Independent Monitoring Board of the Global Polio Eradication Initiative
Eighth Report  October 2013  
[60 pages: http://www.polioeradication.org/Portals/0/Document/Aboutus/Governance/IMB/9IMBMeeting/9IMB_Report_EN.pdf ]
The Independent Monitoring Board provides an independent assessment of the progress being made by the Global Polio Eradication Initiative in the detection and interruption of polio transmission globally.
This eighth report follows our ninth meeting, held in London from 1 to 3 October 2013.
At our meetings, we benefit from the time and energy of many partners of the Global Polio Eradication Initiative. We value our open discussions with these many people, but the views presented here are our own. Independence remains at the heart of our role. Each of us sits on the board in a personal capacity. As always, this report presents our findings frankly, objectively, and without fear or favour.

Selected Excerpts
[From p. 40]
The Red List: countries at highest risk of a polio outbreak
YEMEN  UGANDA  SYRIA  LEBANON  JORDAN  IRAQ  CENTRAL AFRICAN REPUBLIC  UKRAINE
MALI  DJIBOUTI  ERITREA  SUDAN  SOUTH SUDAN
The IMB considers these countries to be on the Red List. The program needs to establish a definitive Red List and act on it quickly.

[Full text of Conclusions And Recommendations beginning p.57 minus a graphic on Program Standards unable to be reproduced here]
Conclusions and recommendations
Unprecedented challenges loom over today’s polio eradication program. Levels of intimidation and violence – including horrific deaths of polio workers – have reached such a level that those giving or accepting the vaccine too often do so in harrowing and hazardous circumstances. The program is banned from accessing crucial areas, in which polio is paralysing and killing children – one million children in Somalia and another million in Pakistan cannot be vaccinated against polio because those in control of the territories are not allowing the program to operate there.

The program has dealt with insecurity before (and continues to do so), but these are different, unprecedented phenomena. All who support the eradication of the second ever disease for humankind should have no greater priority than finding ways to resolve these huge challenges. This is the greatest test of the World Health Assembly’s declaration that global polio eradication is a “programmatic emergency for global public health”.

Operationally, the program has far from perfect control in such circumstances. Whilst we are sympathetic to the challenge that this creates, it is more important than ever that the program’s performance is as eradication-ready – as worthy of a global public health emergency – as it can be, in the many aspects that remain within its control. There are too many instances in which this is not the case. The performance issues to be addressed are illustrated by (but not limited to) the fact that the Horn of Africa was not better protected against an outbreak and that too many other countries remain vulnerable. They are illustrated too by the response in the Horn of Africa, which could not be described as a robust response to a public health emergency of global importance.

It is now fourteen months until the primary goal of the Strategic Plan (stopping global polio transmission) needs to be met. The list of problems to be resolved is formidable. The program needs to address insecurity and inaccessibility in each of the endemic countries, whilst continuing to tackle the campaigns that remain stubbornly suboptimal. It needs to regain lost ground in the Horn of Africa. It needs to pay attention to the considerable ‘Red List’ of vulnerable countries where neglect could enable the polio virus to run amok in parts of the world from which it has been thankfully absent for some time.

As the program enters what is supposed to be the last low season in which polio circulates, we ask ourselves (as should all within the program): it this a program that is eradication-ready? Does what we are seeing really look like a programmatic emergency for global public health?    This report has identified too many ways in which this is not the case.

The goal of stopping polio transmission by the end of 2014 now stands at serious risk. This situation must be turned round with the greatest possible urgency.

This report has made 14 recommendations:
Pakistan
1. We recommend that achieving access in FATA be top priority for Pakistan’s polio program and all who support it, using all diplomatic means available

Nigeria
2. We recommend that the Nigerian Expert Review Committee ensures that detailed area-specific plans are in place to overcome the challenges in each of the Local Government Areas (LGAs) that need priority focus

Horn of Africa outbreak
3. We recommend that a joint WHO-UNICEF central command unit is established for the Horn of Africa, led by a single senior commander
4. We recommend that the Polio Oversight Board is immediately appraised of what partner staff are required in, and in support of, the Horn of Africa and oversees measures to get them in place by the end of November
5. We recommend that environmental surveillance be urgently established in Nairobi, Kenya

The novel situation in Israel
6. We recommend that Israel immediately schedules a second national OPV campaign, to be completed as quickly as possible
7. We recommend that the WHO Director General briefs Member States whose populations are currently protected against polio by IPV only on the implications of circulating poliovirus in Israel

Outbreaks waiting to happen
8. We recommend that a global action plan be drawn up, identifying a definitive Red List of the world’s most polio-vulnerable countries and actions to protect each of them
9. We restate our earlier recommendation that the International Health Regulations be used to ensure that all people travelling from a polio-endemic country be required to have vaccination prior to travel, and add that this should be extended to any persistently affected country

Insecurity and impositions of restrictions to access
10. We recommend that the Polio Oversight Board ensures that all of the planned security posts within the partner agencies are filled by the end of November, even if this requires extraordinary measures
11. We recommend that the partners consult and seek advice from the highest levels of the UN Security system and other experts
12. We recommend that all means be used to ensure that the polio program in every country is known to be politically neutral

Management and oversight of the global program
13. We recommend that the Polio Oversight Board commissions a comprehensive review of the program’s oversight and strategic and operational management, making a decision now about how to optimally time this

Potential IPV use in interrupting transmission
14. We recommend that the program agrees and makes a clear statement of policy on the use of IPV in stopping polio transmission, addressing the questions raised by the IMB in its May and October 2013 reports

Update: Polio this week – As of 30 October 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]

:: Following reports of a cluster of 22 acute flaccid paralysis (AFP) cases on 17 October 2013 in the Syrian Arab Republic, wild poliovirus type 1 (WPV1) has been isolated from ten of the cases under investigation. Final genetic sequencing results are pending. Wild poliovirus was last reported in Syria in 1999. A wide-ranging outbreak response plan is urgently being finalized for Syria and countries in the region. For more on the Syria outbreak, please click here
:: South Sudan has been removed from the list of countries with WPV1. Results of additional molecular and genetic testing by the Global Polio Specialized Laboratory at the US Centers for Disease Control and Prevention (CDC) have revealed that an initial instance of simultaneous handling of test specimens from a number of countries in the Horn of Africa resulted in the unintended contamination of the South Sudan specimens with WPV1.
:: The Independent Monitoring Board (IMB) for polio eradication, following its 1-3 October meeting, has published its IMB report to the Polio Oversight Board. For the full report in English, please click here [see excerpt above]

Pakistan
:: Seven new WPV1 cases were reported in the past week. Four were reported from Federally Administered Tribal Areas (FATA) and one from Khyber Pakhtunkhwa (KP), Punjab and Sindh respectively.
:: The total number of WPV1 cases for Pakistan in 2013 is now 53. The most recent WPV1 case had onset of paralysis on 5 October (from Khyber Agency, FATA). The majority of WPV1 cases in Pakistan this year, 38 (72%), are from FATA, of which 16 are from Khyber Agency and 15 from North Waziristan.
:: One new cVDPV2 case was reported in the past week. The total number of cVDPV2 cases for Pakistan is now 30. The most recent cVDPV2 case had onset of paralysis 26 September (from North Waziristan).
:: The situation in North Waziristan is dire. It is the area with the largest number of children being paralyzed by poliovirus in all of Asia (15 WP1 and 23 cVDPV2 cases). It is in an area where immunization activities have been suspended by local leaders since June 2012. It is critical that children in these areas are vaccinated and protected from poliovirus. Immunizations in neighboring high-risk areas are being intensified, to further boost population immunity levels in those areas and prevent further spread of this outbreak.

Horn of Africa
:: In Ethiopia, one new WPV1 case was reported from the Somali region in the past week.
:: In Somalia, six new WPV1 cases were reported this week (two from Bay region and one from Bakool, Lower Juba, Middle Juba, and Lower Shabelle regions respectively).
:: The total number of WPV cases (all WPV1) for 2013 in the Horn of Africa is now 201 (180 from Somalia, 14 from Kenya and seven from Ethiopia). The most recent WPV1 case in the region had onset of paralysis on 30 September (from Lower Shabelle, Somalia)

Syrian Arab Republic
:: Following reports of a cluster of 22 acute flaccid paralysis (AFP) cases on 17 October 2013 in the Syrian Arab Republic, wild poliovirus type 1 (WPV1) has been isolated from ten of the cases under investigation. Final genetic sequencing results are pending. Wild poliovirus was last reported in Syria in 1999.
:: A comprehensive outbreak response is currently underway. Supplementary immunization activities commenced in Syria on 24 October. The main aim is to rapidly reach children in the immediately-affected and high-risk areas, followed by wider scale immunization campaigns.
:: In further response to the Syria outbreak, multiple large-scale SIAs targeting 22 million children over the next 6 months (starting from early November) are being planned across the region (including Lebanon, Jordan, Turkey, Egypt, Iraq and occupied Palestinian territory (West Bank and Gaza).

.
WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html
Polio in the Syrian Arab Republic
29 October 2013 – Following reports of a cluster of 22 acute flaccid paralysis (AFP) cases on 17 October 2013 in the Syrian Arab Republic, wild poliovirus type 1 (WPV1) has been isolated from ten of the cases under investigation. Final genetic sequencing results are pending to determine the origin of the isolated viruses. Wild poliovirus had not been detected in the Syrian Arab Republic since 1999.

Most of the cases are very young (below two years of age), and were un- or under-immunized. Estimated immunization rates in the Syrian Arab Republic declined from 91 percent in 2010 to 68 percent in 2012.

Even before this laboratory confirmation, health authorities in the Syrian Arab Republic and neighbouring countries had begun the planning and implementation of a comprehensive outbreak response. On 24 October 2013, an already-planned large-scale supplementary immunization activity (SIA) was launched in the Syrian Arab Republic to vaccinate 1.6 million children against polio, measles, mumps and rubella, in both government-controlled and contested areas.

Implementation of an SIA in Deir Al Zour province commenced promptly when the first ‘hot cases’ were reported. Larger-scale outbreak response across the Syrian Arab Republic and neighbouring countries is anticipated to begin in early November 2013, to last for at least six to eight months depending on the area and based on evolving epidemiology.

Given the current situation in the Syrian Arab Republic, frequent population movements across the region and subnational immunity gaps in key areas, the risk of further international spread of wild poliovirus type 1 across the region is considered to be high. A surveillance alert has been issued for the region to actively search for additional potential 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_10_29/en/index.html

The Weekly Epidemiological Record (WER) for 1 November 2013, vol. 88, 44/45 (pp. 477–488) includes:
:: Meeting of the WHO expert working group on surveillance of influenza antiviral susceptibility, Geneva, July 2013
:: Global routine vaccination coverage, 2012
:: WHO advisory committee on immunization and vaccine related implementation research (IVIR, formerly QUIVER): executive summary report of 7th meeting

http://www.who.int/entity/wer/2013/wer8844_45.pdf

WHO: Immunization coverage
Fact sheet N°378
Updated November 2013

Excerpt
Key facts:
:: Immunization prevents illness, disability and death from vaccine-preventable diseases including diphtheria, measles, pertussis, pneumonia, polio, rotavirus diarrhoea, rubella and tetanus.

:: Global vaccination coverage is holding steady.

:: Immunization currently averts an estimated 2 to 3 million deaths every year.

:: But an estimated 22.6 million infants worldwide are still missing out on basic vaccines.

http://www.who.int/mediacentre/factsheets/fs378/en/index.html

WHO: Expert consultation on the use of placebos in vaccine trials.
November 2013
ISBN 978 92 4 150625 0 (NLM classification: QW 805)

The Expert Consultation on the Use of Placebos in Vaccine Trials was convened by the World Health Organization (WHO) in Annecy, France on 17–18 January 2013 under the overall guidance of Rüdiger Krech, WHO Director of the Department of Ethics and Social Determinants, and Marie-Paule Kieny, Assistant Director-General, Health Systems and Innovation.

Excerpt
Conclusion
The use of placebos in a vaccine clinical trial when there is already an effective or partially effective vaccine raises challenging ethical questions. National and international documents on research involving human subjects have set forth valuable guidelines on the circumstances in which use of placebos is ethically acceptable in a randomized controlled trial. However, none of these documents specifically addresses the use of placebos in vaccine trials. The purpose of the expert consultation described in this report was to address the ethical ambiguity in this area and formulate concrete and practical guidance for action. The critical need to develop new and improved vaccines, especially for use in LMICs that bear the heaviest disease burden, provided the impetus for this consultation and the resulting recommendations.

This report presents a typology of cases in which the use of placebos in vaccine clinical trials may be justified, and offers procedural and substantive recommendations to help trial sponsors and researchers, policy-makers, RECs, and other stakeholders evaluate proposed trial designs. The report specifies five situations in which placebos may be ethically acceptable even in the presence of an efficacious vaccine. In these situations, it is recommended that there be ongoing consultation between trial sponsors and host country actors, thorough assessment of and communication about risks, and consideration of alternative trial designs.

Researchers should consider whether risks associated with the use of placebos can be adequately mitigated, and research protocols should explain the scientific necessity and social and public health value of a placebo design. Researchers should also undertake activities to mitigate risks related to the use of placebos. Additionally, the post-trial availability of the vaccine in the trial country should be carefully examined.

This document is not intended to suggest a definitive course of action for all vaccine trials when an effective or partially effective vaccine already exists. Rather, the recommendations set forth here are designed to provide an analytic framework to aid decision-making. Participants at the expert consultation agreed that the ultimate judgement about the use of placebos in these cases will depend on the specifics of the trial vaccine and the circumstances of the country in which the trial will be conducted. A careful weighing of numerous considerations by stakeholders will therefore be required. The overarching goal of these recommendations is two-fold: to assure that participants in vaccine clinical trials are protected from unjustifiable risks, and to facilitate the conduct of beneficial and urgently needed vaccine research. WHO encourages ongoing discussion of these issues and welcomes feedback on the guidance provided here.

UNICEF: Ethical Research Involving Children
Online Resource, November 2013
This on-line resource “brings together the best thinking internationally about key ethical issues involving children and how these might be addressed in different research contexts…The point of the Ethical Research Involving Children Project is to help ensure that the human dignity of children is honoured and that their rights and well-being are respected in all research, irrespective of context.”

The new resources include:
:: An International Charter for Ethical Research Involving Children;
:: A Compendium on ethical issues and challenges, including a collection of over 20 case studies as well as structured questions to guide ethical research involving children (called ‘Getting Started’);
:: A website www.childethics.com specifically designed to provide a rich repository of evidence-based information, resources and links to journal articles to guide and improve research involving children and to provide a platform for further critical reflection and dialogue.

Nearly 400 members of the international research and NGO communities have contributed to this project that has developed a range of resources to provide clear guidance on ethical issues and concerns that can be applied in multiple research contexts.

To view the project www.childethics.com
http://www.unicef.org/media/media_70778.html

American Journal of Infection Control
Vol 41 | No. 11 | November 2013 | Pages 949-114
http://www.ajicjournal.org/current
Immunizing health care workers against influenza: A glimpse into the challenges with voluntary programs and considerations for mandatory policies
Susan Quach, MSc, Jennifer A. Pereira, PhD, Jeffrey C. Kwong, MD, MSc, Sherman Quan, MSc
Lois Crowe, BA, Maryse Guay, MD, Julie A. Bettinger, PhD, MPH
Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Program Delivery and Evaluation Theme Group
http://www.ajicjournal.org/article/S0196-6553%2813%2900941-3/abstract

Abstract
Background
Vaccination of health care workers (HCWs) is an important patient safety initiative. It prevents influenza infection among patients and reduces staff illness and absenteeism. Despite these benefits, HCW influenza immunization uptake is low. Therefore, strategies to achieve high immunization coverage in HCWs, barriers to uptake, and perceptions of mandatory influenza immunization policies were discussed in key informant interviews with influenza immunization program planners.

Methods
We conducted telephone interviews with 23 influenza immunization program planners from 21 organizations (7 acute care hospitals, 6 continuing care facilities, and 8 public health organizations) across Canada. We used content analysis to identify themes from the interviews.

Results
Participants used a variety of promotional and educational activities, and many vaccine delivery approaches, to support HCW immunization programs. Barriers to achieving high coverage in HCWs included misconceptions about the safety and effectiveness of the influenza vaccine, negative personal experiences associated with the vaccine, and antivaccine sentiments. Participants mentioned mandatory influenza immunizations as a solution to low coverage. However, they identified challenges with this approach such as obtaining support from stakeholders, enforcement, and limiting personal autonomy.

Conclusion
Participants believed immunization coverage in health care organizations will continue to be suboptimal using existing program strategies. Although participants discussed mandatory immunization as a way to improve uptake, potential obstacles will need to be addressed for this to be implemented successfully.

BMC Public Health
(Accessed 2 November 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article
Cost-effectiveness and cost utility analysis of three pneumococcal conjugate vaccines in children of Peru
Jorge Alberto Gomez, Juan Carlos Tirado, Aldo Amador Navarro Rojas, Maria Mercedes Castrejon Alba and Oleksandr Topachevskyi
http://www.biomedcentral.com/1471-2458/13/1025/abstract

Abstract (provisional)
Background
The clinical and economic burden associated with invasive and non-invasive pneumococcal and non-typeable Haemophilus influenzae (NTHi) diseases is substantial in the Latin America and Caribbean region, where pneumococcal vaccines have only been introduced to a few countries. This study analyzed the cost-effectiveness and cost utility of three different pneumococcal conjugate vaccines (PCVs) for Peru.

Methods
A Markov model that simulated the disease processes in a birth cohort over a lifetime, within 1,128 month cycles was used to evaluate the cost-effectiveness of 10-valent pneumococcal NTHi protein D conjugate vaccine (PHiD-CV) and 7- and 13-valent PCVs (PCV-7 and PCV-13). Expected quality-adjusted life years (QALYs), cost-savings and incremental cost-effectiveness ratios (ICERs) were calculated.

Results
Without vaccination, pneumonia was associated with the greatest health economic burden (90% of QALYs lost and 63% of lifetime direct medical costs); while acute otitis media (AOM) was responsible for 1% of QALYs lost and 25% of direct medical costs. All vaccines were predicted to be cost-effective for Peru, with PHiD-CV being most cost-effective. PHiD-CV was predicted to generate 50 more QALYs gained and required a reduced investment (-US$ 3.4 million) versus PCV-13 (discounted data), and was therefore dominant and cost saving. The probabilistic sensitivity analysis showed that PHiD-CV generated more QALYs gained at a reduced cost than PCV-13 in 84% of the simulations and less QALYs gains at a reduced cost in 16%. Additional scenarios using different assumptions on vaccine efficacies based on previous evidence were explored, but no significant change in the overall cost-effective results were observed.

Conclusions
The results of this modeling study predict that PCVs are likely to be a cost-effective strategy to help relieve the epidemiological and economic burden associated with pediatric pneumococcal and NTHi diseases for Peru. PHiD-CV is likely to be a dominant (better health gains at a reduced net cost) intervention compared to PCV-13 or PCV-7. The most significant drivers for these results are the better health and economic profile of PHiD-CV against AOM and its reduced cost per dose available through the PAHO Revolving Fund in the LAC region.

Emerging Infectious Diseases
Volume 19, Number 11—November 2013
http://www.cdc.gov/ncidod/EID/index.htm

Research
Mobile Phone–based Syndromic Surveillance System, Papua New Guinea
Alexander Rosewell, Berry Ropa, Heather Randall, Rosheila Dagina, Samuel Hurim, Sibauk Bieb, Siddhartha Datta, Sundar Ramamurthy, Glen Mola, Anthony B. Zwi, Pradeep Ray, and C. Raina MacIntyre
http://wwwnc.cdc.gov/eid/article/19/11/12-1843_article.htm

Abstract
The health care system in Papua New Guinea is fragile, and surveillance systems infrequently meet international standards. To strengthen outbreak identification, health authorities piloted a mobile phone–based syndromic surveillance system and used established frameworks to evaluate whether the system was meeting objectives. Stakeholder experience was investigated by using standardized questionnaires and focus groups. Nine sites reported data that included 7 outbreaks and 92 cases of acute watery diarrhea. The new system was more timely (2.4 vs. 84 days), complete (70% vs. 40%), and sensitive (95% vs. 26%) than existing systems. The system was simple, stable, useful, and acceptable; however, feedback and subnational involvement were weak. A simple syndromic surveillance system implemented in a fragile state enabled more timely, complete, and sensitive data reporting for disease risk assessment. Feedback and provincial involvement require improvement. Use of mobile phone technology might improve the timeliness and efficiency of public health surveillance.

Eurosurveillance
Volume 18, Issue 44, 31 October 201
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Research articles
Dramatic change in public attitudes towards vaccination during the 2009 influenza A(H1N1) pandemic in France
P Peretti-Water ^1,2,3, P Verger^1,2,3, J Raude^4,2, A Constant^2,1, A Gautier⁵, C Jestin⁵, F Beck^5,6
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20623

Abstract
We investigated the potential impact of the 2009 influenza A(H1N1) pandemic on attitudes towards vaccination among people aged 18 to 75 years and living in metropolitan France. We used data from three national telephone surveys conducted on representative samples in 2000, 2005 and 2010 (n=12,256, n=23,931, n=8,573 respectively). In France, unfavourable attitudes towards vaccination in general dramatically increased from 8.5% in 2000 and 9.6% in 2005 to 38.2% in 2010. In 2010, among respondents who held unfavourable attitudes towards vaccination, 50% mentioned specifically their opposition to the influenza A(H1N1) vaccine. The sociodemographic profile associated with these attitudes also changed greatly. In particular, unfavourable attitudes towards vaccination in general became significantly more frequent among less educated people in 2010. These attitudes were also correlated with vaccination behaviours. For example, parents who were unfavourable towards vaccination in general were more likely to report that they had at least one child who did not get the measles-mumps-rubella vaccine. As this shift in attitude may have a significant impact on future vaccination coverage, health authorities should urgently address the vaccine confidence gap.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
November 2013  Volume 9, Issue 11
http://www.landesbioscience.com/journals/vaccines/toc/volume/9/issue/11/

A critical review of cost-effectiveness analyses of vaccinating males against human papillomavirus
Yiling Jiang, Aline Gauthier, Maarten J Postma, Laureen Ribassin-Majed, Nathalie Largeron, Xavier Bresse*
https://www.landesbioscience.com/journals/vaccines/article/25754/

Abstract
A critical review of cost-effectiveness analyses of HPV vaccination in males was conducted and nine studies were identified in different countries. Due to the heterogeneity among these studies in terms of modeling approach, vaccination strategies, health outcomes considered, assumptions and parameters, limited conclusions can be drawn with regard to the absolute cost-effectiveness. Nevertheless, key drivers were identified. More favorable cost-effectiveness appeared when all HPV-related diseases outcomes were considered, a suboptimal vaccine coverage among girls and/or lower vaccine prices were assumed. There was a general lack of transparency to fully describe the details of the methodological approach of modeling and calibration. Further research should be conducted to generate robust evidence-based data sets (HPV-related diseases epidemiology, costs and quality of life). The best modeling practice for HPV vaccination and how to better capture the true economic value of vaccination beyond cost-effectiveness in a broader policy context need to be investigated.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
November 2013  Volume 9, Issue 11
http://www.landesbioscience.com/journals/vaccines/toc/volume/9/issue/11/

Overcoming perceptions of financial barriers to rotavirus vaccine introduction in Asia
E Anthony S Nelson*, Ciro A de Quadros, Mathuram Santosham, Umesh D Parashar, Duncan Steele
https://www.landesbioscience.com/journals/vaccines/article/26107/

Abstract
Despite a WHO recommendation in 2009, reaffirmed in 2013, that all countries should consider introducing rotavirus vaccines into their National Immunization Programs, as of June 2013 only 45 have done so. One major consideration appears to have been the costs of the vaccine to countries. Of concern, is that Asian countries have been slow to introduce rotavirus vaccines despite having robust data that could inform the decision-making process. Although decisions on new vaccine introduction are very complex and vary by country and region, economic evaluations are often pivotal once vaccine efficacy and safety has been established, and disease burden documented and communicated. Unfortunately, with private sector list prices of vaccines often used in economic evaluations, rather than a potential public health sector pricing structure, policy-makers may defer decisions on rotavirus vaccine introduction based on the belief that “the vaccine price is too high,” even though this might be based on erroneous data. The Pan American Health Organization’s Revolving Fund provides one example of how vaccine price can be made more competitive and transparent through a regional tendering process. Other mechanisms, such as tiered pricing and UNICEF procurement, also exist that could help Asian and other countries move forward more quickly with rotavirus vaccine introduction.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
November 2013  Volume 9, Issue 11
http://www.landesbioscience.com/journals/vaccines/toc/volume/9/issue/11/

Social media microblogs as an HPV vaccination forum
Chupei Zhang*, Marientina Gotsis, Maryalice Jordan-Marsh
https://www.landesbioscience.com/journals/vaccines/article/25599/

Abstract
The 2006 US FDA approval of the human papillomavirus (HPV) vaccine brought new hope for cancer prevention. Gardasil and Cervarix are widely available vaccines that can deter HPV infection, which causes 70% of cervical cancer. Acceptance of vaccination varies due to a lack of HPV awareness and HPV vaccine knowledge. Recent observations of the Chinese microblog “SinaWeibo” suggest a new approach to engage health professionals and consumer website bloggers. Websites that present the latest fashion, fitness or beauty news and ways to obtain “deals” have created informative blogs or online communities that appeal to female users. Some users raise health questions of their peers. Health professionals, as website bloggers, can introduce vaccine news or respond to conversations between bloggers and their followers. By transforming medical vocabulary into ordinary chat, microblogs may promote efficiency in vaccine education and communication. A web-based, interactive social media-microblog could offer an ideal platform to speed up information dissemination and increase targeted communication.

The Lancet  
Nov 02, 2013   Volume 382  Number 9903  p1459 – 1534
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Equity in child survival
The Lancet

Preview |
Efforts to meet Millennium Development Goal 4 (MDG 4)—a two-thirds reduction in child mortality by 2015—have led to a substantial decrease in deaths of children younger than 5 years. However, not all children have benefited equally from these gains. Furthermore, despite many country successes, the world as a whole remains off-track in meeting this goal. A growing consensus exists that fresh approaches will be needed in the years up to the MDG deadline and beyond to accelerate progress. A new report from Save the Children—Lives on the Line: An Agenda for Ending Preventable Deaths—highlights how countries need to shift their strategies based on the current child mortality landscape.

The Pediatric Infectious Disease Journal
November 2013 – Volume 32 – Issue 11  pp: 1159-1302,e414-e42
http://journals.lww.com/pidj/pages/currenttoc.aspx
Effectiveness of Pneumococcal Conjugate Vaccine in Infants by Maternal Influenza Vaccination Status
van Santen, Katharina L.; Bednarczyk, Robert A.; Adjaye-Gbewonyo, Dzifa; M

Abstract
Background:  Influenza virus infection can predispose patients to secondary pneumococcal infections. Children are at greatest risk for pneumococcal infection in the first year of life and are not considered fully protected by pneumococcal conjugate vaccine (PCV) until their third dose at 6 months of age. Infants less than 6 months cannot receive influenza vaccination, though maternal influenza vaccination can protect infants.

Methods:  We conducted a retrospective cohort study of 9807 mother–infant pairs enrolled in a managed care organization for infants born June 1, 2002, to December 31, 2009. Exposure was assessed for receipt of infant PCV only and the combination of PCV and maternal influenza vaccine (trivalent inactivated vaccine). Outcomes of interest were acute otitis media and medically attended acute respiratory infection in the first year of life. We estimated the adjusted incidence of illness, incidence rate ratios and vaccine effectiveness using the ratio of incidence rate ratios between the periods of noncirculating influenza and that of at least local influenza circulation.

Results:  For medically attended acute respiratory infection, vaccine effectiveness for the combination of trivalent inactivated vaccine and PCV was 39.6% (95% confidence interval [CI]: 31.6%–46.7%) and for PCV only was 29.8% (95% CI: 11.4%–44.3%). For acute otitis media, vaccine effectiveness for the combination of trivalent inactivated vaccine and PCV was 47.9% (95% CI: 42%–53.3%) and for PCV only was 37.6% (95% CI: 23.1%–49.4%).

Conclusion:  In infants, the combination of maternal influenza vaccine and infant pneumococcal conjugate vaccination confers greater protection from acute otitis media infections and medically attended acute respiratory infections than does PCV alone.

The Pediatric Infectious Disease Journal
November 2013 – Volume 32 – Issue 11  pp: 1159-1302,e414-e42
http://journals.lww.com/pidj/pages/currenttoc.aspx

Comparing Haemophilus influenzae Type b Conjugate Vaccine Schedules: A Systematic Review and Meta-analysis of Vaccine Trials
Low, Nicola; Redmond, Shelagh M.; Rutjes, Anne W. S.; MoreAbstract
Background:  The optimal schedule and the need for a booster dose are unclear for Haemophilus influenzae type b (Hib) conjugate vaccines. We systematically reviewed relative effects of Hib vaccine schedules.Methods:  We searched 21 databases to May 2010 or June 2012 and selected randomized controlled trials or quasi-randomized controlled trials that compared different Hib schedules (3 primary doses with no booster dose [3p+0], 3p+1 and 2p+1) or different intervals in primary schedules and between primary and booster schedules. Outcomes were clinical efficacy, nasopharyngeal carriage and immunological response. Results were combined in random-effects meta-analysis.Results:  Twenty trials from 15 countries were included; 16 used vaccines conjugated to tetanus toxoid (polyribosylribitol phosphate conjugated to tetanus toxoid). No trials assessed clinical or carriage outcomes. Twenty trials examined immunological outcomes and found few relevant differences. Comparing polyribosylribitol phosphate conjugated to tetanus toxoid 3p+0 with 2p+0, there was no difference in seropositivity at the 1.0 μg/mL threshold by 6 months after the last primary dose (combined risk difference −0.02; 95% confidence interval: −0.10, 0.06). Only small differences were seen between schedules starting at different ages, with different intervals between primary doses, or with different intervals between primary and booster doses. Individuals receiving a booster were more likely to be seropositive than those at the same age who did not.Conclusions:  There is no clear evidence from trials that any 2p+1, 3p+0 or 3p+1 schedule of Hib conjugate vaccine is likely to provide better protection against Hib disease than other schedules. Until more data become available, scheduling is likely to be determined by epidemiological and programmatic considerations in individual settings.

Pediatrics
November 2013, VOLUME 132 / ISSUE 5
http://pediatrics.aappublications.org/current.shtml

Article
Measles in Children Vaccinated With 2 Doses of MMR
Fannie Defay, MSca, Gaston De Serres, MD, PhDa,b,c, Danuta M. Skowronski, MD, FRCPCd, Nicole Boulianne, RN, MSca,b, Manale Ouakki, MScb, Monique Landry, MDe, Nicholas Brousseau, MD, FRCPCf, and Brian J. Ward, MD, FRCPCg
http://pediatrics.aappublications.org/content/132/5/e1126.abstract

Abstract
OBJECTIVE: A previous measles outbreak investigation in a high school in Quebec, Canada identified 2-dose vaccine effectiveness of 94%. The risk of measles in 2-dose recipients was significantly higher (2–4 times) when measles vaccine was first administered at 12 versus ≥15 months of age, with no significant effect of the age at second dose. Generalizability of this association was also assessed in the expanded provincial data set of notified cases.

METHODS: This matched case–control study included only 2-dose recipients. All confirmed (laboratory or epidemiologically linked) cases in patients aged 5 to 17 years were included. Each case was matched to 5 controls.

RESULTS: A total of 102 cases and 510 controls were included; 89% of cases were in patients 13 to 17 years old. When the first dose was administered at 12 to 13 months compared with ≥15 months of age, the risk of measles in participants outside the outbreak school was 6 times higher (95% confidence interval, 1.33–29.3) and was 5.2 times higher (95% confidence interval, 1.91–14.3) in the pooled estimate (participants from the outbreak school + outside that school).

CONCLUSIONS: A significantly greater risk of measles among 2-dose recipients whose first dose was given at 12 to 13 months rather than ≥15 months of age is confirmed in the larger Quebec data set. The mechanism remains unknown, but vaccine failures in 2-dose recipients could have substantial implications for measles elimination efforts through 2-dose vaccination. The optimal age at first dose may warrant additional evaluation.

Pediatrics
November 2013, VOLUME 132 / ISSUE 5
http://pediatrics.aappublications.org/current.shtml

Article
Impact of a Routine Two-Dose Varicella Vaccination Program on Varicella Epidemiology
Stephanie R. Bialek, MD, MPHa, Dana Perella, MPHb, John Zhang, PhDa, Laurene Mascola, MD, MPHc, Kendra Viner, PhD, MPHb, Christina Jackson, MPHc, Adriana S. Lopez, MHSa, Barbara Watson, MB, ChB, FRCP, FAAPb, and Rachel Civen, MD, MPHc

Abstract
OBJECTIVE: One-dose varicella vaccination for children was introduced in the United States in 1995. In 2006, a second dose was recommended to further decrease varicella disease and outbreaks. We describe the impact of the 2-dose vaccination program on varicella incidence, severity, and outbreaks in 2 varicella active surveillance areas.

METHODS: We examined varicella incidence rates and disease characteristics in Antelope Valley (AV), CA, and West Philadelphia, PA, and varicella outbreak characteristics in AV during 1995–2010.

RESULTS: In 2010, varicella incidence was 0.3 cases per 1000 population in AV and 0.1 cases per 1000 population in West Philadelphia: 76% and 67% declines, respectively, since 2006 and 98% declines in both sites since 1995; incidence declined in all age groups during 2006–2010. From 2006–2010, 61.7% of case patients in both surveillance areas had been vaccinated with 1 dose of varicella vaccine and 7.5% with 2 doses. Most vaccinated case patients had <50 lesions with no statistically significant differences among 1- and 2-dose cases (62.8% and 70.3%, respectively). Varicella-related hospitalizations during 2006–2010 declined >40% compared with 2002–2005 and >85% compared with 1995–1998. Twelve varicella outbreaks occurred in AV during 2007–2010, compared with 47 during 2003–2006 and 236 during 1995–1998 (P < .01).

CONCLUSIONS: Varicella incidence, hospitalizations, and outbreaks in 2 active surveillance areas declined substantially during the first 5 years of the 2-dose varicella vaccination program. Declines in incidence across all ages, including infants who are not eligible for varicella vaccination, and adults, in whom vaccination levels are low, provide evidence of the benefit of high levels of immunity in the population.

PLoS One
[Accessed 2 November 2013]
http://www.plosone.org/

Research Article
Political and Institutional Influences on the Use of Evidence in Public Health Policy. A Systematic Review
Marc Liverani a, Benjamin Hawkins, Justin O. Parkhurst
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0077404

<iAbstract
Background
There is increasing recognition that the development of evidence-informed health policy is not only a technical problem of knowledge exchange or translation, but also a political challenge. Yet, while political scientists have long considered the nature of political systems, the role of institutional structures, and the political contestation of policy issues as central to understanding policy decisions, these issues remain largely unexplored by scholars of evidence-informed policy making.

Methods
We conducted a systematic review of empirical studies that examined the influence of key features of political systems and institutional mechanisms on evidence use, and contextual factors that may contribute to the politicisation of health evidence. Eligible studies were identified through searches of seven health and social sciences databases, websites of relevant organisations, the British Library database, and manual searches of academic journals. Relevant findings were extracted using a uniform data extraction tool and synthesised by narrative review.

Findings
56 studies were selected for inclusion. Relevant political and institutional aspects affecting the use of health evidence included the level of state centralisation and democratisation, the influence of external donors and organisations, the organisation and function of bureaucracies, and the framing of evidence in relation to social norms and values. However, our understanding of such influences remains piecemeal given the limited number of empirical analyses on this subject, the paucity of comparative works, and the limited consideration of political and institutional theory in these studies.

Conclusions
This review highlights the need for a more explicit engagement with the political and institutional factors affecting the use of health evidence in decision-making. A more nuanced understanding of evidence use in health policy making requires both additional empirical studies of evidence use, and an engagement with theories and approaches beyond the current remit of public health or knowledge utilisation studies.

PLoS Medicine
(Accessed 2 November 2013)
http://www.plosmedicine.org/

Guidelines and Guidance
Complexity in Mathematical Models of Public Health Policies: A Guide for Consumers of Models
Sanjay Basu, Jason Andrews
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001540

Summary Points
:: Mathematical models are increasingly used to inform public health policy, but a major dilemma faced by readers is how to evaluate the quality of models.
:: All models require simplifying assumptions, and there are tradeoffs between creating models that are more “realistic” versus those that are grounded in more well-characterized data on the behavior of disease processes.
:: Complex models are not necessarily more accurate or reliable simply because they can more easily fit real-world data than simpler models; complex models can suffer parameter estimation problems that can be difficult to detect and often cannot be fixed by “calibrating” models to external data. Conversely, complexity can be important to include when uncertain factors are central to a disease process or research question.
:: In many cases, alternative model structures can appear reasonable for the same policy problem. Sensitivity analyses not only around parameter values but also using alternative model structures can help determine which factors are particularly important to disease outcomes of interest. Explicit methods are now available to transparently and objectively compare different model structures.

PLoS Neglected Tropical Diseases
October 2013
http://www.plosntds.org/article/browseIssue.action

Research Article
First Outbreak Response Using an Oral Cholera Vaccine in Africa: Vaccine Coverage, Acceptability and Surveillance of Adverse Events, Guinea, 2012

Francisco J. Luquero, Lise Grout, Iza Ciglenecki, Keita Sakoba, Bala Traore, Melat Heile, Alpha Amadou Dialo, Christian Itama, , icaela Serafini, Dominique Legros, Rebecca F. Grais
Abstract
Background
Despite World Health Organization (WHO) prequalification of two safe and effective oral cholera vaccines (OCV), concerns about the acceptability, potential diversion of resources, cost and feasibility of implementing timely campaigns has discouraged their use. In 2012, the Ministry of Health of Guinea, with the support of Médecins Sans Frontières organized the first mass vaccination campaign using a two-dose OCV (Shanchol) as an additional control measure to respond to the on-going nationwide epidemic. Overall, 316,250 vaccines were delivered. Here, we present the results of vaccination coverage, acceptability and surveillance of adverse events.

Methodology/Principal Findings
We performed a cross-sectional cluster survey and implemented adverse event surveillance. The study population included individuals older than 12 months, eligible for vaccination, and residing in the areas targeted for vaccination (Forécariah and Boffa, Guinea). Data sources were household interviews with verification by vaccination card and notifications of adverse events from surveillance at vaccination posts and health centres. In total 5,248 people were included in the survey, 3,993 in Boffa and 1,255 in Forécariah. Overall, 89.4% [95%CI:86.4–91.8%] and 87.7% [95%CI:84.2–90.6%] were vaccinated during the first round and 79.8% [95%CI:75.6–83.4%] and 82.9% [95%CI:76.6–87.7%] during the second round in Boffa and Forécariah respectively. The two dose vaccine coverage (including card and oral reporting) was 75.8% [95%CI: 71.2–75.9%] in Boffa and 75.9% [95%CI: 69.8–80.9%] in Forécariah respectively. Vaccination coverage was higher in children. The main reason for non-vaccination was absence. No severe adverse events were notified.

Conclusions/Significance
The well-accepted mass vaccination campaign reached high coverage in a remote area with a mobile population. Although OCV should not be foreseen as the long-term solution for global cholera control, they should be integrated as an additional tool into the response.

Vaccine
Volume 31, Issue 48, Pages 5623-5784 (19 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Vaccine effects and impact of vaccination programmes in post-licensure studies
Review Article
Pages 5634-5642
Germaine Hanquet, Marta Valenciano, François Simondon, Alain Moren

Abstract
Once a vaccine is licensed and introduced in the population, post-licensure studies are required to measure vaccine effectiveness and impact of vaccination programmes on the population at large. However, confusion still prevails around these concepts, making it difficult to discern which effects are measured in such studies and how their findings should be interpreted. We review from the public health evaluation perspective the effects of vaccine-related exposures, describe the methods used to measure them and their assumptions.

We distinguish effects due to exposure to individual vaccination from those due to exposure to a vaccination programme, as the latter depends on vaccine coverage, other population factors and includes indirect effects as well. Vaccine (direct) effectiveness is estimated by comparing vaccinated and unvaccinated individuals exposed to the same vaccination programme. The impact of a vaccination programme, defined here as the population prevented fraction when exposure is the programme, is measured by comparing populations with and without a vaccination programme, most commonly the same population before and after vaccination. These designs are based on a number of assumptions for valid inference. In particular, they assume that vaccinees and non-vaccinees do not differ in terms of susceptibility and exposure to the disease or in ascertainment of vaccination and disease status. In pre and post-vaccination design, the population is assumed to have similar baseline transmission, case detection and reporting, risk factors and medical practices in both periods.

These principles are frequently violated in post-licensure studies. Potential confounding and biases must be minimized in study design and analyses, or taken into account during result interpretation. It is also essential to define which exposure is evaluated (individual vaccination or vaccination programme) and which effect is measured. This may help decision-makers clarify which type of study is needed and how to interpret the results.

Vaccine
Volume 31, Issue 47, Pages 5495-5622 (12 November 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/47

Geographic variation in human papillomavirus vaccination uptake among young adult women in the United States during 2008–2010
Pages 5495-5499
Mahbubur Rahman, Tabassum H. Laz, Abbey B. Berenson

Abstract
Very little is known about geographic variation in human papillomavirus (HPV) vaccine uptake among young adult women in the US. To investigate this, we analyzed data from 12 US states collected through the Behavioral Risk Factor Surveillance System between 2008 and 2010. Among 2632 young adult women (18–26 years old) who responded to HPV vaccine uptake questions, weighted vaccine initiation and completion rates were: 28.0% and 17.0% overall, 14.0% and 6.6% in the South, 28.7% and 19.3% in the Midwest/West, and 37.2% and 23.1% in the Northeast (P < 0.001), respectively. Log-binomial regression analysis showed that women living in the South were less likely to initiate (adjusted prevalence ratio (aPR) 0.71, 95% confidence interval (CI) 0.60–0.83) or complete (aPR 0.61, 95% CI, 0.53–0.71) the HPV vaccine series compared to women living in the Northeast. Interventions programs to improve HPV vaccine uptake in the Southern states are warranted.

Vaccine
Volume 31, Issue 47, Pages 5495-5622 (12 November 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/47

Human papillomavirus (HPV), HPV-associated oropharyngeal cancer, and HPV vaccine in the United States—Do we need a broader vaccine policy?
Review Article
Pages 5500-5505
N. Osazuwa-Peters
Abstract
Background
Human papillomavirus (HPV) is a sexually transmitted infection (STI) of global importance; it is the most prevalent STI in the United States, with strains causally linked to oropharyngeal and other cancers. Efforts to prevent HPV have been made to varying degrees by policies implemented by different state governments; however, HPV and associated oropharyngeal cancer continue to show increasing incidence rates in the US.

Design
A narrative review based on search on SciVerse, PubMed/Medline, Google Scholar, and EMBASE databases, as well as literature/documents from the World Health Organization, Centers for Disease Control and Prevention, American Cancer Society, National Conference of State legislatures, and the U.S. Department of Health and Human Services relevant to HPV and HPV vaccine policy in the US.

Results
Vaccination has proved to be a successful policy in the US, and an extant recommendation aimed at preventing HPV and associated cervical and other anogenital cancers is the routine use of HPV vaccines for males and females. However, HPV vaccines are presently not recommended for preventing oropharyngeal cancer, although they have been shown to be highly effective against the HPV strains that are most commonly found in the oropharynx. And while there is a history of successful vaccine mandate in the US with resulting decrease in occurrence of infectious diseases, implementing HPV vaccine mandate has proved to be very unpopular.

Conclusions
With emerging evidence of the efficacy of the use of the HPV vaccine in preventing oral-HPV, more focus should be put on extending HPV vaccine to present oral HPV infection and oropharyngeal cancer. Also, implementing a broader HPV vaccine policy that include mandating HPV vaccines as a school-entry requirement for both sexes may increase vaccine use in the US for the greater good of the public.

Vaccine
Volume 31, Issue 47, Pages 5495-5622 (12 November 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/47

Well-woman visit of mothers and human papillomavirus vaccine intent and uptake among their 9–17 year old children
Original Research Article
Pages 5544-5548
Mahbubur Rahman, Lee B. Elam, Michael I. Balat, Abbey B. Berenson
Abstract
Objective
To examine the association between attending a well-woman clinic in the prior 2 years and obtaining the human papillomavirus (HPV) vaccine for their 9–17-year-old child.

Methods
Women (n = 1256) who attended reproductive health clinics during September 2011 to February 2013 and had ≥1 children 9–17 years of age were asked to complete a self-administered questionnaire containing questions on demographic characteristics, prior well-woman visits, HPV awareness, and HPV vaccine intent and uptake among their adolescent children.

Results
Nearly 78% of women reported having undergone a well-woman visit during the past 2 years. Bivariate analysis showed that the HPV vaccine initiation (23.9% vs. 14.0%, P = .004) and completion (13.6% vs. 6.7%, P = .011) among 9–17 daughters differed between mothers who did or did not have a well-woman visit during the past 2 years. However, intent to vaccinate them (47.2% vs. 53.3%, P = .173) did not differ between these two groups. With regard to 9–17 year old sons, vaccine initiation (10.1% vs. 9.6%, P = .871), completion (4.6% vs. 2.4%, P = .273) and intent to vaccinate (47.3% vs. 52.1%, P = .311) did not differ between these two groups. Multivariable logistic regression analyses confirmed the findings of these bivariate analyses after adjusting for confounder variables.

Conclusion
The well-woman visit may be a missed opportunity for physicians to educate their patients about the benefits of HPV vaccination for their adolescent children in general and sons in particular. Intervention studies are warranted to assess the benefits of using this setting to improve HPV vaccine uptake in the US.

Vaccine
Volume 31, Issue 47, Pages 5495-5622 (12 November 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/47

Template protocol for clinical trials investigating vaccines—Focus on safety elements
Original Research Article
Pages 5602-5620
Jan Bonhoeffer, Egeruan B. Imoukhuede, Grace Aldrovandi, Novilia S. Bachtiar, Eng-Soon Chan, Soju Chang, Robert T. Chen, Rohini Fernandopulle, Karen L. Goldenthal, James D. Heffelfinger, Shah Hossain, Indira Jevaji, Ali Khamesipour, Sonali Kochhar, Mamodikoe Makhene, Elissa Malkin, David Nalin, Rebecca Prevots, Ranjan Ramasamy, Sarah Sellers, et al.

Abstract
This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I–IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts.

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

Association between health care workers’ knowledge of influenza vaccine and vaccine uptake
O Jaiyeoba, M Villers, DE Soper, J Korte, CD Salgado – American Journal of Infection …, 2013

Methods Vaccination was voluntary at our institution prior to 2010 and resulted in compliance rates ranging from 40% to 60%. Our institution adopted a policy for the 2010-2011 season and beyond that stated all employees who refused vaccine were required to …

Immunosignatures can predict vaccine efficacy
JB Legutki, SA Johnston – Proceedings of the National Academy of Sciences, 2013
Abstract The development of new vaccines would be greatly facilitated by having effective methods to predict vaccine performance. Such methods could also be helpful in monitoring individual vaccine responses to existing vaccines. We have developed “ …

Health disparities in human papillomavirus vaccine coverage: Trends analysis from NIS-Teen, 2008-2011
RA Bednarczyk, EA Curran, WA Orenstein, SB Omer – Clinical Infectious Diseases, 2013
Abstract Adolescent uptake of human papillomavirus (HPV) vaccine remains low. We evaluated HPV vaccine uptake patterns over 2008-2011 by race/ethnicity, poverty status, and the combination of race/ethnicity and poverty status, utilizing National Immunization …

[HTML] A Phase I Randomized Clinical Trial of Candidate Human Immunodeficiency Virus type 1 Vaccine MVA. HIVA Administered to Gambian Infants
MO Afolabi, J Ndure, A Drammeh, F Darboe… – PLOS ONE, 2013
Background A vaccine to decrease transmission of human immunodeficiency virus type 1 (HIV-1) during breast-feeding would complement efforts to eliminate infant HIV-1 infection by antiretroviral therapy. Relative to adults, infants have distinct immune development, …

A systems framework for vaccine design
M Mooney, S McWeeney, G Canderan, RP Sékaly – Current Opinion in Immunology, 2013
Numerous challenges have been identified in vaccine development, including variable efficacy as a function of population demographics and a lack of characterization and mechanistic understanding of immune correlates of protection able to guide delivery and …

Special Focus Newsletters
RotaFlash
November 1, 2013
PATH
http://vad.createsend1.com/t/ViewEmail/r/471294C4D2E5E67D2540EF23F30FEDED/E38B11B8894CC5F5DBC23BD704D2542D
Lead story
Burkina Faso takes on burden of diarrhea and pneumonia together
Dual vaccine launch follows success of MenAfriVac® introduction

A Non-State Centric Governance Framework for Global Health – Barcelona Institute for Global Health
A Global Social Contract for a Healthy Global Society: Why, What and How – Barcelona Institute for Global Health

The Huffington Post
http://www.huffingtonpost.com/
Accessed 2 November 2013

Is All Well in the World of Vaccination? We Think a Booster Is Desperately Needed
Huffington Post US | 31 October 2013
Dr. Manica Balasegaram, Executive director of MSF’s Access Campaign

Excerpt
“…Through its medical humanitarian work, Doctors Without Borders/Médecins Sans Frontières (MSF) has been delivering vaccines both in deadly disease outbreaks and through routine vaccination in our clinics for decades, often in places grappling with war and violence. A wake-up call about the fact that life-saving vaccines are not getting to children in some of the hardest-to-reach places, happened in the past several years when we began responding to repeated, massive outbreaks of measles. MSF vaccinated more than four million people in the Democratic Republic of Congo in 2010 alone.

Increasingly, we feel compelled to speak out about what we believe needs to change in the immunization world, both to make our work more effective and to decrease the number of children who miss out on the benefits of vaccines. As GAVI concludes its ‘mid-term review’ meeting — where it reflected on its accomplishments over the last few years and looked ahead to how it will position itself in the future — we think it’s a good time to suggest several short- and long-term changes that could help reach more of the children who are missing out on life-saving vaccination. GAVI now has a real opportunity to change certain policies, push for easier-to-use products, and negotiate lower prices for vaccines…

Vaccines and Global Health: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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– Email Summary: Vaccines and Global health : The Week in Review is published as a single email summary, scheduled for release each Saturday eveningbefore midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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– pdf version: A pdf of the current issues is available here: Vaccines and Global Health_The Week in Review_26 Oct 2013
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– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

World Polio Day – 24 October 2013
“Events worldwide mark World Polio Day, as efforts to eradicate the disease intensify”
http://www.polioeradication.org/tabid/488/iid/327/Default.aspx

Special World Polio Day event:
World Polio Day: Making History, a special Livestream (24 October, 22.30hrs GMT) event presented by Rotary and Northwestern University’s Center for Global Health with speakers including Dr. Bruce Aylward, WHO Assistant Director-General for polio, emergencies and country collaboration, and Dr. Robert Murphy, Director of the Center for Global Health at Northwestern University Feinberg School of Medicine

http://www.polioeradication.org/tabid/488/iid/327/Default.aspx#sthash.TWMBKG6S.dpuf

Update: Polio this week – As of 23 October 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s extract and bolded text]
:: In Syria, reports of suspected polio cases have emerged. A cluster of hot cases is currently being investigated, and has prompted planning for a comprehensive outbreak response across the region. See ‘Syrian Arab Republic’ section below for more.
:: One wild poliovirus type 1 (WPV1) case has been confirmed in Cameroon. This is the first WPV in the country since 2009. WPV1 was isolated from an acute flaccid paralysis (AFP) case from Ouest province, with onset of paralysis on 1 October 2013. Genetic sequencing is on-going to determine origin of the isolated virus. See ‘Chad, Cameroon and Central African Republic’ section for more
Afghanistan
:: One new WPV1 case was reported in the past week. The total number of WPV cases for 2013 is now eight (all WPV1), all of which were reported from Eastern Region, close to the Pakistan border. The most recent WPV1 case had onset of paralysis on 19 September, from Kunar province.
Pakistan
:: Three new WPV1 cases were reported in the past week. All were reported from Federally Administered Tribal Areas (FATA – two from FR Bannu and one from North Waziristan). The total number of WPV1 cases for Pakistan in 2013 is now 46. The most recent WPV1 case had onset of paralysis on 1 October (from FR Bannu). The majority of WPV1 cases in Pakistan this year, 34 (74%), are from FATA, of which 14 from Khyber Agency and 14 from North Waziristan.
:: The situation in North Waziristan is becoming increasingly severe, as it is the area with the largest number of children being paralysed by wild poliovirus (14 cases) and cVDPV2s (22) in all of Asia. It is in an area where immunization activities have been suspended by local leaders since June 2012. It is critical that children in these areas are vaccinated and protected from poliovirus. 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.
Chad, Cameroon and Central African Republic
:: In Cameroon, one WPV1 was reported this week from Ouest province. This is the first WPV in Cameroon since 2009 and had onset of paralysis on 1 October 2013.
:: An outbreak response is now being planned. In 2013, five large-scale supplementary immunization activities (SIAs) have already been conducted in Cameroon (in April, May, August, September and October), as the country was considered at high-risk of re-infection due to its proximity with Nigeria. The latest NIDs were conducted 11-13 October.
Syrian Arab Republic
:: See WHO GAR below

WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html
Report of suspected polio cases in the Syrian Arab Republic
26 October 2013 – On 17 October 2013, WHO received reports of a cluster of acute flaccid paralysis (AFP) cases in the Syrian Arab Republic. This cluster of ‘hot’ AFP was detected in early October 2013 in Deir Al Zour province and is currently being investigated. Initial results from the national polio laboratory in Damascus indicate that two of the cases could be positive for polio – final results are awaited from the regional reference laboratory of the Eastern Mediterranean Region of WHO. Wild poliovirus was last reported in Syria in 1999.

The Ministry of Health of the Syrian Arab Republic confirms that it is treating this event as a cluster of ‘hot’ AFP cases, pending final laboratory confirmation, and an urgent response is currently being planned across the country. Syria is considered at high-risk for polio and other vaccine-preventable diseases due to the current situation.

A surveillance alert has been issued for the region to actively search for additional potential cases. Supplementary immunization activities in neighbouring countries are currently being planned.

WHO’s International Travel and Health recommends that all travelers to and from polio-infected areas be fully vaccinated against polio.
http://www.who.int/csr/don/2013_10_19_polio/en/index.html

UNICEF: Millions of children in Syria and region to be vaccinated against polio, measles, mumps and rubella
Major immunisation campaign under way now in Syria
AMMAN, GENEVA, 25 October 2013 – As Syria awaits confirmation of suspected polio cases in the east of the country, UNICEF has joined the World Health Organisation and other partners in mounting a large-scale immunisation effort aimed at protecting as many children as possible both in the country and across the region against polio, as well as other vaccine-preventable diseases.

Inside Syria, a campaign led by the Ministry of Health began on October 24 targeting 2.4 million children with vaccines against polio, measles, mumps and rubella.

Around 500,000 children in Syria have not been vaccinated against polio in the past two years due to insecurity and access constraints. Prior to the conflict, immunisation coverage in Syria was about 95 per cent.

The conflict in Syria has caused immense displacement, with millions of children on the move, either inside the country or across borders into neighbouring countries and beyond. As a result, routine immunisation systems so critical to preventing childhood diseases have been disrupted     or broken down, and children are now at far higher risk of diseases such as polio and measles.

UNICEF is mobilising a huge supply operation to make sure that vaccines are in place across the region, and reaching out to partners across all sectors to help raise community awareness of the importance of vaccinating children.

Multiple, supplemental immunisation campaigns against polio and other vaccine-preventable diseases will take place inside Syria and across the region through the end of the year.

http://www.unicef.org/media/media_70740.html

WHO/Europe: Support for Turkish polio operations from a new field presence in Gaziantep

24 October 2013

Excerpt

As part of the cross-regional response to a suspected poliomyelitis (polio) outbreak in the Syrian Arab Republic, Turkey is scaling up surveillance of suspected cases and vaccination of Syrian citizens under temporary protection in Turkey. A newly established WHO presence in Gaziantep, Turkey, near the border of the Syrian Arab Republic, is serving as an important centre of operations. 24 October is World Polio Day.

Of the 2 million Syrians displaced in neighbouring countries, over 500 000 have found shelter in 21 Turkish camps and private accommodation in 10 provinces. Turkish health authorities plan two rounds of supplementary immunization activities by the end of the year for all children under 5 years of age in selected provinces and for refugee children elsewhere in Turkey. Along with improved surveillance, an active search is being conducted to provide additional doses of vaccine to un- and under immunized resident children nationwide…

http://www.euro.who.int/en/countries/turkey/news/news/2013/10/whoeurope-supports-turkish-polio-operations-from-a-new-field-presence-in-gaziantep

Fear of violence slows polio immunization drive in Kano, Nigeria

IRIN – UN Office for the Coordination of Humanitarian Affairs

Excerpt

KANO, 22 October 2013 (IRIN) – Fear and secrecy have cloaked the roll-out of a polio campaign currently underway in northern Nigeria. Vaccinators are concealing their identities, hiding vaccinations under their veils and visiting some areas only with undercover armed guards, following the February murder by Boko Haram of nine polio workers in the northern city of Kano.
“The [polio] campaign is done under an atmosphere of fear and secrecy, with vaccinators hiding their identity and moving around furtively for fear of being attacked,” a source at the World Health Organization (WHO) office in Kano, who is involved in polio immunization campaigns, told IRIN.
The Ministry of Health temporarily suspended the immunization campaign in March 2013, as vaccinators were too frightened to continue, said Shehu Abdullahi, executive secretary of Kano State’s Primary Healthcare Management Board (PHMB) in charge of polio immunizations. The campaign resumed in April…

…For the current campaign, vaccinator Jamila Ahmad told IRIN: “We conceal the polio kit under our hijab [veil] and move around as if we are going for a wedding or naming ceremony, while the supervisor trails behind us at a safe distance that will not raise any suspicion that he is with us.”
Most door-to-door polio immunizations are performed by women, who can typically access homes unhindered; men would have to seek the consent of male family heads to enter homes – but male supervisors usually form part of the team…

http://www.irinnews.org/report/98977/fear-of-violence-slows-polio-immunization-drive-in-kano

The Global Fund said the Tahir Foundation, based in Indonesia, will invest US$65 million in Global Fund programs. The contribution is being matched by the Bill & Melinda Gates Foundation for a total US$130 million in support. The Tahir Foundation’s contribution is “…by far the largest ever made to the Global Fund by a private foundation in an emerging economy, (and) will support efforts to diagnose, treat, and prevent AIDS, TB and malaria, leading causes of death and disability in Indonesia.

http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-10-21_Tahir_Contributes_USD_65_Million_to_the_Global_Fund/

PATH announced the appointment of Ashley Birkett, PhD as director of its Malaria Vaccine Initiative (MVI), which “drives the development of safe and effective vaccines for the fight against malaria.”  Dr. Birkett is a five-year veteran of MVI, and was most recently the program’s deputy director, serving simultaneously as director of research and development (R&D)—the latter a position he has held since joining PATH in 2008. Dr. David C. Kaslow, vice president of product development at PATH, said, “Since 2008, Ashley has contributed significantly to every major R&D initiative at MVI.  His technical expertise, tireless passion, and indomitable leadership make him the ideal person to lead MVI in the exciting journey that lies ahead for malaria vaccine development. I am also pleased that PATH can attract and grow top talent and is able to promote such talent from within the organization.”

http://www.prnewswire.com/news-releases/path-malaria-vaccine-initiative-names-new-director-228791311.html

The Weekly Epidemiological Record (WER) for 25 October 2013, vol. 88, 43 (pp. 465–476) includes:
:: Progress towards poliomyelitis eradication: Afghanistan, January 2012–August 2013
:: Estimating meningitis hospitalization rates for sentinel hospitals conducting surveillance of invasive bacterial vaccine-preventable diseases

http://www.who.int/entity/wer/2013/wer8813.pdf

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

:: Human infection with avian influenza A(H7N9) virus – update 24 October 2013
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – update 24 October 2013

:: Cholera in Mexico – 26 October 2013
26 October 2013 – The Ministry of Health in Mexico has reported 171 confirmed cases, including one death, of infection with Vibrio cholerae O1 Ogawa toxigenic between 9 September to 18 October 2013.

In the second week of September 2013, Mexico was affected simultaneously by a hurricane and tropical storm which caused heavy rains, floods, landslides and internal displacement of populations, thus increasing the risk of diarrhoeal diseases.

Of the 171 confirmed cases, two are from the Federal District, 157 cases from the state of Hidalgo, nine from the state of Mexico, one from the state of San Luis Potosi and two from the state of Veracruz.

Eighty-six of the total confirmed cases are women and 85 are men with ages ranging from three months to 88 years old. Of these, thirty-nine cases were hospitalised…

…This is the first local transmission of cholera recorded since the 1991-2001 cholera epidemic in Mexico. The genetic profile of the bacterium obtained from patients in Mexico presents high similarity (95 percent) with the strain that is currently circulating in three Caribbean countries (Haiti, Dominican Republic and Cuba), and is different from the strain that had been circulating in Mexico during 1991-2001 epidemic.

WHO does not recommend that any travel or trade restrictions be applied to Mexico with respect to this event.

WHO: Strategic Advisory Group of Experts (SAGE) on Immunization
The next SAGE meeting will take place n Geneva on 5-7 November 2013.
Draft agenda (as of 17 October 2013)
Selected Agenda Topics (excerpt):
:: Global polio eradication initiative – Session 4
For decision:
–       Optimal schedule for 1 IPV dose
–       Strategic framework for responding to type 2 virus detection post-OPV2 cessation
–       Recommendation for a WHA resolution in 2014 on accelerated IPV introduction, based on the progress toward a global supply and financing strategy

For discussion:
–       Strategy to ensure bOPV access to all OPV-using countries

:: Decade of Vaccines – Global Vaccine Action Plan (GVAP) Monitoring – Session 5
For Decision
SAGE will be expected to produce an independent first report on progress with the Decade of Vaccines Global Vaccine Action Plan.
Specifically, SAGE will be asked to:
– Review the DoV WG “Assessment report on DoV progress” based on:
– the review of the “annual report on the Decade of Vaccines progress” prepared by the DOV secretariat,
– Information provided by other partners’ annual reports on Decade of Vaccines progress.

– Make recommendations on any necessary changes to the formulation of the indicators, operational definitions and/or the processes for data collection.

– Identify successes, challenges and areas where additional efforts or corrective actions by countries, regions, partners, donor agencies or other parties, are needed.

– Provide recommendations and corrective actions for Members States, regions, partners, donor agencies or other parties regarding DoV GVAP implementation in a “SAGE Assessment report on the Decade of Vaccines progress” which will be the basis of the “progress report” for the WHO Board and World Health Assembly.

:: Measles and rubella elimination – Session 7
For discussion:
–       Global status report
–       Report from each Region
–       How to get back on track towards global and Regional targets

For decision:
–        Use of combined measles-rubella vaccine for both routine doses
–        Criteria to guide countries on expansion of the target age range measles and measles-rubella SIAs

For decision:
–        Vaccination of health workers

.
:: Smallpox vaccines – Session 8

For decision
:: The last case of Smallpox occurred in 1977. In 1980 the World Health Assembly declared this disease eradicated. A global stockpile of vaccines, held in Switzerland, was created with donations from Member States.

:: In 2004 Previous the Ad-Hoc Orthopoxvirus Committee, recommended that the stockpile should consist 200 million doses. The current physical WHO stockpile is ~ 2.4 million doses, and the virtual stockpile consists of 31 million doses.

:: In order for WHO to make an informed decision (risk-benefit) on which vaccines to stock and to be able to give advice to countries on their stockpile, WHO would like SAGE to answer the following questions:
–  Which vaccine should be recommended to be used during an outbreak of smallpox? (vaccine used during the eradication, vaccine produced in tissue cell, or further attenuated vaccines).
– Composition of stockpile
–Size of stockpile

–       What groups should be prioritized to be vaccinated while faced with limited vaccine supply?
–Age groups, risk factors/safety aspects, vulnerable populations, ethical considerations

–Which vaccine should be given?

–       Which vaccine should be recommended for preventive use?

–       Who should be targeted and with which immunization schedule? (First aid responders, army, police, health workers)

WHO: Global tuberculosis report 2013
http://www.who.int/entity/tb/publications/global_report/en/index.html
–       Gains in tuberculosis control at risk due to 3 million missed patients and drug resistance
–       Progress in TB control can be substantially accelerated by addressing these challenges

Excerpt from media release
…The new data confirm that the world is on track to meet the 2015 UN Millennium Development Goals (MDGs) target of reversing TB incidence, along with the target of a 50% reduction in the mortality rate by 2015 (compared to 1990). A special “Countdown to 2015” supplement to this year’s report provides full information on the progress to the international TB targets. It details if the world and countries with a high burden of TB are “on-track” or “off-track” and what can be done rapidly to accelerate impact as the 2015 deadline approaches.

Key challenges
The report underlines the need for a quantum leap in TB care and control which can only be achieved if two major challenges are addressed.
–       Missing 3 million – around three million people (equal to one in three people falling ill with TB) are currently being ‘missed’ by health systems.
–       Drug-resistant TB crisis – the response to test and treat all those affected by multidrug-resistant TB (MDR-TB) is inadequate.

Insufficient resources for TB are at the heart of both challenges. TB programmes do not have the capacity to find and care for people who are “hard-to-reach”, often outside the formal or state health system. Weak links in the TB chain (a chain that includes detection, treatment and care) lead to such people being missed…

…Five priority actions
The WHO report recommends five priority actions that could make a rapid difference between now and 2015.
–       Reach the 3 million TB cases missed in national notification systems by expanding access to quality testing and care services across all relevant public, private or community based providers, including hospitals and NGOs which serve large proportions of populations at risk.
–       Address with urgency the MDR-TB crisis. Failure to test and treat all those ill with MDR-TB carries public health risks and grave consequences for those affected. High-level political commitment, ownership by all stakeholders, adequate financing and increased cooperation are needed to solve bottlenecks in drug supply and build capacity to deliver quality care.
–       Intensify and build on TB-HIV successes to get as close as possible to full antiretroviral therapy (ART) coverage for people co-infected with TB and HIV.
–       Increase domestic and international financing to close the resource gaps – now estimated at about US$ 2 billion per year – for an effective response to TB in low- and middle-income countries. Full replenishment of the Global Fund is essential, given that most low-income countries rely heavily on international donor funding, with the Global Fund providing around 75% of financial resources in these countries.
–       Accelerate rapid uptake of new tools – through technology transfer and operational research to ensure that countries and communities most at risk benefit from these innovations.

http://www.who.int/mediacentre/news/releases/2013/tuberculosis-report-2013/en/index.html

British Medical Journal
26 October 2013 (Vol 347, Issue 7930)
http://www.bmj.com/content/347/7930

Editorial
Safety of the quadrivalent human papillomavirus vaccine
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5631 (Published 9 October 2013
Now well established
The prophylactic human papillomavirus (HPV) vaccines are remarkable both for their efficacy against HPV infection and related diseases,1 and for their potential to prevent cervical cancer. Cervical cancer, which is caused by persistent infection with oncogenic HPV types, remains a cause of premature death in women around the world, most of whom have no access to secondary prevention through organised cervical screening programmes.2 The linked study by Arnheim-Dahlström and colleagues (doi:10.1136/bmj.f5906) provides a timely and important contribution to the evidence base on the safety of the quadrivalent HPV vaccine,3 which prevents HPV infection and disease due to the oncogenic types HPV-16 and HPV-18 and types HPV-6 and HPV-11, which cause genital warts.

This population based cohort analysis provides strong evidence that autoimmune conditions, neurological diseases, and thromboembolic disease are not triggered by quadrivalent HPV vaccination. Serious sudden onset conditions such as these, which are largely of undetermined cause, are sometimes falsely attributed to vaccination when population based vaccination programmes are implemented.4 It is crucial that surveillance systems can rule out false associations and identify rare but real …
http://www.bmj.com/content/347/bmj.f5631

Research
Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study
Lisen Arnheim-Dahlström, associate professor1, Björn Pasternak, postdoctoral fellow2, Henrik Svanström, statistician2, Pär Sparén, professor1, Anders Hviid, senior investigator2
http://www.bmj.com/content/347/bmj.f5906

Abstract
Objective
To assess the risk of serious adverse events after vaccination of adolescent girls with quadrivalent human papillomavirus (qHPV) vaccine.

Design
Register based cohort study.

Setting
Denmark and Sweden, October 2006 to December 2010.

Participants
997,585 girls aged 10-17, among whom 296,826 received a total of 696,420 qHPV vaccine doses.

Main outcome measures
Incident hospital diagnosed autoimmune, neurological, and venous thromboembolic events (53 different outcomes) up to 180 days after each qHPV vaccine dose. Only events with at least five vaccine exposed cases were considered for further assessment. Rate ratios adjusted for age, country, calendar year, and parental country of birth, education, and socioeconomic status were estimated, comparing vaccinated and unvaccinated person time. For outcomes where the rate ratio was significantly increased, we regarded three criteria as signal strengthening: analysis based on 20 or more vaccine exposed cases (reliability), rate ratio 3.0 or more (strength), and significantly increased rate ratio in country specific analyses (consistency). We additionally assessed clustering of events in time and estimated rate ratios for a risk period that started on day 181.

Results
Among the 53 outcomes, at least five vaccine exposed cases occurred in 29 and these were analysed further. Whereas the rate ratios for 20 of 23 autoimmune events were not significantly increased, exposure to qHPV vaccine was significantly associated with Behcet’s syndrome, Raynaud’s disease, and type 1 diabetes. Each of these three outcomes fulfilled only one of three predefined signal strengthening criteria. Furthermore, the pattern of distribution in time after vaccination was random for all three and the rate ratios for these outcomes in the period from day 181 after vaccination were similar to the rate ratios in the primary risk period. The rate ratios for five neurological events were not significantly increased and there were inverse associations with epilepsy (rate ratio 0.66, 95% confidence interval 0.54 to 0.80) and paralysis (0.56, 0.35 to 0.90). There was no association between exposure to qHPV vaccine and venous thromboembolism (0.86, 0.55 to 1.36).

Conclusions

This large cohort study found no evidence supporting associations between exposure to qHPV vaccine and autoimmune, neurological, and venous thromboembolic adverse events. Although associations for three autoimmune events were initially observed, on further assessment these were weak and not temporally related to vaccine exposure. Furthermore, the findings need to be interpreted considering the multiple outcomes assessments

Developing World Bioethics
August 2013  Volume 13, Issue 2  Pages ii–iii, 57–104
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2013.13.issue-2/issuetoc

Special Issue: Anti-retrovirals for treatment and prevention – new ethical challenges
[Six articles]

ARTICLE
Ethical Tradeoffs in Trial Design: Case Study of an HPV Vaccine Trial in HIV-Infected Adolescent Girls in Lower Income Settings
J.C. Lindsey, S.K. Shah, G.K. Siberry, P. Jean-Philippe, M.J. Levin
http://onlinelibrary.wiley.com/doi/10.1111/dewb.12028/abstract

Abstract
The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria.

Eurosurveillance
Volume 18, Issue 43, 24 October 2013
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Surveillance and outbreak reports
Study of a measles outbreak in Granada with preventive measures applied by the courts, Spain, 2010 to 2011
by E Navarro, MM Mochón, MD Galicia, I Marín, J Laguna

Abstract
Measles had practically been eliminated in Granada since the systematic vaccination of children with two doses introduced in 1984. However, in 2009 the disease returned in the form of small outbreaks. This study describes the measles outbreak that occurred in Granada from October 2010 to August 2011 and the measures imposed to control it. Information was sourced from the records of the Andalusian epidemiological surveillance system. A total of 308 cases were recorded, representing an incidence rate of 33.6 cases per 100,000 inhabitants. The first wave of the epidemic took place in Granada city, with the majority of cases occurring among families who lived in the Albaycín neighbourhood and were opposed to vaccination for ideological and/or religious reasons. The initial cases were in unvaccinated children  aged 1 to13 years. The outbreak later spread throughout the province. To control the outbreak, the vaccination schedule for the exposed children was brought up to date. The Regional Ministry of Health decided to take legal action in order to ensure vaccination of those in the initial nucleus of the outbreak.

JAMA   
October 23/30, 2013, Vol 310, No. 16
http://jama.jamanetwork.com/issue.aspx

Editorial | October 23/30, 2013
Influenza Vaccination in 2013-2014 – Achieving 100% Participation
Kathleen M. Neuzil, MD, MPH1

Excerpt http://jama.jamanetwork.com/article.aspx?articleid=1758725
Every year, the public and health care system experience clinical and financial consequences of influenza epidemics. Influenza infection leads to hospitalizations, deaths, excess medication usage, and days missed from work and school. Influenza is a preventable disease, and advisory bodies in the United States recommend influenza vaccine for everyone 6 months and older, with particular emphasis on the need to vaccinate young children, older adults, and persons of all ages with high-risk conditions, including cardiovascular disease.1 In 2013, an unprecedented number of influenza vaccines are available in the US market, including quadrivalent vaccines, live, attenuated vaccines, high-dose vaccines, and vaccines manufactured in cell culture.1      Comparative trials in certain pediatric age groups have shown the relative benefits of live, attenuated influenza vaccine and as yet unlicensed adjuvanted vaccines.2,3 Likewise, studies evaluating the comparative benefits of high-dose vs standard-dose influenza vaccines in older adults are nearing completion.4…

JAMA   
October 23/30, 2013, Vol 310, No. 16
http://jama.jamanetwork.com/issue.aspx

Original Investigation | October 23/30, 2013
Association Between Influenza Vaccination and Cardiovascular Outcomes in High-Risk PatientsA Meta-analysis
Jacob A. Udell, MD, MPH, FRCPC1; Rami Zawi, MD2; Deepak L. Bhatt, MD, MPH3,4; Maryam Keshtkar-Jahromi, MD, MPH5,6; Fiona Gaughran, MD7,8; Arintaya Phrommintikul, MD9; Andrzej Ciszewski, MD10; Hossein Vakili, MD11; Elaine B. Hoffman, PhD4; Michael E. Farkouh, MD, MSc, FRCPC12; Christopher P. Cannon, MD4

Abstract http://jama.jamanetwork.com/article.aspx?articleid=1758749
Importance.  Among nontraditional cardiovascular risk factors, recent influenza-like infection is associated with fatal and nonfatal atherothrombotic events.

Objectives.  To determine if influenza vaccination is associated with prevention of cardiovascular events.

Data Sources and Study Selection. A systematic review and meta-analysis of MEDLINE (1946-August 2013), EMBASE (1947-August 2013), and the Cochrane Library Central Register of Controlled Trials (inception-August 2013) for randomized clinical trials (RCTs) comparing influenza vaccine vs placebo or control in patients at high risk of cardiovascular disease, reporting cardiovascular outcomes either as efficacy or safety events.

Data Extraction and Synthesis.   Two investigators extracted data independently on trial design, baseline characteristics, outcomes, and safety events from published manuscripts and unpublished supplemental data. High-quality studies were considered those that described an appropriate method of randomization, allocation concealment, blinding, and completeness of follow-up.

Main Outcomes and Measures  Random-effects Mantel-Haenszel risk ratios (RRs) and 95% CIs were derived for composite cardiovascular events, cardiovascular mortality, all-cause mortality, and individual cardiovascular events. Analyses were stratified by subgroups of patients with and without a history of acute coronary syndrome (ACS) within 1 year of randomization.

Results  Five published and 1 unpublished randomized clinical trials of 6735 patients (mean age, 67 years; 51.3% women; 36.2% with a cardiac history; mean follow-up time, 7.9 months) were included. Influenza vaccine was associated with a lower risk of composite cardiovascular events (2.9% vs 4.7%; RR, 0.64 [95% CI, 0.48-0.86], P = .003) in published trials. A treatment interaction was detected between patients with (RR, 0.45 [95% CI, 0.32-0.63]) and without (RR, 0.94 [95% CI, 0.55-1.61]) recent ACS (P for interaction = .02). Results were similar with the addition of unpublished data.

Conclusions and Relevance  In a meta-analysis of RCTs, the use of influenza vaccine was associated with a lower risk of major adverse cardiovascular events. The greatest treatment effect was seen among the highest-risk patients with more active coronary disease. A large, adequately powered, multicenter trial is warranted to address these findings and assess individual cardiovascular end points.

Journal of Pediatrics
Vol 163 | No. 5 | November 2013 | Pages 1235-1536
http://www.jpeds.com/current

Tdap vaccination during pregnancy—no signal of safety concerns for infants
Sarah S. Long, MD
Abstract  http://www.jpeds.com/article/S0022-3476%2813%2901106-2/preview
Taking advantage of a robust electronic medical record system at Intermountain Healthcare facilities in Utah, Shakib et al performed a retrospective cohort study assessing pregnancy, birth, and infancy outcomes for 138 women who were given tetanus and reduced-content diphtheria toxoids and reduced-content acellular pertussis vaccine (Tdap) compared with 552 randomly selected nonvaccinated pregnant women controls. The study, ending in 2009, was performed before routine recommendation for Tdap administration during pregnancy. The most common reason for Tdap was prophylaxis for open wounds or during acute care visits for trauma. Of pregnant women receiving Tdap, 63% received the vaccine during the first trimester.

Tetanus, Diphtheria, Acellular Pertussis Vaccine during Pregnancy: Pregnancy and Infant Health Outcomes
Julie H. Shakib, DO, MS, MPH, Kent Korgenski, MS, MT, Xiaoming Sheng, PhD, Michael W. Varner, MD, Andrew T. Pavia, MD, Carrie L. Byington, MD

Abstract  http://www.jpeds.com/article/S0022-3476%2813%2900734-8/abstract
Objective
To assess pregnancy and birth outcomes in infants born to women who did or did not receive tetanus, diphtheria, acellular pertussis (Tdap) vaccine during pregnancy.

Study design
Retrospective cohort. Pregnant women 12-45 years of age who received Tdap at Intermountain Healthcare facilities and their infants were identified and compared with mother-infant pairs without documented Tdap from May 2005 through August 2009. Primary measures included pregnancy outcomes and infant health outcomes at birth through 12 months.

Results
From 162 448 pregnancies we identified 138 women (0.08%) with documented Tdap administration during pregnancy (cases); 552 pregnant women without documented Tdap were randomly selected as controls. Of 138 immunized women, 63% received Tdap in the first trimester and 37% after. Tdap was given most commonly as wound prophylaxis. The incidence of spontaneous or elective abortion was no greater in Tdap cases than in controls. There were no significant differences in preterm delivery, gestational age, or birth weight between groups. One or more congenital anomaly was identified in 3.7% (95% CI 1.2%-8.5%) of case infants and 4.4% (95% CI 2.7%-6.5%) of control infants (P = .749). In infants born to women receiving Tdap during pregnancy, 3.6% (0.8%-10.2%) had International Classification of Diseases, Ninth Revision, Clinical Modification diagnoses consistent with complex chronic conditions within 12 months compared with 10.4% (95% CI 7.2%-14.4%) of infants of controls (P = .054).

Conclusions
Documented Tdap administration during pregnancy was uncommon and occurred most often in the first trimester as prophylaxis following trauma. No increase in adverse outcomes was identified in infants born to women receiving Tdap compared with infants of controls.

The Lancet  
Oct 26, 2013  Volume 382  Number 9902  p1381 – 1458
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Polio eradication: where are we now?
The Lancet
[Full Text] http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962196-0/fulltext

On Oct 17, WHO received reports of a cluster of acute cases of flaccid paralysis in Syria. Initial results showed two suspected cases of poliomyelitis, indicating the first apparent outbreak of polio in 14 years in the country. Syria is now considered at high risk for polio and other vaccine-preventable diseases, and this suspected outbreak raises the alarm that the country’s health crisis has deepened further. With the appalling conflict in Syria continuing to damage the health system infrastructure needed for polio eradication, as well as other health services, this new suspected outbreak is a reminder that political determinants of health underscore the success or failure of eliminating this disease once and for all.

Beyond Syria, polio campaigns in Pakistan have been damaged by repeated violent attacks and killings of polio workers, lack of public confidence in vaccines because of the false characterisation of vaccination as a plot to sterilise Muslims, and publicly boycotted polio immunisation by the Taliban. Worryingly, the situation in North Waziristan Federally Administered Tribal Areas—where polio vaccines are strictly blocked—is becoming increasingly severe, with the largest number of children being paralysed by poliomyelitis in all of Asia.    Compared with this time last year, Pakistan has made little progress with almost identical numbers of polio cases. Clearly, attacks on health workers are unacceptable, and those who engage in them must face prosecution. Furthermore, the reasons why the general community might be suspicious of vaccination should be addressed. While health education is an important part of promoting vaccine uptake, the mistrust of authority that fuels anti-vaccination conspiracy theories must also be examined. The latest sociological and psychological research as to how and why people come to hold such beliefs, as well as the specific cultural milieu in which vaccination programmes operate, should be taken into consideration.

Poliomyelitis also re-emerged in the Horn of Africa this May, with 174 cases in Somalia, 14 in Kenya, six in Ethiopia, and three in South Sudan according to the most recent reports. In Somalia, many polio cases are in areas south of Mogadishu where Al-Shabaab operates. The group refused to admit supplies of polio vaccine and launched a propaganda campaign in areas it controls, spreading falsehoods about the vaccine to scare off parents. Furthermore, Somalia has been so dangerous for health workers that Médecins Sans Frontières pulled out of the country in August of this year, ending an involvement of 22 years.

Continued virus transmission in endemic countries, and the outbreaks of polio in the Horn of Africa and Syria, are pertinent reminders that the most difficult challenges for global polio eradication are the political determinants of health such as weak health systems, public mistrust, political instability, and conflict—rather than medical barriers.

With regard to the technical dimension of ending polio, global eradication efforts led by WHO, UNICEF, and the Rotary Foundation have made remarkable progress. Poliomyelitis cases have been reduced by more than 99% and there are only three remaining polio-endemic countries—Afghanistan, Nigeria, and Pakistan. In 2013, the number of polio cases from the three endemic countries—99 in total—is 40% lower than in 2012. To further strengthen the efforts, the Global Polio Eradication Initiative (GPEI) launched the new Eradication & Endgame Strategic Plan 2013—18 in May, with a detailed budget and a new deadline for polio eradication set for 2018.      The plan has four simultaneous objectives: detection and interruption of wild poliovirus, strengthening of routine immunisation and withdrawal of the oral polio vaccine (OPV), containment of all virus samples and certification of interruption of transmission, and legacy planning to benefit other health and development initiatives. Notably, the most ambitious vaccine introduction plan in history has been initiated, which aims to introduce inactivated polio vaccines (IPV) by the end of 2015 in 124 countries to replace OPV and eliminate the rare risk of vaccine-derived cases of polio. In June of this year, the GAVI board agreed to provide financial support and play a lead role in introduction of IPV.

Technical improvements are insufficient, however, unless the political context, which has been paid little attention, is tackled more seriously. World Polio Day on Oct 24 is a reminder of the importance of global polio eradication. To end poliomyelitis at this stage, strong political will from international partners and governments to address the political determinants of disease eradication more vigorously and urgently is key.

New England Journal of Medicine
October 24, 2013  Vol. 369 No. 17
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Access to Patient-Level Trial Data — A Boon to Drug Developers
Hans-Georg Eichler, M.D., Frank Pétavy, M.Sc., Francesco Pignatti, M.D., and Guido Rasi, M.D.
N Engl J Med 2013; 369:1577-1579October 24, 2013DOI: 10.1056/NEJMp1310771
http://www.nejm.org/doi/full/10.1056/NEJMp1310771

Excerpt
The provision of access to clinical trial results that include patient-level data is generating much debate. A growing chorus of transparency advocates is pushing for open access to these data, making a case on the basis of respect for patients’ altruism, the need to safeguard public health, and distrust in the integrity and completeness of published trial information.1 We at the European Medicines Agency (EMA) have been actively engaged in this debate, and the EMA has recently published a draft of a policy that would make patient-level data in its possession publicly accessible. The principle of privacy protection will inform the EMA’s policy and activities; robust and proportionate measures will be adopted to safeguard patients’ privacy, in compliance with applicable data-protection legislation.2

Pharmaceutical-industry organizations, however, have expressed concern that “one of the risks to innovation is disclosure to competitors of companies’ trade secrets and proprietary information that could allow others to `free ride’ off of the substantial investments of innovators”; they fear “degradation of incentives for companies to invest in biomedical research.”3

Industry leaders have rightly complained about the unsustainability of the current drug development and business model. The timelines and costs of clinical drug development are increasing relentlessly, and the attrition rate of assets in development remains high. At the same time, growing cost pressures in all health care environments are forcing restrictions on drug use, aiming to limit coverage only to patients who can be expected to benefit from a given intervention and for whom that intervention is clearly cost-effective.

Contrary to industry fears, we argue that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry. We predict that it will help to increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors…

Health Law, Ethics, and Human Rights
Preparing for Responsible Sharing of Clinical Trial Data
Michelle M. Mello, J.D., Ph.D., Jeffrey K. Francer, J.D., M.P.P., Marc Wilenzick, J.D., Patricia Teden, M.B.A., Barbara E. Bierer, M.D., and Mark Barnes, J.D., LL.M.
N Engl J Med 2013; 369:1651-1658October 24, 2013DOI: 10.1056/NEJMhle1309073

Excerpt  http://www.nejm.org/doi/full/10.1056/NEJMhle1309073
Data from clinical trials, including participant-level data, are being shared by sponsors and investigators more widely than ever before. Some sponsors have voluntarily offered data to researchers,1,2 some journals now require authors to agree to share the data underlying the studies they publish,3 the Office of Science and Technology Policy has directed federal agencies to expand public access to data from federally funded projects,4 and the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have proposed the expansion of access to data submitted in regulatory applications.5,6 Sharing participant-level data may bring exciting benefits for scientific research and public health but may also have unintended consequences. Thus, expanded data sharing must be pursued thoughtfully.

We provide a suggested framework for broad sharing of participant-level data from clinical trials and related technical documents. After reviewing current data-sharing initiatives, potential benefits and risks, and legal and regulatory implications, we propose potential governing principles and key features for a system of expanded access to participant-level data and evaluate several governance structure…

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X
Progress in the establishment and strengthening of national immunization technical advisory groups: Analysis from the 2013 WHO/UNICEF joint reporting form, data for 2012

Original Research Article
Pages 5314-5320
Philippe Duclos, Laure Dumolard, Nihal Abeysinghe, Alex Adjagba, Cara Bess Janusz, Richard Mihigo, Liudmila Mosina, Yashohiro Takashima, Murat Hakan Öztürk

Abstract
The majority of industrialized and some developing countries have established National Immunization Technical Advisory Groups (NITAGs). To enable systematic global monitoring of the existence and functionality of NITAGs, in 2011, WHO and UNICEF included related questions in the WHO/UNICEF Joint Reporting Form (JRF) that provides an official means to globally collect indicators of immunization program performance. These questions relate to six basic process indicators.

According to the analysis of the 2013 JRF, data for 2012, notable progress was achieved between 2010 and 2012 and by the end of 2012, 99 countries (52%) reported the existence of a NITAG with a formal legislative or administrative basis (with a high of 86% in the Eastern Mediterranean Region – EMR), among the countries that reported data in the NITAG section of the JRF.

There were 63 (33%) countries with a NITAG that met six process indicators (47% increase over the 43 reported in 2010) including a total of 38 developing countries. 11% of low income countries reported a NITAG that meets all six process criteria, versus 29% of middle income countries and 57% of the high income ones. Countries with smaller populations reported the existence of a NITAG that meets all six process criteria less frequently than more populated countries (23% for less populated countries versus 43% for more populated ones).

However, progress needs to be accelerated to reach the Global Vaccine Action Plan (GVAP) target of ensuring all countries have support from a NITAG. The GVAP represents a major opportunity to boost the institutionalization of NITAGs. A special approach needs to be explored to allow small countries to benefit from sub-regional or other countries advisory groups

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Vaccines against diseases transmitted from animals to humans: A one health paradigm
Review Article
Pages 5321-5338
Thomas P. Monath

Abstract
This review focuses on the immunization of animals as a means of preventing human diseases (zoonoses). Three frameworks for the use of vaccines in this context are described, and examples are provided of successes and failures. Framework I vaccines are used for protection of humans and economically valuable animals, where neither plays a role in the transmission cycle. The benefit of collaborations between animal health and human health industries and regulators in developing such products is discussed, and one example (West Nile vaccine) of a single product developed for use in animals and humans is described. Framework II vaccines are indicated for domesticated animals as a means of preventing disease in both animals and humans. The agents of concern are transmitted directly or indirectly (e.g. via arthropod vectors) from animals to humans. A number of examples of the use of Framework II vaccines are provided, e.g. against brucellosis, Escherischia coli O157, rabies, Rift Valley fever, Venezuelan equine encephalitis, and Hendra virus. Framework III vaccines are used to immunize wild animals as a means of preventing transmission of disease agents to humans and domesticated animals. Examples are reservoir-targeted, oral bait rabies, Mycobacterium bovis and Lyme disease vaccines. Given the speed and lost cost of veterinary vaccine development, some interventions based on the immunization of animals could lead to rapid and relatively inexpensive advances in public health. Opportunities for vaccine-based approaches to preventing zoonotic and emerging diseases that integrate veterinary and human medicine (the One Health paradigm) are emphasized.

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Influenza cost and cost-effectiveness studies globally – A review
Review Article
Pages 5339-5348
Samuel K. Peasah, Eduardo Azziz-Baumgartner, Joseph Breese, Martin I. Meltzer, Marc-Alain Widdowson

Abstract
Every year, approximately 10–20% of the world’s population is infected with influenza viruses, resulting in a significant number of outpatient and hospital visits and substantial economic burden both on health care systems and society. With recently updated WHO recommendations on influenza vaccination and broadening vaccine production, policy makers in middle- and low-income countries will need data on the cost of influenza disease and the cost effectiveness of vaccination. We reviewed the published literature to summarize estimates of cost and cost-effectiveness of influenza vaccination. We searched PUBMED (MEDLINE), EMBASE, WEB of KNOWLEDGE, and IGOOGLE using the key words ‘influenza’, ‘economic cost’, ‘cost effectiveness’, and ‘economic burden’. We identified 140 studies which estimated either cost associated with seasonal influenza or cost effectiveness/cost–benefit of influenza vaccination. 118 of these studies were conducted in World Bank-defined high income, 22 in upper-middle income, and no studies in low and lower-middle income countries.

The per capita cost of a case of influenza illness ranged from $30 to $64. 22 studies reported that influenza vaccination was cost-saving; reported cost-effectiveness ratios were $10,000/outcome in 13 studies, $10,000 to $50,000 in 13 studies, and ≥$50,000 in 3 studies. There were no studies from low income countries and few studies among pregnant women. Substantial differences in methodology limited the generalization of results.

Decision makers in lower income countries lack economic data to support influenza vaccine policy decisions, especially of pregnant women. Standardized cost-effectiveness studies of influenza vaccination of WHO-recommended risk groups’ methods are urgently needed.

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Adolescents and vaccines in the western world
Review Article
Pages 5366-5374
Nicola Principi, Susanna Esposito

Abstract
Recent data have shown that the immune protection evoked by vaccines given in the first years of life progressively weakens, and that this is associated with a higher than expected incidence of vaccine-preventable diseases in adolescents and young adults. Furthermore, the greater circulation of pathogens among adolescents and young adults leads to a high risk of infection in unvaccinated or not fully vaccinated younger children. These findings, together with the availability of vaccines specifically developed to prevent infections that typically occur during adolescence, have induced a number of experts to suggest radical changes in the immunisation schedules usually recommended by health authorities. The most important of these relate pertussis, meningococcal and human papillomavirus vaccines but, although they are based on unexceptionable scientific premises, the suggestions have been only slowly and partially received in most countries, even in those in which vaccination programmes are usually adequately implemented and monitored. Adolescence is a particular period of life characterised by changes in intellectual, moral, physical, emotional and psychological development. All of these can have a considerable impact on compliance with immunisation schedules because the approach to any preventive method no longer entirely depends on parents’ and pediatricians’ judgements as in the first years of life but is the consequence of a more complex process involving the adolescents’ thoughts and opinions, their relationships with their parents, friends and physicians, and the information they receive from the mass media. Every effort should be made to overcome the barriers to adolescent immunisation, including those arising from the adolescents themselves.

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Cost-effectiveness of targeted vaccination to protect new-borns against pertussis: Comparing neonatal, maternal, and cocooning vaccination strategies
Original Research Article
Pages 5392-5397
Anna K. Lugnér, Nicoline van der Maas, Michiel van Boven, Frits R. Mooi, Hester E. de Melker

Abstract
Pertussis (whooping cough) is a severe infectious disease in infants less than 6 months old. Mass vaccination programmes have been unable to halt transmission effectively. Strategies to protect new-borns against infection include vaccination of the neonate or the mother directly after birth (cocooning), or the mother during pregnancy (maternal). Here we investigate the cost-effectiveness of these three strategies in the Netherlands. Costs for health care utilization and productivity losses, as well as impact on quality of life were calculated for a 10-year vaccination programme, assuming that vaccine-induced immunity lasts 5 years. Cocooning was the most attractive option from a cost-effectiveness viewpoint (€89,000/QALY). However, both cocooning and maternal vaccination would reduce the disease burden in infants and mothers vaccinated (about 17–20 QALY/year). Specifically, with a persistent epidemic as seen in 2012, there is need for reconsidering the vaccination schedules against pertussis in order to increase protection of the vulnerable new-borns.