The Lancet
Volume 376, Issue 9741, Pages 615 – 623, 21 August 2010

Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial
K Zaman, Dang Duc Anh, John C Victor, Sunheang Shin, Md Yunus, Michael J Dallas, Goutam Podder, Vu Dinh Thiem, Le Thi Phuong Mai, Stephen P Luby, Le Huu Tho, Michele L Coia, Kristen Lewis, Stephen B Rivers, David A Sack, Florian Schödel, A Duncan Steele, Kathleen M Neuzil, Max Ciarlet

Background

Rotavirus vaccine has proved effective for prevention of severe rotavirus gastroenteritis in infants in developed countries, but no efficacy studies have been done in developing countries in Asia. We assessed the clinical efficacy of live oral pentavalent rotavirus vaccine for prevention of severe rotavirus gastroenteritis in infants in Bangladesh and Vietnam.

Methods

In this multicentre, double-blind, placebo-controlled trial, undertaken in rural Matlab, Bangladesh, and urban and periurban Nha Trang, Vietnam, infants aged 4—12 weeks without symptoms of gastrointestinal disorders were randomly assigned (1:1) to receive three oral doses of pentavalent rotavirus vaccine 2 mL or placebo at around 6 weeks, 10 weeks, and 14 weeks of age, in conjunction with routine infant vaccines including oral poliovirus vaccine. Randomisation was done by computer-generated randomisation sequence in blocks of six. Episodes of gastroenteritis in infants who presented to study medical facilities were reported by clinical staff and from parent recollection. The primary endpoint was severe rotavirus gastroenteritis (Vesikari score ≥11) arising 14 days or more after the third dose of placebo or vaccine to end of study (March 31, 2009; around 21 months of age). Analysis was per protocol; infants who received scheduled doses of vaccine or placebo without intervening laboratory-confirmed naturally occurring rotavirus disease earlier than 14 days after the third dose and had complete clinical and laboratory results were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT00362648.

Findings

2036 infants were randomly assigned to receive pentavalent rotavirus vaccine (n=1018) or placebo (n=1018). 991 infants assigned to pentavalent rotavirus vaccine and 978 assigned to placebo were included in the per-protocol analysis. Median follow up from 14 days after the third dose of placebo or vaccine until final disposition was 498 days (IQR 480—575). 38 cases of severe rotavirus gastroenteritis (Vesikari score ≥11) were reported during more than 1197 person-years of follow up in the vaccine group, compared with 71 cases in more than 1156 person years in the placebo group, resulting in a vaccine efficacy of 48·3% (95% CI 22·3—66·1) against severe disease (p=0·0005 for efficacy >0%) during nearly 2 years of follow-up. 25 (2·5%) of 1017 infants assigned to receive vaccine and 20 (2·0%) of 1018 assigned to receive placebo had a serious adverse event within 14 days of any dose. The most frequent serious adverse event was pneumonia (vaccine 12 [1·2%]; placebo 15 [1·5%]).

Interpretation

In infants in developing countries in Asia, pentavalent rotavirus vaccine is safe and efficacious against severe rotavirus gastroenteritis, and our results support expanded WHO recommendations to promote its global use.

Funding

PATH (GAVI Alliance grant) and Merck.

Sabin Vaccine Institute, Fogarty International Center of the U.S. National Institutes of Health, and Fundação Oswaldo Cruz convened Smallpox Eradication after 30 Years: Lessons, Legacies and Innovations” in Rio de Janeiro, Brazil on 24 August 2010. The meeting involved “global health dignitaries from 33 countries to share global health lessons, legacies and innovations post smallpox eradication.” 2010 marks the 30th anniversary of the Global Commission for the Certification of Smallpox Eradication officially reporting the elimination of smallpox disease. Smallpox remains the only disease to ever have been eradicated.

Dr. Mirta Roses, Director of the Pan American Health Organization, commented, “The eradication of smallpox has rightly been called one of mankind’s greatest achievements. Not only was it an important public health milestone, but it also gave rise to the founding of the Expanded Program on Immunization, which has been instrumental in saving the lives of millions of children around the world. As we have advanced with polio eradication in the Americas, now a global goal, and the elimination of measles and rubella, the Americas are forging a new future in control of vaccine-preventable diseases that sets examples for the rest of the world. We honor the heroes of smallpox eradication and the millions of health workers who toil selflessly every day to bring life-saving vaccines to the remotest corners of the earth, and we urge continued government, NGO, and private sector support for the goals of universal immunization.”

http://www.sabin.org/pressroom/releases/2010/08/24/sabin-vaccine-institute-fogarty-international-center-us-national-insti

Statement from the International Symposium on Smallpox Eradication

After 30 Years: Lessons, Legacies and Innovations

We, the 260 scientists, public health workers, historians and other professionals from 34 countries who participated in the August 24‐27, 2010 Smallpox Eradication Symposium at the Oswaldo Cruz Foundation in Rio de Janeiro, offer the following observations on smallpox eradication:

– First, smallpox eradication removed from the human population a virus that killed an estimated 300 million people in the twentieth century.

– Second, after 1980 smallpox vaccination was stopped saving the great costs of vaccination programs and eliminating the sometimes severe complications of smallpox vaccination.

– Third, the smallpox eradication program inspired a generation of public health practitioners and several major programs such as:

— A wider program of vaccination (The Expanded Program on Immunizations) that has helped achieve high levels of immunization around the world preventing large numbers of deaths of children and adults.

—- Wide-spread use of epidemiological surveillance as a key tool in disease control.

—- Programs that have made great progress toward the global eradication of polio and Guinea Worm and the elimination of measles and rubella from the Americas.

– Fourth, it demonstrated that international cooperation and solidarity can contribute to major public health improvements around the world.

– Finally, since the end of smallpox vaccination an increasing proportion of the population of the world is susceptible to smallpox. Given the current limited supplies of smallpox vaccine, release of smallpox into the environment could cause a catastrophic global epidemic. Further, smallpox virus is known to be held by only two laboratories in the world as authorized by WHO. Although these two laboratories maintain extensive precautions against release of the virus, no containment system is risk-free. In addition, it cannot be ascertained that there are no unauthorized stores of smallpox virus.

More than 15 years have elapsed since the World Health Assembly agreed to postpone the destruction of the smallpox virus. Therefore, in the interest of global security, consideration should now be given to early destruction of existing laboratory stocks of smallpox virus when on-going WHO-sanctioned research is completed on improved vaccines and diagnostics, effective anti-virals, and reliable animal model.

Finally, possession or deployment of the smallpox virus outside the WHO-sanctioned facilities should be designated a crime against humanity.

http://sabin.org/files/uploads/pdfs/Statement%20from%20the%20International%20Symposium%20on%20Smallpox%20Eradication%20After%2030%20Years-%20Lessons%2C%20Legacies%20and%20Innovations.pdf

The 9th International Rotavirus Symposium, held at Johannesburg, South Africa released the following Call to Action:

We the Participants of the 9th International Rotavirus Symposium
Considering that:
– Diarrhea is the second greatest killer of children under five worldwide, killing 1.33 million children under five each year;
– Rotavirus is the leading cause of severe diarrheal disease;
– Rotavirus-related diarrheal disease takes the lives of more than 500,000 children under five every year and is responsible for the hospitalization of millions more around the world;
– 85% of rotavirus deaths occur in low income countries in sub-Saharan Africa and Asia;
– A growing body of evidence attests to the safety, efficacy, effectiveness and lifesaving potential of rotavirus vaccines;
– In light of the demonstrated burden of rotavirus disease and the evidence supporting the use of vaccines to reduce that burden, there is a need to increase access to affordable rotavirus vaccines in the developing world;
– In 2009 WHO recommended that rotavirus vaccines be included in every nation’s immunization program;
– Adding rotavirus vaccination in national immunization programs and combining it with appropriate diarrhea control interventions as part of a package of strategies to prevent diarrheal diseases-related deaths would be critical to achieving Millennium Development Goal 4 (MDG 4);
– Prevention and control of diarrheal disease requires collaborative action by national governments, industry, civil society organizations, and international health agencies.

Therefore, We Agree to:
– Continue to support immunization as a common public good worldwide, an economic necessity and a vital political priority;
– Enourage increased vaccine research and expanded surveillance for vaccine preventable diseases;
– Encourage the joint collaboration of national governments, health professionals, bilateral and multilateral agencies, the GAVI Alliance, and the manufacturers of vaccines to facilitate and accelerate the introduction of affordable rotavirus vaccines worldwide;
– Advocate for and raise awareness among public and policy makers of the burden of rotavirus-related diarrheal disease and the value of vaccination;
– Call upon political leaders and decision-makers from developing countries to increase financial support to their national immunization programs;
– Call upon political leaders and decision-makers from developed countries and global – immunization partners to scale-up financial support to the GAVI Alliance.

http://www.sabin.org/pressroom/sabin_news/2010/08/09/9th-international-rotavirus-symposium-call-action

Call to Action PDF: here

WHO Director General Dr. Margaret Chan announced the end of the Phase 6 of the Influenza pandemic alert:

H1N1 in post-pandemic period

The world is no longer in phase 6 of influenza pandemic alert. We are now moving into the post-pandemic period. The new H1N1 virus has largely run its course…

As we enter the post-pandemic period, this does not mean that the H1N1 virus has gone away. Based on experience with past pandemics, we expect the H1N1 virus to take on the behaviour of a seasonal influenza virus and continue to circulate for some years to come.

In the post-pandemic period, localized outbreaks of different magnitude may show significant levels of H1N1 transmission. This is the situation we are observing right now in New Zealand, and may see elsewhere.

In fact, the actions of health authorities in New Zealand, and also in India, in terms of vigilance, quick detection and treatment, and recommended vaccination, provide a model of how other countries may need to respond in the immediate post-pandemic period.

Globally, the levels and patterns of H1N1 transmission now being seen differ significantly from what was observed during the pandemic. Out-of-season outbreaks are no longer being reported in either the northern or southern hemisphere. Influenza outbreaks, including those primarily caused by the H1N1 virus, show an intensity similar to that seen during seasonal epidemics.

During the pandemic, the H1N1 virus crowded out other influenza viruses to become the dominant virus. This is no longer the case. Many countries are reporting a mix of influenza viruses, again as is typically seen during seasonal epidemics.

Recently published studies indicate that 20–40% of populations in some areas have been infected by the H1N1 virus and thus have some level of protective immunity. Many countries report good vaccination coverage, especially in high-risk groups, and this coverage further increases community-wide immunity.

Pandemics, like the viruses that cause them, are unpredictable. So is the immediate post-pandemic period. There will be many questions, and we will have clear answers for only some. Continued vigilance is extremely important, and WHO has issued advice on recommended surveillance, vaccination, and clinical management during the post-pandemic period.

Based on available evidence and experience from past pandemics, it is likely that the virus will continue to cause serious disease in younger age groups, at least in the immediate post-pandemic period. Groups identified during the pandemic as at higher risk of severe or fatal illness will probably remain at heightened risk, though hopefully the number of such cases will diminish.

In addition, a small proportion of people infected during the pandemic, including young and healthy people, developed a severe form of primary viral pneumonia that is not typically seen during seasonal epidemics and is especially difficult and demanding to treat. It is not known whether this pattern will change during the post-pandemic period, further emphasizing the need for vigilance.

As I said, pandemics are unpredictable and prone to deliver surprises. No two pandemics are ever alike. This pandemic has turned out to be much more fortunate than what we feared a little over a year ago.

This time around, we have been aided by pure good luck. The virus did not mutate during the pandemic to a more lethal form. Widespread resistance to oseltamivir did not develop. The vaccine proved to be a good match with circulating viruses and showed an excellent safety profile.

Thanks to extensive preparedness and support from the international community, even countries with very weak health systems were able to detect cases and report them promptly.

Had things gone wrong in any of these areas, we would be in a very different situation today….

http://www.who.int/mediacentre/news/statements/2010/h1n1_vpc_20100810/en/index.html

:: Read the report from the Emergency Committee meeting
:: WHO recommendations for the post-pandemic period
:: Press briefing – audio and video files
:: Surveillance recommendations in the post-pandemic period

GAVI announced that Julian Lob-Levyt will step down as CEO of the GAVI Alliance in October “to take up a major role in the private sector after leading the public-private global health partnership through nearly six years of growth and innovation.” Dr Lob-Levyt will continue as CEO until October to oversee GAVI’s first Resource Mobilisation Meeting on 6 October at which “existing and potential donors will be asked to pledge additional funds to enable new vaccines against pneumococcal disease and rotavirus diarrhoea to be added to immunisation programmes.” In November, Dr Lob-Levyt, will become Managing Director of DAI Europe and Senior Vice President of DAI, based in London. DAI “has worked in 150 developing and transition countries, providing comprehensive development solutions in areas including HIV/AIDS and avian influenza control, crisis mitigation and stability operations, agriculture and agribusiness, democratic governance and public sector management, private sector development and financial services, economics and trade, water and natural resources management, and energy and climate change.”

Geneva, 11 August 2010: More at: http://www.gavialliance.org/media_centre/press_releases/ceo.php

The Bill & Melinda Gates Foundation today announced the opening of Round 6 of Grand Challenges Explorations, described as a US$100 million grant initiative to encourage bold and unconventional global health solutions. Proposals are being accepted until November 2, 2010. Grand Challenges Explorations “offers researchers the chance to win US$100,000 grants to foster innovative projects that could transform health in developing countries. The initiative focuses on areas where creative, unorthodox thinking is most urgently needed. For this round, applicants are asked to focus their proposals on these five topic areas:

– Design New Approaches to Cure HIV Infection;

– Create the Next Generation of Sanitation Technologies;

– Create Low-Cost Cell Phone-Based Applications for Priority Global Health Conditions;

– Create New Technologies for the Health of Mothers and Newborns;

– The Poliovirus Endgame: Create Ways to Accelerate, Sustain and Monitor Eradication.

http://www.gatesfoundation.org/press-releases/Pages/grand-challenges-explorations-round-six-100819.aspx

NIH launched a new nationwide research initiative “to define changes in the human immune system, using human and not animal studies, in response to infection or to vaccination.” Six U. S.-based Human Immune Phenotyping Centers will receive a total of US$100 million over five years to conduct this research. NIAID Director Anthony S. Fauci, M.D. commented, “Recognizing the differences in immune system activity before, during and after exposure to an infectious agent or vaccine will help in the development of safer, more effective therapeutics and vaccines. This research effort also will contribute to the ongoing evolution in our ability to study the immune system.”

Investigators will analyze samples from well-characterized groups, including children, the elderly and people with autoimmune diseases such as lupus. These groups represent diverse populations with respect to age, genetics, gender and ethnicity. The research teams will examine immune system elements of these populations before and after exposure to naturally acquired infections or to vaccines or vaccine components. The profile that will emerge of the body’s response to vaccination will be based on the most sophisticated and comprehensive assays currently available. This will enable new approaches to examining vaccine safety, not just of individual vaccines but of the processes of immunization in general.

The following six core institutions and principal investigators will participate in the inaugural program:

Baylor Research Institute, Dallas – Jacques Banchereau, Ph.D.

Dana-Farber Cancer Institute, Boston – Ellis Reinherz, M.D.

Emory University, Atlanta – Bali Pulendran, Ph.D.

Mayo Clinic, Rochester, Minn. – Gregory Poland, M.D.

Stanford University, Calif. – Mark Davis, Ph.D.

Yale University, New Haven, Conn. – David Hafler, M.D., and Erol Fikrig, M.D.

http://www.nih.gov/news/health/aug2010/niaid-11.htm

The Institute of Medicine (IOM) released a letter report outlining “a conceptual framework to help the U.S. Food and Drug Administration evaluate the ethical issues involved in determining whether companies should start or continue clinical trials on approved drugs and in ensuring that these studies are ethically conducted.” The proposed framework “underscores the importance of FDA’s decision-making processes and study design considerations,” and notes that FDA “should ensure that any randomized, controlled trial to evaluate the efficacy and safety of an approved drug that is suspected of causing serious adverse events is conducted only when the existing evidence and any evidence from new observational studies would be insufficient to enable the agency to make responsible policy decisions.  The agency should determine that questions about a drug’s possible risks or risk-benefit balance rise to the level of requiring a policy decision, such as whether to revise the product’s label…”

Te framework also notes that “…FDA should make sure that trials are appropriately designed to resolve uncertainties about efficacy and safety and to minimize risks to participants. Risks should be judged acceptable by appropriate oversight bodies, and participants and studies should be continuously monitored to assure that the risks continue to be acceptable. The process of informed consent should continue over the course of the trials, and participants should be promptly advised of substantial changes in clinical practice or professional standards and new research findings that could affect their willingness to accept the risks associated with a trial.  FDA should apply principles and practices of regulatory science to ensure that its policy decisions reflect the best available scientific evidence and analytic techniques and that they are made in a transparent way to ensure public accountability.”

The report responds to one of several questions FDA asked IOM to explore in a review of ethical and scientific issues related to studying the safety of drugs on the market.  http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12948

The report is available at: http://www.nap.edu/catalog.php?record_id=12948

The 2009 National Immunization Survey-Teen (NIS-Teen) estimates that coverage for adolescent vaccination at the national, state and selected local area levels show continued nationwide improvement – as much as 15 percent – for vaccines specifically recommended for pre-teens. The survey of more than 20,000 teens aged 13-17 found that in 2009 there were increases in the percentage of teens in this age group who had received vaccines routinely recommended for 11- and 12-year-olds. Specifically:

– For one dose of the tetanus-diphtheria-acellular pertussis vaccine (Tdap), coverage went up about 15 points to about 56 percent;

– For one dose of meningococcal conjugate vaccine, coverage went up about 12 points to about 54 percent;

– For girls who received at least one dose of human papillomavirus (HPV) vaccine, coverage increased 7 points to about 44 percent. However, for girls who received the recommended three doses of HPV vaccine, coverage was only about 27 percent (a 9 percent increase);

– For one dose of HPV vaccine, no differences were observed between racial/ethnic groups. However, coverage was higher among teens living in poverty compared with those living at or above the poverty level.

– For the recommended three doses of HPV vaccine, differences were observed between racial/ethnic groups, including significantly lower coverage for blacks and Hispanics compared to whites;

– There were no significant differences in coverage by racial/ethnic group or by poverty status for Tdap or meningococcal conjugate vaccine; and

As in 2008, there was wide variation in adolescent vaccination coverage among state and local areas.

Anne Schuchat, M.D., director of CDC’s National Center for Immunization and Respiratory Diseases, commented, “This year’s data are mixed. We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system’s ability to reach this age group.”

http://www.cdc.gov/media/pressrel/2010/r100819b.htm

Clinical Infectious Diseases
15 September 2010  Volume 51, Number 6
http://www.journals.uchicago.edu/toc/cid/current

Editorial Commentary: The Present and Future Control of Pertussis
James D. Cherry

Emerging Infectious Diseases
Volume 16, Number 9–September 2010
http://www.cdc.gov/ncidod/EID/index.htm

Letters
Mobile Messaging as Surveillance Tool during Pandemic (H1N1) 2009, Mexico
M. Lajous et al.

To the Editor: Pandemic (H1N1) 2009 highlighted challenges faced by disease surveillance systems. New approaches to complement traditional surveillance are needed, and new technologies provide new opportunities. We evaluated cell phone technology for surveillance of influenza outbreaks during the outbreak of pandemic (H1N1) 2009 in Mexico.
On May 12, 2009, at 2:20 pm, a random sample of 982,708 telephones from an 18 million nationwide network of mostly prepaid cell phones (1) received a text message invitation to a Ministry of Health survey. Influenza-like illness (ILI) in April, date of fever onset, severity, number of household members with ILI, age, influenza vaccination, household size, and number of children in each household were assessed (online Technical Appendix Figure 1). ILI was defined as fever and cough or sore throat, and severe ILI was defined as inability to work, study, or maintain family care. Unstructured supplementary service data, an interactive platform available on most cell phones, was used. We obtained daily counts of suspected and confirmed cases of pandemic (H1N1) 2009 from the nationwide clinic-based surveillance system Sistema Nacional de Vigilancia Epidemiológica (SINAVE) (2,3).
Of 70,856 responses received, 56,551 (78.1%) were unique mobile numbers (5.8% response rate; only the first response was used). Within 3 hours, 53% of responses were received and by 24 hours, 89% were received. Mean (SD) age of respondents was 25.2 (10.4) years (online Technical Appendix Table). A total of 9,333 persons reported ILI and 49.3% had severe symptoms. Mean number of other persons with ILI in the household was 1.6 among respondents reporting severe disease and 0.3 among those with nonsevere disease (p<0.0001, by t test)…

Journal of Infectious Diseases
15 September 2010  Volume 202, Number 6
http://www.journals.uchicago.edu/toc/jid/current

Major Articles and Brief Reports: Viruses
School Opening Dates Predict Pandemic Influenza A(H1N1) Outbreaks in the United States [Free full text]
Dennis L. Chao, M. Elizabeth Halloran, and Ira M. Longini, Jr

Abstract
The opening of schools in the late summer of 2009 may have triggered the fall wave of pandemic influenza A(H1N1) in the United States. We found that an elevated percentage of outpatient visits for influenza‐like illness occurred an average of 14 days after schools opened in the fall of 2009. The timing of these events was highly correlated (Spearman correlation coefficient, 0.62; ). This result provides evidence that transmission in schools catalyzes community‐wide transmission. School opening dates can be useful for future pandemic planning, and influenza mitigation strategies should be targeted at school populations before the influenza season.

The Lancet
http://www.thelancet.com/journals/lancet/issue/current
Aug 21, 2010  Volume 376  Number 9741  Pages 565-656

Editorial
Pandemic influenza—(some) reasons to be cheerful?
The Lancet

The Lancet
http://www.thelancet.com/journals/lancet/issue/current
Aug 21, 2010  Volume 376  Number 9741  Pages 565-656

Comment
Rotavirus: realising the potential of a promising vaccine
E Anthony S Nelson, Roger I Glass

Preview
In 2006, two studies that described the efficacy and safety of two new oral rotavirus vaccines were joint winners of The Lancet’s Paper of the Year.1–3 These trials had been done in infants in high-income and middle-income countries in the Americas and Europe, but no efficacy data were available for infants in low-income populations in Africa and Asia where 85% of the more than 500 000 deaths from rotavirus occur.4 Unlike parenteral vaccines, live oral vaccines have behaved differently in high-income and low-income populations because of various immunological factors such as higher titres of transplacental or breast-milk antibodies, host problems related to micronutrient malnutrition, interfering gut flora (tropical enteropathy), intercurrent infections, or an altered distribution of circulating strains.

The Lancet
http://www.thelancet.com/journals/lancet/issue/current
Aug 21, 2010  Volume 376  Number 9741  Pages 565-656

The India HPV-vaccine suspension
Heidi J Larson, Pauline Brocard, Geoffrey Garnett

Preview
In response to demands from advocacy groups, the Indian Government has suspended demonstration projects for HPV vaccination in Andhra Pradesh and Gujarat.1,2 The episode provides salutary lessons about how a lack of public confidence can amplify if not quickly addressed.

The Lancet
http://www.thelancet.com/journals/lancet/issue/current
Aug 21, 2010  Volume 376  Number 9741  Pages 565-656

Articles
Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial
George E Armah, Samba O Sow, Robert F Breiman, Michael J Dallas, Milagritos D Tapia, Daniel R Feikin, Fred N Binka, A Duncan Steele, Kayla F Laserson, Nana A Ansah, Myron M Levine, Kristen Lewis, Michele L Coia, Margaret Attah-Poku, Joel Ojwando, Stephen B Rivers, John C Victor, Geoffrey Nyambane, Abraham Hodgson, Florian Schödel, Max Ciarlet, Kathleen M Neuzil

Preview
Pentavalent rotavirus vaccine is effective against severe rotavirus gastroenteritis in the first 2 years of life in African countries with high mortality in infants younger than 5 years. We support WHO’s recommendation for adoption of rotavirus vaccine into national expanded programmes on immunisation in Africa.

The Lancet Infectious Disease
Sep 2010  Volume 10 Number 9  Pages 577 – 652
http://www.thelancet.com/journals/laninf/issue/current

Review
Guillain-Barré syndrome after exposure to influenza virus
Helmar C Lehmann, Hans-Peter Hartung, Bernd C Kieseier, Richard AC Hughes

Preview
Guillain-Barré syndrome (GBS) is an acute, acquired, monophasic autoimmune disorder of peripheral nerves that develops in susceptible individuals after infection and, in rare cases, after immunisation. Exposure to influenza via infection or vaccination has been associated with GBS. We review the relation between GBS and these routes of exposure. Epidemiological studies have shown that, except for the 1976 US national immunisation programme against swine-origin influenza A H1N1 subtype A/NJ/76, influenza vaccine has probably not caused GBS or, if it has, rates have been extremely low (less than one case per million vaccine recipients). By contrast, influenza-like illnesses seem to be relevant triggering events for GBS. The concerns about the risk of inducing GBS in mass immunisation programmes against H1N1 2009 do not, therefore, seem justified by the available epidemiological data. However, the experiences from the 1976 swine flu vaccination programme emphasise the importance for active and passive surveillance to monitor vaccine safety.

Nature
http://www.nature.com/nature/current_issue.html
Volume 466 Number 7309 pp903-1014  19 August 2010

Editorial
After the pandemic
Despite some mistakes, the World Health Organization handled the flu outbreak well.

New England Journal of Medicine
http://content.nejm.org/current.shtml
August 19, 2010  Vol. 363 No. 8

Special Report
HPV Vaccination Mandates — Lawmaking amid Political and Scientific Controversy

The Pediatric Infectious Disease Journal
September 2010 – Volume 29 – Issue 9
http://journals.lww.com/pidj/pages/currenttoc.aspx

Original Studies
Measles Outbreak Associated With an International Youth Sporting Event in the United States, 2007
Chen, Tai-Ho; Kutty, Preeta; Lowe, Luis E.; Hunt, Elizabeth A.; Blostein, Joel; Espinoza, Rita; Dykewicz, Clare A.; Redd, Susan; Rota, Jennifer S.; Rota, Paul A.; Lute, James R.; Lurie, Perrianne; Nguyen, Michael D.; Moll, Mària; Reef, Susan E.; Sinclair, Julie R.; Bellini, William J.; Seward, Jane F.; Ostroff, Stephen M.
doi: 10.1097/INF.0b013e3181dbaacf

Abstract:
Background: Despite elimination of endemic measles in the United States (US), outbreaks associated with imported measles continue to occur. In 2007, the initiation of a multistate measles outbreak was associated with an imported case occurring in a participant at an international youth sporting event held in Pennsylvania.

Methods: Case finding and contact tracing were conducted. Control measures included isolating ill persons and administering postexposure prophylaxis to exposed persons without documented measles immunity. Laboratory evaluation of suspected cases and contacts included measles serologic testing, viral culture, detection of viral RNA by reverse-transcription polymerase chain reaction, and viral genotyping.

Results: The index case occurred in a child from Japan aged 12 years. Contact tracing among 1250 persons in 8 states identified 7 measles cases; 5 (71%) cases occurred among persons without documented measles vaccination. Epidemiologic and laboratory investigation supported a single chain of transmission, linking the outbreak to contemporaneous measles virus genotype D5 transmission in Japan. Of the 471 event participants, 193 (41%) lacked documentation of presumed measles immunity, 94 (49%) of 193 were US-resident adults, 19 (10%) were non-US-resident adults (aged >18 years), and 80 (41%) were non-US-resident children.

Discussion: Measles outbreaks associated with imported disease are likely to continue in the US. Participants in international events, international travelers, and persons with routine exposure to such travelers might be at greater risk of measles. To reduce the impact of imported cases, high measles, mumps, and rubella vaccine coverage rates should be maintained throughout the US, and support should continue for global measles control and elimination.

Science
http://www.sciencemag.org/current.dtl
27 August 2010  Vol 329, Issue 5995, Pages 985-1112

Reports
Induction of Broadly Neutralizing H1N1 Influenza Antibodies by Vaccination
Chih-Jen Wei, Jeffrey C. Boyington, Patrick M. McTamney, Wing-Pui Kong, Melissa B. Pearce, Ling Xu, Hanne Andersen, Srinivas Rao, Terrence M. Tumpey, Zhi-Yong Yang, and Gary J. Nabel

Abstract
The rapid dissemination of the 2009 pandemic influenza virus underscores the need for universal influenza vaccines that elicit protective immunity to diverse viral strains. Here, we show that vaccination with plasmid DNA encoding H1N1 influenza hemagglutinin (HA) and boosting with seasonal vaccine or replication-defective adenovirus 5 vector encoding HA stimulated the production of broadly neutralizing influenza antibodies. This prime/boost combination increased the neutralization of diverse H1N1 strains dating from 1934 to 2007 as compared to either component alone and conferred protection against divergent H1N1 viruses in mice and ferrets. These antibodies were directed to the conserved stem region of HA and were also elicited in nonhuman primates. Cross-neutralization of H1N1 subtypes elicited by this approach provides a basis for the development of a universal influenza vaccine for humans.

Science
http://www.sciencemag.org/current.dtl
13 August 2010  Vol 329, Issue 5993, Pages 713-876

Perspectives
AIDS/HIV: A Boost for HIV Vaccine Design
Dennis R. Burton1,2 and Robin A. Weiss3

A major roadblock to the development of an effective vaccine against the human immunodeficiency virus (HIV-1) is the lack of an immunogen that elicits broadly protective antibodies (1). Passive transfer studies in animal models have associated protection with neutralizing antibodies and, encouragingly, serum studies show that a subset of HIV-infected individuals produces potent broadly neutralizing antibodies (2). Understanding the viral targets of such antibodies and how they achieve potent and broad neutralization has become a key endeavor in HIV vaccine research. On page 856 of this issue, Wu et al. (3) describe the isolation of particularly potent monoclonal broadly neutralizing antibodies using a novel selection strategy, and on page 811, Zhou et al. (4) solve the crystal structure of the most effective of these antibodies in complex with its target gp120, a viral envelope glycoprotein. These studies further invigorate the currently active field of discovering broadly neutralizing antibodies against HIV (2, 5–7) and provide valuable molecular information for rational vaccine design.

Science Translational Medicine
http://stm.sciencemag.org/content/current
18 August 2010 vol 2, issue 45

Ethics
360 Degrees of Human Subjects Protections in Community-Engaged Research
Lainie Friedman Ross

Abstract
With the introduction of the new National Institutes of Health Roadmap in 2003, there has been a growing emphasis on translational research. Translational research challenges current human subjects protections guidelines that were written in the 1970s and were focused on the protection of the individual participant in a clinical drug trial. Community engagement requires a critical examination of the range of risks that may arise when communities are both participants and partners in research, in order to promote appropriate and effective protection of human subjects as individuals and members of communities. Given that the principal investigator has ultimate responsibility for ensuring the ethical integrity of the research, researchers should be aware of the human subjects protections delineated in the federal regulations that must be fulfilled and the other entities that can help ensure human subjects protections.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 38 pp. 6123-6402 (31 August 2010)

Letter to the Editor
Community-level incentives to increase the use of vaccination services in developing countries: An idea whose time has come?
Pages 6123-6124
Ajay S. Behl, Maya Vijayaraghavan, James D. Nordin, Michael V. Maciosek, Peter M. Strebel

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 38 pp. 6123-6402 (31 August 2010)

Methodology and measurement of the effectiveness of Haemophilus influenzae type b vaccine: Systematic review Review Article
Pages 6128-6136
Rosalyn E. O’Loughlin, Karen Edmond, Punam Mangtani, Adam L. Cohen, Sharmila Shetty, Rana Hajjeh, Kim Mulholland

Abstract
The use of the highly effective Haemophilus influenzae type b (Hib) conjugate vaccine has increased globally. We review the benefits and limitations of studies measuring Hib vaccine effectiveness (VE). We critically examine the case–control approach by assessing the similarities and differences in methodology and findings and discuss the need for future Hib VE studies. In the absence of good surveillance data, vaccine effectiveness studies can play an important role, particularly with the increasing use of pneumococcal vaccine that has not been well tested under field conditions in less developed countries. However, the effectiveness of Hib vaccine has been well documented so the need for future VE Hib studies is minimal.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 38 pp. 6123-6402 (31 August 2010)

High vaccination rates for seasonal and pandemic (A/H1N1) influenza among healthcare workers in Dutch general practice Original Research Article
Pages 6164-6168
Wim Opstelten, Gerrit A. van Essen, Marie-Louise Heijnen, Mireille J.P. Ballieux, Alexander N. Goudswaard

Abstract
In previous years, the influenza vaccination rate among Dutch general practitioners (GPs) was low (36% during the 2007/2008 season). Since 2008, yearly influenza vaccination has been actively recommended for GPs in The Netherlands. Moreover, in 2009 the Dutch government urged healthcare workers to receive additional vaccination against the pandemic influenza (A/H1N1). The effects of these recommendations are unknown. In February 2010, a questionnaire was mailed to random samples of GPs (n = 810) and GP-trainees (n = 300). Vaccination rates were determined and motives and barriers for vaccination were assessed. The response rates for GPs and GP-trainees were 83% and 90%, respectively. In total, 63% of the GPs were vaccinated against seasonal influenza and 85% against pandemic (A/H1N1) influenza. For GP-trainees, these percentages were 47% and 77%, respectively. With regard to the medical staff working in the respondents’ practices, 60% received the seasonal and 76% the pandemic (A/H1N1) influenza vaccine. Reducing the risk of transmitting the virus to vulnerable patients and the individual’s personal protection were the most frequently reported motives for vaccination. Having no medical indication for influenza vaccination and the conviction of being protected against influenza because of frequent professional exposure to the virus were the most frequently mentioned reasons for not being vaccinated. In conclusion, the seasonal influenza vaccination rate among Dutch GPs has risen considerably since the previous survey and the vaccination rate against pandemic (A/H1N1) influenza was very high. Moreover, Dutch GPs were convinced that influenza vaccination will reduce the risk of transmitting the virus to their patients.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 38 pp. 6123-6402 (31 August 2010)

Acceptability of Internet adverse event self-reporting for pandemic and seasonal influenza immunization among health care workers Original Research Article
Pages 6199-6202
Keswadee Lapphra, Simon Dobson, Julie A. Bettinger

Abstract
This study assessed the acceptability and feasibility of Internet self-reporting for adverse events following pandemic and seasonal influenza immunization among 270 health care workers at a tertiary care children’s and women’s hospital in fall 2009. Participants responded to an online questionnaire 72 h after vaccine receipt. Non-responders were sent a reminder email 8–10 days after vaccine receipt, followed by a telephone call for those who did not respond online. The overall online response rate was high (88%). Participants rated the online self-report easy to use and would be willing to use it again. The high response rate and acceptability of the online report method suggest that web-based self-reporting for adverse event following immunization (AEFI) has the potential for rapid assessments of AEFI in mass or new immunization programs.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 38 pp. 6123-6402 (31 August 2010)

Is a mass immunization program for pandemic (H1N1) 2009 good value for money? Evidence from the Canadian Experience Original Research Article
Pages 6210-6220
Beate Sander, Chris T. Bauch, David Fisman, Robert A. Fowler, Jeffrey C. Kwong, Andreas Maetzel, Allison McGeer, Janet Raboud, Damon C. Scales, Marija Zivkovic Gojovic, Murray Krahn

Abstract
In response to the pandemic H1N1 influenza 2009 outbreak, many jurisdictions undertook mass immunization programs that were among the largest in recent history. The objective of this study was to determine the cost-effectiveness of the mass H1N1 immunization program in Ontario, Canada’s most populous province (population 13,000,000). This analysis suggests that a mass immunization program as carried out in Ontario and many other high-income health care systems in response to H1N1 2009 was effective in preventing influenza cases and health care resource use and was also highly cost-effective despite the substantial program cost.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 38 pp. 6123-6402 (31 August 2010)

Modeling the national pediatric vaccine stockpile: Supply shortages, health impacts and cost consequences Original Research Article
Pages 6318-6332
Sundar S. Shrestha, Gregory S. Wallace, Martin I. Meltzer

Abstract
Pediatric vaccine stockpiles have been in place in the U.S. since 1983 to address the potential disruption in supply of routine pediatric vaccines. Increases in the number of vaccines recommended for pediatric and adolescent patients have increased the cost of stocking and maintaining the stockpile. Based on a spreadsheet-based model (VacStockpile) we developed, we estimated potential supply shortages of 14 stockpiled vaccines as of August 1, 2008 and its health and financial impacts under various shortage and stockpile scenarios. To illustrate the implications of policy options, we compared “high” to “low” stockpile scenarios. The high stockpile scenario ensures a 6-month vaccine supply to vaccinate all children according to recommended schedules. The low scenario comprised of 50% of the high scenario or existing stocks, whichever is smaller. For each vaccine, we used a weighted average of five shortage scenarios ranging from 0% to 100%, in 25% increments. Demand for each vaccine was based on current distribution or birth cohort size. The probabilities of shortages were based on number of manufacturers, market stability, history of manufacturing problems, and production complexity. CDC contract prices were used to estimate costs. Expert opinion and literature provided estimates of health impacts due to shortages. Applying the probabilities of shortages to all vaccines in a single year, the “low” scenario could cost $600 million, with 376,000 vaccine-preventable cases occurring and 1774 deaths. The “high” scenario could cost $2 billion, with an additional $1.6 billion initial stocking, and result in 7100 vaccine-preventable cases occurring and 508 deaths. Based on the assumptions in the model, there is the potential for large differences in outcomes between the scenarios although some outcomes could potentially be averted with measures such as catch-up campaigns after shortages. Using the VacStockpile policy makers can readily evaluate the implications of assumptions and decide which set of assumptions they wish to use in planning.

Vaccine
Volume 28, Issue 37  pp. 5931-6122 (23 August 2010)

Short Communications
Attitudes towards vaccination against seasonal influenza of health-care workers in primary health-care settings in Greece
Pages 5931-5933
Xanthi Dedoukou, Georgios Nikolopoulos, Antonios Maragos, Sophia Giannoulidou, Helena C. Maltezou

Abstract
Vaccination of health-care workers (HCWs) against seasonal influenza has been consistently recommended worldwide in order to prevent nosocomial transmission and ensure delivery of health-care services during outbreaks. We describe the effects of a nationwide campaign to promote influenza vaccination among HCWs working in primary health-care centers in Greece. During 2008–2009 the mean vaccination rate among HCWs in primary health-care centers was 22.8% (range: 0–100%), with a considerable variability among Health Districts (range: 12.66–54.68%). Logistic regression showed that history of previous influenza vaccination, influenza vaccination the previous season, being a physician and a larger number of employees were associated with increased vaccination rates. Main reason for vaccination was self-protection (75.90%), while main reasons for refusing vaccination were belief that they are not at risk for contracting influenza (44.5%), doubts about vaccine effectiveness (20.79%), and fear of vaccine adverse effects (20.33%).

Vaccine
Volume 28, Issue 37  pp. 5931-6122 (23 August 2010)

Economics of employer-sponsored workplace vaccination to prevent pandemic and seasonal influenza Original Research Article
Pages 5952-5959
Bruce Y. Lee, Rachel R. Bailey, Ann E. Wiringa, Abena Afriyie, Angela R. Wateska, Kenneth J. Smith, Richard K. Zimmerman

Abstract
Employers may be loath to fund vaccination programs without understanding the economic consequences. We developed a decision analytic computational simulation model including dynamic transmission elements that estimated the cost–benefit of employer-sponsored workplace vaccination from the employer’s perspective. Implementing such programs was relatively inexpensive (<$35/vaccinated employee) and, in many cases, cost saving across diverse occupational groups in all seasonal influenza scenarios. Such programs were cost-saving for a 20% serologic attack rate pandemic scenario (range: −$15 to −$995) per vaccinated employee) and a 30% serologic attack rate pandemic scenario (range: −$39 to −$1,494 per vaccinated employee) across all age and major occupational groups.

Vaccine
Volume 28, Issue 36   pp. 5757-5930 (16 August 2010)

Editorial
Mandating influenza vaccination for health care workers: Putting patients and professional ethics over personal preference
Pages 5757-5759
Gregory A. Poland

[Editor’s Note: Vaccines: The Week in Review will resume publication on 30 August 2010 and will provide a summary of news, announcements and journal activity covering the intervening period from 9 August 2010]

The WHO continues to issue weekly updates and occasional briefing notes on the H1N1 pandemic at http://www.who.int/csr/disease/swineflu/en/index.html

Pandemic (H1N1) 2009 – update 112
Weekly update
6 August 2010

As of 1 August 2010, worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18449 deaths….

Situation update:
The overall situation remains largely unchanged since the last update. Globally, pandemic influenza transmission remains most active in parts of South Asia and in limited areas of tropical South and Central America. In the temperate zone of the southern hemisphere, overall seasonal and pandemic influenza activity remains low, except in South Africa, where peak wintertime influenza transmission due to circulating seasonal influenza viruses (H3N2 and type B) might have recently occurred. Seasonal influenza viruses, particularly H3N2 viruses, continue to circulate in parts of Central America, East Africa, and Southeast Asia…

http://www.who.int/csr/don/2010_08_06/en/index.html

[Editor’s Note: We will occasionally include announcements by commercial organizations that pertain to vaccine ethics and policy issues we are tracking, such as strategies to enhance influenza vaccine uptake. We make no endorsement of the strategy or assessment of its potential impact or propriety.]

Walgreens Offering Flu Shot Gift Cards

Walgreens, describing itself as “the largest retail provider of flu prevention services with more than 24,000 certified immunizers,” said it introduced the flu shot gift card as “a way to help more Americans stay well throughout the upcoming flu season by giving the gift of a flu shot.” Kermit R. Crawford, Walgreens executive vice president of pharmacy, commented, “Whether you have college kids going back to school or have friends, co-workers or family members you want to protect this flu season, the flu shot gift card is a thoughtful way to make it even easier for them to get a flu shot at Walgreens. While millions of Americans are diligent about getting a flu shot every year, gift cards may also help those who might not otherwise take the initiative to get a flu shot. With these gift cards, you can help protect those closest to you.”

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100803006837&newsLang=en

The Pharmaceutical Research and Manufacturers of America (PhRMA) issued the following statement today regarding efforts to enhance transparency:

“PhRMA and its member companies have a longstanding commitment to the ethical conduct of clinical trials and to increasing transparency by reporting more information about clinical trials.

“We are always looking for ways to enhance our voluntary industry codes and, to this end, supported a joint position statement in June with the International Federation of Pharmaceutical Manufacturers & Associations to enhance publication of clinical research. The joint statement calls for publication of summaries of all Phase III clinical trials and all clinical trials of significant medical importance in peer-reviewed journals.

“PhRMA’s commitment to enhanced transparency of clinical research is in addition to our member companies’ unanimous support of PhRMA’s recently revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, which call for registration and online publication of summaries of all clinical trials in patients for approved medicines. What’s more, PhRMA’s Clinical Trial Principles also call for our member companies to disclose summaries of all clinical trials in patients for investigational medicines whose development programs have been discontinued.

“It is our hope that the additional transparency of PhRMA’s member companies will benefit patients and healthcare professionals. PhRMA has also supported continued development of the federal clinical trial database, ClinicalTrials.gov.

“The study, published today by the ‘Annals of Internal Medicine,’ demonstrates one more way that patients and the public health can benefit from increased transparency: The study would not have been possible without the large volume of information about ongoing and completed industry-sponsored clinical trials provided through ClinicalTrials.gov and supported by PhRMA and its member companies.

“While our review of the study continues, it is important to note that the authors acknowledge that industry-funded trials tended to be for later stages in the lengthy drug development process. As the authors note, ‘Later-phase trials may be more likely to have positive outcomes, because there is more certainty about the drug’s efficacy and safety at this advanced stage in the drug-development cycle.’

“Developing a new medicine is costly, time-consuming and the odds of success are quite low. At the earliest stage of discovery, researchers closely analyze up to 10,000 compounds of interest. By the time clinical tests occur in humans, more than 10 years later, promising therapies have been winnowed from the thousands to single digits.

“PhRMA companies lead the world in the search for new cures. Our member companies invested an estimated $45.8 billion in 2009 alone to discover and to develop new medicines.” (August 2, 2010)

http://www.phrma.org/news/news/phrma_statement_supporting_enhanced_transparency

The Weekly Epidemiological Record (WER) for 6 August 2010, vol. 85, 32 includes: Rabies vaccines: WHO position paper

http://www.who.int/wer/2010/wer8532.pdf

Journal of Infectious Diseases
1 September 2010  Volume 202, Number 5 http://www.journals.uchicago.edu/toc/jid/current

EDITORIAL COMMENTARY
Mumps Control Today
M. Patricia Quinlisk
Iowa Department of Public Health, Des Moines
Free: http://www.journals.uchicago.edu/doi/full/10.1086/655395

Viruses
Seroprevalence of Antibody to Mumps Virus in the US Population, 1999–2004
Preeta K. Kutty, Deanna M. Kruszon-Moran, Gustavo H. Dayan, James P. Alexander, Nobia J. Williams, Philip E. Garcia, Carole J. Hickman, Geraldine M. McQuillan, and William. J. Bellini

Abstract
Background.In 2006, the largest mumps outbreak in the United States in 20 years occurred. To understand prior mumps seroprevalence and factors associated with the presence of antibody to mumps virus, data from the 1999–2004 National Health and Nutrition Examination Survey (NHANES) were analyzed.

Methods.A mumps virus–specific enzyme immunoassay was used to measure the seroprevalence of serum immunoglobulin G (IgG) antibody among NHANES participants aged 6–49 years. Participants were grouped on the basis of 10‐year birth cohorts, 95% confidence intervals (CIs) were calculated using SUDAAN software, and logistic regression was used to identify independent predictors.

Results.The overall age‐adjusted seroprevalence of IgG antibody to mumps virus during 1999–2004 was 90.0% (95% CI, 88.8%–91.1%). Seroprevalence was higher among US-born non-Hispanic blacks (96.4% [95% CI, 95.5%–97.2%]) and non–US-born Mexican Americans (93.7% [95% CI, 92.0%–95.2%]). Seroprevalence was significantly lower in the 1967–1976 birth cohort (85.7% [95% CI, 83.5%–87.8%]). The variables sex, education, and race/ethnicity/birthplace were independent predictors in at least 1 of the birth cohorts.

Conclusions.The overall estimate of 90.0% is at the lower end of the estimated population immunity (90%–92%) needed to achieve herd immunity. Lower seroprevalence among groups suggest that they represent populations at an increased risk. For mumps control, high vaccine coverage and high population immunity must be achieved and maintained.

Nature Medicine
August 2010, Volume 16 No 8
http://www.nature.com/nm/index.html

Technical Reports
Dissolving polymer microneedle patches for influenza vaccination
Sean P Sullivan, Dimitrios G Koutsonanos, Maria del Pilar Martin, Jeong Woo Lee, Vladimir Zarnitsyn, Seong-O Choi, Niren Murthy, Richard W Compans, Ioanna Skountzou & Mark R Prausnitz

Abstract
Influenza prophylaxis would benefit from a vaccination method enabling simplified logistics and improved immunogenicity without the dangers posed by hypodermic needles. Here we introduce dissolving microneedle patches for influenza vaccination using a simple patch-based system that targets delivery to skin’s antigen-presenting cells. Microneedles were fabricated using a biocompatible polymer encapsulating inactivated influenza virus vaccine for insertion and dissolution in the skin within minutes. Microneedle vaccination generated robust antibody and cellular immune responses in mice that provided complete protection against lethal challenge. Compared to conventional intramuscular injection, microneedle vaccination resulted in more efficient lung virus clearance and enhanced cellular recall responses after challenge. These results suggest that dissolving microneedle patches can provide a new technology for simpler and safer vaccination with improved immunogenicity that could facilitate increased vaccination coverage.

PLoS Medicine
(Accessed 9 August 2010)
http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1c2a2501181c#results

Ecology: A Prerequisite for Malaria Elimination and Eradication
Heather M. Ferguson, Anna Dornhaus, Arlyne Beeche, Christian Borgemeister, Michael Gottlieb, Mir S. Mulla, John E. Gimnig, Durland Fish, Gerry F. Killeen Policy Forum, published 03 Aug 2010
doi:10.1371/journal.pmed.1000303
Summary Points
– Existing front-line vector control measures, such as insecticide-treated nets and residual sprays, cannot break the transmission cycle of Plasmodium falciparum in the most intensely endemic parts of Africa and the Pacific
– The goal of malaria eradication will require urgent strategic investment into understanding the ecology and evolution of the mosquito vectors that transmit malaria
– Priority areas will include understanding aspects of the mosquito life cycle beyond the blood feeding processes which directly mediate malaria transmission
– Global commitment to malaria eradication necessitates a corresponding long-term commitment to vector ecology

Assessing Strategy and Equity in the Elimination of Malaria
Naman K. Shah Essay, published 03 Aug 2010
doi:10.1371/journal.pmed.1000312
Summary Points
– Recent dialogue around malaria elimination is laden with implicit assumptions.
– While the elimination of malaria may be both feasible and equitable in a few areas, globally the control tools that successfully reduce malaria burden may not be sufficient to interrupt transmission over long periods of time.
– A malaria elimination strategy may inadvertently increase inequity.

WHO said Horn of Africa is marking one year of being polio-free, following an outbreak of polio in Ethiopia, Kenya, Uganda, and Sudan in 2008-2009. The countries in the region “responded rapidly to the outbreak and returned to their polio-free status.” They join neighbour Somalia, which has now been polio-free for three years, WHO said.

The “Global Polio Eradication Initiative: new strategy” is available at:

http://www.polioeradication.org/content/publications/GPEI.StrategicPlan.2010-2012.ENG.May.2010.pdf

The WHO continues to issue weekly updates and occasional briefing notes on the H1N1 pandemic at http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 – update 111
Weekly update
30 July 2010

As of 25 July 2010, worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18398 deaths….

Situation update:
Summary: Worldwide, overall pandemic and seasonal influenza activity remains low. In the southern hemisphere (where the winter season is in progress), current influenza activity remains variable: ranging from low and stable activity in Chile and Argentina, to low but increasing activity in Australia and New Zealand, to elevated and recently peaked activity in South Africa. Significant seasonal and pandemic influenza virus transmission continues to be detected at variable levels across parts of the tropics, particularly in several countries of the Americas and South and Southeast Asia…

More at: http://www.who.int/csr/don/2010_07_30/en/index.html

The MMWR Weekly for July 30, 2010 / Vol. 59 / No. 29 includes:

– Update: Influenza Activity — United States, 2009–10 Season

– Regional Influenza A (H1N1) 2009 Monovalent Vaccination Campaign — Skokie, Illinois, October 16–December 31, 2009

The U.S. Food and Drug Administration announced approval of vaccines for the 2010-2011 influenza season in the United States. The FDA noted that each year, “experts from FDA, World Health Organization, CDC, and other institutions study virus samples and patterns collected worldwide to identify strains likely to cause the most illness during the upcoming season. Based on that information and the recommendations of FDA’s Vaccines and Related Biological Products Advisory Committee, manufacturers are including the respective three strains in the 2010-2011 vaccines:

– A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)

– A/Perth /16/2009 (H3N2)-like virus

– B/Brisbane/60/2008-like virus

The brand names and manufacturers for the upcoming season’s vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220718.htm

The World Vaccine Congress Asia named Dr. John D. Clemens, Director-General of the International Vaccine Institute (IVI) as “Vaccine Executive of the Year” at its Vaccine Industry Excellence (ViE) Asia 2010 Awards in Singapore. IVI, headquartered in Seoul, Korea, is described as “the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines for the world’s poorest people, especially children.”  The award citation stated: “Dr. Clemens was recognized for exhibiting visionary leadership with an outstanding degree of commitment to disease prevention and control with vaccine research and development.” The organization said the finalists included Weidong Yin, CEO of the Chinese vaccine manufacturer Sinovac Biotech, and Cyrus Poonawalla, Chairman of the Serum Institute of India, noting that Dr. Clemens “emerged as the winner in the second round of voting, which involved 10,000 voters.”

http://www.ivi.org/event_news/news_view.asp?enid=112

The Weekly Epidemiological Record (WER) for 30 July 2010, vol. 85, 31 (pp 293-308) includes: Cholera, 2009

http://www.who.int/wer/2010/wer8531.pdf

Emerging Infectious Diseases
Volume 16, Number 8–August 2010
http://www.cdc.gov/ncidod/EID/index.htm

Research
Responses to Pandemic (H1N1) 2009, Australia
K. Eastwood et al.
Abstract
In 2007, adults in Australia were interviewed about their willingness to comply with potential health interventions during a hypothetical influenza outbreak. After the first wave of pandemic (H1N1) 2009 in Australia, many of the same respondents were interviewed about behavior and protection measures they actually adopted. Of the original 1,155 respondents, follow-up interviews were conducted for 830 (71.9%). Overall, 20.4% of respondents in 2009 had recently experienced influenza-like illness, 77.7% perceived pandemic (H1N1) 2009 to be mild, and 77.8% reported low anxiety. Only 14.5% could correctly answer 4 questions about influenza virus transmission, symptoms, and infection control. Some reported increasing handwashing (46.6%) and covering coughs and sneezes (27.8%) to reduce transmission. Compared with intentions reported in 2007, stated compliance with quarantine or isolation measures in 2009 remained high. However, only respondents who perceived pandemic (H1N1) 2009 as serious or who had attained higher educational levels expressed intention to comply with social distancing measures.

Pandemic (H1N1) 2009 Surveillance, New York, New York, April–July 2009
S. Balter et al.
Abstract
On April 23, 2009, the New York City Department of Health and Mental Hygiene (DOHMH) was notified of a school outbreak of respiratory illness; 2 days later the infection was identified as pandemic (H1N1) 2009. This was the first major outbreak of the illness in the United States. To guide decisions on the public health response, the DOHMH used active hospital-based surveillance and then enhanced passive reporting to collect data on demographics, risk conditions, and clinical severity. This surveillance identified 996 hospitalized patients with confirmed or probable pandemic (H1N1) 2009 virus infection from April 24 to July 7; fifty percent lived in high-poverty neighborhoods. Nearly half were <18 years of age. Surveillance data were critical in guiding the DOHMH response. The DOHMH experience during this outbreak illustrates the need for the capacity to rapidly expand and modify surveillance to adapt to changing conditions.

Pandemic (H1N1) 2009 Surveillance in Marginalized Populations, Tijuana, Mexico
T. Rodwell et al.

Quarantine Methods and Prevention of Secondary Outbreak of Pandemic (H1N1) 2009
C.-Y. Chu et al.

Pandemic (H1N1) 2009 Vaccination and Class Suspensions After Outbreaks, Taiwan
P.-R. Hsueh et al.

Effects of School Closures during Pandemic (H1N1) 2009, Pennsylvania
T. Gift et al.

Conference Summary

One Health Approach to Influenza: Assessment of Critical Issues and Options
T. F. Powdrill et al.
A task force of experts on influenza, public health, and animal health met at the conference One Health Approach to Influenza: Assessment of Critical Issues and Options in Washington, DC, on December 1–2, 2009. These experts discussed the role of the One Health approach in preparing for and responding to an influenza pandemic or other emerging zoonotic disease by using pandemic (H1N1) 2009 as a case study. The meeting was convened by the US Department of Homeland Security National Center for Foreign Animal and Zoonotic Disease Defense, and the National Institute of Allergy and Infectious Diseases/National Institutes of Health Western Regional Center of Excellence for Biodefense and Emerging Infectious Diseases.

The One Health concept is the realization that human, animal, and environmental health are interrelated. In practice, it is imperative to implement a One Health approach to high-consequence zoonotic diseases. Although pandemic (H1N1) 2009 virus has primarily affected humans (with some documented human-to-animal transmission), the genesis of this circulating human virus involved reassortment of viral genomic segments from human, porcine, and avian influenza virus lineages. The task force focused on 4 topics: 1) epidemiology and surveillance, 2) transmission dynamics, 3) immunobiology and vaccines, and 4) molecular approaches and pathobiology.

Human Vaccines
Volume 6, Issue 8  August 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/8/

Reviews
Pricing of new vaccines

Bruce Y. Lee and Sarah M. McGlone

New vaccine pricing is a complicated process that could have substantial long-standing scientific, medical, and public health ramifications. Pricing can have a considerable impact on new vaccine adoption and, thereby, either culminate or thwart years of research and development and public health efforts. Typically, pricing strategy consists of the following ten components: 1. Conduct a target population analysis; 2. Map potential competitors and alternatives; 3. Construct a vaccine target product profile (TPP) and compare it to projected or actual TPPs of competing vaccines; 4. Quantify the incremental value of the new vaccine’s characteristics; 5. Determine vaccine positioning in the marketplace; 6. Estimate the vaccine price-demand curve; 7. Calculate vaccine costs (including those of manufacturing, distribution, and research and development); 8. Account for various legal, regulatory, third party payer, and competitor factors; 9. Consider the overall product portfolio; 10. Set pricing objectives; 11. Select pricing and pricing structure. While the biomedical literature contains some studies that have addressed these components, there is still considerable room for more extensive evaluation of this important area.

Human Vaccines
Volume 6, Issue 8  August 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/8/

Short Report
The Spanish human papillomavirus vaccine consensus group: A working model

Javier Cortés-Bordoy and Federico Martinon-Torre

Successful implementation of Human Papillomavirus (HPV) vaccine in each country can only be achieved from a complementary and synergistic perspective, integrating all the different points of view of the diverse related professionals. It is this context where the Spanish HPV Vaccine Consensus Group (Grupo Español de Consenso sobre la Vacuna VPH, GEC-VPH) was created. GEC-VPH philosophy, objectives and experience are reported in this article, with particular attention to the management of negative publicity and anti-vaccine groups. Initiatives as GEC-VPH -adapted to each country’s particular idiosyncrasies- might help to overcome the existing barriers and to achieve wide and early implementation of HPV vaccination.

The Lancet Infectious Disease
Aug 2010  Volume 10  Number 8  Pages 505 – 576
http://www.thelancet.com/journals/laninf/issue/current

Leading Edge
WHO failing in duty of transparency
The Lancet Infectious Diseases

[This editorial carries The Lancet Infectious Disease’s view of the management of the H1N1 pandemic with a focus on WHO transparency]