Vaccines: The Week in Review 20 February 2012 Center for Vaccine Ethics & Policy (CVEP)

This weekly summary targets news, announcements and events in global vaccines ethics and policy gathered from key governmental, NGO and industry sources, key journals and other sources. This summary supports ongoing initiatives of the Center for Vaccine Ethics & Policy, and is not intended to be exhaustive in its coverage. Vaccines: The Week in Review is also posted in pdf form and as a set of blog posts at http://centerforvaccineethicsandpolicy.wordpress.com/. This blog allows full-text searching of some 2,500 entries.. Comments and suggestions should be directed to David R. Curry, MS Editor and Executive Director Center for Vaccine Ethics & Policy david.r.curry@centerforvaccineethicsandpolicy.org

A pdf of this issue is available here: http://centerforvaccineethicsandpolicy.wordpress.com/

WHO announced consensus from a technical consultation held last week on H5N1 research and will convene additional meetings on the issue. The WHO media release noted that A small group of global public health and influenza experts at a WHO-convened meeting reached consensus on two urgent issues related to the newly created H5N1 influenza viruses: extending the temporary moratorium on research with new laboratorymodified H5N1 viruses and recognition that research on naturally-occurring H5N1 influenza virus must continue in order to protect public health. The group also came to a consensus that delayed publication of the entire manuscripts would have more public health benefit than urgently partially publishing. The announcement noted that broad issues raised, but not limited to, these research studies will be discussed at future meetings convened by WHO soon with participation by a broader range of experts and interested parties relevant to these issues. http://www.who.int/mediacentre/news/releases/2012/h5n1_research_2012021 7/en/index.html WHO Technical consultation on H5N1 research issues - consensus points WHO Headquarters, Geneva 16-17 February 2012 [Full text] Two recent research studies examining some factors affecting transmissibility of influenza A(H5N1) viruses prompted WHO to convene a technical consultation on 1617 February 2012. The participants at this meeting reached consensus on the following points. Recent work discussed at this meeting underscores that influenza A(H5N1) viruses remain an important risk for causing a future pandemic. Therefore, research on these viruses, including on transmissibility and pathogenicity, remains critical to close important gaps in knowledge in order to reduce the danger posed; such research should continue. The PIP Framework, which was

adopted by all WHO Member States in 2011 now provides a global framework for the sharing of influenza viruses with human pandemic potential and the sharing of benefits arising from such sharing. Implementation of this Framework is integral to global pandemic preparedness and response. Future research projects should involve countries from which source material were obtained. The two studies that were conducted to better understand the transmissibility of H5N1 influenza viruses have shown that these viruses have the potential to become more transmissible among mammals. In light of the continuing evolution of H5N1 viruses, the results of these studies provide an important contribution to public health surveillance of H5N1 viruses and to a better understanding of the properties of these viruses. At the same time, these studies have raised important and valid concerns about whether they increase risks to the safety of humans. Concerns which have been raised include the potential misuse of the results or methods as well as potential breaches in biosafety and biosecurity related to pathogens. These concerns highlight how important it is that researchers are aware of such issues, exercise judgement about the conduct of their research, dissemination of the results, and for institutional bodies reviewing such studies to identify and address potential concerns about "dual use". Such safeguards already exist, but continued emphasis should be placed on assuring and reinforcing safety and security. The laboratory-modified H5N1 viruses are currently stored in wellestablished research facilities with high security and high safety (BSL3+). There have been no safety breaches related to the storage of the laboratorymodified H5N1 viruses at these facilities. At the same time, the biosafety and biosecurity conditions under which further research is conducted on the laboratory-modified H5N1 viruses should be fully addressed by relevant authorities. This is a matter of urgency and should be achieved as quickly as possible. In the interim, the laboratory-modified H5N1 viruses should remain in their present locations. In addition, the current moratorium on research to enhance the transmissibility of H5N1 influenza viruses and the further research on the laboratory-modified viruses should continue until the conditions have been determined. Other research on H5N1 viruses should not stop. There is a preference, from a public health perspective, for full disclosure of the information in these papers. However, there are significant social concerns surrounding this research. Two critical issues that must be addressed before publication of the papers are: (1) a focused communications plan to increase public awareness and understanding of the significance of these studies and the rationale for their publication, and (2) a review of the essential biosafety and biosecurity aspects of the newly developed knowledge. Participants discussed the concept of publication of redacted manuscripts with a mechanism for providing the restricted information to legitimate recipients. The group recognized the difficulty of rapidly creating and regulating such a mechanism in light of the complexity of international and national legislation. A consensus was reached that the redaction option is not viable to deal with the two papers under discussion in view of the urgency of

the above mentioned public health needs. The participants noted there may be a need for such a mechanism in the future. Apart from consideration of these two manuscripts, participants acknowledged the existence of broader issues requiring more detailed exploration and advised that these be considered in subsequent consultations involving other stakeholders. http://www.who.int/influenza/human_animal_interface/consensus_points/en/in dex.html [Editors Note: See also additional commentary and analysis form the current issue of Science in Journal Watch below.]

Speech/White Paper: Minister of Foreign Affairs Jonas Gahr Stre Launch of the Norwegian white paper on global health Oslo, 15 February 2012 [Full text of speech outline] The Minister based his presentation on the following points: Friends, Colleagues, Ladies and Gentlemen, Great pleasure for me to present the Governments white paper on global health in the presence of so many distinguished guests. A particularly warm welcome to Margaret Chan, Director General of the World Health Organization (WHO) and to those of you who have travelled a long way to take part in the launch. First ever white paper on global health. One of the purposes of the Norwegian global health policy is to be better at integrating health goals in foreign and development policies and strategies. Understand globalization through the lens of health. The new white paper sets out the direction of Norwegian policy on global health for the years to come. 1. Let me first emphasise Norways long traditions in the area of global health. More than a century ago Norwegian missionaries travelled to many parts of the world. Many of them worked in the field of health. They were later joined by representatives of the labour movement, for example, in Kerala, India, just after the Second World War. A more recent example of Norways commitment to this area, is Dr Gro Harlem Brundtlands leadership of the WHO at the turn of the millennium. We are pleased that she has agreed to give her perspectives at the end of this event. 2. Second, the relevance of the white paper in todays global economy The white paper sets out 3 priority areas: (i) Mobilising for womens and childrens rights and health (ii) Reducing the burden of disease with emphasis on prevention (iii) Promoting human security through health There is a strong link between economic fundamentals and global health. I am therefore happy to see so many leading economists here today, like Professor Bloom, as well as those who have fought for womens rights in general, like Ms Gumbonzvanda.

Most striking change in Norway last century: womens participation in the labour market. I am pleased to launch here today an initiative as a follow-up to the white paper: A project that aims at identifying the economic benefits to be gained from investing in womens health. So far Dr. Margaret Chan (DG WHO) and President Michelle Bachelet (UN Women) have joined the initiative by taking part in the leadership group of the project. From experience we know that it is important to secure the involvement of finance ministers and heads of government on the issue of global health as part of our broader efforts to promote equality and human rights. The initiative will last for 18 months and be led by leading experts in the field. The identification of economic benefits to be gained from investing in womens health will culminate in a Lancet report. Key partners will include Bill and Melinda Gates Foundation, Lancet, the UN, the WHO and the World Bank. Invite all to participate in the initiative. 3. Third, role of global health in national, foreign and development policies No coincidence that Health Minister Anne Grete Strm-Erichsen is on the podium here today. Many of the health challenges we are facing in Norway are global and cannot be addressed by Norway alone. International action is needed. Not primarily a question of development assistance. Also an important area for the Norwegian Ministry of Health as well as a number of other ministries. We will work actively to enhance collaboration across the various ministries. Coherence key. Another close colleague present here today is Erik Solheim. He is here in the capacity of minister of the environment as much as in the capacity as minister of international development. Climate change poses serious threats to peoples health and nutrition, but there are situations where interventions for better health also can have a positive impact on the environment and vice versa. Clean cookstoves and the reduction in emissions of black carbon and methane are examples of this. 4. Fourth, civil society and youth Only partnerships can ensure effective action against the global challenges that characterise our time. New democratising technologies such as mobile phones and social networks have increased the opportunities for civil society to play an active role and hold governments accountable. Pleased we have such an outstanding representative like Ms Gumbonzvanda at our panel today to represent the youth (World YWCA). Innovation requires the involvement of young people. The most revolutionary innovations of our time have been created by college drop-outs like Bill Gates and Mark Zuckerberg. 5. Fifth, role of the WHO Last but not least, I should mention the WHO which is at the core of all our global health efforts.

Like to congratulate Margaret Chan on her nomination for a second term. Will follow with great interest your efforts to address the many challenges we are currently facing during your next five years in office. The white paper emphasises the central role played by the WHO in relation to the global health agenda. I congratulate Margaret Chan on the effectiveness of the WHO in recent years in contributing to many other partnerships, not least the UN SecretaryGenerals initiative in this area Every Woman Every Child. Norway will continue to be a strong ally of the WHO. But a demanding ally. Thank you for your attention. http://www.regjeringen.no/en/dep/ud/aktuelt/taler_artikler/utenriksministeren/ 2012/stmeld_helse.html?id=672633 White Paper Citation Meld. St. 11 (20112012) Melding til Stortinget Global helse i utenriks- og utviklingspolitikken Tilrding fra Utenriksdepartementet 3. februar 2012, godkjent i statsrd samme dag. (Regjeringen Stoltenberg II) Dokumentet i pdf-format (3,7 Mb) [No English version available]

The Weekly Epidemiological Record (WER) for 17 February 2012, vol. 87, 7 (pp 6164) includes: Fifth meeting of National Influenza Centres WHO Western Pacific and South-East Asia Regions http://www.who.int/entity/wer/2012/wer8707.pdf

Twitter Watch [accessed 20 February 03:35] Items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and is by no means intended to be exhaustive. WHO @WHO Transcript from news conference on WHO preliminary consultation on #H5N1 research available here goo.gl/cdCB8 #birdflu 4:10 AM - 19 Feb 12 via web HarvardPublicHealth @HarvardHSPH RT @Harvard: Have efforts to combat bird flu increased the risk to public health? hvrd.me/z2J4kh #fluforum WHO @WHO WHO press release on the preliminary consultation on #H5N1 research goo.gl/Pzt4Y #birdflu 1:05 PM - 17 Feb 12 via web Details

RWJF PublicHealth @RWJF_PubHealth The role of social media in reporting critical health information: bit.ly/z7EAyI #hcsm #dhcx #sm Arthur Caplan @ArthurCaplan Important article on anti-vaccine movemnt slate.me/xT8ju5 Amanda Glassman @glassmanamanda Systematic review of costs and cost-eff of malaria interventions malariajournal.com/content/10/1/3 Dagfinn Hybrten @Hoybraten First White Paper on Global Health from the Norwegian government confirms it's strong commitment to #GAVI regjeringen.no/nb/dep/ud/dok/ Retweeted by GAVI Alliance 8:23 AM - 14 Feb 12 via web Details Health Evidence @HealthEvidence Did you know that the @PHAC_GC 'Parents' Guide to Immunization' is available in 11 languages? goo.gl/m6sqy 9:31 AM - 15 Feb 12 via web Details

Journal Watch Vaccines: The Week in Review continues its weekly scanning of key journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher. If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org Annals of Internal Medicine February 7, 2012; 156 (3) http://www.annals.org/content/current [Reviewed last week] British Medical Bulletin Volume 100 Issue 1 December 2011 http://bmb.oxfordjournals.org/content/current [Reviewed earlier; No relevant content] British Medical Journal

18 February 2012 (Vol 344, Issue 7844) http://www.bmj.com/content/current Editorial Improving the delivery of safe and effective healthcare in low and middle income countries BMJ 2012; 344 doi: 10.1136/bmj.e981 (Published 14 February 2012) Cite this as: BMJ 2012;344:e981 Extract Research is needed into creating workable systems that can deliver and sustain interventions Many resource constrained countries are unlikely to attain their millennium development goal targets by 2015,1 despite major global efforts and much progress (figure).2 3 For example, only 23 countries are currently estimated to be on track to achieve the target of a 75% reduction in maternal mortality.4 In addition, the rate of new HIV infections continues to outpace the number of HIV positive patients who start treatmentfor every five people newly infected with HIV only two begin treatment each year, and about 5.5 million people needing treatment for HIV in low and middle income countries still do not receive it.5 6 Cost Effectiveness and Resource Allocation (Accessed 20 February 2012) http://www.resource-allocation.com/ [No new relevant content] Emerging Infectious Diseases Volume 18, Number 2February 2012 http://www.cdc.gov/ncidod/EID/index.htm [Reviewed earlier] Global Health Winter 2012 http://www.globalhealthmagazine.com/in_this_issue/ [Reviewed earlier] Globalization and Health [Accessed 20 February 2012] http://www.globalizationandhealth.com/ Research Positioning women's and children's health in African Union policymaking: A policy analysis Toure K, Sankore R, Kuruvilla S, Scolaro E, Bustreo F and Osotimehin B Globalization and Health 2012, 8:3 (16 February 2012) Abstract (provisional) [Open Access] Background

With limited time to achieve the Millennium Development Goals, progress towards improving women's and children's health needs to be accelerated. With Africa accounting for over half of the world's maternal and child deaths, the African Union (AU) has a critical role in prioritizing related policies and catalysing required investments and action. In this paper, the authors assess the evolution of African Union policies related to women's and children's health, and analyze how these policies are prioritized and framed. Methods The main method used in this policy analysis was a document review of all African Union policies developed from 1963 to 2010, focusing specifically on policies that explicitly mention health. The findings from this document review were discussed with key actors to identify policy implications. Results With over 220 policies in total, peace and security is the most common AU policy topic. Social affairs and other development issues became more prominent in the 1990s. The number of policies that mentioned health rose steadily over the years (with 1 policy mentioning health in 1963 to 7 in 2010). This change was catalysed by factors such as: a favourable shift in AU priorities and systems towards development issues, spurred by the transition from the Organization of African Unity to the African Union; the mandate of the African Commission on Human and People's Rights; health-related advocacy initiatives, such as the Campaign for the Accelerated Reduction of Maternal Mortality in Africa (CARMMA); action and accountability requirements arising from international human rights treaties, the Millennium Development Goals (MDGs), and new health-funding mechanisms, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria. Prioritization of women's and children's health issues in AU policies has been framed primarily by human rights, advocacy and accountability considerations, more by economic and health frames looking at investments and impact. AU policies related to reproductive, maternal, newborn and child health also use fewer policy frames than do AU policies related to HIV/AIDS, tuberculosis and malaria. Conclusion We suggest that more effective prioritization of women's and children's health in African Union policies would be supported by widening the range of policy frames used (notably health and economic) and strengthening the evidence base of all policy frames used. In addition, we suggest it would be beneficial if the partner groups advocating for women's and children's health were multi-stakeholder, and included, for instance, health care professionals, regional institutions, parliamentarians, the media, academia, NGOs, development partners and the public and private sectors. Health Affairs February 2012; Volume 31, Issue 2 http://content.healthaffairs.org/content/current Theme: The Future of The Small Business Insurance Exchange [No relevant content]

Health and Human Rights Vol 13, No 2 (2011) http://hhrjournal.org/index.php/hhr [Reviewed earlier] Health Economics, Policy and Law Volume 7 - Special Issue 01 - January 2012 http://journals.cambridge.org/action/displayIssue?jid=HEP&tab=currentissue [Reviewed earlier] Health Policy and Planning Volume 27 Issue 1 January 2012 http://heapol.oxfordjournals.org/content/current [Reviewed earlier] Human Vaccines & Immunotherapeutics (formerly Human Vaccines) Volume 8, Issue 2 February 2012 http://www.landesbioscience.com/journals/vaccines/toc/volume/8/issue/2/ [Reviewed earlier] International Journal of Infectious Diseases Volume 16, Issue 3 pp. e151-e224 (March 2012) http://www.sciencedirect.com/science/journal/12019712 Original Reports Epidemiological analysis of measles and evaluation of measles surveillance system performance in Iraq, 20052010 Original Research Article Pages e166-e171 Jagar Jasem, Kawa Marof, Adnan Nawar, K.M. Monirul Islam Abstract | Figures/Tables | References Summary Objectives The objectives of this study were to identify the risk factors for measles and low vaccination rates, to evaluate the performance of surveillance, and to calculate vaccine effectiveness and failure in Iraq for the years 2005 to 2010. Methods Logistic regression was used on measles surveillance data from Iraq obtained during the period 1 January 2005 to 31 December 2010; adjusted odds ratios were calculated. The performance of surveillance was evaluated according to World Health Organization (WHO) guidelines. Results Of 18 746 suspected cases, a measles diagnosis was made for 81.4%. Children aged 15 years were the most affected (>48%). The odds of measles were significantly higher in the central and southern provinces than in the northern provinces. Those vaccinated with at least one dose of measles-containing vaccine had a 3.7-times lower risk of contracting measles

than those who were not vaccinated. Lower odds of vaccination were noted for adults aged 18 years and older and those living in central and southern provinces, as well as those living outside the capital city of a province. Three WHO performance indicators were lower than the recommended cut-off levels. A vaccine failure rate of 66.1% and effectiveness of 90.03% were estimated. Conclusions Measles continues to be an important cause of morbidity in Iraq. Improvements in vaccine coverage, proper vaccine handling, and prompt reporting of suspected cases are all necessary to eliminate measles from Iraq. Early impact of pneumococcal conjugate vaccine on invasive pneumococcal disease in Singapore children, 2005 through 2010 Original Research Article Pages e209-e215 Koh Cheng Thoon, Chia Yin Chong, Nancy Wen Sim Tee Abstract | Figures/Tables | References Summary Background In a previous study covering the period 19982004, we estimated the incidence of invasive pneumococcal disease (IPD) in Singapore to be 13.6 per 105 children aged <5 years, and determined that the 7-valent pneumococcal conjugate vaccine (PCV-7) would provide 78.1% serotype coverage for children aged <5 years. In the present study we sought to determine whether incidence and serotype trends have changed and to estimate pneumococcal vaccine coverage. Methods We retrospectively reviewed IPD cases from 2005 to 2010 and calculated separate serotype proportions and population-based incidence rates for 20052007 (early PCV period) and 20082010 (late PCV period). PCV-7 coverage was obtained from the National Immunisation Registry, and patients with PCV-7 vaccine-type IPD (VT IPD) and non-vaccine-type IPD (nonVT IPD) were compared. Results One hundred and eighteen patients, with a mean age of 46 months, were identified during 20052010. The incidence rate of IPD increased to 14.8 (for 20052007) and 15.2 (for 20082010) per 105 children <5 years, despite a gradual increase in PCV-7 coverage to approximately 45% of the birth cohort receiving one or more doses of PCV-7. Although IPD due to serotypes 6B and 19A increased, there was a concomitant reduction in other serotypes. Coverage by PCV-7 progressively declined from 78.6% in 20052007 to 64.4% in 20082010 for children aged <5 years. Conclusions Although population coverage with PCV-7 has risen, it remains suboptimal and the incidence of IPD remains unchanged. Furthermore, significant serotype changes (especially increases in 19A) have occurred. We need to adopt newer PCVs with broader serotype coverage and increase the number of children vaccinated as a matter of urgency.

JAMA February 15, 2012, Vol 307, No. 7, pp 637-742 http://jama.ama-assn.org/current.dtl Viewpoints The Unintended Consequences of Conflict of Interest Disclosure George Loewenstein, Sunita Sah, Daylian M. Cain JAMA. 2012;307(7):669-670.doi:10.1001/jama.2012.154 [No abstract; Initial language per JAMA convention] Conflicts of interest, both financial and nonfinancial, are ubiquitous in medicine, and the most commonly prescribed remedy is disclosure. The Medicare Payment Advisory Commission and the Accountable Care Act impose a range of disclosure requirements for physicians, and almost all medical journals now require authors to disclose conflicts of interest (although these requirements may be imperfectly heeded). Given that some relationships between physicians and industry are fruitful and some conflicts are unavoidable, can disclosure correct the problems that arise when economic interests prevent physicians from putting patients' interests first? Disclosure has appeal across the political spectrum because it acknowledges the problem of conflicts but involves minimal regulation and is less expensive to implement than more comprehensive remedies. More importantly, even if disclosure is rarely seen as providing a complete solution to the problem, it is broadly perceived to have beneficial effects. There are, however, reasons that disclosure can have adverse Journal of Infectious Diseases Volume 205 Issue 5 March 1, 2012 http://www.journals.uchicago.edu/toc/jid/current [Reviewed last week] The Lancet Feb 18, 2012 Volume 379 Number 9816 p589 684 e33 http://www.thelancet.com/journals/lancet/issue/current Comment Prevention of serogroup B meningococcal disease David S Stephens Preview In The Lancet, Mara Elena Santolaya and colleagues1 describe the immunogenicity and safety in healthy Hispanic adolescents of a new multicomponent vaccine, 4CMenB, a potential breakthrough in protection against meningitis, sepsis, and other infections caused by Neisseria meningitidis serogroup B. With the successful development and use of effective polysaccharide-protein glycoconjugate vaccines for serogroups A, C, Y, and W-135,2,3 serogroup B N meningitidis (distinguished by the expression of an [28]-linked polysialic acid capsule) is now the leading cause of meningococcal disease, especially in infants and young children in many countries.

Articles Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study Mara Elena Santolaya, Miguel L O'Ryan, Mara Teresa Valenzuela, Valeria Prado, Rodrigo Vergara, Alma Muoz, Daniela Toneatto, Gabriela Graa, Huajun Wang, Ralf Clemens, Peter M Dull, for the V72P10 Meningococcal B Adolescent Vaccine Study group Summary Background Effective glycoconjugate vaccines against Neisseria meningitidis serogroups A, C, W-135, and Y have been developed, but serogroup B remains a major cause of severe invasive disease in infants and adolescents worldwide. We assessed immunogenicity and tolerability of a four-component vaccine (4CMenB) in adolescents. Methods We did a randomised, observer-blind, placebo-controlled, study at 12 sites in Santiago and Valparaso, Chile. Adolescents aged 1117 years received one, two, or three doses of 4CMenB at 1 month, 2 month, or 6 month intervals. Immunogenicity was assessed as serum bactericidal activity using human complement (hSBA) against three reference strains for individual vaccine antigens, and assessed by ELISA against the fourth strain. Local and systemic reactions were recorded 7 days after each vaccination, and adverse events were monitored throughout the study. Participants were initially randomised to five groups (3:3:3:3:1) during the primary phase to receive either one dose, two doses 1 or 2 months apart, or three doses of 4CMenB, or three doses of placebo, with an additional three groups generated for the booster phase. All subjects received at least one dose of 4CMenB. Geometric mean titres, proportions of participants with serum bactericidal antibody titres of 4 or more, and Clopper-Pearson 95% CIs were calculated. The study is registered with ClinicalTrials.gov, number NCT00661713. Findings Overall, 1631 adolescents (mean age 138 [SD 19] years) received at least one dose of 4CMenB. After two or three doses, 99100% of recipients had hSBA titres of 4 or more against test strains, compared with 9297% after one dose (p<00145) and 2950% after placebo. At 6 months 91100% of participants still had titres of 4 or more for each strain after two or three doses, but only 7376% after one dose; seroresponse rates reached 99 100% for each strain after second or third doses at 6 months. Local and systemic reaction rates were similar after each 4CMenB injection and did not increase with subsequent doses, but remained higher than placebo. No vaccine-related serious adverse events were reported and no significant safety signals were identified. Interpretation On the basis of immunogenicity responses this study provides evidence for an adolescent 4CMenB vaccine schedule of two doses, 16 months apart, to provide protection against meningococcal B infection. The extent of this protection against meningococcus B variants circulating worldwide will be determined by national surveys. Funding

Novartis Vaccines and Diagnostics. The Lancet Infectious Disease Feb 2012 Volume 12 Number 2 p89 - 166 http://www.thelancet.com/journals/laninf/issue/current [Reviewed earlier] Medical Decision Making (MDM) JanuaryFebruary 2012; 32 (1) http://mdm.sagepub.com/content/current [Reviewed earlier] Nature Volume 482 Number 7385 pp275-434 16 February 2012 http://www.nature.com/nature/current_issue.html [No relevant content] Nature Medicine February 2012, Volume 18 No 2 pp179-321 http://www.nature.com/nm/journal/v18/n1/index.html News India mulling stricter laws to curb unethical trials - p182 Killugudi Jayaraman doi:10.1038/nm0212-182 Full Text - India mulling stricter laws to curb unethical trials | PDF (188 KB) Clinicians call for greater transparency in trial recruitment - p186 Rebecca Hersher doi:10.1038/nm0212-186a Full Text - Clinicians call for greater transparency in trial recruitment | PDF (108 KB) Nature Reviews Immunology February 2012 Vol 12 No 2 http://www.nature.com/nri/journal/v12/n2/index.html [No relevant content] New England Journal of Medicine February 16, 2012 Vol. 366 No. 7 http://content.nejm.org/current.shtml [No relevant content] OMICS: A Journal of Integrative Biology Volume 15, Number 12

http://online.liebertpub.com/toc/omi/15/12 [No relevant content] The Pediatric Infectious Disease Journal February 2012 - Volume 31 - Issue 2 pp: A11-A12,109-214,e37-e51 http://journals.lww.com/pidj/pages/currenttoc.aspx [Reviewed earlier] Pediatrics February 2012, VOLUME 129 / ISSUE 2 http://pediatrics.aappublications.org/current.shtml [Reviewed earlier] Pharmacoeconomics March 1, 2012 - Volume 30 - Issue 3 pp: 171-256 http://adisonline.com/pharmacoeconomics/pages/currenttoc.aspx Current Opinion Population- versus Cohort-Based Modelling Approaches Ethgen, Olivier; Standaert, Baudouin Pharmacoeconomics. 30(3):171-181, March 1, 2012. doi: 10.2165/11593050-000000000-00000 Abstract While no single type of model can provide adequate answers under all circumstances, any modelling endeavour should incorporate three fundamental considerations in any decision-making question: the target population, the disease and the intervention characteristics. A target population is likely to be characterized by various types of heterogeneity and a dynamic evolution over time. It is therefore important to adequately capture these population effects on the results of a model. There are essentially two different approaches in modelling a population over time: a cohort-based approach and a population-based approach. In a cohort-based model, a closed group of individuals who have at least one specific characteristic or experience in common over a defined period of time is run through a state transition process. The cohort is generally composed of a hypothetical number of representative or average individuals (i.e. the target population is considered to be a homogeneous group). The population-based approach projects the evolution of the estimated prevalent target population and intends to reflect as much as possible the demographic, epidemiological and clinical characteristics of the prevalent target population relevant for the decision problem. A cohort-based approach is generally used in most published healthcare decision models. However, this choice is rarely discussed by modellers. In this article, we challenge this assumption. To address the underlying decision problem, we affirm it is crucial that modellers consider the characteristics of the target population. Then, they could opt for using the most appropriate approach. Decision makers should also understand the impact on the results of both types of models in order to make informed healthcare decisions.

Commentary Pricing Human Papillomavirus Vaccines: Lessons from Italy Garattini, Livio; van de Vooren, Katelijne; Curto, Alessandro Pharmacoeconomics. 30(3):213-217, March 1, 2012. doi: 10.2165/11596560-000000000-00000 [No abstract] Original Research Articles Methodological Quality of Economic Evaluations of New Pharmaceuticals in the Netherlands Hoomans, Ties; Severens, Johan L.; van der Roer, Nicole; Delwel, Gepke O. Pharmacoeconomics. 30(3):219-227, March 1, 2012. doi: 10.2165/11539850-000000000-00000 Abstract: Background: In the Netherlands, decisions about the reimbursement of new pharmaceuticals are based on cost effectiveness, as well as therapeutic value and budget impact. Since 1 January 2005, drug manufacturers are formally required to substantiate the cost effectiveness of drugs that have therapeutic added value in comparison with existing ones through pharmacoeconomic evaluations. Dutch guidelines for pharmacoeconomic research provide methods guidance, ensuring consistency in both the evidence and the decision-making process about drug reimbursement. Aim: This study reviewed the methodological quality of all 21 formally required pharmacoeconomic evaluations of new pharmaceuticals between 1 January 2005 and 1 October 2008, and verified whether these evaluations complied with pharmacoeconomic guidelines. Methods: Data on the quality of the pharmacoeconomic evaluations were extracted from the pharmacoeconomic reports published by the Dutch Health Care Insurance Board (CVZ). The Board's newsletters provided information on the advice to, and reimbursement decisions made by, the Dutch Minister of Health. All data extraction was carried out by two independent reviewers, and descriptive analyses were conducted. Results: The methodological quality was sound in only 8 of the 21 pharmacoeconomic evaluations. In most cases, the perspective of analysis, the comparator drugs, and the reporting of both total and incremental costs and effects were correct. However, drug indication, form (i.e. cost utility/cost effectiveness) and time horizon of the evaluations were frequently flawed. Moreover, the costs and effects of the pharmaceuticals were not always analysed correctly, and modelling studies were often non-transparent. Twelve drugs were reimbursed, and nine were not. Conclusions: The compliance with pharmacoeconomic guidelines in economic evaluations of new pharmaceuticals can be improved. This would improve the methodological quality of the pharmacoeconomic evaluations and ensure consistency in the evidence and the decision-making process for drug reimbursement in the Netherlands. PLoS One [Accessed 20 February 2012] http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DA A533C413369CD6F3.ambra01?field=date

Trends in Notifiable Infectious Diseases in China: Implications for Surveillance and Population Health Policy Lei Zhang, David P. Wilson PLoS ONE: Research Article, published 16 Feb 2012 10.1371/journal.pone.0031076 Abstract This study aimed to analyse trends in notifiable infectious diseases in China, in their historical context. Both English and Chinese literature was searched and diseases were categorised according to the type of disease or transmission route. Temporal trends of morbidity and mortality rates were calculated for eight major infectious diseases types. Strong government commitment to public health responses and improvements in quality of life has led to the eradication or containment of a wide range of infectious diseases in China. The overall infectious diseases burden experienced a dramatic drop during 19751995, but since then, it reverted and maintained a gradual upward trend to date. Most notifiable diseases are contained at a low endemic level; however, local small-scale outbreaks remain common. Tuberculosis, as a bacterial infection, has re-emerged since the 1990s and has become prevalent in the country. Sexually transmitted infections are in a rapid, exponential growth phase, spreading from core groups to the general population. Together human immunodeficiency virus (HIV), they account for 39% of all death cases due to infectious diseases in China in 2008. Zoonotic infections, such as severe acute respiratory syndrome (SARS), rabies and influenza, pose constant threats to Chinese residents and remain the most deadly disease type among the infected individuals. Therefore, secondgeneration surveillance of behavioural risks or vectors associated with pathogen transmission should be scaled up. It is necessary to implement public health interventions that target HIV and relevant coinfections, address transmission associated with highly mobile populations, and reduce the risk of cross-species transmission of zoonotic pathogens. PLoS Medicine (Accessed 20 February 2012) http://www.plosmedicine.org/article/browse.action?field=date [No new relevant content] PNAS - Proceedings of the National Academy of Sciences of the United States of America (Accessed 20 February 2012) http://www.pnas.org/content/early/recent [No new relevant content] Science 17 February 2012 vol 335, issue 6070, pages 765-880 http://www.sciencemag.org/current.dtl Policy Forum

Public Health and Biosecurity H5N1 Debates: Hung Up on the Wrong Questions Daniel R. Perez Science 17 February 2012: 799-801. Published online 19 January 2012 [DOI:10.1126/science.1219066] Information related to influenza transmissibility should be published in its entirety. Summary Full Text Full Text (PDF) Public Health and Biosecurity Life Sciences at a Crossroads: Respiratory Transmissible H5N1 Michael T. Osterholm and Donald A. Henderson Science 17 February 2012: 801-802. Published online 19 January 2012 [DOI:10.1126/science.1218612] Release of details of recent research on affecting influenza transmissibility poses far more risk than any good that might occur. Summary Full Text Full Text (PDF) Public Health and Biosecurity The Obligation to Prevent the Next Dual-Use Controversy Ruth R. Faden and Ruth A. Karron Science 17 February 2012: 802-804. Published online 9 February 2012 [DOI:10.1126/science.1219668] The recent debates over H5N1 experiments highlight current shortcomings in oversight of potential dual-use research. Summary Full Text Full Text (PDF)

Tropical Medicine & International Health February 2012 Volume 17, Issue 2 Pages 143261 http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-3156/currentissue [Reviewed earlier] Vaccine Volume 30, Issue 9 pp. 1529-1752 (21 February 2012) http://www.sciencedirect.com/science/journal/0264410X [Reviewed last week] Value in Health January 2012, Vol. 15, No. 1 http://www.valueinhealthjournal.com/home [Reviewed earlier]

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Vaccine Center and Childrens Hospital of Philadelphia Vaccine Education Center. Additional support is provided by PATH Vaccine Development Program and the International Vaccine Institute (IVI), and by vaccine industry leaders including GSK and Pfizer (list in formation), as well as the Developing Countries Vaccine Manufacturers Network (DCVMN). Support is also provided by a growing list of individuals who use this service to support their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia.