New England Journal of Medicine
July 7, 2016 Vol. 375 No. 1
http://www.nejm.org/toc/nejm/medical-journal

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Perspective
Zika and the Risk of Microcephaly
M.A. Johansson, L. Mier-y-Teran-Romero, J. Reefhuis, S.M. Gilboa, and S.L. Hills

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Review Article
The Changing Face of Clinical Trials: Adaptive Designs for Clinical Trials
D.L. Bhatt and C. Mehta
Investigators use adaptive trial designs to alter basic features of an ongoing trial. This approach obtains the most information possible in an unbiased way while putting the fewest patients at risk. In this review, the authors discuss selected issues in adaptive design.

Pediatrics
July 2016, VOLUME 138 / ISSUE 1
http://pediatrics.aappublications.org/content/138/1?current-issue=y

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Articles
Febrile Seizure Risk After Vaccination in Children 6 to 23 Months
Jonathan Duffy, Eric Weintraub, Simon J. Hambidge, Lisa A. Jackson, Elyse O. Kharbanda, Nicola P. Klein, Grace M. Lee, S. Michael Marcy, Cynthia C. Nakasato, Allison Naleway, Saad B. Omer, Claudia Vellozzi, Frank DeStefano, on behalf of the Vaccine Safety Datalink
Pediatrics Jul 2016, 138 (1) e20160320; DOI: 10.1542/peds.2016-0320

Parental Country of Birth and Childhood Vaccination Uptake in Washington State
Elizabeth Wolf, Ali Rowhani-Rahbar, Azadeh Tasslimi, Jasmine Matheson, Chas DeBolt
Pediatrics Jul 2016, 138 (1) e20154544; DOI: 10.1542/peds.2015-4544

Pertussis Antibody Concentrations in Infants Born Prematurely to Mothers Vaccinated in Pregnancy
Alison Kent, Shamez N. Ladhani, Nick J. Andrews, Mary Matheson, Anna England, Elizabeth Miller, Paul T. Heath, on behalf of the PUNS study group
Pediatrics Jul 2016, 138 (1) e20153854; DOI: 10.1542/peds.2015-3854

Commentaries
Vaccines and Febrile Seizures: Quantifying the Risk
Mark H. Sawyer, Geoff Simon, Carrie Byington
Pediatrics Jul 2016, 138 (1) e20160976; DOI: 10.1542/peds.2016-0976

Review Articles
Interventions to Improve HPV Vaccine Uptake: A Systematic Review
Emily B. Walling, Nicole Benzoni, Jarrod Dornfeld, Rusha Bhandari, Bryan A. Sisk, Jane Garbutt, Graham Colditz
Pediatrics Jul 2016, 138 (1) e20153863; DOI: 10.1542/peds.2015-3863

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
(Accessed 9 July 2016)

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Research Article
Invasive Meningococcal Meningitis Serogroup C Outbreak in Northwest Nigeria, 2015 – Third Consecutive Outbreak of a New Strain
July 7, 2016
BACKGROUND: In northwest Nigeria in 2013 and 2014, two sequential, localized outbreaks of meningitis were caused by a new strain of Neisseria meningitidis serogroup C (NmC). In 2015, an outbreak caused by the same novel NmC strain occurred over a wider geographical area, displaying different characteristics to the previous outbreaks. We describe cases treated by Médecins Sans Frontières (MSF) in the 2015 outbreak.
METHODS: From February 10 to June 8, 2015, data on cerebrospinal meningitis (CSM) cases and deaths were recorded on standardized line-lists from case management sites supported by MSF. Cerebrospinal fluid (CSF) samples from suspected cases at the beginning of the outbreak and throughout from suspected cases from new geographical areas were tested using rapid Pastorex® latex agglutination to determine causative serogroup. A subset of CSF samples was also inoculated into Trans-Isolate medium for testing by the WHO Collaborating Centre for Reference and Research on Meningococci, Oslo. Reactive vaccination campaigns with meningococcal ACWY polysaccharide vaccine targeted affected administrative wards.
RESULTS: A total of 6394 (65 confirmed and 6329 probable) cases of CSM including 321 deaths (case fatality rate: 5.0%) were recorded. The cumulative attack rate was 282 cases per 100,000 population in the wards affected. The outbreak lasted 17 weeks, affecting 1039 villages in 21 local government areas in three states (Kebbi, Sokoto, Niger). Pastorex® tests were NmC positive for 65 (58%) of 113 CSF samples. Of 31 Trans-Isolate medium samples, 26 (84%) tested positive for NmC (14 through culture and 12 through PCR); all had the same rare PorA type P1.21-15,16 as isolates from the 2013 and 2014 outbreaks. All 14 culture-positive samples yielded isolates of the same genotype (ST-10217 PorA type P1.21-15,16 and FetA type F1-7). More than 222,000 targeted individuals were vaccinated relatively early in the outbreak (administrative coverage estimates 98% and 89% in Kebbi and Sokoto, respectively).
CONCLUSIONS: The outbreak was the largest caused by NmC documented in Nigeria. Reactive vaccination in both states may have helped curtail the epidemic. A vaccination campaign against NmC with a long-lasting conjugate vaccine should be considered in the region.

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Utility of a Dengue-Derived Monoclonal Antibody to Enhance Zika Infection In Vitro
July 5, 2016 · Research Article
Introduction: Zika virus (ZIKV) has emerged in dengue (DENV) endemic areas, where these two related flaviviruses continue to co-circulate. DENV is a complex of four serotypes and infections can progress to severe disease. It is thought that this is mediated by antibody dependent enhancement (ADE) whereby antibodies from a primary DENV infection are incapable of neutralizing heterologous DENV infections with another serotype. ADE has been demonstrated among other members of the Flavivirus group.
Methods: We utilize an in vitro ADE assay developed for DENV to determine whether ZIKV is enhanced by a commonly available DENV serotype 2-derived monoclonal antibody (4G2).
Results: We show that ZIKV infection in vitro is enhanced in the presence of the 4G2 mAb.
Discussion: Our results demonstrate that ADE between ZIKV and DENV is possible and that the 4G2 antibody is a useful tool for the effects of pre-existing anti-DENV antibodies during ZIKV infections.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
[Accessed 9 July 2016]

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Viewpoints
What Is Next for NTDs in the Era of the Sustainable Development Goals?
James Smith, Emma Michelle Taylor
| published 07 Jul 2016 | PLOS Neglected Tropical Diseases
http://dx.doi.org/10.1371/journal.pntd.0004719
…Conclusion: From Invisibility to Ubiquity
We are now firmly in the post-MDG era, but are still feeling our way into the Brave New World of the SDGs. The NTD lobby has been extraordinarily effective in building momentum and ultimately achieving recognition for NTDs within the new SDGs. This success is somewhat tempered by the sheer array of new goals, related targets, and uncertainty about how resources and commitments will map onto them.

The fight now is for traction within the emerging SDG Framework, and this requires a different focus. There is a need to shift from the limited number and international perspective of the MDGs to the much larger number of goals that need to be taken up and acted upon by a huge number of national governments. There is an opportunity here for NTDs to be leveraged throughout the SDGs; focusing on NTDs can assist nation states in grappling with the large array of new goals and targets. National governments must be—and can be—convinced of the crosscutting nature of NTD programmes and the benefits of mainstreaming NTD interventions, securing indicators and, thus, funding. There is a lot of hard work ahead, however.

There is a certain irony here that the previously “invisible” NTDs have gained prominence through their ubiquity within the SDGs, and this prominence is due in no small measure to the work of the NTD lobby thus far. Within the narrower rubric of the MDGs, the lower profile of NTDs was somewhat obscured until concerted efforts were made to underline how NTDs underpinned and interacted with the other goals and the very fabric of poverty itself. There is great value in NTDs being named in target 3.3, but there is still a challenge regarding relevance given the large number of other goals and targets, which may slice funding commitments rather more thinly than was the case with the MDGs. However, the ubiquity of NTDs in relation to the broader SDG agenda can come to the fore in relation to a greater number of goals and targets, especially those for which strong arguments can be made that NTDs may severely hamper progress: for example, goal 1 (end poverty) or goal 2 (end hunger), or where focusing on NTDs can drive progress towards specific targets, for example, 6.1 (achieve universal and equitable access to safe drinking water), 6.2 (achieve access to adequate and equitable sanitation and hygiene for all), and 3.8 (achieve UHC). From this perspective, an investment in NTDs becomes an investment in the broader sustainable development agenda [8,16].

Underlying and implicit in this is the ultimate aim of UHC. Here NTDs can act as both a focal point and a tracer indicator. Perhaps the newfound prominence and enduring ubiquity of NTDs is the mechanism to raise the prominence of the need for ubiquitous health coverage. If NTDs can become a mechanism to drive UHC, there may well be profound implications for the direction the NTD community choose to take next in their advocacy and action. There are a great many potential synergies to be built on, but also a great amount of coordination to be undertaken. Moreover, there is a risk to be managed as the NTD lobby looks to reconcile the WHO’s 2020 goals for the NTD Roadmap with the 2030 timeframe of the SDGs [18].

PLoS One
http://www.plosone.org/
[Accessed 9 July 2016]

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Research Article
Vaccination Confidence and Parental Refusal/Delay of Early Childhood Vaccines
Melissa B. Gilkey, Annie-Laurie McRee, Brooke E. Magnus, Paul L. Reiter, Amanda F. Dempsey, Noel T. Brewer
| published 08 Jul 2016 | PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0159087
Abstract
Objective
To support efforts to address parental hesitancy towards early childhood vaccination, we sought to validate the Vaccination Confidence Scale using data from a large, population-based sample of U.S. parents.
Methods
We used weighted data from 9,354 parents who completed the 2011 National Immunization Survey. Parents reported on the immunization history of a 19- to 35-month-old child in their households. Healthcare providers then verified children’s vaccination status for vaccines including measles, mumps, and rubella (MMR), varicella, and seasonal flu. We used separate multivariable logistic regression models to assess associations between parents’ mean scores on the 8-item Vaccination Confidence Scale and vaccine refusal, vaccine delay, and vaccination status.
Results
A substantial minority of parents reported a history of vaccine refusal (15%) or delay (27%). Vaccination confidence was negatively associated with refusal of any vaccine (odds ratio [OR] = 0.58, 95% confidence interval [CI], 0.54–0.63) as well as refusal of MMR, varicella, and flu vaccines specifically. Negative associations between vaccination confidence and measures of vaccine delay were more moderate, including delay of any vaccine (OR = 0.81, 95% CI, 0.76–0.86). Vaccination confidence was positively associated with having received vaccines, including MMR (OR = 1.53, 95% CI, 1.40–1.68), varicella (OR = 1.54, 95% CI, 1.42–1.66), and flu vaccines (OR = 1.32, 95% CI, 1.23–1.42).
Conclusions
Vaccination confidence was consistently associated with early childhood vaccination behavior across multiple vaccine types. Our findings support expanding the application of the Vaccination Confidence Scale to measure vaccination beliefs among parents of young children.

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Beliefs about Childhood Vaccination in the United States: Political Ideology, False Consensus, and the Illusion of Uniqueness
Mitchell Rabinowitz, Lauren Latella, Chadly Stern, John T. Jost
Research Article | published 08 Jul 2016 | PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0158382
Abstract
Several contagious diseases were nearly eradicated through childhood vaccination, but some parents have decided in recent years not to fully vaccinate their children, raising new public health concerns. The question of whether and how beliefs about vaccination are linked to political ideology has been hotly debated. This study investigates the effects of ideology on perceptions of harms and benefits related to vaccination as well as judgments of others’ attitudes. A total of 367 U.S. adults (131 men, 236 women; Mage = 34.92 years, range = 18–72) completed an online survey through Mechanical Turk. Results revealed that liberals were significantly more likely to endorse pro-vaccination statements and to regard them as “facts” (rather than “beliefs”), in comparison with moderates and conservatives. Whereas conservatives overestimated the proportion of like-minded others who agreed with them, liberals underestimated the proportion of others who agreed with them. That is, conservatives exhibited the “truly false consensus effect,” whereas liberals exhibited an “illusion of uniqueness” with respect to beliefs about vaccination. Conservative and moderate parents in this sample were less likely than liberals to report having fully vaccinated their children prior to the age of two. A clear limitation of this study is that the sample is not representative of the U.S. population. Nevertheless, a recognition of ideological sources of potential variability in health-related beliefs and perceptions is a prerequisite for the design of effective forms of public communication.

PLoS Pathogens
http://journals.plos.org/plospathogens/
(Accessed 9 July 2016)

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Research Article
Preventing Vaccine-Derived Poliovirus Emergence during the Polio Endgame
Margarita Pons-Salort, Cara C. Burns, Hil Lyons, Isobel M. Blake, Hamid Jafari, M. Steven Oberste, Olen M. Kew, Nicholas C. Grassly
| published 06 Jul 2016 | PLOS Pathogens
http://dx.doi.org/10.1371/journal.ppat.1005728
Abstract
Reversion and spread of vaccine-derived poliovirus (VDPV) to cause outbreaks of poliomyelitis is a rare outcome resulting from immunisation with the live-attenuated oral poliovirus vaccines (OPVs). Global withdrawal of all three OPV serotypes is therefore a key objective of the polio endgame strategic plan, starting with serotype 2 (OPV2) in April 2016. Supplementary immunisation activities (SIAs) with trivalent OPV (tOPV) in advance of this date could mitigate the risks of OPV2 withdrawal by increasing serotype-2 immunity, but may also create new serotype-2 VDPV (VDPV2). Here, we examine the risk factors for VDPV2 emergence and implications for the strategy of tOPV SIAs prior to OPV2 withdrawal. We first developed mathematical models of VDPV2 emergence and spread. We found that in settings with low routine immunisation coverage, the implementation of a single SIA increases the risk of VDPV2 emergence. If routine coverage is 20%, at least 3 SIAs are needed to bring that risk close to zero, and if SIA coverage is low or there are persistently “missed” groups, the risk remains high despite the implementation of multiple SIAs. We then analysed data from Nigeria on the 29 VDPV2 emergences that occurred during 2004−2014. Districts reporting the first case of poliomyelitis associated with a VDPV2 emergence were compared to districts with no VDPV2 emergence in the same 6-month period using conditional logistic regression. In agreement with the model results, the odds of VDPV2 emergence decreased with higher routine immunisation coverage (odds ratio 0.67 for a 10% absolute increase in coverage [95% confidence interval 0.55−0.82]). We also found that the probability of a VDPV2 emergence resulting in poliomyelitis in >1 child was significantly higher in districts with low serotype-2 population immunity. Our results support a strategy of focused tOPV SIAs before OPV2 withdrawal in areas at risk of VDPV2 emergence and in sufficient number to raise population immunity above the threshold permitting VDPV2 circulation. A failure to implement this risk-based approach could mean these SIAs actually increase the risk of VDPV2 emergence and spread.

Author Summary
Global, coordinated withdrawal of serotype-2 OPV (OPV2) is planned for April 2016 and will mark a major milestone for the Global Polio Eradication Initiative (GPEI). Because OPV2 withdrawal will leave cohorts of young children susceptible to serotype-2 poliovirus, minimising the risk of new serotype-2 vaccine-derived poliovirus (VDPV2) emergences before and after OPV2 withdrawal is crucial to avoid large outbreaks. Supplementary immunisation activities (SIAs) with trivalent OPV (tOPV) could raise serotype-2 immunity in advance of OPV2 withdrawal, but may also create new VDPV2. To guide the GPEI strategy we examined the risks and benefits of implementing tOPV SIAs using mathematical models and analysis of data on the 29 independent VDPV2 emergences in Nigeria during 2004–2014. We found that in settings with low routine immunisation coverage, the implementation of a small number of tOPV SIAs could in fact increase the probability of VDPV2 emergence. This probability is greater if SIA coverage is poor or if there are persistently unvaccinated groups within the population. A strategy of tOPV SIA in sufficient number and with high coverage to achieve high population immunity in geographically-focused, at-risk areas is needed to reduce the global risk of VDPV2 emergence after OPV2 withdrawal.

Preventive Medicine
Volume 88, Pages 1-240 (July 2016)
http://www.sciencedirect.com/science/journal/00917435/88

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Original Research Article
Self-reported prenatal influenza vaccination and early childhood vaccine series completion
Pages 8-12
Erika L. Fuchs
Abstract
Background
No studies have examined associations between prenatal vaccination and childhood vaccination. Mothers who refuse influenza vaccinations during pregnancy report similar attitudes and beliefs to those who refuse vaccinations for their children. The objective of this study was to examine the association between self-reported prenatal influenza vaccination and early childhood vaccination.
Methods
A retrospective cohort study was conducted with existing surveillance data from 4022 mothers who responded to the 2009–2011 Minnesota Pregnancy Risk Assessment Monitoring System survey and child vaccination records from the Minnesota Immunization Information Connection database. The childhood vaccine series outcome included the following vaccines: diphtheria, tetanus, and pertussis; poliovirus; measles, mumps, and rubella; Haemophilus influenzae type b (Hib); hepatitis B; varicella; and pneumococcal conjugate. To evaluate the association between self-reported prenatal influenza vaccination and early childhood vaccination, unadjusted and adjusted logistic regression was used to estimate log odds for childhood vaccination status, while margins post-estimation commands were used to obtain predicted probabilities and risk differences.
Results
Vaccine series completion was 10.86% higher (95% confidence interval (CI) 7.33%–14.40%, adjusted and weighted model) in children of mothers who had a prenatal influenza vaccine compared to those who did not. For individual vaccines in the recommended series, risk differences ranged from 7.83% (95% CI 5.37%, 10.30%) for the Hib vaccine to 10.06% (95% CI 7.29%, 12.83%) for the hepatitis B vaccine.
Conclusion
Self-reported prenatal influenza vaccination was associated with increased early childhood vaccination. More research is needed to confirm these results and identify potential intervention strategies.

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A double-risk monitoring and movement restriction policy for Ebola entry screening at airports in the United States
Original Research Article
Pages 33-38
Sheldon H. Jacobson, Ge Yu, Janet A. Jokela
Abstract
This paper provides an alternative policy for Ebola entry screening at airports in the United States. This alternative policy considers a social contact tracing (SCT) risk level, in addition to the current health risk level used by the CDC. The performances of both policies are compared based on the scenarios that occur and the expected cost associated with implementing such policies. Sensitivity analysis is performed to identify conditions under which one policy dominates the other policy. This analysis takes into account that the alternative policy requires additional data collection, which is balanced by a more cost-effective allocation of resources.

Risk Management and Healthcare Policy
Volume 9, 2016
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 9 July 2016]

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Review
Multimorbidity in chronic disease: impact on health care resources and costs
McPhail SM
Risk Management and Healthcare Policy 2016, 9:143-156
Published Date: 5 July 2016
Abstract:
Effective and resource-efficient long-term management of multimorbidity is one of the greatest health-related challenges facing patients, health professionals, and society more broadly. The purpose of this review was to provide a synthesis of literature examining multimorbidity and resource utilization, including implications for cost-effectiveness estimates and resource allocation decision making. In summary, previous literature has reported substantially greater, near exponential, increases in health care costs and resource utilization when additional chronic comorbid conditions are present. Increased health care costs have been linked to elevated rates of primary care and specialist physician occasions of service, medication use, emergency department presentations, and hospital admissions (both frequency of admissions and bed days occupied). There is currently a paucity of cost-effectiveness information for chronic disease interventions originating from patient samples with multimorbidity. The scarcity of robust economic evaluations in the field represents a considerable challenge for resource allocation decision making intended to reduce the burden of multimorbidity in resource-constrained health care systems. Nonetheless, the few cost-effectiveness studies that are available provide valuable insight into the potential positive and cost-effective impact that interventions may have among patients with multiple comorbidities. These studies also highlight some of the pragmatic and methodological challenges underlying the conduct of economic evaluations among people who may have advanced age, frailty, and disadvantageous socioeconomic circumstances, and where long-term follow-up may be required to directly observe sustained and measurable health and quality of life benefits. Research in the field has indicated that the impact of multimorbidity on health care costs and resources will likely differ across health systems, regions, disease combinations, and person-specific factors (including social disadvantage and age), which represent important considerations for health service planning. Important priorities for research include economic evaluations of interventions, services, or health system approaches that can remediate the burden of multimorbidity in safe and cost-effective ways.

Science
08 July 2016 Vol 353, Issue 6295
http://www.sciencemag.org/current.dtl

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In Depth
Panel slams plan for human research rules
By David Malakoff
Science08 Jul 2016 : 106-107
National Academies report urges creation of new national commission on ethical studies.
Summary
In a development certain to fuel a long-running controversy, a prominent science advisory panel is calling on the U.S. government to abandon a nearly finished update to rules on protecting human research participants. It should wait until a new high-level commission, created by Congress and the president, to recommend improvements and then start over, the panel says. The recommendation, made 29 June by a committee of the National Academies of Sciences, Engineering, and Medicine that is examining ways to reduce the regulatory burden on academic scientists, is the political equivalent of stepping in front of a speeding car in a bid to prevent a disastrous wreck. It’s not clear, however, whether the panel will succeed in stopping the regulatory express—or just get run over. Both the Obama administration, which has been pushing to complete the new rules this year, and key lawmakers in Congress would need to back the halt—and so far they’ve been silent. Still, many researchers and university groups are thrilled with the panel’s recommendation, noting that they have repeatedly objected to some of the proposed rule changes as unworkable—with little apparent impact.

Tropical Medicine & International Health
July 2016 Volume 21, Issue 7 Pages 819–935
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2016.21.issue-6/issuetoc

Reviews
HIV-free survival at 12–24 months in breastfed infants of HIV-infected women on antiretroviral treatment (pages 820–828)
Lana Clara Chikhungu, Stephanie Bispo, Nigel Rollins, Nandi Siegfried and Marie-Louise Newell
Version of Record online: 24 MAY 2016 | DOI: 10.1111/tmi.12710

Clinical outcomes of HIV-exposed, HIV-uninfected children in sub-Saharan Africa (pages 829–845)
Stanzi M. le Roux, Elaine J. Abrams, Kelly Nguyen and Landon Myer
Version of Record online: 20 MAY 2016 | DOI: 10.1111/tmi.12716

Parental migration and children’s timely measles vaccination in rural China: a cross-sectional study (pages 886–894)
Xianyan Tang, Alan Geater, Edward McNeil, Hongxia Zhou, Qiuyun Deng, Aihu Dong and Qiao Li
Version of Record online: 30 MAY 2016 | DOI: 10.1111/tmi.12719

Vaccine
Volume 34, Issue 31, Pages 3557-3626 (30 June 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/31

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Original Research Article
Prioritizing government funding of adolescent vaccinations: recommendations from young people on a citizens’ jury
Pages 3592-3597
Adriana Parrella, Annette Braunack-Mayer, Joanne Collins, Michelle Clarke, Rebecca Tooher, Julie Ratcliffe, Helen Marshall
Abstract
Objective
Adolescents’ views, and preferences are often over-looked when public health policies that affect them are designed and implemented. The purpose of this study was to describe young people’s views and preferences for determining government funding priorities for adolescent immunization programs.
Methods
In 2015 we conducted a youth jury in metropolitan Adelaide, South Australia to deliberate on the question “What criteria should we use to decide which vaccines for young people in Australia should receive public funding?” Fifteen youth aged 15–19 years participated in the jury. Jury members were recruited from the general community through a market research company using a stratified sampling technique.
Results
The jury’s key priorities for determining publically funded vaccines were:
Disease severity – whether the vaccine preventable disease (VPD) was life threatening and impacted on quality of life.
Transmissibility – VPDs with high/fast transmission and high prevalence.
Demonstration of cost-effectiveness, taking into account purchase price, program administration, economic and societal gain.
The jury’s recommendations for vaccine funding policy were strongly underpinned by the belief that it was critical to ensure that funding was targeted to not only population groups who would be medically at risk from vaccine preventable diseases, but also to socially and economically disadvantaged population groups. A novel recommendation proposed by the jury was that there should be a process for establishing criteria to remove vaccines from publically funded programs as a complement to the process for adding new vaccines.
Conclusions
Young people have valuable contributions to make in priority setting for health programs and their views should be incorporated into the framing of health policies that directly affect them

Vaccine
Volume 34, Issue 31, Pages 3557-3626 (30 June 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/31

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Conference Report
Quality vaccines for all people: Report on the 16th annual general meeting of the Developing Countries Vaccine Manufacturers’ Network, 05–07th October 2015, Bangkok, Thailand
Pages 3562-3567
Sonia Pagliusi, Ching-Chia Ting, Sumana Khomvilai, The DCVMN Executive, Organising Committee Group
Abstract
The Developing Countries Vaccine Manufacturers Network (DCVMN) assembled high-profile leaders from global health organisations and vaccine manufactures for its 16th Annual General Meeting to work towards a common goal: providing quality vaccines for all people.
Vaccines contribute to a healthy community and robust health system; the Ebola outbreak has raised awareness of the threat and damage one single infectious disease can make, and it is clear that the world was not prepared. However, more research to better understand emerging infectious agents might lead to suitable vaccines which help prevent future outbreaks.
DCVMN members presented their progress in developing novel vaccines against Dengue, HPV, Chikungunya, Cholera, cell-based influenza and other vaccines, demonstrating the commitment towards eliminating and eradicating preventable diseases worldwide through global collaboration and technology transfer. The successful introduction of novel Sabin-IPV and Oral Cholera vaccine in China and Korea respectively in 2015 was highlighted.
In order to achieve global immunisation, local authorities and community leaders play an important role in the decision-making in vaccine introduction and uptake, based on the ability of vaccines to protect vaccinated people and protect non-vaccinated in the community through herd immunity. Reducing the risk of vaccine shortages can also be achieved by increasing regulatory convergence at regional and international levels. Combatting preventable diseases remains challenging, and collective efforts for improving multi-centre clinical trials, creating regional vaccine security strategies, fostering developing vaccine markets and procurement, and building trust in vaccines were discussed.

Vaccine
Volume 34, Issue 32, Pages 3627-3710 (12 July 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/32

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Anticipating policy considerations for a future HIV vaccine: a preliminary study
Original Research Article
Pages 3697-3701
Emmanuel Ato Williams, David J.M. Lewis, Sylvie Bertholet, Maurizio Zazzi
Abstract
Background
New human immunodeficiency virus (HIV) infections continue to occur worldwide. Despite previous failures, there is renewed optimism about developing an efficacious HIV prophylactic vaccine following the 31.2% vaccine efficacy (modified intention to treat analysis) achieved in the RV-144 trial. Intense efforts at characterising the immune responses in the trial participants who appeared to gain some protection from the candidate vaccine are ongoing to delineate correlates of protection. However, the characteristics of a vaccine suitable for programmatic introduction in high prevalence areas remain undefined.
Aims
We set out to ascertain the vaccination policies and strategies that policy makers involved in vaccine introductions would advise were a candidate HIV vaccine to become available.
Methods
Structured questionnaires in both English and French were self-administered to consenting policy makers such as members of National Immunisation Technical Advisory Groups. Members from three out of the six WHO regional groups were purposively reached for their responses.
Results
Thirty-seven key opinion leaders were approached through self-administered questionnaires delivered by e-mail or in person. Nine responses were received, representing a 24.3% response rate. The responses received were from three [Africa (6), Americas (1) and Europe (2)] out of the six WHO regions. All respondents would prioritise the vaccination of commercial sex workers over other risk groups if there was an efficacious HIV vaccine. Vaccine efficacy was considered to be the most important factor, ahead of vaccine safety and cost, in determining the acceptability of a new prophylactic HIV vaccine.
Conclusions
It is expected that the first generation HIV vaccines may be modestly efficacious. However, even a modestly efficacious vaccine might curtail the spread of HIV if universal or near-universal coverage is achieved. It is important to anticipate policy discussions which would influence how rapidly an HIV vaccine would be rolled-out programmatically to achieve maximum impact.

Vaccine
Volume 34, Issue 32, Pages 3627-3710 (12 July 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/32

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Dengue vaccine acceptance and associated factors in Indonesia: A community-based cross-sectional survey in Aceh
Original Research Article
Pages 3670-3675
Harapan Harapan, Samsul Anwar, Abdul Malik Setiawan, R. Tedjo Sasmono, on behalf of the Aceh Dengue Study
Abstract
Background
The first dengue vaccine (DV) has been licensed in some countries, but an assessment of the public’s acceptance of DV is widely lacking. This study aimed to explore and understand DV acceptance and its associated explanatory variables among healthy inhabitants of Aceh, Indonesia.
Methods
A community-based cross-sectional survey was conducted from November 2014 to March 2015 in nine regencies of Aceh that were selected randomly. A set of validated questionnaires covering a range of explanatory variables and DV acceptance was used to conduct the interviews. A multi-step logistic regression analysis and Spearman’s rank correlation were employed to assess the role of explanatory variables in DV acceptance.
Results
We included 652 community members in the final analysis and found that 77.3% of them were willing to accept the DV. Gender, monthly income, socioeconomic status (SES), attitude toward dengue fever (DF) and attitude toward vaccination practice were associated with DV acceptance in bivariate analyses (P < 0.05). A correlation analysis confirmed that attitude toward vaccination practice and attitude toward DF were strongly correlated with DV acceptance, rs = 0.41 and rs = 0.39, respectively (P < 0.001). The multivariate analysis revealed that a high monthly income, high SES, and a good attitude toward vaccination practice and toward DF were independent predictors of DV acceptance.
Conclusion
The acceptance rate of the DV among inhabitants of Aceh, Indonesia was relatively high, and the strongest associated factors of higher support for the DV were a good attitude toward vaccination practices and a good attitude toward DF.

Vaccine
Volume 34, Issue 32, Pages 3627-3710 (12 July 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/32

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The impact of implementing a demand forecasting system into a low-income country’s supply chain
Original Research Article
Pages 3663-3669
Leslie E. Mueller, Leila A. Haidari, Angela R. Wateska, Roslyn J. Phillips, Michelle M. Schmitz, Diana L. Connor, Bryan A. Norman, Shawn T. Brown, Joel S. Welling, Bruce Y. Lee
Abstract
Objective
To evaluate the potential impact and value of applications (e.g. adjusting ordering levels, storage capacity, transportation capacity, distribution frequency) of data from demand forecasting systems implemented in a lower-income country’s vaccine supply chain with different levels of population change to urban areas.
Materials and Methods
Using our software, HERMES, we generated a detailed discrete event simulation model of Niger’s entire vaccine supply chain, including every refrigerator, freezer, transport, personnel, vaccine, cost, and location. We represented the introduction of a demand forecasting system to adjust vaccine ordering that could be implemented with increasing delivery frequencies and/or additions of cold chain equipment (storage and/or transportation) across the supply chain during varying degrees of population movement.
Results
Implementing demand forecasting system with increased storage and transport frequency increased the number of successfully administered vaccine doses and lowered the logistics cost per dose up to 34%. Implementing demand forecasting system without storage/transport increases actually decreased vaccine availability in certain circumstances.
Discussion
The potential maximum gains of a demand forecasting system may only be realized if the system is implemented to both augment the supply chain cold storage and transportation. Implementation may have some impact but, in certain circumstances, may hurt delivery. Therefore, implementation of demand forecasting systems with additional storage and transport may be the better approach. Significant decreases in the logistics cost per dose with more administered vaccines support investment in these forecasting systems.
Conclusion
Demand forecasting systems have the potential to greatly improve vaccine demand fulfilment, and decrease logistics cost/dose when implemented with storage and transportation increases. Simulation modeling can demonstrate the potential health and economic benefits of supply chain improvements.

Vaccine
Volume 34, Issue 32, Pages 3627-3710 (12 July 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/32

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Original Research Article
Low vaccination coverage for seasonal influenza and pneumococcal disease among adults at-risk and health care workers in Ireland, 2013: The key role of GPs in recommending vaccination
Pages 3657-3662
Coralie Giese, Jolita Mereckiene, Kostas Danis, Joan O’Donnell, Darina O’Flanagan, Suzanne Cotter
Abstract
The World Health Organization (WHO), and European Agencies recommend influenza vaccination for individuals at-risk due to age (≥65 years), underlying diseases, pregnancy and for health care workers (HCWs) in Europe. Pneumococcal vaccine is recommended for those at-risk of pneumococcal disease. In Ireland, vaccination uptake among at-risk adults is not routinely available. In 2013, we conducted a national survey among Irish residents ≥18 years of age, to estimate size and vaccination coverage of at-risk groups, and identify predictive factors for influenza vaccination.
We used computer assisted telephone interviews to collect self-reported information on health, vaccination status, attitudes towards vaccination. We calculated prevalence and prevalence ratios (PR) using binomial regression.
Overall, 1770 individuals participated. For influenza, among those aged 18–64 years, 22% (325/1485) [95%CI: 17%–20%] were at-risk; 28% [95%CI: 23%–33%] were vaccinated. Among those aged ≥65 years, 60% [95%CI: 54%–66%] were vaccinated. Influenza vaccine uptake among HCWs was 28% [95%CI: 21%–35%]. For pneumococcal disease, among those aged 18–64 years, 18% [95%CI: 16%–20%] were at-risk; 16% [95%CI: 12%–21%] reported ever-vaccination; among those aged ≥65 years, 36% [95%CI: 30%–42%] reported ever-vaccination. Main reasons for not receiving influenza vaccine were perceptions of not being at-risk, or not thinking of it; and among HCWs thinking that vaccination was not necessary or they were not at-risk. At-risk individuals were more likely to be vaccinated if their doctor had recommended it (PR 3.2; [95%CI: 2.4%-4.4%]) or they had access to free medical care or free vaccination services (PR 2.0; [95%CI: 1.5%-2.8%]).
Vaccination coverage for both influenza and pneumococcal vaccines in at-risk individuals aged 18–64 years was very low. Influenza vaccination coverage among individuals ≥65 years was moderate. Influenza vaccination status was associated with GP vaccination recommendation and free access to vaccination services. Doctors should identify and recommend vaccination to at-risk patients to improve uptake.

Vaccine
Volume 34, Issue 32, Pages 3627-3710 (12 July 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/32

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WHO Position Papers
New recommendations to prevent pain during immunizations: WHO position paper – September 2015
Pages 3627-3628
Kevin Pottie, Winnie Siu, Philippe Duclos, The Members of the WHO Technical Consultation on Pain Mitigation

Reducing pain at the time of vaccination: WHO position paper, September 2015—Recommendations
Pages 3629-3630

See posts just below…

BMC Globalization and Health
201612:38
Review
Why might regional vaccinology networks fail? The case of the Dutch-Nordic Consortium
Jan Hendriks and Stuart Blume
Globalization and Health
DOI: 10.1186/s12992-016-0176-6
Published: 7 July 2016
Abstract
We analyzed an attempt to develop and clinically test a pneumococcal conjugate vaccine for the developing world, undertaken by public health institutions from the Netherlands, Sweden, Denmark, Norway and Finland: the Dutch Nordic Consortium (DNC), between 1990 and 2000. Our review shows that the premature termination of the project was due less to technological and scientific challenges and more to managerial challenges and institutional policies. Various impeding events, financial and managerial challenges gradually soured the initially enthusiastic collaborative spirit until near the end the consortium struggled to complete the minimum objectives of the project. By the end of 1998, a tetravalent prototype vaccine had been made that proved safe and immunogenic in Phase 1 trials in adults and toddlers in Finland. The planned next step, to test the vaccine in Asia in infants, did not meet approval by the local authorities in Vietnam nor later in the Philippines and the project eventually stopped.

The Dutch DNC member, the National Institute of Public Health and the Environment (RIVM) learned important lessons, which subsequently were applied in a following vaccine technology transfer project, resulting in the availability at affordable prices for the developing world of a conjugate vaccine against Haemophilus influenzae type b. We conclude that vaccine development in the public domain with technology transfer as its ultimate aim requires major front-end funding, committed leadership at the highest institutional level sustained for many years and a competent recipient-manufacturer, which needs to be involved at a very early stage of the development.

At the national level, RIVM’s policy to consolidate its national manufacturing task through securing a key global health position in support of a network of public vaccine manufacturers proved insufficiently supported by the relevant ministries of the Dutch government. Difficulties to keep up with high costs, high-risk innovative vaccine development and production in a public sector setting led to the gradual loss of production tasks and to the 2009 Government decision to privatize the vaccine production tasks of the Institute.

HIV & AIDS Review
Available online 5 July 2016
Original Research Article
How successful is influenza vaccination in HIV infected patients? Results from an influenza A (H1N1) pdm09 vaccine study
C Schwarze-Zander, B Steffens, J Emmelkamp…
Abstract
Aim
To determine immune response after single vaccination with AS03-adjuvanted pandemic H1N1 vaccine in HIV-infected patients.
Background
Individuals living with human immunodeficiency virus (HIV) are at risk with influenza due to hyporesponsiveness to influenza vaccine and a higher probability for developing severe disease. Especially, immunogenicity and tolerability of adjuvanted influenza vaccines in a pandemic setting are not well characterized in HIV infected individuals.
Methods
Immune response following vaccination with a single dose of influenza A (H1N1)pdm09 AS03-adjuvanted vaccine (H1N1pdm09 vaccine) containing 3.75 μg hemagglutinin was evaluated in HIV infected individuals by hemagglutination inhibition assay. Tolerability was assessed by questionnaires.
Results
Three hundred eighty-nine patients from two German HIV clinics were evaluated. Seroprotection was found in as much as 191/389 (49%) of patients before vaccination. Following vaccination with H1N1pdm09 vaccine seroprotection rate increased to 66% (257/389). Due to high pre-vaccination seroprotection rates seroconversion was only found in a total of 27/389 (7%) of HIV patients. There was no association of seroprotection/seroconversion and current CD4+ T-cell count, HIV-RNA load in plasma, antiretroviral treatment or demographic factors such as gender, age and ethnicity. The vaccine was overall well tolerated.
Conclusions
In this large cohort of HIV infected patients with high baseline H1N1 seroprotective titers only a moderate antibody response to a single vaccination with H1N1pdm09 AS03-adjuvanted vaccine was detected. Emerging influenza pandemics warrant usage of booster vaccinations in order to achieve higher immunogenicity to protect a vulnerable patient population such as HIV positive individuals against influenza.

6th Biennial Conference of the American Society of Health Economists (ASHEcon) – 2016
Selected papers

Effectiveness of Vaccination Recommendations versus Mandates: Evidence from the hepatitis A vaccine
Tuesday, June 14, 2016
Author(s): Emily Lawler
Discussant: Dr. Kerry Anne McGeary
Abstract
In the United States, immunization rates are persistently low for numerous vaccines, and recently there have been multiple outbreaks of vaccine-preventable diseases resulting from undervaccination. In response, a number of policies have been implemented in an attempt to achieve and maintain high population vaccination rates and reduce disease incidence. In this paper I provide novel evidence on the effectiveness of two vaccination policies – simple non-binding recommendations to vaccinate versus mandates requiring vaccination prior to childcare or kindergarten attendance– in the context of the only disease whose institutional features permit a credible examination of both: hepatitis A. Using a difference-in-differences strategy that allows me to take advantage of plausibly exogenous variation across states in the timing of the policy introductions, I find that recommendations significantly increased hepatitis A vaccination rates among young children by at least 20 percentage points, while mandates increased rates by another 8 percentage points. Together these policies explain approximately half of the change in vaccination rates over the sample period. These policies also significantly reduced population hepatitis A incidence, and similarly explain approximately half the change in disease incidence over the period of interest. These results are robust to the inclusion of both a number of controls for state vaccine- and healthcare-related policies, and state-specific linear time trends. I also demonstrate that these results are not present for other vaccines and diseases, which is strong evidence that my findings are not being driven by unobserved state policies that generally increased vaccination or decreased disease incidence.

This paper further provides evidence that the effects of the recommendations and the mandates differ along several important dimensions. First, my results indicate that the mandates are effective at inducing individuals to complete the vaccine series, while the recommendations only significantly increase the probability that individuals initiate the series. Second, when I allow policy effects to vary over time, I find that individuals who are induced to vaccinate by the mandate respond rapidly to the policy, whereas the recommendations have a more gradual effect that continues to increase for several years following implementation. Finally, for the mandates I find no significant heterogeneity in the effects of by ethnicity, mother’s education, or family income, although there is some evidence of a heterogeneous policy response for the recommendations. Overall, my results are informative about responses to vaccination recommendations versus mandates for young children, and suggest a range of policy options for addressing suboptimally low population vaccination rates.

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Group Incentives and the Take–Up of the Flu Vaccine
Monday, June 13, 2016
Author(s): Lenisa V Chang
Discussant: Lisa Schulkind
Abstract
The take-up of the flu vaccine has important benefits, especially among health care workers (HCW) who are in close contact with populations most vulnerable to the flu such as infants, the elderly, and those with chronic conditions and compromised health. Many health care organizations, especially hospitals, have mandated flu vaccination for their workers for years, and others have done so more recently as the flu vaccination rate is used as a publically reported quality measure of care. However, while the take-up of the flu shot by HCW has increased nationwide, it is less than the recommended 90% vaccination rate. Previous experimental work with students has found that financial incentives have increased the take-up of the flu shot (Bronchetti, Huffman, Magenheim, 2015). We study an incentive scheme aimed at residents in a Midwestern medical school that would pay $100 (as a gift card) to each individual resident if they collectively reached a 95% flu vaccination rate by the end of the early flu season on November 1st. While the vaccination target was met and the incentive distributed, we study whether the time to vaccination was shortened from the previous year, if there was a bunching at the deadline, and whether there were any differences compared to nurses, a similar group of workers who was not eligible for the gift card, but also benefitted from the availability of free flu shots and on site walk-in clinics at the hospital.

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The Effect of School-Immunization Exemption Policies on Enrollment Rates for Prekindergarten and Kindergarten
Tuesday, June 14, 2016:
Author(s): Emily Zier; W. David Bradford
Discussant: Lisa Schulkind
Abstract
There is no national immunization policy in the United States, and the strictness of regulations allowing vaccine exemption for school attendance varies greatly by state. Furthermore, despite substantial evidence on the safety and health benefits of immunization, there has been a recent upsurge in skepticism amongst parents regarding vaccine safety and efficacy for their children. In this paper, we analyze whether or not the strength of state vaccine exemption policies affect the enrollment rates for prekindergarten and kindergarten. Given the significant positive effects that pre-k and kindergarten have for a child’s future educational attainment, understanding negative unintended consequences from vaccination policy will be of interest to policy makers who seek to optimize public health and educational policy. We hypothesize that states with stricter exemption policies will have lower average enrollment in prekindergarten and kindergarten amongst children in the relevant age ranges. To test these hypotheses, we construct a long panel of data on state level enrollment rates, state characteristics and utilize a recently validated measure of state vaccination policy effectiveness.

Media/Policy Watch
This section is intended to alert readers to substantive news, analysis and opinion from the general media 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.

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The Atlantic
http://www.theatlantic.com/magazine/
Accessed 9 July 2016
After Ebola [Liberia]
The disease has left a terrible legacy—and another outbreak is likely.
Lois Parshley
July/August 2016 Issue

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New York Times
http://www.nytimes.com/
Accessed 9 July 2016
Utah Resident Who Had Been Infected With Zika Dies: Health Officials
CHICAGO — The Centers for Disease Control and Prevention has confirmed that a Utah resident’s death last month is the first Zika-related death in the continental United States, the CDC said in an emailed statement.
Health officials in the Salt Lake County health department in Utah reported the death on Friday of an elderly resident who had been infected with the Zika virus while traveling to an area with active transmission of the virus.
The exact cause of death is not known, the health department said in a press release.
The resident had an undisclosed health condition and had tested positive for the Zika virus. County health officials said it may not be possible to determine how the Zika infection contributed to the person’s death…
July 08, 2016 – By REUTERS –

Some Malaysians’ Rejection of Vaccines Fans Fears of Disease Surge
KUALA LUMPUR — More children are falling victim to contagious diseases in Muslim-majority Malaysia, worrying health authorities as parents reject immunization programs for fear the vaccines used infringe strict religious rules.
The deaths of five children in June from diphtheria, a disease that can be prevented by vaccines, provoked an outcry among doctors and spurred calls for an edict by religious authorities to compel Muslim families to immunize children.
“Our concern is, if it’s left uncontrolled, in the long-term we might see a significant effect on the nation as a whole,” Health Minister S. Subramaniam told Reuters in an interview.
Although Muslim religious authorities have waived the stringent halal requirement if suitable vaccines are not available, concerns have redoubled recently that some may contain substances such as pig DNA, forbidden by Islam.
Pediatrician Musa Mohamad Nordin said there was a lot of misinformation in Malaysia’s Muslim community, mostly ethnic Malays who form 61 percent of a population of about 30 million that includes substantial ethnic Chinese and Indian minorities.
“I’m upset, and also saddened, that some religious teachers are spreading rumors that vaccines contain a composition that is not permissible by Islamic jurisprudence,” added Musa, a member of Malaysia’s Federation of Islamic Medical Associations…
July 06, 2016 – By REUTERS – World – Print Headline: “Some Malaysians’ Rejection of Vaccines Fans Fears of Disease Surge”

The Cholera Epidemic the U.N. Left Behind in Haiti
By New York Times -THE EDITORIAL BOARD
JULY 6, 2016
…For starters, the international community needs to redouble efforts to fight this preventable and curable disease. In 2012, the United Nations set out to rid Haiti and its neighbor the Dominican Republic of cholera, by expanding access to clean water and improving Haiti’s beleaguered health care system. The initiative has been inadequate and underfunded, and cholera continues to sicken people.
Beyond that, the United Nations must acknowledge its role in the epidemic. Only by doing that will it be able to establish stronger safeguards for future peacekeeping operations. Experts believe that Nepalese peacekeepers in camps with poor sanitation introduced cholera to Haiti. That raised questions about health screening for peacekeepers and the sanitation standards they use.
Finally, Mr. Ban should heed the organization’s watchdogs who urged him last year to establish a system to compensate victims. “The United Nations has a particular responsibility to ensure that a very large number of victims are not left without any effective remedy for human rights violations that result from actions of forces operating under the authority of the United Nations,” they said. It’s not too late for Mr. Ban to take those words to heart.

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Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 9 July 2016
Brazilian Researchers Join With U.S. in Hunt for Zika Vaccine
More than a dozen drug companies already looking for a solution, which is likely several years away
By Reed Johnson and Rogerio Jelmayer
5 July 2016
A leading Brazilian biomedical research center is teaming up with the U.S. and the World Health Organization in the latest effort to develop a vaccine for the mosquito-borne Zika virus. The Butantan Institute here has said it would partner with a division of the U.S. Department of Health and Human Services to develop the new vaccine for the virus, which spread across the Americas and raised concerns ahead of next month’s Rio Olympics Games in Rio de Janeiro. The U.S. division, known as the Biomedical Advanced Research and Development Authority, or Barda, will supply initial funding of $3 million for the project. The funds will be invested in equipment and other research-related areas, according to officials…

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Washington Post
http://www.washingtonpost.com/
Accessed 9 July 2016
Arizona is site of largest current US measles outbreak
Health officials in Arizona say the largest current measles outbreak in the United States is in part because some workers at a federal immigration detention center refuse to get vaccinated.
Astrid Galvan | AP | National | Jul 8, 2016

WHO predicts modest rise in yellow fever deaths in Africa
A top U.N. health agency official says he expects some increase in yellow fever deaths in coming months from the current outbreak in Angola and Congo, but it will be “incremental not exponential.”
Associated Press | Foreign | Jul 7, 2016

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_2 July 2016

– 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.

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

Zika virus [to 2 July 2016]
Public Health Emergency of International Concern (PHEIC)
http://www.who.int/emergencies/zika-virus/en/

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Zika situation report – 30 June 2016
Full report: http://apps.who.int/iris/bitstream/10665/246155/1/zikasitrep30Jun16-eng.pdf?ua=1

Summary [Initial text]
As of 22 June 2016, 61 countries and territories report continuing mosquito-borne transmission (Fig. 1) of which:
:: 47 countries are experiencing a first outbreak of Zika virus since 2015, with no previous evidence of circulation, and with ongoing transmission by mosquitoes.
:: 14 countries reported evidence of Zika virus transmission between 2007 and 2014, with ongoing transmission…
[No change from 23 June 2016]

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Zika Open [to 2 July 2016]
[Bulletin of the World Health Organization]
:: All papers available here
No new papers identified.

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CDC/ACIP [to 2 July 2016]
http://www.cdc.gov/media/index.html
Press Release
FRIDAY, JULY 1, 2016
CDC Awards Funds for States and Territories to Prepare for Zika
The Centers for Disease Control and Prevention (CDC) has awarded $25 million in funding to states, cities, and territories to support efforts to protect Americans from Zika virus infection and…

Media Statement
THURSDAY, JUNE 30, 2016
CDC adds Anguilla to interim travel guidance related to Zika virus
CDC is working with other public health officials to monitor for ongoing Zika virus transmission. Today, CDC posted a Zika virus travel notice for Anguilla.

Press Release
WEDNESDAY, JUNE 29, 2016
New study sheds light on how some survive Ebola
Finding points way to new approaches to Ebola treatment

EBOLA/EVD [to 2 July 2016]
“Threat to international peace and security” (UN Security Council)

[Editor’s Note:
We deduce that WHO has suspended issuance of new Situation Reports after resuming them for several weekly cycles. Most recent report summary below]
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EBOLA VIRUS DISEASE – Situation Report – 10 JUNE 2016
[Excerpt]
Risk assessment:
Guinea and Liberia declared the end of the most recent outbreak of EVD on 1 and 9 June, respectively. The performance indicators suggest that Guinea, Liberia and Sierra Leone still have variable capacity to prevent, detect and respond to new outbreaks (Table 1). The risk of additional outbreaks originating from exposure to infected survivor body fluids remains and requires sustained mitigation through counselling on safe sex practices and testing of body fluids.

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CDC/ACIP [to 2 July 2016]
http://www.cdc.gov/media/index.html
MONDAY, JUNE 27, 2016
Global Health Security in Liberia
CDC works with the Government of Liberia and partners to improve health systems and outcomes by building on existing disease prevention, detection and response capacities, as well as those developed during the response to the Ebola epidemic. Efforts continue to help public health systems created as a result of the epidemic and to support specific programs that meet the needs of Ebola survivors.

Our activities support the Global Health Security Agenda (GHSA), which aims to improve countries’ abilities to prevent, detect, and respond to health threats. In Liberia, we are doing this by focusing on key activities to:
:: build surveillance systems that monitor cases of infectious diseases
:: improve the safety and quality of national laboratory systems
:: develop the skills of the public health workforce
:: establish emergency operations centers that can quickly launch coordinated responses to a public health threat.

The 2014-2015 Ebola epidemic in West Africa was the largest in history. Liberia and the other affected countries suffered significant loss of human life that continues to adversely affect communities and health systems. In the wake of the outbreak, there have been a number of additional cases/clusters of Ebola. CDC assists with detection and control of these cases/clusters, while supporting research and programs designed to meet the needs of survivors. Our experience in Liberia has demonstrated the importance of having systems to detect and respond to health threats, and building capacity before diseases appear…

POLIO [to 2 July 2016]
Public Health Emergency of International Concern (PHEIC)

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Polio this week as of 29 June 2016
:: The Expert Review Committee on Polio Eradication and Routine Immunization met in Abuja on 21 – 22 June, and emphasised that the strategy in Nigeria must now shift from interrupting transmission to staying polio free, sustaining the hard-won gains, strengthening routine immunization and responding to outbreaks of vaccine-derived polioviruses. More

:: The Pakistan Technical Advisory Group met this week in Islamabad to discuss progress towards interrupting the transmission of polio and to discuss solutions to the upcoming challenges.

:: Surveillance is an essential part of polio eradication efforts in countries around the world. Michel Zaffran, Director of GPEI, explains these crucial efforts to Rotary in this blog post.

Selected Country Levels Updates [excerpted]
Pakistan
:: One new case of wild poliovirus type 1 (WPV1) was reported in the past week in Dera Ismail Khan in Khyber Pakhtunkhwa with onset of paralysis on 6 June. The total number of WPV1 cases for 2016 is now 12, compared to 25 at this time in 2015.

Yellow Fever [to 2 July 2016]
http://www.who.int/emergencies/yellow-fever/en/

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Yellow Fever – Situation Report – 30 June 2016
Full Report:
http://apps.who.int/iris/bitstream/10665/246156/1/yellowfeversitrep30Jun16-eng.pdf?ua=1
[Excerpt]
…The risk of spread
Two additional countries have reported confirmed yellow fever cases imported from Angola: Kenya (two cases) and People’s Republic of China (11 cases). These cases highlight the risk of international spread through non-immunised travellers.

Seven countries (Brazil, Chad, Colombia, Ghana, Guinea, Peru and Uganda) are currently reporting yellow fever outbreaks or sporadic cases not linked to the Angolan outbreak…

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IOM / International Organization for Migration [to 2 July 2016]
http://www.iom.int/press-room/press-releases
06/28/16
Yellow Fever Outbreak Confirmed in DR Congo: IOM Trains Border Health Officers
Democratic Republic of Congo – IOM has trained a first group of border health officials to combat an outbreak of yellow fever.

The training was held in the town of Matadi, which borders Angola, and was attended by 25 health officers from Kinshasa’s Ndjili Airport, Beach Ngobila on the Congo River and other main border posts in Mbanza Ngungu, Kimpese Lufu, Ango-Ango (Matadi), Boma, Lindu, Yema, Yatch and Moanda.

The workshop was designed to improve participants’ understanding of an Integrated Surveillance of Diseases and Response, international health regulations, the management of migration flows during outbreaks, and the registration of suspected cases.

Saturnin Phuati Nganzi, who heads the National Border Hygiene Programme, said: “This first training has equipped my team with the right tools to reinforce existing epidemiological surveillance at the borders.”…

MERS-CoV [to 2 July 2016]

Disease Outbreak News (DONs)
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Qatar 29 June 2016
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 22 June 2016

WHO & Regional Offices [to 2 July 2016]

WHO announces head of new Health Emergencies Programme
WHO statement
28 June 2016
WHO has announced the appointment of Dr Peter Salama as the Executive Director of its new Health Emergencies Programme, at the level of Deputy Director-General. He takes up his new post on 27 July 2016.

Dr Salama is from Australia and is currently UNICEF Regional Director for Middle East and North Africa and Global Emergency Coordinator for the Crises in Syria, Iraq and Yemen. He has previously served with UNICEF as Country Representative in Ethiopia and Zimbabwe, as Global Coordinator for Ebola, and as Chief of Global Health.

Prior to joining UNICEF in 2002, he worked with the United States Centers for Disease Control and Prevention (US CDC), Concern Worldwide and MSF. Dr Salama is a medical epidemiologist who brings a wealth of experience in management of humanitarian crises and disease outbreaks. He has worked in public health for more than 20 years and published widely in the fields of maternal and child survival, refugee and forced migration and complex emergencies.
WHO’s new Health Emergencies Programme is designed to deliver rapid, predictable and comprehensive support to countries and communities as they prepare for, face or recover from emergencies caused by any type of hazard to human health, whether disease outbreaks, natural or man-made disasters or conflicts.

The development of the new Programme is the result of a reform effort, based on recommendations from a range of independent and expert external reports, involving all levels of WHO – country offices, regional offices and headquarters.

The new Programme unifies WHO’s standards and processes to strengthen the Organization’s response to health emergencies across the full risk management cycle of prevention, preparedness, response and early recovery.

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New checklist to make health estimates more transparent, accurate and reliable
June 2016
…The Guidelines for Accurate and Transparent Health Estimates Reporting, or GATHER, is a checklist of 18 best practices that sets the standard for disclosing how health estimates are developed. The GATHER checklist was developed by WHO and researchers from around the world including the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle, and was published today in the Lancet and PLOS Medicine.

“When the health and well-being of millions of people is at stake you need to be sure you have the best possible information to make the best possible decisions,” said Dr Ties Boerma, Director of WHO’s Department of Information, Evidence and Research. “GATHER is a crucial step towards making sure health estimates can stand up to scrutiny.”

GATHER includes requirements for disclosing which data are used to calculate estimates, and for making them available to others. It also includes a requirement to disclose how the computer code used to crunch the numbers can be accessed, making it possible for others to reproduce estimates, making them more robust.

Both WHO and IHME have agreed to comply with GATHER when they publish new global health estimates. Journals including the Lancet, PLOS Medicine, the International Journal of Epidemiology and the Bulletin of the World Health Organization plan to ask authors to comply with GATHER, and it is expected that other journals to follow suit. Several estimates compiled by WHO already follow GATHER principles, including child mortality, childhood causes of death and maternal mortality.

Better transparency improves credibility
GATHER will also help researchers to be more efficient and make better use of research funds; greater transparency will enable researchers to build on the work done by others, instead of wasting months or even years of work trying to reproduce it.

“Transparency gets to the essence of credibility in health science,” said Dr Christopher Murray, Director of IHME. “If researchers are not willing to be completely open about their sources of information and methods used for analysis, the credibility of their findings may be questioned. Those who adhere to the guidelines will raise the bar in terms of research excellence. And all of us will benefit from that higher bar.”

The production of global health estimates has increased tremendously in the past years, driven mainly by an increasing global demand for data on key indicators, such as those used to measure progress towards the Millennium Development Goals (MDGs).

The Sustainable Development Goals, which are far broader in scope than the MDGs, will only increase the demand for more, better data. Through initiatives such as the Health Data Collaborative, WHO is working with countries and partners to meet that demand.

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Global food safety standards body issues new guidance
28 June 2016 – The international food standards-setting body, the Codex Alimentarius Commission, is meeting to discuss guidelines and standards for a range of issues, including the control of Salmonella in beef and pork, food hygiene to control foodborne parasites, nutrient reference values for food package nutrition labels, safety of food additives, pesticide residues in food, and arsenic levels in rice. The Codex is also considering its future work on antimicrobial resistance

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Highlights
WHO reaches 40 000 people with lifesaving treatments in Syria
June 2016 – As part of the United Nations interagency convoy on 29 June 2016, WHO delivered 43 000 lifesaving treatments to people in need in Arbeen and Zamalka, East Ghouta.

Improving access to quality medicines in Africa
June 2016 — WHO met with the European Union and the African, Caribbean and Pacific Group of States recently to review a joint 4-year programme to improve access to quality medicines for 15 countries in sub-Saharan Africa. The quality, safety, and pricing of medicines have been addressed by the programme.

Commitment to advancing global health security
June 2016 — WHO, governments, financial institutions, development partners, and health agencies from across the world have committed to accelerate strengthening and implementation of capacities required to cope with disease outbreaks and other health emergencies.

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Weekly Epidemiological Record (WER) 1 July 2016, vol. 91, 26/27 (pp. 329–340)
Contents
329 Index of countries/areas
329 Index, Volume 91, 2016, Nos. 1–27
331 Health conditions for travellers to Saudi Arabia for the pilgrimage to Mecca (Hajj), 2016
336 Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2016

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GIN – June 2016 pdf, 1.13Mb 30 June 2016

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Disease Outbreak News (DONs)
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Qatar 29 June 2016
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 22 June 2016

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:: WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO, governments and health agencies commit to advancing global health security
Bali, Indonesia, 30 June 2016 – The World Health Organization (WHO), governments, financial institutions, development partners, and health agencies from across the world have committed to accelerate strengthening and implementation of capacities required to cope with disease outbreaks and other health emergencies.
:: Fifteen African Countries and Partners Take stock of Progress Made in Access to Medicines – 29 June 2016

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

WHO South-East Asia Region SEARO
:: WHO, governments and health agencies commit to advancing global health security
30 June 2016

WHO European Region EURO
:: New course builds “soft skills” for greater health equity and well-being in policy 01-07-2016
:: New report calls for improved maternal nutrition to decrease children’s long-term risk of noncommunicable diseases (NCDs) and obesity 29-06-2016
:: Fight against TB in focus during Regional Director’s visit to Slovakia 28-06-2016

WHO Eastern Mediterranean Region EMRO
:: WHO, governments and health agencies commit to advancing global health security
30 June 2016

WHO Western Pacific Region
:: Global Youth Tobacco Survey underscores urgent need to protect youth from tobacco harms
28 June 2016

CDC/ACIP [to 2 July 2016]
http://www.cdc.gov/media/index.html

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Press Release
FRIDAY, JULY 1, 2016
CDC Awards Funds for States and Territories to Prepare for Zika
The Centers for Disease Control and Prevention (CDC) has awarded $25 million in funding to states, cities, and territories to support efforts to protect Americans from Zika virus infection and…

Media Advisory
THURSDAY, JUNE 30, 2016
Federal Select Agent Program first annual report released
The Federal Select Agent Program (FSAP) released today its first annual report of data on the regulation and oversight of laboratories that work with biological agents and toxins that have…

Media Statement
THURSDAY, JUNE 30, 2016
CDC adds Anguilla to interim travel guidance related to Zika virus
CDC is working with other public health officials to monitor for ongoing Zika virus transmission. Today, CDC posted a Zika virus travel notice for Anguilla.

Press Release
WEDNESDAY, JUNE 29, 2016
New study sheds light on how some survive Ebola
Finding points way to new approaches to Ebola treatment

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MONDAY, JUNE 27, 2016
Global Health Security in Liberia
CDC works with the Government of Liberia and partners to improve health systems and outcomes by building on existing disease prevention, detection and response capacities, as well as those developed during the response to the Ebola epidemic. Efforts continue to help public health systems created as a result of the epidemic and to support specific programs that meet the needs of Ebola survivors.

Our activities support the Global Health Security Agenda (GHSA), which aims to improve countries’ abilities to prevent, detect, and respond to health threats. In Liberia, we are doing this by focusing on key activities to:
:: build surveillance systems that monitor cases of infectious diseases
:: improve the safety and quality of national laboratory systems
:: develop the skills of the public health workforce
:: establish emergency operations centers that can quickly launch coordinated responses to a public health threat.

The 2014-2015 Ebola epidemic in West Africa was the largest in history. Liberia and the other affected countries suffered significant loss of human life that continues to adversely affect communities and health systems. In the wake of the outbreak, there have been a number of additional cases/clusters of Ebola. CDC assists with detection and control of these cases/clusters, while supporting research and programs designed to meet the needs of survivors. Our experience in Liberia has demonstrated the importance of having systems to detect and respond to health threats, and building capacity before diseases appear…

Gavi [to 2 July 2016]
http://www.gavialliance.org/library/news/press-releases/

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30 June 2016
Gavi Board reappoints WHO’s Flavia Bustreo as vice-chair
Board also confirms appointment of four new members and two alternates.
Geneva, 30 June 2016 – Dr Flavia Bustreo, WHO’s Assistant Director-General for Family, Women’s and Children’s Health, has been reappointed as Vice-Chair of the Board of Gavi, the Vaccine Alliance. Dr Bustreo has held the role since January 2015, and is also the chair of the Governance Committee.

Dr Bustreo has been instrumental in the early stages of the implementation of Gavi’s 2016-2020 strategy, which aims to support developing countries to immunise a further 300 million children against life threatening diseases, leading to 5 to 6 million lives being saved…

The Gavi Board also approved the following appointments:
:: Irene Koek of the United States as Board Member representing the United States
:: Helen Rees as an Unaffiliated Board Member
:: Ramjanam Chaudhary, Minister for Health and Population, Nepal, representing the developing country constituency
:: David Loew, Executive Vice President and General Manager of Sanofi Pasteur, as a Board Member representing the vaccine industry industrialised countries

Additionally, the Board approved the reappointment of Donal Brown of the United Kingdom as Board Member representing the United Kingdom.

The following Alternate Board Members were also appointed
:: Jason Lane of the United Kingdom as Alternate Board Member to Donal Brown
:: Bounkong Syhavong, Minister of Health, Lao PDR, as Alternate Board Member to Ramjanam Chaudhary

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Gavi welcomes price trend for pentavalent vaccine
Latest price information published by UNICEF.
Geneva, 26 May 2016 – Gavi, the Vaccine Alliance welcomes the continued trend of decreasing prices for five-in-one pentavalent vaccine. Prices for pentavalent doses to be supplied to Gavi-supported countries over the next two years have been published by UNICEF following the completion of the first stage of a multi-stage tender.

The pentavalent vaccine protects against five major infections in one shot: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type b (Hib). It remains a cornerstone of Gavi’s immunisation efforts and is the first vaccine to have been introduced into the routine immunisation systems of all Gavi-supported countries.
Between 2000 and 2015, more than 200 million children living in the world’s poorest countries were protected with the pentavalent vaccine. Gavi estimates that investment in pentavalent vaccination between 2011 and 2020 will avert 5.6 million deaths.

In recent years the pentavalent market has become highly competitive – and more stable – through an increasing number of prequalified vaccines, new vaccine presentations, and production capacity that now exceeds aggregate demand. This increasing competition and the high level of predictable demand from Gavi-supported countries have contributed to a decreasing pricing trend.

Through this tender Gavi seeks to cultivate a healthy vaccine market to ensure that the supply of high-quality, affordable vaccines meets demand and that the developing countries’ needs are fully met through continued innovation. The tender also aims to preserve long-term market competition with multiple suppliers and to achieve low and sustainable prices for developing countries, including those that have transitioned from Gavi support. See UNICEF Request for Proposal section 2.2. for full description of tender objectives.

The multi-phase tender covers the three year period 2017 to 2019. It is an innovative procurement method for vaccines where manufacturers are invited to submit offers and are awarded volumes in phases, with UNICEF publishing prices after finalisation of each phase. The first phase of the tender is now complete, resulting in UNICEF – as the procuring body – awarding a large portion of the forecasted volume in 2017 as well as a portion of volumes in 2018. The second phase will commence in June, when all manufacturers who took part in the first phase of the tender will be able to re-submit offers. At the end of the second phase of the tender UNICEF and Gavi will have a clear picture on whether the full tender objectives for the first 2 years of supply have been met.

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Gavi welcomes contribution of US$ 76 million from Government of Japan
26 May 2016
New multi-year commitment will help Vaccine Alliance partners towards goal of immunising 300m children by 2020.

IAVI – International AIDS Vaccine Initiative [to 2 July 2016]
http://www.iavi.org/

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July 1, 2016
IAVI and Partners Receive Funding from USAID to Advance and Accelerate the Research and Development of an AIDS Vaccine for Africa, with Africa
Africa-centered global partnership will advance pre-clinical and clinical AIDS vaccine research, strengthen local capacity and ownership and support sustainable development of African countries

The International AIDS Vaccine Initiative (IAVI) and its partners have received a five-year cooperative agreement award with a US$160 million ceiling from the U.S. Agency for International Development (USAID) provided through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). The award is part of USAID’s HIV Vaccine and Biomedical Prevention Research Project (HVBP).

Building on long-standing partnerships with USAID and African research centers, this new program to Accelerate the Development of Vaccines and New Technologies to Combat the AIDS Epidemic (ADVANCE) will advance the design and development of HIV vaccines and biomedical prevention tools while ensuring they are effective and accessible for all in need. The new program will increase the impact of research efforts and enhance capacity building and sustainable development in Africa. ADVANCE will increase alignment and synergies, invest in the next generation of researchers and ultimately transfer leadership to African scientists.

Through the ADVANCE Centers of Research Excellence (CORE) network, IAVI will work with eight partners in five African countries, including the Aurum Institute (South Africa), the Kenya AIDS Vaccine Initiative-Institute for Clinical Research, the Kenya Medical Research Institute-Wellcome Trust Research Programme, the Medical Research Council/Uganda Virus Research Institute (UVRI), the UVRI-IAVI HIV Vaccine Program, Projet San Francisco (Rwanda), the University of Kwa-Zulu Natal Human Pathogenesis Programme (South Africa) and the Zambia-Emory HIV Research Project, along with Imperial College London.

ADVANCE will facilitate broader engagement of and strategic collaboration with leading AIDS vaccine researchers and centers of scientific excellence around the world to help speed the development, availability and impact of promising AIDS vaccine candidates and other biomedical prevention innovations to reduce the continuing spread of HIV infection.

“IAVI is delighted to be part of this accomplished international network,” says Anatoli Kamali, Regional Director for Africa at IAVI. “ADVANCE will leverage the expertise of African AIDS vaccine researchers and, through strategic partnerships with key global HIV researchers, help expedite the translation of scientific advances into vaccines and other new prevention products that will help control, and hopefully, one day eliminate HIV/AIDS.”

“The design and testing of improved candidates, guided by African scientific leadership, will move the world closer to a globally-effective HIV vaccine,” says Benny Kottiri, Research Division Chief at USAID. “ADVANCE supports this objective by building vital research capacity in Africa with the intent of resulting in sustainable scientific talent capable of gold-standard clinical research.”

The HVBP award is part of USAID’s HIV/AIDS biomedical research portfolio that prioritizes investments in HIV vaccine and microbicides research and that works to ensure cost-effective, sustainable, and integrated HIV and AIDS programming that harnesses the latest science and technological innovations – all in order to achieve the goal of a world where HIV and AIDS are no longer such a burden on health and development.

Sabin Vaccine Institute [to 2 July 2016]
http://www.sabin.org/updates/ressreleases

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June 22, 2016
Third Sabin Vaccine Institute Colloquium on Sustainable Immunization Financing
Dates: 19-21 July, 2016
Venue: Hotel Yak & Yeti, Kathmandu, Nepal
Participants: Members of Parliament; Ministry of Finance officials; national immunization program managers, Health Planning/Budget Directors from the Ministry of Health from the 21 partner countries of the Sabin Vaccine Institute’s Sustainable Immunization Financing Program, as well as global immunization partners.
Countries: Armenia, Cambodia, Cameroon, Democratic Republic of Congo, Georgia, Indonesia, Kenya, Liberia, Madagascar, Mali, Moldova, Mongolia, Nepal, Nigeria, Republic of Congo, Senegal, Sierra Leone, Sri Lanka, Uganda, Uzbekistan, Vietnam

Background
Vaccines are an essential public good that governments provide to their citizens. Vaccine costs are rising, often faster than public immunization budgets are expanding. Many countries currently eligible for external financial support are graduating or will soon graduate from this support. These countries must therefore depend on domestic sources to maintain or improve their immunization programs. Over the past few years, many countries have worked to increase domestic funding for national immunization programs. Their efforts have helped build institutional capacity to run vaccination services in the long term and will ultimately enable countries to achieve financial independence, speed up economic growth and save millions of lives. At a three-day colloquium in Kathmandu, Nepal, sponsored by the Sabin Vaccine Institute, senior representatives from 21 countries will assess their progress to date and discuss key priorities for achieving immunization goals by the Decade of Vaccines target year 2020…

IVI – International Vaccine Institute [to 2 July 2016]
http://www.ivi.org/web/www/home

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June 30, 2016
International Vaccine Institute and MilliporeSigma to Develop Next-Generation Purification Processes
– Company to provide expertise on clarification and purification
– Collaboration will improve manufacturing processes to deliver greater yield, allowing higher recovery and providing higher purity vaccines

Seoul, South Korea, – The International Vaccine Institute (IVI) and MilliporeSigma has entered into a research agreement to help develop more robust, scalable vaccine manufacturing processes. MilliporeSigma will provide funding and expertise to IVI in the areas of clarification and purification for vaccines that may improve the efficiency of vaccine production.

IVI is a nonprofit international organization committed to the discovery, development and delivery of safe, effective and affordable vaccines for global public health. The new collaboration between MilliporeSigma and IVI is aimed at improving the manufacturing process to deliver greater yield, allowing higher recovery and purer vaccines. Many vaccine manufacturers in the United States and Western Europe face also high manufacturing costs, and the partnership aims to addresses these challenges.

“Complex manufacturing processes along with poor yield and recovery result in vaccines that are not easily affordable by resource-challenged countries,” said Udit Batra, Member of the Executive Board, Merck KGaA, Darmstadt, Germany and CEO, MilliporeSigma. “Through our partnership with IVI, we will help create a more modern, scalable and robust manufacturing process, which in turn will help increase access to life-saving vaccines in developing countries.”

“We expect that our collaboration with MilliporeSigma will result in important dividends to a large population of people with unmet medical needs,” said Jerome Kim, MD, IVI Director General. “This partnership will help us better address the vaccine needs of low – and middle-income countries and ultimately contribute to our mission.”

Initially, the project will focus on a vaccine for typhoid developed by IVI, with the goal of applying findings to the processes for pneumococcal, meningococcal, haemophilus, staphylococcus, streptococcus B and other conjugated polysaccharide vaccines…

Global Fund [to 2 July 2016]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=

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Jun 27, 2016
UNDP and the Global Fund sign US$8.7m grant to scale up HIV prevention measures in Afghanistan
The United Nations Development Programme (UNDP) and the Global Fund signed a US$8.7 million grant to scale up HIV prevention measures and treatment for people most at risk of contracting the virus in Afghanistan, including injecting drugs users and prisoners.

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27 June 2016
Italy Makes Strong Commitment to Global Fund
ROME – The Government of Italy announced today a pledge of €130 million to the Global Fund to Fight AIDS, Tuberculosis and Malaria for the three-year period beginning in 2017, highlighting Italy’s leadership in global health.

The commitment, an increase of 30 percent over Italy’s last contribution of €100 million, is a strong signal as the Global Fund prepares for a Replenishment conference in September. With the support of countries like Italy, the Global Fund is accelerating the end of the three diseases while building resilient and sustainable systems for health.

“For Italy, these three epidemics are a cause and a consequence of poverty,” said Benedetto Della Vedova, Under-secretary of State for Foreign Affairs and International Cooperation. “It is very important that the Global Fund remains on track to reach 22 million lives saved by the end of 2016. Italy is at the forefront alongside the Global Fund, both politically and financially.

Taking decisive action means putting a strong focus on human rights and on the vulnerable groups most affected by the diseases, starting with children, women and girls. Italy’s International Cooperation strongly supports the Global Fund’s commitment to promote gender equality and access to health for all, without discrimination.”…

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26 June 2016
France Pledges €1.08 billion to Global Fund
PARIS – The Government of France announced today it will contribute €1.08 billion to the Global Fund to Fight AIDS, Tuberculosis and Malaria for the three-year period beginning in 2017, demonstrating strong leadership in global health.

France is the second leading donor to the Global Fund, and has consistently played a pioneering role in scientific research, promoting human rights and serving people affected by HIV. The new pledge, which represents a sustained commitment of France’s previous support, represents a significant contribution to the Global Fund’s three-year replenishment.

“This contribution demonstrates the strong commitment of France in the fight against pandemics and to strengthen health systems, especially in African countries,” the announcement said.

France has contributed more than €3.8 billion to the Global Fund since it was established in 2002 to accelerate the end of the epidemics…

PATH [to 2 July 2016]
http://www.path.org/news/index.php

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Announcement | June 24, 2016
PATH announces leader for India country program
Mr. Neeraj Jain to lead PATH in India

Hilleman Laboratories [to 2 July 2016]
http://www.hillemanlabs.org/news.aspx

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Date: 23/06/2016
Hilleman Laboratories scientist Dr. Ankur Mutreja awarded prestigious – “DBT Cambridge Lectureship”
New Delhi, 23rd June 2016: Recognising an exemplary achievement by one of its scientists, Hilleman Laboratories, a first-of- its-kind joint-venture partnership between MSD and the Wellcome Trust, proudly announces Dr. Ankur Mutreja’s appointment at the University of Cambridge under the prestigious “DBT Cambridge Lectureship” programme.

FDA [to 2 July 2016]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
Summary Basis for Regulatory Action, June 10, 2016 – VAXCHORA (PDF – 258KB)
Posted: 7/1/2016

Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry (PDF – 174KB)
Posted: 6/30/2016

Draft Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products
Posted: 6/29/2016

CBER Vacancy: Staff Fellow
Posted: 6/27/2016

FDA Information Regarding FluMist Quadrivalent Vaccine
Posted: 6/27/2016
…Based on data from observational studies showing lower than expected effectiveness of FluMist Quadrivalent from 2013 through 2016, on June 22, 2016, the Advisory Committee on Immunization Practices (ACIP), an advisory committee to the Centers for Disease Control and Prevention (CDC), voted to recommend that FluMist Quadrivalent should not be used during the 2016-2017 influenza season. FDA’s considerations regarding this vaccine are noted and explained below….

NIH [to 2 July 2016]
http://www.nih.gov/news-events/news-releases
June 30, 2016
NIH-led effort uses implementation science approaches to reduce mother-to-child HIV transmission
— Studies investigate best practices to ease major disease burden in Sub-Saharan Africa.

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June 29, 2016
Analysis of 1976 Ebola outbreak holds lessons relevant today
— Report describes early cases of Ebola.

European Medicines Agency [to 2 July 2016]
http://www.ema.europa.eu/

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30/06/2016
Strengthening interaction with academia
EMA consults academia in preparation of a framework of collaboration
The European Medicines Agency (EMA) has held a workshop with representatives from academia to explore new ways to engage with academics and researchers. The workshop was hosted by EMA’s Healthcare Professionals Working Party (HCPWP) on 15th June.

The collaboration between EMA and academia is longstanding. Many representatives from the academic sector contribute their expertise and knowledge as experts in the evaluation of medicines, ensuring that regulatory developments in the evaluation and monitoring of medicines are keeping pace with the speed of scientific development.

“EMA wants to move to a new level of collaboration with academia. Science is progressing fast and we see an unprecedented level of complexity in the development and evaluation of new medicines. Academia play an important role in helping the EU medicines regulatory network to keep abreast of the opportunities and challenges brought by science and to have access to the right expertise to evaluate these innovative medicines,” explained EMA Executive Director Guido Rasi at the workshop. “Interaction with EU regulators and a better understanding of the regulatory environment can help academia translate their discoveries into patient-focused medicines. I believe that working more closely together will bring great benefits to public health.”

More than forty representatives from academic organisations, including European Research Infrastructures, European learned societies and universities attended the workshop. At the meeting, EMA presented the pillars of a future framework of collaboration with academia to the participants. Objectives of the framework include enhancing academia’s understanding of the EU medicines regulatory framework and increasing regulators’ understanding of the needs and expectations of academia.

The outcome of the discussion will contribute to the development of the framework which will be presented to EMA’s Management Board for adoption at its December 2016 meeting.
Presentations from the workshop are published on the event page.
A full workshop report will be published on the EMA website in the coming weeks.

UNICEF [to 2 July 2016]
http://www.unicef.org/media/media_89711.html

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The State of the World’s Children 2016 Report: A fair chance for every child
UNICEF
June 2016 :: 180 pages
Full report pdf: http://www.unicef.org/publications/index_91711.html#

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FOREWORD
Inequity imperils millions of children and threatens the future of the world
As we look around the world today, we’re confronted with an uncomfortable but undeniable truth: Millions of children’s lives are blighted, for no other reason than the country, the community, the gender or the circumstances into which they are born.

And, as the data in this report show, unless we accelerate the pace of our progress in reaching them, the futures of millions of disadvantaged and vulnerable children – and therefore the future of their societies – will be imperilled.

Before they draw their first breath, the life chances of poor and excluded children are often being shaped by inequities. Disadvantage and discrimination against their communities and families will help determine whether they live or die, whether they have a chance to learn and later earn a decent living. Conflicts, crises and climate-related disasters deepen their deprivation and diminish their potential.

But it need not be so. As this report also illustrates, the world has made tremendous progress in reducing child deaths, getting children into school and lifting millions out of poverty. Many of the interventions behind this progress – such as vaccines, oral rehydration salts and better nutrition – have been practical and cost-effective. The rise of digital and mobile technology, and other innovations have made it easier and more cost-effective to deliver critical services in hard-to reach communities and to expand opportunities for the children and families at greatest risk.

For the most part, the constraints on reaching these children are not technical. They are a matter of political commitment. They are a matter of resources. And they are a matter of collective will – joining forces to tackle inequity and inequality head-on by focusing greater investment and effort on reaching the children who are being left behind.

The time to act is now. For unless we accelerate our progress, by 2030:
:: Almost 70 million children may die before reaching their fifth birthdays – 3.6 million in 2030 alone, the deadline year for the Sustainable Development Goals.

:: Children in sub-Saharan Africa will be 10 times more likely to die before their fifth birthdays than children in high-income countries.

:: Nine out of 10 children living in extreme poverty will live in sub-Saharan Africa.

:: More than 60 million primary school-aged children will be out of school – roughly the same number as are out of school today. More than half will be from sub-Saharan Africa.

:: Some 750 million women will have been married as children – three quarters of a billion child brides.

These vast inequities and dangers do more than violate the rights and imperil the futures of individual children. They perpetuate intergenerational cycles of disadvantage and inequality that undermine the stability of societies and even the security of nations everywhere.

More than ever, we should recognize that development is sustainable only if it can be carried on – sustained – by future generations. We have an opportunity to replace vicious cycles with virtuous cycles in which today’s poor children – if given a fair chance at health, education and protection from harm – can, as adults, compete on a more level playing field with children from wealthier backgrounds. Thus making not only their own lives better, but their societies richer in every sense of the word.

For when we help a boy access the medicine and nutrition he needs to grow up healthy and strong, we not only increase his chances in life, we also decrease the economic and social costs associated with poor health and low productivity.

When we educate a girl, we not only give her the tools and knowledge to make her own decisions and shape her own future, we also help raise the standard of living of her family and her community.

When we provide education, shelter and protection for children caught in conflicts, we help mend their hearts and their minds – so that someday, they will have the ability and the desire to help rebuild their countries.

This report concludes with five ways to strengthen our work, building on what we have learned over the last 25 years – and what we are still learning: Increasing information about those being left behind. Integrating our efforts across sectors to tackle the multiple deprivations that hold so many children back. Innovating to accelerate progress and drive change for the most excluded children and families. Investing in equity and finding new ways of financing efforts to reach the most disadvantaged children. And involving everyone, beginning with communities
themselves, and with businesses, organizations and citizens around the world who believe we can change the outcome for millions of children.

We can. Inequity is not inevitable. Inequality is a choice. Promoting equity – a fair chance for every child, for all children – is also a choice. A choice we can make, and must make. For their future, and the future of our world.

Wellcome Trust [to 2 July 2016]
http://www.wellcome.ac.uk/News/2016/index.htm

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News 1 July 2016
Smallpox inoculation had royal seal of approval 70 years before Jenner
A letter from George I, which lay uncatalogued in the Wellcome Library for over 70 years, reveals that the King urged his daughter to inoculate her children against smallpox.
In the letter to Sophia Dorothea, Queen of Prussia, George expresses relief that his grandson has recovered from a recent bout of smallpox. He urges his daughter to protect her other children from the disease.

The letter was written in 1724, 70 years before Jenner began his experiments with cowpox.

At that time inoculation was a new and risky technique. The crude process involved taking pus from someone with smallpox and deliberately infecting a healthy person by putting it into a scrape in their skin. This could give immunity against future, more dangerous, infections, but in some cases proved fatal.

The dangerous and disfiguring disease threatened everyone – including royal families – and terrified people.
Despite Jenner’s transformative discoveries in 1796, the threat lasted for a further 250 years until smallpox was eradicated in 1980.

Read more about George’s letter in the catalogue entry on the Wellcome Library website

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

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

American Journal of Infection Control
July 2016 Volume 44, Issue 7, p739-856, e103-e124
http://www.ajicjournal.org/current

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Parents’ and staff’s support for a childcare agency employee mandatory vaccination policy or agency certification program
Terri Rebmann, Jing Wang, Kristin D. Wilson, Philip G. Gilbertson, Mary Wakefield
p799–804
Published online: March 24 2016
Abstract
Background
Vaccine-preventable diseases pose a significant risk to children in childcare. However, few regulations exist regarding childcare staff vaccination. This study aimed to assess support for a childcare agency staff mandatory vaccination policy.
Methods
Surveys were distributed to staff and parents at 23 St Louis, Mo, childcare agencies during fall 2014. Staff and parents’ support for a mandatory vaccination and/or agency certification program were compared using χ2 tests. Multivariate logistic regression was conducted using a 2-level nested design and controlling for gender, race, age, and income to determine predictive models for support for a mandatory staff vaccination policy and/or agency certification program.
Results
Overall, 354 parents and staff participated (response rate, 32%). Most supported a mandatory staff vaccination policy (80.0%; n = 280) or agency certification program (81.2%; n = 285), and there were no differences between parents versus staff. Determinants of support for a mandatory policy included willingness to receive influenza vaccine annually, belief that vaccines are safe and effective, and support for the policy only if there were no costs.
Conclusions
There is strong support for some type of childcare agency staff vaccination policy. Implementing such a policy/program should be a collaborative endeavor that addresses vaccine cost and access.

American Journal of Infection Control
July 2016 Volume 44, Issue 7, p739-856, e103-e124
http://www.ajicjournal.org/current

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Major Articles
Tetanus, diphtheria, and acellular pertussis vaccination among women of childbearing age—United States, 2013
Alissa C. O’Halloran, Peng-jun Lu, Walter W. Williams, Helen Ding, Sarah A. Meyer
p786–793
Published in issue: July 01 2016
Highlights
-Among women 18-44 years old, 38.4% (Behavioral Risk Factor Surveillance System) and 23.3% (National Health Interview Survey) reported tetanus, diphtheria, and acellular pertussis vaccination.
-Racial and ethnic disparities were observed based on the results from both surveys.
-Living in a household with a child was associated with higher coverage.
-Access to health care was associated with higher coverage.
-Coverage among all women 18-44 years old varied widely by state.
Abstract
The incidence of pertussis in the United States has increased since the 1990s. Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination of pregnant women provides passive protection to infants. Tdap vaccination is currently recommended for pregnant women during each pregnancy, but coverage among pregnant women and women of childbearing age has been suboptimal. Data from the 2013 Behavioral Risk Factor Surveillance System (BRFSS) and 2013 National Health Interview Survey (NHIS) were used to determine national and state-specific Tdap vaccination coverage among women of childbearing age by self-reported pregnancy status at the time of the survey. Although this study could not assess coverage of Tdap vaccination received during pregnancy because questions on whether Tdap vaccination was received during pregnancy were not asked in BRFSS and NHIS, demographic and access-to-care factors associated with Tdap vaccination coverage in this population were assessed. Tdap vaccination coverage among all women 18-44 years old was 38.4% based on the BRFSS and 23.3% based on the NHIS. Overall, coverage did not differ by pregnancy status at the time of the survey. Coverage among all women 18-44 years old varied widely by state. Age, race and ethnicity, education, number of children in the household, and access-to-care characteristics were independently associated with Tdap vaccination in both surveys. We identified associations of demographic and access-to-care characteristics with Tdap vaccination that can guide strategies to improve vaccination rates in women during pregnancy.

American Journal of Public Health
Volume 106, Issue 7 (July 2016)
http://ajph.aphapublications.org/toc/ajph/current

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VACCINES
Pediatric Care Provider Density and Personal Belief Exemptions From Vaccine Requirements in California Kindergartens
Edward T. Walker, Christopher M. Rea
American Journal of Public Health: July 2016, Vol. 106, No. 7: 1336–1341.
ABSTRACT
Objectives. To understand contextual associations between medical care providers—pediatricians, family medical practitioners, and alternative medicine practitioners—and personal belief exemptions (PBEs) from mandated school entry vaccinations.
Methods. Data on kindergarten PBEs from the California Department of Public Health were analyzed for 2010, 2011, and 2012, with each school sorted into Primary Care Service Areas (PCSAs). Provider data from federal sources and state records of alternative medicine providers, alongside controls for school factors, were used to estimate panel models.
Results. Each 10% increase in the relative proportion of pediatricians in a given PCSA was associated with a statistically significant 11% decrease in PBE prevalence. The same increase in the proportion of family medical practitioners was associated with a 3.5% relative increase. Access to alternative medicine practitioners was also associated with a significantly higher PBE prevalence.
Conclusions. Medical provider contexts are associated with PBEs, reflecting a combination of contextual effects and self-selection of families into schools and PCSAs that share their preferences. The geographic distribution of child primary care services may be a key factor in a school’s health risk associated with lack of immunization or under-immunization.

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 2 July 2016)

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Research article
Fast and accurate dynamic estimation of field effectiveness of meningococcal vaccines
Lorenzo Argante, Michele Tizzoni and Duccio Medini
Published on: 30 June 2016
Abstract
Background
Estimating the effectiveness of meningococcal vaccines with high accuracy and precision can be challenging due to the low incidence of the invasive disease, which ranges between 0.5 and 1 cases per 100,000 in Europe and North America. Vaccine effectiveness (VE) is usually estimated with a screening method that combines in one formula the proportion of meningococcal disease cases that have been vaccinated and the proportion of vaccinated in the overall population. Due to the small number of cases, initial point estimates are affected by large uncertainties and several years may be required to estimate VE with a small confidence interval.
Methods
We used a Monte Carlo maximum likelihood (MCML) approach to estimate the effectiveness of meningococcal vaccines, based on stochastic simulations of a dynamic model for meningococcal transmission and vaccination. We calibrated the model to describe two immunization campaigns: the campaign against MenC in England and the Bexsero campaign that started in the UK in September 2015. First, the MCML method provided estimates for both the direct and indirect effects of the MenC vaccine that were validated against results published in the literature. Then, we assessed the performance of the MCML method in terms of time gain with respect to the screening method under different assumptions of VE for Bexsero.
Results
MCML estimates of VE for the MenC immunization campaign are in good agreement with results based on the screening method and carriage studies, yet characterized by smaller confidence intervals and obtained using only incidence data collected within 2 years of scheduled vaccination. Also, we show that the MCML method could provide a fast and accurate estimate of the effectiveness of Bexsero, with a time gain, with respect to the screening method, that could range from 2 to 15 years, depending on the value of VE measured from field data.
Conclusions
Results indicate that inference methods based on dynamic computational models can be successfully used to quantify in near real time the effectiveness of immunization campaigns against Neisseria meningitidis. Such an approach could represent an important tool to complement and support traditional observational studies, in the initial phase of a campaign.

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 2 July 2016)

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Research article
Local networks of community and healthcare organisations: a mixed methods study
Local collaboration of community organisations and healthcare organisations is seen as relevant for the efficiency and efficacy of health and social care because of their potential role in providing social inv...
Wendy Kemper-Koebrugge, Jan Koetsenruijter, Anne Rogers, Miranda Laurant and Michel Wensing
BMC Research Notes 2016 9:331
Published on: 1 July 2016

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Short Report
Towards the implementation of large scale innovations in complex health care systems: views of managers and frontline personnel
Increasingly, theorists and academic researchers develop, implement and test frameworks and strategies for improving the safety, effectiveness and efficiency of health care—at scale. The purpose of this research…
Sonia Wutzke, Murray Benton and Raj Verma
BMC Research Notes 2016 9:327
Published on: 28 June 2016

Current Opinion in Infectious Diseases
August 2016 – Volume 29 – Issue 4 pp: v-vi,319-431
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx

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NOSOCOMIAL AND HEALTHCARE RELATED INFECTIONS
Prevention of common healthcare-associated infections in humanitarian hospitals
Murphy, Richard A.; Chua, Arlene C.
Abstract
Purpose of review: Humanitarian medical organizations focus on vulnerable patients with increased risk for healthcare-associated infections (HAIs) and are obligated to minimize them in inpatient departments (IPDs). However, in doing so humanitarian groups face considerable obstacles. This report will focus on approaches to reducing common HAIs that the authors have found to be helpful in humanitarian settings.
Recent findings: HAIs are common in humanitarian contexts but there are few interventions or guidelines adapted for use in poor and conflict-affected settings to improve prevention and guide surveillance. Based on existing recommendations and studies, it appears prudent that all humanitarian IPDs introduce a basic infection prevention infrastructure, assure high adherence to hand hygiene with wide accessibility to alcohol-based hand rub, and develop pragmatic surveillance based on clinically evident nosocomial infection. Although microbiology remains out of reach for most humanitarian hospitals, rapid tests offer the possibility of improving the diagnosis of HAIs in humanitarian hospitals in the decade ahead.
Summary: There is a dearth of new studies that can direct efforts to prevent HAIs in IPDs in poor and conflict-affected areas and there is a need for practical, field-adapted guidelines from professional societies, and international bodies to guide infection prevention efforts in humanitarian environments.

Global Health: Science and Practice (GHSP)
June 2016 | Volume 4 | Issue 2
http://www.ghspjournal.org/content/current

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EDITORIALS
A Convenient Truth: Cost of Medications Need Not Be a Barrier to Hepatitis B Treatment
Drugs that are inexpensive to manufacture and simple to administer greatly expand the potential to help tens of millions of people who need treatment for chronic hepatitis B virus (HBV) infection. Key program implementation challenges include identifying who would benefit from antiviral medication and ensuring long-term and consistent treatment to people who feel well. The best opportunities are where health systems are advanced enough to effectively address these challenges and in settings where HIV service platforms can be leveraged. Research, innovation, and collaboration are critical to implement services most efficiently and to realize economies of scale to drive down costs of health care services, drugs, and diagnostics.
Matthew Barnhart
Glob Health Sci Pract 2016;4(2):186-190. First published online June 16, 2016. http://dx.doi.org/10.9745/GHSP-D-16-00128

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COMMENTARIES
Investing in Family Planning: Key to Achieving the Sustainable Development Goals
Voluntary family planning brings transformational benefits to women, families, communities, and countries. Investing in family planning is a development “best buy” that can accelerate achievement across the 5 Sustainable Development Goal themes of People, Planet, Prosperity, Peace, and Partnership.
Ellen Starbird, Maureen Norton, Rachel Marcus
Glob Health Sci Pract 2016;4(2):191-210. First published online June 9, 2016. http://dx.doi.org/10.9745/GHSP-D-15-00374

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mHealth for Tuberculosis Treatment Adherence: A Framework to Guide Ethical Planning, Implementation, and Evaluation
Promising mHealth approaches for TB treatment adherence include:
:: Video observation
:: Patient- or device-facilitated indirect monitoring
:: Direct monitoring through embedded sensors or metabolite testing
To mitigate ethical concerns, our framework considers accuracy of monitoring technologies, stigmatization and intrusiveness of the technologies, use of incentives, and the balance of individual and public good.
Michael J DiStefano, Harald Schmidt
Glob Health Sci Pract 2016;4(2):211-221. http://dx.doi.org/10.9745/GHSP-D-16-00018

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