infant formula, pork, cooking oil, and water. The scandals, one after another, have undermined trust in the government’s ability to keep the public safe…
 

BBC
http://www.bbc.co.uk/
Accessed 28 Jul 2018
[No new, unique, relevant content]
 

The Economist
http://www.economist.com/
Accessed 28 Jul 2018
A vaccine scandal shakes trust in China’s government
More than 200,000 babies may have been given substandard jabs
Jul 26th 2018 | BEIJING
 
Financial Times
http://www.ft.com/home/uk
Accessed 28 Jul 2018
[No new, unique, relevant content]
 
Forbes
http://www.forbes.com/
Accessed 28 Jul 2018
[No new, unique, relevant content]

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 28 Jul 2018
[No new, unique, relevant content]

 

Foreign Policy
http://foreignpolicy.com/
Accessed 28 Jul 2018
Welcome to the Next Deadly AIDS Pandemic
Laurie Garrett | 26 July 2018
The world thought it had fought the HIV virus to a stalemate — but its strategy was flawed in ways that are only now becoming clear.

The Guardian
http://www.guardiannews.com/
Accessed 28 Jul 2018
China
‘They are devils’: China’s parents demand answers over vaccine scandal
Protest groups want to know how hundreds of thousands of faulty vaccines came to be used
Lily Kuo in Beijing
Wed 25 Jul 2018
 

New Yorker
http://www.newyorker.com/
Accessed 28 Jul 2018
[No new, unique, relevant content]
 

New York Times
http://www.nytimes.com/
Accessed 28 Jul 2018
Asia Pacific
China Says Vaccine Maker Changsheng Broke Manufacturing Rules, Faked Records – Xinhua
July 27, 2018
BEIJING — China’s cabinet investigation group has found that vaccine maker Changsheng Bio-technology broke the law in manufacturing rabies vaccines, the state news agency Xinhua reported on Friday.
The investigation group said the company had systematically falsified production and testing records to avoid regulatory scrutiny, according to Xinhua.
“The company used expired materials to produce some rabies vaccine and falsified the production date,” the investigation group found.
“To cover up violations, the company systematically fabricated production and testing records.”
China has launched sweeping spot checks on vaccine makers around the country after Changsheng was found to have falsified data and sold ineffective vaccines for children…

 

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 28 Jul 2018
Review & Outlook
China’s Vaccine Scandal
Children get phony protection but officials aren’t held accountable.
By The Editorial Board
July 27, 2018
Xi Jinping boasts that he is building the “Chinese Dream” of a strong and prosperous nation, but the vision of China’s supreme leader is losing some of its luster. Over the past couple of weeks parents in China have learned that a compulsory public-health program injected an unknown number of children with substandard vaccines. They are understandably furious.

Mr. Xi called the case “hideous and appalling,” and he has promised a thorough investigation. But websites and state-run media are only allowed to republish official pronouncements on the case, suggesting the authorities are still covering up the extent of the crime.

Last November officials in Jilin province found that the Changsheng Biotechnology Co. falsified production data for a diphtheria, pertussis and tetanus (DPT) vaccine. After national regulators found similar problems with Changsheng’s rabies vaccine this month, the provincial government revealed that problems with the DPT vaccine affected more than 250,000 doses. Another company in Wuhan was responsible for 400,000 faulty DPT injections.

On July 21 an anonymous report on the WeChat messaging platform, similar to WhatsApp, accused corrupt regulators of hiding the problems of vaccines made by Changsheng. That was plausible because officials have been disciplined for taking bribes from the company in the past. Online expressions of anger at the scandal exploded.

Chinese are particularly angry because similar cases have happened in recent years, followed by similar promises to crack down. In 2010 and 2013 hundreds of children were hospitalized and several died from faulty vaccines. Chinese companies have used official connections to avoid accountability for producing a range of defective products that kill and maim. In 2008 Chinese dairy companies knowingly sold infant formula that contained melamine, a chemical that damaged the kidneys of hundreds of thousands of children. At least six died. A decade later, many parents will only feed their children imported formula.

The official response follows a familiar pattern. Journalists and lawyers who try to follow up or investigate similar cases are jailed. The officials responsible are transferred to new posts, having learned that covering up scandals is more important than preventing them. Sun Xianze, one of the food-safety regulators disciplined in the 2008 dairy scandal, was in charge of drug safety until his retirement in March.

The scandal will hurt Mr. Xi’s plan to build the pharmaceutical industry as part of his “Made in China 2025” industrial policy. But the damage to the public’s faith in his administration is harder to quantify. Because the Communist Party is effectively above the law and China lacks a free media capable of being a watchdog, his promise to get to the bottom of the problem rings hollow.

Officials insist that Mr. Xi’s anticorruption campaign is a serious attempt to improve Communist Party governance and not merely a tool to remove political opponents. Ordinary Chinese can be forgiven for reaching a different conclusion as the health of children is sacrificed to protect the Party’s power. And Americans enamored of China’s supposed authoritarian efficiency might contemplate the cost of its lack of accountability.

 

Washington Post
http://www.washingtonpost.com/
Accessed 28 Jul 2018
Vaccine scandal gripping China could cause serious problems for the government
Rebecca Tan| 26 July 2018

Think Tanks et al

Think Tanks et al
 
Brookings
http://www.brookings.edu/
Accessed 28 Jul 2018
[No new relevant content]

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 28 Jul 2018
[No new relevant content]

CSIS
https://www.csis.org/
Accessed 28 Jul 2018
[No new relevant content]

Council on Foreign Relations
http://www.cfr.org/
Accessed 28 Jul 2018
July 24, 2018
China
Chinese Parents, Pharma Industry Worried Sick After Latest Vaccine Scandal
In a society that cherishes health, longevity, and continuation of the family line, there is a lingering and growing fear that the existing system is broken.

Vaccines and Global Health: The Week in Review :: 21 July 2018

.– 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_21 Jul 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

Record number of infants vaccinated in 2017

Milestones :: Perspectives

Record number of infants vaccinated in 2017
As over 19 million children miss out on vaccinations, UNICEF and WHO call for concerted efforts to reach all children
New York, 16 July 2018: A record 123 million infants were immunized globally in 2017 with at least one dose of the diphtheria-tetanus-pertussis vaccine , according to data released today by the World Health Organization and UNICEF.

The data shows that:
:: 9 out of every 10 infants received at least one dose of diphtheria-tetanus-pertussis (DTP) vaccine in 2017, gaining protection against these deadly diseases.
:: An additional 4.6 million infants were vaccinated globally in 2017 with three doses of the diphtheria-tetanus-pertussis vaccine compared to 2010.
:: 167 countries included a second dose of measles vaccine as part of their routine vaccination schedule.
:: 162 countries now use rubella vaccines and global coverage against rubella has increased from 35 per cent in 2010 to 52 per cent.
:: The human papillomavirus (HPV) vaccine was introduced in 80 countries to help protect women against cervical cancer.
::Additional vaccines are being included into the immunization schedule, such as new formulations of meningitis and polio vaccines.

Despite these successes, almost 20 million infants did not receive the benefits of full immunization in 2017, as they were not vaccinated with three doses of the diphtheria-tetanus-pertussis vaccine. Of these, almost 8 million (40 per cent) live in fragile or humanitarian settings, including countries affected by conflict. In addition, a growing share are from middle-income countries, where inequity and marginalization, particularly among the urban poor, prevent many from getting immunized. 

As populations grow, more countries need to increase their investments in immunization programmes. To reach all children  with much-needed vaccines, the world will need to vaccinate an estimated 20 million additional children every year with three doses of the diphtheria-tetanus-pertussis vaccine (DTP3); 45 million with a second dose of measles vaccine; and 76 million children with 3 doses of pneumococcal conjugate vaccine.

In support of these efforts, WHO and UNICEF are working to expand access to immunization by:
:: Strengthening the quality, availability and use of vaccine coverage data.
:: Better targeting resources.
:: Planning actions at sub-national levels and
:: Ensuring that vulnerable people can access vaccination services.
WHO/UNICEF 2017 country and regional immunization coverage data

Featured Journal Content – Dengue Vaccine :: Vaccination in a “me first” era :: Dengue vaccine: reliably determining previous exposure :: Countries step up to tackle antimicrobial resistance

Featured Journal Content – Dengue Vaccine

 
Vaccination in a “me first” era
The Lancet Global Health – Editorial
Volume 6, No. 8, e811, August 2018
DOI: https://doi.org/10.1016/S2214-109X(18)30331-0

In this month’s issue, Kevin Ariën and Annelies Wilder-Smith outline the ideal attributes of a diagnostic test to identify previous exposure to dengue virus. The need for such an assay stems from the worrying revelation by Sanofi Pasteur last November that its licensed tetravalent vaccine, Dengvaxia, was associated with an increased risk of severe dengue in individuals who were seronegative for dengue virus at the time of vaccination. It was assumed that the vaccine, the efficacy of which is higher for serotypes 3 and 4 than for 1 and 2, was mimicking a primary infection, which is known to be a risk factor for future severe disease if the individual becomes infected with a different serotype at a later date. Sanofi Pasteur thus proposed a label change to the effect that vaccination should not be recommended in those who have not been previously infected. Further, in April, 2018, WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) released revised recommendations that also indicated a preferred strategy of prevaccination screening for previous exposure and vaccination only of seropositive individuals. SAGE additionally called for research into “development of a highly sensitive and specific rapid diagnostic test to determine serostatus”.

In the Philippines—where the disease is highly prevalent and whose Government boldly announced a programme to vaccinate 830,000 schoolchildren in 2016—this transparent, cautious, and responsible approach to a safety concern was unfortunately lost amid an avalanche of alarmist governmental statements, screaming headlines, and law suits. The Government withdrew approval of the vaccine in December 2017.

What can cause a public health programme to go so disastrously wrong and what can academics, health professionals, and communicators do to assuage concerns about vaccine safety? These were some of the questions put to a panel of experts at the International Society for Neglected Tropical Diseases 3 in London last month. Tikki Pangestu, professor at the Lee Kuan Yew School of Public Policy in Singapore and previously of WHO, highlighted what he saw as the “enabling environment” that led to the dengue vaccine saga. First, the immunisation programme was launched in the Philippines to much fanfare very swiftly after the vaccine’s approval and during an election year. The Government’s eagerness to introduce the programme could thus have been seen as politically motivated. Second, a failure of leadership saw public health officials join with anti-vaccine groups and a media focused on getting a juicy story to seed mass fear among parents. Finally, and common to all immunisation programmes, is the very concept of intervening medically in healthy children—an understandably combustible notion, the benefits, risks, and uncertainties of which are difficult to convey to a lay audience. Add to these general elements of distrust the tensions between individual rights and wider societal benefits, and religious and philosophical beliefs, and you have quite an explosive mix, added Pauline Paterson from the London School of Hygiene and Tropical Medicine’s Vaccine Confidence Project.

The answer? “Very difficult”, said Paterson. Psychological research shows that changing misconceptions is not easy, and that the mere process of debunking a myth can make the myth more prominent in the mind of the receiver. However, identifying susceptible populations, exploring the underlying reasons for non-vaccination, and designing evidence-informed responses are important features of success, she advised. Additionally, people are more likely to vaccinate or be vaccinated if a health-care provider recommends it, and vaccinated health-care providers are more likely to recommend vaccination to others. Some clear messages to health-care providers, then: acknowledge your patients’ concerns, engage with them, recommend vaccination, and get yourself or your children vaccinated.

And what about communicators? We are all communicators, insisted Sanofi Pasteur’s Angus Thomson. Researchers, practitioners, editors, and policy makers can and should be part of the discussion, he said, offering evidence to counter misinformation where we encounter it on social media, helping journalists to understand complex risk-benefit scenarios, and assisting governments with risk management planning. “Don’t wait for the crisis before you lean into the problem”, agreed Rachel Grant from the Coalition for Epidemic Preparedness Innovations (CEPI).

Finally, we need to be prepared to meet individuals wherever their own personal beliefs lie and not simply try to convert them to our own mindset. Because one thing we cannot assume in this “me first” era is that every citizen will see the wider societal benefits as a good reason to take a personal risk, however small that may be in reality.
 
 
Comment
Dengue vaccine: reliably determining previous exposure
Kevin K Ariën, Annelies Wilder-Smith
Dengue fever is the most prevalent and widespread mosquito-borne viral disease, and can only be countered by integrated prevention and control strategies, including sustained vector control programmes, the best evidence-based clinical care, and vaccination.

The first dengue vaccine, CYD-tetravalent dengue vaccine (CYD-TDV) or Dengvaxia (Sanofi Pasteur, Lyon, France), is licensed in 20 countries. Initial findings from two large phase 3 clinical trials have shown good but incomplete protection, in particular against severe dengue and dengue disease that requires hospital admission.1, 2 In November, 2017, Sanofi Pasteur announced the results from additional studies showing that the vaccine has a differential performance in individuals who have previously been infected by dengue virus (seropositive) versus those without previous dengue virus infection (seronegative).3 Vaccine efficacy against laboratory-confirmed symptomatic dengue virus infection was high among individuals who were seropositive at baseline and aged at least 9 years (76%, 95% CI 63·9–84·0), but much lower among participants who were seronegative at baseline (38%, −0·9 to 62·9). Furthermore, vaccination of individuals who are seronegative increases their risk of severe dengue or dengue that requires hospital admission.4 Subsequently, in April, 2018, WHO’s Strategic Advisory Group of Experts recommended that in countries considering the introduction of vaccination with CYD-TDV, pre-vaccination screening should be preferred to assess dengue virus serostatus, and only people who are dengue seropositive should be vaccinated. To this end, WHO also encouraged the urgent development of rapid diagnostic tests (RDTs) to establish serostatus.

Because dengue viruses are of the genus Flavivirus, composed of genetically, structurally, and antigenically related viruses, such as Zika virus, yellow fever virus, and tick-borne encephalitis virus, antibody detection tests have high cross-reactivity and consequently poor reliability for the diagnosis of past dengue virus infection.5 With large flavivirus-exposed populations in Latin America, Asia, and Africa, a rapidly growing population of travellers from and to endemic areas,6 and increased vaccination coverage against yellow fever virus, tick-borne encephalitis virus, and Japanese encephalitis virus in travellers and in certain endemic regions, it is evident that establishing serostatus is extremely challenging.

Many commercial immunoglobulin (Ig)G-containing point-of-care tests (POCTs) and dengue IgG ELISA assays are available. For the purpose of pre-vaccination screening, the assay with the highest sensitivity and specificity would be the desirable option. Low sensitivity would result in under-vaccinating individuals who are truly seropositive and who would benefit from the vaccine, whereas low specificity would lead to falsely vaccinating people who are truly seronegative, putting them at risk of severe dengue during the next natural infection with dengue virus.

The plaque reduction neutralisation test (PRNT) is still considered the gold standard for establishing serostatus, but requires specific laboratory and technical capacity, and is labour intensive, costly, and time consuming. Although dengue IgG ELISA correlates reasonably well with the results of a PRNT, the test has a lower sensitivity and specificity than PRNT, although the studies7, 8 that showed this lower sensitivity and specificity were done before Zika virus became a widespread problem in the Americas. Dengue IgG ELISA requires about 2·5 h of laboratory time, excluding the time needed for sample transportation to the laboratory, batch analysis, and reporting to the clinician, which requires two visits for the vaccinees. Point-of-care testing that uses RDTs provides the vaccine recipient with a result within 15–30 min, and can be done in an outpatient or outreach setting, such as schools and care facilities, using a finger prick sample. Thus, a decision on vaccination eligibility can be made during the same visit, thereby ensuring a reasonable vaccine uptake. POCTs generally have lower sensitivity and specificity than dengue IgG ELISAs. However, this low sensitivity and specificity needs to be weighed up against the faster speed of testing, lower cost, and improved accessibility outside specialised laboratories compared with IgG ELISAs.

As available RDTs were mainly developed for the purpose of diagnosing acute dengue virus infection, further efforts would be justified to fine-tune such RDTs to increase sensitivity and specificity for diagnosing serostatus. To increase the sensitivity of dengue RDTs to detect previous dengue virus infection, several modifications could be contemplated, one of which would be recalibration by changing the concentration of the IgG capture antigen or detection reagent to lower the limit of anti-dengue IgG detection. To address cross-reactivity with other flaviviruses, particularly Zika, other modifications should be considered to improve specificity.

Diagnostic methods for flavivirus antibody detection use the entire virus particle, recombinant surface E-protein, or NS1 protein as antibody-capturing antigens. Epitopes with high aminoacid sequence homology among serotypes or flaviviruses can trigger cross-reactive responses, but type-specific antibodies directed towards unique E and NS1 epitopes are also raised.9, 11 The art of making specific serological tests lies in the identification, selection, and presentation of those epitopes, either as recombinant protein fragments or peptides that only bind type-specific IgG, instead of using the entire virion or recombinant protein that contains both type-specific and cross-reactive antibody epitopes. Dengue virus antibody tests that use recombinant E-protein to absorb IgG will not be useful anymore for pre-testing purposes or for seroprevalence studies once the dengue vaccine (that uses dengue virus E-protein as an immunogen) is widely spread. Capturing type-specific non-E-protein-directed antibodies could be an alternative approach, as applied in the recently developed Zika virus-specific NS1 blockade-of-binding ELISA.10 Comparative epitope modelling and genome-wide peptide microarray analysis can help to identify virus-specific epitopes targeted by antibodies in individuals who are flavivirus seropositive. Whereas obtaining type-specific epitopes is challenging but technically feasible, the difficulty might be in retaining sufficiently high sensitivity when aiming to detect specific subsets of antibodies in people who have been exposed to flavivirus. The epitope specificity and the abundance of such subsets of antibodies might also differ between populations and individuals as a result of differences in genetic background, co-circulating pathogens, vaccination, history of natural infection, and timing of sampling. Combining multiple type-specific epitopes and antigen–antibody crosslinking could potentially help address this issue. Evaluation platforms and access to well characterised samples to accelerate test development and access to market are urgently needed.

We declare no competing interests. KKA serves as a consultant on diagnostics to WHO and AW-S as a consultant on arboviral diseases to WHO. KKA also serves as an expert for the Belgian Federal Agency for Medicines and Health Products. The views expressed in this manuscript do not necessarily represent the views of WHO or the Belgian Federal Agency for Medicines and Health Products. KKA is a member of ZikaPLAN and AWS is the coordinator of the ZikaPLAN consortium that received funding from the European Union’s Horizon 2020 research and innovation programme, under the ZikaPLAN grant agreement 734584.4.
References at title link above
 
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Countries step up to tackle antimicrobial resistance
Joint News Release – FAO-OIE-WHO
18 July 2018
Countries are making significant steps in tackling antimicrobial resistance (AMR), but  serious gaps remain and require  urgent action, according to a report released today by the Food and Agriculture Organization of the United Nations (FAO), World Organisation for Animal Health (OIE) and the World Health Organization (WHO).
The report charts progress in 154 countries and reveals wide discrepancies.  Some, including many European countries, have been working on AMR policies in human and animal sectors for more than 4 decades. Others have only recently started to take action to contain this growing threat. Progress in developing and implementing plans is greater in high-income than low-income countries but all countries have scope for improvement. No country  reports sustained capacity at scale in all areas.
The report looks at surveillance, education, monitoring and regulating consumption and use of antimicrobials in human health, animal health and production, as well as plants and the environment – as recommended in the Global Action Plan published in 2015.
Promising findings include 105 countries with a surveillance system in place for reporting drug-resistant infections in human health and 68 countries with a system for tracking consumption of antimicrobials.  In addition, 123 countries reported that they have policies to regulate the sale of antimicrobials, including the requirement of a prescription for human use – a key measure to tackle overuse and misuse of antimicrobials.
But implementation of these policies varies and unregulated medicines are still available in places such as street markets, with no limits on how they are used. Medicines are very often sold over the counter and no prescription is requested. This puts human and animal health at risk, potentially contributing to the development of antimicrobial resistance…

Link to database and report: http://www.who.int/antimicrobial-resistance/global-action-plan/database/en/
 
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Emergencies

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 17 July 2018 [GPEI]
:: The Minister of Health of Papua New Guinea officially launched the outbreak response campaign on 16 July in Morobe, Madang and Eastern Highlands provinces.

Summary of new cases this week:
Afghanistan:
:: There is advance notification of one wild poliovirus type 1 (WPV1) case in Chawkay district, Kunar province. The case has onset of paralysis on 22 June. Once confirmed (officially to be reflected in next week’s data), this will bring the total number of WPV1 cases in 2018 (in Afghanistan) to ten.
Nigeria:
:: One new case of circulating vaccine-derived poliovirus type 2 (cVDPV2) from Geidam LGA in Yobe State has been confirmed. The case has onset of paralysis on 16 June 2018. This is the second cVDPV2 case in Nigeria this year after the one reported from Jigawa state, Kaugama LGA on 15 April 2018. As part of the outbreak response, two campaigns using monovalent vaccine type 2 are planned, subject to review from the Advisory group. Additionally, three confirmed [Sokoto (2) and Yobe 1] and two advanced notice (Sokoto) cVDPV2 positive environmental samples are being reported from May.

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WHO Grade 3 Emergencies  [to 21 Jul 2018]
The Syrian Arab Republic
:: Southern Syrian Arab Republic Health Cluster report pdf, 82kb  13 – 16 July 2018

Nigeria 
:: Borno targets more than 1 million children with anti-malaria therapy  Maiduguri, 13 July 2018

Iraq  – No new announcements identified
South Sudan  – No new announcements identified
Yemen  – No new announcements identified

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WHO Grade 2 Emergencies  [to 21 Jul 2018]
[Several emergency pages were not available at inquiry]
Cameroon  – No new announcements identified
Central African Republic  No new announcements identified.
Democratic Republic of the Congo  No new announcements identified
Ethiopia  No new announcements identified.
LibyaNo new announcements identified.
Myanmar  – No new announcements identified
Niger  – No new announcements identified.
UkraineNo 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. 
Syrian Arab Republic 
:: Syrian Arab Republic: Dar’a, Quneitra, As-Sweida Situation Report No. 3 as of 19 July 2018
 
Yemen
:: Yemen: Al Hudaydah Update Situation Report No. 8 – Reporting Period: 4 – 13 July 2018

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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.
Ethiopia 
:: Ethiopia Humanitarian Bulletin Issue 57 | 2-15 July 2018

Somalia   – No new announcements identified.

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

EBOLA/EVD  [to 21 Jul 2018]
http://www.who.int/ebola/en/
No new announcements identified.

MERS-CoV [to 21 Jul 2018]
http://who.int/emergencies/mers-cov/en/
No new announcements identified.
 
Yellow Fever  [to 21 Jul 2018]
http://www.who.int/csr/disease/yellowfev/en/
No new announcements identified.

Zika virus  [to 21 Jul 2018]
http://www.who.int/csr/disease/zika/en/
No new announcements identified.

WHO & Regional Offices [to 21 Jul 2018]

WHO & Regional Offices [to 21 Jul 2018]

The 22nd International AIDS Conference (AIDS 2018)
23 – 27 July 2018  Amsterdam, the Netherlands

WHO at AIDS 2018
The 22nd International AIDS Conference (AIDS 2018) to be held in Amsterdam, the Netherlands, 22-27 July will be a milestone event for WHO for a range of reasons: WHO Director-General Dr Tedros will participate in opening ceremony. He will be joined by other senior WHO leaders in attending several key events and engage with HIV community and partners. WHO will host over 20 satellites, workshops or other events and will release several new publications, including on the use of dolutegravir in HIV treatment, HIV testing, pre-exposure prophylaxis, HIV drug resistance, toxicity monitoring, key populations and HIV strategic information. WHO sessions will highlight integrating HIV into universal health coverage, the importance of reaching key populations and addressing the rising HIV epidemics in Eastern Europe and Central Asia

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Weekly Epidemiological Record, 20 July 2018, vol. 93, 29/30 (pp. 388–396)
:: Global Advisory Committee on Vaccine Safety, 6–7 June 2018
 
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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
Selected Featured News
:: WHO secured over 562 000 doses of oral cholera vaccine for pre-emptive campaigns in South Sudan in 2018  21 July 2018
:: Baseline assessment of the national Viral Hepatitis response in Namibia  20 July 2018
:: South Sudan held a high level Polio Transition Advocacy and Resource Mobilization meeting to prevent the collapse of key immunization health system functions  20 July 2018
:: WHO strengthened the National Public Health Laboratory to safely manage infectious specimens in South Sudan  19 July 2018
:: WHO strengthens sentinel surveillance for vaccine preventable diseases  17 July 2018

WHO Region of the Americas PAHO
No new announcements identified.
 
WHO South-East Asia Region SEARO
:: Strengthen efforts to immunize five million unvaccinated children: WHO
SEAR/PR/1691
New Delhi, 17 July 2018: Lauding efforts being made by countries to save more and more lives through immunization, including during public health emergencies, World Health Organization today called for further accelerating efforts to reach the nearly five million unvaccinated children in WHO South-East Asia Region.
“It is critical to identify who are missing vaccination and reach them with lifesaving vaccines. Equity and improving vaccination coverage is the key to preventing resurgence of diseases, especially the ones eradicated with painstaking efforts, and for further reducing diseases and deaths among children,” said Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia, inaugurating a three-day meeting of Immunization Technical Advisory Group, here.
The WHO South-East Asia Region records about 37 million births every year, of them over 88% children are now getting three doses of diphtheria, pertussis and tetanus (DPT) vaccines annually, an indicator of basic vaccination coverage.
“Mapping hard-to-reach areas and population, addressing social and cultural and other barriers for them to access immunization services, and closely monitoring these activities for progress, should be among our immediate priorities,” the Regional Director said…
 
WHO European Region EURO
:: European Commission and WHO strengthen collaboration on public health 19-07-2018
:: How to ensure access to essential medicines for all? New WHO report reviews medicines reimbursement policies in Europe 18-07-2018

WHO Eastern Mediterranean Region EMRO
:: WHO responds to growing health needs in Gaza
Gaza, 18 July 2018 – In response to increasing violence in Gaza, WHO is scaling up its response by providing life-saving medicines and medical supplies to hospitals and frontline trauma stabilization points. Since the start of demonstrations on 30 March, 148 Palestinians have died and 16 496 have been injured. To date, 500 000 emergency and trauma patients have been treated with supplies from WHO’s recent delivery of medicines, assistive devices and medical equipment.

WHO Western Pacific Region
:: WHO calls on businesses to create smoke-free workplaces
MANILA, 16 July 2018 – The World Health Organization is inviting businesses across the Western Pacific Region to join a new campaign, “Revolution Smoke-Free”, and establish smoke-free workplaces in which everyone is free from tobacco smoke in their workplaces and beyond.

Announcements

Announcements
 
AERAS  [to 21 Jul 2018]
http://www.aeras.org/pressreleases
No new digest content identified.
 

BMGF – Gates Foundation  [to 21 Jul 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

Bill & Melinda Gates Medical Research Institute    [to 21 Jul 2018]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

CARB-X   [to 21 Jul 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.
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations  [to 21 Jul 2018]
http://cepi.net/
No new digest content identified.

EDCTP    [to 21 Jul 2018]
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
No new digest content identified.

Emory Vaccine Center    [to 21 Jul 2018]
http://www.vaccines.emory.edu/
No new digest content identified.

European Medicines Agency  [to 21 Jul 2018]
http://www.ema.europa.eu/ema/
16/07/2018
EMA’s proactive publication of clinical data a success
First report on unprecedented transparency policy shows high user satisfaction
The European Medicines Agency (EMA) has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070). Under this policy citizens, including researchers and academics, can directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing authorisation applications for new medicines as of 1 January 2015. Clinical reports give information on the methods used and results of clinical trials conducted to demonstrate the safety and efficacy of medicines.
The report covers one year from the launch of EMA’s clinical data website on 20 October 2016 and lists the 50 medicines for which clinical data were published, including orphan, paediatric, biosimilar and generic medicines, as well as the corresponding 54 regulatory dossiers. These data have attracted a total of 3,641 users, resulting in 22,164 document ‘views’ and 80,537 ‘downloads’ for non-commercial research purposes…
 

European Vaccine Initiative  [to 21 Jul 2018]
http://www.euvaccine.eu/news-events
19 July 2018
First pre-clinical results of the PRIMALVAC project published in npj Vaccines
New article published on 17 July 2018 in npj  Vaccines: “Down-selection of the VAR2CSA DBL1-2 expressed in E. coli as a lead…

FDA [to 21 Jul 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
July 19, 2018 –
 Statement by FDA Commissioner Scott Gottlieb, M.D., on the formation of a new work group to develop focused drug importation policy options to address access challenges related to certain sole-source medicines with limited patient availability, but no blocking patents or exclusivities
 
July 18, 2018 –
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan
 
July 18, 2018 –
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
 
July 17, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs

 
Fondation Merieux  [to 21 Jul 2018]
http://www.fondation-merieux.org/
No new digest content identified.

 
Gavi [to 21 Jul 2018]
http://www.gavi.org/library/news/press-releases/
No new digest content identified.
 
 

GHIT Fund   [to 21 Jul 2018]
https://www.ghitfund.org/newsroom/press
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
No new digest content identified.

Global Fund [to 21 Jul 2018]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Breaking Barriers. Building Bridges.
20 July 2018
Peter Sands, Executive Director of the Global Fund, speaks in our video series from the 22nd International AIDS Conference.

News
New Agreements with HIV Drug Suppliers to Save $324 Million
16 July 2018
GENEVA – The Global Fund to Fight AIDS, Tuberculosis and Malaria has signed multi-year framework agreements with suppliers of HIV medication that will save US$324 million by the end of 2021 and secure the supply of lifesaving drugs for over 4 million people.
The framework agreements, engaging 14 pharmaceutical companies, build an enlarged base of suppliers and deliver cost competitiveness and supply security, essential elements in expanding HIV treatment in the most reliable and cost-effective way. Projected contracts for antiretroviral drugs total US$1.2 billion over the coming four years.
“These agreements are a strategically smart and highly effective way to secure greater volumes of medication that save lives,” said Peter Sands, Executive Director of the Global Fund. “In a complex, high-volume business, it’s a performance-based approach that reduces risk and gets essential HIV drugs at the most competitive prices, with consistency and reliability.”…
 

Hilleman Laboratories   [to 21 Jul 2018]
http://www.hillemanlabs.org/
No new digest content identified.
 

Human Vaccines Project   [to 21 Jul 2018]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 

IAVI  [to 21 Jul 2018]
https://www.iavi.org/
No new digest content identified.

 

IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.

 

IVAC  [to 21 Jul 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 

IVI   [to 21 Jul 2018]
http://www.ivi.int/
No new digest content identified.

 
JEE Alliance  [to 21 Jul 2018]
https://www.jeealliance.org/
No new digest content identified.
 

MSF/Médecins Sans Frontières  [to 21 Jul 2018]
http://www.msf.org/
Selected Press Releases/Statements
Tuberculosis
Last-minute pressure to drop language on protecting access to affordable medicines from TB Summit declaration negotiations
20 Jul 2018

Central African Republic
Protecting as many children as possible in an emergency context
20 Jul 2018
HIV/AIDS
MSF at AIDS 2018
16 Jul 2018
 

NIH  [to 21 Jul 2018]
http://www.nih.gov/news-events/news-releases
July 17, 2018
Broadly acting antibodies found in plasma of Ebola survivors
— NIAID-supported discovery could lead to therapy for deadly illness.

 

PATH  [to 21 Jul 2018]
https://www.path.org/media-center/
July 17, 2018 by PAT

PATH, reimagined
Leading global public health organization celebrates 40th anniversary with dynamic new brand experience

 

Sabin Vaccine Institute  [to 21 Jul 2018]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 

UNAIDS [to 21 Jul 2018]
http://www.unaids.org/en
No new digest content identified.

 

UNICEF  [to 21 Jul 2018]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Statement
Access to children in need in Syria continues to be severely restricted
Statement by Geert Cappelaere, UNICEF Regional Director for the Middle East and North Africa

Press release
16/07/2018
Statement by UNICEF Executive Director Henrietta Fore at High Level Political Forum side event on ending newborn deaths

News note
16/07/2018
Record number of infants vaccinated in 2017
As over 19 million children miss out on vaccinations, UNICEF and WHO call for concerted efforts to reach all children
[See Milestones/Perspectives above for more detail]
 
 

Vaccine Confidence Project  [to 21 Jul 2018]
http://www.vaccineconfidence.org/
No new digest content identified.
 

Vaccine Education Center – Children’s Hospital of Philadelphia  [to 21 Jul 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
Published on Jul 16, 2018
Dr. Offit Addresses Reintroduction of Intranasal Flu Vaccine and Recommendations for Use
After a three-year hiatus, the intranasal flu vaccine is once again recommended for use during the 2018-2019 influenza season. In these videos, Dr. Offit explains the changes to the intranasal flu vaccine and the recommendations regarding its use by the CDC and AAP.
 

Wellcome Trust  [to 21 Jul 2018]
https://wellcome.ac.uk/news
Published: 18 July 2018
How lived experiences of dementias have informed science and the arts
Since October 2016, a team of scientists and artists and people experiencing dementias have been exploring, challenging and shaping perceptions of dementias. As their two-year residency in The Hub at Wellcome Collection draws to a close, here are some highlights
 

The Wistar Institute   [to 21 Jul 2018]
https://www.wistar.org/news/press-releases
No new digest content identified.

World Organisation for Animal Health (OIE)   [to 21 Jul 2018]
http://www.oie.int/en/for-the-media/press releases/2018/
18/07/18
Countries step up to tackle antimicrobial resistance
Paris/Geneva/Rome, 18 July 2018 – Countries are making significant steps in tackling antimicrobial resistance (AMR), but  serious gaps remain and require  urgent action, according to a report released today by the Food and Agriculture Organization of the United Nations (FAO), World Organisation for Animal Health (OIE) and the World Health Organization (WHO).
The report charts progress in 154 countries and reveals wide discrepancies. Some, including many European countries, have been working on AMR policies in human and animal sectors for more than 4 decades. Others have only recently started to take action to contain this growing threat. Progress in developing and implementing plans is greater in high-income than low-income countries but all countries have scope for improvement. No country  reports sustained capacity at scale in all areas.
The report looks at surveillance, education, monitoring and regulating consumption and use of antimicrobials in human health, animal health and production, as well as plants and the environment – as recommended in the Global Action Plan published in 2016…

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BIO    [to 21 Jul 2018]
https://www.bio.org/insights/press-release
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network  [to 21 Jul 2018]
http://www.dcvmn.org/
No new digest content identified

IFPMA   [to 21 Jul 2018]
http://www.ifpma.org/resources/news-releases/
No new digest content identified

PhRMA    [to 21 Jul 2018]
http://www.phrma.org/press-room
No new digest content identified.

Industry Watch  [to 21 Jul 2018]
:: Moderna Opens New Manufacturing Site in Norwood, MA
200,000 Square Foot State-of-the-Art Plant Built to Support Development of mRNA Medicines
July 17, 2018
NORWOOD, Mass.–(BUSINESS WIRE)–Moderna Therapeutics, a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the opening of its state-of-the-art manufacturing facility in Norwood, Massachusetts.
“Thanks to companies like Moderna, Massachusetts continues to be a global leader in the industry and we welcome their growth and investment in Norwood to support the manufacturing market here in the Commonwealth.”
The digitally-enabled and environmentally sustainable 200,000 square foot clinical development manufacturing plant was built to advance Moderna’s pipeline of mRNA-based medicines. Designed to Current Good Manufacturing Practices (cGMP) specifications, the site gives the company the capacity to develop materials for preclinical toxicology studies as well as Phase 1 and 2 clinical development programs, and to manufacture, test and run fill/finish operations for its portfolio of mRNA development candidates.
Today, Moderna has 21 programs in its mRNA pipeline, including potential treatments for different forms of cancer, rare diseases, infectious diseases and heart failure…

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

 

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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

Efficacy, effectiveness and safety of vaccination against human papillomavirus in males: a systematic review

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 21 Jul 2018)
Research article

Efficacy, effectiveness and safety of vaccination against human papillomavirus in males: a systematic review
Human papillomavirus (HPV) vaccination is safe and effective in preventing cervical cancer in females. As HPV infections can also induce cancers of the anus, penis and oral cavity, male vaccination is also adv…
Authors: Thomas Harder, Ole Wichmann, Stefanie J. Klug, Marianne A. B. van der Sande and Miriam Wiese-Posselt
Citation: BMC Medicine 2018 16:110
Published on: 18 July 2018

The impact of demographic changes, exogenous boosting and new vaccination policies on varicella and herpes zoster in Italy: a modelling and cost-effectiveness study

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 21 Jul 2018)
Research article

Research article
The impact of demographic changes, exogenous boosting and new vaccination policies on varicella and herpes zoster in Italy: a modelling and cost-effectiveness study
The present study aims to evaluate the cost-effectiveness of the newly introduced varicella and herpes zoster (HZ) vaccination programmes in Italy. The appropriateness of the introduction of the varicella vacc…
Authors: Alessia Melegaro, Valentina Marziano, Emanuele Del Fava, Piero Poletti, Marcello Tirani, Caterina Rizzo and Stefano Merler
Citation: BMC Medicine 2018 16:117
Published on: 17 July 2018

Modelling population-level impact to inform target product profiles for childhood malaria vaccines

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 21 Jul 2018)
Research article

Research article
Modelling population-level impact to inform target product profiles for childhood malaria vaccines
The RTS,S/AS01 vaccine for Plasmodium falciparum malaria demonstrated moderate efficacy in 5–17-month-old children in phase 3 trials, and from 2018, the vaccine will be evaluated through a large-scale pilot imple…
Authors: Alexandra B. Hogan, Peter Winskill, Robert Verity, Jamie T. Griffin and Azra C. Ghani
Citation: BMC Medicine 2018 16:109
Published on: 13 July 2018

Gender aspects on HIV prevention efforts and participation in HIV vaccine trials among Police officers in Dar es Salaam, Tanzania

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 21 Jul 2018)

Research article
Gender aspects on HIV prevention efforts and participation in HIV vaccine trials among Police officers in Dar es Salaam, Tanzania
For more than three decades, Human Immunodeficiency Virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS) continue to dominate the health agenda. In sub-Saharan African countries, women are at m…
Authors: Edith A. M. Tarimo, Deodatus C. V. Kakoko, Thecla W. Kohi, Muhammad Bakari, Eric Sandstrom, David Siyame, Fred Mhalu and Asli Kulane
Citation: BMC Public Health 2018 18:905
Published on: 21 July 2018

Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 21 Jul 2018)

Study protocol
Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol
ROTAVAC, an indigenous rotavirus vaccine, was introduced in the universal immunization program of India in four states in 2016 and expanded to five more states in 2017. The clinical trial on efficacy of ROTAVA…
Authors: Samarasimha Reddy, Nayana P. Nair, Sidhartha Giri, Venkata Raghava Mohan, Jacqueline E. Tate, Umesh D. Parashar, Mohan D. Gupte, Rashmi Arora and Gagandeep Kang
Citation: BMC Public Health 2018 18:898
Published on: 20 July 2018

The influence of education on the access to childhood immunization: the case of Spain

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 21 Jul 2018)

Research article
The influence of education on the access to childhood immunization: the case of Spain
In order to enhance childhood vaccination uptake and the health consequences for the whole society, there is a need to study predictors that might help in understanding parents’ behaviour in relation to childh…
Authors: T. Mora and M. Trapero-Bertran
Citation: BMC Public Health 2018 18:893
Published on: 18 July 2018

Increasing influenza and pneumococcal vaccine uptake in the elderly: study protocol for the multi-methods prospective intervention study Vaccination60+

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 21 Jul 2018)

Research article
Increasing influenza and pneumococcal vaccine uptake in the elderly: study protocol for the multi-methods prospective intervention study Vaccination60+
Influenza and pneumococcal vaccination can prevent disease and potentially life-threatening complications like sepsis. Elderly people have an increased risk of severe disease and therefore constitute a major t…
Authors: Cornelia Betsch, Constanze Rossmann, Mathias W. Pletz, Horst C. Vollmar, Antje Freytag, Ole Wichmann, Regina Hanke, Wolfgang Hanke, Dorothee Heinemeier, Philipp Schmid, Sarah Eitze, Winja Weber, Anne Reinhardt, Nora K. Küpke, Christina Forstner, Carolin Fleischmann-Struzek…
Citation: BMC Public Health 2018 18:885
Published on: 16 July 2018
 
 

Proceedings of the University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding Data and Safety Monitoring Committees in clinical trials

Clinical Trials
Volume 15 Issue 4, August 2018
http://journals.sagepub.com/toc/ctja/15/3

Conference Proceedings
Proceedings of the University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding Data and Safety Monitoring Committees in clinical trials
Susan S Ellenberg, Jonas H Ellenberg
First Published June 22, 2018; pp. 319–320

How HIPAA Harms Care, and How to Stop It

JAMA
July 17, 2018, Vol 320, No. 3, Pages 215-316
http://jama.jamanetwork.com/issue.aspx

Viewpoint
How HIPAA Harms Care, and How to Stop It
Donald M. Berwick, MD, MPP; Martha E. Gaines, JD, LLM
JAMA. 2018;320(3):229-230. doi:10.1001/jama.2018.8829
In this Viewpoint, Berwick and Gaines review common misconceptions about Health Insurance Portability and Accountability Act (HIPAA) requirements regarding personal health information and propose steps the Department of Health and Human Services (DHHS) can take to better balance privacy protections with the need to ensure health information is available for clinical care in reasonable time at reasonable expense.

HIPAA and Protecting Health Information in the 21st Century

JAMA
July 17, 2018, Vol 320, No. 3, Pages 215-316
http://jama.jamanetwork.com/issue.aspx

HIPAA and Protecting Health Information in the 21st Century
Glenn Cohen, JD; Michelle M. Mello, JD, PhD
JAMA. 2018;320(3):231-232. doi:10.1001/jama.2018.5630
This Viewpoint posits that HIPAA no longer fully protects health information in today’s big data era in which health data are collected and exchanged in nonclinical settings, such as social media, apps, and search engines, and proposes principles around which reform of health information privacy protections should be organized.

Health Data and Privacy in the Digital Era

JAMA
July 17, 2018, Vol 320, No. 3, Pages 215-316
http://jama.jamanetwork.com/issue.aspx

Health Data and Privacy in the Digital Era
Lawrence O. Gostin, JD; Sam F. Halabi, JD, MPhil; Kumanan Wilson, MD, MSc
JAMA. 2018;320(3):233-234. doi:10.1001/jama.2018.8374
This Viewpoint discusses personal health information on social media and other sites and ways in which this information can and should be protected.

Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

JAMA
July 17, 2018, Vol 320, No. 3, Pages 215-316
http://jama.jamanetwork.com/issue.aspx

Research Letter
Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation
Jeremy Puthumana, MS; Joshua D. Wallach, PhD, MS; Joseph S. Ross, MD, MHS
JAMA. 2018;320(3):301-303. doi:10.1001/jama.2018.7619
This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that serve as the basis of FDA approval), and premarket development and review times to assess the strength of evidence supporting breakthrough approvals.
 

Ebola virus disease: 11,323 deaths later, how far have we come?

The Lancet
Jul 21, 2018 Volume 392 Number 10143 p187-252  e4-e5
https://www.thelancet.com/journals/lancet/issue/current

Ebola virus disease: 11,323 deaths later, how far have we come?
Joseph A Lewnard
…The data presented by the Ebola Outbreak Epidemiology Team indicate key areas of progress since the 2014 outbreak in west Africa. By contrast with a 5·0 day average time from illness onset to hospitalisation in that outbreak, and 4·7 days in an outbreak in the Democratic Republic of the Congo in the same year, the median time from illness onset to first hospitalisation was 1 day (range 0–10).2, 3, 4 Rapid case ascertainment and isolation narrows a crucial period of transmission risk within households and communities, and was facilitated by installation of Ebola virus disease treatment centres in Bikoro, Iboko, and Mbandaka by Médecins Sans Frontières mere days after the outbreak declaration.1 Modelling studies indicate that such timely mobilisation could have averted thousands of deaths from Ebola virus disease in west Africa,5, 6 many outside the doors of treatment centres that were already operating at capacity.
An efficacious, field-tested vaccine (rVSV-ZEBOV) is among the most important developments since 2014.7 Within 2 weeks of the outbreak declaration, more than 7500 doses were delivered to the Democratic Republic of the Congo for administration to primary and secondary contacts of cases. The authors report coverage among 496 of 504 vaccine-eligible contacts as of May 30, 2018;2 by June 16, 2920 contacts had been reached.1 On-the-ground vaccination teams—some operating in communities without electricity or telecommunications, and maintaining −70°C cold chains on the backs of motorcycles2, 8—have performed a heroic feat in this first use of the vaccine outside Guinea. Ongoing studies of clinical outcomes, immunological parameters, and adverse events among recipients will provide important data about vaccine safety and effectiveness…

A new step towards an HIV/AIDS vaccine

The Lancet
Jul 21, 2018 Volume 392 Number 10143 p187-252  e4-e5
https://www.thelancet.com/journals/lancet/issue/current

Comment
A new step towards an HIV/AIDS vaccine
George N Pavlakis, Barbara K Felber
A preventive vaccine is an essential part of the strategy to eradicate the HIV pandemic.1 Although the search for an AIDS vaccine has led to many scientific advances, a vaccine remains out of reach. Major impediments include the protean ability of HIV to mutate rapidly and the lack of definitive correlates of vaccine protection. Over the years, a multitude of vaccine methodologies have been tested, but few have progressed to efficacy trials2–7 and only one provided evidence for protection.7 Current HIV vaccine efficacy trials aim to improve on the success of the RV144 trial7 in Thailand, which showed a modest 31·2% protection.

Outbreak of Ebola virus disease in the Democratic Republic of the Congo, April–May, 2018: an epidemiological study

The Lancet
Jul 21, 2018 Volume 392 Number 10143 p187-252  e4-e5
https://www.thelancet.com/journals/lancet/issue/current

Articles
Outbreak of Ebola virus disease in the Democratic Republic of the Congo, April–May, 2018: an epidemiological study
The Ebola Outbreak Epidemiology Team
Summary
Background
On May 8, 2018, the Government of the Democratic Republic of the Congo reported an outbreak of Ebola virus disease in Équateur Province in the northwest of the country. The remoteness of most affected communities and the involvement of an urban centre connected to the capital city and neighbouring countries makes this outbreak the most complex and high risk ever experienced by the Democratic Republic of the Congo. We provide early epidemiological information arising from the ongoing investigation of this outbreak.
Methods
We classified cases as suspected, probable, or confirmed using national case definitions of the Democratic Republic of the Congo Ministère de la Santé Publique. We investigated all cases to obtain demographic characteristics, determine possible exposures, describe signs and symptoms, and identify contacts to be followed up for 21 days. We also estimated the reproduction number and projected number of cases for the 4-week period from May 25, to June 21, 2018.
Findings
As of May 30, 2018, 50 cases (37 confirmed, 13 probable) of Zaire ebolavirus were reported in the Democratic Republic of the Congo. 21 (42%) were reported in Bikoro, 25 (50%) in Iboko, and four (8%) in Wangata health zones. Wangata is part of Mbandaka, the urban capital of Équateur Province, which is connected to major national and international transport routes. By May 30, 2018, 25 deaths from Ebola virus disease had been reported, with a case fatality ratio of 56% (95% CI 39–72) after adjustment for censoring. This case fatality ratio is consistent with estimates for the 2014–16 west African Ebola virus disease epidemic (p=0·427). The median age of people with confirmed or probable infection was 40 years (range 8–80) and 30 (60%) were male. The most commonly reported signs and symptoms in people with confirmed or probable Ebola virus disease were fever (40 [95%] of 42 cases), intense general fatigue (37 [90%] of 41 cases), and loss of appetite (37 [90%] of 41 cases). Gastrointestinal symptoms were frequently reported, and 14 (33%) of 43 people reported haemorrhagic signs. Time from illness onset and hospitalisation to sample testing decreased over time. By May 30, 2018, 1458 contacts had been identified, of which 746 (51%) remained under active follow-up. The estimated reproduction number was 1·03 (95% credible interval 0·83–1·37) and the cumulative case incidence for the outbreak by June 21, 2018, is projected to be 78 confirmed cases (37–281), assuming heterogeneous transmissibility.
Interpretation
The ongoing Ebola virus outbreak in the Democratic Republic of the Congo has similar epidemiological features to previous Ebola virus disease outbreaks. Early detection, rapid patient isolation, contact tracing, and the ongoing vaccination programme should sufficiently control the outbreak. The forecast of the number of cases does not exceed the current capacity to respond if the epidemiological situation does not change. The information presented, although preliminary, has been essential in guiding the ongoing investigation and response to this outbreak.
Funding
None.

Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)

The Lancet
Jul 21, 2018 Volume 392 Number 10143 p187-252  e4-e5
https://www.thelancet.com/journals/lancet/issue/current

Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)
Dan H Barouch, Frank L Tomaka, Frank Wegmann, Daniel J Stieh, Galit Alter, Merlin L Robb, Nelson L Michael, Lauren Peter, Joseph P Nkolola, Erica N Borducchi, Abishek Chandrashekar, David Jetton, Kathryn E Stephenson, Wenjun Li, Bette Korber, Georgia D Tomaras, David C Montefiori, Glenda Gray, Nicole Frahm, M Juliana McElrath, Lindsey Baden, Jennifer Johnson, Julia Hutter, Edith Swann, Etienne Karita, Hannah Kibuuka, Juliet Mpendo, Nigel Garrett, Kathy Mngadi, Kundai Chinyenze, Frances Priddy, Erica Lazarus, Fatima Laher, Sorachai Nitayapan, Punnee Pitisuttithum, Stephan Bart, Thomas Campbell, Robert Feldman, Gregg Lucksinger, Caroline Borremans, Katleen Callewaert, Raphaele Roten, Jerald Sadoff, Lorenz Scheppler, Mo Weijtens, Karin Feddes-de Boer, Daniëlle van Manen, Jessica Vreugdenhil, Roland Zahn, Ludo Lavreys, Steven Nijs, Jeroen Tolboom, Jenny Hendriks, Zelda Euler, Maria G Pau, Hanneke Schuitemaker
Summary
Background
More than 1·8 million new cases of HIV-1 infection were diagnosed worldwide in 2016. No licensed prophylactic HIV-1 vaccine exists. A major limitation to date has been the lack of direct comparability between clinical trials and preclinical studies. We aimed to evaluate mosaic adenovirus serotype 26 (Ad26)-based HIV-1 vaccine candidates in parallel studies in humans and rhesus monkeys to define the optimal vaccine regimen to advance into clinical efficacy trials.
Methods
We conducted a multicentre, randomised, double-blind, placebo-controlled phase 1/2a trial (APPROACH). Participants were recruited from 12 clinics in east Africa, South Africa, Thailand, and the USA. We included healthy, HIV-1-uninfected participants (aged 18–50 years) who were considered at low risk for HIV-1 infection. We randomly assigned participants to one of eight study groups, stratified by region. Participants and investigators were blinded to the treatment allocation throughout the study. We primed participants at weeks 0 and 12 with Ad26.Mos.HIV (5 × 1010 viral particles per 0·5 mL) expressing mosaic HIV-1 envelope (Env)/Gag/Pol antigens and gave boosters at weeks 24 and 48 with Ad26.Mos.HIV or modified vaccinia Ankara (MVA; 108 plaque-forming units per 0·5 mL) vectors with or without high-dose (250 μg) or low-dose (50 μg) aluminium adjuvanted clade C Env gp140 protein. Those in the control group received 0·9% saline. All study interventions were administered intramuscularly. Primary endpoints were safety and tolerability of the vaccine regimens and Env-specific binding antibody responses at week 28. Safety and immunogenicity were also assessed at week 52. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. We also did a parallel study in rhesus monkeys (NHP 13-19) to assess the immunogenicity and protective efficacy of these vaccine regimens against a series of six repetitive, heterologous, intrarectal challenges with a rhesus peripheral blood mononuclear cell-derived challenge stock of simian-human immunodeficiency virus (SHIV-SF162P3). The APPROACH trial is registered with ClinicalTrials.gov, number NCT02315703.
Findings
Between Feb 24, 2015, and Oct 16, 2015, we randomly assigned 393 participants to receive at least one dose of study vaccine or placebo in the APPROACH trial. All vaccine regimens demonstrated favourable safety and tolerability. The most commonly reported solicited local adverse event was mild-to-moderate pain at the injection site (varying from 69% to 88% between the different active groups vs 49% in the placebo group). Five (1%) of 393 participants reported at least one grade 3 adverse event considered related to the vaccines: abdominal pain and diarrhoea (in the same participant), increased aspartate aminotransferase, postural dizziness, back pain, and malaise. The mosaic Ad26/Ad26 plus high-dose gp140 boost vaccine was the most immunogenic in humans; it elicited Env-specific binding antibody responses (100%) and antibody-dependent cellular phagocytosis responses (80%) at week 52, and T-cell responses at week 50 (83%). We also randomly assigned 72 rhesus monkeys to receive one of five different vaccine regimens or placebo in the NHP 13-19 study. Ad26/Ad26 plus gp140 boost induced similar magnitude, durability, and phenotype of immune responses in rhesus monkeys as compared with humans and afforded 67% protection against acquisition of SHIV-SF162P3 infection (two-sided Fisher’s exact test p=0·007). Env-specific ELISA and enzyme-linked immunospot assay responses were the principal immune correlates of protection against SHIV challenge in monkeys.
Interpretation
The mosaic Ad26/Ad26 plus gp140 HIV-1 vaccine induced comparable and robust immune responses in humans and rhesus monkeys, and it provided significant protection against repetitive heterologous SHIV challenges in rhesus monkeys. This vaccine concept is currently being evaluated in a phase 2b clinical efficacy study in sub-Saharan Africa (NCT03060629).
Funding
Janssen Vaccines & Prevention BV, National Institutes of Health, Ragon Institute of MGH, MIT and Harvard, Henry M Jackson Foundation for the Advancement of Military Medicine, US Department of Defense, and International AIDS Vaccine Initiative.

 

Time to deliver: report of the WHO Independent High-Level Commission on NCDs

The Lancet
Jul 21, 2018 Volume 392 Number 10143 p187-252  e4-e5
https://www.thelancet.com/journals/lancet/issue/current

Commission
Time to deliver: report of the WHO Independent High-Level Commission on NCDs
Sania Nishtar, Sauli Niinistö, Maithripala Sirisena, Tabaré Vázquez, Veronika Skvortsova, Adolfo Rubinstein, Festus Gontebanye Mogae, Pirkko Mattila, Seyyed Hassan Ghazizadeh Hashemi, Sicily Kariuki, José Narro Robles, Isaac F Adewole, Adboulaye Diouf Sarr, Kim Yong Gan, Saia Ma’u Piukala, Abdul Rahman Bin Mohammed Al Owais, Eric Hargan, George Alleyne, Ala Alwan, Arnaud Bernaert, Michael Bloomberg, Katie Dain, Tom Frieden, Vikram Harshad Patel, Annette Kennedy, Ilona Kickbusch, Commissioners of the WHO Independent High-Level Commission on NCDs