Vaccine
Volume 36, Issue 4   Pages 427-594 (25 January 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/4

HIV population-level adaptation can rapidly diminish the impact of a partially effective vaccine
Open access – Original research article
Pages 514-520
Joshua T. Herbeck, Kathryn Peebles, Paul T. Edlefsen, Morgane Rolland, … Steven M. Goodreau
Development of an HIV vaccine might be essential to ending the HIV/AIDS pandemic. However, vaccines can result in the emergence and spread of vaccine-resistant strains. Indeed, analyses of breakthrough infections in the HIV phase 3 vaccine trial RV144 identified HIV genotypes with differential rates of transmission in vaccine and placebo recipients. We hypothesized that, for HIV vaccination programs based on partially effective vaccines similar to RV144, HIV adaptation will rapidly diminish the expected vaccine impact.

Vaccine
Volume 36, Issue 4   Pages 427-594 (25 January 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/4

Healthcare worker’s attitude to seasonal influenza vaccination in the South Tyrolean province of Italy: barriers and facilitators
Original research article
Pages 535-544
Andrea Rabensteiner, Alessandra Buja, Dagmar Regele, Martin Fischer, Vincenzo Baldo

Vaccine
Volume 36, Issue 4   Pages 427-594 (25 January 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/4

Measuring vaccine acceptance among Canadian parents: A survey of the Canadian Immunization Research Network
Original research article
Pages 545-552
Eve Dubé, Dominique Gagnon, Manale Ouakki, Julie A. Bettinger, … Devon Greyson

Vaccine
Volume 36, Issue 4   Pages 427-594 (25 January 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/4

Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008–2012
Original research article
Pages 553-558
Beth F. Hibbs, Elaine Miller, Jing Shi, Kamesha Smith, … Tom T. Shimabukuro

Vaccine
Volume 36, Issue 4   Pages 427-594 (25 January 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/4

Predictors of measles vaccination coverage among children 6–59  months of age in the Democratic Republic of the Congo
Open access – Original research article
Pages 587-593
Hayley R. Ashbaugh, Nicole A. Hoff, Reena H. Doshi, Vivian H. Alfonso, … Anne W. Rimoin
Highlights
:: DRC’s overall measles vaccination coverage level of 70% is too low to halt the spread of measles.
:: Socioeconomic variables and residence are associated with vaccination coverage disparities.
:: Vaccination coverage and data quality are linked, and as such, dated records must be increased.

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

 
Frontiers in Public Health
Received: 11 Nov 2017; Accepted: 16 Jan 2018. doi: 10.3389/fpubh.2018.00013
Original Research Aerticle
National immunisation campaigns with oral polio vaccine reduce all-cause mortality: A natural experiment within seven randomised trials
Andreas Andersen1, Ane B. Fisker1, Amabelia Rodrigues1, Cesario Martins1, Henrik Ravn1, Najaaraq Lund1, Sofie Biering-Sørensen1, Christine S. Benn1 and Peter Aaby1*
Abstract
Background
A recent WHO review concluded that live BCG and measles vaccine (MV) may have beneficial non-specific effects (NSEs) reducing mortality from non-targeted diseases. NSEs of oral polio vaccine (OPV) were not examined. If OPV vaccination campaigns reduce the mortality rate it would suggest beneficial NSEs.
Setting
Between 2002 and 2014 Guinea-Bissau had 15 general OPV campaigns and other campaigns with OPV plus vitamin A supplementation (VAS), VAS-only, MV and H1N1 vaccine. In this period, we conducted seven randomised controlled trials (RCTs) with mortality as main outcome.
Methods
Within these RCTs we assessed whether the mortality rate was lower after-campaign than before-campaign. We used Cox models with age as underlying time and further adjusted for low birth-weight, season and time trend in mortality. We calculated the adjusted mortality rate ratio (MRR) for after-campaign versus before-campaign.
Results
The mortality rate was lower after OPV-only campaigns than before, the MRR being 0.81 (95% CI=0.68-0.95). With each additional dose of campaign-OPV the mortality rate declined further (MRR=0.87 (95% CI: 0.79-0.96) per dose) (test for trend, p=0.005). No other type of campaign had similar beneficial effects. Depending on initial age and with follow-up to 3 years of age, the number needed to treat with campaign-OPV-only to save one life was between 68 and 230 children.
Conclusions
Bissau had no case of polio infection so the results suggest that campaign-OPV has beneficial NSEs. Discontinuation of OPV-campaigns in low-income countries may affect general child mortality levels negatively

Journal of Pediatric Infectious Diseases
DOI: 10.1055/s-0037-1620266
Original Article
Development of Vaccine Preferences among Parents of Newborns
JN Yarnall, J Knowles, JA Lohr -, 2018
Abstract
Objective
Vaccine hesitancy and refusal and the resulting outbreaks of vaccine-preventable diseases continue to be an issue today. Most of contemporary research on these issues has focused on underlying characteristics of non-vaccinators and ambivalent parents; however, few studies have looked into how or when vaccine preferences develop. In this study, we sought to explore when parental preferences for vaccines develop in relation to a pregnancy. We also examined self-reported influences on vaccine decision making.
Methods
We recruited and administered a short survey to parents at the North Carolina Women’s Hospital in Chapel Hill, NC, following the birth of their child from February to April 2015.
Results
A total of 166 parents (55%) completed the entire survey. Seventy-two percent of surveyed parents reported deciding on their vaccine preferences for their newborn before conception. Parents who were older, Caucasian, married, and had attained higher levels of education were significantly more likely to develop preconception vaccine preferences. The presence of partner conversations in the past and the desire for more information on vaccines were also significant predictors of preconception vaccine preference development. After logistic regression adjustment, only education level and past vaccine conversations remained significant. The most common influences for vaccine decision making were family, friends, and medical staff and organizations.
Conclusion
Our study documents that a majority of parents establish vaccine decision making and preferences before conception. Notable influences from friends, family, and medical sources are part of the process. These findings suggest that vaccine information and interventions currently are given too late in the vaccine preference decision-making process.

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.

Forbes
http://www.forbes.com/
Accessed 27 January 2018
Here Are 2 Possible Steps Toward A Universal Flu Vaccine
24 Jan 2018
Bruce Y. Lee, Contributor
This year’s harsher flu season is a not-so-gentle reminder that we really, really need a universal flu vaccine, a vaccine that works against all influenza viruses. Are newly published studies in the journal Science and in the journal Nature Communications significant steps?
 
The Guardian
http://www.guardiannews.com/
Accessed 27 January 2018
Brazil yellow fever crisis: dozens dead as São Paulo closes city …
24 Jan 2018
… São Paulo closed its zoo and botanical gardens Tuesday as a yellow fever outbreak that has led to 70 deaths is picking up steam. The big Inhotim art park, which attracts visitors from all over the world, also announced that all visitors would have to show proof of vaccination to be allowed in…
 
The anti-vaxxers have a new target in their sights – pets | Life and …
24 Jan 2018
… A growing movement of animal anti-vaccine advocates claim that immunising cats and dogs can cause a range of diseases and disorders – including autism.
 
New York Times
http://www.nytimes.com/
Accessed 27 January 2018
Killing of Mother-Daughter Team Shakes Polio Fighters in Pakistan
The country had just eight polio cases last year. The murder of a 38-year-old woman and her 16-year-old daughter won’t derail vaccinations, a leader says.
January 22, 2018 – By DONALD G. McNEIL Jr –

New UNICEF Chief to Engage Private Sector to Help Children
19 January 2018  By THE ASSOCIATED PRESS

The new leader of UNICEF says the children’s agency is taking a new approach in 2018 by engaging with private companies to help prepare young people for productive lives.
In an interview with The Associated Press, executive director Henrietta Holsman Fore said she plans to draw on her experience in the business and development worlds. The American was the first woman to lead the U.S. Agency for International Development and was CEO of Holsman International, an investment and management firm….
 
Times of India
https://timesofindia.indiatimes.com/
Accessed 27 January 2018
India: Vaccines from Chengalpet complex will meet three-fourths of country’s requirements, minister says
25 January 2018
Work on the Integrated Vaccine Complex — a nodal centre for manufacture and research of vaccines — in Chengalpet is complete and it will be dedicated to the nation soon, Tamil Nadu health minister C Vijaya Baskar said on Thursday. The complex will supply vaccines at affordable prices for the centre’s Universal Immunisation Programme (UIP). The vaccines manufactured from here would meet three-fourths of the country’s requirements, particularly for infants and women, the minister said. The centre will produce over 500 million doses of pentavalent combination (DPT plus Hep B plus Hib), BCG and other vaccines, the minister said.
 
Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 27 January 2018
U.S.–Schools Close as Flu Epidemic Spreads
1/27/2018
By Sarah Toy, Tawnell D. Hobbs
Schools in at least 11 states have closed as the worst flu epidemic in nearly a decade intensifies

Think Tanks et al

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 27 January 2018
Blog Post
Measuring the Reproductive Ecosystem: Modern Contraception and Women’s Empowerment in the Developing World
1/24/18
Nancy Birdsall
Modern contraception may be the single most important technology for development—it liberates women to think ahead, as men have always been able to do. Last month, CGD hosted the Third Annual Birdsall House Conference on Women: “Reproductive Choices to Life Chances: New and Existing Evidence on the Impact of Contraception on Women’s Empowerment.” The conference featured presentations from some of the world’s top scholars.

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

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

– pdf version:  A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_20 Jan 2018

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

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

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

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

Milestones :: Perspectives

142nd session of the WHO Executive Board
19 January 2018 – Next week the WHO Executive Board will set the agenda for the World Health Assembly, and determine how to best promote health, keep the world safe, and serve the vulnerable. The session takes place on
22–27 January 2018 in Geneva, Switzerland, and will be webcast live.
:: Provisional agenda
:: All documentation
[Selected Documentation]
EB142/10 – Public health preparedness and response
Implementation of the International Health Regulations (2005)
 
EB142/11 – Polio transition planning
 
EB142/13 – Addressing the global shortage of, and access to, medicines and vaccines

EB142/16 – Preparation for a high-level meeting of the General Assembly on ending tuberculosis
 
EB142/24 – Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits
 
EB142/35 – Global vaccine action plan
 
EB142/37 – Eradication of poliomyelitis

CDC to Scale Back Work in Dozens of Foreign Countries Amid Funding Worries

Efforts to prevent infectious-disease epidemics and other health threats were funded mostly through a five-year supplemental package
By  Betsy McKay
Wall Street Journal, Jan. 19, 2018 4:51 p.m. ET
The Centers for Disease Control and Prevention plans to scale back or discontinue its work to prevent infectious-disease epidemics and other health threats in 39 foreign countries because it expects funding for the work to end, the agency told employees.

The CDC currently works in 49 countries as part of an initiative called the global health security agenda, to prevent, detect and respond to dangerous infectious disease threats. It helps expand surveillance for new viruses and​ ​drug-resistant bacteria, modernize laboratories to detect dangerous pathogens​and train workers who respond to epidemics.

The activities are funded mostly through a five-year supplemental package that was awarded to the CDC and other government agencies in fiscal 2015 to respond to the Ebola epidemic in West Africa.

The package included $582 million in funds to work with countries around the world after the Ebola crisis in 2014 and 2015. But that funding runs out at the end of fiscal 2019.

Public health leaders had said they hoped dollars for the work would eventually be added into the CDC’s core budget, after the epidemic delivered a wake-up call about the world’s lack of preparedness for deadly epidemics. More than 11,300 people died in the Ebola epidemic, mainly in Africa.

In an email to U.S. and overseas leaders in its global health center, the CDC said it anticipates that if its funding situation remains the same, it will have to narrow activities to 10 “priority countries” starting in October 2019. The email was reviewed by The Wall Street Journal.

The Division of Global Health Protection “will have to scale its global health security portfolio to focus efforts based on existing resources,” wrote Rebecca Martin, director of the CDC’s Center for Global Health. “Faced with this anticipated fiscal reality, we have had to make some very difficult decisions.”

The 10 countries where global health security activities will remain are India, Thailand, Vietnam, Kenya, Uganda, Liberia, Nigeria, Senegal, Jordan and Guatemala, according to the email—countries of strategic or regional importance for the CDC.

Other countries where the agency currently conducts global health security agenda activities include Democratic Republic of the Congo, one of the world’s main hot spots for emerging infectious diseases and the site of the first Ebola outbreak in history; Pakistan; Indonesia; Haiti; and China, where CDC provides technical assistance to the country, which is devoting increasing resources to global health needs. In these 39 countries, the CDC “will plan for the completion of its country-based programs,” transitioning them to other possible funders by October 2020, according to the email.

But if more funding becomes available in fiscal 2019, work in the 10 priority countries could be enhanced and could continue in some of the other countries, according to the email.

Those countries next on the priority list, after the top 10, are China, the DRC, Ethiopia, Indonesia and Sierra Leone, according to another CDC document reviewed by the Journal.

The CDC said in a statement that it is taking these steps now because “we recognize the need for forward planning, and are confident that by planning now we will successfully achieve smooth transitions.”

The CDC is carrying out the work as part of a global health security agenda launched in 2014. Professionals trained in the initiative have helped quickly contain an anthrax outbreak in Kenya and yellow fever in Uganda and identify over 4,000 cases of measles in Sierra Leone.

Reductions now would halt critical work midstream and result in a loss of newly trained local experts, said Tom Frieden, the former CDC director who led the effort until a year ago and is now president and chief executive of Resolve to Save Lives, an initiative working on strengthening epidemic preparedness.

“They’re more likely to have outbreaks and less likely to be able to stop them themselves,” he said of countries that will be affected. “We’ll have to respond instead of having them respond.”
The global health security agenda is “the most important international intervention for emerging infectious disease infrastructure in many years,” said Tom Inglesby, director of the Center for Health Security of the Johns Hopkins Bloomberg School of Public Health. He added that U.S. leadership has helped persuade other nations to help fund the effort.

The CDC will continue to help respond to emerging disease threats and conduct work that had already been under way to improve detection of emerging infectious diseases globally. It will also continue programs combating HIV, tuberculosis, malaria, flu, and conducting immunization programs, Dr. Martin wrote.

Inoculate against a global vaccine crisis

By Laurie Garrett
Foreign Policy – 16 January 2018
On Feb. 27, 2017, the World Health Organization (WHO) named a dozen bacteria as major global health threats, underscoring the surge in antibiotic resistance and paucity of vaccines that, combined, now render incurable the infections caused by those germs.

There is plenty to fret about on the microbial front at the moment: Several scary strains of flu are circulating, and Australia’s winter 2017 flu season was one of the country’s deadliest in recent years. Any hope of protecting the world, generally, against the resurgence of old microbes, as well as the emergence of new ones — man-made biological menaces, for example — hinges on resolving the breakdown in the manufacturing of vaccines and moving the best, most applicable pharmaceutical innovations into the commercial pipeline for affordable access.

Ever since the 2014 Ebola epidemic in West Africa claimed 11,000 lives, global health experts, including those at Doctors Without Borders, have insisted on WHO reforms and an overhaul of the ways governments respond to outbreaks. But topping the list of needed changes is the speed with which the pharmaceutical industry develops new vaccines to guard against everything from Zika virus and tuberculosis to Ebola and drug-resistant bacteria.

But the reality is that … the world faces an even bigger problem: shortages and completely diminished stores of older but highly effective vaccines and a shrinking pool of manufacturers that can produce them.

This search for new protections against infection captured attention at the World Economic Forum in Davos, Switzerland, in January 2017 and at the G-20 summit later in July. It’s certainly appealing to imagine that pharmaceutical innovation fueled by Wall Street investments could lead to the quick creation of technological solutions to ward off outbreaks. But the reality is that, as 2018 begins, the world faces an even bigger problem: shortages and completely diminished stores of older but highly effective vaccines and a shrinking pool of manufacturers that can produce them.

In an average year between 2011 and 2015, data submitted to WHO and UNICEF showed that one-third of 194 countries ran out of a vaccine for a month or longer. Nearly 13 million infants received no vaccines at all in 2016, and by 2017 supplies of vaccines that target yellow fever, hepatitis B, cholera, meningitis C, diphtheria, whooping cough, tetanus, hepatitis A, and tuberculosis were critically low. And these shortages are acute in both poor and rich countries, with 77 percent of European nations telling WHO in 2015 that they had depleted supplies. By September 2017, Switzerland was experiencing shortages of 16 essential vaccines, prompting Daniel Desgrandchamps, an infectious diseases expert at the University of Geneva, to say, “This isn’t a Swiss problem — it’s an international problem.… I can’t remember a situation like this in my 30 years of professional life as a vaccination expert.”

The global pharmaceutical market is worth more than $1 trillion a year, but the vaccines portion of it is trivial, amounting to merely $24 billion — or about 2.4 percent. Yet the tried-and-true ways of targeting viruses and bacteria to prevent infection garner less industry interest. Though low profit margins, despite high demand, have long blocked the vaccine pipeline, the situation is worsening and now has impact on new product development. Few solutions have been suggested, but one country — Brazil — was able to handle a potentially catastrophic shortage better than any other because it manufactures its own vaccines in a unique public-private arrangement that fulfills the country’s constitutional requirement of providing health care for all of its citizens. The government sets production priorities and purchases from local pharmaceutical manufacturers, avoiding the unreliable international market.

In 2016, outbreaks of two mosquito-spread viruses — yellow fever and Zika — exploded in Angola and Brazil, respectively. The yellow fever outbreak spread to nearby Democratic Republic of the Congo as the entire world supply of yellow fever vaccine dwindled dangerously toward zero.

The irony is that the vaccine is almost 100 percent effective and a full dose protects patients for life. But the drug had become so cheap — by 2008, it cost a mere 60 cents for each vaccine — that few companies were interested in making it. With tens of millions of African lives at stake, WHO took a big gamble, diluting donated vaccines from countries such as Brazil — which donated 18 million doses — by 5 to 1 and hoping they would still work. Briefly, by January 2017, the epidemic seemed to be under control. But then it began to sweep across Brazil and the region, with cases popping up in the states of São Paulo and Rio de Janeiro. As the disease continued to spread, placing the global supply under further strain, stockpiles at the U.S. Centers for Disease Control and Prevention (CDC) disappeared. The CDC now estimates that its supplies won’t be replenished until the end of 2018, perhaps not until 2019.

The Zika epidemic and vaccine invention offer a cautionary tale of how these contradicting interests culminate in a less-than-desirable scenario. Before Zika first surfaced in Brazil in 2015 and then spread across the Americas, it had been too obscure to draw pharmaceutical industry interest. But once it hit Puerto Rico and Florida, the industry raced to create a vaccine, and the manufacturer Sanofi developed one that seemed safe and almost completely effective. Officials sighed in relief. But in 2017, when an epidemic in the wealthy United States failed to materialize, Sanofi shut down its Zika vaccine program. And as the year closed, another manufacturer, Merck, failed to apply to the U.S. Food and Drug Administration for approval of its Ebola vaccine — a product supported by strong clinical data — even after signing a $5 million advance purchase commitment with Gavi, the global vaccine alliance.

The challenge for 2018 will be finding a way to keep the pharmaceutical pipeline flowing, both for vaccines against 20th-century threats such as measles and cholera and for 21st-century challenges including SARS, MERS, new forms of deadly influenza, and the unknown microbes lurking out there. Many things have been tried: creating pots of gold for guaranteed bulk purchases, improving global shipping and delivery systems to better target limited supplies, and promoting the entry of vaccine manufacturers from emerging economies. These measures have acted like fingers in a dike, holding back a flood of further market failures. But Doctors Without Borders and many global health leaders fear that nothing less than a change to the capitalist underpinnings of the pharmaceutical industry will resolve the vaccine crisis — a step so extreme that only Brazil and a handful of left-leaning nations have dared put in practice.
     Garrett is a Pulitzer Prize-winning writer and global health policy analyst.

Featured Journal Content

Science

18 January 2018
Letter
Vaccine mandates in France will save lives
by Stanley A. Plotkin, Paul Offit, Pierre Bégué
In their Letter “France’s risky vaccine mandates” (27 October 2017, p. 458), J. K. Ward et al. question the adoption of mandatory vaccination in France. Their prediction that such a step will encourage resistance to vaccination is unsupported by the facts and could prolong a dangerous situation in which French citizens have the right to allow their children to catch and transmit potentially fatal infections.
The French recommendation—which has now gone into effect (1)—was the product of two juries composed of both medical professionals and lay citizens (2), suggesting that Ward et al.’s concerns about acceptance by doctors and the public are unfounded. Moreover, evidence shows that mandates are effective. In California, immunization rates increased after so-called “philosophical exemptions” were eliminated (3).
Vaccine-hesitancy in French physicians has been found to be only moderate in prevalence (4). Even one vaccine-hesitant doctor is too many, but Ward et al. do not offer a solution to the problem, such as better education by medical schools. Furthermore, a reference cited by Ward et al. does not, as they claim, show that mandating vaccines increases antivaccinationism, but rather that citing dangers of diseases is more effective than arguing for safety of vaccination (5).
Ward et al.’s reasoning could be extrapolated to argue against mandating car seats for young    children. Like car seats, vaccination mandates will likely save lives.

References
.1. Association Française de Pédiatrie Ambulatoire, Obligation Vaccinale: Ce Qu’il Faut Savoir (2018); https://afpa.org/obligation-vaccinale/ [in French].
.2. Concertation Citoyenne sur la Vaccination, “Rapport sur la Vaccination” (2016); http://concertationvaccination.fr/la-restitution/.
.3. L. Sun, “California vaccination rate hits new high after tougher immunization law,” Washington Post (2017).
.4. P. Verger et al., Euro Surveill. 27, 30406 (2016).
.5. Z. Horne et al, ., Proc. Natl. Acad. Sci. U.S.A. 112, 10321 (2015).

Featured Journal Content

Pan American Journal of Public Health
December 2017
Special Issue

The past, present, and future of immunization in the Americas
Jon Kim Andrus1, Ananda Sankar Bandyopadhyay2, M. Carolina Danovaro-Holliday3, Vance Dietz4, Carla Domingues5, J. Peter Figueroa6, Leila Posenato Garcia7, Alan Hinman8, Mirta Roses9, Cuauhtémoc Ruiz Matus10, Jose Ignácio Santos11, Fred Were12
The Pan American Journal of Public Health recognizes with appreciation the contributions of the members of the Editorial Committee, and authors of the Overview article. Their contributions and dedication to this issue on immunization in the Region of the Americas were extraordinary and helped make the manuscripts more interesting, more accurate, and more useful to our readers and all others who work to improve the health of the peoples of the Americas. The Journal would like to give special thanks to the General Coordination of the National Immunization Program, Department of Transmissible Disease Surveillance, Health Surveillance Secretariat, Ministry of Health, Brazil, whose financial and programmatic contributions were essential to the publication of this special issue.

Leadership in global health: the case of Ciro de Quadros, a testament to values, valor, and vision
Andrus, Jon Kim (2017-12)
When Dr. Bill Foege wrote “When Words Fail,” he was referring to how difficult it was for him to describe adequately, in written words, all the effort that is involved from the scientific conceptualization of a new …

Policies and processes for human papillomavirus vaccination in Latin America and the Caribbean
De la Hoz Restrepo, Fernando; Alvis Guzman, Nelson; De la Hoz Gomez, Alejandro; Ruiz, Cuauhtémoc (2017-12)
[ABSTRACT]. Objectives. Three highly effective vaccines are available to prevent human papillomavirus (HPV) infection, and they have been introduced in many countries around the world. This article describes advances and …

The Expanded Program on Immunization in the English- and Dutch-speaking Caribbean (1977–2016): reasons for its success
Lewis-Bell, Karen N.; Irons, Beryl; Ferdinand, Elizabeth; Jackson, Laura L.; Figueroa, J. Peter (2017-12)
[ABSTRACT]. The year 2017 marks the 40th year of the establishment of the Expanded Program on Immunization (EPI) by the Pan American Health Organization (PAHO), the regional office of the World Health Organization (WHO) …

Progress towards a comprehensive approach to maternal and neonatal immunization in the Americas
Ropero Alvarez, Alba Maria; Jauregui, Barbara; El Omeiri, Nathalie (2017-12)
[ABSTRACT]. Maternal and neonatal immunization (MNI) is a core component of the new immunization model in the Americas, which transitioned from immunization of children to that of the entire family. Immunization during …

Experiencia del desarrollo de herramientas para el monitoreo de coberturas de vacunación y quimioterapia preventiva
Saboyá-Díaz, Martha Idalí; Morice, Ana; Danovaro-Holliday, M. Carolina; Ruiz Matus, Cuauhtémoc; Castellanos, Luis Gerardo; Velandia-González, Martha Patricia (2017-12)
[RESUMEN]. Objetivo. Describir la experiencia y las lecciones aprendidas en el desarrollo de herramientas para el monitoreo de las coberturas de vacunación y de quimioterapia preventiva en las Américas. Métodos. Se …

El desafío de la sostenibilidad de los programas ampliados de inmunizaciones
Báscolo, Ernesto; Cid, Camilo; Pagano, Juan Pablo; Urrutia, María Soledad; Del Riego, Amalia (2017-12)
[RESUMEN]. Objetivo. Analizar la sostenibilidad y la integración de los programas prioritarios en el marco de la Estrategia para el acceso universal a la salud y la cobertura universal de salud (Salud Universal) de la …

The path towards polio eradication over 40 years of the Expanded Program on Immunization in the Americas
Pedreira, Cristina; Thrush, Elizabeth; Rey-Benito, Gloria; Chévez, Ana Elena; Jauregui, Barbara (2017-12)
[ABSTRACT]. This article synthesizes the important lessons learned from polio eradication in the Region of the Americas, including initial and more recent challenges and best practices, as well as particular factors …

Motivos de no vacunación en menores de cinco años en cuatro ciudades colombianas
Escobar-Díaz, Fabio; Osorio-Merchán, May Bibiana; De la Hoz-Restrepo, Fernando (2017-12)
[RESUMEN]. Objetivo. Conocer las barreras y los motivos de no vacunación en niños y niñas menores de cinco años en algunas ciudades de Colombia. Métodos. Diseño cualitativo basado en entrevistas y grupos focales a …

The evolution of Vaccination Week in the Americas
Ropero Alvarez, Alba Maria; Kurtis, Hannah Jane; Vulanovic, Lauren; Hasan, Hayatee; Ruiz, Cuauhtémoc; Thrush, Elizabeth (2017-12)
[ABSTRACT]. This report covers the background and evolution of Vaccination Week in the Americas (VWA), an initiative that started as a coordinated response to a 2002 measles outbreak in Colombia and Venezuela, and evolved …
 

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 17 January 2018 [GPEI]
:: Summary of newly-reported viruses this week:
…Afghanistan:  One new case of wild poliovirus type 1 (WPV1) reported in Kandahar province. Five new WPV1 positive environmental samples have been reported, three collected from Nangarhar province, one from Hilmand province, and one from Kunar province.
… Pakistan: Pakistan: Three new WPV1 positive environmental samples have been reported, two collected from Balochistan province, and one from Punjab province.
…Democratic Republic of the Congo: Five new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) have been reported in Tanganyika province.

::::::
 
Syria cVDPV2 outbreak situation report 30, 16 January 2018
Situation update 16 January 2018
:: No new cases of cVDPV2 were reported this week. The total number of cVDPV2 cases remains 74.
:: The most recent case (by date of onset of paralysis) is 21 September 2017 from Boukamal district, Deir Ez-Zor governorate.
:: The first round of the second phase of the outbreak response started in Deir Ez-Zor city and in Hasakah and Homs governorates on 14 January. The round will commence in other parts of Deir Ez-Zor and in Raqqa in the coming days.

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

WHO Grade 3 Emergencies  [to 20 January 2018]
The Syrian Arab Republic
:: Syria cVDPV2 outbreak situation report 30, 16 January 2018
[See Polio above for detail]

Yemen
:: Weekly epidemiology bulletin, 8–14 January 2018
Cumulative figures
– The cumulative total from 27 April 2017 to 14 Jan 2018 is 1,035,676 suspected cholera cases and 2,244 associated deaths,
(CFR 0.22%), 1100 have been confirmed by culture.

::::::
 
WHO Grade 2 Emergencies  [to 20 January 2018]
Myanmar 
:: Nearly half a million children being vaccinated against diphtheria in Cox’s Bazar
SEAR/PR/1676
14 January 2018, Cox’s Bazar, Bangladesh – As part of an intensified response to the current diphtheria outbreak, WHO, UNICEF and health sector partners are working with the Bangladesh Ministry of Health and Family Welfare to vaccinate more than 475,000 children in Rohingya refugee camps, temporary settlements and surrounding areas.
“All efforts are being made to stop further spread of diphtheria. The vaccination of children in the Rohingya camps and nearby areas demonstrates the health sector’s commitment to protecting people, particularly children, against deadly diseases,” said Dr Bardan Jung Rana, ai WHO Representative to Bangladesh.
Nearly 150,000 children aged six weeks to seven years received pentavalent vaccine (that protects against diphtheria, tetanus, pertussis, haemophilus influenza type b and hepatitis B), and nearly 166,000 children aged 7 to 17 years were given tetanus and diphtheria (Td) vaccine, during a three-week vaccination campaign that ended on 31 December. Two more rounds of vaccination with a diphtheria-containing vaccine, at intervals of one month, are planned to fully protect the children in camps and surrounding areas.
“Children are particularly vulnerable to diphtheria. Volunteers are making door-to-door visits in the Rohingya settlements to ensure all children receive vaccination. The massive influx within a very short time has heavily affected basic services in the settlement areas. They have no choice but to live in a very congested environment, which is impacting their health and quality of life. We are making continued efforts to improve conditions of the camps. At the same time, diphtheria vaccination is vital to reducing the risk of further outbreak,” said the UNICEF Country Representative Mr. Edouard Beigbeder.
To limit the spread of diphtheria to communities living near the Rohingya camps and settlements, nearly 160,000 children in 499 schools of Teknaf and Ukhiya sub-districts are also being vaccinated. This initiative began on 1 January. Vaccination was initiated on a day when children attend school in large numbers to avail themselves of free books provided by the government at the start of the academic year.
WHO, UNICEF and other health partners are working with the Ministry of Health and Family Welfare to establish fixed locations for immunization in the Rohingya camps to continue to provide life-saving vaccines to children, in line with Bangladesh’s childhood immunization programme.

Democratic Republic of the Congo
15 January 2018
Cholera in Kinshasa – WHO is redeploying experts to control the epidemic
Kinshasa — On a 24-hour working visit to the Democrati Republic of Congo’s capital, heavily affected by the cholera epidemic, Dr Matshidiso MOETI, WHO Regional Director for Africa, told the Minister of Health, Public Health, Dr Oly ILUNGA Monday, of a reinforced emergency support mechanism putting all the experts from the Country Office and those deployed in the Democratic Republic of the Congo (epidemiologists, logisticians, data managers, specialists in communication on risks, social mobilization and community engagement etc.) available to the DPS to strengthen the response against cholera.

::::::
::::::
 
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
:: 18 Jan 2018   Syria cVDPV2 Outbreak Situation Report #30 – 16 January 2018
:: Statement by the UN in Syria on civilians impacted by increase in hostilities [EN/AR]  17 January 2018
 
::::::

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.
ROHINGYA CRISIS
:: ISCG Situation Report: Rohingya Refugee Crisis, Cox’s Bazar | 14 January 2018

Somalia
:: 17 Jan 2018  Somalia: US$1.6 billion urgently needed to save and protect 5.4 million lives from unprecedented drought
 
::::::
::::::
 
Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO webpages for updates and key developments.
 
Yellow Fever  [to 20 January 2018]
http://www.who.int/csr/disease/yellowfev/en/
16 January 2018
Updates on yellow fever vaccination recommendations for international travelers related to the current situation in Brazil
Information for international travellers
…Considering the increased level of yellow fever virus activity observed across the state of São Paulo, the WHO Secretariat has determined that, in addition to the areas listed in previous updates, the entire state of São Paulo should also be considered at risk for yellow fever transmission.
Consequently, vaccination against yellow fever is recommended for international travellers visiting any area in the state of São Paulo.
The determination of new areas considered to be at risk for the yellow fever transmission is an ongoing process and updates will be provided regularly…
 
 

WHO & Regional Offices [to 20 January 2018]

142nd session of the WHO Executive Board
19 January 2018 – Next week the WHO Executive Board will set the agenda for the World Health Assembly, and determine how to best promote health, keep the world safe, and serve the vulnerable. The session takes place on
22–27 January 2018 in Geneva, Switzerland, and will be webcast live.
:: Provisional agenda
:: All documentation
[See Milestones above for more detail]

::::::
 
Weekly Epidemiological Record, 19 January 2018, vol. 93, 03 (pp. 17–32)
:: Global Advisory Committee on Vaccine Safety, 6–7 December 2017
:: Monthly report on dracunculiasis cases, January-November 2017

::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO supports Ministry of Health to contain Chikungunya Outbreak  18 January 2018
:: WHO Director General attributes Rwanda’s Health Sector achievements to a supportive Government  14 January 2018

WHO South-East Asia Region SEARO
:: Nearly half a million children being vaccinated against diphtheria in Cox’s Bazar  14 January 2018
 
WHO European Region EURO
::  New WHO Country Office to open in Greece 19-01-2018
:: WHO/Europe and ECDC intensify collaboration on infectious diseases and health emergencies 19-01-2018
:: Ukraine’s efforts to stop measles outbreak continue as case total increases 16-01-2018
:: The year ahead: key milestones and events for the WHO European Region in 2018 15-01-2018

WHO Western Pacific Region
:: Healthy Islands: South Pacific Tourism Organisation and WHO forge new partnership
SUVA, Fiji, 17 January 2018 – The World Health Organization and the South Pacific Tourism Organisation join forces to promote healthy tourism in the Pacific. Through a new partnership, the organizations commit to promoting the health and well-being of tourists and the tourism workforce by establishing smoke-free public places, increasing access to healthy local food options and physical activities and improving accessibility for persons with disabilities in the tourism sector.

CDC/ACIP [to 20 January 2018]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
 
MMWR – Morbidity and Mortality Weekly Report
2018;67:33–38. DOI: http://dx.doi.org/10.15585/mmwr.mm6701a7
Recommendation of the Advisory Committee on Immunization Practices for Use of a Third Dose of Mumps Virus–Containing Vaccine in Persons at Increased Risk for Mumps During an Outbreak
Mona Marin, MD1; Mariel Marlow, PhD1; Kelly L. Moore, MD2,3; Manisha Patel, MD
A substantial increase in the number of mumps outbreaks and outbreak-associated cases has occurred in the United States since late 2015 (1,2). To address this public health problem, the Advisory Committee on Immunization Practices (ACIP) reviewed the available evidence and determined that a third dose of measles, mumps, rubella (MMR) vaccine is safe and effective at preventing mumps. During its October 2017 meeting, ACIP recommended a third dose of a mumps virus–containing vaccine* for persons previously vaccinated with 2 doses who are identified by public health authorities as being part of a group or population at increased risk for acquiring mumps because of an outbreak. The purpose of the recommendation is to improve protection of persons in outbreak settings against mumps disease and mumps-related complications. This recommendation supplements the existing ACIP recommendations for mumps vaccination (3)…

Africa CDC   [to 20 January 2018]
https://au.int/en/africacdc

January 18, 2018
Africa Centres for Disease Control and Prevention and Japan International Cooperation Agency (JICA) to strengthen public health partnership to combat infectious diseases threats in Africa

January 18, 2018
Africa Union’s Peace and Security Council discuss public health threats to the Continent Urge integration of effective public health strategies in the African Union Peace and Security Architecture

Announcements
 
FDA [to 20 January 2018]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
January 16, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
Today the U.S. Government Accountability Office (GAO) published a report titled “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs.” In preparing the report, GAO studied a number of issues related to the FDA’s review and approval of “nonbiological complex drugs.” The report contained a single recommendation for the FDA — that the agency publicly announce its plans to issue or revise guidance for these drug products. We agree with GAO’s recommendation and the FDA is actively working to accomplish this goal through new policies that are already underway…

January 16, 2018 –
FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
Scientific progress and new drug innovation don’t take place in a vacuum. The exchange of information that informs decisions to undertake research, invest in new scientific endeavors, and prescribe and use certain treatments effectively are a critical part of enabling the development and dissemination of new medical technology. Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations.
As part of our efforts to enhance transparency around our drug approval decisions, we’re exploring new ways the U.S. Food and Drug Administration can continue to build on its obligation to share information about product approvals. We’re especially focused on information that can improve patient care and better inform providers about the products they prescribe. One place where we are evaluating how we can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs).
Right now, when a drug is approved, the FDA releases certain information that the agency used when reviewing the new drug application (NDA). This includes summaries written by our medical reviewers that capture their assessment of the data, the proposed labeling or other requirements, and other important, relevant data supporting safe and effective use. This information is included in our drug approvals database, Drugs@FDA…

What’s New for Biologics
Updated: 1/19/2018
SOPP 8795: Posting and Announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials- pdf (PDF – 56KB)

Posted: 1/19/2018
Statistical Review – Fluarix Quadrivalent (PDF – 242KB)

Posted: 1/19/2018 \
Clinical Review – Fluarix Quadrivalent (PDF – 1.2MB)

Posted: 1/17/2018
January 11, 2018 Summary Basis for Regulatory Action – Fluarix Quadrivalent (PDF – 339KB)

Fondation Merieux  [to 20 January 2018]
http://www.fondation-merieux.org/
18 January 2018
The “Forum Espace Humanitaire”: 100 Leaders Discuss Perspectives for Humanitarian Action
Nearly 100 humanitarian leaders and experts will meet at Les Pensières Center for Global Health January 18-20 for the “Forum Espace Humanitaire” (FEH). This forum brings together leaders to address the issues, methods and future evolution of humanitarian action. FEH is organized every 18 months by the Mérieux Foundation in partnership with the French Red Cross and Fondation de France.
 
PATH  [to 20 January 2018]
http://www.path.org/news/index.php
Press release | January 16, 2018
Tata Trusts and PATH announce India’s first Impact Lab for Public Health
New Delhi, January 16, 2018—Tata Trusts and PATH today announced the establishment of the Tata Trusts-PATH Impact Lab, the first such in India, to support and bring to market innovations for affordable public health solutions to benefit vulnerable populations with limited resources. Among the priorities will be solutions in maternal and child health, nutrition, and diagnostics for chronic and infectious diseases…
 

UNAIDS [to 20 January 2018]
http://www.unaids.org/en
19 January 2018
A 30-year response to HIV in Morocco
Morocco marks 30 years of its response to HIV in 2018, with much to celebrate. Concerted efforts in the country have resulted in a 42% reduction in new HIV infections since 2010, significantly greater than the decline across the Middle East and North Africa of just 4%. HIV treatment coverage has also increased in the country, from 16% in 2010 to 48% in 2016.

18 January 2018
Harnessing human rights for the AIDS response
A special section on HIV and human rights has been published in the Health and Human Rights Journal. Eleven papers—covering issues such as HIV-related stigma and discrimination, gender inequality and the effects of the abuse and criminalization of key populations—offer critical reflections on the AIDS response and call for renewed efforts to confront legal, social and structural barriers in order to realize better health for all… The special section is accessible at https://www.hhrjournal.org/volume-19-issue-2-december-2017/

17 January 2018
UNAIDS is saddened by the death of Mathilde Krim
UNAIDS is deeply saddened by the death of the prominent AIDS researcher and activist Mathilde Krim. Ms Krim was a pioneer in AIDS research from the earliest days of the AIDS epidemic and a dedicated defender of human rights and justice.
Ms Krim was a research scientist, dedicated to increasing awareness around HIV. She was one of the Founding Chairmen of the Foundation for AIDS Research (amfAR), an organization dedicated to AIDS research, HIV prevention, treatment education and the advocacy of sound AIDS-related public policy.
Her activism, dedication and compassion were instrumental in influencing public policy mobilizing funds for AIDS research and protecting the human rights of people living with HIV or affected by HIV.
In 2000, Ms Krim was awarded the Presidential Medal of Freedom, the highest civilian honour in the United States of America.

UNICEF  [to 20 January 2018]
https://www.unicef.org/media/
16 January 2018
Half a million Rohingya refugee children at risk in overcrowded camps in Bangladesh with cyclone and monsoon season on horizon
COX’S BAZAR, Bangladesh, 16 January 2018 – The health and safety of more than 520,000 Rohingya children living in overcrowded camps and informal settlements in Bangladesh is likely to be put at even greater risk ahead of upcoming cyclone and monsoon seasons, UNICEF warned today…
“Unsafe water, inadequate sanitation and poor hygiene conditions can lead to cholera outbreaks and to Hepatitis E, a deadly disease for pregnant women and their babies, while standing water pools can attract malaria-carrying mosquitos. Keeping children safe from disease must be an absolute priority,” Beigbeder added.
More than 4,000 suspected cases of diphtheria have been reported among the refugee population, with 32 deaths including at least 24 children. UNICEF and partners have launched a diphtheria vaccination campaign, and are working to provide children and families with access to safe water and sanitation facilities, but overcrowding and the growing risk of extreme weather increases the risk of further outbreaks…

Wellcome Trust  [to 20 January 2018]
https://wellcome.ac.uk/news
Opinion / Published: 18 January 2018
Researchers crack DNA riddle to show how process of mitosis works
Researchers have answered a fundamental question that has perplexed cell biologists for almost 150 years.   
Tom Collins, from Wellcome’s Genetics and Molecular Sciences team, explains why the discovery is so important and how the research team finally found what had evaded them for so long.

News / Published: 17 January 2018
Wellcome’s approach to engaging the public is going to change
Wellcome has a new public engagement strategy. Imran Khan, Head of Public Engagement, explains why we think it’s necessary and what it means for the way we will work

The Wistar Institute   [to 20 January 2018]
https://www.wistar.org/news/press-releases
Press Releases
The Wistar Institute Awarded More Than $1.4 Million to Create a Malaria Vaccine Through Synthetic DNA-Based Technology
PHILADELPHIA—(Jan. 18, 2018)—The Wistar Institute is pleased to announce it has been awarded a $1,494,972 grant by the Bill & Melinda Gates Foundation to advance a DNA-based vaccine candidate for protection against malarial infection utilizing a synthetic DNA platform created in the lab of David B. Weiner, Ph.D., executive vice president, director of the Vaccine & Immunotherapy Center at The Wistar Institute and the W.W. Smith Charitable Trust Professor in Cancer Research.

Wistar will collaborate with Inovio Pharmaceuticals, Inc. (NASDAQ: INO) and Johns Hopkins Malaria Research Institute at the Johns Hopkins Bloomberg School of Public Health on this research effort.

Currently, RTS,S (Mosquirix™) is the only malaria vaccine that has moved through phase III trials, delivering modest protection for the populations most at risk. The vaccine also requires four doses and decreases in effectiveness over time providing partial protection. This issue of durability of protection as well as limited group protection supports the need to develop second generation vaccine candidates.

Incorporating Weiner’s and collaborators’ more than 25 years of research in design and delivery of synthetic DNA vaccines, the team’s goal is to generate a new vaccine that drives robust antigen-specific antibody and T cell immune responses. The Weiner Lab helped to found the field of nucleic acid vaccines and was the first to move DNA vaccines to clinical studies, establishing their safety and immunogenicity and opening up the field of DNA vaccines for clinical development.

“DNA vaccines have a significant public health potential to rapidly impact emerging pandemics, as this technology has conceptual safety, development, speed of production, field stability, and deliverability advantages for vaccine and immunotherapy development,” said Weiner. “These synthetic DNA approaches can be developed for important infectious diseases, and with our collaborators, we have shown this consistently by rapidly engineering multiple synthetic DNA vaccines and advancing them to clinical study with positive outcomes of safety and immune potency.”

Funding from the Bill & Melinda Gates Foundation will enable this team to adapt the technology to produce a synthetic DNA vaccine encoding antigens of Plasmodium (P.) faliciparum, the micro-organism that causes malaria. This strategy instructs the vaccine recipient to produce the antigen in his/her own body so that the immune system can be activated and mount a rapid and potent response against malaria. Fidel Zavala, M.D., professor in the Bloomberg School’s Department of Microbiology and Immunology and senior member of the Johns Hopkins Malaria Research Institute, will be responsible for testing the vaccine in animal models. Inovio Pharmaceuticals, Inc. will bring improved vaccine delivery and production know-how with their advanced CELLECTRA® electroporation delivery device that generates small, directional electric currents into the skin to facilitate optimal vaccine uptake, production of the antigen, and generation of relevant immune responses…

::::::

DCVMN – Developing Country Vaccine Manufacturers Network  [to 20 January 2018]
http://www.dcvmn.org/
No new digest content identified.
 
IFPMA   [to 20 January 2018]
http://www.ifpma.org/resources/news-releases/
18 January 2018
Report shows life sciences industry alliance is taking action to curb antimicrobial resistance, with more to come
[See Reports/Research below for more detail]

Industry Watch   [to 20 January 2018]
:: Historic Deal Signed Between Panacea Biotec and Serum Institute of India
Jan 19, 2018, Panacea Biotec Ltd. (PBL), India’s leading biopharmaceutical company and among the largest manufacturer of vaccines, has signed two long-term collaboration agreements with Serum Institute of India Pvt. Ltd. (SII), world’s largest manufacturer of vaccines and SII’s wholly owned subsidiary, Bilthovan Biologicals B.V. (BBIO)…
Under the collaboration, SII is entitled to manufacture and sell fully liquid Whole cell Pertussis (wP) and Salk based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed and commercialized by PBL, a first-of-its-kind in this category…

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

 
TRACKING PROGRESS TO ADDRESS AMR
AMR Industry Alliance – amrindustryalliance.org
JANUARY 2018 :: 108 pages
Overview
The AMR Industry Alliance launched its first progress report on 18 January 2018. This report shows the commitment of the life sciences industry to tackle the public health threat of antimicrobial resistance (AMR). The Alliance brings together over 100 biotech, diagnostics, generics and research-based biopharmaceutical companies and trade associations from 20 countries.
The report was compiled by the consultancy SustainAbility. The data and case studies collected in the Alliance report provide unique insights into the practical steps Alliance’s members are taking to respond to AMR in the areas of research and science, access, appropriate use, and the environment.
The report presents data on AMR-relevant products, including therapeutic agents or technologies that have the potential to treat or prevent infectious diseases and/or combat resistance, including but not limited to antibiotics, vaccines, diagnostics, and novel approaches to address AMR.
[Excerpt p. 31]
AMR-RELEVANT VACCINE CANDIDATES IN DEVELOPMENT
Vaccines hold significant promise in the field of AMR. Vaccines targeting bacteria directly limit
infections and therefore the use of antibiotics, which would be the recommended treatment.
Vaccines targeting viruses can also reduce antibiotic use, by preventing viral infections that
might otherwise be inappropriately treated with antibiotics.
Six responding companies are involved in AMR-relevant vaccine R&D, with 13 candidates in
active development in the last five years… The Beam Alliance reported other preventive approaches – including immunomodulating, antivirulence and decontamination/decolonization – under development by SMEs including Antabio, Arsanis, BioVersys, BioFilmControl, Centauri Therapeutics, DaVolterra, Eligo Bioscience, Helperby, Maat Pharma, Mutabilis and Quretech.

Press Release
18 January 2018
Report shows life sciences industry alliance is taking action to curb antimicrobial resistance, with more to come
The new AMR Industry Alliance of more than 100 biotech, diagnostics, generics and research-based biopharmaceutical companies and trade associations launches its first progress report today. The report measures action taken in four areas: research and science, access, appropriate use, and the environment.
:: In 2016, the report shows that 22 Alliance companies invested at least USD 2 billion in R&D dedicated to AMR-related products. The funds cover costs for early-stage R&D, exploring new product classes, ten antibiotics in late-stage clinical development, 13 clinical bacterial vaccine candidates, 18 AMR-relevant diagnostic products, and other preventive therapies.
:: More than two out of three Alliance companies surveyed with marketed AMR products, have strategies, policies or plans in place to improve access to their AMR-relevant products.
: The Alliance is appealing to policy makers to draw from the evidence provided in this report, and invites stakeholders to work more systematically with the life sciences industry, to find sustainable solutions to tackling antimicrobial resistance.
:: The Alliance plans to give further impetus to industry efforts to curb AMR by increasing levels of response in the next progress report in 2020.

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

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 20 January 2018)

Research article
Monitoring vaccine and non-vaccine HPV type prevalence in the post-vaccination era in women living in the Basilicata region, Italy
A large free-of-charge quadrivalent HPV (qHPV) vaccination program, covering four cohorts annually (women 11, 14, 17 and 24 years), has been implemented in Basilicata since 2007. This study evaluated vaccine a…
Authors: Francesca Carozzi, Donella Puliti, Cristina Ocello, Pasquale Silvio Anastasio, Espedito Antonio Moliterni, Emilia Perinetti, Laurence Serradell, Elena Burroni, Massimo Confortini, Paola Mantellini, Marco Zappa and Géraldine Dominiak-Felden
Citation: BMC Infectious Diseases 2018 18:38
Published on: 15 January 2018

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 20 January 2018)

Research article
Evaluation of two health education interventions to improve the varicella vaccination: a randomized controlled trial from a province in the east China
We evaluated the effect of two Elaboration Likelihood Model (ELM)-based health educational interventions on varicella vaccine (VarV) vaccination among pregnant women in a province in the east China.
Authors: Yu Hu, Qian Li and Yaping Chen
Citation: BMC Public Health 2018 18:144
Published on: 16 January 2018

Contemporary Clinical Trials
Volume 64, Pages 1-280 (January 2018)
https://www.sciencedirect.com/science/journal/15517144/64
Clinical Trial Management and Optimization

Clinical trial conduct in special populations and developing regions: An overview of the DOVE study in pediatric patients with sickle cell disease
Original Research Article
Pages 88-94
Stephen G. Reams, Linda Messana, Patricia B. Brown, Kevin Nanry, Alexandria E. Gunnell
Abstract
Clinical trials conducted in unique patient populations or individuals with rare diseases are typically hampered by limitations in availability of qualified patients, requiring sponsors to broaden their global outreach to achieve enrollment. Engaging clinical study centers in developing regions may offer access to a substantially larger patient pool. However, they provide a unique set of challenges based on local cultures and requirements. The DOVE study (Determining effects Of platelet inhibition on Vaso-occlusive Events) was a clinical trial of prasugrel hydrochloride (prasugrel) in pediatric patients (aged 2 to < 18 years) with sickle cell anemia. The study was conducted at centers located in both well-developed and developing regions, enrolling 341 children. Study planning and execution required careful consideration of cultural requirements in each region and implementation of additional trial initiation and execution processes to address those needs. Innovative strategies were employed to ensure global consistency and quality in study execution. Significant regional- and country-specific differences were observed in site activation and enrollment. Although site activation processes were more complex and slower in developing countries, enrollment rates were much higher, which helped mitigate the site activation delays and allowed significant contribution to complete study enrollment. Data quality and patient retention in developing countries were equivalent to those observed in more developed countries, further supporting the ability to successfully conduct high-quality global registration trials in those countries. This report provides an overview of the experiences in site identification, site qualification, enrollment, patient retention, and data quality assurance in the DOVE study.

Global Public Health
Volume 13, 2017   Issue 3
http://www.tandfonline.com/toc/rgph20/current
Special Issue: Im/Mobilities and Dis/Connectivities in Medical Globalization: How Global is Global Health? Guest Editors: Dominik Mattes and Hansjörg Dilger

Introduction Article
Im/mobilities and dis/connectivities in medical globalisation: How global is Global Health?
Hansjörg Dilger & Dominik Mattes
Pages: 265-275
ABSTRACT
The interdisciplinary, politically contested field of Global Health has often been described as a consequence of, and response to, an intensification of the mobilities of, and connectivities between, people, pathogens, ideas, and infrastructure across national borders and large distances. However, such global mobilities and connectivities are not as omnidirectional and unpatterned as the rhetoric of many Global Health actors suggests. Instead, we argue that they are suffused by a plethora of institutional, national, and global political agendas, and substantially shaped by transnational and postcolonial power relations. Furthermore, the configurations that are typically subsumed under the category of Global Health represent only a minor part of the range of im/mobilities and dis/connectivities that are essential for understanding transformations of epidemiological patterns, health care infrastructures, and the responses to health-related challenges in a globalising world. In order to broaden such a limiting analytical perspective, we propose to expand the analytical focus in studying Global Health phenomena by paying close attention to the myriad ways in which particular im/mobilities and dis/connectivities constitute medicine and well-being in global and transnational settings. Pursuing a conceptual shift from studies of ‘Global Health’ to studying ‘medical globalization’ may carve out new analytical ground for such an endeavour.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 20 January 2018]

Editorial
Advancing STI priorities in the SDG era: priorities for action
The Sustainable Development Goals present an opportunity to reimagine and then reconfigure the approach to controlling sexually transmitted infections (STIs). The predilection of STIs for women and for vulnera…
Authors: Matthew F. Chersich, Sinead Delany-Moretlwe, Greg Martin and Helen Rees
Citation: Globalization and Health 2018 14:6
Published on: 16 January 2018

Journal of Empirical Research on Human Research Ethics
Volume 13, Issue 1, February 2018
http://journals.sagepub.com/toc/jre/current
Ethical Issues in Clinical Trials

The Ethics of Health Care Delivery in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania
Claire Leonie Ward, David Shaw, Evelyn Anane-Sarpong, Osman Sankoh, Marcel Tanner, Bernice Elger
First Published November 28, 2017; pp. 26–41
Preview
This study explores ethical issues raised in providing medical care to participants and communities of low-resource settings involved in a Phase II/III pediatric malaria vaccine trial (PMVT). We conducted 52 key informant interviews with major stakeholders of an international multi-center PMVT (GSK/PATH-MVI RTS,S) (NCT00866619) in Ghana and Tanzania. Based on their stakeholder experiences, the responses fell into three main themes: (a) undue inducement, (b) community disparities, and (c) broad therapeutic misconceptions. The study identified the critical ethical aspects, from the perspectives of stakeholders, of delivering health care during a PMVT. The study showed that integrating research into health care services needs to be addressed in a manner that upholds the favorable risk–benefit ratio of research and attends to the health needs of local populations. The implementation of research should aim to improve local standards of care through building a collaborative agenda with local institutions and systems of health.

Journal of Empirical Research on Human Research Ethics
Volume 13, Issue 1, February 2018
http://journals.sagepub.com/toc/jre/current

Ethical Issues in Social Science and Health Systems Research
Seeking Ways to Inform the Uninformed: Improving the Informed Consent Process in Online Social Science Research
Evan K. Perrault, David M. Keating
First Published November 8, 2017; pp. 50–60
Preview
Participants often do not read consent forms in social science research. This is not surprising, especially for online studies, given they do not typically offer greater risk than what is encountered in daily life. However, if no one is reading, are participants really informed? This study used previous research to craft experimentally manipulated consent forms utilizing different visual presentations (e.g., greater use of line spacing, bullets, bolding, diagrams). Participants (n = 547) were randomly exposed to one of seven form variations. Results found no significant differences between forms in reading or comprehension. Open-ended questions asked participants why they do not read consent forms and what would influence them to read the forms. Participants most frequently stated forms need to be shorter, and important information needs to be highlighted. We suggest improvements to informed consent forms, including removing much of the information that is constant across forms, and only including unique aspects of studies.

Journal of Empirical Research on Human Research Ethics
Volume 13, Issue 1, February 2018
http://journals.sagepub.com/toc/jre/current

Ethical Issues in Social Science and Health Systems Research
Readability of Human Subjects Training Materials for Research
Kristie B. Hadden, Latrina Prince, Laura James, Jennifer Holland, Christopher R. Trudeau
First Published December 15, 2017; pp. 95–100
Preview
Institutions are required to ensure that persons involved in human subjects research receive appropriate human subjects protections training and education. Several organizations use the Collaborative Institutional Training Initiative (CITI) program to fulfill training requirements. Most researchers find the CITI program too complex for community members who collaborate with researchers. This study aimed to determine the readability of CITI modules most frequently used in community-based participatory research (CBPR). The mean readability level of the CITI modules is 14.8 grade; CBPR readability levels ranged from 11.6 to 12.0 grade (sixth- to eighth-grade reading level is recommended). With a baseline objective measure, modifications can be made to improve the plain language quality and understandability of human subjects training modules for community members.

Journal of Immigrant and Minority Health
Volume 20, Issue 1, February 2018
https://link.springer.com/journal/10903/20/1/page/1

Original Paper
Barriers to Accessing Testing and Treatment for Chronic Hepatitis B in Afghan, Rohingyan, and South Sudanese Populations in Australia
Significant barriers to screening and engagement with healthcare persist due to stigma and perceptions associated with CHB within these communities. Our study was a pilot intervention aimed at engaging Afghan, Rohingyan, and Sudanese populations into CHB care through an initial needs assessment.
Katherine Sievert, Paul O’Neill, Youlin Koh, Jia-Hui Lee, Anouk Dev, Suong Le

Journal of Public Health Policy
Volume 39, Issue 1, February 2018
https://link.springer.com/journal/41271/39/1/page/1
ToxicDocs: Opening a new era of evidence for policies to protect public health

EDITORIAL
ToxicDocs (www.ToxicDocs.org) goes live: A giant step toward leveling the playing field for efforts to combat toxic exposures
Anthony Robbins, Phyllis Freeman
…One of the main obstacles to creating the scientific evidence needed to reduce the adverse impact of corporations on health has been the extensive efforts of corporations to shield their harmful practices from scrutiny, scientific or public. To achieve this goal, corporations have
:: Falsified data, including when Volkswagen lied about its emission control devices [7] and Kobe steel reported fabricated data on the durability and safety of its metal products [8],
:: Engaged in ‘credibility engineering,’ a practice by which corporations seek to repair damage to their credibility by reframing the problem [9],
:: Obscured their conflicts of interest to enable them to appear to be a legitimate and disinterested participant in the policy process [10],
:: Attacked and harassed critics by hacking their private communications [11], maligning their reputation [12], or threatening lawsuits [13],
:: Helped pass laws limiting the public’s and scientists right to know [14], and
:: Acted vigorously to defeat public health measures [15].
Fortunately, in response to growing corporate efforts to limit public access to scientific evidence and free debate, researchers, activists, public interest lawyers, and public health professionals have created new ways of collecting, analyzing, and publicizing the evidence, ways that can illuminate what corporations seek to keep in the dark.
The new website, http://www.ToxicDocs.org [16], is an example. It provides scholars and activists with an important new resource to harness the power of new search technologies, worldwide Internet availability, and the growing recognition of corporate practices as a fundamental social determinant of health. By using www.ToxicDocs.org’s embedded search methods, investigators can answer legal and scientific questions such as the following: What did corporate executives know about the harmful effects of their products and practices? What steps did they take to reveal or hide this knowledge? And, what was their understanding of the mechanisms by which their practices influenced the health of workers, consumers, and the environment?…

Journal of Travel Medicine
Volume 25, Issue 1, 1 January 2018
https://academic.oup.com/jtm/issue/25/1

Original Article
Susceptibility to measles in migrant population: implication for policy makers
Giancarlo Ceccarelli, MD, PhD, MSc; Serena Vita, MD; Elisabetta Riva, MSc; Eleonora Cella, MSc; Maurizio Lopalco, MD …
Journal of Travel Medicine, Volume 25, Issue 1, 1 January 2018, tax080, https://doi.org/10.1093/jtm/tax080

Original Article
Safety of live vaccines on immunosuppressive or immunomodulatory therapy—a retrospective study in three Swiss Travel Clinics
Fabienne Huber, MD; Benoît Ehrensperger, MD; Christoph Hatz, MD; François Chappuis, MD PhD; Silja Bühler, MD MSc …
Journal of Travel Medicine, Volume 25, Issue 1, 1 January 2018, tax082, https://doi.org/10.1093/jtm/tax082

The Lancet
Jan 20, 2018 Volume 391 Number 10117 p179-280
http://www.thelancet.com/journals/lancet/issue/current

Review
What works in inclusion health: overview of effective interventions for marginalised and excluded populations
Serena Luchenski, Nick Maguire, Robert W Aldridge, Andrew Hayward, Alistair Story, Patrick Perri, James Withers, Sharon Clint, Suzanne Fitzpatrick, Nigel Hewett
Summary
Inclusion health is a service, research, and policy agenda that aims to prevent and redress health and social inequities among the most vulnerable and excluded populations. We did an evidence synthesis of health and social interventions for inclusion health target populations, including people with experiences of homelessness, drug use, imprisonment, and sex work. These populations often have multiple overlapping risk factors and extreme levels of morbidity and mortality. We identified numerous interventions to improve physical and mental health, and substance use; however, evidence is scarce for structural interventions, including housing, employment, and legal support that can prevent exclusion and promote recovery. Dedicated resources and better collaboration with the affected populations are needed to realise the benefits of existing interventions. Research must inform the benefits of early intervention and implementation of policies to address the upstream causes of exclusion, such as adverse childhood experiences and poverty.

Maternal and Child Health Journal
Volume 22, Issue 1, January 2018
https://link.springer.com/journal/10995/22/1/page/1

Original Paper
Illness Representations of Pertussis and Predictors of Child Vaccination Among Mothers in a Strict Vaccination Exemption State
Vaccine preventable diseases are making a comeback in the US. However, research is lacking on illness representations of vaccine preventable diseases and their application in improving childhood immunization.
Rahul Garg, Abdulkarim Meraya, Pamela J. Murray, Kimberly Kelly

Nature 
Volume 553 Number 7688 pp249-366  18 January 2018
http://www.nature.com/nature/current_issue.html

EDITORIAL
17 January 2018
Laws are not the only way to boost immunization
The French government must mitigate the risks in its legal imposition of vaccinations by promoting more coherent and proactive vaccine policies.
[Excerpt]
…A new French law requires that babies born after 1 January be vaccinated in their early years against 11 diseases. Previously, vaccines against only three of these — diptheria, tetanus and polio — were mandatory. The others were recommended, but the decision was left to parents. Now, children must also be vaccinated against Haemophilus influenzae B, hepatitis B, pertussis, pneumococcal disease, meningitis C, measles, mumps and rubella. Those who haven’t had all their immunizations, including booster shots, the government says, will be refused admission to nurseries, schools and camps in France.
This policy is dividing public-health scientists in the country. Many French general practitioners are among those who argue that the measure is authoritarian and could backfire, not least by alienating parents and increasing wariness of vaccines in a country where various health scandals (most infamously, HIV-infected blood transfusions given in the early 1980s to people with haemophilia) have spread mistrust of health authorities…

PharmacoEconomics
Volume 36, Issue 1, January 2018
https://link.springer.com/journal/40273/36/1/page/1

Systematic Review
Capturing Budget Impact Considerations Within Economic Evaluations: A Systematic Review of Economic Evaluations of Rotavirus Vaccine in Low- and Middle-Income Countries and a Proposed Assessment Framework
Six budget impact analyses and 60 cost-effectiveness analyses were identified. Budget impact analyses adhered to most International Society for Pharmacoeconomics and Outcomes Research recommendations, with key exceptions being provision of undiscounted financial streams for each budget period and model validation. Most cost-effectiveness analyses could not be extended to provide useful budget impact information; cost-effectiveness analyses also rarely presented undiscounted annual costs, or estimated financial streams during the first years of programme scale-up….Cost-effectiveness analyses vastly outnumber budget impact analyses of rotavirus vaccination, despite both being critical for policy decision making. Straightforward changes to the presentation of cost-effectiveness analyses results could facilitate their adaptation into budget impact analyses.
Natalie Carvalho, Mark Jit, Sarah Cox, Joanne Yoong…

PharmacoEconomics
Volume 36, Issue 1, January 2018
https://link.springer.com/journal/40273/36/1/page/1

Original Research Article
Research Costs Investigated: A Study Into the Budgets of Dutch Publicly Funded Drug-Related Research
Thea van Asselt, Bram Ramaekers, Isaac Corro Ramos, Manuela Joore…

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 20 January 2018]

Incidence Prediction for the 2017-2018 Influenza Season in the United States with an Evolution-informed Model
January 17, 2018 · Research Article
Introduction: Seasonal influenza is responsible for a high disease burden in the United States and worldwide. Predicting outbreak size in advance can contribute to the timely control of seasonal influenza by informing health care and vaccination planning.
Methods: Recently, a process-based model was developed for forecasting incidence dynamics ahead of the season, with the approach validated by several statistical criteria, including an accurate real-time prediction for the past 2016-2017 influenza season before it started.
Results: Based on this model and data up to June 2017, a forecast for the upcoming 2017-2018 influenza season is presented here, indicating an above-average, moderately severe, outbreak dominated by the H3N2 subtype.
Discussion: The prediction is consistent with surveillance data so far, which already indicate the predominance of H3N2. The forecast for the upcoming 2017-2018 influenza season reinforces the importance of the on-going vaccination campaign.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 20 January 2018)

Research Article
Modelling the large-scale yellow fever outbreak in Luanda, Angola, and the impact of vaccination
Shi Zhao, Lewi Stone, Daozhou Gao, Daihai He
| published 16 Jan 2018 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006158

PLoS One
http://www.plosone.org/
[Accessed 20 January 2018]

Research Article
Impact of educational interventions on adolescent attitudes and knowledge regarding vaccination: A pilot study
Kate Carolan, Joanna Verran, Matthew Crossley, James Redfern, Nicola Whitton, Martyn Amos
Research Article | published 19 Jan 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0190984

Research Article
Event based surveillance of Middle East Respiratory Syndrome Coronavirus (MERS- CoV) in Bangladesh among pilgrims and travelers from the Middle East: An update for the period 2013–2016
K. M. Muraduzzaman, Manjur Hossain Khan, Rezina Parveen, Sharmin Sultana, Ahmed Nawsher Alam, Arifa Akram, Mahmudur Rahman, Tahmina Shirin
Research Article | published 16 Jan 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0189914

Science         
19 January 2018  Vol 359, Issue 6373
http://www.sciencemag.org/current.dtl

The 1918 flu, 100 years later
By Jessica A. Belser, Terrence M. Tumpey
Summary
Combating a disease of unknown cause is a daunting task. One hundred years ago, a pandemic of poorly understood etiology and transmissibility spread worldwide, causing an estimated 50 million deaths. Initially attributed to Haemophilus influenzae, it was not until the 1930s that an H1 subtype was identified as the causative strain. Subsequent influenza pandemics in 1957, 1968, and 2009 did not approach levels of morbidity and mortality comparable to those of the 1918 “Spanish flu,” leaving unanswered for almost a century questions regarding the extraordinary virulence and transmissibility of this unique strain. Technological advances made reconstruction of the 1918 virus possible; now, continued research, vaccine development, and preparedness are essential to ensure that such a devastating public health event is not repeated.

Science         
19 January 2018  Vol 359, Issue 6373
http://www.sciencemag.org/current.dtl

Letters
Vaccine mandates in France will save lives
By Stanley A. Plotkin, Paul Offit, Pierre Bégué
Science19 Jan 2018 : 283-284

Science         
19 January 2018  Vol 359, Issue 6373
http://www.sciencemag.org/current.dtl

Research Articles
Genome-wide identification of interferon-sensitive mutations enables influenza vaccine design
By Yushen Du, Li Xin, Yuan Shi, Tian-Hao Zhang, Nicholas C. Wu, Lei Dai, Danyang Gong, Gurpreet Brar, Sara Shu, Jiadi Luo, William Reiley, Yen-Wen Tseng, Hongyan Bai, Ting-Ting Wu, Jieru Wang, Yuelong Shu, Ren Sun
Science19 Jan 2018 : 290-296 Restricted Access
Avoiding interferon avoidance
Interferon (IFN) expression is a mammal’s first response to viral infection. Many viruses have thus evolved mechanisms to evade IFN. Du et al. developed a method to systematically ablate IFN evasion genes from live, attenuated influenza virus (see the Perspective by Teijaro and Burton). A combination of mutants was assembled to construct a virus that triggered transient IFN responses in mice but that was unable to replicate effectively. The transient IFN responses led to robust antibody and memory responses that protected against subsequent challenge with different influenza viruses. This approach could be adapted to improve other RNA virus vaccines.
Abstract
In conventional attenuated viral vaccines, immunogenicity is often suboptimal. Here we present a systematic approach for vaccine development that eliminates interferon (IFN)–modulating functions genome-wide while maintaining virus replication fitness. We applied a quantitative high-throughput genomics system to influenza A virus that simultaneously measured the replication fitness and IFN sensitivity of mutations across the entire genome. By incorporating eight IFN-sensitive mutations, we generated a hyper–interferon-sensitive (HIS) virus as a vaccine candidate. HIS virus is highly attenuated in IFN-competent hosts but able to induce transient IFN responses, elicits robust humoral and cellular immune responses, and provides protection against homologous and heterologous viral challenges. Our approach, which attenuates the virus and promotes immune responses concurrently, is broadly applicable for vaccine development against other pathogens.

Vaccine
Volume 36, Issue 3   Pages 343-426 (8 January 2018)
http://www.sciencedirect.com/journal/vaccine/vol/36/issue/

Commentary
The Advisory Committee on Immunization Practices recommendation regarding the use of live influenza vaccine: A rejoinder
Pages 343-344
Edward A. Belongia, Ruth A. Karron, Arthur Reingold, Emmanuel B. Walter, Nancy M. Bennett

Vaccine
Volume 36, Issue 3   Pages 343-426 (8 January 2018)
http://www.sciencedirect.com/journal/vaccine/vol/36/issue/

Editorial
Hospital-based collaboration for epidemiological investigation of vaccine safety: A potential solution for low and middle-income countries?
Pages 345-346
Hector S. Izurieta, Pedro L. Moro, Robert T. Chen

Vaccine
Volume 36, Issue 3   Pages 343-426 (8 January 2018)
http://www.sciencedirect.com/journal/vaccine/vol/36/issue/

Original research article
Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing: The global vaccine safety multi country collaboration initiative
Pages 355-362
Christine Guillard-Maure, Varalakshmi Elango, Steven Black, Silvia Perez-Vilar, … Carlos Zunino
Abstract
Timely and effective evaluation of vaccine safety signals for newly developed vaccines introduced in low and middle- income countries (LMICs) is essential. The study tested the development of a global network of hospital-based sentinel sites for vaccine safety signal verification and hypothesis testing. Twenty-six sentinel sites in sixteen countries across all WHO regions participated, and 65% of the sites were from LMIC. We describe the process for the establishment and operationalization of such a network and the lessons learned in conducting a multi-country collaborative initiative. 24 out of the 26 sites successfully contributed data for the global analysis using standardised tools and procedures. Our study successfully confirmed the well-known risk estimates for the outcomes of interest. The main challenges faced by investigators were lack of adequate information in the medical records for case ascertainment and classification, and access to immunization data. The results suggest that sentinel hospitals intending to participate in vaccine safety studies strengthen their systems for discharge diagnosis coding, medical records and linkage to vaccination data. Our study confirms that a multi-country hospital-based network initiative for vaccine safety monitoring is feasible and demonstrates the validity and utility of large collaborative international studies to monitor the safety of new vaccines introduced in LMICs.

Vaccine
Volume 36, Issue 3   Pages 343-426 (8 January 2018)
http://www.sciencedirect.com/journal/vaccine/vol/36/issue/

Original research article
Building capacity for active surveillance of vaccine adverse events in the Americas: A hospital-based multi-country network
Pages 363-370
Pamela Bravo-Alcántara, Silvia Pérez-Vilar, Helvert Felipe Molina-León, Miriam Sturkenboom, … Carlos Zunino
Abstract
New vaccines designed to prevent diseases endemic in low and middle-income countries are being introduced without prior utilization in countries with robust vaccine pharmacovigilance systems. Our aim was to build capacity for active surveillance of vaccine adverse events in the Americas. We describe the implementation of a proof-of-concept study for the feasibility of an international collaborative hospital-based active surveillance system for vaccine safety. The study was developed and implemented in 15 sentinel sites located in seven countries of the region of the Americas, under the umbrella of the World Health Organization (WHO) Global Vaccine Safety Initiative. The study evaluated the associations between measles-mumps-rubella vaccines and two well-recognized adverse events: Immune thrombocytopenic purpura (ITP) and aseptic meningitis. The regional network contributed 63 confirmed ITP and 16 confirmed aseptic meningitis eligible cases to the global study, representing, respectively, 33% and 19% of the total cases. To ensure long-term sustainability and usefulness to investigate adverse events following new vaccine introductions in low and middle-income countries, the network needs to be strengthened with additional sites and integrated into national health systems.

Vaccine
Volume 36, Issue 3   Pages 343-426 (8 January 2018)
http://www.sciencedirect.com/journal/vaccine/vol/36/issue/3

Original research article
Implementing a province-wide mandatory vaccinate-or-mask policy at healthcare facilities in British Columbia, Canada
Alexandra Nunn, Audrey C. Campbell, Monika Naus, Jeffrey C. Kwong, … Bonnie Henry
Abstract
Objectives
In 2012, British Columbia (BC) became the first Canadian province to implement an influenza prevention policy requiring healthcare workers (HCW) to either be vaccinated annually against influenza or wear a mask in patient care areas during the influenza season. This study describes an evaluation of influenza policy implementation processes and identifies supports and challenges related to successful policy implementation at the level of healthcare facilities, during the second policy year (2013/14).
Methods
Implementation leaders from 262 long-term care (LTC) and acute care facilities, mostly in three of BC’s five regional Health Authorities, were invited to participate in an online survey following the 2013/14 influenza season. Descriptive quantitative and qualitative analyses identified common and effective strategies for improving vaccination coverage and policy compliance.
Results
A total of 127 respondents completed the survey on behalf of 33 acute care and 99 LTC facilities, representing 36% of acute care and 27% of LTC facilities in BC. Respondents agreed that the policy was successfully implemented at 89% of facilities, and implementation was reported to be easy at 52% of facilities. The findings elaborate on communication and leadership strategies, campaign logistics and enforcement approaches involved in policy implementation.
Conclusion
Implementation of a vaccinate-or-mask influenza policy is complex. This study provides insight for other jurisdictions considering implementing such a policy and offers practical recommendations for facilities and health authorities.
 

Vaccine
Volume 36, Issue 3   Pages 343-426 (8 January 2018)
http://www.sciencedirect.com/journal/vaccine/vol/36/issue/3

Original research article
Cost-effectiveness of dengue vaccination in ten endemic countries
Pages 413-420
Wu Zeng, Yara A. Halasa-Rappel, Nicolas Baurin, Laurent Coudeville, Donald S. Shepard
Abstract
Following publication of results from two phase-3 clinical trials in 10 countries or territories, endemic countries began licensing the first dengue vaccine in 2015. Using a published mathematical model, we evaluated the cost-effectiveness of dengue vaccination in populations similar to those at the trial sites in those same Latin American and Asian countries. Our main scenarios (30-year horizon, 80% coverage) entailed 3-dose routine vaccinations costing US$20/dose beginning at age 9, potentially supplemented by catch-up programs of 4- or 8-year cohorts. We obtained illness costs per case, dengue mortality, vaccine wastage, and vaccine administration costs from the literature. We estimated that routine vaccination would reduce yearly direct and indirect illness cost per capita by 22% (from US$10.51 to US$8.17) in the Latin American countries and by 23% (from US$5.78 to US$4.44) in the Asian countries. Using a health system perspective, the incremental cost-effectiveness ratio (ICER) averaged US$4,216/disability-adjusted life year (DALY) averted in the five Latin American countries (range: US$666/DALY in Puerto Rico to US$5,865/DALY in Mexico). In the five Asian countries, the ICER averaged US$3,751/DALY (range: US$1,935/DALY in Malaysia to US$5,101/DALY in the Philippines). From a health system perspective, the vaccine proved to be highly cost effective (ICER under one times the per capita GDP) in seven countries and cost effective (ICER 1–3 times the per capita GDP) in the remaining three countries. From a societal perspective, routine vaccination proved cost-saving in three countries. Including catch-up campaigns gave similar ICERs. Thus, this vaccine could have a favorable economic value in sites similar to those in the trials.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 20 January 2018)
Open Access  Review

Development of Zika Virus Vaccines
by Huda Makhluf and Sujan Shresta
Vaccines 2018, 6(1), 7; doi:10.3390/vaccines6010007 – 18 January 2018
Abstract
Zika virus (ZIKV) is a mosquito-borne flavivirus that emerged as a global threat following the most recent outbreak in Brazil in 2015. ZIKV infection of pregnant women is associated with fetal abnormalities such as microcephaly, and infection of adults can lead to Guillain–Barré syndrome, an autoimmune disease characterized by neurological deficits. Although there are currently licensed vaccines for other flaviviruses, there remains an urgent need for preventative vaccines against ZIKV infection. Herein we describe the current efforts to accelerate the development of ZIKV vaccines using various platforms, including live attenuated virus, inactivated virus, DNA and RNA, viral vectors, and in silico-predicted immunogenic viral epitopes. Many of these approaches have leveraged lessons learned from past experience with Dengue and other flavivirus vaccines