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Sanofi Pasteur Inaugurates High Tech Vaccine Production Facility to Respond to Soaring Demand Worldwide   - New 100 million euros facility incorporates latest technology to produce vaccines meeting the highest quality standards -   Val de Reuil, France, June 25, 2008 - Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced the inauguration of a high-tech vaccine production facility in France to respond to soaring demand worldwide. This new 100 million euros facility located in Val de Reuil (North West of France) incorporates the latest technology to produce vaccines that meet the highest standards of quality. It is part of 600 million euros investments undertaken by sanofi pasteur in France between 2005 and 2008.   “Sanofi Pasteur’s commitment to global health is exemplified by significant investments in vaccine production infrastructures. These efforts are aimed at meeting a world demand for vaccines expected to double by 2016”, said Wayne Pisano, President and Chief Executive Officer of sanofi pasteur, who inaugurated the new production unit. “The new facility will provide high-end production work environment for dedicated people who produce vaccines for the world.”   The new highly automated facility can produce vaccines against 20 diseases. It is designed to be ready to switch to pandemic influenza vaccine in the event of a human pandemic influenza, and once a pandemic influenza strain is identified by the World Health Organization (WHO).   “Sanofi Pasteur Val de Reuil site is a hub for global health with over two million doses of vaccines shipped worldwide each day. The new facility will further enable sanofi pasteur to fulfill its commitment of providing highest quality vaccines to protect people from infectious diseases wherever they live,” added Pisano.   Construction of the 7,800 square-meter building began in 2006. It is projected to be operational by the end of 2008, upon certification by health authorities. The facility is scaled to fill 200 million syringes and vials per year, increasing by two fold the current capacity at this site. The new filling lines are part of a 200 million euros investment project in Val de Reuil that also includes a new building dedicated to vaccine formulation, currently under construction. Formulation, filling and packaging operations are the last manufacturing steps before vaccines are shipped to customers under cold chain conditions. Formulation and filling are performed in a highly automated aseptic environment that meets the most stringent international good manufacturing practices.   A hub for global health Sanofi Pasteur Val de Reuil operational site is a hub for global health: over 700 million doses of vaccines per year shipped worldwide. Val de Reuil is also the world’s largest production site for seasonal influenza vaccine with 130 million doses produced in 2007. The Val de Reuil vaccine site was created in 1973 by Institut Pasteur Production. In 1976, Sanofi - now sanofi-aventis - invested in Institut Pasteur Production to support its industrial development. Institut Mérieux - now Sanofi Pasteur - acquired Institut Pasteur Production in 1985.   Over one billion Euros invested in five years Sanofi Pasteur has invested over one billion euros in industrial capacities worldwide during the last five years (2004-2008) to meet the growing global demand for vaccines. Key recent investments include formulation and filling capacities, completion of the world’s largest production unit for inactivated polio vaccine, and a new influenza vaccine production facility. In 2008, investments translated into the groundbreaking of a new production building for pediatric vaccines located in Marcy L’Etoile, near Lyon, France.   About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).   Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than a 1.6 billion doses of vaccine in 2007, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, sanofi pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development.   For more information, please visit: www.sanofipasteur.com  or www.sanofipasteur.us   Source: Sanofi-aventis Press Release

World Health Assembly Sets Bold New Action for WHO -New public health, innovation and intellectual property strategy endorsed by the Health Assembly-   Sixty-first World Health Assembly at http://www.who.int/mediacentre/events/2008/wha61/en/index.html   24 MAY 2008 | GENEVA -- The 61st World Health Assembly, which comprised of a record 2704 participants from 190 nations, set WHO on a course to tackle longstanding, new and looming threats to global public health. Among its achievements, the Health Assembly produced a public health breakthrough by providing a platform for removing barriers and using innovative methods to encourage research, development and access to medicines for the common diseases of the developing world.   "This is a major breakthrough for public health that will benefit many millions of people for many years to come," said WHO Director-General Dr Margaret Chan. "This is a contribution to fairness in health and this is pro-active public health at its very best."   The public health, innovation and intellectual property strategy endorsed by the Health Assembly is designed to promote new approaches to pharmaceutical research and development (R&D), and to enhance access to medicines. It is also designed to provide a medium-term framework for enhancing and making sustainable essential R&D relevant to diseases impacting developing countries. The strategy proposes clear objectives and priorities, and estimates of funding needs in this area.   Delegates to the Health Assembly directly confronted major public health challenges which are now results of complex interactions of factors beyond health.   "At this World Health Assembly, we witnessed the interplay between the political, trade and health interests," said the President of the Health Assembly, Dr Leslie Ramsammy who is the Minister of Health of Guyana. "Child and maternal health, and the prevention and management of noncommunicable diseases rely on the supply chain and commodities. We are now much closer to having an increased flow of quality health commodities that will lead to better health."   The Health Assembly endorsed a six-year action plan to tackle what are now the leading threats to human health: noncommunicable diseases. These diseases - particularly cardiovascular diseases, diabetes, cancers and chronic respiratory diseases - caused 60% of all deaths globally in 2005 (estimated at 35 million deaths). Low- and middle-income countries are the worst affected by these diseases which are largely preventable by modifying four common risk factors: tobacco use, unhealthy diet, physical inactivity and harmful use of alcohol.   Delegates also requested WHO - through a resolution - to intensify its work to curb harmful use of alcohol, which is the fifth leading risk factor for death and disability in the world. They called upon WHO to develop a global strategy for this purpose. The work on the strategy will start immediately and Member States will be consulted throughout the drafting process. The resolution also requests the Director- General to consult with intergovernmental organizations, health professionals, nongovernmental organizations and economic operators on ways they could contribute to reducing harmful use of alcohol.   Delegates to the Health Assembly also requested WHO and committed their own Ministries of Health to take action to protect health from climate change. They adopted a resolution that urges Member States to take decisive action to address health impacts from climate change, warning of its potential risks on human health. The resolution calls on the health sector --to scale up adaptation projects that would limit the impacts of climate change on health; --to raise global awareness of the impacts of health from climate change at national and international levels; and --to boost political attention and action.   Member States also called on WHO to develop and strengthen the evidence base on links between climate change and health, and to help developing countries address health impacts from climate change.   The Health Assembly's actions were not limited to new challenges. Delegates also reaffirmed their commitments to eradicating polio and preparing for an influenza pandemic. Other actions included:   Female genital mutilation (FGM): Member States committed themselves to accelerating action towards the elimination of this practice through laws and educational and community efforts. Moreover, women and girls who have undergone FGM will be better supported, particularly as regards their care during childbirth, as well as in the social and psychological areas.   Global immunization strategy: Vaccines already prevent 2 to 3 million deaths a year but the Health Assembly noted that they are still underutilized. Delegates directed WHO to help countries reach higher immunization coverage and to encourage development of new vaccines.   Migrant health: Member States requested WHO to assess the health aspects in migrant environments and to explore options to improve the health of migrants.   "Health leaders from around the world have joined together in a united front on many big and difficult issues," said Dr Chan in closing the Health Assembly. "You consistently demonstrated a desire to reach consensus, and showed great flexibility in achieving compromise despite some significant differences."   Source: WHO Press Release

Grant Proposals Sought by Bill and Melinda Gates Foundation for Innovative Global Health Research   --First round of Grand Challenges Explorations to support bold, unconventional ideas to fight infectious diseases--   SEATTLE -- The Bill & Melinda Gates Foundation announced today that beginning March 31, 2008, it will accept grant proposals for the first funding round of Grand Challenges Explorations, a new $100 million initiative to help scientists across the globe pursue ideas that have never before been tested for solving major health problems. The four topics for the first funding round were also announced.   Initial grants through the Explorations initiative will be $100,000 each, and projects showing success will have the opportunity to receive additional funding of $1 million or more. The initiative will use an agile, accelerated grant-making process—applications will be two pages, and preliminary data are not required. The foundation will select and award grants within approximately three months from the proposal submission deadline of May 30, 2008.   "Breakthrough ideas can come from anywhere, and we hope this new process will encourage a broad range of scientists from around the world to bring their ideas to the table," said Dr. Tachi Yamada, president of the Gates Foundation's Global Health Program.  "We're especially interested in reaching people who work outside the field of global health, innovators in the developing world, and young investigators."   Grand Challenges Explorations is an expansion of the Grand Challenges in Global Health initiative, which was launched in 2003 to spur the discovery of new technologies to improve global health. The Explorations initiative focuses on research areas where creative, unorthodox thinking is most urgently needed.   Topics for First Funding Round   The first funding round of Grand Challenges Explorations will consider proposals in four topic areas:   * Creating new ways to protect against infectious diseases: Untried or unproven approaches to protect against infectious diseases, including harnessing natural or synthetic immune responses, or eliminating the need for an effective immune response.     * Creating drugs or delivery systems that limit the emergence of resistance: Innovative ideas for discovering or delivering drugs that are less likely to lose effectiveness because of resistance developing in the disease-causing agent.     * Creating new ways to prevent or cure HIV infection: Innovative ideas for HIV prevention or treatment methods that fall outside current research on vaccines, antiretroviral drugs, and other biomedical and behavior-change strategies.     * Exploring the basis for latency in TB: Unconventional approaches to understanding latent TB infection, with the goal of discovering new ways to identify and eliminate latent infection, and break the cycle of TB transmission.   Grant proposals for the first Explorations funding round will be accepted online at Grand Challenges Explorations from March 31 through May 30, 2008; applicants must register intent to submit a proposal by May 15, 2008.   Once the first Explorations funding round is complete, the foundation will announce subsequent funding rounds. Topics may vary over time, to cover a range of priorities in global health research.   Full descriptions of the initial topic areas and application instructions are available at www.gcgh.org/explorations.   About Bill & Melinda Gates Foundation Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, the foundation is led by CEO Patty Stonesifer and co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.   Contact: Bill & Melinda Gates Foundation Phone: 206.709.3400 Email: media@gatesfoundation.org   Share your Favorite Biotech/Pharma/Medicine/Clinical Trials articles on Your Helix!-Professional Networking Site Designed for Biotech/Pharma Community:

New Survey Finds Highest Rates of Drug-resistant Tuberculosis to Date    26 February 2008-- Multidrug-resistant tuberculosis (MDR-TB) has been recorded at the highest rates ever, according to a new report published by WHO. The report presents findings from the largest survey to date on the scale of drug resistance in tuberculosis.   Read "Anti-tuberculosis drug resistance in the world " The complete report http://www.who.int/tb/publications/2008/drs_report4_26feb08.pdf   Read "The Global MDR-TB & XDR-TB Response Plan" http://whqlibdoc.who.int/hq/2007/WHO_HTM_TB_2007.387_eng.pdf   Read "The Global Response Fact-sheet" http://www.who.int/tb/challenges/xdr/xdr_mdr_factsheet_2007_en.pdf     The report, "Anti-tuberculosis drug resistance in the world", is based on data collected between 2002 and 2006 on 90 000 TB patients in 81 countries. It found that extensively drug-resistant tuberculosis (XDR-TB), a virtually untreatable form of the respiratory disease, has been recorded in 45 countries.   The report also found a link between HIV infection and MDR-TB. Surveys in Latvia and Ukraine found nearly twice the level of MDR-TB among TB patients living with HIV compared with patients without HIV.   Based on the analysis of the survey data, WHO estimates there are nearly half a million new cases of MDR-TB a year, which is about 5% of nine million new TB cases of all types. The highest rate was recorded in Baku, the capital of Azerbaijan, where nearly a quarter of all new TB cases (22.3%) were reported as multidrug-resistant.   Proportions of MDR-TB among new TB cases were 19.4% in Moldova, 16% in Donetsk in Ukraine, 15% in Tomsk Oblast in the Russian Federation, and 14.8% in Tashkent in Uzbekistan. These rates surpass the highest levels of drug resistance published in the last WHO report in 2004. Surveys in China also suggest that MDR-TB is widespread there.   Frontal assault needed "TB drug resistance needs a frontal assault. If countries and the international community fail to address it aggressively now we will lose this battle," said Dr Mario Raviglione, Director of the WHO Stop TB Department. "In addition to specifically confronting drug-resistant TB and saving lives, programmes worldwide must immediately improve their performance in diagnosing all TB cases rapidly and treating them until cured, which is the best way to prevent the development of drug resistance."   For the first time, the global survey includes analysis of XDR-TB. However, because few countries are currently equipped to diagnose it, limited data were available for this report.   The report also points to some successes. Thirteen years ago, Estonia and Latvia were singled out by WHO as drug-resistant TB "hotspots". Following a substantial investment and a sustained assault on MDR-TB, rates in these two Baltic countries are today stabilizing and TB case notification rates are falling.   The true scale of the problem also remains unknown in some pockets of the world. Only six countries in Africa - the region with the highest incidence of TB in the world - were able to provide drug resistance data. Other countries in the region could not conduct surveys because they lack the equipment and trained personnel needed to identify drug-resistant TB. "Without these data, it is difficult to estimate the true burden and trends of MDR-TB and XDR-TB in the region. It is likely there are outbreaks of drug resistance going unnoticed and undetected," said WHO TB expert Abigail Wright, the principal author of the report.   WHO estimates that US$ 4.8 billion is needed for overall TB control in low- and middle-income countries in 2008, with US$ 1 billion for MDR-TB and XDR-TB. But there is a total finance gap of US$ 2.5 billion, including a US$ 500 million gap for MDR-TB and XDR-TB.   "The threat created by TB drug resistance demands that we fill these gaps, as laid out in the Global Plan to Stop TB, a roadmap for halving TB prevalence and deaths compared with 1990 levels by 2015," said Dr Marcos Espinal, Executive Secretary of the Stop TB Partnership. "The Plan also calls for another imperative - sufficient resources for research to find new diagnostics, new drugs effective against resistant strains and an effective TB vaccine."   For copies of the report or more information contact: Glenn Thomas WHO Stop TB Department Mobile: +41 795090677 E-mail: thomasg@who.int   Judith Mandelbaum-Schmid Stop TB Partnership Mobile: +41 792546835 E-mail: schmidj@who.int Share your Favorite articles on the following Social Networks: Share on Facebook

NIH Launches Human Microbiome Project   --NIH Roadmap Effort to Use Genomic Technologies to Explore Role of Microbes in Human Health and Disease--   The human body contains trillions of microorganisms, living together with human cells, usually in harmony. Because of their small size, however, microorganisms make up only about one to two percent of the body's mass. Many microbes maintain our health, while others cause illness. Yet, surprisingly little is known about the role this astounding assortment of bacteria, fungi and other microbes play in human health and disease. To better understand these interactions, the National Institutes of Health (NIH) today announced the official launch of the Human Microbiome Project. The human microbiome is the collective genomes of all microorganisms present in or on the human body.   "The human microbiome is largely unexplored," said NIH Director Elias A. Zerhouni, M.D. "It is essential that we understand how microorganisms interact with the human body to affect health and disease. This project has the potential to transform the ways we understand human health and prevent, diagnose and treat a wide range of conditions."   Part of the NIH's Roadmap for Medical Research, the Human Microbiome Project will award a total of $115 million to researchers over the next five years. Initially, researchers will sequence 600 microbial genomes, completing a collection that will total some 1,000 microbial genomes and providing a resource for investigators interested in exploring the human microbiome. Other microbial genomes are being contributed to the collection by individual NIH institutes and internationally funded projects. A meeting between international partners was recently convened to discuss forming an international consortium.   Researchers will then use new, comprehensive laboratory technologies to characterize the microbial communities present in samples taken from healthy human volunteers, even for microbes that cannot be grown in the laboratory. The samples will be collected from five body regions known to be inhabited by microbial communities: the digestive tract, the mouth, the skin, the nose, and the female urogenital tract. Demonstration projects will subsequently be funded to sample the microbiomes from volunteers with specific diseases. This will allow researchers to correlate the relationship between changes in a microbiome present at a particular body site to a specific illness.   "We now understand that there are more microbial cells than human cells in the human body. The Human Microbiome Project offers an opportunity to transform our understanding of the relationships between microbes and humans in health and disease," said Dr. Alan Krensky, the director of the Office of Portfolio Analysis and Strategic Initiatives (OPASI), which oversees the NIH Roadmap for Medical Research.   While the term "microbiome" may be relatively new in biomedical research, most people are familiar with some of the effects - both good and bad - that microbes can have on our health. Consider the example of the biggest reservoir of microbes in humans: the digestive tract. The human gut harbors many beneficial microorganisms, including certain bacteria called probiotics. There is evidence these probiotics, found in dietary supplements, yogurt and other dairy products as well as various soy products, can stimulate the immune system and improve digestive functions. In contrast, previous research suggests that variations in the composition of microbial communities may contribute to chronic health conditions, including diabetes, asthma, obesity and digestive disorders.   "Microbes play a significant role in the health of the digestive tract and many digestive diseases result when the microbial environment is out of balance," said Griffin P. Rodgers, M.D., M.A.C.P., director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and co-chair of the Human Microbiome Project's Implementation Group. "The Human Microbiome Project will help us better understand the microbial environment in the gut, as well as provide us with the tools and technology to expand our exploration into this field of research."   Traditionally, microbiology has focused on the study of individual species as isolated units, making it difficult to develop and inventory all of the microbes in and on the human body. Because their growth is dependent upon a specific natural environment, it's difficult to recreate microbe-host interactions in the laboratory. Advances in next generation DNA sequencing technologies relying on a process called metagenomic sequencing will be used. Instead of isolating each microbe, all of the DNA within the collected samples will be sequenced.   "Our goal is to discover what microbial communities exist in different parts of the human body and to explore how these communities change in the presence of health or disease," said National Human Genome Research Institute Director, Francis S. Collins, M.D., Ph.D., co-chair of the Human Microbiome Project Implementation Group. "In addition, we will likely identify novel genes and functional elements in microbial genomes that will reshape the way we think about and approach human biology."   NIH recently awarded $8.2 million to four sequencing centers, to start building a framework and data resources for the Human Microbiome Project. One-year awards were given to the sequencing centers at the Baylor College of Medicine, Houston, and Washington University School of Medicine, St. Louis, which are part of the NHGRI Large-Scale Sequencing Research Network; and the Broad Institute of MIT/ Harvard, Cambridge, Mass., and the J. Craig Venter Institute, Rockville, Md., which are funded through the National Institute of Allergy and Infectious Diseases (NIAID) Microbial Genome Sequencing Centers Program.   The objectives of this initial work are to sequence the genomes of 200 microbes that have been isolated from the human body as part of the 1,000 microbial genomes collection. Researchers will also begin recruiting healthy volunteers who will donate samples from the five body regions. NHGRI, NIAID, and the National Institute of Dental and Craniofacial Research (NIDCR) have led the initial phases of the project.   "The recent emergence of faster and cost-effective sequencing technologies promises to provide an unprecedented amount of information about these microbial communities, which in turn will bolster the development and refinement of analytical tools and strategies," said NIAID Director Anthony S. Fauci, M.D., co-chair of the Human Microbiome Project's Implementation Group.   Following the precedents set by other large-scale genomics efforts, such as the Human Genome Project and the International HapMap Project, data from the Human Microbiome Project will be swiftly deposited in public databases, including those supported by the National Center for Biotechnology Information (www.ncbi.nlm.nih.gov/mapview), part of the National Library of Medicine. The project also will fund the establishment of a Data Analysis and Coordinating Center, which will coordinate data access and develop data retrieval tools for the research community.   Also following on the lead of those efforts, the Human Microbiome Project will monitor and support research on the ethical, legal and social implications of the research. Areas of focus include the clinical and health implications of using probiotics, potential forensic uses of microbiome profiles, bioterrorism and biodefense applications, the application of new technologies from the project, and patenting and privacy issues.   "Examining and addressing the emerging ethical, legal and social implications of metagenomics research is central to our goal of one day moving any resulting diagnostic, prevention, or treatment tools into the clinic in a safe and effective manner," said NIDCR Director Lawrence Tabak, D.D.S., Ph.D., co-chair for the NIH Human Microbiome Project Implementation Group.   Additional information about the Human Microbiome Project is available at www.nihroadmap.nih.gov/hmp. For more information about funding opportunities, go to: www.nihroadmap.nih.gov/hmp/grants.asp.   A high resolution image of the bacteria, Entercoccus faecalis, a microbe that lives in the human gut, is available in color at www.genome.gov/pressDisplay.cfm?photoID=20023, or in black and white at www.genome.gov/pressDisplay.cfm?photoID=20024.   The Human Microbiome Project is part of the NIH Roadmap for Medical Research. The Roadmap is a series of initiatives designed to pursue major opportunities and gaps in biomedical research that no single NIH institute could tackle alone, but which the agency as a whole can address to make the biggest impact possible on the progress of medical research. Additional information about the NIH Roadmap can be found at www.nihroadmap.nih.gov.   The National Institutes of Health (NIH) -"The Nation's Medical Research Agency" - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.   Share your Favorite articles on the following Social Networks: Share on Facebook

AIDS AWARENESS   December 1 is World AIDS Day, which reminds us of the impact of HIV/AIDS on the world’s health. In 2007, approximately 33.2 million people worldwide were living with HIV, and more than 2 million people died from AIDS. In the U.S., an estimated 1 million persons are living with HIV; of these, approximately 25 percent are unaware of their HIV infection and at risk for infecting others.   Getting tested for HIV remains an important part of preventing the spread of HIV, both in the United States and worldwide. People who know they are HIV infected can fully benefit from available life-saving treatments. They can also take steps to protect their partners and protect their community. Being tested for HIV also is important since unrecognized HIV infections account for more than half of all new sexually transmitted HIV infections each year.   In the United States: CDC recommends that adults and adolescents between the ages of 13– 64 years be routinely screened for HIV infection in all healthcare settings. Pregnant women in the US should be screened for HIV infection as part of the routine panel of prenatal tests. To find a HIV testing site center near you, visit HIVtest.org or, on your cell phone, text your zip code to Know It – 566948.   Around the World: For World AIDS Day, CDC is releasing a critical new HIV testing and counseling tool, the Couples HIV Counseling and Testing (CHCT) Intervention and Training Curriculum. For more information, visit the CDC.gov Global AIDS feature.   What Can You Do? Whether you lead a large company, work as a health professional, or attend high school, you can join CDC and its partners in supporting World AIDS Day and working to end the HIV/AIDS pandemic, both here in the United States and around the world.   Individuals can:   • Become a volunteer for a local HIV/AIDS organization   • Confront stigma, racism and other forms of discrimination associated with HIV/AIDS   • Get tested for HIV   • Make a personal commitment to protect their partners and encourage others to do the same   Organizations are encouraged to:   • Promote World AIDS Day in their own organization by using promotional materials available at www.hivtest.org   • Support employees and volunteers to get involved in World AIDS Day activities   • Develop HIV/AIDS policies for their workplaces   • Educate staff/workers about HIV/AIDS   World AIDS Day Resources:   World AIDS Day Observance Materials Available Health communication materials and tools available for personal and professional Web sites and World AIDS Day events   AIDS.gov Webinar Featuring Dr. Kevin Fenton from CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Dr. Deborah Parham from HRSA, Beverly Watts Davis from SAMHSA, and Dr. Anthony Fauci from NIH.   World AIDS Day — December 1, 2007,  Morbidity and Mortality Weekly Report (MMWR)     Additional Resources from CDC: Rapid HIV Testing in Outreach and Community Settings — United States, 2004–2006, Morbidity and Mortality Weekly Report (MMWR)    Discussion with Dr. Kevin Fenton on HIV Testing- A Cup of Health (podcast) Rapid HIV Testing   (podcast)   CDC HIV Testing Database  Locate an HIV testing site near you CDC HIV/AIDS   CDC’s Web site for HIV/AIDS in the United States   CDC Global HIV/AIDS Program   CDC Business and Labor Responds to AIDS CDC’s HIV/AIDS resource for businesses and labor organizations   CDC National Prevention Information Network (NPIN) The U.S. reference, referral, and distribution service for information on HIV/AIDS, sexually transmitted diseases (STDs), and tuberculosis (TB)

Projected Supply Of Pandemic Influenza Vaccine Sharply Increases - A WHO Report e-published on MedicineandBiotech.com November 1st, 2007 Read the full-length report “Global pandemic influenza action plan to increase vaccine supply”   According to FDA, Licensed Influenza Vaccines for 2007-2008 are: Fluarix, for use by people ages 18 and older. FluLaval, for use by people ages 18 and older Afluria, for use by people ages 18 and older Fluvirin, for people ages 4 and older. Fluzone, for people 6 months and older. FluMist, for people ages 2 to 49. November 2007, GENEVA -- Recent scientific advances and increased vaccine manufacturing capacity have prompted experts to increase their projections of how many pandemic influenza vaccine courses can be made available in the coming years. Last spring, the World Health Organization (WHO) and vaccine manufacturers said that about 100 million courses of pandemic influenza vaccine based on the H5N1 avian influenza strain could be produced immediately with standard technology. Experts now anticipate that global production capacity will rise to 4.5 billion pandemic immunization courses per year in 2010. "With influenza vaccine production capacity on the rise, we are beginning to be in a much better position vis-à-vis the threat of an influenza pandemic," Dr Marie-Paule Kieny, Director of the Initiative for Vaccine Research at WHO, said today. "However, although this is significant progress, it is still far from the 6.7 billion immunization courses that would be needed in a six month period to protect the whole world." "Accelerated preparedness activities must continue, backed by political impetus and financial support, to further bridge the still substantial gap between supply and demand," she said. This year, manufacturers have been able to step up production capacity of trivalent (three viral strains) seasonal influenza vaccines to an estimated 565 million doses, from 350 million doses produced in 2006, according to the International Federation of Pharmaceutical Manufacturers & Associations. According to experts working in this field, the yearly production capacity for seasonal influenza vaccine is expected to rise to 1 billion doses in 2010, provided corresponding demand exists. This would help manufacturers to be able to deliver around 4.5 billion pandemic influenza vaccine courses because a pandemic vaccine would need about eight times less antigen, the substance that stimulates an immune response. Vaccine production capacity is linked to the amount of antigen that has to be used to make each dose of the vaccine. Scientists have recently discovered they can reduce the amount of antigen used to produce pandemic influenza vaccines by using water-in-oil substances that enhance the immune response. The progress was reported at the first meeting of a WHO Advisory Group on pandemic influenza vaccine production and supply.The Global Action Plan Advisory Group, an independent, international committee of 10 members, met at WHO headquarters one year after eight new strategies to increase pandemic influenza vaccine were identified and published in the WHO “Global pandemic influenza action plan to increase vaccine supply.” At the Advisory Group meeting, other progress on the Global Action Plan was discussed. WHO reported it is setting up a training hub that would serve as a source of technology transfer to developing countries. The Advisory Group also discussed a new business plan which assessed options for further increasing vaccine production capacity and reviewed priority next steps. The three most valuable options include continuing to promote seasonal influenza vaccine programmes, supporting the industry to sustain production capacity beyond seasonal demand and enabling some vaccine production facilities to change, at the onset of a pandemic, from producing inactivated vaccines to live attenuated vaccines. Due to the higher yields obtained with live attenuated influenza vaccine technology, facility conversion could, by 2012, bridge the expected supply-demand gap and produce enough vaccine to protect the global population within six months of the declaration of a pandemic. For further information, please contact: Department of Immunization, Vaccines and Biologicals WHO, Geneva Tel.: +41 22 791 2103 Mobile: +41 79 351 6330   Share your Favorite articles on the following Social Networks: Share on Facebook

On-going Ebola haemorrhagic fever outbreak in the Democratic Republic of the Congo   ---WHO and partners respond to Ebola fever in DRC---   Read the fact sheet on Ebola virus related fever at http://www.who.int/mediacentre/factsheets/fs103/en/index.html   Updated Info as of  October 3, 2007   The Ministry of Health has confirmed that, as of 2 October 2007, a total of 25 out of 76 suspected cases of Ebola haemorrhagic fever from the province of Kasai Occidental have now tested positive for the disease. A further 187 contacts are currently under medical observation and will remain so until each has reached the end of their respective potential incubation periods without developing any symptoms of the disease.   Although there is now strong clinical and epidemiological evidence to suggest that the outbreak is slowing, identifying and isolating all suspect cases is still a priority for the response teams to ensure that the chains of transmission are broken. This includes following up any contacts over the incubation period in order to isolate them immediately if they become ill. Two consecutive incubation periods must elapse, a total of 42 days following the identification and isolation of the last confirmed case, before the outbreak is considered controlled.   The international response team, with the participation of members of the Global Outbreak Alert and Response Network, is continuing to work with the Ministry of Health in all areas of disease control including community health education, social mobilization, contact tracing, clinical management, infection control in health facilities and rapid on-site laboratory diagnosis. The international team is also assisting in conducting retrospective epidemiological studies to further characterize the outbreak.   ######   September 28, 2007 -The Ministry of Health of the Democratic Republic of the Congo (DRC) is continuing to respond to the on-going outbreak of Ebola haemorrhagic fever in the Province of Kasai Occidental with the support of a wide range of international partners.   As of today, there has been a total of 17 laboratory-confirmed cases of Ebola haemorrhagic fever reported in the Mweka and Luebo health zone, Kasai Occidental Province, along with additional confirmations of other etiologies associated with this outbreak including typhoid and Shigella dysenteriae type 1. The last confirmed case of Ebola died on 22 September in Kampungu MSF isolation ward and was buried safely. Mobile laboratories, installed by specialists from the Centers for Disease Control and Prevention in the United States and the National Public Health Agency of Canada in two of the affected villages are enabling the teams on the ground to conduct rapid and precise diagnosis of new suspected Ebola cases within two to six hours.   Teams on the ground are focusing on breaking the chain of transmission and are continuing to monitor additional suspected cases in isolation facilities and to trace contacts. The national health authorities are putting in place stringent infection control measures in health centres and hospitals in the affected area to minimize the risk of infection among health care workers. Information and training material on infection control is being prepared and disseminated to provincial health authorities across the country in case additional cases are identified beyond the currently affected area.   The local health authorities in the affected area are working closely with social mobilization experts, and communication teams to develop key information messages for the local communities. Journalists are preparing and broadcasting radio sketches on the prevention of Ebola as well as providing communities with information on how to recognize its early symptoms and alert the relevant authorities. It is estimated that up to 60% of the local population is being reached through these radio broadcasts.    The communications teams are also working through local civil society groups including women and youth associations, churches, military units, schools and markets to reach as wide a spectrum of the population as possible. These activities are essential to alert the communities to the risk of transmission while at the same time reducing the panic and fear that are frequently associated with outbreaks of viral haemorrhagic fever.   Retrospective investigations of hospital records are under-way to determine the progress the outbreak took in its initial stages and to document the spread of the epidemic in the first few months. Share your Favorite articles on the following Social Networks: Share on Facebook

The World Health Report 2007 - A Safer Future: Global Public Health Security In The 21st Century   Read complete WHO report at: http://www.who.int/whr/2007/en/index.html (in English) http://www.who.int/whr/2007/es/index.html (in Spanish) http://www.who.int/whr/2007/fr/index.html  (in French)   Infectious diseases are spreading faster than ever before, the World Health Organization annual report says. With about 2.1 billion airline passengers flying each year, there is a high risk of another major epidemic such as AIDS, SARS or Ebola fever. The WHO urges increased efforts to combat disease outbreaks, and sharing of virus data to help develop vaccines. Without this, it says, there could be devastating impacts on the global economy and international security.   In the report, A Safer Future, the WHO says new diseases are emerging at the "historically unprecedented" rate of one per year.  Since the 1970s, 39 new diseases have developed, and in the last five years alone, the WHO has identified more than 1,100 epidemics including cholera, polio and bird flu.   "It would be extremely naive and complacent to assume that there will not be another disease like AIDS, another Ebola, or another SARS, sooner or later," the report says.   Some important points of the report are:   -Flu pandemic could affect more than 1.5 billion people or 25% of world population.   -Comeback by cholera, yellow fever and epidemic meningococcal disease in the last quarter of the 20th Century.   -685 verified events of international public health concern from September 2003 to September 2006.   -Growth of anti-microbial resistance, notably drug-resistant TB.   In an introduction to the report, WHO Director-General Margaret Chan says co-operation is crucial to combat outbreaks. "Given today's universal vulnerability to these threats, better security calls for global solidarity," Dr Chan says.   "International public health security is both a collective aspiration and a mutual responsibility."   Share your Favorite articles on the following Social Networks: Share on Facebook

Protecting the Public's Health against Tuberculosis: Moving Forward- CDC Advisory

Published by CDC: July 26, 2007 Q&A Related to CDC July 3, 2007 Press Conference with National Jewish Medical and Research Center We share in the optimism associated with the recent news that indicates patients originally identified with extensively drug-resistant tuberculosis (XDR TB) may have additional drug treatment options. Yet, the reality remains that these patients and many others across the world are suffering from a very serious form of multi-drug resistant tuberculosis (MDR TB). Drug-resistant TB poses a grave and growing threat to global public health which we as a nation must take action to address. We must ensure that the public health messages and necessary responses to drug-resistant tuberculosis are not quickly forgotten, but rather propel us toward new solutions. First, it is critical that we ensure that the public understand the basic facts about how this disease evolves, how it is transmitted, and how to protect their own health and that of others. Like many infectious diseases, tuberculosis takes weeks to months to identify or diagnose, is challenging to treat and can sometimes be spread by people who don't appear to be ill. The challenging nature of TB also means that effectively treating it, and preventing its transmission, requires a sustained partnership between health care providers, local and state public health practitioners and patients infected with the disease. Second, it is worth reiterating that anyone with active TB disease, regardless of whether it is drug-resistant, should avoid situations that place them in prolonged contact with others, including flying on commercial aircraft. TB is generally not spread by casual contact, but typically requires relatively prolonged contact in shared airspace. The environment on long flights in commercial aircraft, particularly those of eight or more hours in length, has been previously implicated in TB transmission, especially to passengers seated in close proximity. This is the basis for the World Health Organization (WHO) guidelines for the prevention of TB transmission during air travel. Protecting the health of international air travelers requires building and sustaining partnerships between public health and infected individuals. Third, in moving forward, we need to increase our efforts to communicate strongly and clearly about risks posed by tuberculosis; strengthen our efforts to reduce the fear and stigma associated with this devastating disease; and clarify and reinforce the roles that patients, clinicians, and public health officials play in infectious disease control. There's no doubt we have had considerable success in TB prevention and control in the United States. There's also no doubt the increasing prevalence of drug-resistant tuberculosis bacteria across the world is a reminder that much more needs to be done. Beyond improved awareness and education, scientific advances will also be required to reduce the threat of this disease. The current methods to diagnose TB are complex, are not available everywhere they are needed, and require far too much time to provide results. New methods are needed that can give us reliable answers in hours or days instead of weeks. Similarly, new safe and effective vaccines and treatments are urgently needed to combat drug-resistant TB bacteria to prevent a return to the pre-antibiotic era. Effective public health response to MDR and XDR TB requires accelerated efforts and earnest engagement by multiple sectors of society. All of us—patients, providers, health officials, and policymakers—share a responsibility to take action now to prevent further transmission. Martin S Cetron, MD Captain, U.S. Public Health Service Director, Global Migration and Quarantine Centers for Disease Control and Prevention Kenneth G. Castro, M.D. Assistant Surgeon General, U.S. Public Health Service Director, Tuberculosis Elimination Centers for Disease Control and Prevention Q&A Related to CDC July 3, 2007 Press Conference with National Jewish Medical and Research Center Press Briefing Transcript How can drug susceptibility testing have different results on specimens from the same patient? TB bacteria can show variable resistance to second-line TB medications. Thus, a change or difference in test results can, and does, happen when it comes to MDR and XDR TB. Different specimens/samples from the same person can produce different results. The patient may also be infected with more than one strain of TB. TB that consists of more than one strain is not uncommon. For example, in one recent study, 19% of patients were infected with two different strains of TB at the same time. [Reference: Warren RM et al. Patients with Active Tuberculosis often Have Different Strains in the Same Sputum Specimen. Am J Respir Crit Care Med 2004;169:610-4.] How do these results affect the follow-up of persons exposed to this patient? The public health response to drug resistant TB infections, whether MDR or XDR, is the same under the World Health Organization's TB and Airline Travel guidelines. It is important to remember that a patient who has drug-resistant TB represents a significant public health concern. MDR-TB is a rare version of TB and is resistant to the most commonly used drug therapies. It is a serious illness that can be transmitted to others, and thus put others at risk for getting a difficult-to-treat disease. People with these infections should not be flying on commercial airlines and if it is discovered that such travel has taken place, an effort should be made to notify and evaluate passengers who were seated near them. CDC continues efforts to ensure the well being of persons who may have been exposed and infected by this patient. What is multidrug-resistant tuberculosis (MDR TB)? Multidrug-resistant tuberculosis (MDR TB) is TB that is resistant to at least two of the best anti-TB medications, isoniazid and rifampin. These medications are considered first-line drugs and are used to treat all persons with drug-susceptible TB disease. A more serious form of MDR TB is called extensively drug-resistant TB (XDR TB). XDR TB is a relatively rare type of TB that is resistant to nearly all medicines used to treat TB disease. Because XDR TB is resistant to the most effective TB medicines used to treat TB, patients are left with very limited useful treatment options. Treatment for MDR TB is considerably less effective, more toxic, and more expensive than for drug-susceptible TB. MDR TB, as is XDR TB, is a difficult to treat disease that is often fatal. Treatment of MDR TB requires a patient to take 18–24 months of medication, including taking multiple second-line medications, to kill the bacteria. What is extensively drug resistant tuberculosis (XDR TB)? XDR TB is a more serious form of multidrug-resistant TB (MDR TB). In both cases, the TB is resistant to the "first-line" antibiotics available for treatment, as well as some of the second-line antibiotics. Both MDR TB and XDR TB, are difficult to treat and are often fatal. XDR TB is defined as TB which is resistant to isoniazid and rifampin, plus resistant to any fluoroquinolone and at least one of three injectable second-line drugs (i.e., amikacin, kanamycin, or capreomycin). Because XDR TB is resistant to first-line and second-line drugs, patients are left with very limited treatment options that are even less effective than for MDR TB that does not qualify as XDR TB. What is drug susceptibility testing? Drug susceptibility testing uses laboratory techniques to determine which medicines will kill the TB bacteria in the patient's specimen. The results of drug susceptibility tests can help clinicians choose the appropriate treatment regimen for each patient. Why are National Jewish Medical Center's test results different from CDC's results? It is not unusual to have differing drug susceptibility results from multiple specimens from the same patient. Reasons for differing results include The TB bacteria in a sputum specimen may come from different parts of the lung or different lesions in the lung. The TB bacteria in a sputum specimen may have different types of bacteria such as drug-susceptible bacteria (bacteria that can be killed by TB medicines) and drug-resistant (bacteria that cannot be killed by most TB medicines). The amount of the different types of bacteria may vary over time and from specimen to specimen. When drug susceptibility test results from different specimens from one patient are not the same, a treatment regimen is chosen that is most likely to be effective on the most predominant TB bacteria. CDC's laboratory functions as a national and supranational (i.e., for other countries) reference facility to provide access to drug susceptibility testing for second-line drugs. How is drug susceptibility testing conducted? CDC receives samples of M. tuberculosis that have been obtained from cultures performed in labs outside of CDC (for example, state public health, international, and private laboratories). Before sending samples to CDC, the labs smear cultures on media and keep the cultures warm media until bacteria grow (colonies). Colonies of bacteria are scraped from the surface of the culture media, taking care to sample all parts of this growth (colonies). The colonies are placed into a broth and kept warm for approximately one week. At one week, the broth is diluted to obtain the number of organisms needed to perform susceptibility testing.