The European Medicines Agency and Publication of Clinical Study ReportsA Challenge for the US FDA

JAMA
March 7, 2017, Vol 317, No. 9, Pages 883-984
http://jama.jamanetwork.com/issue.aspx

Viewpoint
The European Medicines Agency and Publication of Clinical Study ReportsA Challenge for the US FDA
Anna L. Davis, JD, MPH; James Dabney Miller, JD, MPH
JAMA. 2017;317(9):905-906. doi:10.1001/jama.2017.0918
This Viewpoint argues that publication by the European Medicines Agency of clinical study reports as part of its approval process for commercial drugs sets a standard of transparency that could challenge the reputation of the US Food and Drug Administration as the international standard-bearer in drug and device approval.

Improving Access to Evidence-Based Antipoverty Government Programs in the United States – A Novel Primary Care Initiative

JAMA Pediatrics
March 1, 2017, Vol 171, No. 3, Pages 207-312
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
Improving Access to Evidence-Based Antipoverty Government Programs in the United States – A Novel Primary Care Initiative
Michael K. Hole, MD, MBA; Lucy E. Marcil, MD, MPH; Robert J. Vinci, MD
JAMA Pediatr. 2017;171(3):211-212. doi:10.1001/jamapediatrics.2016.3868
This Viewpoint discusses ways in which the medical community can help low-income families by providing other services, namely free tax preparation, in primary care clinics.

In the Aftermath of the National Children’s Study Is Large Birth Cohort Data Still a Priority?

JAMA Pediatrics
March 1, 2017, Vol 171, No. 3, Pages 207-312
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
In the Aftermath of the National Children’s Study Is Large Birth Cohort Data Still a Priority?
Terence Dwyer, MPH, MD, MB, BS, AO; Per Magnus, MD, PhD; Jørn Olsen, MD, PhD
JAMA Pediatr. 2017;171(3):214-215. doi:10.1001/jamapediatrics.2016.3968
This Viewpoint discusses the ending of the National Children’s Study and the implications for the future of large birth cohort studies.

Association Between Pandemic Influenza A(H1N1) Vaccination in Pregnancy and Early Childhood Morbidity in Offspring

JAMA Pediatrics
March 1, 2017, Vol 171, No. 3, Pages 207-312
http://archpedi.jamanetwork.com/issue.aspx

Original Investigation
Association Between Pandemic Influenza A(H1N1) Vaccination in Pregnancy and Early Childhood Morbidity in Offspring
Anders Hviid, DrMedSci; Henrik Svanström, PhD; Ditte Mølgaard-Nielsen, MSc; et al.
JAMA Pediatr. 2017;171(3):239-248. doi:10.1001/jamapediatrics.2016.4023
This cohort study evaluates whether influenza A(H1N1) vaccination in pregnancy is associated with early childhood morbidity in offspring.
Key Points
Question  Is pandemic influenza A(H1N1) vaccination in pregnancy associated with an increased risk for early childhood morbidity in offspring?
Findings  In this cohort study, children exposed to maternal vaccination during pregnancy were not significantly more likely to be hospitalized in early childhood than unexposed children.
Meaning  These results support the safety profile of influenza A(H1N1) vaccine used in pregnancy.

Antiviral Activity of Pocapavir in a Randomized, Blinded, Placebo-Controlled Human Oral Poliovirus Vaccine Challenge Model

Journal of Infectious Diseases
Volume 215, Issue 3 1 Feburayr 2017
http://jid.oxfordjournals.org/content/current

VIRUSES
Antiviral Activity of Pocapavir in a Randomized, Blinded, Placebo-Controlled Human Oral Poliovirus Vaccine Challenge Model
Marc S. Collett; Jeffrey R. Hincks; Kimberley Benschop; Erwin Duizer; Harrie van der Avoort …
Abstract
Background.
Immunodeficient individuals who excrete vaccine-derived polioviruses threaten polio eradication. Antivirals address this threat.
Methods.
In a randomized, blinded, placebo-controlled study, adults were challenged with monovalent oral poliovirus type 1 vaccine (mOPV1) and subsequently treated with capsid inhibitor pocapavir or placebo. The time to virus negativity in stool was determined.
Results.
A total of 144 participants were enrolled; 98% became infected upon OPV challenge. Pocapavir-treated subjects (n=93) cleared virus a median duration of 10 days after challenge, compared with 13 days for placebo recipients (n=48; P=.0019). Fifty-two of 93 pocapavir-treated subjects (56%) cleared virus in 2–18 days with no evidence of drug resistance, while 41 of 93 (44%) treated subjects experienced infection with resistant virus while in the isolation facility, 3 (3%) of whom were infected at baseline, before treatment initiation. Resistant virus was also observed in 5 placebo recipients (10%). Excluding those with resistant virus, the median time to virus negativity was 5.5 days in pocapavir recipients, compared with 13 days in placebo recipients (P<.0001). There were no serious adverse events and no withdrawals from the study.
Conclusions.
Treatment with pocapavir was safe and significantly accelerated virus clearance. Emergence of resistant virus and transmission of virus were seen in the context of a clinical isolation facility.
Clinical Trials Registration.
EudraCT 2011-004804-38.

National legislation and spending on vaccines in Latin America and the Caribbean

Journal of Public Health Policy
Volume 38, Issue 1, February 2017
http://link.springer.com/journal/41271/38/1/page/1

Original Article
National legislation and spending on vaccines in Latin America and the Caribbean
Michael McQuestion, Ana Gabriela Felix Garcia…
Abstract
This study examined the dynamics of vaccine spending and vaccine legislation in the Americas Region over the period 1980–2013. Annual vaccine expenditures from thirty-one countries were extracted from the Pan American Health Organization Revolving Fund database. Information on vaccine laws and regulations was provided by the PAHO Family, Gender, and Life Course Unit. Both time series and event history models were estimated. The results show that passing an immunization law led a representative country to increase its vaccine spending, controlling for income, infant mortality, population size, and DPT3 vaccine coverage. Countries with higher vaccine coverage were also more likely to have passed laws. Conversely, higher income countries were less likely to have vaccine laws. Vaccine legislation will likely play a similarly important role in other regions as more countries move towards immunization program ownership

Knowledge and perceptions of polio and polio immunization in polio high-risk areas of Pakistan

Journal of Public Health Policy
Volume 38, Issue 1, February 2017
http://link.springer.com/journal/41271/38/1/page/1

Original Article
Knowledge and perceptions of polio and polio immunization in polio high-risk areas of Pakistan
Muhammad Atif Habib, Sajid Bashir Soofi, Noshad Ali…
Abstract
Pakistan and Afghanistan remain the only countries where polio is endemic, and Pakistan reports the most cases in the world. Although the rate is lower than in previous years, the situation remains alarming. We conducted a mixed methods study in high-risk areas of Pakistan to identify knowledge, attitudes, and practices of target populations about polio vaccine and its eradication, and to estimate coverage of routine immunization and oral polio vaccine. We surveyed 10,685 households in Karachi, 2522 in Pishin, and 2005 in Bajaur. Some knowledge of polio is universal, but important misconceptions persist. The findings of this study carry strategic importance for program direction and implementation.

Understanding ‘perceptions’ is critical for all vaccination efforts, not only polio eradication

Journal of Public Health Policy
Volume 38, Issue 1, February 2017
http://link.springer.com/journal/41271/38/1/page/1

Commentary
Understanding ‘perceptions’ is critical for all vaccination efforts, not only polio eradication
Roy Widdus
Abstract
Because Pakistan is the country with the most daunting challenges for ending transmission of endemic poliovirus, the work of Habib et al in this issue is critical for achieving polio eradication globally. Understanding why immunization programs are not reaching all children is important for success in reducing spread of all vaccine preventable diseases. The methods and insights are important for public health generalists, not only those employed in the pursuit of polio eradication.

Peer-reviewed public health journals from Arabic-speaking countries: An updated snapshot

Journal of Public Health Policy
Volume 38, Issue 1, February 2017
http://link.springer.com/journal/41271/38/1/page/1

Viewpoint
Peer-reviewed public health journals from Arabic-speaking countries: An updated snapshot
Basil H. Aboul-Enein, Joshua Bernstein…
Abstract
There is a positive association between availability of regional peer-reviewed public health information systems and progressive change in community and population health. The objective of this brief report was to identify public health journals in Arabic-speaking countries actively publishing as of 2016. We conducted an electronic search in several electronic database records for public health journals using a combination of search terms. We excluded journals that focused on human medicine, veterinary medicine, nursing, and other discipline-specific or clinical health professions. We identified twenty-five public health journals for review. Five journals were interrupted or discontinued. Only three journals had a consistent, uninterrupted active publication history of greater than 20 years. Most journals were not in the regional native language. Introduction of regional public health-dedicated journals with in-print and electronic availability and also to be published in region-native languages may require interdisciplinary partnerships. Region-wide public health journals such as the Eastern Mediterranean Health Journal could serve as an ideal model for the establishment of additional local and regional public health journals in Arabic-speaking countries.

Evaluating industry’s role in vaccine access

The Lancet
Mar 11, 2017 Volume 389 Number 10073 p983-1074
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Evaluating industry’s role in vaccine access
The Lancet
Published: 11 March 2017
DOI: http://dx.doi.org/10.1016/S0140-6736(17)30694-3
On March 6, 2017, the Access to Medicine Foundation released its first Access to Vaccines Index, a baseline analysis of industry activities to improve access to vaccines worldwide. Two targets for the Sustainable Development Goals (SDG 3.8 and SDG 3.B) explicitly mention vaccines. Yet, despite the global consensus on the centrality of vaccines to modern health systems, access is highly variable, and in 2016 there were 19 million unvaccinated and under-vaccinated children in the world.
Challenges to universal and sustainable access to vaccines include development of new vaccines, financing, affordability, supply, and implementation. Recognising the vital role of the pharmaceutical industry—as innovators, manufacturers, and suppliers—the index examines the behaviour of eight companies across 69 diseases, 107 countries, and three areas: research and development (R&D), pricing and registration, and manufacture and supply. Although most companies were found to make some consideration of affordability when setting vaccine prices, a more systematic approach is required, particularly for middle-income countries. For the most part, current R&D activities are linked to commercial incentives, with vaccines for seasonal influenza, pneumococcal disease, and human papillomavirus receiving the most attention. Although a third of R&D projects targeted a disease for which no vaccine exists, the report also identified 32 important diseases with no current R&D projects, including yaws, cytomegalovirus, and schistosomiasis. While detailing recent successes in the development of new vaccines for diseases of global health importance (specifically, dengue and malaria), the report highlights the ongoing need to improve vaccines once they reach the market to ensure they address usage needs in resource-limited settings.
Overall, the index paints a mixed picture of industry efforts. But in setting clear benchmarks it shows a path forward for industry to take a conscious and leading role in ensuring that every person, regardless of geography or income, has access to effective and affordable vaccines.

The price of delaying measles eradication

Lancet Public Health
Mar 2017 Volume 2 Number 3 e121-e156
http://thelancet.com/journals/lanpub/issue/current

Comment
The price of delaying measles eradication
Open Access
David N Durrheim, Natasha S Crowcroft
DOI: http://dx.doi.org/10.1016/S2468-2667(17)30026-9

On September 27, 2016, the Pan American Health Organization (PAHO) verified that the Americas had eliminated endemic measles transmission.1 This phenomenal achievement provides irrefutable empirical evidence supporting the determination reached by a global technical consultation, convened by WHO in 2010, that global measles eradication is biologically, technically, and operationally feasible.2 The prospect of a world where no child dies because of measles has resonated with global leaders and all WHO regions have established goals to eliminate measles by 2020 or before. Against this backdrop of proven feasibility and stated political will, it is truly disappointing that the recently completed mid-term review of the Global Measles and Rubella Strategic Plan, 2012–2020, states that “recent years have seen a slowing of progress” and “it is premature to set a timeframe for eradication at this point”.3

The increasing global coverage with measles vaccination accounted for a cumulative estimated 17·1 million lives saved between 2000 and 2015.4 However, with the stagnation of progress, tragically an estimated 114 900 people, mostly children, died due to measles in 2014.5 These deaths could have been prevented with a simple, safe, cost-effective health measure—timely measles vaccination.

The gains in reducing measles mortality and morbidity are fragile—each new birth cohort requires effective vaccine delivery to ensure that at least 95% of individuals are immune or measles virus comes back with a vengeance to discover the immunity gaps.6 Unfortunately many mature immunisation programmes have cohorts of older children or young adults remaining susceptible to measles owing to incomplete reach of immunisation programmes in previous years. Once children leave school, they are difficult to reach with immunisation. Global surveillance data show 40% of confirmed cases in the European region and 29% in the Western Pacific region were 15 years of age or older, and 19% in the European region and 13% in the Western Pacific region were 25 years of age or older. 7

Waning immunity could be more important than previously recognised with the window for eradicating measles potentially closing. Older generations, who were immune through natural infection, are dying and being replaced with infants with lower levels of immunity who are born to mothers immune through vaccination. Reinfection of fully vaccinated individuals with transmission of infection to others might present a real risk in elimination settings where natural boosting is no longer occurring.8 Sustaining herd immunity while the rest of the world catches up is now the greatest challenge facing the Americas and countries in other regions that have been verified as having interrupted endemic measles transmission.

Responding to outbreaks in countries that have achieved, or are close to achieving, elimination of endemic transmission can be enormously expensive and disruptive to the health service and society. Thus, it is not surprising that the Columbian Minister of Health, Alejandro Gaviria Uribe, will present a resolution calling for a measles eradication target date at the 2017 World Health Assembly, a proposal supported by all Latin American Ministers of Health.9

Measles vaccination, providing each child with two immunisation doses either through the routine programme or campaigns, is one of the most cost-effective public health interventions but eradication is even more financially attractive because treatment costs for measles infections are avoided (>US$2 billion per year) and prevents disability-adjusted life year (DALY) losses prevented (>15 million DALYs per year valued at >$63 billion).10 Measles vaccination can also prevent congenital rubella syndrome through combining measles and rubella vaccines, and there is the potential to add a range of other health interventions.

Important ethical drivers exist to complete measles eradication. The 1989 Convention on the Rights of the Child states that children have the right to the best health care possible and that rich countries should help poorer countries achieve this. Every government and the international donor community have a duty of care to ensure that children enjoy the protection offered by measles vaccine, which is both affordable and effective in preventing severe disease and death. The rule of rescue demands that those that are able, in this case governments and international donors, rescue identifiable individuals facing avoidable death if personal sacrifice is not excessive. Because children who are at high-risk for missing out on vaccine, including migrants, nomadic communities, and the rural poor, are often at greatest risk of severe disease because of poor nutrition, co-infections, and limited access to health care, reaching them with immunisation can have a real effect on health inequities. Measles could be called the equity virus: without vaccination, everyone gets measles, and without equitable health-care systems to deliver vaccination, measles will continue to present a threat to the most vulnerable. We should not risk waiting for the perfect day to set a target. An aspirational vision could fan the flames of optimism we need to drive us to the target of eradication faster. The world needs a global measles eradication target supported by a global verification commission; we should not settle for less.
We declare no competing interests. [Reference at link in title]

Volunteering for Clinical Research Studies and Public Health (pages 40–42)

The Milbank Quarterly
A Multidisciplinary Journal of Population Health and Health Policy
March 2017 Volume 95, Issue 1 Pages 1–209
http://onlinelibrary.wiley.com/doi/10.1111/milq.2017.95.issue-1/issuetoc

Op-Eds
Volunteering for Clinical Research Studies and Public Health (pages 40–42)
CATHERINE D. DeANGELIS
Version of Record online: 7 MAR 2017 | DOI: 10.1111/1468-0009.12244

Measuring, Reporting, and Rewarding Quality of Care in 5 Nations: 5 Policy Levers to Enhance Hospital Quality Accountability (pages 136–183)

The Milbank Quarterly
A Multidisciplinary Journal of Population Health and Health Policy
March 2017 Volume 95, Issue 1 Pages 1–209

Original Investigations
Measuring, Reporting, and Rewarding Quality of Care in 5 Nations: 5 Policy Levers to Enhance Hospital Quality Accountability (pages 136–183)
CHRISTOPH PROSS, ALEXANDER GEISSLER and REINHARD BUSSE
Version of Record online: 7 MAR 2017 | DOI: 10.1111/1468-0009.12248
Abstract
Policy Points:
:: Similarities and disparities between countries and initiatives are identified. Measuring, reporting, and rewarding quality is heavily focused on process measures. Hospital-level benchmarking is not always available publicly. Quality-related payment schemes vary widely, with several countries only piloting small-scale initiatives.
:: To increase quality accountability, the government has to set standards and incentives. The right balance between system centralization and decentralization has to be struck. Accountability needs to be based on outcomes, not process measures, and focus should be on hospital and medical condition levels. Providers have a central role as quality accountability advocates.
Context
Studies have documented wide quality variation among hospitals within and across countries. Increasing quality-of-care accountability for hospitals, especially for patients and the general public, is an important policy objective, but no study has yet systematically and comprehensively compared leading countries’ initiatives in this regard.
Methods
Based on expert interviews and an extensive literature review, we investigate hospital quality accountability in England, Germany, the Netherlands, Sweden, and the United States. The underlying framework includes 3 elements: measuring quality, reporting quality, and rewarding quality. Each element is subdivided into 2 dimensions, with measuring composed of indicator type and data source, reporting composed of degree of reporting centralization and data accessibility, and rewarding composed of extent of application and type of quality-related payments.
Findings
The results show a wide spectrum of approaches and progress levels. Measuring strategies are more similar across countries, while quality reporting and financial rewards are more dissimilar. Reporting of process indicators is more prevalent than reporting of outcomes. Most countries have introduced some quality-related payment schemes, with the United States having the most comprehensive approach. Based on the cross-country assessment, 5 policy levers to enhance quality transparency are identified and illustrated through country-specific examples: (1) the government should take a central role in establishing standards and incentives for quality transparency and health IT system integration; (2) system centralization and decentralization need to be balanced to ensure both national comparability and local innovation; (3) health systems need to focus more on outcome transparency and less on process measures; (4) health systems need to engage providers as proponents of quality transparency; and (5) reporting should focus on hospital and condition levels to ensure comparability and enable meaningful patient choice.
Conclusions
The findings facilitate cross-country learning and best-practice adoption by assessing hospital quality accountability strategies in 5 countries in a structured and comparative manner. The identified policy levers are relevant for enhancing breadth, depth, and value of quality accountability.

Show drugs work before selling them

Nature
Volume 543 Number 7644 pp152-280 9 March 2017
http://www.nature.com/nature/current_issue.html

Comment
Show drugs work before selling them
08 March 2017
Regulation makes economic sense, argue Douglas Sipp, Christopher McCabe and John E. J. Rasko.
Under US President Donald Trump, defunct economic arguments about prescription drugs are coming to the fore. His advisers contend that today’s system is a bad deal. They want to undo regulations that require companies to show that a medical product actually works before it is sold. The advisers argue that removing the burden of large, lengthy clinical trials will cut costs and reduce delays, and that the marketplace can be trusted to sort good drugs from bad ones
Although many have raised concerns about a Trump Food and Drug Administration (FDA; see, for example, Nature http://doi.org/bz92; 2017), few have debunked the economic arguments. Here we outline what the case for deregulation gets wrong. All nations should take note — weaker standards for entry of drugs onto the US market will harm health everywhere…

Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination

Nature
Volume 543 Number 7644 pp152-280 9 March 2017
http://www.nature.com/nature/current_issue.html

Letters
Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination
Norbert Pardi, Michael J. Hogan, Rebecca S. Pelc, Hiromi Muramatsu, Hanne Andersen+ et al.
A single, low-dose intradermal immunization with lipid-nanoparticle-encapsulated nucleoside-modified mRNA encoding the pre-membrane and envelope glycoproteins of Zika virus protects both mice and rhesus macaques against infection and elicits rapid and long-lasting neutralizing antibody responses.
Zika virus (ZIKV) has recently emerged as a pandemic associated with severe neuropathology in newborns and adults1. There are no ZIKV-specific treatments or preventatives. Therefore, the development of a safe and effective vaccine is a high priority. Messenger RNA (mRNA) has emerged as a versatile and highly effective platform to deliver vaccine antigens and therapeutic proteins2, 3. Here we demonstrate that a single low-dose intradermal immunization with lipid-nanoparticle-encapsulated nucleoside-modified mRNA (mRNA–LNP) encoding the pre-membrane and envelope glycoproteins of a strain from the ZIKV outbreak in 2013 elicited potent and durable neutralizing antibody responses in mice and non-human primates. Immunization with 30 μg of nucleoside-modified ZIKV mRNA–LNP protected mice against ZIKV challenges at 2 weeks or 5 months after vaccination, and a single dose of 50 μg was sufficient to protect non-human primates against a challenge at 5 weeks after vaccination. These data demonstrate that nucleoside-modified mRNA–LNP elicits rapid and durable protective immunity and therefore represents a new and promising vaccine candidate for the global fight against ZIKV.

Chimpanzee Adenovirus Vector Ebola Vaccine

New England Journal of Medicine
March 9, 2017  Vol. 376 No. 10
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Chimpanzee Adenovirus Vector Ebola Vaccine
Julie E. Ledgerwood, D.O., Adam D. DeZure, M.D., Daphne A. Stanley, M.S., Emily E. Coates, Ph.D., Laura Novik, M.A., Mary E. Enama, M.A., Nina M. Berkowitz, M.P.H., Zonghui Hu, Ph.D., Gyan Joshi, M.S., Aurélie Ploquin, Ph.D., Sandra Sitar, M.S., Ingelise J. Gordon, R.N., Sarah A. Plummer, C.R.N.P., LaSonji A. Holman, F.N.P., Cynthia S. Hendel, C.R.N.P., Galina Yamshchikov, M.S., Francois Roman, M.D., Alfredo Nicosia, Ph.D., Stefano Colloca, Ph.D., Riccardo Cortese, M.D., Robert T. Bailer, Ph.D., Richard M. Schwartz, Ph.D., Mario Roederer, Ph.D., John R. Mascola, M.D., Richard A. Koup, M.D., Nancy J. Sullivan, Ph.D., and Barney S. Graham, M.D., for the VRC 207 Study Team*
N Engl J Med 2017; 376:928-938 March 9, 2017 DOI: 10.1056/NEJMoa1410863
Abstract
Background
The unprecedented 2014 epidemic of Ebola virus disease (EVD) prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant chimpanzee adenovirus type 3–vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species, that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation.
Full Text of Background...
Methods
We conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. Twenty healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2×1010 particle units or 2×1011 particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 8 weeks after vaccination; in addition, longer-term vaccine durability was assessed at 48 weeks after vaccination.
Full Text of Methods…
Results
In this small study, no safety concerns were identified; however, transient fever developed within 1 day after vaccination in two participants who had received the 2×1011 particle-unit dose. Glycoprotein-specific antibodies were induced in all 20 participants; the titers were of greater magnitude in the group that received the 2×1011 particle-unit dose than in the group that received the 2×1010 particle-unit dose (geometric mean titer against the Zaire antigen at week 4, 2037 vs. 331; P=0.001). Glycoprotein-specific T-cell responses were more frequent among those who received the 2×1011 particle-unit dose than among those who received the 2×1010 particle-unit dose, with a CD4 response in 10 of 10 participants versus 3 of 10 participants (P=0.004) and a CD8 response in 7 of 10 participants versus 2 of 10 participants (P=0.07) at week 4. Assessment of the durability of the antibody response showed that titers remained high at week 48, with the highest titers in those who received the 2×1011 particle-unit dose.
Full Text of Results…
Conclusions
Reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. At the 2×1011 particle-unit dose, glycoprotein Zaire–specific antibody responses were in the range reported to be associated with vaccine-induced protective immunity in challenge studies involving nonhuman primates, and responses were sustained to week 48. Phase 2 studies and efficacy trials assessing cAd3-EBO are in progress. (Funded by the Intramural Research Program of the National Institutes of Health; VRC 207 ClinicalTrials.gov number, NCT02231866.)

GOST: A generic ordinal sequential trial design for a treatment trial in an emerging pandemic

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 11 March 2017)

Research Article
GOST: A generic ordinal sequential trial design for a treatment trial in an emerging pandemic
John Whitehead, Peter Horby
| published 09 Mar 2017 P
http://dx.doi.org/10.1371/journal.pntd.0005439
This is an uncorrected proof.
Abstract
Background
Conducting clinical trials to assess experimental treatments for potentially pandemic infectious diseases is challenging. Since many outbreaks of infectious diseases last only six to eight weeks, there is a need for trial designs that can be implemented rapidly in the face of uncertainty. Outbreaks are sudden and unpredictable and so it is essential that as much planning as possible takes place in advance. Statistical aspects of such trial designs should be evaluated and discussed in readiness for implementation.
Methodology/Principal findings
This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. The primary endpoint is a categorisation of patient outcome according to an ordinal scale. A sequential approach is adopted, stopping as soon as it is clear that the experimental treatment has an advantage or that sufficient advantage is unlikely to be detected. The properties of the design are evaluated using large-sample theory and verified for moderate sized samples using simulation. The trial is powered to detect a generic clinically relevant difference: namely an odds ratio of 2 for better rather than worse outcomes. Total sample sizes (across both treatments) of between 150 and 300 patients prove to be adequate in many cases, but the precise value depends on both the magnitude of the treatment advantage and the nature of the ordinal scale. An advantage of the approach is that any erroneous assumptions made at the design stage about the proportion of patients falling into each outcome category have little effect on the error probabilities of the study, although they can lead to inaccurate forecasts of sample size.
Conclusions/Significance
It is important and feasible to pre-determine many of the statistical aspects of an efficient trial design in advance of a disease outbreak. The design can then be tailored to the specific disease under study once its nature is better understood.
Author summary
Since many outbreaks of infectious diseases last only six to eight weeks, there is a need for trial designs that can be implemented rapidly in the face of uncertainty. The Generic Ordinal Sequential Trial (GOST) is a flexible statistical design for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The details of the design are derived to satisfy a generic power requirement using large sample theory. The accuracy of the approach for moderate sample sizes is then checked using million-fold simulations, and found to be very reliable under a wide range of circumstances. Total sample sizes (across both treatments) of between 150 and 300 patients prove to be adequate in many cases, although more patients may be needed if the majority of patients die or if the majority experience complete recovery, as there is then less evidence available to distinguish between treatments. An advantage of the approach is that any erroneous assumptions made at the design stage about the proportion of patients falling into each outcome category have little effect on the error probabilities of the study, although they can lead to inaccurate forecasts of sample size.

Volunteer feedback and perceptions after participation in a phase I, first-in-human Ebola vaccine trial: An anonymous survey

PLoS One
http://www.plosone.org/
[Accessed 11 March 2017]

Research Article
Volunteer feedback and perceptions after participation in a phase I, first-in-human Ebola vaccine trial: An anonymous survey
Julie-Anne Dayer, Claire-Anne Siegrist, Angela Huttner
Research Article | published 08 Mar 2017 P
http://dx.doi.org/10.1371/journal.pone.0173148
Abstract
The continued participation of volunteers in clinical trials is crucial to advances in healthcare. Few data are available regarding the satisfaction and impressions of healthy volunteers after participation in phase I trials, many of which lead to unexpected adverse events. We report feedback from over 100 adult volunteers who took part in a first-in-human trial conducted in a high-income country testing an experimental Ebola vaccine causing significant reactogenicity, as well as unexpected arthritis in one fifth of participants. The anonymous, internet-based satisfaction survey was sent by email to all participants upon their completion of this one-year trial; it asked 24 questions concerning volunteers’ motivations, impressions of the trial experience, and overall satisfaction. Answers were summarized using descriptive statistics. Of the 115 trial participants, 103 (90%) filled out the survey. Fifty-five respondents (53%) were male. Thirty-five respondents (34%) were healthcare workers, many of whom would deploy to Ebola-affected countries. All respondents cited scientific advancement as their chief motivation for participation, while 100/103 (97%) and 61/103 (59%) reported additional “humanitarian reasons” and potential protection from Ebolavirus, respectively. Although investigators had documented adverse events in 97% of trial participants, only 74 of 103 respondents (72%) recalled experiencing an adverse event. All reported an overall positive experience, and 93/103 (90%) a willingness to participate in future trials. Given the high level of satisfaction, no significant associations could be detected between trial experiences and satisfaction, even among respondents reporting adverse events lasting weeks or months. Despite considerable reactogenicity and unexpected vaccine-related arthritis, all survey respondents reported overall satisfaction. While this trial’s context was unique, the positive feedback is likely due at least in part to the intense communication of trial information to participants, which included both general findings and personalized results.

Research capacity strengthening for sexual and reproductive health: a case study from Latin America

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 11 March 2017]

Review
Research capacity strengthening for sexual and reproductive health: a case study from Latin America
Rita Kabra, Marco Castillo, Mercedes Melián, Moazzam Ali, Lale Say and A. Metin Gulmezoglu
Reproductive Health 2017 14:35
Published on: 7 March 2017
Abstract
An essential, but often overlooked part of health promotion and development support to achieve self-sufficiency in developing countries is the concomitant need to build and strengthen research capacity. This is even more challenging and critical in the area of sexual and reproductive health because of diverse interplay of socio cultural, religious, economic factors in relation to reproductive health.
This paper presents the case study of HRP’s efforts to build research capacity in Latin America by studying and analyzing the 5-year history of institutional development support to an institution in Paraguay. In reviewing the efforts, we identify the strengths in the approaches used by HRP, the challenges and outcomes of the process and we present recommendations for future efforts to strengthen research capacity to improve sexual and reproductive health. The authors call for greater support from and collaborative efforts of developmental partners and governments to strengthen research capacity in low and middle-income countries to improve sexual and reproductive health.

Science Translational Medicine – 08 March 2017 Vol 9, Issue 380

Science Translational Medicine
08 March 2017 Vol 9, Issue 380
http://stm.sciencemag.org/

Research Articles
An oral microjet vaccination system elicits antibody production in rabbits
By Kiana Aran, Marc Chooljian, Jacobo Paredes, Mohammad Rafi, Kunwoo Lee, Allison Y. Kim, Jeanny An, Jennifer F. Yau, Helen Chum, Irina Conboy, Niren Murthy, Dorian Liepmann
Science Translational Medicine08 Mar 2017 Restricted Access
A needle-free device delivers a liquid jet of vaccine that penetrates the buccal mucosa and elicits antibody production in rabbits.

Research Articles
A semisynthetic Streptococcus pneumoniae serotype 8 glycoconjugate vaccine
By Benjamin Schumann, Heung Sik Hahm, Sharavathi G. Parameswarappa, Katrin Reppe, Annette Wahlbrink, Subramanian Govindan, Paulina Kaplonek, Liise-anne Pirofski, Martin Witzenrath, Chakkumkal Anish, Claney L. Pereira, Peter H. Seeberger
Science Translational Medicine08 Mar 2017 Restricted Access
Automated glycan assembly enabled antibody reverse engineering to develop a semisynthetic carbohydrate–based vaccine against the highly virulent Streptococcus pneumoniae serotype 8.

Equity in healthcare resource allocation decision making: A systematic review

Social Science & Medicine
Volume 175, Pages 1-252 (February 2017)
http://www.sciencedirect.com/science/journal/02779536/175

Review articles
Equity in healthcare resource allocation decision making: A systematic review
Review Article
Pages 11-27
Haylee Lane, Mitchell Sarkies, Jennifer Martin, Terry Haines
Abstract
Objective
To identify elements of endorsed definitions of equity in healthcare and classify domains of these definitions so that policy makers, managers, clinicians, and politicians can form an operational definition of equity that reflects the values and preferences of the society they serve.
Design
Systematic review where verbatim text describing explicit and implicit definitions of equity were extracted and subjected to a thematic analysis.
Data sources
The full holdings of the AMED, CINAHL plus, OVID Medline, Scopus, PsychInfo and ProQuest (ProQuest Health & Medical Complete, ProQuest Nursing and Allied Health Source, ProQuest Social Science Journals) were individually searched in April 2015.
Eligibility criteria for selecting studies
Studies were included if they provided an original, explicit or implicit definition of equity in regards to healthcare resource allocation decision making. Papers that only cited earlier definitions of equity and provided no new information or extensions to this definition were excluded.
Results
The search strategy yielded 74 papers appropriate for this review; 60 of these provided an explicit definition of equity, with a further 14 papers discussing implicit elements of equity that the authors endorsed in regards to healthcare resource allocation decision making.
Five key themes emerged
i) Equalisation across the health service supply/access/outcome chain, ii) Need or potential to benefit, iii) Groupings of equalisation, iv) Caveats to equalisation, and v) Close enough is good enough.
Conclusions
There is great inconsistency in definitions of equity endorsed by different authors. Operational definitions of equity need to be more explicit in addressing these five thematic areas before they can be directly applied to healthcare resource allocation decisions.

Effects of donor proliferation in development aid for health on health program performance: A conceptual framework

Social Science & Medicine
Volume 175, Pages 1-252 (February 2017)
http://www.sciencedirect.com/science/journal/02779536/175

Review Article
Effects of donor proliferation in development aid for health on health program performance: A conceptual framework
Pages 177-186
Sarah Wood Pallas, Jennifer Prah Ruger
Abstract
Development aid for health increased dramatically during the past two decades, raising concerns about inefficiency and lack of coherence among the growing number of global health donors. However, we lack a framework for how donor proliferation affects health program performance to inform theory-based evaluation of aid effectiveness policies. A review of academic and gray literature was conducted. Data were extracted from the literature sample on study design and evidence for hypothesized effects of donor proliferation on health program performance, which were iteratively grouped into categories and mapped into a new conceptual framework. In the framework, increases in the number of donors are hypothesized to increase inter-donor competition, transaction costs, donor poaching of recipient staff, recipient control over aid, and donor fragmentation, and to decrease donors’ sense of accountability for overall development outcomes. There is mixed evidence on whether donor proliferation increases or decreases aid volume. These primary effects in turn affect donor innovation, information hoarding, and aid disbursement volatility, as well as recipient country health budget levels, human resource capacity, and corruption, and the determinants of health program performance. The net effect of donor proliferation on health will vary depending on the magnitude of the framework’s competing effects in specific country settings. The conceptual framework provides a foundation for improving design of aid effectiveness practices to mitigate negative effects from donor proliferation while preserving its potential benefits.

Factors affecting the willingness of nursing students to receive annual seasonal influenza vaccination: A large-scale cross-sectional study

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Regular Papers
Factors affecting the willingness of nursing students to receive annual seasonal influenza vaccination: A large-scale cross-sectional study
Original Research Article
Pages 1482-1487
Kin Cheung, Sin Man Simone Ho, Winsome Lam
Abstract
Nursing students are at high risk of exposure to vaccine-preventable diseases such as seasonal influenza. However, due to the limited number of studies conducted in this area, the prevalence and factors affecting annual seasonal influenza vaccination (ASIV) uptake remain unclear. This was a large-scale cross-sectional survey study conducted among 902 nursing students in different years of study. The questionnaire was developed based on the Health Belief Model (HBM), and logistic regression was used to determine the predictors of ASIV uptake. The results of our study reveal that only 15.2% of nursing students declared having the vaccine in the previous year, and that ASIV uptake was self-reported. ASIV uptake was associated with perceived susceptibility (odds ratio = 2.76), perceived seriousness (odds ratio = 2.06) and perceived barriers (odds ratio = 0.50). The odds of receiving ASIV were 17.96 times higher for those participants having had ASIV at least once than those who had not received ASIV in the previous five years. In addition, the odds of receiving ASIV were 4.01 times higher for master’s than undergraduate students. Our study concludes that the ASIV uptake among nursing students is low. In order to increase vaccination uptake in subsequent years, future studies should promote vaccination based on HBM, focusing on nursing students in undergraduate studies by emphasizing not only vaccination knowledge, but also their social responsibility to protect patients. Influenza vaccination can be viewed as an ethical professional responsibility and a patient safety issue, as well as being an infection control strategy.

Demographics, epidemiology and the impact of vaccination campaigns in a measles-free world – Can elimination be maintained?

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Demographics, epidemiology and the impact of vaccination campaigns in a measles-free world – Can elimination be maintained?
Original Research Article
Pages 1488-1493
J.M. Prada, C.J.E. Metcalf, S. Takahashi, J. Lessler, A.J. Tatem, M. Ferrari
Abstract
Introduction
All six WHO regions currently have goals for measles elimination by 2020. Measles vaccination is delivered via routine immunization programmes, which in most sub-Saharan African countries reach children around 9 months of age, and supplementary immunization activities (SIAs), which target a wider age range at multi-annual intervals. In the absence of endemic measles circulation, the proportion of individuals susceptible to measles will gradually increase through accumulation of new unvaccinated individuals in each birth cohort, increasing the risk of an epidemic. The impact of SIAs and the financial investment they require, depend on coverage and target age range.
Materials and methods
We evaluated the impact of target population age range for periodic SIAs, evaluating outcomes for two different levels of coverage, using a demographic and epidemiological model adapted to reflect populations in 4 sub-Saharan African countries.
Results
We found that a single SIA can maintain elimination over short time-scales, even with low routine coverage. However, maintaining elimination for more than a few years is difficult, even with large (high coverage/wide age range) recurrent SIAs, due to the build-up of susceptible individuals. Across the demographic and vaccination contexts investigated, expanding SIAs to target individuals over 10 years did not significantly reduce outbreak risk.
Conclusions
Elimination was not maintained in the contexts we evaluated without a second opportunity for vaccination. In the absence of an expanded routine program, SIAs provide a powerful option for providing this second dose. We show that a single high coverage SIA can deliver most key benefits in terms of maintaining elimination, with follow-up campaigns potentially requiring smaller investments. This makes post-campaign evaluation of coverage increasingly relevant to correctly assess future outbreak risk.

Is Colombia reaching the goals on infant immunization coverage? A quantitative survey from 80 municipalities

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Is Colombia reaching the goals on infant immunization coverage? A quantitative survey from 80 municipalities
Original Research Article
Pages 1501-1508
Javier Narváez, May Bibiana Osorio, Carlos Castañeda-Orjuela, Nelson Alvis Zakzuk, Natalia Cediel, Luz Ángela Chocontá-Piraquive, Fernando de La Hoz-Restrepo
Abstract
Objectives
This study aimed to evaluate the coverage of the Colombian Expanded Program on Immunization among children less than 6 years old, to evaluate the timeliness of immunization, to assess the coverage of newly introduced vaccines, and to identify factors associated with lack of immunization.
Methods
We conducted a cross-sectional survey in 80 municipalities of Colombia, using a two-stage cluster random sampling. We attempted to contact all children less than 6 years old living in the sampled blocks, and asked their caregivers to provide immunization record cards. We also collected basic sociodemographic information.
Results
We reached 81% of the attempted household contacts, identifying 18,232 children; of them, 14,805 (83%) had an immunization record card. Coverage for traditional vaccines was above 90%: BCG (tuberculosis) 95.7% (95%CI: 95.1–96.4), pentavalent vaccine 93.3% (92.4–94.3), MMR (measles, mumps, rubella) initial dose 94.5% (93.5–95.6); but it was lower for recently introduced vaccines: rotavirus 80% (77.8–82.1), influenza 48.4% (45.9–50.8). Results for timely vaccination were not equally successful: pentavalent vaccine 44.2% (41.4–47.1), MMR initial dose 71.2% (68.9–73.4). Mother’s education was significantly associated with higher immunization odds. Older age, a greater number of siblings, low socioeconomic status, and not having health insurance were significantly associated with lower immunization odds. There was significant heterogeneity in immunization rates by municipality across the country.
Conclusions
Although absolute immunization coverage for traditional vaccines met the goal of 90% for the 80 municipalities combined, disparities in coverage across municipalities, delayed immunization, and decline of coverage with age, are common problems in Colombia that may result in reduced protection. Newly introduced vaccines require additional efforts to reach the goal. These results highlight the association of health inequities with low immunization coverage and delayed immunization. Identification of vulnerable populations and their missed opportunities for vaccination may help to improve the reach of immunization programs.

Investigating adverse events following immunisation with pneumococcal polysaccharide vaccine using electronic General Practice data

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Investigating adverse events following immunisation with pneumococcal polysaccharide vaccine using electronic General Practice data
Original Research Article
Pages 1524-1529
L. Trinh, K. Macartney, P. McIntyre, C. Chiu, A. Dey, R. Menzies
Abstract
Background
In early 2011, following an increased number of reports of severe vaccine-related injection site reactions, Australian authorities recommended against administering repeat doses of the 23-valent pneumococcal polysaccharide vaccine (23vPPV) in otherwise healthy adults. The aim of this study was to assess a source of electronic medical record data from primary care providers (General Practitioners, GPs), for validity and ability to retrospectively detect this adverse event signal.
Methods
The General Practice Research Network (GPRN) holds data routinely collected from a representative sample of Australian GPs. Data were extracted on persons 18 years or older who had received at least one dose of 23vPPV or influenza vaccine (as comparator) between January 2002 and June 2012. Increases above background levels were assessed using 95% confidence intervals of reaction rates, calculated from the Poisson distribution of counts.
Results
There was an average of 253 practices and 532 GPs contributing data per year. Over the study period there were 95,760 recorded 23vPPV administrations and 823 reactions, of which 233 were local. For influenza vaccine the numbers were 683,829 doses, 3001 and 387 respectively. Patterns of vaccinations and reactions were consistent with known safety profiles. There were 3 local reactions following 23vPPV in early 2011 (235/100,000 doses, 95% CI 49–717), which was not significantly different to the historical average (260, 225–298). We estimate that this system could have detected a 3-fold increase over background levels.
Conclusions
Using GP consultation data, we were unable to confirm an increase in local reactions detected by passive surveillance, suggesting that this apparent signal was artefactual. GP consultation data captures large numbers of vaccine recipients and medically attended adverse reactions at low cost. If available in a timely manner and expanded, this system has significant potential for use in validation of apparent signals from passive surveillance.

Safety of the oral cholera vaccine in pregnancy: Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Safety of the oral cholera vaccine in pregnancy: Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh
Original Research Article
Pages 1538-1543
Ashraful Islam Khan, Mohammad Ali, Fahima Chowdhury, Amit Saha, Iqbal Ansary Khan, Arifuzzaman Khan, Afroza Akter, Muhammad Asaduzzaman, Md. Taufiqul Islam, Alamgir Kabir, Young Ae You, Nirod Chandra Saha, Alejandro Cravioto, John D. Clemens, Firdausi Qadri
Abstract
Background
Pregnant women are vulnerable to complications of cholera. Killed oral cholera vaccines (OCV) are not recommended for pregnant women though there is no evidence of harmful effects during pregnancy. We evaluated the effect of a killed OCV, Shanchol™, on pregnancy outcomes during an effectiveness trial of the vaccine in urban Bangladesh.
Methodology
Individuals ⩾1 year were invited to participate in the trial, conducted in 2011 in Dhaka, Bangladesh. Pregnancy by history was an exclusion criterion and all women of reproductive age (15–49 years) were verbally questioned about pregnancy at enrollment and prior to vaccination. Out of 48,414 women of reproductive age 286 women received the OCV unknowingly while pregnant. Out of these, we could recruit 69 women defined as exposed to OCV. Accordingly, we selected 69 pregnant women randomly from those who did not take the OCV (non-exposed to OCV). We evaluated adverse pregnancy outcome (spontaneous miscarriages, still births, or congenital malformations) between those who were exposed to OCV and those who were not exposed to OCV.
Results
About 16% of pregnant women exposed to OCV had pregnancy loss, as compared to 12% of unvaccinated pregnant women (P = 0.38). One congenital anomaly was observed and occurred in women non-exposed to OCV group. Models that adjusted for baseline characteristics that were unbalanced between the exposed and non-exposed groups, revealed a no elevation of risk of adverse pregnancy outcomes in vaccinees versus non-vaccinees (Adj. OR (95% CI): 0.45 (0.11–1.88).
Conclusions
No excess of adverse fetal outcomes associated with receipt of OCV was observed in this study.
Trial registration: Clinical Trials.gov number NCT01339845.

Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial
Original Research Article
Pages 1551-1558
Jennifer L. Kriss, Paula M. Frew, Marielysse Cortes, Fauzia A. Malik, Allison T. Chamberlain, Katherine Seib, Lisa Flowers, Kevin A. Ault, Penelope P. Howards, Walter A. Orenstein, Saad B. Omer
Abstract
Background
Vaccination coverage with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnancy or immediately postpartum has been low. Limited data exist on rigorously evaluated interventions to increase maternal vaccination, including Tdap. Tailored messaging based on the Elaboration Likelihood Model (ELM) framework has been successful in improving uptake of some public health interventions. We evaluated the effect of two ELM-based vaccine educational interventions on Tdap vaccination among pregnant African American women, a group of women who tend to have lower vaccine uptake compared with other groups.
Methods
We conducted a prospective randomized controlled trial to pilot test two interventions – an affective messaging video and a cognitive messaging iBook – among pregnant African American women recruited during routine prenatal care visits. We measured Tdap vaccination during the perinatal period (during pregnancy and immediately postpartum), reasons for non-vaccination, and intention to receive Tdap in the next pregnancy.
Results
Among the enrolled women (n = 106), 90% completed follow-up. Tdap vaccination in the perinatal period was 18% in the control group; 50% in the iBook group (Risk Ratio [vs. control group]: 2.83; 95% CI, 1.26–6.37), and 29% in the video group (RR: 1.65; 95% CI, 0.66–4.09). From baseline to follow-up, women’s reported intention to receive Tdap during the next pregnancy improved in all three groups. Among unvaccinated women, the most common reason reported for non-vaccination was lack of a recommendation for Tdap by the woman’s physician.
Conclusions
Education interventions that provide targeted information for pregnant women in an interactive manner may be useful to improve Tdap vaccination during the perinatal period. However, larger studies including multiple racial and ethnic groups are needed to evaluate robustness of our findings.
Trial Registration: clinicaltrials.gov Identifier: NCT01740310.

The Cost of Cost-Sharing: The Impact of Medicaid Benefit Design on Influenza Vaccination Uptake

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 11 March 2017)
Article
The Cost of Cost-Sharing: The Impact of Medicaid Benefit Design on Influenza Vaccination Uptake
by Charles Stoecker, Alexandra M. Stewart and Megan C. Lindley
Vaccines 2017, 5(1), 8; doi:10.3390/vaccines5010008 – 6 March 2017
Abstract
Prior research indicates that cost-sharing and lack of insurance coverage reduce preventive services use among low-income persons. State Medicaid policy may affect the uptake of recommended adult vaccinations. We examined the impact of three aspects of Medicaid benefit design (coverage for vaccines, prohibiting cost-sharing, and copayment amounts) on vaccine uptake in the fee-for-service Medicaid population 19–64 years old. We combined previously published reports to obtain state Medicaid policy information from 2003 and 2012. Data on influenza vaccination uptake were taken from the Behavioral Risk Factor Surveillance System. We used a differences-in-differences framework, controlling for national trends and state differences, to estimate the effect of each benefit design factor on vaccination uptake in different Medicaid-eligible populations. Each additional dollar of copayment for vaccination decreased influenza vaccination coverage 1–6 percentage points. The effects of covering vaccines or prohibiting cost-sharing were mixed. Imposing copayments for vaccination is associated with lower vaccination coverage. These findings have implications for the implementation of Medicaid expansion in states that currently impose copayments.

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

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

Global Health Action
Volume 9, 2016 – Issue 1
http://www.tandfonline.com/toc/zgha20/9/1
Special Issue: Millennium Development Goals in Vietnam: the Progress and Social Determinants
Original Articles
Timely immunization completion among children in Vietnam from 2000 to 2011: a multilevel analysis of individual and contextual factors
Article: 29189 | Received 18 Jul 2015, Accepted 11 Jan 2016, Published online: 01 Mar 2016
Dao Thi Minh An, Jong-Koo Lee, Hoang Van Minh, Nguyen Thi Huyen Trang, Nguyen Thi Thu Huong, You-Seon Nam & show all
Abstract
Background
Since the beginning of 2014, there have been nearly 6,000 confirmed measles cases in northern Vietnam. Of these, more than 86% had neither been immunized nor was their vaccination status confirmed.
Objective
To establish the likelihood that children under five in Vietnam had ‘timely immunization completion’ (2000–2011) and identify factors that account for variations in timely immunization completion.
Design
Secondary data from the Multiple Indicator Cluster Survey (MICS), which sampled women aged 15–49 from the 1999 Vietnamese Population and Housing Census frame, were analyzed. Multilevel analysis using Poisson regression was undertaken.
Results
Proportions of children under five who had timely immunization completion were low, especially for HBV dose 2 and HBV dose 3, which decreased between 2000 and 2011. Among seven vaccines used in the National Expanded Program of Immunization (EPI) in 2000, 2006, and 2011, measles dose 1 had the highest timely immunization completion at 65.3%, 66.7%, and 73.6%, respectively, and hepatitis B dose 1 had the lowest at 17.5%, 19.3%, and 45.5%, respectively. Timely immunization completion was less common among children whose mothers had relatively less household wealth, were from ethnic minorities, lived in rural areas, and had less education. At the community level, the child’s region of residence was the main predictor of timely immunization completion, and the availability of hospital delivery and community prenatal care in the local community were also determinants.
Conclusion
The EPI should include ‘timely immunization completion’ as a quality indicator. There should also be greater focus and targeting in rural areas, and among women who have relatively low education, belong to minority groups, and have less household wealth. Further research on this topic using multilevel analysis is needed to better understand how these factors interact.

Australian Nursing and Midwifery Journal
Volume 24 Issue 8 (Mar 2017)
https://search.informit.com.au/documentSummary;dn=657984558266413;res=IELHEA
Journal Article
Ethics, evidence and the anti-vaccination debate
Johnstone, Megan-Jane1
Abstract:
In this statement the NMBA made clear its expectation that, when providing advice on immunisation, nurses and midwives have a fundamental responsibility to make use of ‘the best available evidence’ and to uphold their respective profession’s code of conduct and code of ethics. It further warned that any nurse or midwife who failed to uphold the standards of evidence based immunisation or who published or gave advice on immunisation that was ‘false, misleading or deceptive’ could face prosecution by the Australian Health Practitioner Regulation Agency. Significantly, the NMBA released its statement after it became aware that a small number of nurses and midwives were promoting anti-vaccination statements via social media.

Challenges in Health and Development
Date: 07 March 2017
Development in Failed and Fragile States
SA Johnson
Abstract
Failed states and states in conflict are special cases in terms of health and development in that the national government, the main party responsible for directing policy to improve national well-being, may lack the resources, will or legitimacy to provide health infrastructure or opportunities for economic development . Although NGOs can fill the power and resource vacuum in these states in the short term, they may not contribute to sustainable health care delivery or development. A main policy challenge in failed and conflict-ridden states is how best to scale up programs offered by diverse actors targeting health and/or development. A second challenge is building resources and capacity to transform fragility into stability and achieving an adequate level of sectoral development in order to be able to respond to extraordinary threats to national and human security . The first two case studies examined in this chapter are Partners-in-Health/Zanmi LaSante in Haiti , which serves as a model for up-scaling, and the Government of Rwanda , which worked to consolidate and direct the resources of disparate non-governmental actors in order to meet national development and health goals. The final case study explores the Ebola outbreak in Western Africa, which took hold in three fragile states where it grew to unprecedented levels.

Journal of Women’s Health
Online Ahead of Print: March 6, 2017
Human Papillomavirus Vaccine as an Anticancer Vaccine: Collaborative Efforts to Promote Human Papillomavirus Vaccine in the National Comprehensive Cancer Control Program
Julie S. Townsend, MS,1 C. Brooke Steele, DO,1 Nikki Hayes, MPH,1 Achal Bhatt, PhD,2 and Angela R. Moore, MPH1
1Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.
2National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Abstract
Widespread use of the human papillomavirus (HPV) vaccine has the potential to reduce incidence from HPV-associated cancers. However, vaccine uptake among adolescents remains well below the Healthy People 2020 targets. The Centers for Disease Control and Prevention (CDC) National Comprehensive Cancer Control Program (NCCCP) awardees are well positioned to work with immunization programs to increase vaccine uptake. The CDC chronic disease management information system was queried for objectives and activities associated with HPV vaccine that were reported by NCCCP awardees from 2013 to 2016 as part of program reporting requirements. A content analysis was conducted on the query results to categorize interventions according to strategies outlined in The Guide to Community Preventive Services and the 2014 President’s Cancer Panel report. Sixty-two percent of NCCCP awardees had planned or implemented at least one activity since 2013 to address low HPV vaccination coverage in their jurisdictions. Most NCCCP awardees (86%) reported community education activities, while 65% reported activities associated with provider education. Systems-based strategies such as client reminders or provider assessment and feedback were each reported by less than 25% of NCCCP awardees. Many NCCCP awardees report planning or implementing activities to address low HPV vaccination coverage, often in conjunction with state immunization programs. NCCCP awardees can play a role in increasing HPV vaccination coverage through their cancer prevention and control expertise and access to partners in the healthcare community.

Cancer Epidemiology. Biomarkers & Prevention
March 2017 Volume 26, Issue 3
ASPO 41st Annual Meeting Abstracts
Health System-Based HPV Vaccine Reminders: Randomized Trial Results
N Henrikson, W Zhu, M Nguyen, L Baba, H Berthoud and A Hofstetter
DOI: 10.1158/1055-9965.EPI-17-0031 Published March 2017
Abstract
Purpose: Evaluate the impact of health system-based outreach and reminders on human papillomavirus (HPV) vaccine series initiation and completion.
Methods: We conducted a 12-month randomized trial at an integrated care system in the Pacific Northwest in 2015–2016. Parents of 10–12 year olds who had not received any doses of HPV vaccine were randomized to an intervention group (mailed letter and brochure followed by an interactive voice recognition (IVR) reminder call encouraging HPV vaccine initiation) or usual care control group. Parents could opt in to receive future messages via SMS text message on all calls. Parents of intervention group children who initiated vaccination were re-randomized to receive either no further reminders or reminders for doses 2/3. We interviewed a subset of 50 parents to assess were HPV vaccine initiation (within 12 months or 120 days of the initial letter), on-time series completion (within 210 days of initiation), and time to vaccination, assessed with Kaplan-Meier survival analyses.
Results: 1624 children were eligible for randomization (46% age 10, 32.9% age 11, 20.4% age 12). The sample was 48.3% female and 64.6% white. Rates of overall HPV vaccine initiation were similar between the intervention and control groups (49.0% and 45.8%, P = 0.26), but initiation within 120 days of outreach was higher in the intervention group (23.6% and 18.8%, P = 0.04). This effect continued through to completion within 12 months (10.3% vs. 6.8%, P = 0.04). Opt-in rates to SMS were low: 24 people completed the opt-in process. Rates of on-time series completion were similar in those who received dose 1 reminders only compared to those who received reminders for all vaccine doses (12.1% and 19.7%, P = 0.10); time-to-completion results were similar. Parent interviews suggested reminders were acceptable and useful.
Conclusion: Reminder calls after an outreach letter led to more timely vaccine initiation and overall completion. Reminders beyond the initial letter and reminder call did not appear to impact vaccine series completion. The program was acceptable to parents, though there was low uptake of SMS reminders

Media/Policy Watch

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

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

Los Angeles Times
http://www.latimes.com/
Accessed 11 March 2017
One way the Islamic world is tackling its problem with childhood vaccines
1 March 2017
By Muhammad Naeem Khan, assistant secretary general of the Organization of Islamic Cooperation
Around the world, some 1.5 million children die each year from vaccine-preventable diseases.
The problem? Most vaccines are imported from developed nations, making them unaffordable for those who need them most in developing nations. And vaccine shortages that threaten polio eradication goals in Nigeria, Pakistan and Afghanistan — the three countries where the disease is still endemic — only compound the problem.
It’s a concern the Organization of Islamic Cooperation, or OIC, which represents 57 predominately developing Muslim nations, is trying to resolve by helping its member attain self-reliance in the production and supply of essential vaccines…

.

New York Times
http://www.nytimes.com/
Accessed 11 March 2017
Rio State to Vaccinate Population Against Yellow Fever
SAO PAULO — Rio de Janeiro state plans to vaccinate its entire population against yellow fever as a precaution amid Brazil’s largest outbreak of the disease in years.
The Health Ministry has confirmed more than 300 cases of yellow fever so far during Brazil’s summer rainy season. Over 100 of them died. Much of Brazil is considered at risk for the mosquito-borne disease and people in those areas are supposed to be vaccinated.
Rio state was not in that at-risk area for this outbreak and it has not had any cases. But the World Health Organization expanded its vaccination recommendation to include parts of the state in January.
The state said Saturday it expects to reach a 90 percent vaccination rate this year. It will need 12 million vaccine doses to do that.
March 11, 2017 – By THE ASSOCIATED PRESS –

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The Opinion Pages | Op-Ed Contributor
Bernie Sanders: Trump Should Avoid a Bad Zika Deal
By BERNIE SANDERS MARCH 10, 2017
March 11, 2017

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Measles Outbreak in Romania Causes 17 Deaths
BUCHAREST, Romania — Thousands of people have caught measles in an ongoing outbreak that has caused 17 deaths in Romania, the health minister said Friday.
Florian Bodog said that around 3,400 people had contracted the disease since the outbreak began in September 2016. He said the virus was similar to strains found in Hungary or Italy, but couldn’t say whether it was the same one.
Romania has lowered the age for administering the first vaccine dose from the usual 12 months to nine months, recommending all children under 9 are vaccinated.
The European Center for Disease Prevention and Control warned this week that “the likelihood of exportation of measles (from Romania) cases is high.”…
March 10, 2017 – By THE ASSOCIATED PRESS

Vaccines and Global Health: The Week in Review 4 March 2017

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

.– 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_4-march-2017-docx

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

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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David R. Curry, MS
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Center for Vaccine Ethics and Policy

Milestones :: Perspectives :: Featured Articles

Milestones :: Perspectives :: Featured Articles

ETHICAL CONSIDERATIONS FOR ZIKA VIRUS HUMAN CHALLENGE TRIALS
REPORT & RECOMMENDATIONS
February 2017 :: 43 pages
The National Institute of Allergy and Infectious Diseases (NIAID) and the Walter Reed Army Institute of Research (WRAIR)
WRITING GROUP AUTHORS
Seema K. Shah, J.D., Committee chair
Associate Professor, Treuman Katz Center for Pediatric Bioethics, University of Washington &
Seattle Children’s Research Institute, Seattle, Washington, U.S.A.
Jonathan Kimmelman, Ph.D.
Associate Professor, Interim Director, Department of Biomedical Ethics, McGill University,
Montreal, Canada
Anne Drapkin Lyerly, M.D., M.A.
Professor, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.
Holly Fernandez Lynch, J.D., M.Bioethics.
Executive Director, Petrie-Flom Center; Faculty, Harvard Medical School Center for Bioethics,
Cambridge, Massachusetts, U.S.A.
Francine McCutchan, Ph.D.
Director, CHIM Consortium Project, Center for Vaccine Innovation and Access, PATH,
Washington, D.C., U.S.A.
Franklin G. Miller, Ph.D.
Professor, Weil Cornell Medical College, New York, New York, U.S.A.
Ricardo Palacios, M.D., Ph.D.
Clinical R&D Manager, Instituto Butantan, São Paulo, Brazil
Carlos Pardo-Villamizar, M.D.
Director, Neurovirus Emerging in the Americas Study (NEAS), Johns Hopkins University,
Baltimore, Maryland, U.S.A.
Carmen Zorrilla, M.D.
Professor, University of Puerto Rico School of Medicine, San Juan, Puerto Rico, U.S.A.
Pdf:

Click to access EthicsZikaHumanChallengeStudiesReport2017.pdf

[Excerpts; Editor’s text-bolding]

Executive Summary
1. The National Institute of Allergy and Infectious Diseases (NIAID) and the Walter Reed Army Institute of Research (WRAIR) convened a planning committee with members from relevant federal agencies, researchers, and ethicists to determine how best to address the ethical issues raised by a possible Zika virus human challenge study. This group planned an expert consultation meeting in Rockville, Maryland, on December 12, 2016 and formed an independent writing committee with cross-disciplinary expertise to develop recommendations. The writing committee was charged with answering the following questions:
:: Can a Zika virus human challenge trial be ethically justified?
:: If so, under what conditions?

2. Given the potentially devastating effects of Zika infection during pregnancy, the insidious nature of the disease, and the promise of what can be learned from human challenge trials, the writing committee concluded that a Zika virus human challenge trial could be ethically justified if certain conditions were met. However, at this point in time, based on what was heard at the consultation meeting and on our review of the latest scientific and ethics research, the writing committee has determined that these conditions preclude the conduct of a Zika virus human challenge trial, as detailed in the body of this report.

3. At some point in the future, if circumstances change or if a protocol is designed to address the recommendations in this report, members of this writing committee (or a similar body) should apply these recommendations to determine if a specific proposal for a Zika virus human challenge study is ethically sound…

Part 4: Summary of Recommendations and Answers to the Charge of the Consultation
The Zika virus human challenge research writing committee has the following findings and recommendations regarding the charge of the consultation:

1A: There is substantial uncertainty about the risks to potential volunteers in a Zika virus human challenge study. Although the known risks of a Zika virus human challenge trial appear comparable to the risks of phase I research with healthy volunteers, without greater knowledge about outcomes from Zika exposure, these risks would require high social benefit to be justified. Strategies to minimize risks include careful selection of inclusion and exclusion criteria, close medical monitoring, relatively long periods of confinement, and prompt medical attention for volunteers who become ill.

1B: The committee was particularly concerned about possible risks to third parties, i.e., that Zika virus might be transmitted from study volunteers to others, such as fetuses and members of the community. Because these third parties generally cannot know about, protect themselves from, or consent to risks, risks to them are only reasonable if they can be reduced to near-zero. However, the mechanisms of transmission of Zika virus and how long individuals with Zika virus can infect others are not fully understood. Before proceeding with a Zika virus challenge study, researchers should therefore demonstrate that the risks to third parties are not likely to be realized. This could be done through developing risk management strategies and obtaining relevant data. Approaches to minimizing risk would rely upon either relatively long periods of isolation, the use of effective long-acting reversible contraception, careful inclusion and exclusion criteria (including potentially enrolling only women), and/or individual participants’ self-report about their own sexual practices as well as the practices of their partners, though the committee was not certain to what extent these strategies would be compatible with appropriate scientific design. Additional information could be gathered through modeling based on rates of transmission and pregnancy in similar studies and research to characterize the modes of infection and transmissibility of Zika virus. More research using virus culture, which detects infectious virus rather than virus genetic material, could clarify the period of infectiousness and the relative risk of exposure to different body fluids, and is an important priority for the development of a Zika virus human challenge study.

2: Whether a Zika virus human challenge trial has sufficient social value to proceed depends on the reasons for doing it and whether there are alternative ways to obtain the information. The most compelling rationale for conducting a Zika virus human challenge trial, given the risks and uncertainty, would be if field trials were prohibitively difficult to conduct in light of a waning epidemic. This rationale is not currently met, but it could come to pass in the future. Another valuable reason to conduct a challenge trial would be to accelerate the development of a vaccine that could prevent congenital Zika infection. This rationale must be accompanied with strong evidence that results from a Zika virus human challenge trial would be used by stakeholders (e.g., indication from regulatory agencies that finding a correlate would speed up the licensing of a vaccine). The committee did not hear sufficient evidence that this rationale is currently met. Finally, using a challenge trial solely to learn about the pathogenesis and natural history of Zika infection is unlikely to justify the risk involved given the alternative ways to obtain similar information.

3: A Zika virus human challenge trial should only enroll individuals with capacity to provide their voluntary informed consent. Such a trial should also take steps to minimize the risks to fetuses to as close to zero as possible.

4: Researchers and sponsors of a Zika virus human challenge trial should use a robust informed consent process. For example, researchers and sponsors could require multiple voluntary steps for individuals to take to enroll, adequate time for discussion, and evaluation of and feedback given to enhance participant understanding about critical issues (e.g., the uncertainty involved, the risks to third parties and fetuses, precautions that should be taken, and restrictions on the right to withdraw).

5: Volunteers should be paid fairly for their time and inconvenience, but they should demonstrate understanding of the risks and uncertainties involved and be evaluated with objective evidence of their eligibility and compliance wherever possible.

6: The right to withdraw should be respected in challenge trials by halting the collection of data for volunteers who want to withdraw even if they will have to remain confined to protect themselves or others.

7: Contemporaneous external evaluation of risk by relevant experts is advisable before a Zika virus human challenge trial proceeds.

8: In the event a Zika virus CHIM trial proceeds, study sponsors should ensure that sites are adequately insured to cover the costs of care and compensation for research-related injury, to both study participants and third parties, and that insurance policies that are purchased have adequate processes in place to efficiently and fairly evaluate and resolve claims.

9: Community engagement with the geographical community surrounding the site(s) of a Zika virus human challenge trial should be conducted in advance of the research to show respect for the community and its values, obtain community buy-in to the goals of the research, and proceed with transparency.

::::::

WHO publishes list of bacteria for which new antibiotics are urgently needed
News release
27 February 2017 | GENEVA – WHO today published its first ever list of antibiotic-resistant “priority pathogens” – a catalogue of 12 families of bacteria that pose the greatest threat to human health.

The list was drawn up in a bid to guide and promote research and development (R&D) of new antibiotics, as part of WHO’s efforts to address growing global resistance to antimicrobial medicines.

The list highlights in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics. These bacteria have built-in abilities to find new ways to resist treatment and can pass along genetic material that allows other bacteria to become drug-resistant as well.

“This list is a new tool to ensure R&D responds to urgent public health needs,” says Dr Marie-Paule Kieny, WHO’s Assistant Director-General for Health Systems and Innovation. “Antibiotic resistance is growing, and we are fast running out of treatment options. If we leave it to market forces alone, the new antibiotics we most urgently need are not going to be developed in time.”
The WHO list is divided into three categories according to the urgency of need for new antibiotics: critical, high and medium priority.

The most critical group of all includes multidrug resistant bacteria that pose a particular threat in hospitals, nursing homes, and among patients whose care requires devices such as ventilators and blood catheters. They include Acinetobacter, Pseudomonas and various Enterobacteriaceae (including Klebsiella, E. coli, Serratia, and Proteus). They can cause severe and often deadly infections such as bloodstream infections and pneumonia.

These bacteria have become resistant to a large number of antibiotics, including carbapenems and third generation cephalosporins – the best available antibiotics for treating multi-drug resistant bacteria.

The second and third tiers in the list – the high and medium priority categories – contain other increasingly drug-resistant bacteria that cause more common diseases such as gonorrhoea and food poisoning caused by salmonella.

G20 health experts will meet this week in Berlin. Mr Hermann Gröhe, Federal Minister of Health, Germany says “We need effective antibiotics for our health systems. We have to take joint action today for a healthier tomorrow. Therefore, we will discuss and bring the attention of the G20 to the fight against antimicrobial resistance. WHO’s first global priority pathogen list is an important new tool to secure and guide research and development related to new antibiotics.”

The list is intended to spur governments to put in place policies that incentivize basic science and advanced R&D by both publicly funded agencies and the private sector investing in new antibiotic discovery. It will provide guidance to new R&D initiatives such as the WHO/Drugs for Neglected Diseases initiative (DNDi) Global Antibiotic R&D Partnership that is engaging in not-for-profit development of new antibiotics.

Tuberculosis – whose resistance to traditional treatment has been growing in recent years – was not included in the list because it is targeted by other, dedicated programmes. Other bacteria that were not included, such as streptococcus A and B and chlamydia, have low levels of resistance to existing treatments and do not currently pose a significant public health threat.

The list was developed in collaboration with the Division of Infectious Diseases at the University of Tübingen, Germany, using a multi-criteria decision analysis technique vetted by a group of international experts. The criteria for selecting pathogens on the list were: how deadly the infections they cause are; whether their treatment requires long hospital stays; how frequently they are resistant to existing antibiotics when people in communities catch them; how easily they spread between animals, from animals to humans, and from person to person; whether they can be prevented (e.g. through good hygiene and vaccination); how many treatment options remain; and whether new antibiotics to treat them are already in the R&D pipeline.

“New antibiotics targeting this priority list of pathogens will help to reduce deaths due to resistant infections around the world,” says Prof Evelina Tacconelli, Head of the Division of Infectious Diseases at the University of Tübingen and a major contributor to the development of the list. “Waiting any longer will cause further public health problems and dramatically impact on patient care.”

While more R&D is vital, alone, it cannot solve the problem. To address resistance, there must also be better prevention of infections and appropriate use of existing antibiotics in humans and animals, as well as rational use of any new antibiotics that are developed in future.

WHO priority pathogens list for R&D of new antibiotics
Priority 1: CRITICAL
Acinetobacter baumannii, carbapenem-resistant
Pseudomonas aeruginosa, carbapenem-resistant
Enterobacteriaceae, carbapenem-resistant, ESBL-producing

Priority 2: HIGH
Enterococcus faecium, vancomycin-resistant
Staphylococcus aureus, methicillin-resistant, vancomycin-intermediate and resistant
Helicobacter pylori, clarithromycin-resistant
Campylobacter spp., fluoroquinolone-resistant
Salmonellae, fluoroquinolone-resistant
Neisseria gonorrhoeae, cephalosporin-resistant, fluoroquinolone-resistant

Priority 3: MEDIUM
Streptococcus pneumoniae, penicillin-non-susceptible
Haemophilus influenzae, ampicillin-resistant
Shigella spp., fluoroquinolone-resistant

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WHO stresses urgent need for R&D for drug-resistant TB alongside newly-prioritized antibiotic-resistant pathogens
28 February 2017 | GENEVA – WHO reaffirms the critical need for research and development (R&D) of new antibiotics to tackle the threat of drug-resistant tuberculosis (TB).

“Addressing drug-resistant TB research is a top priority for WHO and for the world,” said Dr Margaret Chan, WHO Director-General. “More than US$ 800 million per year is currently necessary to fund badly needed research into new antibiotics to treat TB.”

The MDR-TB public health crisis continues: there were an estimated 580 000 cases and 250 000 related deaths in 2015. Only 125 000 were started on treatment, and just half of those people were cured.

Only two new antibiotics to address MDR-TB have completed Phase IIB trials in the past 50 years. Both are still in Phase III trials, and more funding will be required to complete the process and to develop other effective treatment regimens.

On 27 February, WHO published a list of antibiotic-resistant pathogens that have recently been prioritized as posing great risk to human health.

“Mycobacterium tuberculosis, the bacterium responsible for human TB, was not included in the scope of the prioritization exercise as the intention was to identify previously unrecognised health threats due to increasing antibiotic resistance. There is already consensus that TB is a top priority for R&D for new antibiotics,” said Dr Marie-Paule Kieny, Assistant Director-General at WHO.

A series of high-level global meetings on TB have been scheduled in 2017-2018. Drug-resistant TB and research will be major themes at the WHO Ministerial Conference on TB planned in Moscow in November 2017. It will also be a key agenda item at the UN General Assembly high-level meeting on TB in 2018. MDR-TB and research needs are also under discussion in wider fora such as those focusing on antimicrobial resistance and health security.

::::::

Featured Article

Bulletin of the World Health Organization
Article ID: BLT.16.175166
This online first version has been peer-reviewed, accepted and edited, but not formatted and finalized with corrections from authors and proofreaders.
Lessons learnt from 12 oral cholera vaccine campaigns in resource-poor settings
A Hsiao, SN Desai, V Mogasale, JL Excler, L Digilio
[Free full-text from title link above]
Abstract
Improving water and sanitation is the preferred choice for cholera control in the long-term. Nevertheless, vaccination is an available tool that has been shown to be a cost‒effective option for cholera prevention in endemic countries or during outbreaks. In 2011 the first low-cost oral cholera vaccine for international use was given prequalification by the World Health Organization (WHO). To increase and prioritize use of the vaccine, WHO created a global stockpile in 2013 from which countries may request oral cholera vaccine for reactive campaigns. WHO has issued specific guidelines for applying for the vaccine, which was previously in short supply (despite prequalification for a second oral vaccine in 2015). The addition of a third WHO-prequalified oral cholera vaccine in 2016 is expected to increase the global stockpile considerably and alleviate supply issues. However, prioritization and best use of the vaccine
(e.g. how, when and where to use) will remain challenges. We describe 12 past oral cholera vaccine campaigns, conducted in settings with varying burdens of cholera. These case studies illustrate three key challenges faced in the use of the oral cholera vaccines: regulatory hurdles, cold chain logistics and vaccine coverage and uptake. To pave the way for the introduction of
current and future oral cholera vaccines, we discuss operational challenges and make recommendations for future research with respect to each of these challenges.

Emergencies

Emergencies

WHO Grade 3 Emergencies [to 4 March 2017]
Iraq
:: WHO responds to reported use of chemical weapons agents in East Mosul, Iraq
3 March 2017 – Following the reported use of chemical weapons agents in East Mosul, Iraq, WHO, partners and local health authorities have activated an emergency response plan to safely treat men, women and children who may be exposed to the highly toxic chemical.
Since 1 March, 12 patients including women and children with respiratory symptoms and blistering have been received for treatment by a referral hospital in Erbil according to local health authorities. Of these, 4 patients are showing severe signs associated with exposure to a blister agent. WHO and partners are working with health authorities in Erbil to provide support in managing these patients.
Since the beginning of the Mosul crisis, WHO has been taking concrete steps to ensure preparedness for the potential use of chemical weapons, together with local health authorities. As part of a chemical weapons contingency plan, WHO experts have trained more than 120 clinicians and provided them with equipment to safely decontaminate and stabilise patients before they are referred to pre-identified hospitals for further care. Field decontamination and contaminated patients stabilization are built into all field hospitals, and referral systems to pre-identified hospitals are in place.
WHO is extremely alarmed by the use of chemical weapons in Mosul, where innocent civilians are already facing unimaginable suffering as a result of the ongoing conflict.
The use of chemical weapons is a war crime and is prohibited in a series of international treaties. These include the Hague Declaration concerning Asphyxiating Gases, the 1925 Geneva Protocol, the Chemical Weapons Convention and the Statute of the International Criminal Court (ICC).

NigeriaNo new announcements identified
South SudanNo new announcements identified
The Syrian Arab RepublicNo new announcements identified
YemenNo new announcements identified

::::::

WHO Grade 2 Emergencies [to 4 March 2017]
Cameroon No new announcements identified.
Central African Republic No new announcements identified.
Democratic Republic of the Congo No new announcements identified.
Ethiopia No new announcements identified.
Libya No new announcements identified.
Myanmar No new announcements identified.
Niger No new announcements identified.
Ukraine No new announcements identified.

::::::

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 

Iraq
:: OCHA Iraq | Flash Update #5: Mosul Humanitarian Response, 1 March 2017 [EN/AR/KU]
:: Iraq: Mosul Humanitarian Response Situation Report No. 22 (20 February – 26 February 2017)

Syria
:: 4 Mar 2017 2016 Regional Refugee & Resilience Plan – 3RP (all agencies) – Funding snapshot as of End of 2016 (Final)

Yemen
:: Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, Stephen O’Brien Remarks to the Media, Sana’a, Yemen, 2 March 2017
:: OCHA Note to correspondents, Tuesday 28 February

::::::

WHO: Cholera and tuberculosis medical supplies airlifted to Yemen
March 2017 – A plane carrying 8 metric tonnes of cholera kits and tuberculosis medicines provided by WHO and the Global Fund has landed in the Yemeni capital, Sana’a. The cholera kits include anti-diarrhoeal treatment for 12 000 people, laboratory equipment, and rapid diagnostics tests.

UNICEF [to 4 March 2017]
https://www.unicef.org/media/media_94367.html
2 March 2017
More than 1 million children affected by drought in Kenya – UNICEF
NAIROBI, Kenya, 2 March 2017 – The onset of a severe drought in 2016 has hit arid and semi-arid regions in Kenya, affecting over 2.7 million people. UNICEF is supporting the Government of Kenya in initiating and implementing emergency response efforts by delivering life-saving assistance to affected households, strengthening coordination activities, assisting in monitoring of vulnerable groups and in advocacy.

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

POLIO [to 4 March 2017]
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 1 March 2017
Country Updates [Selected Excerpts]
Pakistan
:: Three new environmental WPV1 positive samples were reported in the past week, from Pishin and Killa Abdullah in Balochistan, and greater Karachi, Sindh, all collected during the first week of February.

[See CDC announcement below]

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

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

EBOLA/EVD [to 4 March 2017]
http://www.who.int/ebola/en/
Report
WHO: Building the legacy of Ebola: Survivors, health systems, and a blueprint for research and development
This report describes the work done by WHO from January 2015 up to the end of December 2016 to address the long-term issues of survivor care, health-systems strengthening and research. This work would not otherwise have been possible without the foresight and commitment of donors  who, having contributed generously to the WHO-led response to the outbreak, recognised the importance of dealing with its consequences.
PDF:  Ebola Response Report 2016 (2.1 MB)

Zika virus [to 4 March 2017]
http://www.who.int/emergencies/zika-virus/en/
[See CDC announcement below]

Yellow Fever [to 4 March 2017]
http://www.who.int/emergencies/yellow-fever/en/
No new digest content identified for this edition.

MERS-CoV [to 4 March 2017]
http://www.who.int/emergencies/mers-cov/en/
No new digest content identified for this edition.

WHO & Regional Offices [to 4 March 2017]

WHO & Regional Offices [to 4 March 2017]

Check the source: WHO-validated websites provide trustworthy information on vaccine safety
March 2017
When people need advice about topics like health, careers, or relationships, the first place they often look is the internet. The same is true when parents and caregivers are seeking credible information about whether vaccines are safe for their children.
…”Every day, misinformation about vaccines continues to proliferate on the internet,” says Isabelle Sahinovic, Vaccine Safety Net coordinator at WHO. “This is dangerous. We need to make sure that all parents, caregivers, and health care professionals can easily access accurate and trustworthy information about vaccines.”
WHO’s Vaccine Safety Net, a global network of vaccine safety websites, aims to do just this. Today, the network has 47 member websites in 12 languages. It is estimated that more than 173 million users every month access VSN websites that contain, among other information, credible vaccine safety information…

::::::

Highlights
Borno State Reports First Lassa Fever Outbreak in 48 Years
March 2017 – Borno state in northeast Nigeria has recorded its first Lassa fever outbreak in almost five decades. The last confirmed outbreak of the deadly disease was in 1969. WHO is supporting the government to contain the outbreak in an area of the country which is already coping with a humanitarian crisis resulting from years of conflict.

Cholera and tuberculosis medical supplies airlifted to Yemen
March 2017 – A plane carrying 8 metric tonnes of cholera kits and tuberculosis medicines provided by WHO and the Global Fund has landed in the Yemeni capital, Sana’a. The cholera kits include anti-diarrhoeal treatment for 12 000 people, laboratory equipment, and rapid diagnostics tests.

Tobacco control: saving lives and driving development
March 2017 – A new study by WHO and partners, titled The Economics of Tobacco and Tobacco Control, shows highly cost-effective measures exist to control the health and economic impacts of tobacco which pose no economic harm and, in turn, save lives and generate financial gains for communities and governments.

WHO scales up response in Somalia as drought-affected populations face difficult situation
February 2017 – WHO is scaling up its response in Somalia to provide critical health services for 1.5 million people currently affected by severe drought conditions and a worsening food crisis. However, the Organization urgently requires US$ 10 million as part of the United Nations appeal for the first 6 months of 2017.

::::::

Weekly Epidemiological Record, 3 March 2017, vol. 92, 9/10 (pp. 97–116)
:: Roadmap to elimination standard measles and rubella surveillance
:: Meeting of the International Task Force for Disease Eradication, November 2016

GIN February 2017 pdf, 2.13Mb 1 March 2017

::::::

:: WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: About 17 million people are affected by crisis in the Lake Chad Basin – 24 February 2017

WHO Region of the Americas PAHO
:: WHO publishes list of bacteria for which new antibiotics are urgently needed (02/27/2017)

WHO South-East Asia Region SEARO
:: Prevent and control birth defects 3 March 2017
:: Maldives making commendable efforts for measles elimination and rubella control
26 February 2017 The World Health Organization commends Maldives for its unprecedented efforts to eliminate measles. The launch of the Measles and Rubella campaign today is a demonstration of its strong commitment to rid the country of the disease, a major childhood killer globally as well as in WHO South-East Asia Region.
Though countries in WHO South-East Asia Region are rolling out MR campaigns, Maldives’ intervention is unique as it covers adults up to the age of 25 years. The campaign will help close any immunity gaps and lay the groundwork for elimination of this life-threatening disease.
Maldives has not reported any measles case since 2010. This mass campaign will fast track progress towards WHO’s regional goal of measles elimination by 2020, and achieving the Sustainable Development Goal of ending preventable deaths of newborns and children under five by 2030, and ensuring health and wellbeing for all at all ages…

WHO European Region EURO
:: A journey interrupted: the changing health needs of refugees and migrants stranded in Greece 02-03-2017
:: What is a migrant? How definitions affect access to health care 02-03-2017
:: WHO mobile clinics bring health care to northern Syria 01-03-2017
:: Health and well-being depend on action at city level 01-03-2017

WHO Eastern Mediterranean Region EMRO
:: WHO responds to reported use of chemical weapons agents in East Mosul, Iraq 3 March 2016
WHO steps up medical preparations in response to West Mosul operations 28 February 2017
:: WHO scales up response for drought-affected populations in Somalia
Cairo, 27 February 2017 –WHO  is scaling up its response in Somalia to provide critical health services for 1.5 million people currently affected by severe drought conditions and a worsening food crisis. However, the Organization urgently requires US$ 10 million as part of the United Nations appeal for the first 6 months of 2017. The humanitarian situation in Somalia continues to deteriorate, and there is a high risk that the country will face its third famine in 25 years.

WHO Western Pacific Region
No new digest content identified for this edition.

CDC/ACIP [to 4 March 2017]

CDC/ACIP [to 4 March 2017]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/
THURSDAY, MARCH 2, 2017
CDC study estimates 20-fold increase in certain types of birth defects in pregnancies with possible Zika infection compared with pre-Zika years
The proportion of Zika-affected pregnancies with birth defects is approximately 20-fold higher compared with the proportion of pregnancies seen in 2013-2014, which is before Zika was introduced into the Americas,…

MMWR Weekly March 3, 2017 / No. 7
[Excerpts]
:: Baseline Prevalence of Birth Defects Associated with Congenital Zika Virus Infection — Massachusetts, North Carolina, and Atlanta, Georgia, 2013–2014
The proportion of Zika-affected pregnancies with birth defects is approximately 20-fold higher compared with the proportion of pregnancies seen in 2013-2014, which is before Zika was introduced into the Americas, according to an article published today in CDC’s Morbidity and Mortality Weekly Report. The types of birth defects—including brain abnormalities and/or microcephaly, neural tube defects and other early brain malformations, eye defects, and other central nervous system (CNS) problems—were seen in about 3 of every 1,000 births in 2013-2014. In 2016, the proportion of infants with these same types of birth defects born to women with Zika virus infection during pregnancy was about 6% or nearly 60 of every 1,000 completed pregnancies with Zika infections.
The researchers analyzed 2013-2014 data from three birth defects surveillance programs in the United States (Massachusetts, North Carolina, and Georgia) to provide the baseline frequency for Zika-related birth defects. To assess the effect of Zika virus infection during pregnancy, the scientists compared that 2013-2014 baseline number with previously published numbers among pregnancies with Zika virus infection from the US Zika Pregnancy Registry (USZPR) from 2016…

:: Response to a Large Polio Outbreak in a Setting of Conflict — Middle East, 2013–2015
As the world advances toward the eradication of polio, outbreaks of wild poliovirus (WPV) in polio-free regions pose a substantial risk to the timeline for global eradication. Countries and regions experiencing active conflict, chronic insecurity, and large-scale displacement of persons are particularly vulnerable to outbreaks because of the disruption of health care and immunization services (1). A polio outbreak occurred in the Middle East, beginning in Syria in 2013 with subsequent spread to Iraq (2). The outbreak occurred 2 years after the onset of the Syrian civil war, resulted in 38 cases, and was the first time WPV was detected in Syria in approximately a decade (3,4). The national governments of eight countries designated the outbreak a public health emergency and collaborated with partners in the Global Polio Eradication Initiative (GPEI) to develop a multiphase outbreak response plan focused on improving the quality of acute flaccid paralysis (AFP) surveillance* and administering polio vaccines to >27 million children during multiple rounds of supplementary immunization activities (SIAs).† Successful implementation of the response plan led to containment and interruption of the outbreak within 6 months of its identification. The concerted approach adopted in response to this outbreak could serve as a model for responding to polio outbreaks in settings of conflict and political instability…

CEPI – Coalition for Epidemic Preparedness Innovations [to 4 March 2017]

Announcements

CEPI – Coalition for Epidemic Preparedness Innovations [to 4 March 2017]
http://cepi.net/
28 February 2017
Dr Richard Hatchett offered position as permanent CEO of CEPI
Media release, Oslo, Coalition for Epidemic Preparedness Innovations
The interim CEPI board decided at its meeting 27 February to offer the position of permanent CEO of CEPI to Dr Richard Hatchett. He comes to the position from the Biomedical Advanced Research & Development Authority (BARDA) at the U.S. Department of Health and Human Services (HHS), where he was Deputy Director and Chief Medical Officer.
Over the course of his career Dr Hatchett has led medical countermeasure development programs at BARDA and the U.S. National Institutes of Health (NIH). He has played leading roles at HHS and the White House in designing these programs as well as in planning for and responding to H5N1 avian influenza (“bird flu”), the 2009 H1N1 influenza pandemic, and the Ebola, MERS, and Zika epidemics.
Professor K Vijay Raghavan, chair of the interim CEPI board, said: “The board is delighted to offer Dr Hatchett the position as the CEO of CEPI. He has the right expertise and experience to take CEPI into the next and permanent phase of its work. His experience from public health preparedness, both from BARDA, NIH and previously from the White House, makes him very well equipped to deliver on the vision and mission of CEPI.”…

Global Fund [to 4 March 2017]

Global Fund [to 4 March 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
03 March 2017
Global Fund Names Marijke Wijnroks Interim Executive Director
GENEVA – The Board of the Global Fund has appointed Marijke Wijnroks as Interim Executive Director, to serve from 1 June 2017 until a new Executive Director selected by the Board is able to begin.
Dr. Wijnroks has served as a leader at the Global Fund since 2013, effectively acting as second in command to Mark Dybul, the current Executive Director, who steps down on 31 May 2017 after completion of a four-year term.
The Board said that Dr. Wijnroks brings an incisive degree of knowledge about internal operations at the Global Fund, where she oversees day-to-day work. She chairs decision-making groups such as the Management Executive Committee and Policy Committee when Dr. Dybul is unavailable, and chairs the Grant Approvals Committee on a regular basis. She frequently represents the Global Fund at external events.
“Marijke is a highly effective leader and manager who can get things done,” said Dr. Dybul. “She knows the Global Fund better than anyone and can steer our exceptional staff until a new Executive Director starts.”…

.

Global Fund Board to Continue Search for Executive Director
27 February 2017
The Board of the Global Fund announced today that it will continue to search for a new Executive Director.
“The Board is committed to a process that adheres to the highest possible standards, and is fair, transparent, merit-based, and conducted with due diligence and professionalism,” said Norbert Hauser, the Chair of the Board.
The Board convened in Geneva on 27 February to review finalists recommended by the Board’s Nominations Committee.
Due to issues encountered in the recruitment process, the Board felt they were unable to bring the process to conclusion. While expressing its complete support for the work of the Nominations Committee, the Board decided to restart the process.
The Board’s overarching priority is to continue looking for a new Executive Director to provide visionary leadership and implement an ambitious new strategy to end AIDS, tuberculosis and malaria as epidemics.

Sabin Vaccine Institute [to 4 March 2017]

Sabin Vaccine Institute [to 4 March 2017]
http://www.sabin.org/updates/pressreleases
Wednesday, March 1, 2017
European Leaders Gather in Georgia for Regional Workshop on Immunization Legislation
TBILISI, GEORGIA — March 1, 2017 — Today, the Sabin Vaccine Institute and the Government of Georgia assembled senior officials from Armenia, Georgia and Moldova to develop legislative roadmaps that will support the sustainability of national immunization programs to protect more than 16.6 million people.
As low- or middle-income countries, many countries in Eastern Europe received significant support from Gavi, the Vaccine Alliance, to purchase vaccines for their citizens. National immunization programs in Eastern Europe have reduced vaccine-preventable disease and improved quality of life. For instance, recent introductions of rotavirus vaccines have led to rapid reductions in hospitalizations in Armenia and Moldova, and have contributed to a 68 percent average decrease in child mortality from diarrheal disease in Armenia, Georgia and Moldova between 2000 and 2015.
However, due to their rising national incomes, Armenia, Georgia and Moldova will soon be ineligible for Gavi support. These countries must transition to independent management and financing of immunization with domestic resources. Failure to continue these Gavi-supported immunization programs by shielding them from competing domestic priorities endangers citizens’ health by risking the extraordinary public health benefits provided by current immunization programs…

Fondation Merieux [to 4 March 2017]

Fondation Merieux [to 4 March 2017]
http://www.fondation-merieux.org/news
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
28 February 2017, Antananarivo (Madagascar)
A new center in Madagascar, in the memory of Dr. Bénédicte Contamin, the former head of Fondation Mérieux in Madagascar
On January 4, 2017, the “Maison Bénédicte”(Bénédicte’s Home) was inaugurated in Antananarivo. Its name commemorates the life of Dr. Bénédicte Contamin, who served as the head of Fondation Mérieux in Madagascar for almost a decade. The inauguration ceremony for the training and community center, which bears the name of the woman who initiated the first Fondation Mérieux mission to Madagascar in 2006, was attended by Alain Mérieux, Fondation Mérieux’s President, and its Director General, Benoît Miribel.

NIH [to 4 March 2017]

NIH [to 4 March 2017]
http://www.nih.gov/news-events/news-releases
February 28, 2017
Open Science Prize announces epidemic tracking tool as grand prize winner
A prototype online platform that uses real-time visualization and viral genome data to track the spread of global pathogens such as Zika and Ebola is the grand prize winner of the Open Science Prize (link is external). The international team competition is an initiative by the National Institutes of Health, in collaboration with the Wellcome Trust and the Howard Hughes Medical Institute (HHMI). The winning team, Real-time Evolutionary Tracking for Pathogen Surveillance and Epidemiological Investigation (link is external), created its nextstrain.org (link is external) prototype to pool data from researchers across the globe, perform rapid phylogenetic analysis, and post the results on the platform’s website. The winning team will receive $230,000 to fully develop their prototype with NIH awarding $115,000 to the U.S. members of the winning team, and the Wellcome Trust and HHMI also contributing $115,000 to the winning team…

Wellcome Trust [to 4 March 2017]

Wellcome Trust [to 4 March 2017]
https://wellcome.ac.uk/news
News / Published: 28 February 2017
Epidemic tracking tool wins Open Science Prize
An online tool that helps researchers and public health workers track epidemics in real time has won the Open Science Prize.
Nextstrain.org (opens in a new tab) is a prototype online platform that visualises viral genome data in real time to track the spread of global pathogens such as Zika and Ebola.
Viral genomes provide a hugely valuable insight into the spread of an infectious disease. But for this information to be useful during an epidemic, samples have to be collected, analysed and the results disseminated in near real time.
NextStrain can conduct statistical analyses in minutes, revealing when diseases were introduced into a population and their patterns of geographic spread. It can also help public health officials to connect individual cases to aid contact tracing…

FDA [to 4 March 2017]

FDA [to 4 March 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
FDA News Release
Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union
March 2, 2017
The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
The amended agreement ‎represents the culmination of nearly three years of U.S. Food and Drug Administration and EU cooperation as part of the Mutual Reliance Initiative and will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.
“The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs,” said Dara Corrigan, FDA’s associate commissioner for global regulatory policy…

What’s New for Biologics
:: Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Public Workshop Transcript (PDF – 622KB) Posted: 3/3/2017
:: February 23, 2017 Approval Letter – RotaTeq (PDF – 48KB) Posted: 3/3/2017
:: February 16, 2017 Summary Basis for Regulatory Action – VARIVAX (PDF – 152KB) Posted: 2/27/17

UNAIDS [to 4 March 2017]

UNAIDS [to 4 March 2017]
http://www.unaids.org/
Update
First Lady of Benin launches the Claudine Talon Foundation to improve the lives of women and children across the country
03 March 2017
The First Lady of Benin has launched a foundation to improve the lives of the most vulnerable women and children in the western African country, nestled between Nigeria and Togo. The foundation will work under the umbrella of six core values: solidarity, the family, respect for differences, integrity, humility and efficiency.
The Claudine Talon Foundation will take a holistic approach to improving health and social outcomes for women and children in Benin. It will focus on expanding maternal and paediatric health services, improving general hygiene and sanitation, increasing access to quality drinking water, improving standards of nutrition and raising literacy rates through a wider access to education. Activities will include increasing access to HIV testing in paediatric health centres and supporting organizations caring for orphans. It will also focus on ending discrimination for people living with and affected by HIV…

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Update
Hospitals in South-East Asia ramp up efforts against HIV-related stigma
02 March 2017
The Bamrasnaradura Infectious Disease Institute in Nonthaburi is one of Thailand’s premier hospitals in AIDS treatment and care. Its waiting rooms welcome many patients. This month, people waiting for appointments will see on hospital screens stories about people living with HIV who overcame stigma thanks to support from their communities. Bamrasnaradura is one of around 1000 hospitals in Thailand that have joined the zero discrimination in health-care settings campaign.
The Ministry of Public Health of Thailand, the Thai Network of People Living with HIV/AIDS (TNP+) and UNAIDS launched the campaign on 2 March at Bamrasnaradura.
“More than 30 years since HIV was detected in Thailand, stigma still remains a major challenge,” said Jessada Chokdamrongsuk, Director-General, Department of Disease Control, Ministry of Public Health. “Thailand is committed to ensuring health-care settings are safe and supportive environments.”…

IVI [to 4 March 2017]

IVI [to 4 March 2017]
http://www.ivi.int/
February 27, 2017
High incidences of typhoid and invasive Salmonella infection confirmed in sub-Saharan Africa
Findings of IVI-led study in 10 African countries published in The Lancet Global Health – High disease burden findings support the introduction of typhoid conjugate vaccines in high-incidence settings
An IVI-led study found that typhoid fever and invasive non-typhoidal Salmonella (iNTS) disease are major causes of invasive bacterial febrile illness in some African countries, and they most commonly afflict children in low and high population density settings.
Large variations exist in the disease burden of Salmonella Typhi and non-typhoidal Salmonella in sub-Saharan Africa, with rates of disease reaching as high as 383 per 100,000 persons per years (PY) for S. Typhi and 237 per 100,000 PY for iNTS disease in Burkina Faso. A rate of more than 100 per 100,000 is considered “high” as defined by the World Health Organization (WHO). Typhoid was found in both infants and school-age children, with a higher incidence in children below 15 years old, according to the study recently published in The Lancet Global Health

EDCTP [to 4 March 2017]

EDCTP [to 4 March 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials.
28 February 2017
UK All-Party Parliamentary Group on Global Health hosted meeting on value of EDCTP
The meeting on EDCTP as ‘African-European partnership for global health benefit’ took place on 27 February 2017 at the Houses of Parliament in London, United Kingdom. It was hosted by Dr Daniel Poulter MP of the UK All-Party Parliamentary Group on Global Health.
The development of paediatric fixed-dose combination therapy for HIV-infected children in two EDCTP-funded trials, CHAPAS-1 and CHAPAS-3, was presented as a case study of the impact of the programme. CHAPAS-1 resulted in the first paediatric antiretroviral formula which was rolled out on a large scale. CHAPAS-3 developed paediatric formulas for a new generation of antiretrovirals. Dr Veronica Mulenga, paediatrician at the University Teaching Hospital in Lusaka, Zambia and Professor Diana Gibb, programme Leader of the Paediatric Programme of trials and cohorts at the MRC Clinical Trials Unit at University College London, United Kingdom presented these trials…

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders
Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

IAVI – International AIDS Vaccine Initiative [to 4 March 2017]
https://www.iavi.org/
Technical Report
Regulatory Capacity Strengthening in Africa-2017
African research partners consistently state the need to strengthen national regulatory and research facilities. This need is echoed in national frameworks and strategies related to HIV/AIDS and health research. While IAVI/partner commitment to health research capacity building has remained consistent, more recently it has focused on nationally- and regionally- defined research- and regulatory-strengthening initiatives to increase country ownership and commitment to health research.
Moving forward, IAVI and its partners remain committed to supporting locally defined and country-owned plans to strengthen regulatory and ethics bodies. This work will continue to improve their capacity to effectively review HIV vaccine research submissions, ensure adequate national and regional policy frameworks to effectively and efficiently review HIV vaccine research submissions, and support nationally and regionally defined regulatory/ethics strengthening initiatives. Such investments advance HIV vaccine research and development while strengthening local health research overall.
PDF: https://www.iavi.org/phocadownload/userupload/regulatory%20capacity%20strengthening%20in%20africa-2017.pdf

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IFPMA [to 4 March 2017]
http://www.ifpma.org/resources/news-releases/
28 February 2017
IFPMA launches new policy principles and report on Rare Disease Day 2017 to benefit patients, patients, healthcare and society
:: New set of policy principles outlines critical elements for a global framework on rare disease policy.
:: New report “Rare diseases: shaping a future with no one left behind” is a new resource to understand key challenges in areas such as R&D, clinical trials, diagnosis, and access to treatment.
:: More than 560 medicines are currently being developed for patients with rare diseases thanks to new technologies and a growing scientific understanding of these diseases[1].

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PhRMA
http://www.phrma.org/press-room
February 28, 2017
Rare Disease Day: Accelerating innovation for patients in need
The biopharmaceutical industry is committed to advancing novel therapies for the more than 30 million Americans suffering from a rare disease today.

Journal Watch

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org