WHO: Pandemic (H1N1) 2009 – update 84 Weekly 22 January 2010

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

Pandemic (H1N1) 2009 – update 84
Weekly update
22 January 2010

As of 17 January 2010, worldwide more than 209 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 14142 deaths.

WHO is actively monitoring the progress of the pandemic through frequent consultations with the WHO Regional Offices and member states and through monitoring of multiple sources of information.

Situation update:
The overall situation in largely unchanged since last week. The most intense transmission of pandemic influenza virus continues to occur in North Africa, South Asia, and in limited areas of Eastern Europe. Overall pandemic influenza activity in the temperate northern hemisphere peaked between late October and late November 2009 and has continued to decline since…

More at: http://www.who.int/csr/don/2010_01_22/en/index.html

WHO Director-General Report: Progress in public health during the previous decade, major challenges ahead

WHO published the report by the Director-General to the Executive Board at its 126th session in Geneva, Switzerland on 18 January 2010. We excerpt a portion of the speech which addresses immunization issues and the H1Ni pandemic below. Dr. Chan’s full speech text is available at the link below and is titled:

Progress in public health during the previous decade and major challenges ahead

“…We are at the start of the second decade of the 21st century. And we are just five years away from 2015. A report on progress towards the health-related Millennium Development Goals is on your agenda.

Several other reports describe activities that are contributing to achievement of the Goals or point to specific challenges that need to be addressed. As these reports show, progress in individual countries tends to be greatest in the better-off populations. We are still not doing enough to improve life for the most vulnerable and the poorest of the poor.

At the international level, the picture is mixed, and the African region must continue to be a focus of particular concern. But there are many bright and motivating examples of success everywhere.

Some of these examples come from big-picture trends. Towards the end of last year, WHO and other agencies issued substantial reports on trends for HIV/AIDS, tuberculosis, malaria, vaccines and immunization, and the health of children.

You will be familiar with the positive trends in all these areas. The progress is sometimes fragile, threatened by factors ranging from drug resistance to uncertain funding for the future. But the trends are definitely positive. While optimism about the malaria situation must be cautious, this is the first time, in decades, that we are getting some good news. This, too, is progress.

We can all be proud that the drive to reach international health commitments has never faltered, even at a time of multiple global crises on multiple fronts.

Apart from these big-picture trends, reports prepared for this session cover many specific indicators of progress. Vitamin A supplementation has been implemented as a life-saving measure in 66 of 68 countries with a high burden of child deaths. Since 2000, measles deaths have dropped by 78%. As the report on this item concludes, measles eradication is achievable. If we want to do this, we can.

By 2007, 98% of reported tuberculosis cases were being diagnosed and treated in DOTS programmes. WHO Child Growth Standards have been adopted by more than 100 countries. This, in turn, has led to increased investment in programmes to reduce undernutrition, but also to tackle the growing problem of childhood obesity. As I have said on many occasions, what gets measured gets done.

Ten years into this new century, we are seeing signs that aid for health development can bring solid results. Equally important, in the drive to reach a limited number of time-bound health goals, fundamental problems are being uncovered, and solutions are being found that benefit public health across the board.

We are making progress, as the reports before you show. We need to keep on setting our sights higher, aiming to do more, for more and more people.

Ladies and gentlemen,

For me, the best health news of the previous decade is the fact that the long overdue influenza pandemic has been so moderate in its impact. Had the pandemic taken another course, the agenda for this session would have looked very different. Had the virus mutated to a more virulent form, we would not be talking about forging ahead. We would be standing still or dealing with serious setbacks.

We have been fortunate since the very emergence of the new H1N1 virus, and have remained fortunate up to now. The virus initially spread in countries with good surveillance systems. The honesty and speed of early reporting set the standard for the international response.

The virus did not mutate to a more virulent form. Resistance to oseltamivir did not become widespread. The vaccine proved safe and a close match with circulating virus. Things could have gone wrong in any of these areas.

We were fortunate in other ways. This is the first pandemic to occur since the revolution in communications and information technologies. For the first time in history, the international community could watch a pandemic unfold, and chart its evolution, in real time.

The amount of data that have been collected since April of last year, and the number of research reports and studies that have been published, have been remarkable. This quick collection of information has allowed WHO to issue treatment guidelines, track the epidemiology, and keep a close watch for mutations, including those that confer resistance to antiviral drugs.

When the history of this pandemic is written, I believe that the speed of actions taken by governments to protect their populations will earn the highest marks. Though the burden on emergency rooms and intensive care units has been heavy, nearly all health systems have coped well. Let me pay tribute to all the health care workers who have worked tirelessly to care for patients.

The early standard of rapid and transparent reporting was upheld, and the sharing of information, diagnostic support, test kits, and viruses has been commendably generous. To date, well over 23,000 viruses and other specimens have been submitted to WHO network laboratories for analysis.

During any public health emergency, health officials must make urgent, often far-reaching decisions in an atmosphere of considerable scientific uncertainty. Given our duty to safeguard public health, the tendency of officials facing such a situation is nearly always to err on the side of caution. I believe we would all rather see a moderate pandemic with ample supplies of vaccine than a severe pandemic with inadequate supplies of vaccine.

In some countries in the northern hemisphere with good surveillance systems, the pandemic appears to be easing. The worst may be over. But it would be unwise for anyone to reach firm conclusions before April, when the normal influenza season usually ends. There is still quite a lot of winter left.

In addition, we cannot predict what will happen between now and later in the year, when the southern hemisphere enters its influenza season and the virus becomes more transmissible.

Data for most parts of Africa are sparse. We are concerned that some countries in the western part of the continent remain susceptible to intense waves of transmission. We do not know for sure, but we are keeping a careful watch.

Population susceptibility to infection by a new virus drives the dynamics of an influenza pandemic. This is the critical question. Are there enough susceptible people left to sustain further waves of community-wide transmission? At present, we simply do not have enough data to answer this question with certainty. Studies are, however, under way.

We can estimate how much immunity has been conferred through vaccination. But knowing how much natural immunity has been acquired through infection is more difficult, especially given the very mild nature of illness in the vast majority of patients. Some infections produced no symptoms, and quick surveys of influenza-like illness will not capture these infections.

In short: I believe that what most countries are doing, that is, urging their populations to get vaccinated, is the prudent public health approach. Each country has to assess its own epidemiological situation and the needs and concerns of its citizens. For developing countries concerned about their lack of access to pandemic vaccines, WHO is ramping up its donation programme.

This pandemic has also been the first major test of the revised International Health Regulations. They have given the world an orderly, rules-based way to respond, and this has been an asset. With few exceptions, social and economic disruptions have been far less significant than feared. Another strength of the International Health Regulations is its system of checks and balances. They ensure that no one, myself included, has unfettered power.

Although the virus has not yet delivered any devastating surprises, we have seen some surprises on other fronts. We anticipated problems in producing enough vaccine fast enough, and this did indeed happen. But we did not anticipate that people would decide not to be vaccinated.

I mentioned the revolution in communications and information technologies. In today’s world, people can draw on a vast range of information sources. People make their own decisions about what information to trust, and base their actions on those decisions.

The days when health officials could issue advice, based on the very best medical and scientific data, and expect populations to comply, may be fading. It may no longer be sufficient to say that a vaccine is safe, or testing complied with all regulatory standards, or a risk is real.

In my view, this is a new communications challenge that we may need to address. As the items on your agenda show, persuading people to adopt healthy behaviours is one of the biggest challenges in public health.

In terms of managing public perceptions, part of the problem arises from the big difference between what was expected, after watching the highly lethal H5N1 virus for so long, and what fortunately happened. An event similar to the 1918 pandemic was feared, when what actually happened is probably closer to the 1957 or 1968 pandemics.

Let me introduce a word of caution. Reliable estimates of the number of deaths and the mortality rate during the current pandemic will not be possible until one to two years after the pandemic has ended.

Let me reassure you on a final point. This has been the most closely watched and carefully scrutinized pandemic in history. We will have a wealth of new knowledge as a result. It is natural that every decision or action that shaped the response will likewise be closely and carefully scrutinized.

WHO can withstand this scrutiny…”

http://www.who.int/dg/speeches/2010/executive_board_126_20100118/en/index.html

PATH welcomes GSK announcements on RTS,S malaria vaccine candidate

PATH said it welcomed announcements made by GlaxoSmithKline (GSK) CEO Andrew Witty concerning sustainable pricing and vaccine donations for RTS,S malaria vaccine candidate, currently in a large, late-stage clinical trial that is supported by the PATH Malaria Vaccine Initiative (MVI). Christian Loucq, director of MVI, said, “The announcements…are positive steps in the long pathway from discovery to delivery of RTS,S. These commitments help to illustrate the potential of product development partnerships—like the one between MVI and GSK Biologicals—for meeting the health needs of people in developing countries.”

In a speech at the Council on Foreign Relations, Mr. Witty “committed to setting a price for RTS,S that would cover GSK’s costs and generate a small return that would be re-invested in research and development for next-generation malaria vaccines and vaccines against other neglected diseases. GSK also committed to donating at least 12.5 million doses of RTS,S (if approved for use) to PATH.”

PATH said that GSK Biologicals, the vaccine division of GSK, and PATH signed a collaboration agreement in 2001 to pursue the pediatric clinical development of RTS,S in Africa. To advance the development program, African research centers in five countries, and collaborating institutions, joined the partnership. Centers in two additional African countries have joined for the Phase 3 trial. Together, these partners comprise the Clinical Trials Partnership Committee and lead the clinical development of RTS,S, PATH said.

Christopher J. Elias, president and CEO of PATH, commented, “Like other PATH programs, MVI’s mission goes beyond development of a health intervention to ensuring that it is available at the lowest price possible and readily accessible to all who need it. In light of the commitments made today and as we get closer to the day that the RTS,S vaccine candidate—if all goes well—could be available for use, we look forward to working with GSK, as well as other global partners, to ensure that malaria vaccines are available to the children that need them most.”

20 January 2010. http://www.path.org/news/an100120-MVI.php

IVI announces the licensure of oral cholera vaccine

IVI announced the licensure of Shanchol, an oral cholera vaccine, in India in 2009, noting that “efforts to accelerate the global use of new generation cholera vaccines gained significant momentum with the licensure. IVI said its scientists developed this vaccine, with funding from the Bill & Melinda Gates Foundation, “by significantly modifying a vaccine used and produced only in Vietnam so that it meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines.”

http://www.ivi.org/popup/files/ocv_article.pdf

Weekly Epidemiological Record (WER) for 22 January 2009

The Weekly Epidemiological Record (WER) for 22 January 2009, vol. 85, 4 (pp 21–28) includes: Preliminary review of D222G amino acid substitution in the haemagglutinin of pandemic influenza A (H1N1) 2009 viruses; African Programme for Onchocerciasis Control – report of the sixth meeting of national task forces, October 2009

http://www.who.int/wer/2010/wer8504.pdf

MMWR Weekly for January 22, 2010

The MMWR Weekly for January 22, 2010 / Vol. 59 / No. 2 includes:

Prevalence of Abnormal Lipid Levels Among Youths — United States, 1999–2006

Transfusion-Related Transmission of Yellow Fever Vaccine Virus — California, 2009

Update: Influenza Activity — United States, August 30, 2009–January 9, 2010

Interim Results: Influenza A (H1N1) 2009 Monovalent Vaccination Coverage — United States, October–December 2009

http://www.cdc.gov/mmwr/mmwr_wk.html

Mask Use, Hand Hygiene, and Seasonal Influenza-Like Illness

Journal of Infectious Diseases
15 February 2010  Volume 201, Number 4
http://www.journals.uchicago.edu/toc/jid/current

Editorial Commentaries
Unmasking the Confusion of Respiratory Protection to Prevent Influenza-Like Illness in Crowded Community Settings
Titus L. Daniels and Thomas R. Talbot
http://jid.oxfordjournals.org/content/201/4/483.full
Extract
…Fortunately, several well-designed in vivo studies have now been published that conclude there is no significant advantage of one mask type over another for respiratory protection against influenza or ILI. Loeb et al [10] conducted a noninferiority randomized, controlled study of mask use among nurses in Ontario, Canada, which demonstrated that the attack rate of laboratory-confirmed influenza was not different between those who wore facemasks and those who wore N95 respirators as respiratory protection (23.6% vs 22.9%, respectively). Although unable to demonstrate a protective benefit of mask use in households, MacIntyre et al [3] did note that adherence to mask use (face mask or N95 respirator) was associated with a reduction in ILI (hazard ratio, 0.26; 95% CI, 0.09–0.77).

Taken together with the Aiello et al [1] study, these data suggest that influenza transmission and ILI can be effectively interrupted with the use of a face mask and hand hygiene in settings of close contact. In addition, these data could inform the ongoing debate concerning respiratory protection for HCWs. Although the majority of data supporting prevention of influenza transmission with face masks has been derived from community sites, interactions between HCWs and patients are generally of a magnitude similar to what would be encountered in domestic settings. One could even argue that the household setting poses greater risk of transmission as a result of continued, prolonged exposure, whereas most HCW encounters with patients are brief, albeit possibly more frequent.

Aiello et al [1] have conducted a well-designed cluster randomized study demonstrating that use of a face mask combined with hand hygiene in a crowded community setting is helpful in preventing ILI. Although it would be difficult to extrapolate these data to the general public in noncrowded conditions (ie, nonresidential settings), these data can inform policy makers on the recommendations for mask use in community settings and perhaps other settings (eg, health care institutions)…

.

MAJOR ARTICLE
Mask Use, Hand Hygiene, and Seasonal Influenza-Like Illness among Young Adults: A Randomized Intervention Trial
Allison E. Aiello,1,2; Genevra F. Murray,3; Vanessa Perez,1,2; Rebecca M. Coulborn,1,2; Brian M. Davis,1,2; Monica Uddin,1,2; David K. Shay,4; Stephen H. Waterman,4 and
Arnold S. Monto,1
1Department of Epidemiology and 2Center for Social Epidemiology and Population Health, School of Public Health, University of Michigan, Ann Arbor, Michigan; 3Department of Sociology, Anthropology, and Social Work, University of South Alabama; 4Centers for Disease Control and Prevention, Atlanta, Georgia

Background.During the influenza A(H1N1) pandemic, antiviral prescribing was limited, vaccines were not available early, and the effectiveness of nonpharmaceutical interventions (NPIs) was uncertain. Our study examined whether use of face masks and hand hygiene reduced the incidence of influenza-like illness (ILI).

Methods.A randomized intervention trial involving 1437 young adults living in university residence halls during the 2006–2007 influenza season was designed. Residence halls were randomly assigned to 1 of 3 groups—face mask use, face masks with hand hygiene, or control— for 6 weeks. Generalized models estimated rate ratios for clinically diagnosed or survey-reported ILI weekly and cumulatively.

Results.We observed significant reductions in ILI during weeks 4–6 in the mask and hand hygiene group, compared with the control group, ranging from 35% (confidence interval [CI], 9%–53%) to 51% (CI, 13%–73%), after adjusting for vaccination and other covariates. Face mask use alone showed a similar reduction in ILI compared with the control group, but adjusted estimates were not statistically significant. Neither face mask use and hand hygiene nor face mask use alone was associated with a significant reduction in the rate of ILI cumulatively.

Conclusions.These findings suggest that face masks and hand hygiene may reduce respiratory illnesses in shared living settings and mitigate the impact of the influenza A(H1N1) pandemic.

Trial Registration.ClinicalTrials.gov identifier: NCT00490633.

The Global Health System…Learning from Malaria

PLoS Medicine
(Accessed 24 January 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

The Global Health System: Linking Knowledge with Action—Learning from Malaria
Gerald T. Keusch, Wen L. Kilama, Suerie Moon, Nicole A. Szlezák, Catherine M. Michaud Policy Forum, published 19 Jan 2010
doi:10.1371/journal.pmed.1000179

WHO: Pandemic (H1N1) 2009 – update 83

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

Pandemic (H1N1) 2009 – update 83
Weekly update
15 January 2010 — As of 10 January 2010, worldwide more than 208 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 13554 deaths.

WHO is actively monitoring the progress of the pandemic through frequent consultations with the WHO Regional Offices and member states and through monitoring of multiple sources of information.

Situation update:
The most intense areas of pandemic influenza virus transmission currently are in parts of North Africa, South Asia, and east and southeastern Europe….more at: http://www.who.int/csr/don/2010_01_15/en/index.html

WHO Press Conference 14 January 2010
Listen to Dr Keiji Fukuda, Special Adviser to the Director-General on Pandemic Influenza [mp3 24.0Mb]
Read the transcript of the 14 January 2010 press briefing [pdf 910kb]

Interim Results: Influenza A (H1N1) 2009 Monovalent Vaccination Coverage in U.S.

The MMWR for 15 January 2010 includes:
Interim Results: Influenza A (H1N1) 2009 Monovalent Vaccination Coverage — United States, October–December 2009
Early Release   January 15, 2010 / 59(Early Release); 1-5

“…To estimate 2009 H1N1 vaccination coverage to date for the 2009–10 influenza season, CDC analyzed results from the National 2009 H1N1 Flu Survey (NHFS) and the Behavioral Risk Factor Surveillance System (BRFSS) survey, conducted during December 27, 2009–January 2, 2010, and December 1–27, 2009, respectively.

The results indicated that, as of January 2, an estimated 20.3% of the U.S. population (61 million persons) had been vaccinated, including 27.9% of persons in the initial target groups and 37.5% of those in the limited vaccine subset. An estimated 29.4% of U.S. children aged 6 months–18 years had been vaccinated. Now that an ample supply of 2009 H1N1 vaccine is available, efforts should continue to increase vaccination coverage among persons in the initial target groups and to offer vaccination to the rest of the U.S. population, including those aged ≥65 years…”

The survey reported that the uptake rate for health-care personnel was 22.3%.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm59e0115a1.htm

Ireland announces further €1 million funding for GAVI Alliance

Ireland “reaffirmed its commitment to children in the developing world” in announcing a further €1 million in funding to the GAVI Alliance to “support GAVI’s efforts to increase and sustain vaccination rates in the world’s poorest countries against major diseases such as diphtheria, whooping cough, tetanus, Haemophilus influenzae type B, hepatitis B and yellow fever.” Peter Power, Ireland’s Minister for Overseas Development, commented,

“Children in developing countries are 10 times more likely to die from a vaccine-preventable disease than they are in wealthier nations. In 2008 alone, almost nine million children died before their fifth birthday, nearly a quarter of whom succumbed to vaccine-preventable illnesses. GAVI’s effective and strategic programme of support to the world’s poorest countries is playing a key role in stemming these unconscionable losses.” http://www.gavialliance.org/media_centre/press_releases/2010_01_11_ireland_donation.php

PATH’s Malaria Vaccine Initiative (MVI) announces collaboration on transmission-blocking vaccines (TBVs)

PATH’s Malaria Vaccine Initiative (MVI) announced a new collaboration with the Johns Hopkins Bloomberg School of Public Health (JHSPH) and the Sabin Vaccine Institute (Sabin) “to initiate development toward a vaccine that may eventually help eliminate and eradicate malaria.” The collaboration “marks MVI’s first investment in transmission-blocking vaccines (TBVs),” which aim “to stop the malaria parasite from developing in the mosquito, effectively blocking transmission of malaria from mosquitoes to humans.” PATH noted that malaria kills nearly 900,000 people per year, most of them children younger than age five.

Dr. Peter Agre, Nobel Laureate and Director of the Johns Hopkins Malaria Research Institute (JHMRI), said, “Blocking transmission by novel vaccines may provide the approach needed to stop the epidemic. MVI deserves great credit for supporting potentially exciting research that would otherwise be abandoned due to lack of precedent.” Dr. Christian Loucq, Director of MVI, commented, “Although eradication is a very long-term and aspirational goal, we are excited by the potential of transmission-blocking vaccines to significantly limit the spread of malaria infection. In combination with other interventions, we believe a successful TBV would provide another important tool in the fight against malaria.”

Over the next 18 months, MVI’s partners will collaborate to produce and characterize an antigen that can activate the body’s defenses to disrupt the complex human-mosquito transmission cycle of malaria. An antigen is any substance that triggers the immune system to produce antibodies against it. The development team will identify the optimal conditions needed to manufacture clinical supplies of AnAPN1, a mosquito antigen that appears to play a major role in parasite establishment within the mosquito. Preliminary field research has shown that antibodies induced by this antigen are capable of blocking transmission of the two deadliest malaria parasites, Plasmodium falciparum and P. vivax. When a mosquito takes blood from a vaccinated person, these antibodies prevent the parasite from attaching to and invading the mosquito’s gut.

PATH noted that the collaboration—MVI’s first project focused on TBVs— “reflects MVI’s redesigned research and development strategy. The new strategy encompasses a broader outlook on malaria vaccine development and promotes early investment in a variety of approaches that have the potential to reach the malaria community’s long-term goal of a vaccine that is at least 80 percent effective against clinical disease for more than four years by 2025.”  More at: http://www.path.org/news/pr100115-malaria-vaccine.php

Rite Aid launching national shingles vaccination and education campaign

[Editor’s Note: We have not attempted to cover the growing volume of media releases from pharmacy chains and retailers in the U.S. which now offer various vaccination services. But we noted the announcement below because it includes what is described as a “national education and vaccination campaign.” We are monitoring with interest the growing role of the retail sector in delivering vaccinations and associated educational services.]

Rite Aid, the U.S. consumer pharmacy chain, said it is “launching a national shingles vaccination and education campaign against the painful nerve disease that strikes 1 million adult Americans annually – half of them over the age of 60. The disease and long-term pain that may result can leave victims bed-ridden for weeks, months or even years.” Rite Aid said it is offering the shingles vaccine at more than 1,200 Rite Aid pharmacies in 31 U.S. states and the District of Columbia, and that “nearly all insurance plans including Medicare Part D will cover at least some of the cost, which varies by insurance coverage.” Rite Aid noted that the Centers for Disease Control and Prevention (CDC) has recommended the ZOSTAVAX vaccine as the only way to reduce the risk of developing shingles, which is caused by viral remnants of chickenpox that lay dormant in spinal fluid for decades and can flair up later in life causing long-term pain and inflammation.

Rite Aid said its pharmacists can also “counsel customers and answer questions about shingles including who should and should not be vaccinated. Besides information about shingles at www.riteaid.com/shingles and the shingles shot locator at the same site, in-store signage urges vaccination for protection against shingles, and brochures explaining shingles are available in all Rite Aid stores offering the vaccine. Rite Aid is launching this nationwide campaign after conducting several regional clinics last year and encountering high demand from patients and healthcare providers.”

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100113005218&newsLang=en

Global Vaccines Revenues Projected to More than Double by 2016

[Editor’s Note: We do not generally cover – and do not in any way endorse – commercial market research about the vaccines sector. But we do recognize the rapid growth of the vaccine industry and the revenue and profit contribution of vaccines in a number of pharma companies. These dynamics clearly affect vaccine ethics and policy. The research below provides projections about the scale and projected growth of the sector and is interesting in that regard.]

Research and Markets: By 2016, the Global Vaccines Market is Expected to Generate More Than Twice the Annual Revenue of 2009

“The global vaccines industry was valued at $24 billion in 2009 and is expected to reach $52 billion in 2016 at a Compounded Annual Growth Rate (CAGR) of 11.5%. The vaccines market, which was once considered a low-profit segment of the top players’ portfolios, showed a turnaround after the resounding success of Prevnar, the first blockbuster vaccine. The ability of vaccines to generate high revenue and profits despite being priced at a premium has proven attractive to both existing players in the market and to big pharmaceutical companies who have been watching the development of the market with interest.

“The surge in revenues and growth rates came at a time when the pharmaceutical industry was under huge pressure from patent expiries and weakened pipelines. The pharmaceutical industry has been intent on strengthening their revenue streams and streamlining operations through lay-offs and shutdowns of manufacturing and R&D operations. The success of premium priced vaccines such as Prevnar, Gardasil, and Cervarix has prompted big pharmaceutical players such as Pfizer and AstraZeneca to invest in the vaccines industry which promises safe revenues due to a lack of threat from generics….”

“…The authors analyze that licensing and co-development agreements are characteristic of the global vaccines market where technologies and development platforms are highly dispersed amongst small and big companies. Smaller vaccine companies that do not have the financial muscle to compete against the top vaccine players make use of their technologies to generate revenues through royalties and through other revenue sharing agreements. Also, a number of public-private partnerships help the vaccines industry develop interventions for new diseases

‘”The global vaccines industry is a difficult industry for smaller companies to succeed in due to the high development costs required for licensing, acquisitions, marketing and manufacturing. Vaccine companies with promising candidates in the pipeline engage in out-licensing agreements with the top players, who in turn provide marketing, sales, and regulatory support. However, the vaccines industry remains an attractive one for large and small companies alike due to its potential to generate revenues from smaller disease populations too. Hence, the vaccines industry is expected to remain highly active in the future fuelled by the encouragement and financing from governments and other health organizations.”

More at: http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100115005381&newsLang=en

Lancet: Editorial – Rethinking strategies to control hepatitis B and hepatitis C

The Lancet
Jan 16, 2010  Volume 375  Number 9710  Pages 171 – 252
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Rethinking strategies to control hepatitis B and hepatitis C
The Lancet

Hepatitis B and hepatitis C viruses are common, infecting about 500 million people worldwide. Often asymptomatic, the disease might not be noticed until complications, such as hepatocellular carcinoma, develop. Hepatitis B can be prevented by vaccination, and simple precautions reduce infection from both viruses. But this knowledge has not been translated into decreased incidence in the USA. The Institute of Medicine investigated why not in Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C published on Jan 11.

Risk factors for H1N1 influenza complications in 2009 Hajj pilgrims

The Lancet
Jan 16, 2010  Volume 375  Number 9710  Pages 171 – 252
http://www.thelancet.com/journals/lancet/issue/current

Correspondence
Risk factors for H1N1 influenza complications in 2009 Hajj pilgrims
Philippe Gautret, Philippe Parola, Philippe Brouqui

Preview
Z A Memish and colleagues (Nov 21, p 1786)1 describe the outcome of a consultation between Saudi Arabia and WHO that resulted in a plan to mitigate the transmission of influenza A H1N1 at the 2009 Hajj pilgrimage to Mecca. Of these recommendations, the most challenging was the one suggesting that the population groups at highest risk of the complications of influenza (pregnant women, those with chronic diseases, and people younger than 12 years or older than 65 years) voluntarily refrain from the 2009 Hajj…

Science: Special Issue – Innate Immunity

Science
15 January 2010  Vol 327, Issue 5963, Pages 237-380
http://www.sciencemag.org/current.dtl

Special Issue: Innate Immunity

Editorial
New Approaches in Immunotherapy
Paul G. Thomas1 and Peter C. Doherty2

The past decade of research on the immune system has seen an incredible expansion of knowledge in the area of innate immunity. Analysis over the preceding years had focused largely on how T and B cells orchestrate immune responses to specific pathogens, and how their memory of these encounters confers long-lasting protection. In contrast to these specific “adaptive” mechanisms, innate immunity is driven by a plethora of proteins produced by a wide range of cells throughout the body, and it provides immediate broad-spectrum responses to foreign invaders. This new understanding of innate immunity is providing insights into host reactions to noninfectious diseases such as cancer, to antigen-independent inflammatory conditions such as periodic fever syndromes, and to the inflammatory modulation of basic cellular metabolic processes. As this special issue on innate immunity points out (p. 283), ongoing research to further characterize this complex response system has great potential for identifying new therapies to treat human disease.

1 Paul G. Thomas is an Assistant Member in the Department of Immunology at St. Jude Children’s Research Hospital in Memphis, TN.
2 Peter C. Doherty is the Michael F. Tamer Chair of Biomedical Research in the Department of Immunology at St. Jude Children’s Research Hospital in Memphis, TN, and a Laureate Professor in the Department of Microbiology and Immunology, University of Melbourne, Australia. He received the Nobel Prize in Physiology and Medicine in 1996.

Editorial: Governments, off-patent vaccines, smallpox and universal childhood immunization

Vaccine
http://www.sciencedirect.com/science?_ob=PublicationURL&_cdi=5188&_pubType=J&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=06a70dff873c73731f4a31331c8deee2&jchunk=28#28
Volume 28, Issue 4, Pages 869-1132 (22 January 2010)

Editorial
Governments, off-patent vaccines, smallpox and universal childhood immunization
Stanley Music

Abstract
WHO is now celebrating more than 30 years of freedom from smallpox. What was originally seen as a victory over an ancient scourge can now be viewed as an epidemiologically driven programme to overcome governmental inertia and under-achievement in delivering an off-patent vaccine. Though efforts are accelerating global vaccine use, a plea is made to push the world’s governments to commit to universal childhood vaccination via a proposed new programme. The latter should begin by exploiting a long list of ever more affordable off-patent vaccines, vaccines that can virtually eliminate the bulk of the world’s current vaccine-preventable disease burden.

Preventive HIV vaccine acceptability: men and transgenders in Thailand

Vaccine
http://www.sciencedirect.com/science?_ob=PublicationURL&_cdi=5188&_pubType=J&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=06a70dff873c73731f4a31331c8deee2&jchunk=28#28
Volume 28, Issue 4, Pages 869-1132 (22 January 2010)

Preventive HIV vaccine acceptability and behavioral risk compensation among high-risk men who have sex with men and transgenders in Thailand
Peter A. Newman, Surachet Roungprakhon, Suchon Tepjan, Suzy Yim

Abstract
Thailand, with the highest number of volunteers to have participated in preventive HIV-1 vaccine trials globally, may be an early adopter of HIV vaccines. We conducted a mixed methods investigation, including 30 in-depth interviews and a venue-based survey. We used a structured questionnaire including conjoint analysis and a fractional factorial experimental design to assess preventive HIV vaccine acceptability and risk compensation among 255 high-risk men who have sex with men (MSM) and transgenders (mean age = 26.6 years). HIV vaccine acceptability ranged from 31.6 to 73.8 on a 100-point scale; mean = 58.3 (SD = 17.1). Vaccine-induced seropositivity (VISP) had the greatest impact on acceptability, followed by efficacy, side effects, duration of protection, out-of-pocket cost and social saturation. Over one-third (34.6%) reported intentions to increase post-vaccination risk behaviors in response to a highly efficacious HIV vaccine. Social and structural interventions to promote HIV vaccine uptake as a prosocial behavior, provide accessible assays to detect VISP, and subsidize vaccine costs, and support for uptake of partially efficacious vaccines in the context of combination prevention, will facilitate HIV vaccine dissemination in Thailand.

HPV vaccine utilization within a university-based health system

Vaccine
http://www.sciencedirect.com/science?_ob=PublicationURL&_cdi=5188&_pubType=J&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=06a70dff873c73731f4a31331c8deee2&jchunk=28#28

Volume 28, Issue 4, Pages 869-1132 (22 January 2010)

Patient and clinic factors associated with adolescent human papillomavirus vaccine utilization within a university-based health system
Amanda Dempsey, Lisa Cohn, Vanessa Dalton, Mack Ruffin

Abstract
We reviewed clinical and billing data from a university-based health system to assess HPV vaccine utilization among 9–18-year-old girls by individual, visit and medical specialty characteristics. Our sample included 10,082 adolescent patients with 27,928 visits to outpatient family medicine (FM), pediatric and gynecology clinics between January 2007 and March 2008. Vaccine series completion was low among eligible adolescents (15%), with important disparities in vaccine utilization by medical specialty, age, race and insurance status. Missed opportunities for vaccination were common. Our findings may help to target future interventions aimed at increasing adolescent HPV vaccine utilization.

Immunizing school-age children and adolescents: low- and middle-income countries

Vaccine
Volume 28, Issue 5, Pages 1133-1436 (3 February 2010)

Immunizing school-age children and adolescents: Experience from low- and middle-income countries
Maria Sophia Mackroth, Kathleen Irwin, Jos Vandelaer, Joachim Hombach, Linda O. Eckert

Conclusions
This baseline description may facilitate immunization program planning in countries considering vaccinating this age group. Additionally, this summary may inform plans for operational research and program evaluation designed to expand vaccine delivery to school-age children and adolescents in low- and middle-income countries.

The expanding vaccine development pipeline, 1995–2008

Vaccine
Volume 28, Issue 5, Pages 1133-1436 (3 February 2010)

The expanding vaccine development pipeline, 1995–2008
Matthew M. Davis, Amy T. Butchart, Margaret S. Coleman, Dianne C. Singer, John R.C. Wheeler, Angela Pok, Gary L. Freed

Abstract
Successful launches of recently licensed vaccines contrast with pharmaceutical industry concerns about unfavorable market conditions, making the status and future of vaccine development uncertain. We assessed trends in private-sector vaccine research and development for the period 1995–2008, using a global pharmaceutical database to identify prophylactic vaccines in preclinical, Phase I, Phase II, or Phase III stages of development. We counted companies that research and/or manufacture vaccines (“vaccine originators”) and their vaccine products in each year. The global number of vaccine originators doubled (to 136), as did the number of prophylactic vaccine products in development (to 354); the majority of this growth was in preclinical and early phase clinical research. Because rapid growth in earlier research phases has not yet led to growth in Phase III, it is not yet clear whether recent industry expansion will translate to an increase in the number of available vaccines in the near future.

WHO: Pandemic (H1N1) 2009 – update 82 Weekly update

The WHO continues to issue weekly “updates” and briefing notes on the H1N1 pandemic at: http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 – update 82  Weekly update
8 January 2010

As of 3 January 2009, worldwide more than 208 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 12799 deaths….

Situation update:
The most active areas of pandemic influenza transmission currently are in parts of central, eastern and southeastern Europe, North Africa, and South Asia.

In Europe, pandemic influenza transmission remains geographically widespread throughout the continent and there continues to be intense virus circulation in several countries of central, eastern, and southeastern Europe – particularly in Poland, Serbia, Ukraine, Georgia – where a high a intensity of respiratory diseases activity has been recently reported. Among countries testing more than 20 clinical specimens from sentinel sites in the past week, the greatest proportions of samples testing positive for influenza were observed in Greece (72%), Georgia (54%), Switzerland (49%), Portugal (48%), Germany (48%), Luxembourg (40%), Romania (30%), Poland (25%), and Albania (23%). In most of western and northern Europe, rates of ILI/ARI continued to decline substantially, and in many places have returned to near seasonal baselines. Sporadic cases of seasonal H3N2 influenza have been identified in Western Europe but in very small numbers. Crude mortality rates among most European countries, measured as the cumulative number of pandemic H1N1 influenza associated deaths per million population, appear to be within the same range as rates observed elsewhere in northern and southern hemisphere, suggesting a relatively consistent global pattern of mortality…

More at: http://www.who.int/csr/don/2010_01_08/en/index.html

Gates Foundation announces Global Health Program senior appointments

The Bill & Melinda Gates Foundation announced three senior staff appointments. Each will report directly to Tachi Yamada, president of the foundation’s Global Health Program.

– Jaime Sepulveda was promoted to Senior Fellow and will serve as a deputy to Yamada, “playing a central role in shaping the foundation’s overall global health strategy as part of its executive team. He will work closely with key foundation partners—including the GAVI Alliance, where he chairs the Executive Committee—to increase access to vaccines and other effective health solutions in developing countries. He will also serve as Director of Special Initiatives in the Global Health Program.

– Gary Darmstadt becomes Director of Family Health, “overseeing a multidisciplinary team of program and technical experts to develop and implement strategies to improve maternal, newborn, and child health; nutrition; and family planning.”

– Girindre Beeharry will become Director of Strategy, “leading a team of strategy and evaluation experts to help guide strategic planning across the Global Health Program. His team will help ensure that the foundation’s grant portfolio has the greatest possible impact on health in developing countries.”

http://www.gatesfoundation.org/press-releases/Pages/sepulveda-darmstadt-beeharry-leadership-roles-100106.aspx

Global Immunization News (GIN) for 23 December 2009

Global Immunization News (GIN) for 23 December 2009 was published by WHO on 5 January 2010. This issue includes notice of WHO’s revised New and Under-utilized Vaccines Implementation (NUVI) website www.who.int/nuvi with information on the following strategic work areas:

– Country Decision Making

– Vaccine Products

– Surveillance and Monitoring

– Advocacy and Communication

– Immunization Financing

– Integrated Approaches to Disease Control and Prevention

http://www.who.int/immunization/GIN_December_2009.pdf

MMWR for 8 January 2010

The MMWR for 8 January 2010 / Vol. 58 / No. 51 & 52 includes:

Patients Hospitalized with 2009 Pandemic Influenza A (H1N1) — New York City, May 2009

Outbreak of 2009 Pandemic Influenza A (H1N1) at a School — Hawaii, May 2009

Announcement: National Influenza Vaccination Week — January 10–16, 2010

Recommended Immunization Schedules for Persons Aged 0 Through 18 Years — United States, 2010

2009 Influenza A(H1N1) Monovalent Vaccine: Children

JAMA
Vol. 303 No. 1, pp. 9-90, January 6, 2010
http://jama.ama-assn.org/current.dtl

Editorials
2009 Influenza A(H1N1) Monovalent Vaccines for Children
Anthony E. Fiore; Kathleen M. Neuzil

Preliminary Communications
Immunogenicity of a Monovalent 2009 Influenza A(H1N1) Vaccine in Infants and Children: A Randomized Trial
Terry Nolan, MBBS, PhD; Jodie McVernon, MBBS, PhD; Maryanne Skeljo, PhD; Peter Richmond, MBBS; Ushma Wadia, MBBS; Stephen Lambert, MBBS, MAppEpid; Michael Nissen, BMedSc, MBBS; Helen Marshall, MBBS, MPH; Robert Booy, MD, MSc; Leon Heron, MBChB, MPH; Gunter Hartel, MS, PhD; Michael Lai, MBBS, MMedSc; Russell Basser, MBBS, MD; Charmaine Gittleson, MBBCh; Michael Greenberg, MD, MPH
JAMA. 2010;303(1):37-46. Published online December 21, 2009 (doi:10.1001/jama.2009.1911).

Context  In the ongoing influenza pandemic, a safe and effective vaccine against 2009 influenza A(H1N1) is needed for infants and children.

Objective  To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in children.

Design, Setting, and Participants  Randomized, observer-blind, age-stratified, parallel group study assessing 2 doses of an inactivated, split-virus 2009 influenza A(H1N1) vaccine in 370 healthy infants and children aged 6 months to less than 9 years living in Australia.

Intervention  Intramuscular injection of 15 µg or 30 µg of hemagglutinin antigen dose of monovalent, unadjuvanted 2009 influenza A(H1N1) vaccine in a 2-dose regimen, administered 21 days apart.

Main Outcome Measures  Hemagglutination inhibition assay to estimate the proportion of participants with antibody titers of 1:40 or greater, seroconversion, or a significant antibody titer increase, and factor increase in geometric mean titer. Assessments of solicited adverse events during 7 days and unsolicited adverse events for 21 days after each vaccination.

Results  Following the first dose of vaccine, antibody titers of 1:40 or greater were observed in 161 of 174 infants and children in the 15-µg group (92.5%; 95% confidence interval [CI], 87.6%-95.6%) and in 168 of 172 infants and children in the 30-µg group (97.7%; 95% CI, 94.2%-99.1%). Corresponding seroconversion rates were 86.8% (95% CI, 80.9%-91.0%) and 94.2% (95% CI, 89.6%-96.8%), and factor increases in geometric mean titer were 13.6 (95% CI, 11.8-15.6) and 18.3 (95% CI, 15.7-21.4). All participants demonstrated antibody titers of 1:40 or greater after the second vaccine dose. Immune responses were robust regardless of age, baseline serostatus, or seasonal influenza vaccination status. The majority of adverse events were mild to moderate in severity.

Conclusion  One 15-µg dose of vaccine was immunogenic in infants and children starting at 6 months of age and vaccine-associated reactions were mild to moderate in severity.

Trial Registration  clinicaltrials.gov Identifier: NCT00940108

Pneumococcal vaccine coverage in Mexico

The Lancet
Jan 09, 2010  Volume 375  Number 9709  Pages 93 – 170
http://www.thelancet.com/journals/lancet/issue/current

Perspectives
The art of public health: pneumococcal vaccine coverage in Mexico
Norman Daniels, Atanacio Valencia-Mendoza, Adriane Gelpi, Mauricio Hernandez Avila, Stefano Bertozzi

If the art of medicine involves making hard choices about how to improve individual health using evidence but facing uncertainty, then the art of public health involves making hard choices about improving population health and distributing it fairly under conditions of limited evidence, uncertainty, social and political constraints, and professional incentives that may be in conflict with fairly maximising population health. To illustrate the kind of public health choices a health minister faces, we focus on a current controversy in Mexico.

WHO: Pandemic (H1N1) 2009 vaccine deployment update – 23 December 2009

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

The Pandemic (H1N1) 2009 vaccine deployment update – 23 December 2009 notes that “the Director-General has called for international solidarity to provide equitable access to pandemic influenza vaccine for all countries. Final preparations are underway to distribute donated pandemic influenza vaccines to 95 low- and middle-income countries to help prevent severe disease.”
Current situation:

1. All of the first 35 countries have requested vaccine donations.
2. 23 have signed agreements with WHO.
3. 6 have finalized National Deployment Plans.

Azerbaijan and Mongolia are reported as the first countries actually scheduled to receive vaccine with estimated delivery dates in January 2010.

http://www.who.int/csr/disease/swineflu/vaccines/h1n1_vaccination_deployment_update_20091223.pdf

WHO issues “2009 in review: key health issues, December 2009”

The WHO issued “2009 in review: key health issues, December 2009” as a “photo feature.” The overview noted:

“In 2009, the emergence of the new H1N1 influenza virus saw the world brace itself for the first influenza pandemic since 1968. This was with the backdrop of the global financial crisis, that could negatively impact spending on health.

“Yet 2009 also saw H1N1 vaccines becoming available, global responses under way to support developing countries from the health effects of the financial crisis, and global action for public health being recognized.

“WHO and UNICEF launched new plans to tackle the two biggest child killers – pneumonia and diarrhoea, and the number of people receiving antiretroviral therapy in low- and middle-income countries topped four million. Making hospitals safe in emergencies, a new look at women’s health, global health risks, and progress towards tackling malaria also made news in 2009. http://www.who.int/features/2009/year_review2009/en/index.html

WHO releases World Malaria Report 2009

The WHO released the World Malaria Report 2009 on 15 December 2009, noting that “half of the world’s population is at risk of malaria, and an estimated 243 million cases led to nearly 863,000 deaths in 2008. The advent of long-lasting insecticidal nets and artemisinin-based combination therapy, plus a revival of support for indoor residual spraying of insecticide, presents a new opportunity for large-scale malaria control. The World Malaria Report 2009 describes the global distribution of cases and deaths, how WHO-recommended control strategies have been adopted and implemented in endemic countries, sources of funding for malaria control, and recent evidence that prevention and treatment can alleviate the burden of disease. http://www.who.int/malaria/publications/atoz/9789241563901/en/index.html

Merck names Dr. Julie Gerberding president of Merck Vaccines

Merck announced that Dr. Julie Gerberding will become president of Merck Vaccines effective January 25, 2010. Dr. Gerberding led the Centers for Disease Control and Prevention (CDC) as director from 2002 to 2009. Merck chairman and CEO Richard T. Clark commented, “Vaccines are a cornerstone of Merck’s commitment to health and wellness. We are delighted to welcome an expert of Dr. Gerberding’s caliber to Merck. As a preeminent authority in public health, infectious diseases and vaccines, Dr. Gerberding is the ideal choice to lead Merck’s engagement with organizations around the world that share our commitment to the use of vaccines to prevent disease and save lives.” Merck said that in her new role, Dr. Gerberding will lead the company’s $5 billion global vaccine business. Merck “currently markets a broad range of pediatric, adolescent and adult vaccines and is a leading provider of vaccines in countries around the world; in the U.S., Merck markets vaccines for 12 of the 17 diseases for which the U.S. Advisory Committee for Immunization Practices currently recommends vaccines.”

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20091221005649&newsLang=en

MMWR: Intent to Receive H1N1 and Seasonal Influenza Vaccines

The MMWR for December 25, 2009 / Vol. 58 / No. 50 includes:

Intent to Receive Influenza A (H1N1) 2009 Monovalent and Seasonal Influenza Vaccines
Two Counties, North Carolina, August 2009
To assess intent to receive influenza vaccines among children and adults, during August 2009, the North Carolina Center for Public Health Preparedness conducted a community assessment in two counties to measure knowledge of and intent to receive H1N1 and seasonal influenza vaccines. The results determined that 64% of adults reported intent to receive H1N1 vaccine. In addition, 65% of parents reported intent to have all their children vaccinated for H1N1, whereas 51% said they would have all their children vaccinated for both H1N1 and seasonal influenza.

Impact of Seasonal Influenza-Related School Closures on Families — Southeastern Kentucky, February 2008

JAMA Letter: HPV Vaccines: AEs, Efficiacy, Marketing

JAMA
Vol. 302 No. 24, pp. 2625-2722, December 23/30, 2009
http://jama.ama-assn.org/current.dtl

Letters
Adverse Events and Quadrivalent Human Papillomavirus Recombinant Vaccine
Vicky Debold; Eric Hurwitz
JAMA. 2009;302(24):2657.
Adverse Events and Quadrivalent Human Papillomavirus Recombinant Vaccine—Reply
John Iskander; Claudia Vellozzi; Barbara A. Slade
JAMA. 2009;302(24):2657-2658.
Efficacy Data and HPV Vaccination Studies
Norman W. Baylor; Melinda Wharton
JAMA. 2009;302(24):2658-2659.
Efficacy Data and HPV Vaccination Studies
Rebecca B. Perkins
JAMA. 2009;302(24):2659.
Efficacy Data and HPV Vaccination Studies—Reply
Charlotte Haug
JAMA. 2009;302(24):2659-2660.
Marketing and the HPV Vaccine
L. Stewart Massad
JAMA. 2009;302(24):2660.
Marketing and the HPV Vaccine
Marisol Betensky
JAMA. 2009;302(24):2660-2661.
Marketing and the HPV Vaccine—Reply
Sheila M. Rothman; David J. Rothman
JAMA. 2009;302(24):2661.

Evidence of Bias in Studies of Influenza Vaccine Effectiveness in Elderly Patients

Journal of Infectious Diseases
1 January 2010  Volume 201, Number 1
http://www.journals.uchicago.edu/toc/jid/current

Major Articles and Brief Reports: Viruses
Evidence of Bias in Studies of Influenza Vaccine Effectiveness in Elderly Patients
Roger Baxter, Janelle Lee, and Bruce Fireman

Although studies have shown influenza vaccines to be effective in preventing death in the elderly population, these findings may be the result of selection bias. We examined the relationship between vaccination, age, underlying morbidity, and probability of death in the upcoming year. Vaccination coverage varied in a curvilinear fashion with age, morbidity, and risk of death. Forgoing vaccination predicted death in those who had received vaccinations in the previous 5 years, but it predicted survival in patients who had never before received a vaccination. We conclude that bias is inherent in studies of influenza vaccination and death among elderly patients.

Large trials confirm immunogenicity of H1N1 vaccines

The Lancet
Jan 02, 2010  Volume 375  Number 9708  Pages 1 – 92
http://www.thelancet.com/journals/lancet/issue/current

Comment
Large trials confirm immunogenicity of H1N1 vaccines
Heath Kelly, Ian Barr

Preview
Since the recognition of a novel influenza A H1N1 virus, in March, 2009, the virus has spread throughout the world to cause the first influenza pandemic of this century, resulting in a cumulative incidence of death of 5–14 per million in populous southern hemisphere countries.1 In view of the high likelihood that pandemic H1N1 will circulate as a dominant strain for several years, a vaccine will be the most effective long-term mitigation measure. The Lancet today includes three studies of candidate vaccines against pandemic H1N1 that report on several separate randomised trials in China, Hungary, and the USA.

Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials
Eric Plennevaux, Eric Sheldon, Mark Blatter, Mary-Kate Reeves-Hoché, Martine Denis

Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009–10 influenza season: a multicentre, randomised controlled trial
Zoltan Vajo, Ferenc Tamas, Laszlo Sinka, Istvan Jankovics

Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial
Xiao-Feng Liang, Hua-Qing Wang, Jun-Zhi Wang, Han-Hua Fang, Jiang Wu, Feng-Cai Zhu, Rong-Cheng Li, Sheng-Li Xia, Yu-Liang Zhao, Fang-Jun Li, Shao-Hong Yan, Wei-Dong Yin, Kang An, Duo-Jia Feng, Xuan-Lin Cui, Feng-Chun Qi, Chang-Jun Ju, Yu-Hui Zhang, Zhi-Jun Guo, Ping-Yu Chen, Ze Chen, Kun-Ming Yan, Yu Wang

Defining the safety profile of pandemic influenza vaccines
Dina Pfeifer, Claudia Alfonso, David Wood
Preview
Vaccines have side-effects. When making decisions about regulatory approval and public health use of vaccines, authorities need to be convinced that the benefits of reduced disease outweigh actual and potential risks of vaccination. The side-effect profiles of influenza vaccines are well known due to more than 50 years of large-scale use. However, influenza vaccines uniquely undergo changes in their strain composition virtually every year. Critical evaluation of the safety profile of the vaccines manufactured to respond to the 2009 H1N1 pandemic is of the highest priority.

Programmes, partnerships, and governance for elimination and control of neglected tropical diseases

The Lancet
Jan 02, 2010  Volume 375  Number 9708  Pages 1 – 92
http://www.thelancet.com/journals/lancet/issue/current

Series
Programmes, partnerships, and governance for elimination and control of neglected tropical diseases
Bernhard Liese, Mark Rosenberg, Alexander Schratz

Preview
Neglected tropical diseases represent one of the most serious burdens to public health. Many can be treated cost-effectively, yet they have been largely ignored on the global health policy agenda until recently. In this first paper in the Series we review the fragmented structure of elimination and control programmes for these diseases, starting with the ambiguous definition of a neglected tropical disease. We describe selected international control initiatives and present their effect, governance arrangements, and financing mechanisms, including substantial drug-donation programmes.

Mandatory influenza immunisation of health-care workers

The Lancet Infectious Disease
Jan 2010  Volume 10  Number 1   Pages 1 – 66
http://www.thelancet.com/journals/laninf/issue/current

Reflection and Reaction
Mandatory influenza immunisation of health-care workers
Gwendolyn L Gilbert, Ian Kerridge, Paul Cheung

Preview
Seasonal influenza imposes an enormous but poorly defined burden of excess deaths, hospital admissions, and health-care costs, and often spreads within health-care facilities. Hospital patients with influenza are a potential source of infection for health-care workers that are not immunised, with attack rates among health-care workers of 18–24%.1 Unfortunately, health-care workers infected with influenza often continue to work, despite symptoms, with potentially devastating consequences for high-risk patients, including those who are very young, elderly, or immunocompromised—for example, patients receiving bone-marrow transplants have a high risk of pneumonia and death from influenza.

NEJM Editorial: The Need for Science in the Practice of Public Health

New England Journal of Medicine
Volume 361 — December 24, 2009 — Number 26
http://content.nejm.org/current.shtml

Editorial
The Need for Science in the Practice of Public Health
N. Lurie
[Free Full-text]

When H5N1 avian influenza emerged in 1997, much of the world began planning for an eventual pandemic. Most planners expected the pandemic to begin in Asia and believed the virus would be highly lethal. In the United States, planning efforts for pandemic influenza escalated again in November 2005, with the publication of the National Strategy for Pandemic Influenza.1 The H1N1 pandemic that emerged in the spring of 2009 did not conform to prior planning assumptions. It began in Mexico rather than Asia and to date has not been as lethal as first feared.

Since 2005, global influenza surveillance has vastly improved. Many countries, including China, markedly increased disease-surveillance efforts after the outbreak of severe acute respiratory syndrome (SARS) in 2003. The report by Cao and colleagues in this issue of the Journal2 demonstrates the progress China has made in developing robust surveillance in a relatively short period. Surveillance has also improved in the United States, where detection of the first two cases of H1N1 infection was the result of investments leading to experimental diagnostic tests and enhanced border surveillance.

The planners involved in efforts to contain pandemics called for a layered approach to protecting the population, including steps to prevent or slow the spread of disease, communication with the public, and treatment with antiviral medications until a vaccine could be manufactured and made widely available. The world’s response to this pandemic is far better than it would have been without the aggressive planning that has been done since 1997, but experience with the H1N1 virus to date reminds us that even though we have made great strides, additional science is needed to better inform public health responses.

By the time the H1N1 virus was recognized, infection was already widespread in Mexico and in several sites in the United States. From the perspective of many in the public health community, it made little sense to try to close the border with Mexico, since doing so would not stop the spread of disease within the United States. In addition to the preventive measures recommended for the individual person (e.g., hand washing, covering one’s cough), early prevention efforts focused on isolation of infected persons, early detection, and postexposure prophylaxis. As local outbreaks progressed, some communities closed their schools. Unfortunately, we still have little science to tell us whether and under what circumstances measures such as school closures are most effective, but we do know the closures were disruptive to children’s learning and to working parents and their employers.

China built on its post-SARS disease-surveillance capability and focused first on early detection and postexposure prophylaxis. China also implemented a strict isolation and quarantine policy in the hope of preventing or slowing the spread of disease. But as Cao and colleagues remind us, further data are needed to inform screening and the actions based on it. For example, the accuracy of large-scale thermal screening is variable. As noted by Cao and colleagues and by other investigators, roughly one quarter of those infected are afebrile.3,4 Hence, screening that relies on the presence of fever will mean that many infected persons will be overlooked. Testing with real-time reverse transcriptase–polymerase chain reaction (RT-PCR) is important in making a diagnosis, but it is both expensive and of limited practicality on a very large scale. Since people are likely to remain PCR-positive for several days after they stop shedding viable virus and are infectious,5 the practice of basing either community mitigation or social distancing policies on PCR-positivity could result in unnecessary interventions for people who are no longer able to transmit the virus. This speaks to the need to better understand the practical aspects of transmission and the need for simple, accurate tests with rapidly produced results that can be used to guide decisions about diagnosis, treatment, and social distancing.

Many observers think that China’s isolation and quarantine policy, like the school closures in the United States, was disruptive. Unfortunately, we do not yet have adequate data to help us understand whether any of these measures worked, nor do we have a good understanding of the levels of individual or social disruption that are acceptable to different people, communities, and countries. Clarifying the benefits of social distancing and mitigation measures will be critical to understanding whether the burdens to society are worth bearing.

The ultimate way to protect individual persons and populations from disease is with vaccination, and the rapid development and manufacture of the H1N1 vaccine represent a triumph of modern science. Even so, the United States, which was one of the first countries to mount a large-scale vaccination campaign, has not yet reached the aspirational goal articulated in the pandemic preparedness plan published in November 2005 — that is, to attain within 5 years the domestic manufacturing capacity to produce sufficient pandemic vaccine for the U.S. population within 6 months of pandemic onset. Additional breakthroughs in the development of safe cell-based, plant-based, and recombinant vaccines, combined with large-scale manufacturing capacity, are needed to reach this goal. Analogous global goals — and plans for achieving them — are badly needed.

Once vaccine is widely available, it must rapidly reach those who need it. Comparatively little research has been conducted in operations and logistics to inform us of how best to do this. Although methods of reaching high-risk patients are admittedly country-specific and health system–specific, a substantial effort in operations research would be likely to help us better understand how to accomplish more rapid delivery of vaccine — or any other countermeasure — to those who most need it anywhere in the world.

Effective communication with the public is central to any public health emergency response. The widespread misunderstanding of vaccine safety and effectiveness speaks to the need to improve not only safety science but also communication science — to enhance our ability to reach and educate the public, especially those who are at highest risk for disease.

We will all have the opportunity to learn lessons from the 2009 pandemic H1N1 virus. Although we would like to believe that pandemics occur rarely and that we have plenty of time until the next one, new infectious diseases, as well as other kinds of threats, can emerge at any time. One challenge will be to continue to invest in science — whether that means basic virology; surveillance; mitigation measures; vaccine development, manufacture, and distribution; operations and logistics; or communication — so that when the next pandemic or other emerging infectious disease appears, we will have the data we need to make informed decisions about how to confront it. A second challenge will be to strengthen the nation’s public health infrastructure so that we can rapidly turn scientific knowledge into action.

Financial and other disclosures provided by the author are available with the full text of this article at NEJM.org.

The views expressed here are those of the author and do not necessarily reflect the policies of the Department of Health and Human Services.

Source Information

Dr. Lurie is the Assistant Secretary for Preparedness and Response, Department of Health and Human Services.
This article (10.1056/NEJMe0911050) was published on December 9, 2009, at NEJM.org.

References

National strategy for pandemic influenza. Washington, DC: United States Homeland Security Council, 2005.

Cao B, Li X-W, Mao Y, et al. Clinical features of the initial cases of 2009 pandemic influenza A (H1N1) virus infection in China. N Engl J Med 2009;361:2507-2517. [Free Full Text]

Carrat F, Vergu E, Ferguson NM, et al. Time lines of infection and disease in human influenza: a review of volunteer challenge studies. Am J Epidemiol 2008;167:775-785. [Free Full Text]

Introduction and transmission of 2009 pandemic influenza A (H1N1) virus — Kenya June-July 2009. MMWR Morb Mortal Wkly Rep 2009;58:1143-1146. [Medline]

Witkop CT, Duffy MR, Macias EA, et al. Novel influenza A (H1N1) outbreak at the U.S. Air Force Academy: epidemiology and viral shedding duration. Am J Prev Med 2009 October 21 (Epub ahead of print).

Empyema Hospitalizations Increased in US Children Despite Pneumococcal Conjugate Vaccine

Pediatrics
January 2010 / VOLUME 125 / ISSUE 1
http://pediatrics.aappublications.org/current.shtml

Empyema Hospitalizations Increased in US Children Despite Pneumococcal Conjugate Vaccine
Su-Ting T. Li, MD, MPH and Daniel J. Tancredi, PhD
Department of Pediatrics, University of California at Davis, Sacramento, California

OBJECTIVE: To determine if the incidence of empyema among children in the United States has changed since the introduction of the pneumococcal conjugate vaccine in 2000.

METHODS: We used the nationally representative Kids’ Inpatient Database to estimate the annual total number of hospitalizations of children 18 years of age that were associated with empyema in 1997, 2000, 2003, and 2006. Using US Census data, estimated counts were converted into annual incidence rates per 100000 children. Incidence rates were compared between 1997 and later years to determine the impact of pneumococcal conjugate vaccine on hospitalization rates.

RESULTS: During 2006, an estimated total of 2898 (95% confidence interval [CI]: 2532–3264) hospitalizations of children 18 years of age in the United States were associated with empyema. The empyema-associated hospitalization rate was estimated at 3.7 (95% CI: 3.3–4.2) per 100000 children, an increase of almost 70% from the 1997 empyema hospitalization rate of 2.2 (95% CI: 1.9–2.5) per 100000. The rate of complicated pneumonia (empyema, pleural effusion, or bacterial pneumonia requiring a chest tube or decortication) similarly increased 44%, to 5.5 (95% CI: 4.8–6.1) per 100000. The rate of bacterial pneumonia decreased 13%, to 244.3 (95% CI: 231.1–257.5) per 100000. The rate of invasive pneumococcal disease (pneumonia, sepsis, or meningitis caused by Streptococcus pneumoniae) decreased 50%, to 6.3 (95% CI: 5.7–6.9) per 100000.

CONCLUSIONS: Among children 18 years of age, the annual empyema-associated hospitalization rates increased almost 70% between 1997 and 2006, despite decreases in the bacterial pneumonia and invasive pneumococcal disease rates. Pneumococcal conjugate vaccine is not decreasing the incidence of empyema.

Health Care Utilization by Adolescents on Medicaid: Implications for Delivering Vaccines

Pediatrics
January 2010 / VOLUME 125 / ISSUE 1
http://pediatrics.aappublications.org/current.shtml

Health Care Utilization by Adolescents on Medicaid: Implications for Delivering Vaccines
Amanda F. Dempsey, MD, PhD, MPH and Gary L. Freed, MD, MPH
Child Health Evaluation and Research Unit, Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, Michigan

OBJECTIVE: To examine the degree to which current health care utilization patterns of Medicaid-enrolled adolescents living in Michigan would allow opportunities for adolescent immunizations to be provided.

METHODS: Outpatient claims data from 2001–2005 were analyzed for 11- to 18-year-old Medicaid-enrolled adolescents living in Michigan. Visits were classified as either health-maintenance examinations (HMEs) or problem focused by using diagnostic and procedural codes. Data were divided into 4 overlapping 2-year time periods, and the age-specific proportion of adolescents who attended these 2 visit types was calculated for each. 2 tests were used to evaluate associations of visit patterns with gender.

RESULTS: Of the 718847 adolescents included in the study, <50% had 1 HME visit within any 2-year time period, and substantially fewer (<15%) had annual HMEs. In contrast, at least 75% of the adolescents had 1 problem-focused visit in any given 2-year period, and approximately half had participated in at least 2 problem-focused visits. Problem-focused, but not HME, visit utilization was significantly associated with gender, with girls increasing, but boys decreasing, visit utilization as they aged.

CONCLUSIONS: Similar to privately insured adolescents, most Medicaid-enrolled adolescents do not have annual preventive-care visits, which calls into question the feasibility of providing immunizations primarily at annual HMEs. Participation in problem-focused encounters was generally high in our study. However, even problem-focused visit utilization was low among older adolescent boys. This suggests that in addition to strengthening immunization within the medical home, alternative venues for reaching certain subpopulations of adolescents should also be developed.