Vaccine review: “Staphyloccocus aureus vaccines: Problems and prospects”

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.

An overview of meningococcal disease in India: Knowledge gaps and potential solutions

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

Economic evaluation of vaccination programme of 13-valent pneumococcal conjugate vaccine to the birth cohort in Japan

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.

Reducing children’s pain and distress towards flu vaccinations: A novel and effective application of humanoid robotics

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.

HPV vaccination among adolescent males: Results from the National Immunization Survey-Teen

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.

Removing the regional level from the Niger vaccine supply chain

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.

Cost-utility analysis of 10- and 13-valent pneumococcal conjugate vaccines: Protection at what price in the Thai context?

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.

Population access to new vaccines in European countries

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.

Barriers to influenza vaccination among pregnant women

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 + [to 1 June 2013]

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.

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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.

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[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 …

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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.

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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 …

No Woman Should Die From Cervical Cancer [Forbes]

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/

In Somalia, some parents say no to polio vaccine

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.”…