Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 22, Pages 2539-2598 (24 May 2013)
Cost–benefit analysis of hospital based postpartum vaccination with combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap)
Original Research Article
Pages 2558-2564
Yao Ding, Sylvia H. Yeh, Chris Anna M. Mink, Kenneth M. Zangwill, Norma J. Allred, Joel W. Ha

Abstract
Objective
To assess the economic benefits associated with hospital-based postpartum Tdap (combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccination.

Methods
A decision tree model was constructed to calculate the potential cost–benefit of this strategy from both a health care system and a societal perspective. Probabilities and costs were derived from published literature, data reported to Centers for Disease Control and Prevention, and recommendations from expert panels. The maternal vaccination protection period for infants was defined as 7 months, and 10 years of waning immunity following Tdap for birth mothers was estimated in the model. All cost estimates were inflated to year 2012 US dollars and discounted at a 3% annual discount rate.

Results
In the base case from a societal perspective, the expected costs per vaccinated and unvaccinated mother were estimated at $129.27 and $187.97, respectively, suggesting an expected net benefit of $58.70 per vaccinated mother. The overall societal benefits in the cohort of 3.6 million U.S. birth mothers ranged from $52.8–126.8 million, depending on the vaccination coverage level. If including direct medical costs only, the strategy would not generate net savings from a health care system perspective. Annual incidence of pertussis in birth mothers and Tdap efficacy exhibited substantial impact on the model as shown in one-way and two-way sensitivity analyses.

Conclusions
Although postpartum Tdap vaccination is not cost-beneficial from a health care system perspective in the base case, this strategy is likely to generate net benefits from a societal perspective

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 22, Pages 2539-2598 (24 May 2013)
Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children
Original Research Article
Pages 2578-2583
Hung Fu Tseng, Lina S. Sy, In-Lu Amy Liu, Lei Qian, S. Michael Marcy, Eric Weintraub, Katherine Yih, Roger Baxter, Jason M. Glanz, James Donahue, Allison Naleway, James Nordin, Steven J. Jacobsen

Abstract
Although no increased risk was detected for serious adverse events in the prelicensure trials for the 13-valent pneumococcal vaccine, Prevnar 13® (PCV13), continued monitoring of rare but serious adverse events is necessary. A surveillance system using cohort study design was set up to monitor safety of PCV13 immediately after it was included in the childhood immunization program in the United States. The exposed population included children of 1 month to 2 years old who received PCV13 from April, 2010 to January, 2012 from the eight managed care organizations participating in the Vaccine Safety Datalink Project in the United States. The historical unexposed population was children of the same age who received the 7-valent pneumococcal conjugate vaccine Prevnar 7® (PCV7) in 2007 (or 2005 depending on the outcome of interest) to 2009. The risk of pre-specified adverse events in the risk window following PCV13 was repeatedly compared to that in the historical comparison group. The number of doses included in the study was 599,229. No increased risk was found for febrile seizures, urticaria or angioneurotic edema, asthma, thrombocytopenia, or anaphylaxis. An increased risk for encephalopathy was not confirmed following the medical record review. The relative risk for Kawasaki disease in 0–28 days following vaccination was 1.94 (95% confidence interval: 0.79–4.86), comparing PCV13 to PCV7. Comparing to PCV7 vaccine, we identified no significant increased risk of pre-specified adverse events in the Vaccine Safety Datalink study cohort. The possible association between PCV13 and Kawasaki disease may deserve further investigation.

Vaccine
Volume 31, Issue 23, Pages 2599-2658 (28 May 2013)
Long-term safety assessment of live attenuated tetravalent dengue vaccines: Deliberations from a WHO technical consultation
Original Research Article
Pages 2603-2609
Live Dengue Vaccines Technical Consultation Reporting Group, Adwoa D. Bentsi-Enchill, Julia Schmitz, Robert Edelman, Anna Durbin, John T. Roehrig, Peter G. Smith, Joachim Hombach, Jeremy Farrar

Abstract
Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use.

Vaccine
Volume 31, Issue 23, Pages 2599-2658 (28 May 2013)
Introducing vaccination against serogroup B meningococcal disease: An economic and mathematical modelling study of potential impact
Original Research Article
Pages 2638-2646
Hannah Christensen, Matthew Hickman, W. John Edmunds, Caroline L. Trotter

Abstract
Background
Meningococcal disease remains an important cause of morbidity and mortality worldwide. The first broadly effective vaccine against group B disease (which causes considerable meningococcal disease in Europe, the Americas and Australasia) was licensed in the EU in January 2013; our objective was to estimate the potential impact of introducing such a vaccine in England.

Methods
We developed two models to estimate the impact of introducing a new ‘MenB’ vaccine. The cohort model assumes the vaccine protects against disease only; the transmission dynamic model also allows the vaccine to protect against carriage (accounting for herd effects). We used these, and economic models, to estimate the case reduction and cost-effectiveness of a number of different vaccine strategies.

Results
We estimate 27% of meningococcal disease cases could be prevented over the lifetime of an English birth cohort by vaccinating infants at 2,3,4 and 12 months of age with a vaccine that prevents disease only; this strategy could be cost-effective at £9 per vaccine dose. Substantial reductions in disease (71%) can be produced after 10 years by routinely vaccinating infants in combination with a large-scale catch-up campaign, using a vaccine which protects against carriage as well as disease; this could be cost-effective at £17 per vaccine dose.

Conclusions
New ‘MenB’ vaccines could substantially reduce disease in England and be cost-effective if competitively priced, particularly if the vaccines can prevent carriage as well as disease. These results are relevant to other countries, with a similar epidemiology to England, considering the introduction of a new ‘MenB’ vaccine.

Vaccine
Volume 31, Issue 23, Pages 2599-2658 (28 May 2013)
Indicators to assess National Immunization Technical Advisory Groups (NITAGs)
Original Research Article
Pages 2653-2657
Julia Blau, Nahad Sadr-Azodi, Marine Clementz, Nihal Abeysinghe, Niyazi Cakmak, Philippe Duclos, Cara Janusz, Barbara Jauregui, Richard Mihigo, Liudmila Mosina, Yoshihiro Takashima, Kamel Senouci

Abstract
A National Immunization Technical Advisory Group (NITAG) is an expert advisory committee that provides evidence-based recommendations to the Ministry of Health (MoH) to guide immunization programs and policies. The World Health Organization (WHO), the Initiative for Supporting National Independent Immunization and Vaccine Advisory Committees (SIVAC) at Agence de Médecine Préventive (AMP) and the US Centers for Disease Control and Prevention (US CDC) engaged NITAG stakeholders and technical partners in the development of indicators to assess the effectiveness of NITAGs. A list of 17 process, output and outcome indicators was developed and tested in 14 countries to determine whether they were understandable, feasible to collect, and useful for the countries. Based on the findings, a revised version of the indicators is proposed for self-assessment in the countries, as well as for global monitoring of the NITAGs.

Vaccine
Volume 31, Issue 24, Pages 2659-2722 (31 May 2013)
Economic analysis of measles elimination program in the Republic of Korea, 2001: A cost benefit analysis study
Original Research Article
Pages 2661-2666
Geun-Ryang Bae, Young June Choe, Un Yeong Go, Yong-Ik Kim, Jong-Koo Lee

Abstract
Background
In this study, we modeled the cost benefit analysis for three different measles vaccination strategies based upon three different measles-containing vaccines in Korea, 2001. We employed an economic analysis model using vaccination coverage data and population-based measles surveillance data, along with available estimates of the costs for the different strategies. In addition, we have included analysis on benefit of reduction of complication by mumps and rubella.

Methods
We evaluated four different strategies: strategy 1, keep-up program with a second dose measles-mumps-rubella (MMR) vaccine at 4–6 years without catch-up campaign; strategy 2, additional catch-up campaign with measles (M) vaccine; strategy 3, catch-up campaign with measles-rubella (MR) vaccine; and strategy 4, catch-up campaign with MMR vaccine. The cost of vaccination included cost for vaccines, vaccination practices and other administrative expenses. The direct benefit of estimated using data from National Health Insurance Company, a government-operated system that reimburses all medical costs spent on designated illness in Korea.

Results
With the routine one-dose MMR vaccination program, we estimated a baseline of 178,560 measles cases over the 20 years; when the catch-up campaign with M, MR or MMR vaccines was conducted, we estimated the measles cases would decrease to 5936 cases. Among all strategies, the two-dose MMR keep-up program with MR catch-up campaign showed the highest benefit-cost ratio of 1.27 with a net benefit of 51.6 billion KRW.

Conclusion
Across different vaccination strategies, our finding suggest that MR catch-up campaign in conjunction with two-dose MMR keep-up program was the most appropriate option in terms of economic costs and public health effects associated with measles elimination strategy in Korea.

Vaccine
Volume 31, Issue 24, Pages 2659-2722 (31 May 2013)
Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)?
Original Research Article
Pages 2673-2679
Michael M. McNeil, Rongxia Li, Susanne Pickering, Theresa M. Real, Philip J. Smith, Michael R. Pemberton

Abstract
Background
Healthcare provider (HCP) reporting to the Vaccine Adverse Event Reporting System (VAERS) is important to assuring the safety of U.S. licensed vaccines. HCP awareness of and practices regarding reporting of adverse events following immunization (AEFI) is understudied.

Methods
A large, nationally representative sample of U.S. office-based HCP across three occupational groups (physicians, mid-level providers [physician assistants, advanced practice nurses] and nurses) and three primary care practice areas (pediatrics, family medicine, internal medicine) were surveyed utilizing standardized methodology. We assessed HCP familiarity with VAERS, the situations under which they were likely to report an AEFI, and the methods they used and preferred for reporting. We used logistic regression to determine factors associated with HCP not reporting AEFI to VAERS.

Results
Our survey response rate was 54.9%. The percentage of HCP aware of VAERS (71%) varied by occupation and primary care practice area. About 37% of HCP had identified at least one AEFI with only 17% of these indicating that they had ever reported to VAERS. More serious events were more likely to be reported. Factors associated with HCP not reporting AEFI included: HCP not familiar versus very familiar with filing a paper VAERS report (OR = 12.84; p < 0.0001), primary care practice area of internal medicine versus pediatrics (OR = 4.22; p = 0.0005), and HCP not familiar versus very familiar with when it was required to file a VAERS report (OR = 5.52; p = 0.0013).

Conclusions
Specific educational interventions targeted to HCP likely to see AEFI but not currently reporting may improve vaccine safety reporting practices.

Vaccine
Volume 31, Issue 24, Pages 2659-2722 (31 May 2013)
Have changing pneumococcal vaccination programmes impacted disease in Ontario?
Original Research Article
Pages 2680-2685
Gillian H. Lim, Anne E. Wormsbecker, Allison McGeer, Dylan R. Pillai, Jonathan B. Gubbay, Wallis Rudnick, Don E. Low, Karen Green, Natasha S. Crowcroft, Shelley L. Deeks

Abstract
Background
Publicly funded infant 7-valent pneumococcal conjugate vaccine (PCV7) was introduced in Ontario, Canada in 2005 and was replaced by 10- and 13-valent vaccines (PCV10, PCV13) in October 2009 and November 2010, respectively. Among adults ≥ 65 years, a 23-valent polysaccharide vaccine (PPV23) has been universally available since 1996. In January 2012, PCV13 was approved for adults  ≥ 50 years. This study examines the impact of publicly funded vaccination programmes on invasive pneumococcal disease (IPD).

Methods
Laboratory data from population-based surveillance for IPD conducted at the Toronto Invasive Bacterial Disease Network and from Public Health Ontario Laboratories between January 1, 2008 and December 31, 2010 were analyzed.

Results
Between 2008 and 2010 there were 3259 cases of IPD; overall incidence was 7.4/9.3/8.3 per 100,000 in 2008/9/10, respectively. Incidence increased significantly among adults 65+ years during the period; this group had the highest incidence (21.5–25.6/100,000). The second highest incidence in 2008 and 2009 was in infants <1 year, whereas in 2010 it was in children 1–4 years. Among children <5 years, 68% and 19% of serotypes were covered by PCV13 and PCV10, respectively, between 2008 and 2010. In 2009, 6 cases with the 3 additional PCV10 serotypes were reported in infants compared with 2 in 2010. Among persons eligible for PCV7 (born ≥ 2004), there was a 77% decrease in the rate of IPD due to PCV7 serotypes between 2008 and 2010 and a 60% decrease in PCV7 serotypes among persons not vaccine-eligible (born < 2004). There was a 15% difference in serotype coverage between PCV13 and the 23-valent polysaccharide vaccine in adults ≥ 50 years.

Conclusions
During Ontario’s PCV7 programme, serotype-specific decreases in IPD were observed, suggesting vaccine programme success, including herd immunity. Our results also suggest some early impact among infants from PCV10 introduction. A substantial burden of disease was also observed among older adults.

Vaccine
Volume 31, Issue 25, Pages 2723-2786 (7 June 2013)
Vaccine review: “Staphyloccocus aureus vaccines: Problems and prospects”
Review Article
Pages 2723-2730
Kathrin U. Jansen, Douglas Q. Girgenti, Ingrid L. Scully, Annaliesa S. Anderson

Abstract
Staphylococcus aureus is a leading cause of both healthcare- and community-associated infections globally. S. aureus exhibits diverse clinical presentations, ranging from benign carriage and superficial skin and soft tissue infections to deep wound and organ/space infections, biofilm-related prosthesis infections, life-threatening bacteremia and sepsis. This broad clinical spectrum, together with the high incidence of these disease manifestations and magnitude of the diverse populations at risk, presents a high unmet medical need and a substantial burden to the healthcare system. With the increasing propensity of S. aureus to develop resistance to essentially all classes of antibiotics, alternative strategies, such as prophylactic vaccination to prevent S. aureus infections, are actively being pursued in healthcare settings. Within the last decade, the S. aureus vaccine field has witnessed two major vaccine failures in phase 3 clinical trials designed to prevent S. aureus infections in either patients undergoing cardiothoracic surgery or patients with end-stage renal disease undergoing hemodialysis. This review summarizes the potential underlying reasons why these two approaches may have failed, and proposes avenues that may provide successful vaccine approaches to prevent S. aureus disease in the future.

Vaccine
Volume 31, Issue 25, Pages 2723-2786 (7 June 2013)
An overview of meningococcal disease in India: Knowledge gaps and potential solutions
Review Article
Pages 2731-2737
T. Jacob John, Sunil Gupta, A.J. Chitkara, Ashok Kumar Dutta, Ray Borrow

Abstract
The Global Meningococcal Initiative (GMI) consists of an international group of scientists and clinicians, with expertise in meningococcal immunology, epidemiology, public health and vaccinology that aims to prevent meningococcal disease worldwide through education, research, cooperation and vaccination. In India, there is no national policy on routine meningococcal vaccination to control the disease. The GMI convened a meeting in India, with local medical leaders and public policy personnel, to gain insight into meningococcal disease burden and current surveillance and vaccination practices in the country. Neisseria meningitidis is the third most common cause of sporadic bacterial meningitis in children <5 years, with higher incidence in temperate northern versus tropical southern India. Incidence is not reliably known due to suboptimal surveillance and insufficient microbiological support for diagnosis. Since 2005, there have been a number of outbreaks, all attributable to serogroup A. Outbreak responses were ad hoc and included mandatory case reporting by hospitals in Delhi, temporary strengthening of laboratory diagnostics, chemoprophylaxis of close contacts/high-risk groups and limited reactive use of polysaccharide vaccine. Although a conjugate serogroup A vaccine (MenAfriVac™) is manufactured in India, it is not presently used in India. Epidemiological data on meningococcal disease in India are sparse. Meningococcal disease control efforts should focus on establishing systematic surveillance and educating physicians and officers of the Immunization Division of the Ministry of Health on the importance of N. meningitidis as a cause of morbidity and mortality. Conjugate vaccine should be used for outbreak control and the immunization of high-risk persons

Vaccine
Volume 31, Issue 25, Pages 2723-2786 (7 June 2013)
Economic evaluation of vaccination programme of 13-valent pneumococcal conjugate vaccine to the birth cohort in Japan
Original Research Article
Pages 2762-2771
Shu-ling Hoshi, Masahide Kondo, Ichiro Okubo

Abstract
Japan is now preparing to incorporate PCV-7 into the national childhood immunisation programme. Our recently published economic evaluation of using PCV-7 to the birth cohort suggests that the cost to gain one QALY is lower than the WHO’s cost-effectiveness criterion for intervention. However, many countries have started to introduce PCV-13 into their national immunisation schedule replacing PCV-7 for preventing pneumococcal diseases among young children. These raise the need to appraise the ‘value for money’ of replacing PCV-7 with PCV-13 vaccination programme in Japan.

We conducted a cost-effectiveness analysis with Markov model and calculated incremental cost effectiveness ratios (ICERs). Our base-case analyses, which assumed both PCVs have no net indirect effect and set the cost of PCV-7/PCV-13 per shot at ¥10,000 (US$125)/¥13,000 (US$163).

The results show that in Base-case A (assumed PCV-13 has no additional protection against AOM compared to PCV-7), replacing PCV-7 with PCV-13 will cost ¥37,722,901 (US$471,536) or ¥35,584,455 (US$444,850) per QALY when the caregiver’s productivity loss is not included or is included, respectively. While in Base-case B (assumed PCV-13 has additional protection against AOM compared to PCV-7), ¥343,830 (US$4298) per QALY or more QALY is gained by saving money without or with caregiver’s productivity loss, respectively.

We also find that, in Base-case B if cost per PCV-13 shot is equal to or less than that ¥17,000, then a PCV-13 vaccination programme offered to the birth cohort in Japan is likely to be a socially acceptable option compared to the current PCV-7 vaccination programme. Furthermore, if cost per PCV-13 shot is equal to or less than ¥12,000, replacing PCV-7 with PCV-13 will save money and gain more QALYs. While in Base-case A, the replacement can only be socially acceptable if cost per PCV-13 shot is equal to or less than ¥11,000.

Vaccine
Volume 31, Issue 25, Pages 2723-2786 (7 June 2013)
Reducing children’s pain and distress towards flu vaccinations: A novel and effective application of humanoid robotics
Original Research Article
Pages 2772-2777
Tanya N. Beran, Alex Ramirez-Serrano, Otto G. Vanderkooi, Susan Kuhn

Abstract
Objective
Millions of children in North America receive an annual flu vaccination, many of whom are at risk of experiencing severe distress. Millions of children also use technologically advanced devices such as computers and cell phones. Based on this familiarity, we introduced another sophisticated device – a humanoid robot – to interact with children during their vaccination. We hypothesized that these children would experience less pain and distress than children who did not have this interaction.

Method
This was a randomized controlled study in which 57 children (30 male; age, mean ± SD: 6.87 ± 1.34 years) were randomly assigned to a vaccination session with a nurse who used standard administration procedures, or with a robot who was programmed to use cognitive-behavioral strategies with them while a nurse administered the vaccination. Measures of pain and distress were completed by children, parents, nurses, and researchers.

Results
Multivariate analyses of variance indicated that interaction with a robot during flu vaccination resulted in significantly less pain and distress in children according to parent, child, nurse, and researcher ratings with effect sizes in the moderate to high range (Cohen’s d = 0.49–0.90).

Conclusion
This is the first study to examine the effectiveness of child–robot interaction for reducing children’s pain and distress during a medical procedure. All measures of reduction were significant. These findings suggest that further research on robotics at the bedside is warranted to determine how they can effectively help children manage painful medical procedures.

Vaccine
Volume 31, Issue 26, Pages 2787-2848 (10 June 2013)
HPV vaccination among adolescent males: Results from the National Immunization Survey-Teen
Original Research Article
Pages 2816-2821
Paul L. Reiter, Melissa B. Gilkey, Noel T. Brewer

Abstract
US guidelines provided a permissive recommendation for HPV vaccine for males in 2009, with an updated recommendation for routine vaccination in 2011. Data on vaccine uptake among males, however, remain sparse. We analyzed 2010–2011 data (collected mostly prior to the recommendation for routine vaccination) from the National Immunization Survey-Teen for a nationally representative sample of adolescent males ages 13–17 (n = 22,365). We examined HPV vaccine initiation (receipt of at least one dose based on healthcare provider records) as the primary outcome. Analyses used weighted logistic regression. HPV vaccine initiation increased from 1.4% in 2010 to 8.3% in 2011. Parents who reported receiving a healthcare provider recommendation to get their sons HPV vaccine were much more likely to have vaccinated sons (OR = 19.02, 95% CI: 14.36–25.19). Initiation was also higher among sons who were Hispanic (OR = 1.83, 95% CI: 1.24–2.71) or who were eligible for the Vaccines for Children program (OR = 1.53, 95% CI: 1.01–2.31). Only 31.0% of parents with unvaccinated sons indicated their sons were “somewhat likely” or “very likely” to receive HPV vaccine in the next year. The most common main reasons for parents not intending to vaccinate were believing vaccination is not needed or not necessary (24.5%), not having received a provider recommendation (22.1%), and lack of knowledge (15.9%). HPV vaccination is low among adolescent males in the US, and provider recommendation for vaccination is likely key to improving vaccine uptake. Given the updated recommendation for routine vaccination and the changes in health insurance coverage that are likely to follow, continued efforts are needed to monitor HPV vaccination among males.

Vaccine
Volume 31, Issue 26, Pages 2787-2848 (10 June 2013)
Removing the regional level from the Niger vaccine supply chain
Original Research Article
Pages 2828-2834
Tina-Marie Assi, Shawn T. Brown, Souleymane Kone, Bryan A. Norman, Ali Djibo, Diana L. Connor, Angela R. Wateska, Jayant Rajgopal, Rachel B. Slayton, Bruce Y. Lee

Abstract
Objective
Since many of the world’s vaccine supply chains contain multiple levels, the question remains of whether removing a level could bring efficiencies.

Methods
We utilized HERMES to generate a detailed discrete-event simulation model of Niger’s vaccine supply chain and compared the current four-tier (central, regional, district, and integrated health center levels) with a modified three-tier structure (removing the regional level). Different scenarios explored various accompanying shipping policies and frequencies.

Findings
Removing the regional level and implementing a collection-based shipping policy from the district stores increases vaccine availability from a mean of 70–100% when districts could collect vaccines at least weekly. Alternatively, implementing a delivery-based shipping policy from the central store monthly in three-route and eight-route scenarios only increases vaccine availability to 87%. Restricting central-to district vaccine shipments to a quarterly schedule for three-route and eight-route scenarios reduces vaccine availability to 49%. The collection-based shipping policy from district stores reduces supply chain logistics cost per dose administered from US$0.14 at baseline to US$0.13 after removing the regional level.

Conclusion
Removing the regional level from Niger’s vaccine supply chain can substantially improve vaccine availability as long as certain concomitant adjustments to shipping policies and frequencies are implemented.

Vaccine
Volume 31, Issue 26, Pages 2787-2848 (10 June 2013)
Cost-utility analysis of 10- and 13-valent pneumococcal conjugate vaccines: Protection at what price in the Thai context?
Original Research Article
Pages 2839-2847
Wantanee Kulpeng, Pattara Leelahavarong, Waranya Rattanavipapong, Vorasith Sornsrivichai, Henry C. Baggett, Aronrag Meeyai, Warunee Punpanich, Yot Teerawattananon

Abstract
Objective
This study aims to evaluate the costs and outcomes of offering the 10-valent pneumococcal conjugate vaccine (PCV10) and 13-valent pneumococcal conjugate vaccine (PCV13) in Thailand compared to the current situation of no PCV vaccination.

Methods
Two vaccination schedules were considered: two-dose primary series plus a booster dose (2 + 1) and three-dose primary series plus a booster dose (3 + 1). A cost-utility analysis was conducted using a societal perspective. A Markov simulation model was used to estimate the relevant costs and health outcomes for a lifetime horizon. Costs were collected and values were calculated for the year 2010. The results were reported as incremental cost-effectiveness ratios (ICERs) in Thai Baht (THB) per quality adjusted life year (QALY) gained, with future costs and outcomes being discounted at 3% per annum. One-way sensitivity analysis and probabilistic sensitivity analysis using a Monte Carlo simulation were performed to assess parameter uncertainty.

Results
Under the base case-scenario of 2 + 1 dose schedule and a five-year protection, without indirect vaccine effects, the ICER for PCV10 and PCV13 were THB 1,368,072 and THB 1,490,305 per QALY gained, respectively. With indirect vaccine effects, the ICER of PCV10 was THB 519,399, and for PCV13 was THB 527,378. The model was sensitive to discount rate, the change in duration of vaccine protection and the incidence of pneumonia for all age groups.

Conclusions
At current prices, PCV10 and PCV13 are not cost-effective in Thailand. Inclusion of indirect vaccine effects substantially reduced the ICERs for both vaccines, but did not result in cost effectiveness.

Vaccine
Volume 31, Issue 27, Pages 2849-2910 (12 June 2013)
Population access to new vaccines in European countries
Original Research Article
Pages 2862-2867
Patricia R. Blank, Matthias Schwenkglenks, Christelle Saint Sardos, Julien Patris, Thomas D. Szucs

Abstract
Time from registration to population access to new vaccines can take considerable time in European countries. Reasons might be found in the regulatory framework, decision-making processes or the assessment of vaccines by evaluating bodies. The aim of this study was to determine whether some decision-making processes can explain between-country differences in the time to population access to new vaccination programs. Information gathered from a survey among European National Vaccine Industry Groups was combined with information from official health authorities, vaccine manufacturers and literature published. Firstly, a retrospective survey was conducted to measure access time to new vaccines against three diseases in 17 European countries. Secondly, qualitative information on the country-specific decision-making frameworks for the introduction of new “vaccination programs” was identified in a cross-sectional survey. Spearman’s rank correlation coefficients (ρ) were used for data analysis. The median access time to new vaccines was 6.4 years (95% confidence interval: 5.7–7.1 years) post marketing authorization. National assessments underlying immunization policy decisions (recommendation phase) absorbed most of the access time. Correlation analysis suggested that processes with established timelines and clarity in regard to vaccine evaluation criteria used could ameliorate the effectiveness of the decision-making process. In order to reduce the time to access for new, beneficial vaccines, the underlying vaccination recommendation, implementation and funding process needs to be understood and optimized, where necessary.

Vaccine
Volume 31, Issue 27, Pages 2849-2910 (12 June 2013)
Barriers to influenza vaccination among pregnant women
Original Research Article
Pages 2874-2878
Catherine Eppes, Alison Wu, Whitney You, K.A. Cameron, Patricia Garcia, William Grobman
Abstract
Objective
Despite pregnant women’s increased morbidity and mortality from influenza, vaccination rates remain low. This study intended to evaluate barriers to pregnant women’s uptake of influenza vaccine.

Study design
A survey was designed that assessed participant demographics, knowledge, beliefs, attitudes, and general experiences with seasonal and 2009 novel H1N1 influenza. Associations between patient characteristics and vaccine uptake were then assessed.

Results
88 women completed the survey. Women who correctly answered >75% of knowledge questions regarding influenza were significantly more likely to accept the influenza vaccine (seasonal: p = 0.04, H1N1: p < 0.01). Conversely, patients who declined the vaccine were more likely to hold false beliefs, such as perceiving that the vaccine was not protective (seasonal: p < 0.01, H1N1: p < .01) and that they were not at risk for influenza (seasonal: p< 0.01).

Conclusion
The reasons for influenza vaccine declination in pregnant patients include lower levels of knowledge and unfavorable attitudes regarding the safety and efficacy of the vaccine, and suggest the importance of education as a tool to improve vaccination uptake

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

Viewpoint
Social Media and the Empowering of Opponents of Medical Technologies: The Case of Anti-Vaccinationism
Kumanan Wilson1, MD, MSc, FRCP; Jennifer Keelan2, PhD
[HTML]
J Med Internet Res 2013;15 (5):e103)
doi:1.2196/jmir.2409
ABSTRACT
Social media has contributed positively to the interaction between proponents of medical products and technologies and the public by permitting more direct interaction between these two groups. However, it has also provided opponents of these products a new mechanism to organize opposition. Using the example of anti-vaccinationism, we provide recommendations for how proponents of medical products and technologies should address this new challenge.

.

Dissertation: U Maryland
Improving the rates of pertussis vaccination in the retail clinic setting through provider education
Dye, Alissa

Problem: Pertussis is an emerging public health risk with the infant population posing greatest risk of morbidity and mortality. Over the past two decades, the incidence of pertussis has been increasing in the United States, making it the most common preventable childhood illness by vaccine. Despite recommendations from the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control (CDC), the rates of vaccination against pertussis remain low, with only 56 percent of adolescents and 5.9 percent of adults having obtained the Tdap vaccine. The National Foundation for Infectious Diseases posited that many providers are unaware of the ACIP guidelines for adolescents and adults or have personal reservations about vaccination, therefore, are less likely to recommend routine vaccinations. Retail clinics present an opportunity to reach target patient populations through convenience and affordability; every patient visit is an opportunity to address patients’ vaccination status. There is evidence that education can be an effective tool to increase immunization frequency, both for providers and patients when combined with other strategies such as making vaccinations affordable and convenient.

Purpose: The purpose of this capstone project was to determine if an electronic educational intervention in the provider’s weekly newsletter increased the number of Tdap vaccinations in a clinical retail setting. Methods: The educational intervention and retrospective chart review was conducted over a ten week period from February to April 2013 across twelve states. Data were collected four weeks prior to the first educational intervention, two weeks following the first educational intervention, two weeks following the second educational intervention, and four weeks following the second intervention. The rate of Tdap vaccination per visits was analyzed across each of the five two week periods.

Results: Twelve states were selected to participate in this project. On average, each state had an average of 6,583 visits per two-week period, with 5.7 Tdap vaccines being given. Using Friedman’s ANOYA, there was a difference in the rates of Tdap vaccinations (x2 (4) = 11.25, P < 0.05. Wilcoxon signed-rank tests were used to follow up on this finding. A Bonferroni correction was applied so all effects are reported at the 0.005 level. None of the tested pairs were statistically significant at the 0.005 level.

Conclusion: Despite a lack of statistical significance, the project demonstrated the importance of using an electronic educational intervention as a plausible method to educate providers in clinical retail settings on standards of practice. Individually, some of the states demonstrated changes in trends, which indicates the clinical significance of the intervention. Educating providers on best standards for routine vaccinations is a necessary strategy in order to promote adherence to national guidelines.

.

[PDF] Advances in Biopharmaceutical and Vaccine Manufacturing Plants
S Murakami, EH Suzuki – Hitachi Review, 2013
OVERVIEW: The development of innovative pharmaceuticals with potential for meeting unmet medical needs and vaccines that protect against infectious diseases is very important for ensuring people’s health and welfare. However, biopharmaceuticals and vaccines that …

.

Fear factor Deferring, forgoing vaccination to avoid seizures is not always necessary
M Wiznitzer – AAP News, 2013
… Given the amount of information available, some vaccine providers may be unclear as to when they should defer vaccines to prevent seizures in certain patients as well as the contraindications for vaccination.

.

On the Trail of Preventing Meningococcal Disease: A Survey of Students Planning to Travel to the United States
HL Huang, SY Cheng, LT Lee, CA Yao, CW Chu… – Journal of Travel Medicine, 2013
… Many Taiwanese students preparing to study in the United States are required to have the
vaccination, which is not a routine immunization in Taiwan.[14] In addition, the vaccine is available only at 12 Centers for Disease Control contracted hospitals due to the scarceness of the …

Forbes
http://www.forbes.com/
Accessed 1 June 2013
Entrepreneurs
5/30/2013 @ 10:32PM

No Woman Should Die From Cervical Cancer
This article is part of a special edition of Impact—PSI’s global health magazine—and was produced in partnership  with Women Deliver and the Skoll World Forum on Social Entrepreneurship. Launching this week at Women Deliver 2013 in Kuala Lumpur, Malaysia, this issue brings insightful dialogue on the value of investing in girls and women’s health.

Girls and women in the developing world are losing the fight against cervical cancer because we have failed to close deadly gaps in prevention, screening and treatment that could spare their lives and end this disease.

More than 85 percent of the estimated 275,000 women who die from cervical cancer globally every year live in low- and middle income countries.

As global leaders convene in Kuala Lumpur for the third Women Deliver conference, the American Cancer Societyand PSI are proud to join forces with other critical members of civil society to raise our collective voices and amplify the message that no woman should die from cervical cancer. We know what it takes to save lives from this disease – and we have a moral obligation to ensure that all girls and women, regardless of their location, benefit from this knowledge.

The control of cervical cancer is at a global tipping point with the advent of the human papillomavirus (HPV) vaccine. HPV is the leading cause of cervical cancer. And new screening technologies that enable cervical cancer to be effectively detected and addressed in all resource settings.

But we must accelerate adoption of the HPV vaccine, improve access to resource-appropriate cervical cancer screenings, and increase global resources for and attention to cervical cancer prevention and treatment. With proven, cost-effective interventions at hand and a recent commitment to wider accessibility of the HPV vaccine by the GAVI Alliance and the Pan American Health Organization Revolving Fund, as well as engagement from the Bill & Melinda Gates Foundation, we have an unprecedented opportunity to save lives from this disease.

Partnerships are absolutely critical to advance the fight against cervical cancer worldwide and to ensure that women and girls are given priority on global health and development agendas. One example is the Taskforce on Non-Communicable Diseases (NCDs) and Women’s Health that launched during the first-everUnited Nations High-level Meeting on NCDs in September 2011. This initiative, co-chaired by PSI and Jhpiego, with the American Cancer Society providing secretariat support, brings together leading global health organizations from the women’s health and NCD communities and supports a gender-focused approach to women’s health. The taskforce collectively advocates for the prevention and treatment of these diseases to be integrated into current programs, policies and services that address women’s health needs.

The global toll of NCDs is staggering, with more than half of all female deaths in low- and middle-income countries caused by these diseases. Left unaddressed, NCDs risk undermining decades of progress in women’s health and development.

The American Cancer Society is working to strengthen advocacy efforts for national adoption of the HPV vaccine and improved screening policies, as well as drive public demand and acceptability of the vaccine and cervical cancer screening. As the American Cancer Society celebrates its 100th birthday this year, it is also urging people to raise their voices against the silence and complacency that have allowed this disease to claim so many lives unnecessarily.

As part of global efforts to support the prevention and awareness of cervical cancer, PSI is integrating cervical cancer screening and treatment services into many existing sexual and reproductive health services. PSI is offering women the opportunity to further protect their health by building upon existing resources and programs and forging new partnerships.

We have an unprecedented opportunity – and a moral obligation – to change the course of cervical cancer and NCDs. But we must ensure they are a priority at the global policy level, with investments and action reflecting these diseases’ tremendous impact on society, health and the economy. Please join us in our efforts to ensure that where a person lives does not determine whether they live.

http://www.forbes.com/sites/skollworldforum/2013/05/30/no-woman-should-die-from-cervical-cancer/

Washington Post
http://www.washingtonpost.com/
Accessed 1 June 2013
In Somalia, some parents say no to polio vaccine
Abdi Guled 5:51 PM ET

Excerpt
Islamist rebels are opposing a campaign in Somalia to administer a polio vaccine.

The al-Shabab extremists have been pushed out of virtually all of Somalia’s cities and face continued military pressure from African Union and government troops. Health workers are gaining access to more children to give the life-saving polio vaccine. But some parents are refusing the inoculation, apparently heeding the advice of the Islamist militants who warn that the vaccination exercise is part of a foreign conspiracy to kill or weaken Somali children.

Vaccination workers who walked door to door in the capital, Mogadishu, were turned away by some parents who often didn’t state why they objected to the vaccination. One man told the workers to leave immediately because they were carrying “toxic things.”…

Editor’s Notes:

– Email Summary: Vaccines: The Week in Review is available as a weekly email summary: please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_25 May 2013

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

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

– Support: If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…

   UNICEF: Emergency measles vaccination campaign to protect 125,000 children in Central African Republic
UNICEF and its partners announced an emergency measles vaccination campaign in Bangui, the conflict-hit capital of the Central African Republic, after eight children tested positive for the disease in April. UNICEF said it is working with the Ministry of Health, WHO and NGO partners Merlin, IMC, ACF, PU-AMI and COOPI to reach 125, 000 children during the 22-26 May campaign. UNICEF noted that “recent fighting in the country has led to a breakdown of basic services and increased the risk of disease outbreaks in Bangui and across the country. This, along with poor living conditions, and a historically low vaccination rate for measles of 62 per cent, means that the lives of large numbers of children are now at risk from the disease.”

UNICEF also said the campaign faces considerable challenges. “Secure humanitarian access to those in need remains difficult in CAR. Following the coup on 24 March 2013, the security situation continues to be tenuous as law and order have yet to be fully restored in the capital. Many regions remain difficult to reach because of violence and insecurity and will be even harder to access as the rainy season sets in. Despite this, UNICEF is working with partners on the ground to respond to the emergency that is either directly or indirectly affecting the entire population of 4.6 million.” In preparation for the measles campaign, UNICEF said that 246,500 units of vaccine arrived in Bangui on 15 May, including 100,000 vaccines purchased by funds donated by the airline easyJet.

Full media release: http://www.unicef.org/media/media_69308.html

WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html

. Novel coronavirus infection – update (Middle East respiratory syndrome- coronavirus) – update 23 May 2013
Excerpt
23 May 2013 – The Ministry of Health in Saudi Arabia has notified WHO of an additional laboratory-confirmed case of infection with the Middle East respiratory syndrome coronavirus (MERS-CoV).
The fatal case was reported from Al-Qaseem region in the Central part of the country and is not related to the cluster of cases reported from Al-Ahsa region in the Eastern part of the country. The patient was a 63-year-old man with an underlying medical condition who was admitted to a hospital with acute respiratory distress on 15 May 2013 and died on 20 May 2013. Investigation into contacts of this case is ongoing.

The Saudi authorities are also continuing the investigation into the outbreak that began in a health care facility since the beginning of April 2013 in Al-Ahsa. To date, a total of 22 patients including 10 deaths have been reported from the outbreak.

Globally, from September 2012 to date, WHO has been informed of a total of 44 laboratory-confirmed cases of infection with MERS-CoV, including 22 deaths.

WHO has received reports of laboratory-confirmed cases from the following countries in the Middle East: Jordan, Qatar, Saudi Arabia, and the United Arab Emirates (UAE). France, Germany, Tunisia and the United Kingdom also reported laboratory-confirmed cases; they were either transferred for care of the disease or returned from Middle East and subsequently became ill. In France, Tunisia and the United Kingdom, there has been limited local transmission among close contacts who had not been to the Middle East but had been in close contact with the laboratory-confirmed or probable cases.

Based on the current situation and available information, WHO encourages all Member States to continue their surveillance for severe acute respiratory infections (SARI) and to carefully review any unusual patterns.

Health care providers are advised to maintain vigilance. Recent travellers returning from the Middle East who develop SARI should be tested for MERS-CoV as advised in the current surveillance recommendations. Specimens from patients’ lower respiratory tracts should be obtained for diagnosis where possible. Clinicians are reminded that MERS-CoV infection should be considered even with atypical signs and symptoms, such as diarrhoea, in patients who are immunocompromised…
http://www.who.int/csr/don/2013_05_23_ncov/en/index.html
.

. Wild poliovirus in the Horn of Africa – 22 May 2013
Excerpt
22 May 2013 – The Horn of Africa is currently experiencing an outbreak of wild poliovirus type 1 (WPV1). A four-month-old girl near Dadaab, Kenya, developed symptoms of acute flaccid paralysis (AFP) on 30 April 2013. Two healthy contacts of the child tested positive for WPV1.    They are the first laboratory confirmed cases in Kenya since July 2011. Investigation into this outbreak is ongoing. In addition, a case of WPV1 in Banadir, Somalia was confirmed on 9 May 2013.

In response to the outbreak, the first vaccination campaign, reaching 440 000 children began on 14 May 2013 in Somalia and a second round of vaccination is planned for 26 May 2013 in synchronization with the affected parts of Kenya.

The risk to neighbouring countries is deemed as very high, due to large-scale population movements across the Horn of Africa and persistent immunity gaps in some areas. Dadaab hosts a major refugee camp, housing nearly 500 000 persons from across the Horn of Africa.

An alert for enhanced surveillance for polio has been issued to all countries across the Horn of Africa, highlighting the need to conduct active searches for any suspected cases. All countries are urged to rapidly identify sub-national surveillance gaps and to take measures to fill the gaps.

In 2005, polio spread east across the African continent, and into Yemen and the Horn of Africa, resulting in over 700 cases. Since then, international outbreak responses have been adopted and new monovalent and bivalent oral polio vaccines have been developed, which can significantly reduce the severity and length of polio outbreaks.

Some areas of Somalia (south-central) are also affected by an outbreak due to circulating vaccine-derived poliovirus type 2 (cVDPV2), which has resulted in 18 cases in Somalia since 2009. In 2012, this strain spread to Dadaab, causing three cases.

WHO’s International Travel and Health recommends that all travellers to and from polio-infected areas be fully vaccinated against polio…
http://www.who.int/csr/don/2013_05_22/en/index.html

Update: Polio this week – As of 22 May 2013
Global Polio Eradication Initiative
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s extract and bolded text]
. A wild poliovirus type 1 (WPV1) case has been confirmed in Kenya, the first WPV in the country since July 2011, with onset of paralysis 30 April. The location is a refugee camp in the Dadaab area, close to the border with Somalia, where a child was paralysed by polio near the capital Mogadishu on 18 April. Outbreak response activities are being planned. See ‘Horn of Africa’ section for more.

Pakistan
. No new WPV cases were reported in the past week. The total number of WPV cases for 2013 remains eight. The most recent WPV case had onset of paralysis on 24 April (WPV1 from Federally Administered Tribal Areas – FATA).

. One new cVDPV2 case was reported in the past week (from North Waziristan, FATA), bringing the total number of cVDPV2 cases for 2013 to four. It is the most recent cVDPV2 case in the country and had onset of paralysis on 22 April.

. It is the second cVDPV2 case from North Waziristan, an area where immunizations have been suspended by local leaders since last June. To minimize the risk of a major outbreak in this area, it is critical that access to children is granted as quickly as possible. Immunizations in neighbouring high-risk areas are being intensified, to further boost population immunity levels in those areas and prevent further spread of this outbreak.

. Pakistan is also affected by transmission of WPV1, with eight cases this year (compared to 16 cases for the same period in 2012). Wild poliovirus type 3 (WPV3) has not been detected in the country in more than 12 months (since April 2012, from Khyber Agency, FATA).

. Confirmation of these latest cases underscores the risk which ongoing polio transmission (be it due to WPV or cVDPV) in the country continues to pose to children everywhere, and in particular to children living in areas where access has not been possible for extended periods of time.

. The security situation continues to be monitored closely, in consultation with law enforcement agencies. Immunization activities continue to be implemented, in some areas staggered or postponed, depending on the security situation at the local level.

Horn of Africa
. One new WPV case was reported in the past week (WPV1 from a refugee camp in Dadaab, north-eastern Kenya), with onset of paralysis on 30 April. It is the first WPV in Kenya since July 2011, and it follows last week’s confirmation of a WPV1 case from Somalia (onset of paralysis 18 April).

. The child is a four-month-old girl. Two healthy contacts of the child tested positive for WPV1. Dadaab hosts several large refugee camps, housing nearly 500,000 people from across the Horn of Africa, including from Somalia.

. An emergency outbreak response is being planned, to reach nearly 440,000 children aged less than 15 years across Dadaab, beginning on 26 May, using bivalent OPV. Further campaigns are planned across a wider area, including parts of Nairobi, on 9 June, followed by large-scale subnational immunization days (SNIDs) in late June.

. In Somalia, an outbreak response immunization activity was held last week (14-16 May), to reach 350,000 children across Banadir region (including Mogadishu), with further activities across Banadir and other regions planned for 26-29 May and again in early June.

. Immunization campaigns are also planned in other areas of the Horn of Africa, notably Ethiopia and Yemen, to urgently boost population immunity levels and minimize the risk of spread of the outbreak. Countries across the Horn of Africa are at significant risk, due to large-scale population movements and persistent immunity gaps in some areas. In 2005, polio spread across the African continent, and into Yemen and the Horn of Africa, resulting in over 700 cases. The adoption of international outbreak response guidelines and the development of new vaccines since then, have – when fully implemented – considerably reduced the severity and duration of such outbreaks.

Sixty-sixth World Health Assembly
20–28 May 2013
Geneva
Daily notes on proceedings – Editor’s Excerpts

66th WHA – Notes: Monday, 20 May 2013
World Health Assembly opens with focus on the Post Millennium Development Goals Agenda
The Sixty-sixth World Health Assembly opened this morning with the election of  Dr Shigeru Omi, Special Assistant for International Affairs, Ministry of Health, Labour and Welfare of Japan, as its new president. Five vice-presidents were also appointed from Angola, Haiti, Nepal, Oman, and Ukraine, representing their respective regions.

. Last 1,000 days for MDGs and the path forward
In his message, which was read by Mr Kassym-Jomart Tokayev, Director-General of the United Nations Office in Geneva, UN Secretary-General Ban Ki-moon drew attention to the positive effect the Millennium Development Goals (MDGs) have had on the global health agenda. He noted that the Health Assembly will discuss a number of MDG-related issues, such as implementation of the Global Vaccine Action Plan and recommendations from the UN Commission on life-saving commodities for women and children. He described the pressing challenge presented by the rise in noncommunicable diseases, highlighting the role of universal health coverage in ensuring equitable access to health services. He emphasized the continuing need for WHO to handle unforeseen global health events, such as newly emerging viruses.

Dr Omi observed that reform of WHO, the topic of tomorrow’s plenary discussion, aims to make the Organization more relevant, more effective and more dynamic.
Watch the President’s speech on video
Streaming wmv, 00:12:44

. Opening address of the WHO Director-General
In her opening address, WHO Director-General Dr Margaret Chan reiterated the importance of transparent reporting and vigilance in disease outbreaks, including recent cases of novel coronavirus and influenza H7N9, whilst at the same time maintaining the momentum made in addressing long-standing health issues such as tuberculosis, HIV, malaria; the emerging problem of noncommunicable diseases; and eradication of polio.

Dr Chan reiterated WHO’s refusal to work with the tobacco industry. However, she did not exclude the opportunity for cooperation with the food and beverage industry to address noncommunicable diseases, while supporting existing safeguards which ensure no conflicts of interest.

Read the Director-General’s address to the Sixty-sixth World Health Assembly

Watch the Director-General’s address
Streaming wmv, 00:31:48

66^th WHA – Notes: Wednesday, 22 May 2013
. Accelerating achievement of health-related MDGs: The Global Fund New Funding Model, implications for country level cooperation and WHO’s support
Technical briefing
Dr Margaret Chan, Director-General of WHO, applauded the contribution made by the Global Fund to Fight AIDS, Tuberculosis and Malaria to progress towards the MDGs at today’s lunchtime technical briefing on the Fund’s New Funding Model. Dr Mark Dybul, Executive Director of the Global Fund, explained that the new approach builds on three core principles: working as a financing institution that partners with others to serve countries; providing predictability around resource availability; and creating a platform for broader public health support.

Ministers of Health from El Salvador, Myanmar and Zimbabwe, all of whom have made proposals using the new funding model, welcomed the changes enthusiastically and commended support provided by WHO and other technical partners. Other speakers praised the Fund’s closer alignment with country plans and willingness to provide more support for health systems as well as its readiness to learn from experience and to increase transparency.
http://www.who.int/mediacentre/events/2013/wha66/journal/en/index3.html

66^th WHA – Notes: Thursday, 23 May 2013
. Implementation of the International Health Regulations (2005)
Item 15.1 – documents A66/16 and A66/16 Add.1
Before the item was undertaken, delegates requested an update from the WHO Secretariat and the Kingdom of Saudi Arabia on the recent emergence of MERS-CoV (previously known as Novel Coronavirus). The Secretariat and the Saudi Ministry of Health provided background information and a history of the emergence and response to the virus to date. The WHO presentation is attached. The discussion of the item will restart tomorrow.
Global overview of an emerging novel coronavirus
pdf, 741kb
Saudi Arabia’s response to novel coronavirus
pdf, 993kb
Implementation of the International Health Regulations (2005) (A66/16)
pdf, 178kb
Implementation of the International Health Regulations (2005) (A66/16 Add.1)
http://www.who.int/mediacentre/events/2013/wha66/journal/en/index2.html

66^th WHA – Notes: Friday, 24 May 2013
. Implementation of the International Health Regulations (2005)
Item 15.1 – document A66/16 and A66/16 Add.1
The newly identified H7N9 and MERS-CoV outbreaks lent even greater relevance to discussions on the International Health Regulations. Delegates voiced widespread support for the IHR and acknowledgement of WHO’s role in assisting countries. The Director-General told delegates that WHO was committed to supporting countries affected by MERS-CoV and to helping “unpack the barriers” standing in the way of the full implementation of the IHR. She added newly emerging diseases are not just a country problem but a global problem and WHO and the IHR can help bring together “the assets of the world” to fight such threats. The Secretariat stressed the need for countries to provide the necessary resources to ensure IHR work can continue in countries and at WHO. Delegates noted a report updating progress in taking forward 15 recommendations that seek to further improve the effectiveness of the regulations. Countries that have not yet met their IHR obligations and are requesting an extension to the deadline beyond 2014, will be required to inform the WHO Director-General and explain why they have not been able to put IHR in place.
Implementation of the International Health Regulations (2005) (A66/16)
pdf, 177kb
Addendum (A66/16 Add.1)
pdf, 81.8kb
. Pandemic influenza preparedness: sharing of influenza viruses and access to vaccine and other benefits
Item 15.2 – document A66/17
This is the first annual report of the pandemic influenza preparedness (PIP) framework which delegates were agreed to note. The report covers three main areas: virus sharing, benefit sharing, and governance.
It was noted that many countries still lack basic capacities. Laboratory and disease surveillance were highlighted by some countries. A similar concern was highlighted on the regulation and deployment of influenza vaccines during a pandemic.

Lengthy negotiations to conclude binding SMTA2s (Standard Material Transfer Agreement 2) are ongoing. Delegates called for an acceleration on the processes to enable agreements to be signed.

Delegates emphasized the need for transparency related to use of partnership contribution funds.
Pandemic Influenza Preparedness Framework 2013 biennial report (A66/17)
pdf, 204Kb

. Poliomyelitis: intensification of the global eradication initiative
Item 15.3 – document A66/18
The World Health Assembly acknowledged the progress achieved in the past year in bringing polio to its lowest ever levels, thanks to actions of Member States in placing polio eradication on an emergency footing. Delegates endorsed the new Polio Eradication and Endgame Strategic Plan 2013-2018 to secure a lasting polio-free world and urged for its full implementation and financing.

At the same time, the Assembly received stark warning of the ongoing risk the disease poses to children everywhere, with confirmation of a new polio outbreak in the Horn of Africa (Somalia and Kenya)

Noting the generous pledges made to support polio eradication at the Global Vaccine Summit, delegates urged donors to rapidly convert these pledges into contributions. The WHA pointed out that this funding was critical for accelerated implementation of the Plan, given the complexity and scale of introducing inactivated polio vaccine worldwide.

Delegates condemned the deadly attacks on health workers in Pakistan (in December 2012) and Nigeria (in February 2013), and called on all governments to ensure the safety and security of frontline health workers.
Poliomyelitis: intensification of the global eradication initiative (A66/18)
pdf, 146kb
http://www.who.int/mediacentre/events/2013/wha66/journal/en/index1.html

66^th WHA – Notes: Saturday, 25 May 2013
. Global Vaccine Action Plan
Item 16.1 – document A66/19
Member States reiterated their support to the Global Vaccine Action Plan (GVAP) to prevent millions of deaths by 2020 through more equitable access to vaccines for people in all communities, and for the proposed Framework for Monitoring, Evaluation and Accountability (which is linked to the Commission on Information and Accountability for Women’s and Children’s Health).

Delegates also supported the independent review process to assess and report progress and acknowledged the leadership demonstrated by the Strategic Advisory Group of Experts on immunization (SAGE) in this process. Speakers highlighted the need to mobilize greater resources to support low- and middle-income countries to implement the Plan and monitor impact; ensure that support to countries to implement the Plan includes a strong focus on strengthening routine immunization; and to facilitate vaccine technology transfer.
Global Vaccine Action Plan (A66/19)
pdf, 205kb
http://www.who.int/mediacentre/events/2013/wha66/journal/en/index.html

Speech and Response: Harnessing the power of science and the private sector: a 21st century model for international development
Dr Seth Berkley, CEO of the GAVI Alliance
Inaugural Lecture: Wellcome Trust – Cambridge Centre for Global Research University of Cambridge
2nd May 2013

Slides: http://www.thrive.cam.ac.uk/thrive/Seth%20Berkley%20GAVI%20Cambridge%20Final%20slides.pdf

Video: http://www.thrive.cam.ac.uk/thrive/GAVI%20CEO%20lecture%20in%20Cambridge%20(02052013)%20-%20%20540p.mp4

Video HD: http://www.thrive.cam.ac.uk/thrive/GAVI%20CEO%20lecture%20in%20Cambridge%20(02052013)%20-%20high%20definition%20720p.mp4

“The world-leading flu expert, Professor Derek Smith (Director of the WHO Collaborating Centre for Modelling, Evolution and Control of Emerging Infectious Diseases at the University of Cambridge, and Co-PI for the WT-CCGHR) gave a great presentation in response to Dr Berkley’s lecture, and that talk is also available on the video recording.”
http://www.thrive.cam.ac.uk/

GAVI Coverage: Excerpt
“…In the lecture Dr Berkley explained how GAVI operates and why this is critical to ensuring it has a lasting impact. As a 21st Century development organisation, GAVI is an inclusive and diverse partnership bringing together the World Health Organization, UNICEF, and recipient and donor countries together with NGOs, vaccine manufacturers, technical research institutes and individuals with skills and commitment to immunise children.

“In the GAVI model, developing countries lead vaccine uptake and co-finance the cost of the vaccines they receive to ensure immunisation programmes are sustainable after GAVI support ends. With a Board structure drawn from a diverse range of sectors, GAVI seeks to inject private sector innovation into public health issues…”

http://www.gavialliance.org/library/news/gavi-features/2013/gavi-as-a-model-of-21st-century-development/#sthash.i5vwCgxh.dpuf

PATH CEO Steve Davis announced a pledge “…to work with partners to save the lives of two million children affected by pneumonia and diarrhea by the end of 2015.”  Mr. Davis said “PATH is in the business of providing the world—particularly many of the poorest parts of the world—with a set of tools so good health can be in reach of everyone. And we’re here today to discuss these tools, and how PATH is thinking and acting differently to deploy them.”

Webcast of the event

http://www.path.org/news/an130524-breakfast-webcast.php

IVI: Strategic Plan 2013-2017 Chart
pdf

VISION: Developing countries free of suffering from infectious disease

MISSION: Discover, develop, and deliver safe, effective, and affordable vaccines for the world’s developing nations

GOALS: To ensure continued success in both vaccine sciences and public health, IVI’s new strategic plan for 2013-2017 will focus its efforts around the following four goals:
. Accelerate the development and introduction of safe and effective vaccines (cholera, typhoid, dengue and other EDD);
. Discover and pursue proof of concept for new vaccine candidates, with a particular focus on new vaccines against enteric and diarrheal diseases;
. Advance science driving new achievements in vaccinology, specifically through conducting further research in vaccine-enhancing technology and understanding how the immune system works in response to vaccination;
. Contribute to building vaccine technology and systems capacity in developing countries.

The chart includes specific goal level indictors.

The Weekly Epidemiological Record (WER) for 24 May 2013, vol. 88, 21 (pp. 217–224) includes:
– Building rotavirus laboratory capacity to support the Global Rotavirus Surveillance Network
– WHO Task Force on Immunization: call for nominations
http://www.who.int/entity/wer/2013/wer8821.pdf

Meeting: ACIP (ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES)
June 19 – 20, 2013
Centers for Disease Control and Prevention
Atlanta, Georgia

Meeting Agenda/Draft at 21 May 2013: http://www.cdc.gov/vaccines/acip/meetings/downloads/agenda-archive/agenda-2013-06.pdf

Agenda topics:
–       Japanese Encephalitis Vaccine
–       General Recommendations on Immunization
–       Pertussis Vaccines
–       Human Papillomavirus (HPV) Vaccine
–       Rotavirus Vaccines: Update on Intussusception
–       The Role of Retail Pharmacies/Pharmacists in Vaccine Delivery in the United States
–       Vaccine Supply
–       Herpes Zoster Vaccine
–       Influenza

Meeting: “Cooperation Among First-to-Introduce Countries for Dengue Vaccines 2013 Meeting”
Dengue Vaccine Initiative (DVI); Hosted by the Ministry of Health of Brazil
April 9-11, 2013
Brasilia, Brazil

The meeting had three main objectives: 1) For developers to present status and timelines of dengue vaccine candidates under development; 2) For countries to present epidemiology data and points to consider for dengue vaccine introduction; and 3) For first-to-introduce countries to find mechanisms for collaboration in preparing introduction of dengue vaccines. Participating countries included Colombia, Indonesia, Mexico, Thailand, Malaysia and the Philippines, in addition to Brazil.
The meeting led to the identification of several areas for collaboration between countries and DVI: surveillance, regulatory pathways, modeling, strategic demand forecasting, financing, and communications.  Specific examples of follow-on collaborations were: 1) In collaboration with WHO and WHO regional offices, to standardize dengue surveillance; 2) To implement regulatory support activities such as access to knowledge and literature on dengue and dengue vaccines, facilitation of inter-agency collaborations for evaluation of dengue vaccines, National Regulatory Agency and National Immunization Technical Advisory Group coordination; 3) The application of a computer model to design the potentially most effective immunization strategies; 4) The preparation of demand forecasts that can take into account the potential limited supply; 5) The identification of resources to support the costs of the vaccine and its distribution; and 6) The development of accurate and informative communication messages to prepare communities for vaccine introduction.
The countries will meet again in October in Thailand to discuss collaborative activities to be undertaken in preparation for a dengue vaccine introduction.  The meeting will be held in conjunction with the Third International Conference on Dengue and Dengue Haemorrhagic Fever, “Global Dengue: Challenges and Promises”, which meets in Bangkok from the 21st to the 23rd of October.

Agenda and slide presentations: http://www.denguevaccines.org/news-events/cooperation-among-first-introduce-countries-dengue-vaccines-2013-meeting

BMC Public Health
(Accessed 25 May 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article
Using HPV vaccination for promotion of an adolescent package of care: opportunity and perspectives
Catherine MacPhail, Emilie Venables, Helen Rees and Sinead Delany-Moretlwe

Abstract (provisional)
Background
Adolescents are a difficult population to access for preventive health care, particularly in less resourced countries. Evidence from developed countries indicates that the HPV vaccine schedule may be a useful platform from which to deliver other adolescent health care services. We conducted a qualitative cross sectional study to assess the potential for using the HPV vaccine in the South African public health care system as an opportunity for integrated health care services for adolescents.

Methods
Parents, young adolescents, community members and key informants participated in interviews and focus group discussions about feasibility and acceptability, particularly the use of the HPV vaccination as the basis for an integrated adolescent package of care. Health care providers in both provinces participated in focus group discussions and completed a pairwise ranking exercise to compare and prioritise interventions for inclusion in an adolescent package of care.

Results
Participants were in favour of integration and showed preference for detailed information about the HPV vaccine, general health information and specific sexual and reproductive health information. Among health care workers, results differed markedly by location. In North West, prioritisation was given to information, screening and referral for tobacco and alcohol abuse, and screening for hearing and vision. In Gauteng integration with referral for male circumcision, and information, screening and referral for child abuse were ranked most highly.

Conclusions
There is generally support for the delivery of adolescent preventive health services. Despite national priorities to address adolescent health needs, our data suggest that national policies might not always be appropriate for vastly different local situations. While decisions about interventions to include have traditionally been made at country level, our results suggest that local context needs to be taken account of. We suggest low resource strategies for ensuring that national policies are introduced at local level in a manner that addresses local priorities, context and resource availability.
http://www.biomedcentral.com/1471-2458/13/493/abstract

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

Emerging Infectious Diseases
Volume 19, Number 6—June 2013
http://www.cdc.gov/ncidod/EID/index.htm

Letter
Wild Poliovirus Importation, Central African Republic
Excerpt
To the Editor: Since the Global Polio Eradication Initiative was launched in 1988, indigenous transmission of wild poliovirus (WPV) has been interrupted in all countries except Afghanistan, Pakistan, and Nigeria (1). However, during 2003–2011, outbreaks resulting from importation of WPV occurred in 29 previously polio-free countries in Africa, including Central African Republic (CAR) (1–3). In 2011, 350 WPV cases were reported from 12 countries in Africa, a 47% decrease from the 657 cases reported by 12 countries in Africa in 2010 (1).

In CAR, the last case of poliomyelitis caused by indigenous transmission of wild poliovirus was reported in 2000, but importation of WPV type 1 has been reported (4). We describe the importation of WPV1 and WPV3 into CAR during successive events in 2008, 2009, and 2011…

http://wwwnc.cdc.gov/eid/article/19/6/pdfs/12-1821.pdf

Emerging Infectious Diseases
Volume 19, Number 6—June 2013
http://www.cdc.gov/ncidod/EID/index.htm

Perspective
Prospects for Emerging Infections in East and Southeast Asia 10 Years after Severe Acute Respiratory Syndrome
P. Horby et al.
http://wwwnc.cdc.gov/eid/article/19/6/pdfs/12-1783.pdf

Abstract
It is 10 years since severe acute respiratory syndrome (SARS) emerged, and East and Southeast Asia retain a reputation as a hot spot of emerging infectious diseases. The region is certainly a hot spot of socioeconomic and environmental change, and although some changes (e.g., urbanization and agricultural intensification) may reduce the probability of emerging infectious diseases, the effect of any individual emergence event may be increased by the greater concentration and connectivity of livestock, persons, and products. The region is now better able to detect and respond to emerging infectious diseases than it was a decade ago, but the tools and methods to produce sufficiently refined assessments of the risks of disease emergence are still lacking. Given the continued scale and pace of change in East and Southeast Asia, it is vital that capabilities for predicting, identifying, and controlling biologic threats do not stagnate as the memory of SARS fades.

Perspective
Public Health Lessons from Severe Acute Respiratory Syndrome a Decade Later
J. P. Koplan et al.
http://wwwnc.cdc.gov/eid/article/19/6/pdfs/12-1426.pdf

Abstract
The outbreak of severe acute respiratory syndrome in 2002–2003 exacted considerable human and economic costs from countries involved. It also exposed major weaknesses in several of these countries in coping with an outbreak of a newly emerged infectious disease. In the 10 years since the outbreak, in addition to the increase in knowledge of the biology and epidemiology of this disease, a major lesson learned is the value of having a national public health institute that is prepared to control disease outbreaks and designed to coordinate a national response and assist localities in their responses.

Eurosurveillance
Volume 18, Issue 21, 23 May 2013
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Rapid communications
Ongoing outbreak of rubella among young male adults in Poland: increased risk of congenital rubella infections
by I Paradowska-Stankiewicz, MP Czarkowski, T Derrough, P Stefanoff

Journal of Medical Ethics
June 2013, Volume 39, Issue 6
http://jme.bmj.com/content/current

Brief report
Comprehension of a simplified assent form in a vaccine trial for adolescents
Sonia Lee, Bill G Kapogiannis, Patricia M Flynn, Bret J Rudy, James Bethel, Sushma Ahmad,    Diane Tucker, Sue Ellen Abdalian, Dannie Hoffman, Craig M Wilson, Coleen K  Cunningham,
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN

Abstract
Introduction
Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general.

Methods
Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative.

Results
123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly.

Conclusions
Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.

http://jme.bmj.com/content/39/6/410.abstract

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 2 Issue 2 June 2013
http://jpids.oxfordjournals.org/content/current

Measles Outbreak Associated With International Travel, Indiana, 2011
J Ped Infect Dis (2013) 2(2): 110-118 doi:10.1093/jpids/pis132
Melissa G. Collier, Angela Cierzniewski, Thomas Duszynski, Cheryl Munson, Mona Wenger, Brad Beard, Ryan Gentry, Joan Duwve, Preeta K. Kutty, and Pamela Pontones

Abstract
Background
Endemic measles was declared eliminated in the United States in 2000, but imported measles cases continue to cause outbreaks. On June 20, 2011, 5 epidemiologically linked measles cases were reported to the Indiana State Department of Health. We investigated to identify additional cases and to prevent further spread.

Methods
Case findings and contact investigations during the June 3, 2011–August 13, 2011 outbreak identified measles cases, exposed persons, and exposure settings. Laboratory confirmation included measles serology and reverse-transcription polymerase chain reaction. Control measures included evaluating measles immune status and providing post-exposure prophylaxis, isolation, and quarantine.

Results
Fourteen confirmed measles illnesses were identified (10 [71%] females; median age, 11.5 years [range, 15 months–27 years]). The source patient was an unvaccinated US resident who recently traveled from Indonesia. Twelve patients were unvaccinated members of the source patient’s extended family. Two hospitalizations and no deaths were reported. Among 868 exposed persons identified through contact investigation, 644 (74%) had documented measles immunity, 153 (18%) were lost to follow-up, and 71 (8%) lacked evidence of immunity.

Conclusions
Misdiagnosis of measles in an unvaccinated patient with recent travel history to a measles-endemic region resulted in the second largest measles outbreak in the United States during 2011. Clinicians should consider measles among patients presenting with febrile rash illness and history of recent travel, and clinicians should promptly report suspected illnesses. Early identification of infectious patients, rapid public health investigation, and maintenance of high vaccine coverage are critical for the prevention and control of measles outbreaks.

http://jpids.oxfordjournals.org/content/2/2/110.abstract

Journal of Pediatrics
Vol 162 | No. 6 | June 2013 | Pages 1087-1298
http://www.jpeds.com/

Generalists’ role in vaccine safety reporting
Thomas R. Welch, MD
Every pediatrician involved in the day-to-day process of administering vaccines is aware of how fraught with complexity it has become. On one hand, many pediatricians have seen in their professional lifetimes the virtual disappearance of once-feared childhood disorders. On the other hand, unwarranted concerns about vaccine safety are leaving more and more children unprotected.

Journal of Pediatrics
Vol 162 | No. 6 | June 2013 | Pages 1087-1298
http://www.jpeds.com/

Comprehensive Assessment of Serious Adverse Events Following Immunization by Health Care Providers
S. Elizabeth Williams, Kathryn M. Edwards, MD, Roger P. Baxter, MD, Philip S. LaRussa, MD,     Neal A. Halsey, MD, Cornelia L. Dekker, MD, Claudia Vellozzi, MD, MPH, Colin D. Marchant, MD,    Peter D. Donofrio, MD, Tyler E. Reimschisel, MD, Melvin Berger, MD, Jane F. Gidudu, MD,     Nicola P. Klein, MD, PhD

Abstract
Many events occurring after vaccination have been attributed to vaccines, when in fact the association was often due to chance.1 However, as with any medical intervention, there are times when adverse events are caused by immunizations.2 Distinguishing which events are causally related to vaccine, rather than coincidental events, is a challenge for the pediatrician and a major focus of vaccine safety science. Consider a child who presents with aseptic meningitis after immunization. Because of the temporal relationship, one may suspect the immunizations as the cause, yet subsequent isolation of enterovirus from cerebrospinal fluid implicates the enteroviral infection instead.3 The term adverse event following immunization (AEFI) is defined as any untoward event that occurs after immunization, regardless of causal association.4 AEFI is the preferred notation to describe such clinical events because the term is free from implications regarding causal relationship and favors an open mind about the role of immunizations. AEFIs are a common part of routine clinical practice. The Clinical Immunization Safety Assessment (CISA) network has reviewed many individual cases of AEFIs and found that when a comprehensive investigation for alternative etiologies of the AEFI is completed, other causes for the event can often be identified. Yet, such comprehensive evaluations are rarely performed.8 We describe a stepwise approach to the comprehensive assessment of serious AEFIs by health care providers. The main objective is to highlight the important role that health care providers play in this effort by actively evaluating for the most likely causes of serious events when they occur after immunization.
http://www.jpeds.com/article/S0022-3476%2813%2900062-0/preview

The Lancet Infectious Diseases
Jun 2013   Volume 13  Number 6  p465 – 558
http://www.thelancet.com/journals/laninf/issue/current

Comment
AS03-adjuvanted influenza vaccine in elderly people
Julie E Ledgerwood

Preview
The best available method for prevention of influenza is vaccination. However, the effectiveness of inactivated trivalent influenza vaccine (TIV) is variable, generally reaching 60% in the overall population when vaccine strains and outbreak strains are well matched.1 Even with available licensed vaccines, up to 15% of the world’s population become infected with influenza every year, with as many as 5 million cases of severe illness and 500 000 deaths.2 In developed countries, most influenza deaths occur in elderly people, and, depending on the endpoint assessed, TIV effectiveness is as low as 9% in this population.

Articles
AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial
Janet E McElhaney, Jiri Beran, Jeanne-Marie Devaster, Meral Esen, Odile Launay, Geert Leroux-Roels, Guillermo M Ruiz-Palacios, Gerrit A van Essen, Adrian Caplanusi, Carine Claeys, Christelle Durand, Xavier Duval, Mohamed El Idrissi, Ann R Falsey, Gregory Feldman, Sharon E Frey, Florence Galtier, Shinn-Jang Hwang, Bruce L Innis, Martina Kovac, Peter Kremsner, Shelly McNeil, Andrzej Nowakowski, Jan Hendrik Richardus, Andrew Trofa, Lidia Oostvogels, for the Influence65 study group
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2813%2970046-X/abstract

Summary
Background
We aimed to compare AS03-adjuvanted inactivated trivalent influenza vaccine (TIV) with non-adjuvanted TIV for seasonal influenza prevention in elderly people.

Methods
We did a randomised trial in 15 countries worldwide during the 2008—09 (year 1) and 2009—10 (year 2) influenza seasons. Eligible participants aged at least 65 years who were not in hospital or bedridden and were without acute illness were randomly assigned (1:1) to receive either AS03-adjuvanted TIV or non-adjuvanted TIV. Randomisation was done in an internet-based system, with a blocking scheme and stratification by age (65—74 years and 75 years or older). Participants were scheduled to receive one vaccine in each year, and remained in the same group in years 1 and 2. Unmasked personnel prepared and gave the vaccines, but participants and individuals assessing any study endpoint were masked. The coprimary objectives were to assess the relative efficacy of the vaccines and lot-to-lot consistency of the AS03-adjuvanted TIV (to be reported elsewhere). For the first objective, the primary endpoint was relative efficacy of the vaccines for prevention of influenza A (excluding A H1N1 pdm09) or B, or both, that was confirmed by PCR analysis in year 1 (lower limit of two-sided 95% CI had to be greater than zero to establish superiority). From Nov 15, to April 30, in both years, participants were monitored by telephone or site contact and home visits every week or 2 weeks to identify cases of influenza-like illness. After onset of suspected cases, we obtained nasal and throat swabs to identify influenza RNA with real-time PCR. Efficacy analyses were done per protocol. This trial is registered with ClinicalTrials.gov, number NCT00753272.

Findings
We enrolled 43 802 participants, of whom 21 893 were assigned to and received the AS03-adjuvanted TIV and 21 802 the non-adjuvanted TIV in year 1. In the year 1 efficacy cohort, fewer participants given AS03-adjuvanted than non-adjuvanted TIV were infected with influenza A or B, or both (274 [1·27%, 95% CI 1·12—1·43] of 21 573 vs 310 [1·44%, 1·29—1·61] of 21 482; relative efficacy 12·11%, 95% CI −3·40 to 25·29; superiority not established). Fewer participants in the year 1 efficacy cohort given AS03-adjuvanted TIV than non-adjuvanted TIV were infected with influenza A (224 [1·04%, 95% CI 0·91—1·18] vs 270 [1·26, 1·11—1·41]; relative efficacy 17·53%, 95% CI 1·55—30·92) and influenza A H3N2 (170 [0·79, 0·67—0·92] vs 205 [0·95, 0·83—1·09]; post-hoc analysis relative efficacy 22·0%, 95% CI 5·68—35·49).

Interpretation
AS03-adjuvanted TIV has a higher efficacy for prevention of some subtypes of influenza than does a non-adjuvanted TIV. Future influenza vaccine studies in elderly people should be based on subtype or lineage-specific endpoints.

Funding
GlaxoSmithKline Biologicals SA.

PLoS One
[Accessed 25 May 2013]
http://www.plosone.org/

Influenza Mortality in the United States, 2009 Pandemic: Burden, Timing and Age Distribution
Ann M. Nguyen, Andrew Noymer Research Article | published 22 May 2013 | PLOS ONE 10.1371/journal.pone.0064198

Abstract
Background
In April 2009, the most recent pandemic of influenza A began. We present the first estimates of pandemic mortality based on the newly-released final data on deaths in 2009 and 2010 in the United States.

Methods
We obtained data on influenza and pneumonia deaths from the National Center for Health Statistics (NCHS). Age- and sex-specific death rates, and age-standardized death rates, were calculated. Using negative binomial Serfling-type methods, excess mortality was calculated separately by sex and age groups.

Results
In many age groups, observed pneumonia and influenza cause-specific mortality rates in October and November 2009 broke month-specific records since 1959 when the current series of detailed US mortality data began. Compared to the typical pattern of seasonal flu deaths, the 2009 pandemic age-specific mortality, as well as influenza-attributable (excess) mortality, skewed much younger. We estimate 2,634 excess pneumonia and influenza deaths in 2009–10; the excess death rate in 2009 was 0.79 per 100,000.

Conclusions
Pandemic influenza mortality skews younger than seasonal influenza. This can be explained by a protective effect due to antigenic cycling. When older cohorts have been previously exposed to a similar antigen, immune memory results in lower death rates at older ages. Age-targeted vaccination of younger people should be considered in future pandemics.

PLoS Medicine
(Accessed  25 May 2013)
http://www.plosmedicine.org/

Integrating Global and National Knowledge to Select Medicines for Children: The Ghana National Drugs Programme
David Sinclair, Martha Gyansa-Lutterodt, Brian Asare, Augustina Koduah, Edith Andrews, Paul Garner

Summary Points
–    This paper reports the experience of the Ghana National Drugs Programme as they reviewed the international evidence base for five priority paediatric medicines.

–    Applying the global recommendations to Ghana was not straightforward for any of the five medicines, regardless of the presence of high quality evidence of important clinical benefits.

–    Four main factors generated debate and uncertainty in the committee: (1) effect unproven in African settings; (2) control group in trials not consistent with current practice; (3) little evidence on cost and cost effectiveness; and (4) limited supply chain.

–    This project demonstrates why global recommendations should be presented alongside transparent descriptions of the evidence base, allowing policy groups to identify where, when, and how the interventions have been evaluated, and any factors limiting applicability.

–    As many policy questions are relevant across sub-Saharan Africa, and policy makers are likely to encounter similar problems, we encourage regional collaboration on health technology assessment, and sharing of information and resources.

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

Liability for Failure to Vaccinate
By Art Caplan
Bill of Health, Harvard Law Petrie-Flom Center
http://blogs.law.harvard.edu/billofhealth/2013/05/23/liability-for-failure-to-vaccinate/
Posted on May 23, 2013

Safety and Immunogenicity of a Recombinant Tetravalent Dengue Vaccine in 9-16-Year-Olds: A Randomized, Controlled, Phase II Trial in Latin America
LÁ Villar, DM Rivera-Medina, JL Arredondo-García… – The Pediatric Infectious …, 2013
Background. The dengue virus is a member of the Flavivirus (FV) genus, which also includes the yellow fever virus. Dengue disease is caused by any one of four dengue virus serotypesand is a serious public health concern in Latin America. This study evaluated the …

[HTML] In pursuit of an HIV vaccine: an interview with Andrew McMichael
AJ McMichael – BMC Biology, 2013
Andrew McMichael qualified in Medicine before doing a PhD in Immunology with Ita Askonas and Alan Williamson in the 1970s. His research during this time and later work done in his group has made a major contribution to our understanding of T-cell-mediated …

Vaccination Errors Reported to the Vaccine Adverse Event Reporting System 2000-2011
https://cste.confex.com/cste/2013/webprogram/Paper1777.html
2013 CSTE Annual Conference, 2013
Wednesday, June 12, 2013: 2:22 PM
Ballroom B (Pasadena Convention Center)
Beth Hibbs , Pedro Moro , Paige Lewis , Elaine Miller , Karen Broder , Claudia Vellozzi , Centers for Disease Control and Prevention, Atlanta, GA

BACKGROUND: Medication errors are an important public health problem and the subgroup of vaccination errors is relatively understudied. We characterized vaccination error reports to the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive surveillance system for vaccine adverse events (AEs).

METHODS:  Signs and symptoms of AEs described in VAERS reports and reported medical errors are coded using the Medical Dictionary for Regulatory Activities (MedDRA).  We searched VAERS for U.S. reports of vaccination errors from 2000-2011 using 39 MedDRA medical error coding terms and categorized them into 11 error groups.  We performed manual review of selected reports and available medical records.

RESULTS:  Of the 255,528 reports received by VAERS from 2000-2011, we identified 13,137 (5.1% ) vaccination error reports.  The number of annual vaccination error reports increased from 10 reports in 2000 to 1,396 in 2011, peaking at 2,696 in 2008.  Of the vaccination error reports, 8813 (67%) reported the error without any AE while 4,324 (32.9%) documented an AE. Among these reports the most common AEs were injection site erythema (n=583, 13.5%), fever  (n=495, 11.4%) and  injection site pain (n=468, 10.8%).  The most common vaccination error reported was inappropriate schedule (i.e. wrong age, wrong schedule) (n=3,886, 29.6%), most often described for pediatric rotavirus vaccines (n=620, 16%).  The second most common vaccination error was wrong vaccine administered (n=2,693, 20.5%).  In a random sample of 100 reports of wrong vaccine administered, the most common mix-ups involved similar or related vaccines (i.e. Varicella and Zoster, pediatric DTaP and adult Tdap) in vaccination settings that served both children and adults.  We identified an unexpected vaccination error: 25 reports of rotavirus vaccine eye splashes affecting mainly healthcare providers (16 associated with ocular symptoms).  Cluster reports occurring in multiple individuals (range 2-500 persons) at the same vaccination location and date were noted 208 times; the most common error for clusters was expired drug administered.

CONCLUSIONS: Although VAERS data have limitations of passive surveillance, the data show that potentially preventable vaccination errors have occurred since 2000 in individuals and in clusters.   The most common vaccination errors, inappropriate schedule and wrong vaccine, as well as unexpected rotavirus eye splashes, may be prevented with education or packaging changes.  Even though most vaccination errors are not temporally associated with an adverse health event, errors potentially could cause adverse events, incur additional costs, inconvenience patients and impact confidence in vaccination programs.  Prevention strategies should be considered and evaluated.

Possible Factors Contributing to Vaccine Hesitancy Among Parents of Two Year Old Children in Georgia, 2010-2012
https://cste.confex.com/cste/2013/webprogram/Paper1613.html
2013 CSTE Annual Conference, 2013
Tuesday, June 11, 2013: 11:15 AM
Ballroom F (Pasadena Convention Center)
Rebecca M Willis , Georgia Department of Public Health, Atlanta, GA
Jessica Tuttle , Georgia Department of Public Health, Atlanta, GA

BACKGROUND:
Since 1997, the Georgia Immunization Office has conducted the annual Georgia Immunization Study (GIS) – a retrospective cohort study to determine the statewide and regional immunization coverage rates for 24 month old children born in the state of Georgia.  In 2010, data collection was expanded to include reasons for incomplete immunization. This study aims to assess the contribution of vaccine hesitancy to inadequate immunization in Georgia.

METHODS:
We analyzed data from the Georgia Registry of Immunization Transactions and Services (GRITS), which provided information on approximately 7,000 children who received immunizations during 2010-2012. We assessed the proportion of children who were inadequately immunized (4:3:1:3:3:1:4 level), analyzed the reasons listed for inadequate immunization, and used descriptive statistics to characterize demographic or other factors that may contribute to vaccine hesitancy –  measured as parent choosing delayed schedule or refusing any vaccines.

RESULTS:
During 2010-2012, a total of 462 (6.5%) two-year-olds were inadequately immunized by the end of the data collection period. During this time, there were a total of 261 (56.5%) reasons for inadequate immunization related to vaccine hesitancy, the most-frequently cited reason being “parent chose a delayed schedule” (141; 30.5%). The racial/ ethnic breakdown of the inadequately immunized subsample was: white, non-Hispanic (215; 46.5%), black, non-Hispanic (166; 35.9%) and Hispanic (28; 6.1%), similar to the overall eligible sample. The white, non-Hispanic children were inadequately immunized due primarily to a parent refusing one or more vaccines (48; 16.9%) versus children of black and Hispanic mothers (18; 5.0% and 5; 8.3%, respectively). Parents of children enrolled in WIC less often refused one or more vaccines when compared to parents of children not enrolled in WIC (10% versus 21%) (2011). Parents of children whose mother was 25-34 years old at the time of birth more often chose a delayed immunization schedule for their child than both the under 25 year and 35+ years age groups (79; 35.1% versus 51; 27.4% and 11; 21.6%, respectively).

CONCLUSIONS:
Inadequate immunization may be attributed, in part, to vaccine hesitancy in more than 2.5% of the cohort of two year olds in Georgia during 2010-2012. Inadequately immunized children differ by race/ethnicity, maternal age, and maternal WIC enrollment. Healthcare providers should take into account these differences to target vaccine education and improve vaccine coverage in Georgia.

New Yorker
http://www.newyorker.com/
Accessed 25 May 2013

Books
Resistant
Why a century-old battle over vaccination continues to rage.
by Michael Specter May 30, 2013
http://www.newyorker.com/arts/critics/books/2011/05/30/110530crbo_books_specter

BOOK review about the battle over vaccination. Smallpox claimed the lives of tens of thousands of French soldiers during the Franco-Prussian War, yet the Prussians lost fewer than five hundred men. That was because Prussia vaccinated its entire Army against the virus, and France did not. By the end…

Wall Street Journal
http://online.wsj.com/home-page
May 20, 2013, 4:02 a.m. ET

Polio-Vaccine Team Attacked in Pakistan
Associated Press
KHAR, Pakistan—Officials say gunmen have killed a policeman guarding a polio-vaccination team in northwestern Pakistan.

Local government administrator Faramosh Khan says the gunmen attacked on Monday in the town of Mamound in the Bajur tribal area, just as the team started a vaccination drive.

No one has claimed responsibility for the shooting, but suspicion will likely fall on Islamic militants suspected in similar attacks.

Jehanzeb Dawar, a senior regional health official, said a total of 624 teams are taking part in the latest push in Bajur to vaccinate more than 220,000 children. The teams relaunched the drive after taking a couple of months off because of past attacks on vaccination teams in the country.

It’s unclear whether the campaign will continue after Monday’s attack.

http://online.wsj.com/article/SB10001424127887324787004578494402823401718.html

Washington Post
http://www.washingtonpost.com/
Accessed 25 May 2013

WHO: Competition, rules dispute mar efforts to combat new Mideast virus that has killed 22
By Associated Press, Published: May 23
GENEVA — International efforts to combat a new pneumonia-like virus that has now killed 22 people are being slowed by unclear rules and competition for the potentially profitable rights to disease samples, the head of the World Health Organization warned Thursday.

Dr. Margaret Chan, in a blunt warning to the U.N. agency’s annual global assembly, portrayed a previously little-known flap over who owns a sample of the virus as a global game-changer that could put people’s lives at risk. The virus, which first emerged in Saudi Arabia where most cases have arisen, is called MERS for Middle East respiratory syndrome.

“Please, I’m very strong on this point, and I want you to excuse me,” she said. “Tell your scientists in your country, because you’re the boss. You’re the national authority. Why would your scientists send specimens out to other laboratories on a bilateral manner and allow other people to take intellectual property rights on a new disease?”

The controversy stems from a sample taken by Saudi microbiologist Ali Mohamed Zaki that he mailed last year to virologist Ron Fouchier at the Erasmus Medical Center in the Netherlands.

Fouchier tested, sequenced and identified it last September as a new virus. Then his private medical center patented how it synthesized the germ and required other researchers who wanted samples to first sign an agreement that could trigger a payment.

Saudi Arabia, which had the first case, said the patenting delayed its development of diagnostic kits and blood tests. “There was a lag of three months where we were not aware of the discovery of the virus,” Deputy Health Minister Ziad Memish told the Geneva assembly. He said the sample was sent to the Dutch lab without official permission.

So far there is no blood test for detecting infection in communities. Memish said that patients need to be isolated because in some cases, diarrhea or vomiting may help spread the germ.

Dr. Keiji Fukuda, WHO’s assistant director-general for health security, said his agency also has been “struggling with diagnostics” because of property rights concerns and ill-defined international rules for sharing such materials.

Chan railed against any arrangement that could prevent rapid sharing of information or that would enable individual scientists or private labs to profit.

WHO officials say the delays involve blood and other tests though a few other facilities in Canada, Britain and Germany have samples.

Fouchier, however, said the agreements between individual countries are similar to those within WHO’s networks.

“There are no restrictions to the use of the virus for research and public health purposes. There are only restrictions for commercial exploitation and forwarding virus to third parties,” he wrote in an email, responding to questions from The Associated Press.

Any delays claimed by WHO are a misconception, he said.

“After the first identification of the virus, diagnostic tests were developed in collaboration with several public health laboratories, and these tests were distributed free of charge to everyone around the world who asked for them,” Fouchier added. “We have not denied access to the virus to any research and public health laboratory with the appropriate facilities to handle this virus safely.”

The World Health Assembly, the decision-making body of WHO, meets from May 20-28.

Indonesia has previously refused to share samples of the bird flu virus that has been seen in Southeast Asia for several years. That country claimed vaccines made from those samples would be too expensive for developing countries to afford. That dispute led to a protracted series of negotiations with WHO and others to ensure poor nations would have access to vaccines in a global epidemic…

Copyright 2013 The Associated Press.

http://www.washingtonpost.com/world/europe/un-22-deaths-worldwide-from-44-cases-of-new-coronavirus/2013/05/23/6eb63bb6-c3b4-11e2-9642-a56177f1cdf7_story.html

Editor’s Notes:

– Email Summary: Vaccines: The Week in Review is available as a weekly email summary: please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_18 May 2013_PDF

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

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

– Support: If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…

WHO: Landmark reached with tetanus elimination achieved in over half of 59 priority countries
The Maternal and Neonatal Tetanus (MNT) Elimination Initiative announced that tetanus has been eliminated in over half of 59 priority countries. Since 1999, more than 118 million women of child-bearing age have been vaccinated against tetanus in 52 countries. Many of these women received their tetanus vaccine as part of an integrated campaign which included other life-saving interventions for children including immunization against measles, vitamin A supplements, deworming tablets and information on umbilical cord care. The MNT Elimination Initiative is an international private-public partnership that includes national governments, WHO, UNFPA, UNICEF, GAVI Alliance, USAID/Immunization Basics, CDC, UNICEF National Committees, the Government of Japan, Save the Children, PATH, RMHC, Bill & Melinda Gates Foundation, Kiwanis International, Pampers – a division of Procter & Gamble, and BD.

Countries that have eliminated MNT include: Bangladesh; Benin; Burkina Faso; Burundi; Cameroon; China; Comoros; Congo; Cote d’ Ivoire; Egypt; Eritrea; Ghana; Guinea Bissau; Iraq; Liberia; Malawi; Mozambique; Myanmar; Namibia; Nepal; Rwanda; Senegal; South Africa; Tanzania (United Republic of); Timor Leste; Togo; Turkey; Uganda; Viet Nam; Zambia and Zimbabwe.

Priority countries “still working toward elimination” include Afghanistan; Angola; Cambodia; Central African Republic; Chad; Congo (Democratic Republic of the); Equatorial Guinea; Ethiopia; Gabon; Guinea; Haiti; India; Indonesia; Kenya; Lao People’s Democratic Republic; Madagascar; Mali; Mauritania; Niger; Nigeria; Pakistan; Papua New Guinea; Philippines; Sierra Leone; Somalia; South Sudan; Sudan; and Yemen
http://www.who.int/immunization/newsroom/Landmark_reached_in_fight_against_tetanus/en/index.html