Lumidigm announced that as a result of its multispectral imaging fingerprint sensors “biometric vaccine records are now in place for tens of thousands of adults and children in Kenya, Uganda, Benin and Zambia” and that the solution – supplied in partnership with Fulcrum Biometrics – is “helping to stop vaccine waste for the millions of Africans not yet vaccinated.” The company noted that the delivery model in many parts of Africa “depends on a multitude of healthcare workers who serve very large and remote areas. When there are no vaccination records to consult, many patients are re-immunized unnecessarily, others are simply missed and a finite supply of vaccine is wasted. Unfortunately, without a proper and reliable means of identification, vaccine wastage rates are higher than 50 percent in some of the most challenging geographies.” VaxTrac is solving this problem with a biometric vaccination registry that is operated and managed in the field with low-cost mobile devices. Adult and child patients “are identified in the registry with fingerprint sensors from Lumidigm. Returning patients can pull up their vaccination records with the touch of a finger allowing the healthcare worker to deliver appropriate care.”

More at: http://www.businesswire.com/news/home/20131112006254/en/Lumidigm-Fingerprint-Sensors-Track-Vaccination-Histories-Children

IFFIm: Rating downgrade action by Standard and Poor’s follows France downgrade
Standard & Poor’s has downgraded the long-term credit rating of the International Finance Facility for Immunisation (IFFIm) from AA+ to AA with a stable outlook. The short-term rating on IFFIm remains unchanged at A-1+.

S&P explained the decision as being linked to its rating action on France today. France is the second largest financial contributor to IFFIm.

“IFFIm, donor countries and the World Bank continuously reiterate their full confidence in IFFIm’s mission and overall financial position, as well as the commitment of donor countries to fulfill their pledging obligations,” said René Karsenti, Chair of the IFFIm Board. “The downgrade is not expected to impact the amount of funds available to IFFIm and GAVI.”

IFFIm is currently rated AA+ by Fitch with stable outlook, Aa1 by Moody’s with a negative outlook and AA by S&P with a stable outlook.
http://www.iffim.org/library/news/press-releases/2013/iffim-rating-action-by-standard-and-poor-s-follows-france-downgrade/

   The Weekly Epidemiological Record (WER) for 15 November 2013, vol. 88, 46 (pp. 489–500) includes:
:: Validation of maternal and neonatal tetanus elimination in Cameroon, 2012
:: Monthly report on dracunculiasis cases, January–September 2013
http://www.who.int/entity/wer/2013/wer8846.pdf

CDC/MMWR Watch [to 16 November 2013]
November 15, 2013 / Vol. 62 / No. 45
Use of Japanese Encephalitis Vaccine in Children: Recommendations of the Advisory Committee on Immunization Practices, 2013

WHO: Summary of the SAGE November 2013 meeting
C. Scudamore
Full text

11 November 2013 – While acknowledging the progress made in endemic countries to date – including the absence of type 3 wild poliovirus cases, the 40% decline in polio cases in endemic countries, and the absence of endemic virus in Afghanistan – the Strategic Advisory Group of Experts (SAGE) on immunization echoed the alarm of the Independent Monitoring Board that the insecurity and lack of access for vaccinators in large areas of northwest Pakistan and northeastern states in Nigeria now constituted the greatest risk to completing polio eradication.

This risk was compounded by the increasing international spread of the virus into the Horn of Africa and the Middle East in 2013, particularly into highly vulnerable areas such as south/central Somalia and Syria where vaccinator access and security were also severely compromised.

SAGE provided several recommendations to address the wild polio virus risks and in relation to IPV introduction globally in the context of the polio endgame, including:
:: countries introducing 1 dose of inactivated polio vaccine (IPV) into the routine immunization schedule should administer the dose at or after 14 weeks of age, in addition to the 3-4 doses of oral polio vaccine (OPV) in the primary vaccination series;
:: countries have flexibility to consider alternative schedules (e.g. earlier IPV administration) based on local conditions (e.g. documented risk of vaccine-associated paralytic poliomyelitis or VAPP prior to 4 months of age); and
:: to help accelerate eradication and reduce vulnerability, all polio endemic countries should establish a plan for IPV introduction by mid-2014 and other high-risk countries by end-2014.

SAGE endorsed the proposed strategy on IPV supply, financing and introduction including the tiering of countries based on the risk of circulating vaccine-derived poliovirus (cVDPV) emergence and spread.

SAGE discussed the first annual report on the implementation of the Decade of Vaccine (DoV) Global Vaccine Action Plan (GVAP). SAGE endorsed the following recommendations as the major areas of necessary focus: 1. Improving data quality, 2. Increasing immunization coverage, 3. Accelerating progress towards measles and rubella/CRS elimination, and 4. Enhancing country ownership of national programmes. This should allow the WG to prioritize the specific issues to focus on during the next few years.

SAGE expressed its grave concern around the current situation in Syria and its neighboring countries as reported by the Eastern Mediterranean region (EMR). Effectiveness of immunization campaigns to stop the spread of polio and measles were not able to achieve the envisaged level of immunization coverage. SAGE reemphasized the need for political intervention as well as financial and technical support to countries affected by the current crisis to sustain adequate health services. Coordinated involvement of partners was crucial to stabilize the situation; SAGE encouraged donors to provide additional funding to support and strengthen routine immunization and enable conduction of urgently required interventions such as high quality supplementary immunization activities.

SAGE also expressed deep concern about the mounting challenges being faced by in-country supply chain systems that are stretched to effectively manage existing vaccines and handle the surge of new ones to be introduced and wants to draw the attention of all partners on this issue and encourage greater investments and attention to strengthening immunization supply chain systems in-country.

SAGE concluded that the recommending bodies, including WHO, need to clearly quantify and communicate the favorable risk benefit ratio of maternal immunization, and to engage in a dialogue with regulators and manufacturers to review current regulatory practices against the evidence on risks and benefits and biological plausibility on product safety. SAGE requested the secretariat to develop a process and a plan to move this agenda forward creating alignment between data safety evidence, public health needs and regulatory processes.

SAGE recommended that no physical stockpile on H5N1 vaccine should be created in view of the Pandemic Influenza Preparedness Framework provisions, on condition that equity is considered and established when vaccine is distributed to low and middle income countries.

The meeting report will be published in the WHO Weekly Epidemiological Record on 3 January 2014.
View the meeting documents, including presentations and background readings
http://www.who.int/immunization/sage/report_summary_november_2013/en/index.html

British Medical Journal
16 November 2013 (Vol 347, Issue 7933)
http://www.bmj.com/content/347/7933

Head to Head
Should influenza vaccination be mandatory for healthcare workers?
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6705 (Published 12 November 2013)
Amy Behrman, medical director, occupational medicine1,
Will Offley, casualty nurse 2
   Amy Behrman believes that mandatory vaccination is needed to protect vulnerable patients, but Will Offley argues that evidence on effectiveness is not sufficient to over-ride healthcare workers’ right to choose

Yes—Amy Behrman
Advocacy for influenza vaccination begins with recognising the impact of the disease. Globally, seasonal influenza causes an estimated 300 000-500 000 deaths and 3-5 million cases of severe disease every year.1 Methods that distinguish between influenza and other viruses causing influenza-like illnesses estimate that influenza infections and complications cause an average 226 000 hospital admissions annually in the United States, including 3000-49 000 deaths, depending on seasonal severity.2 Influenza vaccines are estimated to prevent thousands of admissions and millions of illnesses annually with current usage.3 4 5

Complications and deaths from influenza are highest in elderly people, infants, and patients with compromised cardiopulmonary or immune systems.1 2 6 These vulnerable populations are most likely to enter healthcare settings and least likely to mount effective immune responses to vaccination.2 6 Influenza vaccines have excellent safety records6 and are most effective (59% reduction in laboratory proved influenza6 and 47-73% reduction in influenza-like illness2) in healthy non-elderly adults, precisely the demographic of most healthcare workers.

Nosocomial transmission is well documented.7 Influenza infection control should include, in addition to vaccination, hand hygiene, isolation of infected patients, targeted masking, and leave of absence for healthcare workers with influenza-like illness.8 Vaccination is a keystone intervention, differing from others by reducing risk in all encounters without repeated effort or time from busy healthcare workers.

Annual vaccination is therefore widely recommended to reduce the risk of healthcare acquired influenza.2 8 9 10 11 12 13 Advocates and opponents of mandatory vaccination share goals of enhancing patient and staff safety. Disagreements centre on evidence of efficacy, ethical concerns, and how best to achieve meaningful levels of immunisation. My institution’s evolution to a mandatory policy epitomises the issues.

Mandatory vaccination in practice
The University of Pennsylvania Health System has 18 000 staff. Immunisations are free for all vaccine preventable occupational infections. Influenza vaccine has been offered annually since 2003 but was initially voluntary. Uptake by healthcare workers averaged <40%, and many staff avoided immunisation even during years with clear evidence of hospital transmission. Despite prioritisation of influenza vaccination through enhanced availability on all units and shifts and at “flu fairs” with educational materials, over two years, vaccination rose to an unimpressive 45%.

We implemented declination forms in 2006-07 to survey the concerns of unvaccinated staff. As in other institutions, many declined because they underestimated influenza morbidity, feared vaccination would cause illness, or believed “clean living” would prevent transmission. Vaccination rates crept to 50%.

In 2008, we further increased outreach, including a music video addressing the concerns highlighted in the survey (www.youtube.com/watch?v=ruGgZbAVnko). Talented staff participated enthusiastically; the video played continuously; compliance inched to 54%.

By 2009, we perceived limits to non-mandatory immunisation despite maximal efforts. In an anonymous survey, 85% of medical staff supported mandatory immunisation, with 90% agreeing that healthcare workers have an ethical obligation to be vaccinated annually.14   Evidence for patient benefit from immunisation of staff working in long term care, although imperfect, supported our aim to improve compliance among our healthcare workers.15 16 17 18 19 Other mandatory programmes had achieved strikingly increased compliance without safety problems.20 21

In 2009, our health system approved a mandatory policy for all staff. Implementation was complicated by the H1N1 epidemic, with dual vaccine shortages necessitating a tiered approach to prioritise medically compromised staff and those caring for the most vulnerable patients.  Despite this, 99% of staff were vaccinated for seasonal influenza.

Subsequently, medical and religious exemptions have remained stable at <2%, while the mandatory policy is largely accepted as integral to patient and staff safety. Exempted staff are transferred from vulnerable patient units while influenza circulates. Non-compliant staff face escalating penalties (beginning with written warnings), which have been successful without having to terminate employment. Nosocomial influenza has decreased from significant to negligible since 2010, albeit with complementary policies for hand hygiene, isolation of those with influenza-like illnesses, testing healthcare workers with influenza symptoms, and leave of absence for staff with transmissible illnesses. A preliminary safety review of 40 560 staff immunisations over three years found 29 associated clinical complaints, of which eight (0.02%) were systemic symptoms possibly related to vaccination. The remaining 21 (0.05%) were arm pain likely related to injection. All symptoms resolved fully.

Mandatory vaccination is effective and ethical
Recent studies robustly support the effectiveness of mandatory policies in improving vaccination rates.7 20 21 22 Proving that vaccination of healthcare workers decreases the risk of transmission is more difficult for reasons including suboptimal immunisation rates, variable viral severity and vaccine effectiveness, visitor exposures, evolving laboratory diagnostics, and the confounding effects of other infection control interventions. Nevertheless, existing research from long term care facilities supports increasing healthcare workers vaccination to improve patient outcomes.8 15 16 17 18 19 Although acute and ambulatory care patients are likely to be discharged before nosocomial influenza can be recognised, the principles of transmission and immunity are the same,8 23 24 and these patients also deserve vaccinated healthcare workers.    More definitive studies and better vaccines are wanted,1 6 7 but existing vaccines are safe and effective for healthy adults.2 4 6 Mandatory policies make them more effective.

Finally, healthcare workers have an ethical imperative to prevent harm to patients.25 Healthcare workers can infect patients,7 8 and influenza vaccination reduces adult infections,1 3 6 24 therefore vaccination of healthcare workers should reduce risk while setting an example for patients and communities to get recommended immunisations. Maximising compliance should optimise outcomes.8 19 23 Ideally, healthcare workers will take individual responsibility for being fully immunised. When this does not occur, healthcare institutions have an ethical obligation to intervene, just as they do to optimise handwashing and minimise surgical site errors. Mandatory vaccination policies accomplish this.

Healthcare institutions should maximise the use and benefit of a vaccine that is moderately effective, extremely safe, and logically likely to reduce the risk of healthcare acquired influenza for vulnerable patients as well as decrease illness among healthcare workers. First do no harm.

No—Will Offley
The debate around compulsory influenza vaccination for healthcare workers revolves around one central question: does current scientific evidence justify over-ruling the right to informed consent to an invasive and imperfect medical procedure, with documented risks of adverse effects.

Many in this debate answer in the affirmative. For them, patient safety outweighs the right of healthcare workers to refuse influenza vaccines. They argue that compulsory vaccination is consistent with the ethic to “do no harm” and protects vulnerable people from contracting influenza from their caregivers. The only problem is that there is no persuasive scientific evidence to support this view.

Benefits are unproved
Vaccinating healthcare workers against influenza has not been shown to reduce the transmission of influenza to patients. A recent Cochrane review of five studies (four cluster randomised studies and one cohort trial of nearly 20 000 healthcare workers) concluded that “there is no evidence that only vaccinating healthcare workers prevents laboratory-proven influenza or its complications (lower respiratory tract infection, hospitalization or death due to lower respiratory tract infection) in individuals in [long term care] and thus no evidence to mandate compulsory vaccination of healthcare workers.”26

Several of Canada’s leading influenza researchers have also noted the lack of evidence that vaccination of healthcare workers reduces the incidence of influenza in patients.27 Even groups that support mandatory immunisation such as the Centers for Disease Control and Prevention (CDC)28 and Association of Medical Microbiology and Infectious Disease Canada29 have had to acknowledge the lack of data to support this assertion.

Mistaken beliefs
The argument for mandatory vaccination rests on several major fallacies that combine to inflate the perceived effect and virulence of influenza and exaggerate the effectiveness of influenza vaccines.

Firstly, the burden of disease represented by influenza is often expressed by referring to surveillance statistics. In the United States, the CDC attributes 3000 to 49 000 deaths annually to influenza.30 However, its final data for 2010 show that of the 50 097 deaths recorded for influenza and pneumonia combined, only 500 were from influenza.31 In addition, the threat from seasonal influenza is dropping, not increasing. Mortality in the US has dropped from 30-40/100 000 cases in the mid-1930s to less than 5/100 000 from the 1950s onwards, and before the advent of mass public immunisation campaigns.32

Another problem is that influenza vaccines only protect against influenza. However, 85% of influenza-like illness is not caused by influenza but by any of about 200 viral and bacterial pathogens, none of which is prevented by seasonal influenza vaccines.32

Furthermore, the ability of influenza vaccines to prevent true influenza varies considerably from year to year. It has varied from a reported high of 93%33 to a low of 4.6% in a nine year study from California.34 In 2012, vaccine effectiveness against the dominant A(H3N2) influenza was 47% in the US35 and 45% in Canada.36

Recent European studies conducted during the 2011-12 season and involving more than 9000 participants have reported that the effectiveness of influenza vaccine dropped by more than 50% within four months of being vaccinated.37 Thus vaccination imparts only partial immunity to begin with, and even that does not seem to last for the full length of an influenza season.

It is therefore unsurprising that the American College of Occupational and Environmental Medicine has adopted a position against compulsory influenza vaccination, stating that current evidence regarding its ability to protect patients “is inadequate to override the worker’s autonomy to refuse vaccination.”13 The US Occupational Safety and Health Administration, which is responsible for workplace health and safety, has stated that “there is insufficient evidence for the federal government to promote mandatory influenza vaccination programmes that may result in employment termination.”38

Risks of vaccination
Influenza vaccines are relatively safe, not absolutely safe. Adverse effects, while uncommon, are nonetheless real, particularly (but not exclusively) for children and adolescents. Studies indicate that individuals receiving trivalent inactivated vaccine have a one in a million chance of contracting Guillain-Barré syndrome39 and a 13% higher incidence of oculorespiratory syndrome.40 Happily, most of these reactions have been limited to certain manufacturers and formulations, although not all were discovered before the vaccine was administered.41 A Canadian study also found a 1.4 to 2.5 higher rate of pandemic H1N1 influenza among people who had received the 2008 seasonal influenza vaccine, which did not contain this strain.42

Ethical rights of staff
Compulsory vaccination against seasonal influenza is based on an exaggerated threat and an exaggerated cure. Despite a lack of reliable, disinterested scientific evidence to show that healthcare workers are an important source of transmission to our patients, mandatory vaccination is promoted as a panacea without due regard to risks. Compulsion strips healthcare providers of a basic right guaranteed to every other patient—the right to informed consent.

Healthcare workers can and must make a real contribution to protecting patients from influenza—by isolating patients with symptoms of respiratory infection, improving infection control, covering our coughs, washing our hands, and, above all, staying home when we are sick. But until there is more persuasive evidence, it is neither a breach of ethics nor a disservice to patients to insist that influenza vaccination remains a personal decision based on informed consent.

http://www.bmj.com/content/347/bmj.f6705

Journal of Medical Ethics
December 2013, Volume 39, Issue 1
http://jme.bmj.com/content/current

Research ethics
Paper
Preventive misconception and adolescents’ knowledge about HIV vaccine trials
Mary A Ott1, Andreia B Alexander1, Michelle Lally2, John B Steever3, Gregory D Zimet1, the Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions

Author Affiliations
1Section of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA
2Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island, USA
3Department of Pediatrics, Mount Sinai School of Medicine, New York, New York, USA
Correspondence to Dr Mary A Ott, Section of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, 410 West 10th Street, HS 1001, Indianapolis, IN 46202, USA;
http://jme.bmj.com/content/39/12/765.abstract

Abstract 
Objective  Adolescents have had very limited access to research on biomedical prevention interventions despite high rates of HIV acquisition. One concern is that adolescents are a vulnerable population, and trials carry a possibility of harm, requiring investigators to take additional precautions. Of particular concern is preventive misconception, or the overestimation of personal protection that is afforded by enrolment in a prevention intervention trial.

Methods  As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16–19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their understanding and opinions related to enrolment in a HIV vaccine trial. A grounded theory analysis looked for shared concepts, and focused on the content and process of adolescent participants’ understanding of HIV vaccination and the components of preventive misconception, including experiment, placebo and randomisation.

Results  Across interviews, adolescents demonstrated active processing of information, in which they questioned the interviewer, verbally worked out their answers based upon information provided, and corrected themselves. We observed a wide variety of understanding of research concepts. While most understood experiment and placebo, fewer understood randomisation. All understood the need for safer sex even if they did not understand the more basic concepts.

Conclusions  Education about basic concepts related to clinical trials, time to absorb materials and assessment of understanding may be necessary in future biomedical prevention trials.

The Lancet  
Nov 16, 2013   Volume 382 Number 9905  p1609 – 1678 e23 – 24
http://www.thelancet.com/journals/lancet/issue/current

Comment
Polio lessons 2013: Israel, the West Bank, and Gaza
Theodore H Tulchinsky, Asad Ramlawi, Ziad Abdeen, Itamar Grotto, Antoine Flahault
Preview |
In 2013, Israel’s Ministry of Health reported that wild poliovirus (ie, non Sabin) type 1 (WPV1) had been detected in many environmental sewage samples from southern and central Israel.1 WHO also reported that WPV1 had been isolated in Israeli sewage samples and in stool samples; by contrast, there were only three positive sewage samples in the West Bank and one in the Gaza Strip, with no positive stool samples from ten samples from patients with suspected acute flaccid paralysis.2 The virus has been identified as the same virus present in Egypt; both viruses are related to the WPV1 still endemic in Pakistan.

Pneumonia
Vol 2 (2013)
https://pneumonia.org.au/index.php/pneumonia/issue/current

Vaccination for the control of childhood bacterial pneumonia – Haemophilus influenzae type b and pneumococcal vaccines
Diana C Otczyk, Allan W Cripps
https://pneumonia.org.au/index.php/pneumonia/article/view/229
Abstract
Pneumonia in childhood is endemic in large parts of the world and in particular, in developing countries, as well as in many indigenous communities within developed nations. Haemophilus influenzae type b and Streptococcus pneumoniae conjugate vaccines are currently available against the leading bacterial causes of pneumonia.  The use of the vaccines in both industrialised and developing countries have shown a dramatic reduction in the burden of pneumonia and invasive disease in children.  However, the greatest threat facing pneumococcal conjugate vaccine effectiveness is serotype replacement.  The current vaccines provide serotype-specific, antibody–mediated protection against only a few of the 90+ capsule serotypes.  Therefore, there has been a focus in recent years to rapidly advance technologies that will result in broader disease coverage and more affordable vaccines that can be used in developing countries.  The next generation of pneumococcal vaccines have advanced to clinical trials.

Pneumonia
Vol 2 (2013)
https://pneumonia.org.au/index.php/pneumonia/issue/current

Delivering vaccines for the prevention of pneumonia – programmatic and financial issues
Diana C Otczyk, Allan W Cripps
https://pneumonia.org.au/index.php/pneumonia/article/view/244
Abstract
Pneumonia is the leading cause of morbidity and mortality in children younger than 5 years. Vaccines are available against the main bacterial pathogens Haemophilus influenzae type b and Streptococcus pneumoniae.  There are also vaccines against measles and pertussis; diseases that can predispose a child to pneumonia.   Partners such as GAVI, the Hib Initiative, the Accelerated Development and Introduction Plan for pneumococcal vaccines and the Measles Initiative have accelerated the introduction of vaccines into developing countries.  Whilst significant improvements in vaccine coverage have occurred globally over the past decade, there still remains an urgent need to scale-up key pneumonia protection and treatment interventions as identified in the Global Action Plan for the Prevention and Control of Pneumonia (GAPP).  There is promise that global immunisation will continue to improve child survival.    However, there are several challenges to vaccine implementation that must first be addressed, including: a lack of access to under-served and marginalised populations; inadequate planning and management; a lack of political commitment; weak monitoring and surveillance programmes and assured sustainable finance and supply of quality vaccines.  There is an urgent need to increase global awareness of the devastation that pneumonia brings to the world’s poorest communities.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 50, Pages 5923-6040 (5 December 2013)

Vaccinomics, the new road to tick vaccines
Original Research Article
Pages 5923-5929
José de la Fuente, Octavio Merino

Abstract
Ticks are a threat to human and animal health worldwide. Ticks are considered to be second worldwide to mosquitoes as vectors of human diseases, the most important vectors of diseases that affect cattle industry worldwide and important vectors of diseases affecting pets. Tick vaccines are a cost-effective and environmentally friendly alternative to protect against tick-borne diseases through the control of vector infestations and reducing pathogen infection and transmission. These premises stress the need for developing improved tick vaccines in a more efficient way. In this context, development of improved vaccines for tick-borne diseases will be greatly enhanced by vaccinomics approaches starting from the study of tick–host–pathogen molecular interactions and ending in the characterization and validation of vaccine formulations. The discovery of new candidate vaccine antigens for the control of tick infestations and pathogen infection and transmission requires the development of effective screening platforms and algorithms that allow the analysis and validation of data produced by systems biology approaches to tick research. Tick vaccines that affect both tick infestations and pathogen transmission could be used to vaccinate human and animal populations at risk and reservoir species to reduce host exposure to ticks while reducing the number of infected ticks and their vectorial capacity for pathogens that affect human and animal health worldwide.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 50, Pages 5923-6040 (5 December 2013)

Infectious disease research investments: Systematic analysis of immunology and vaccine research funding in the UK
Original Research Article
Pages 5930-5933
Joseph R. Fitchett, Michael G. Head, Rifat Atu

Abstract
Financing for global health is a critical element of research and development. Innovations in new vaccines are critically dependent on research funding given the large sums required, however estimates of global research investments are lacking. We evaluate infectious disease research investments, focusing on immunology and vaccine research by UK research funding organisations. In 1997–2010, £2.6 billion were spent by public and philanthropic organisations, with £590 million allocated to immunology and vaccine research. Preclinical studies received the largest funding amount £505 million accounting for 85.6% of total investment. In terms of specific infection, “the big three” infections dominated funding: HIV received £127 million (21.5% of total), malaria received £59 million (10.0% of total) and tuberculosis received £36 million (6.0% of total). We excluded industry funding from our analysis, as open-access data were unavailable. A global investment surveillance system is needed to map and monitor funding and guide allocation of scarce resources.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 50, Pages 5923-6040 (5 December 2013)

Evaluating the safety of influenza vaccine using a claims-based health system
Original Research Article
Pages 5975-5982
Natalie L. McCarthy, Julianne Gee, Nancy D. Lin, Veena Thyagarajan, Yi Pan, Sue Su, Bruce Turnbull, K. Arnold Chan, Eric Weintraub

Abstract
Introduction
As part of the Centers for Disease Control and Prevention’s monitoring and evaluation activities for influenza vaccines, we examined relationships between influenza vaccination and selected outcomes in the 2009–2010 and 2010–2011 influenza seasons in a claims-based data environment.

Methods
We included patients with claims for trivalent influenza vaccine (TIV) and/or 2009 pandemic influenza A H1N1 vaccine (H1N1) during the 2009–2010 and 2010–2011 influenza seasons. Patients were followed for several pre-specified outcomes identified in claims. Seizures and Guillain–Barré Syndrome were selected a priori for medical record confirmation. We estimated incidence rate ratios (IRR) using a self-controlled risk interval (SCRI) or a historical comparison design. Outcomes with elevated IRRs, not selected a priori for medical record review, were further investigated with review of claims histories surrounding the outcome date to determine whether the potential event could be ruled-out or attributed to other causes based on the pattern of medical care.

Results
In the 2009–2010 season, no significant increased risks for outcomes following H1N1 vaccination were observed. Following TIV administration, the IRR for peripheral nervous system disorders and neuropathy was slightly elevated (1.07, 95% CI: 1.01–1.13). The IRR for anaphylaxis following TIV was 28.55 (95% CI: 3.57–228.44). After further investigation of claims histories, the majority of potential anaphylaxis cases had additional claims around the time of the event indicating alternate explanatory factors or diagnoses. In the 2010–2011 season following TIV administration, a non-significant elevated IRR for anaphylaxis was observed with no other significant outcome findings.

Conclusion
After claims history review, we ultimately found no increased outcome risk following administration of 998,881 TIV and 538,257 H1N1 vaccine doses in the 2009–2010 season, and 1,158,932 TIV doses in the 2010–2011 season

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 50, Pages 5923-6040 (5 December 2013)

A cluster randomised controlled trial of a web based decision aid to support parents’ decisions about their child’s Measles Mumps and Rubella (MMR) vaccination
Original Research Article
Pages 6003-6010
S. Shourie, C. Jackson, F.M. Cheater, H.L. Bekker, R. Edlin, S. Tubeuf, W. Harrison, E. McAleese, M. Schweiger, B. Bleasby, L. Hammond

Abstract
Objective
To evaluate the effectiveness of a web based decision aid versus a leaflet versus, usual practice in reducing parents’ decisional conflict for the first dose MMR vaccination decision. The, impact on MMR vaccine uptake was also explored.

Design
Three-arm cluster randomised controlled trial. Setting: Fifty GP practices in the north of, England. Participants: 220 first time parents making a first dose MMR decision. Interventions: Web, based MMR decision aid plus usual practice, MMR leaflet plus usual practice versus usual practice only, (control). Main outcome measures: Decisional conflict was the primary outcome and used as the, measure of parents’ levels of informed decision-making. MMR uptake was a secondary outcome.

Results
Decisional conflict decreased post-intervention for both intervention arms to a level where, parents could make an informed MMR decision (decision aid: effect estimate = 1.09, 95% CI −1.36 to −0.82; information leaflet: effect estimate = −0.67, 95% CI −0.88 to −0.46). Trial arm was significantly, associated (p < 0.001) with decisional conflict at post-intervention. Vaccination uptake was 100%, 91%, and 99% in the decision aid, leaflet and control arms, respectively (χ2 (1, N = 203) = 8.69; p = 0.017). Post-hoc tests revealed a statistically significant difference in uptake between the information leaflet, and the usual practice arms (p = 0.04), and a near statistically significant difference between the, decision aid and leaflet arms (p = 0.05).

Conclusions
Parents’ decisional conflict was reduced in both, the decision aid and leaflet arms. The decision aid also prompted parents to act upon that decision and, vaccinate their child. Achieving both outcomes is fundamental to the integration of immunisation, decision aids within routine practice. Trial registration: ISRCTN72521372.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 50, Pages 5923-6040 (5 December 2013)

Cochrane re-arranged: Support for policies to vaccinate elderly people against influenza
Original Research Article
Pages 6030-6033
Walter E.P. Beyer, Janet McElhaney, Derek J. Smith, Arnold S. Monto, Jonathan S. Nguyen-Van-Tam, Albert D.M.E. Osterhaus

Abstract
The 2010 Cochrane review on efficacy, effectiveness and safety of influenza vaccination in the elderly by Jefferson et al. covering dozens of clinical studies over a period of four decades, confirmed vaccine safety, but found no convincing evidence for vaccine effectiveness (VE) against disease thus challenging the ongoing efforts to vaccinate the elderly.

However, the Cochrane review analyzed and presented the data in a way that may itself have hampered the desired separation of real vaccine benefits from inevitable ‘background noise’. The data are arranged in more than one hundred stand-alone meta-analyses, according to various vaccine types, study designs, populations, and outcome case definitions, and then further subdivided according to virus circulation and antigenic match. In this way, general vaccine effects could not be separated from an abundance of environmental and operational, non vaccine-related variation. Furthermore, expected impacts of changing virus circulation and antigenic drift on VE could not be demonstrated.

We re-arranged the very same data according to a biological and conceptual framework based on the basic sequence of events throughout the ‘patient journey’ (exposure, infection, clinical outcome, observation) and using broad outcome definitions and simple frequency distributions of VE values. This approach produced meaningful predictions for VE against influenza-related fatal and non-fatal complications (average ∼30% with large dispersion), typical influenza-like illness (∼40%), disease with confirmed virus infection (∼50%), and biological vaccine efficacy against infection (∼60%), under conditions of virus circulation. We could also demonstrate a VE average around zero in the absence of virus circulation, and decreasing VE values with decreasing virus circulation and increasing antigenic drift.

We regard these findings as substantial evidence for the ability of influenza vaccine to reduce the risk of influenza infection and influenza-related disease and death in the elderly.

Vaccine
Volume 31, Issue 49, Pages 5785-5922 (2 December 2013)

HPV vaccination in Hong Kong: Uptake and reasons for non-vaccination amongst Chinese adolescent girls
Pages 5785-5788
Sophia Ling Li, Yu Lung Lau, Tai Hing Lam, Paul Siu Fai Yip, Susan Yun Sun Fan, Patrick Ip

Abstract
Objectives
The study aims to determine HPV vaccine uptake (≥1 dose) amongst adolescent girls in Hong Kong and to explore the reasons for non-acceptance of the vaccine.

Study design
A total of 1832 secondary school girls (15.5 ± 2.0 years) were randomly surveyed. Their HPV vaccine uptake was estimated, and their reasons for non-vaccination summarised.

Results
A total of 131 (7.2%, 95% CI: 6.0–8.4%) adolescent girls had received the HPV vaccine (≥1 dose). Vaccine uptake was positively associated with a higher maternal education level and locally born status. Amongst the non-vaccinated girls, 20.6% had never heard of or knew little about the vaccine, 20.2% ‘did not know where to receive’, and 17.8% were concerned about the cost.

Conclusions
The HPV vaccine uptake amongst adolescent girls in Hong Kong is very low. A school-based education and service programme is needed to improve uptake and prevent disparities in the Chinese population.

Vaccine
Volume 31, Issue 49, Pages 5785-5922 (2 December 2013)

Vaccination coverage levels among children enrolled in the Vaccine Safety Datalink
Original Research Article
Pages 5822-5826
Natalie L. McCarthy, Stephanie Irving, James G. Donahue, Eric Weintraub, Julianne Gee, Edward Belongia, James Baggs

Abstract
Introduction
The Vaccine Safety Datalink (VSD) is a collaborative project whose infrastructure provides comprehensive medical and immunization histories for more than 9 million adults and children annually, a predominantly insured population. This study provides the coverage rates of recommended vaccines among children 19–35 months in the VSD from 2005 through 2010. We examine the consistency in vaccine coverage levels, detect possible trends, and evaluate any effect of vaccine shortages on coverage in the VSD.

Methods
We included data from all 10 VSD sites, and examined each year independently. Coverage rates were defined as the percentage of children in the VSD aged 19, 24, or 35 months in a given study year who had received the specified Advisory Committee on Immunization Practices (ACIP) recommended vaccine(s).

Results
We assessed coverage on 658,154 children. The overall coverage rate for children receiving all of the specified ACIP recommended vaccines was 73%, 80%, and 78% at ages 19, 24, and 35 months respectively. The range of coverage across all ages and years was 95–97% for polio vaccine, 91–97%, for MMR vaccine, 94–97% for HepB vaccine, 81–95% for DTaP vaccine, 90–95% for varicella vaccine, 66–91% for PCV, and 93–98% for Hib vaccine. Coverage rates of 4 or more doses of PCV were relatively low in 2005 possibly due to a vaccine shortage, and increased sharply in 2007. Hib vaccine coverage was relatively stable among all ages until 2009 when rates declined among children aged 19 and 24 months also during a vaccine shortage.

Conclusions
Vaccine coverage in the VSD is high, but there is a decline from 2005 to 2010. The results of this study provide benchmark data for future studies, and describe how vaccine supply shortages and resulting changes in ACIP recommendations may have affected vaccine coverage rates in the VSD.

Vaccine
Volume 31, Issue 49, Pages 5785-5922 (2 December 2013)

Impact of medical education on knowledge and attitudes regarding the human papilloma virus and vaccination: Comparison before and 6 years after the introduction of the vaccines
Original Research Article
Pages 5843-5847
K.W.M. D’Hauwers, P.F.E. Gadet, A.R.T. Donders, W.A.A. Tjalma

Abstract
Aim
The lifetime risk for acquiring a human papilloma virus (HPV) infection is 80% for sexually active people. High-risk HPVs are causally related to almost every case of cervical cancer, and to a subgroup of vaginal, vulvar, anal, penile and oral/oropharyngeal cancer. Low-risk HPVs are related to cutaneous, anogenital, and oral warts.
Two prophylactic vaccines were launched in 2007: they were included in the national vaccination program in Belgium (2009) and in the Netherlands (2010). The objectives of the present study were to determine and compare knowledge and attitudes regarding HPV and vaccination among a study population in 2006 and in 2012.

Materials and methods
Shortly before the introduction, and three years after the inclusion, 715 (2006) and 678 participants (2012) were questioned. Participants were categorised as into non-medics, medics, or paramedics.

Results
In general, knowledge about HPV has increased over time (p < 0.01).
Well-known facts are the relationship of HPV with cervical cancer (>94% in 2006; >96% in 2012), and that an HPV infection might be asymptomatic (>95% in 2006; >99% in 2012).
In 2012, versus in 2006, paramedics and non-medics (both p < 0.01), were more likely to vaccinate all female teenagers. Medics were less likely to support this (p = 0.001). More respondents agreed to vaccinate their daughters (p < 0.01), as well as their sons (p < 0.01).
In 2012, when compared with 2006, less non-medics and medics (both p < 0.01) and more paramedics (p = 0.001) would accept a free catch-up vaccination. Arguments against catch-up vaccination reflected the belief not being at risk and doubts about the vaccines’ safety.

Conclusion
The facts that vaccination programs are regarded as being important, and that knowledge on HPV increased, do not automatically result in an increase in participation in HPV vaccination programs. To increase participation, information must be provided with arguments that cannot be misinterpreted.

Vaccine
Volume 31, Issue 49, Pages 5785-5922 (2 December 2013)

Can vaccine legacy explain the British pertussis resurgence?
Original Research Article
Pages 5903-5908
Maria A. Riolo, Aaron A. King, Pejman Rohani

Abstract
Pertussis incidence has been rising in some countries, including the UK, despite sustained high vaccine coverage. We questioned whether it is possible to explain the resurgence without recourse to complex hypotheses about pathogen evolution, subclinical infections, or trends in surveillance efficiency. In particular, we investigated the possibility that the resurgence is a consequence of the legacy of incomplete pediatric immunization, in the context of cohort structure and age-dependent transmission. We constructed a model of pertussis transmission in England and Wales based on data on age-specific contact rates and historical vaccine coverage estimates. We evaluated the agreement between model-predicted and observed patterns of age-specific pertussis incidence under a variety of assumptions regarding the duration of immunity. Under the assumption that infection-derived immunity is complete and lifelong, and regardless of the duration of vaccine-induced immunity, the model consistently predicts a resurgence of pertussis incidence comparable to that which has been observed. Interestingly, no resurgence is predicted when infection- and vaccine-derived immunities wane at the same rate. These results were qualitatively insensitive to rates of primary vaccine failure. We conclude that the alarming resurgence of pertussis among adults and adolescents in Britain and elsewhere may simply be a legacy of historically inadequate coverage employing imperfect vaccines. Indeed, we argue that the absence of resurgence at this late date would be more surprising. Our analysis shows that careful accounting for age dependence in contact rates and susceptibility is prerequisite to the identification of which features of pertussis epidemiology want additional explanation.

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

[PDF] Attitude on Human Papilloma Virus vaccination
V Jose, MG Nayak, P Jawahar – Int. J. Curr. Microbiol. App. Sci, 2013
… Int.J.Curr.Microbiol.App.Sci (2013) 2(11): 90-95 91 and 20 million new cases of genital herpes annually worldwide. Human Papilloma Virus (HPV) vaccine has undergone successful trials and has recently been approved for use for the primary prevention of cervical cancer…

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 16 November 2013

The Cancer Vaccine
Only one in three American girls is vaccinated against HPV. That will mean thousands of gratuitous cancer deaths. Young people in the South are especially unlikely to get the vaccine, according to a new study. Why?
James Hamblin   Nov 13 2013, 2:35 PM ET
http://www.theatlantic.com/health/archive/2013/11/the-cancer-vaccine/281365/

New York Times
http://www.nytimes.com/
Accessed 16 November 2013

William Pollack Dies at 87; His Vaccine Saved Infants
By PAUL VITELLO
Published: November 12, 2013

Dr. Pollack was a senior scientist in the research laboratory of Ortho Pharmaceutical Company in Raritan, N.J., in the early 1960s when he began a collaboration with two Columbia University researchers, Dr. Vincent J. Freda and Dr. John G. Gorman, to conceive a novel treatment for erythroblastosis fetalis, a blood disorder commonly called Rh disease. The ailment is caused by seemingly superficial differences in the blood types of pregnant women and their fetuses.

Besides the biochemical traits that define the major blood types — A, B, AB and O — the blood of 85 percent of people carries a cluster of surface proteins known as the Rh factor, named for the rhesus monkeys in which it was first identified in 1940. Blood transfusions between people who have the Rh factor (known as Rh positive) and people who do not (Rh negative) cause severe immune reactions.

Rh disease occurs when a pregnant woman is Rh negative and her fetus is Rh positive. In the mixing of blood between the two during pregnancy, the mother’s Rh-negative blood cells produce antibodies that attack the blood cells of the fetus. Depending on the strength of the mother’s immune response, the effects on the baby can range from mild anemia to stillbirth.

Dr. Pollack and his partners devised an “ingenious” counterattack, as it was described in an introduction to their work in “Hematology: Landmark Papers of the Twentieth Century,” a collection published in 2000 by hematologist organizations.

The three men produced a vaccine that patrols the mother’s body, dispatches invading Rh-positive cells and causes no harm to the fetus. The vaccine was made from a passive Rh-negative antibody, which soon wears out. It not only solves the mother’s temporary immunity problem but also, more important, prevents her immune system from mounting a full-fledged response of its own, which would endanger the fetus she was carrying as well as any future ones.

“It was an absolutely brilliant idea,” said Dr. Richard L. Berkowitz, the obstetrics and gynecology director of resident education at NewYork-Presbyterian/Columbia hospital. “A lot of people know who Jonas Salk is, but they should know William Pollack’s name, too. This disease was a major, major problem, and it’s been virtually eradicated.”

http://www.nytimes.com/2013/11/13/us/william-pollack-dies-at-87-his-vaccine-saved-infants.html?_r=0

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″
.
– 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.
.
– pdf version: A pdf of the current issues is available here: Vaccines and Global Health_The Week in Review_9 Nov 2013
.
– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
.
– Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
.
– Support: If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…
.
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

Joint statement: Over 20 million children to be vaccinated in Syria and neighbouring countries
WHO and UNICEF
8 November 2013

Excerpt
The largest-ever consolidated immunization response in the Middle East is under way to stop a polio outbreak, aiming to vaccinate over 20 million children in seven countries and territories repeatedly. Emergency immunization campaigns in and around Syria to prevent transmission of polio and other preventable diseases have vaccinated more than 650,000 children in Syria, including 116,000 in the highly-contested north-east Deir-ez-Zor province where the polio outbreak was confirmed a week ago…

The outbreak of paralytic polio among children in Syria has catalysed the current mass response. The first polio outbreak in the country since 1999, it has so far left 10 children paralyzed, and poses a risk of paralysis to hundreds of thousands of children across the region. Preliminary evidence indicates that the poliovirus is of Pakistani origin and is similar to the strain detected in Egypt, Israel, the West Bank and Palestine.

Dr. Ala Alwan, the World Health Organization Regional Director for the Eastern Mediterranean noted, “The Middle East has shown exactly the coordinated leadership needed to combat a deadline virus: a consolidated and sustained assault on a vaccine-preventable disease and an extraordinary commitment to a common purpose.”

UNICEF said it has procured 1.35 billion doses of oral polio vaccine (OPV) to date in 2013 and by the end of the year will have procured up to 1.7 billion doses to meet increased demand. Global supply of OPV was already under constraint with vaccine manufacturers producing at full capacity. The new outbreak in Syria is adding further pressure to the supply but WHO, UNICEF and manufacturers are working to secure sufficient quantities to reach all children…

http://www.unicef.org/media/media_70833.html

Update: Polio this week – As of 6 November 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]

:: Following confirmation of polio in Syria, health ministers of the Eastern Mediterranean declared the circulation of poliovirus in the Region an ‘emergency’ for all Member States at its Regional Committee meeting in Oman last week. It called on Pakistan to take necessary steps to ensure all children were accessed and vaccinated as a matter of utmost emergency to prevent further international spread and requested Syria and adjoining countries to coordinate intensified mass vaccination campaigns using the most appropriate tactics and vaccines to interrupt this new outbreak within six months. For more on the Regional Committee meeting click here.

:: The Strategic Advisory Group of Experts on immunization (SAGE) is meeting this week in Geneva, Switzerland. Among other topics, the SAGE is expected to review the latest global polio epidemiology, strategies for accelerating polio eradication and plans for introduction of inactivated poliovirus vaccine (IPV) into routine immunization.

Afghanistan
One new WPV1 case was reported in the past week (from Chapa Dara district, Kunar province). The total number of WPV cases for 2013 is now nine (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 27 September, from Kunar province.

Nigeria
Two new WPV cases were reported this week. The total number of WPV cases for 2013 is now 51 (all WPV1s). The two cases were reported from Local Government Areas (LGA) Nasarawa and Kumbotso in Kano state. The most recent WPV1 case in the country had onset of paralysis on 8 October (from Kumbotso, Kano).

 The GAVI Alliance said it welcomes the introduction of pneumococcal and measles-rubella vaccines in Senegal. Dr Seth Berkley, CEO of the GAVI Alliance, said, “Senegal is investing in the health of its children by protecting them from these three potentially fatal diseases. We want to see children benefitting from the power of vaccines no matter where in the world they live.” Awa Marie Coll Seck, Senegal Health Minister, commwented, “These introductions are very important for Senegal because children are dying every day from these vaccine-preventable diseases. I am happy that we have been able to introduce these vaccines for our children with GAVI Alliance support.” Senegal plans to introduce pneumococcal vaccine into its routine child vaccination schedule immediately while the measles-rubella introduction will initially begin as a campaign before moving in to routine immunisation from the beginning of 2014.

http://www.gavialliance.org/library/news/statements/2013/gavi-alliance-welcomes-introduction-of-two-life-saving-vaccines-in-senegal/

The Global Fund said it worked with partners to establish a “new framework to systematically organize the purchase of massive amounts of mosquito nets, anti-HIV drugs and other products that will improve delivery and make significant savings. In a first step, the Global Fund will sign contracts with 7 manufacturers “for the largest-ever bulk purchase of mosquito nets treated with insecticide, with immediate costs savings of  US$51.2 million, and projected overall savings of US$140 million for the Global Fund over two years.” The announcement noted that the initial contracts, for 90 million mosquito nets, will be part of an overall purchase of 190 million nets by partners in 2014. The new framework reduces base prices across the board, for all partners, and also reduces bottlenecks and shortages in countries where malaria threatens the lives of millions of children under the age of 5. The Global Fund said that the new framework emerged from a special partnership launched in May 2013 between the Global Fund, the UK’s Department for International Development, the U.S. President’s Malaria Initiative and UNICEF, who collectively represent about 87 percent of the purchases of insecticide-treated nets. Other partners also participated, including the Clinton Health Access Initiative (CHAI), Roll Back Malaria Partnership and the office of Raymond G. Chambers, the UN Secretary-General’s Special Envoy for Financing the Health MDGs and for Malaria…

http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-11-05_Breakthrough_on_Procurement_to_Save_USD_140_Million/

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

Meeting: Vaccines for Enteric Diseases (VED) Conference
Coalition against Typhoid (CaT), an initiative of the Sabin Vaccine Institute.
Scientists, researchers and biotech experts this week at the to discuss how a highly anticipated conjugate typhoid vaccine could expedite global efforts to help prevent this disease. For the first time, children as young as six months of age can be protected against typhoid with a vaccine. Both adults and children will receive high levels of long lasting protection.
http://www.sabin.org/updates/pressreleases/leaders-fight-against-typhoid-express-hope-light-new-vaccines

Forum: Human Resources for Health: foundation for Universal Health Coverage and the post-2015 development agenda.
Third Global Forum on Human Resources for Health
Recife, Brazil
10–13 November, 2013
http://www.who.int/mediacentre/events/meetings/2013/human-resources/en/index.html
Main issues for discussion
:: Learning from a decade of action on HRH with respect to efforts to achieve the health-related MDGs as well as other important national and global health goals? Are we on the right track towards universal health coverage (UHC)?
:: Matching health workforce production to population needs and expectations.
:: Social needs and the regulatory role of the State.
:: Deployment, retention and management for an effective health workforce.
:: Empowerment and incentives for health personnel as we move towards UHC.
:: Exploring a forward looking agenda to make sure the health workforce is the vanguard for UHC.

Workshop: Adult Vaccination in Middle and Low Income Countries: TB, HIV, and Malaria.
Aeras
Presentations: http://www.aeras.org/blog.

American Journal of Public Health
Volume 103, Issue 12 (December 2013)
http://ajph.aphapublications.org/toc/ajph/current

Ethical Community-Engaged Research: A Literature Review.      
Lisa Mikesell, Elizabeth Bromley, and Dmitry Khodyakov.
American Journal of Public Health: December 2013, Vol. 103, No. 12, pp. e7-e14.
doi: 10.2105/AJPH.2013.301605
http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2013.301605
Abstract
Health research has relied on ethical principles, such as those of the Belmont Report, to protect the rights and well-being of research participants.
Community-based participatory research (CBPR), however, must also consider the rights and well-being of communities. This requires additional ethical considerations that have been extensively discussed but not synthesized in the CBPR literature.
We conducted a comprehensive thematic literature review and summarized empirically grounded discussions of ethics in CBPR, with a focus on the value of the Belmont principles in CBPR, additional essential components of ethical CBPR, the ethical challenges CBPR practitioners face, and strategies to ensure that CBPR meets ethical standards. Our study provides a foundation for developing a working definition and a conceptual model of ethical CBPR.

Ethical Research and Minorities
Mark A. Rothstein.
American Journal of Public Health, December 2013, Vol. 103, No. 12, pp. 2118-2118.
doi: 10.2105/AJPH.2013.301390

Building Trust for Engagement of Minorities in Human Subjects Research: Is the Glass Half Full, Half Empty, or the Wrong Size?
Sandra C. Quinn, Nancy E. Kass, and Stephen B. Thomas.
American Journal of Public Health December 2013: Vol. 103, No. 12, pp. 2119-2121.
doi: 10.2105/AJPH.2013.301685

Rethinking the Vulnerability of Minority Populations in Research.
Wendy Rogers and Margaret Meek Lange.
American Journal of Public Health: December 2013, Vol. 103, No. 12, pp. 2141-2146.
doi: 10.2105/AJPH.2012.301200
http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2012.301200
Abstract
The Belmont Report, produced in 1979 by a United States government commission, includes minority populations among its list of vulnerable research participants. In this article, we consider some previous attempts to understand the vulnerability of minorities in research, and then provide our own account.
First we examine the question of the representation of minorities in research. Then we argue that the best understanding of minorities, vulnerability, and research will begin with a broad understanding of the risk of individual members of minority groups to poor health outcomes.    We offer a typology of vulnerability to help with this task.
Finally, we show how researchers should be guided by this broad analysis in the design and execution of their research.

Adapting Western Research Methods to Indigenous Ways of Knowing.
Vanessa W. Simonds and Suzanne Christopher.
American Journal of Public Health: December 2013, Vol. 103, No. 12, pp. 2185-2192.
doi: 10.2105/AJPH.2012.30115
http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2012.301157
Abstract
Indigenous communities have long experienced exploitation by researchers and increasingly require participatory and decolonizing research processes. We present a case study of an intervention research project to exemplify a clash between Western research methodologies and Indigenous methodologies and how we attempted reconciliation. We then provide implications for future research based on lessons learned from Native American community partners who voiced concern over methods of Western deductive qualitative analysis. Decolonizing research requires constant reflective attention and action, and there is an absence of published guidance for this process. Continued exploration is needed for implementing Indigenous methods alone or in conjunction with appropriate Western methods when conducting research in Indigenous communities. Currently, examples of Indigenous methods and theories are not widely available in academic texts or published articles, and are often not perceived as valid.

American Journal of Tropical Medicine and Hygiene
November 2013; 89 (5)
http://www.ajtmh.org/content/current

The Economic Case for Combating Malaria
Mark Purdy, Matthew Robinson, Kuangyi Wei, and David Rublin
Am J Trop Med Hyg 2013 89:819-823; doi:10.4269/ajtmh.12-0689
http://www.ajtmh.org/content/89/5/819.abstract

Abstract.
To date, existing studies focus largely on the economic detriments of malaria. However, if we are to create suitable incentives for larger-scale, more sustained anti-malaria efforts from a wider group of stakeholders, we need a much better understanding of the economic benefits of malaria reduction and elimination. Our report seeks to rectify this disjuncture by showing how attaining the funding needed to meet internationally agreed targets for malaria elimination would, on conservative assumptions, generate enormous economic improvements. We use a cost-benefit analysis anchored in Global Malaria Action Plan projections of malaria eradication based on fully met funding goals. By calculating the value of economic output accrued caused by work years saved and subtracting the costs of intervention, we find that malaria reduction and elimination during 2013–2035 has a 2013 net present value of US $208.6 billion.

.
Malaria Diagnostics in Clinical Trials
Sean C. Murphy*, Joseph P. Shott, Sunil Parikh, Paige Etter, William R. Prescott and V. Ann Stewart

Abstract.
Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wide array of available malaria diagnostic tests for their suitability for screening trial participants and/or obtaining study endpoints for malaria clinical trials, including studies of HIV/malaria co-infection and other malaria natural history studies. The MLN provides recommendations on microscopy, rapid diagnostic tests, serologic tests, and molecular assays to guide selection of the most appropriate test(s) for specific research objectives. In addition, this report provides recommendations regarding quality management to ensure reproducibility across sites in clinical trials. Performance evaluation, quality control, and external quality assessment are critical processes that must be implemented in all clinical trials using malaria tests.

Eurosurveillance
Volume 18, Issue 45, 07 November 2013
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Perspectives
Ethics of mandatory vaccination for healthcare workers
E Galanakis 1, A Jansen2, P L Lopalco2, J Giesecke2
1.Department of Paediatrics and Joint Graduate Programme in Bioethics, University of Crete, Heraklion, Greece
2.European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20627

Abstract
Healthcare workers (HCWs) are at increased risk of contracting infections at work and further transmitting them to colleagues and patients. Immune HCWs would be protected themselves and act as a barrier against the spread of infections and maintain healthcare delivery during outbreaks, but vaccine uptake rates in HCWs have often been low. In order to achieve adequate immunisation rates in HCWs, mandatory vaccination policies are occasionally implemented by healthcare authorities, but such policies have raised considerable controversy. Here we review the background of this debate, analyse arguments for and against mandatory vaccination policies, and consider the principles and virtues of clinical, professional, institutional and public health ethics. We conclude that there is a moral imperative for HCWs to be immune and for healthcare institutions to ensure HCW vaccination, in particular for those working in settings with high-risk groups of patients. If voluntary uptake of vaccination by HCWs is not optimal, patients’ welfare, public health and also the HCW’s own health interests should outweigh concerns about individual autonomy: fair mandatory vaccination policies for HCWs might be acceptable. Differences in diseases, patient and HCW groups at risk and available vaccines should be taken into consideration when adopting the optimal policy.

JAMA   
November 6, 2013, Vol 310, No. 17
http://jama.jamanetwork.com/issue.aspx

Viewpoint | November 6, 2013
Managing the Human Toll Caused by Seasonal Influenza: New York State’s Mandate to Vaccinate or Mask
Arthur Caplan, PhD1; Nirav R. Shah, MD, MPH2
http://jama.jamanetwork.com/article.aspx?articleid=1746248

Initial Text [per JAMA convention]
New York State and the nation as a whole experienced one of the worst influenza seasons in a decade during the winter of 2012-2013. In the peak week ending January 19, 2013, New York alone reported more than 5000 cases of laboratory-confirmed influenza, more than 1120 hospitalizations as a result of influenza, and 5 flu-related pediatric deaths. By the season’s end, more than 45 000 cases had been confirmed, more than 9500 people had been hospitalized, and 14 children had died.1…

JAMA Pediatrics
November 2013, Vol 167, No. 11
http://archpedi.jamanetwork.com/issue.aspx

Association Between Undervaccination With Diphtheria, Tetanus Toxoids, and Acellular Pertussis (DTaP) Vaccine and Risk of Pertussis Infection in Children 3 to 36 Months of Age
Jason M. Glanz, PhD; Komal J. Narwaney, MD, PhD; Sophia R. Newcomer, MPH; Matthew F. Daley, MD; Simon J. Hambidge, MD, PhD; Ali Rowhani-Rahbar, MD, PhD; Grace M. Lee, MD, MPH; Jennifer C. Nelson, PhD; Allison L. Naleway, PhD; James D. Nordin, MD, MPH; Marlene M. Lugg, DrPH; Eric S. Weintraub, MPH

Abstract
Importance  Undervaccination is an increasing trend that potentially places children and their communities at an increased risk for serious infectious diseases.

Objective  To examine the association between undervaccination and pertussis in children 3 to 36 months of age.

Design  Matched case-control study with conditional logistic regression analysis.

Setting  Eight managed care organizations of the Vaccine Safety Datalink between 2004 and 2010.

Participants  Each laboratory-confirmed case of pertussis (72 patients) was matched to 4 randomly selected controls (for a total of 288 controls). The case patients were matched to controls by managed care organization site, sex, and age at the index date. The index date was defined as the date of pertussis diagnosis for the case patients.

Exposure  Undervaccination for the diphtheria, tetanus toxoids, and acellular pertussis (DTaP) vaccine. Undervaccination was defined as the number of doses of DTaP vaccine that was either missing or delayed by the index date. Case patients and controls could be undervaccinated by 0, 1, 2, 3, or 4 doses of DTaP vaccine. Children undervaccinated by 0 doses were considered age-appropriately vaccinated by the index date.

Main Outcome and Measure  Pertussis.

Results  Of the 72 case patients with pertussis, 12 (16.67%) were hospitalized, and 34 (47.22%) were undervaccinated for DTaP vaccine by the date of pertussis diagnosis. Of the 288 matched controls, 64 (22.22%) were undervaccinated for DTaP vaccine. Undervaccination was strongly associated with pertussis. Children undervaccinated for 3 or 4 doses of DTaP vaccine were 18.56 (95% CI, 4.92-69.95) and 28.38 (95% CI, 3.19-252.63) times more likely, respectively, to have received a diagnosis of pertussis than children who were age-appropriately vaccinated.

Conclusions and Relevance  Undervaccination with DTaP vaccine increases the risk of pertussis among children 3 to 36 months of age.

JAMA Pediatrics
November 2013, Vol 167, No. 11
http://archpedi.jamanetwork.com/issue.aspx

The Relationship Between Parent Attitudes About Childhood Vaccines Survey Scores and Future Child Immunization Status: A Validation Study
Douglas J. Opel, MD, MPH; James A. Taylor, MD; Chuan Zhou, PhD; Sheryl Catz, PhD; Mon Myaing, PhD; Rita Mangione-Smith, MD, MPH

Abstract
Importance  Acceptance of childhood vaccinations is waning, amplifying interest in developing and testing interventions that address parental barriers to immunization acceptance.

Objective  To determine the predictive validity and test-retest reliability of the Parent Attitudes About Childhood Vaccines survey (PACV), a recently developed measure of vaccine hesitancy.

Design, Setting, and Participants  Prospective cohort of English-speaking parents of children aged 2 months and born from July 10 through December 10, 2010, who belonged to an integrated health care delivery system based in Seattle and who returned a completed baseline PACV. Parents who completed a follow-up survey 8 weeks later were included in the reliability analysis. Parents who remained continuous members in the delivery system until their child was 19 months old were included in the validity analysis.

Exposure  The PACV, scored on a scale of 0 to 100 (100 indicates high vaccine hesitancy).

Main Outcomes and Measures  Child’s immunization status as measured by the percentage of days underimmunized from birth to 19 months of age.

Results  Four hundred thirty-seven parents completed the baseline PACV (response rate, 50.5%), and 220 (66.5%) completed the follow-up survey. Of the 437 parents who completed a baseline survey, 310 (70.9%) maintained continuous enrollment. Compared with parents who scored less than 50, parents who scored 50 to 69 on the survey had children who were underimmunized for 8.3% (95% CI, 3.6%-12.8%) more days from birth to 19 months of age; those who scored 70 to 100, 46.8% (40.3%-53.3%) more days. Baseline and 8-week follow-up PACV scores were highly concordant (ρ = 0.844).

Conclusions and Relevance  Scores on the PACV predict childhood immunization status and have high reliability. Our results should be validated in different geographic and demographic samples of parents

Journal of Community Health
Volume 38, Issue 6, December 2013
http://link.springer.com/journal/10900/38/6/page/1

Human Papillomavirus Knowledge and Awareness Among Vietnamese Mothers
Jenny K. Yi, Susan C. Lackey, Marion P. Zahn, Juan Castaneda, Jessica P. Hwang
Abstract
Human papillomavirus (HPV) is the most common sexually transmitted disease in the US and the primary cause of cervical cancer. Vietnamese American women have the highest incidence rates of cervical cancer but one of the lowest HPV vaccination rates. Parental knowledge is an important predictor of HPV vaccination; however, little is known about HPV knowledge in the Vietnamese American community. We aimed to describe the HPV knowledge of Vietnamese mothers in Houston, Texas and their intention to vaccinate their daughters. We conducted face-to-face interviews with Vietnamese mothers who had daughters aged 9–26 years. We collected data on demographics, acculturation, HPV knowledge, and vaccination intention. Knowledge scores (0–5) were calculated using 5 knowledge questions. We used logistic regression to identify predictors of HPV knowledge. Participants had low levels of acculturation by report of reading (31 %) and writing (23 %) English well. Less than 50 % of participants (n = 47) had heard of HPV, and among these, the mean HPV knowledge score was 4. Although only 1 in 3 had discussed HPV with their medical provider, nearly 86 % of participants who had not heard of HPV would vaccinate their daughter if their doctor had recommended it. Good written English skills and belief that the HPV vaccine was not expensive were predictors of HPV awareness. HPV awareness is low among less acculturated Vietnamese mothers in Houston. Future educational efforts about the role of HPV vaccine in preventing cervical cancer should be made in their language when targeting parents of a high risk Vietnamese population.

HPV Vaccination and Sexual Behavior in a Community College Sample
Erica Marchand, Beth A. Glenn, Roshan Bastani
Abstract
Many US parents are concerned that vaccinating daughters against human papillomavirus (HPV) will communicate implicit approval for sexual activity and be associated with early or risky sexual behavior (Scarinci et al. in J Womens Health 16(8):1224–1233, 2007; Schuler et al. in Sex Transm Infect 87:349–353, 2011) [7, 8]. The aims of this study were to understand (a) whether the HPV vaccine was associated with risky sexual behavior among a diverse sample of female adolescents and young adults, and (b) to better understand the chronology of HPV vaccination and sexual behavior. An anonymous web-based survey was used to collect data from 114 female community college students. T test and Chi square analyses were used to compare vaccinated and unvaccinated groups on age at first intercourse and proportion who had ever had sexual intercourse. Linear multiple regression was used to predict frequency of condom use and number of sexual partners in the past year, using vaccination status and demographic factors as predictors. About 38 % reported receiving at least one dose of the HPV vaccine. Many of those vaccinated (45 %) received the vaccine after having initiated sexual activity. The proportion of women who were sexually experienced did not differ by HPV vaccine status, nor did age at first intercourse, number of partners in the past year, or frequency of condom use. Current findings suggest that HPV vaccination is not associated with riskier sexual activity for the young women in this sample. Adolescents and their parents may benefit from education about the need to receive the HPV vaccine before onset of sexual activity.

HPV and HPV Vaccines: The Knowledge Levels, Opinions, and Behavior of Parents
Marlee Grabiel, Thomas J. Reutzel, Sheila Wang…
Abstract
To measure parent knowledge levels and opinions related to the human papillomavirus (HPV) and the two vaccines used to prevent it. To measure parent behavior in terms of whether or not to have their children vaccinated. Between June 19, 2012, and August 24, 2012, questionnaires were distributed to parents while waiting for their child to see their pediatrician at a local group practice. The survey was reviewed for face validity by College of Pharmacy social science and clinical faculty members, and an earlier version of it had been used successfully in a published study of biomedical students’ knowledge of and attitudes toward the HPV vaccine. 129 usable surveys were obtained. 48.1 % of subjects said they learned about the HPV vaccines from the media, while 47.3 % identified health care practitioner(s) as a source of knowledge. The mean score on a 20-item knowledge test regarding the infection and vaccines was 36 % (range 0–80 %). Opinions on the subject varied widely. For example, 22.4 % of subjects agreed that schools should require that students be vaccinated before enrolling, while 3.2 % agreed that vaccination causes patients to become sexually active. Subjects reported vaccination status for 253 children (mean age 13) as follows: 33 % vaccinated; 28 % not vaccinated but will be; 11 % will never be vaccinated; and 28 % not decided. These results are somewhat encouraging, because many parents are hearing about the vaccines from their providers. Although not an equally valid source, the media are also raising awareness. Based on the knowledge and opinion results of this study, there is a need for pharmacists and other providers to educate their patients about the vaccines and the virus and to converse with them regarding the moral and psychological implications of vaccination. Still, it is encouraging that these subjects had or plan to have over half (61 %) of their children vaccinated.

Knowledge and Beliefs Regarding Human Papillomavirus Among College Nursing Students at a Minority-Serving Institution
Geri L. Schmotzer, Kerryn W. Reding
Abstract
Cervical cancer is a leading cause of death in US women, with Hispanic women at higher risk of mortality than non-Hispanic white women. While the human papillomavirus (HPV) vaccine represents substantial progress towards cervical cancer prevention, little is currently known about Hispanic student’s beliefs regarding the HPV vaccine. To assess the knowledge, attitudes, behaviors, and beliefs of college students in the US–Mexico border region following the release of the HPV vaccine for both males and females. This survey was conducted using a convenience sample were participants were recruited from pre-nursing and nursing courses. The self-administered questionnaire ascertained HPV vaccination status, and knowledge and beliefs regarding the HPV vaccine. 202 male and female students responded. 28.9 % of respondents reported having received the HPV vaccine. Of the non-vaccinated students under age 27, 27.3 % Hispanic students reported an intention to receive the vaccine. Misinformation about HPV was common and was associated with intention to get vaccinated among non-Hispanic white students. We found a relatively small proportion of unvaccinated Hispanic and non-Hispanic nursing students intend to be vaccinated for HPV. Findings indicate an intervention to increase vaccination rates among college-aged students may not be as straightforward as increasing knowledge of HPV. Nurses are in a unique position to educate and recommend HPV to underserved patients. Thus, educating nursing students regarding HPV and the associated cancers is paramount if we are to encourage ethnic minorities to receive the HPV vaccine.

New England Journal of Medicine
November 7, 2013  Vol. 369 No. 19
http://www.nejm.org/toc/nejm/medical-journal

Review Article
Global Health
Natural Disasters, Armed Conflict, and Public Health
Jennifer Leaning, M.D., and Debarati Guha-Sapir, Ph.D.
N Engl J Med 2013; 369:1836-1842November 7, 2013DOI: 10.1056/NEJMra1109877
http://www.nejm.org/doi/full/10.1056/NEJMra1109877

Excerpt
Natural disasters and armed conflict have marked human existence throughout history and have always caused peaks in mortality and morbidity. But in recent times, the scale and scope of these events have increased markedly. Since 1990, natural disasters have affected about 217 million people every year,1 and about 300 million people now live amidst violent insecurity around the world.2 The immediate and longer-term effects of these disruptions on large populations constitute humanitarian crises. In recent decades, public health interventions in the humanitarian response have made gains in the equity and quality of emergency assistance…

…Conclusions
The effects of armed conflict and natural disasters on global public health are widespread. Much progress has been made in the technical quality, normative coherence, and efficiency of the health care response. But action after the fact remains insufficient. In the years ahead, the international community must address the root causes of these crises. Natural disasters, particularly floods and storms, will become more frequent and severe because of climate change. Organized deadly onslaughts against civilian populations will continue, fueled by the availability of small arms, persistent social and political inequities, and, increasingly, by a struggle for natural resources. These events affect the mortality, morbidity, and well-being of large populations. Humanitarian relief will always be required, and there is a demonstrable need, as in other areas of global health, to place greater emphasis on prevention and mitigation.

PLoS One
[Accessed 9 November 2013]
http://www.plosone.org/

Research Article
Timeliness Vaccination of Measles Containing Vaccine and Barriers to Vaccination among Migrant Children in East China
Yu Hu mail, Qian Li, Shuying Luo, Linqiao Lou, Xiaohua Qi, Shuyun Xie
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0073264

Abstract
Background
The reported coverage rates of first and second doses of measles containing vaccine (MCV) are almost 95% in China, while measles cases are constantly being reported. This study evaluated the vaccine coverage, timeliness, and barriers to immunization of MCV1 and MCV2 in children aged from 8–48 months.

Methods
We assessed 718 children aged 8–48 months, of which 499 children aged 18–48 months in September 2011. Face to face interviews were administered with children’s mothers to estimate MCV1 and MCV2 coverage rate, its timeliness and barriers to vaccine uptake.

Results
The coverage rates were 76.9% for MCV1 and 44.7% for MCV2 in average. Only 47.5% of surveyed children received the MCV1 timely, which postpone vaccination by up to one month beyond the stipulated age of 8 months. Even if coverage thus improves with time, postponed vaccination adds to the pool of unprotected children in the population. Being unaware of the necessity for vaccination and its schedule, misunderstanding of side-effect of vaccine, and child being sick during the recommended vaccination period were significant preventive factors for both MCV1 and MCV2 vaccination. Having multiple children, mother’s education level, household income and children with working mothers were significantly associated with delayed or missing MCV1 immunization.

Conclusions
To avoid future outbreaks, it is crucial to attain high coverage levels by timely vaccination, thus, accurate information should be delivered and a systematic approach should be targeted to high-risk groups.

PLoS One
[Accessed 9 November 2013]
http://www.plosone.org/

Potential Benefits of Second-Generation Human Papillomavirus Vaccines
Sorapop Kiatpongsan, Nicole Gastineau Campos, Jane J. Kim
Research Article | published 07 Nov 2012 | PLOS ONE 10.1371/journal.pone.0048426

Abstract
Background
Current prophylactic vaccines against human papillomavirus (HPV) target two oncogenic types (16 and 18) that contribute to 70% of cervical cancer cases worldwide. Our objective was to quantify the range of additional benefits conferred by second-generation HPV prophylactic vaccines that are expected to expand protection to five additional oncogenic types (31, 33, 45, 52 and 58).

Methods
A microsimulation model of HPV and cervical cancer calibrated to epidemiological data from two countries (Kenya and Uganda) was used to estimate reductions in lifetime risk of cervical cancer from the second-generation HPV vaccines. We explored the independent and joint impact of uncertain factors (i.e., distribution of HPV types, co-infection with multiple HPV types, and unidentifiable HPV types in cancer) and vaccine properties (i.e., cross-protection against non-targeted HPV types), compared against currently-available vaccines.

Results
Assuming complete uptake of the second-generation vaccine, reductions in lifetime cancer risk were 86.3% in Kenya and 91.8% in Uganda, representing an absolute increase in cervical cancer reduction of 26.1% in Kenya and 17.9% in Uganda, compared with complete uptake of current vaccines. The range of added benefits was 19.6% to 29.1% in Kenya and 14.0% to 19.5% in Uganda, depending on assumptions of cancers attributable to multiple HPV infections and unidentifiable HPV types. These effects were blunted in both countries when assuming vaccine cross-protection with both the current and second-generation vaccines.

Conclusion
Second-generation HPV vaccines that protect against additional oncogenic HPV types have the potential to improve cervical cancer prevention. Co-infection with multiple HPV infections and unidentifiable HPV types can influence vaccine effectiveness, but the magnitude of effect may be moderated by vaccine cross-protective effects. These benefits must be weighed against the cost of the vaccines in future analyses.

PLoS Medicine
(Accessed 9 November 2013)
http://www.plosmedicine.org/

Measles Outbreak Response Immunization Is Context-Specific: Insight from the Recent Experience of Médecins Sans Frontières
Andrea Minetti mail, Cameron Bopp, Florence Fermon, Gwenola François, Rebecca F. Grais, Lise Grout, Northan Hurtado, Francisco J. Luquero, Klaudia Porten, Laurent Sury, Meguerditch Terzian
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001544

Summary Points
:: During the recent resurgence of measles in sub-Saharan Africa, the majority of cases were reported from the Democratic Republic of the Congo and Malawi, two countries with vastly different measles epidemiology.
:: Non-selective mass vaccination campaigns targeting children aged 6 months to <15 years old are the commonly implemented strategy for responding to measles outbreaks in humanitarian emergencies.
:: Differences in measles epidemiology and country-specific control goals necessitate more than a one-size-fits-all strategy.
:: Measles outbreak responses should be tailored to local measles epidemiology following early assessment: the age distribution of early cases should guide the decision on which age groups to vaccinate.
:: In settings where the main objective is mortality reduction, the youngest children—who account for the most deaths and complications—should be prioritized by the outbreak response.

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

Hepatitis B vaccination coverage among health-care personnel in the United States.
KK Byrd, PJ Lu, TV Murphy – Public health reports (Washington, DC: 1974), 2013
… OBJECTIVES: We compared self-reported hepatitis B (HepB) vaccine coverage among health-care personnel (HCP) with HepB vaccine coverage among the general population and determined trends in vaccination coverage among HCP. …

A systematic evaluation of different methods for calculating adolescent vaccination levels using immunization information system data.
C Gowda, S Dong, RC Potter, KJ Dombkowski… – Public health reports ( …, 2013
… We explored alternative methods for estimating the vaccine-eligible population when calculating adolescent immunization levels using a statewide IIS. … Further research is needed to ascertain the most appropriate method for estimating vaccine coverage levels using IIS data. …

[PDF] Estimation of HPV prevalence in young women in Scotland; monitoring of future vaccine impact
K Kavanagh, K Sinka, K Cuschieri, J Love, A Potts… – BMC Infectious Diseases, 2013
Background Estimation of pre-immunisation prevalence of HPV and distribution of HPV types is fundamental to understanding the subsequent impact of HPV vaccination. We describe the type specific prevalence of HPV in females aged 20–21 in Scotland who ..
 

Special Focus Newsletters
RotaFlash
November 8, 2013
PATH
Lead story: Rotavirus vaccines will help 2.8 million Ethiopian children live healthier lives
Celebration in Addis Ababa marks start of nationwide introduction
http://vad.createsend4.com/t/r-e-niuguy-mhyjuirjk-j/

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″
.
– 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.
.
– pdf version: A pdf of the current issues is available here: Vaccines and Global Health_The Week in Review_2 Nov 2013
.
– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
.
– Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
.
– Support: If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…
.
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

Media Release: UNICEF and senior Syrian officials agree on urgency of reaching more war-affected children, as UNICEF Executive Director visits Syria

DAMASCUS, 29 October 2013 – Following ‘businesslike and encouraging’ discussions, senior Syrian officials and UNICEF Executive Director Anthony Lake agreed on the importance of reaching hundreds of thousands of children in some of the worst-affected parts of war-torn Syria with life-saving vaccines, including those against polio, as Mr Lake ended a two-day visit to Damascus.

The need to immunize every child quickly and without obstacle was a key focus of Mr. Lake’s discussions with Syrian Prime Minister Wael Al Halqi, Vice Minister of Foreign Affairs Dr. Faisal Miqdad, and Deputy Minister of Foreign Affairs Hosam Eddin A’ala.

“Immunizing children is in its very nature non-political and has no connection to any military considerations,” said Mr. Lake. “With cases of polio now emerging in Syria for the first time since 1999, reaching every child with polio and other vaccinations is an urgent and critical priority not only for Syria but for the whole world.”

In a meeting with frontline volunteers from the Syrian Arab Red Crescent (SARC) Mr. Lake expressed on behalf of UNICEF his admiration for all the work SARC volunteers are doing, their courage, and the sacrifices they have made in this cause.

With SARC and with national and other partners UNICEF will be working to reach the more than 500,000 children who have not been reached with vaccinations due to the conflict in some of the hardest to reach parts of the country.

http://www.unicef.org/media/media_70763.html

GAVI and its partners met in Stockholm to review their progress since June 2011. The meeting convened donor and implementing country representatives and Alliance partners including the World Health Organization, UNICEF, the World Bank, the Bill & Melinda Gates Foundation, civil society organisations and vaccine manufacturers. GAVI CEO Dr Seth Berkley presented “a detailed update on progress since the successful London pledging conference in June 2011. This success has been made possible through GAVI’s unique funding model which brings together donor funding, financial contributions from developing countries, and supply and price commitments from vaccine industry partners.” New pledges were announced including from Sweden, who in 2011 pledged US$40 million per year to GAVI to 2015, will now provide a total of US$129 million for 2013 and 2014, and from the Republic of Korea which announced a new commitment to GAVI of a total of US$5 million from 2013-2017.

GAVI said delegates also “engaged in detailed discussions around the challenges of maintaining vaccination programmes while also reaching the 22 million children who go unvaccinated each year.” The event closed with a Ministerial Conversation on Sustainable Funding which highlighted the opportunities and challenges of securing long-term, predictable funding to secure vaccination programmes. The European Commission also announced that it will host a high-level preparatory meeting for GAVI partners in early 2014 ahead of the Alliance’s next funding cycle.

More at: http://www.gavialliance.org/library/news/press-releases/2013/gavi-alliance-partners-reaching-more-children-than-ever-before-with-accelerated-access-to-vital-vaccines/#sthash.gNJsgkeG.dpuf

MSF made a series of recommendations to the GAVI Alliance and the Mid-Term Review meetings in four key areas “where changes at GAVI could make an important difference.” The recommendation includes “making GAVI prices available to humanitarian actors like MSF, further lowering vaccine prices for all in need, extending vaccination to children above one year of age, and incentivizing for development of vaccines that do not rely on cold-chain logistics.” MSF also released a series of videos that “summarize the views of key experts, stakeholders and influencers in the field of global immunization that met in Oslo in October 2013 to share ideas on how to overcome current barriers, and effectively reach out to the one in five children currently unprotected from killer diseases each year.” More here:

http://www.doctorswithoutborders.org/press/release.cfm?id=7125&cat=press-release

   The Gates Foundation announced formation of the Vaccine Discovery Partnership, which it described as “a way for our foundation to work directly with pharmaceutical companies on promising new vaccines for global health.” Gates said GlaxoSmithKline (GSK) and Sanofi are the first two companies involved and said it is “optimistic that other pharmaceutical companies will also join the partnership.” Gates said it will “work with each company individually to identify a promising set of research projects that are aligned with our foundation’s priorities. Projects funded through the Vaccine Discovery Partnership will span the R&D lifecycle – from preclinical to experimental medicine Phase IIa trials.” One of the first projects under the program involves GSK and “focuses on increasing the thermostabilization of new generation vaccines to facilitate delivery of such vaccines in special administration and campaign settings in resource-limited countries. The goal would be to build thermostability into vaccines as an integral  part of new generation vaccine development.” The Foundation noted that “by working together with pharmaceutical companies, these new partnerships will reduce the risks associated with early-stage vaccine research, and increase the likelihood that the most promising new vaccines are developed quickly, and at lower cost. This will be a win for everyone involved but most importantly for the children around the world who will get the life-saving vaccines they need.’

http://www.impatientoptimists.org/Posts/2013/10/A-New-Partnership-to-Accelerate-Vaccine-Research-amp-Development

WHO: Oral cholera vaccine stockpile
November 2013

A global stockpile of oral cholera vaccine (OCV) has been created, as an additional tool to help control cholera epidemics. Over the period July 2013 /June 2014 the stockpile will have available 2 million doses of vaccine.

The OCV stockpile, is managed as a rotating fund, by the International Coordinating Group (ICG) which already manages similar stockpiles of meningococcal meningitis and Yellow Fever vaccines for outbreak response.

The ICG is comprised of four decision making partners: the International Federation of Red Cross and Red Crescent Societies (IFRC), Médecins Sans Frontières (MSF), United Nations Children’s Fund (UNICEF) and WHO, which also serves as the Secretariat.

The ICG members will continue to communicate with partners and stakeholders to increase awareness of the OCV stockpile, placing vaccine in the context of an integrated cholera response which is based around early detection, case management, provision of safe water, sanitation, and raising awareness among the affected communities.

More information, applications and guidance is available here:
http://www.who.int/cholera/vaccines/ocv_stockpile_2013/en/index.html

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.