29 May 2009 -- As of 06:00 GMT, 29 May 2009, 53 countries have officially reported 15,510 cases of influenza A(H1N1) infection, including 99 deaths.

The breakdown of the number of laboratory-confirmed cases by country is given in the following table.

Laboratory-confirmed cases of new influenza A(H1N1) as officially reported to WHO by States Parties to the International Health Regulations (2005)

Chinese Taipei has reported 9 confirmed cases of influenza A (H1N1) with 0 deaths. Cases from Chinese Taipei are included in the cumulative totals provided in the table above.

Cumulative and new figures are subject to revision

Ministerial meeting of countries with high M/XDR-TB burdens

http://www.who.int/tb_beijingmeeting/en/index.html

WHO Stop TB Department

http://www.who.int/tb/en/index.html

Stop TB Partnership

http://www.stoptb.org/

Global leaders, including WHO Director-General Dr Margaret Chan and the Co-Chair of the Bill and Melinda Gates Foundation, Mr Bill Gates, were joined by the Vice Premier of the People's Republic of China, Mr Li Keqiang, and ministers and high-level representatives of 27 countries with high burden, at a three-day meeting organized by WHO.

The governments present issued a Call for Action at the conclusion of the opening day of the meeting. The Call for Action, which was supported by senior representatives from international health and aid agencies and non-governmental organizations, asserts that all countries would move:

towards universal access to M/XDR-TB diagnosis and treatment by 2015;

to ensure removal of financial barriers to TB care;

to ensure development of a comprehensive M/XDR-TB management and care framework;

to ensure sufficient staff are trained and deployed;

to strengthen laboratory systems;

to ensure collaboration with all partners;

to ensure development and implementation of airborne infection control policies;

to ensure a sufficient supply of high-quality anti-TB drugs;

strengthen mechanisms to ensure availability of TB medicines is regulated;

to ensure advocacy and communication and social mobilization are included in policies and plans; and

to develop the new tools needed to combat M/XDR-TB.

Chinese Vice Premier Li Keqiang said China will work with the world to improve TB control. In facing drug-resistant TB, he said "the Chinese government will strengthen prevention and treatment work".

M/XDR-TB in high burden countries

Multidrug-resistant tuberculosis (MDR-TB) is defined as resistance to the two most powerful first-line anti-TB drugs (isoniazid and rifampicin). Extensively drug-resistant tuberculosis (XDR-TB) is defined as MDR-TB plus resistance to the most powerful second-line anti-TB drugs (any fluoroquinolone and any of the three injectable drugs: amikacin, capreomycin and kanamycin). MDR-TB and XDR-TB together are defined as M/XDR-TB.

There are 27 countries with a high burden of M/XDR-TB: Armenia, Azerbaijan, Bangladesh, Belarus, Bulgaria, China, DR Congo, Estonia, Ethiopia, Georgia, India, Indonesia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Rep of Moldova, Myanmar, Nigeria, Philippines, Russian Federation, Pakistan, South Africa, Tajikistan, Ukraine, Uzbekistan, Viet Nam. A high burden country is defined as one where there 4000 or more new cases of drug-resistant TB per year, or where 10% of new TB cases are drug resistant.

WHO Director General Dr Margaret Chan said preventing and managing drug-resistant TB was a global health imperative. "We need high-level political attention because national TB programmes cannot by themselves manage these new threats. The problem has become too great," she said.

Mr Bill Gates urged all countries to invest in innovative methods to fight TB. "Every country should feel the urgency, whether it is suffering from TB or not. Every country is capable of innovation, whether it is has a high-tech economy or not. And every country can adapt its systems to use the best innovations of others."

The Call for Action signals a major step forward in coordinated planning for M/XDR-TB prevention, treatment and care and a commitment to achieve universal access to diagnosis and treatment for MDR-TB patients by 2015.

The final two days of the meeting will be spent outlining the technical implications of the Call for Action for governments and stakeholders.

Four of the countries represented at the three-day meeting - China, India, the Russian Federation and South Africa account for 60% of the global number of MDR-TB cases and have increased their financing for TB control. Still, only 3% of the half million MDR-TB cases estimated to emerge each year worldwide are known to be receiving treatment according to WHO guidelines.

Participants committed to help mobilize the estimated US$ 15 billion needed to finance the TB and M/XDR-TB response from both domestic and international resources through to 2015, and called for increased investment in the research and development of new TB diagnostics, drugs and vaccines. They asked for WHO and the Stop TB Partnership to ensure there is the necessary technical support needed to implement the M/XDR-TB response plans.

These further commitments are expected to have a significant impact in these and other countries in saving lives, enabling care for those in need, and 'turning off the tap' that produces M/XDR-TB.

Source: WHO Press Release

25 FEBRUARY 2009 | GENEVA -- WHO said that the emergence of parasites resistant to artemisinin at the Thai-Cambodia border could seriously undermine the success of the global malaria control efforts.

Surveillance systems and research studies supported by WHO to monitor antimalarial drug efficacy in countries are providing new evidence that parasites resistant to artemisinin have emerged along the border between Cambodia and Thailand. If local people, who walk for miles every day to clear forests, were infected with a drug-resistant form of malaria, it could set back recent successes to control the disease.

Huge strides have been made in the past 10 years to reduce the burden of malaria, one of the world's major killer diseases. Strong malaria control programmes have helped to lower infection rates in several countries. The recent shift from failing drugs to the highly effective artemisinin-based combination therapies (ACTs) has been a breakthrough. Appropriate treatment with ACTs succeeds in more than 90% of cases. But malaria drug resistance now emerging along the Thai-Cambodia border threatens these gains.

With a US$ 22.5 million grant from the Bill & Melinda Gates Foundation, WHO will endeavour to contain artemisinin-resistant malaria parasites before they spread. WHO will work in collaboration with several key partners including the National Center for Parasitology, Entomology and Malaria Control of the Cambodian Ministry of Health, Bureau of Vector-Borne Disease of the Thai Ministry of Public Health, Faculty of Tropical Medicine of Mahidol University Bangkok, Institut Pasteur Cambodia, Mahidol Oxford Tropical Medicine Research Unit, Bangkok and the Malaria Consortium.

"If we do not put a stop to the drug-resistant malaria situation that has been documented in the Thai-Cambodia border, it could spread rapidly to neighbouring countries and threaten our efforts to control this deadly disease," said Dr Hiroki Nakatani, Assistant Director-General of WHO.

Resistance along the Thai-Cambodia border started with chloroquine, followed by resistance to sulfadoxine-pyrimethamine and mefloquine, drugs used in malaria control several years ago.

Malaria poses a risk to half of the world's population and more than one million people die of the disease each year. The malaria map, or the area where it is prevalent, has been reduced considerably over the past 50 years, but the disease has defied elimination in areas of intense transmission.

Obstacles to malaria control include drug resistance in the parasite that causes the disease, as well as resistance of the vector mosquito to insecticides, environmental factors and counterfeit medicines. The likelihood of drug resistance is increased with the use of single-drug therapies for malaria, especially monotherapies of artemisinin and its derivatives. Monotherapy fosters resistance because it is easier for the parasite to adapt and eventually overcome the obstacles presented by a single drug than a combination of drugs delivered together. This makes it crucial for monotherapies to be removed from the market. WHO's treatment policy is to treat all cases of uncomplicated falciparum malaria with artemisinin combination therapy (ACTs).

"We know that malaria can be treated and prevented,” said Dr Regina Rabinovich, Director of Infectious Diseases Development at the Bill & Melinda Gates Foundation, “and if we lose the key treatment available at this time, it's like living in a house with a half a roof.”

The grant will be used to meet the following key objectives:

    * eliminate artemisinin-tolerant parasites by detecting all malaria cases in target areas and ensuring effective treatment;

    * reduce exposure of the parasites to artemisinin to limit emergence of resistance;

    * prevent transmission of artemisinin-tolerant malaria parasites through mosquito control and personal protection;

    * limit the spread of artemisinin-tolerant malaria parasites by mobile populations;

    * support the containment and elimination of artemisinin-tolerant parasites through comprehensive behaviour change, communication, community mobilization and advocacy;

    * undertake basic and operational research to fill knowledge gaps and ensure that strategies applied are evidence-based; and

    * provide effective management, surveillance and coordination to enable a rapid and high-quality implementation of the strategy.

Source: WHO Press Release

28 January 2009 -- Approximately half of the world's population is at risk of malaria, particularly those living in lower-income countries. An updated fact sheet on malaria describes the magnitude of the risk and strategies to reduce this life-threatening disease.

Malaria

Key facts

• Malaria is a life-threatening disease caused by parasites that are transmitted to people through the bites of infected mosquitoes.
• A child dies of malaria every 30 seconds.
• There were 247 million cases of malaria in 2006, causing about 880,000 deaths, mostly among African children.
• Malaria is preventable and curable.
• Approximately half of the world's population is at risk of malaria, particularly those living in lower-income countries.
• Travellers from malaria-free areas to disease "hot spots" are especially vulnerable to the disease.
• Malaria takes an economic toll - cutting economic growth rates by as much as 1.3% in countries with high disease rates

Malaria is caused by parasites of the species Plasmodium. The parasites are spread to people through the bites of infected mosquitoes.

There are four types of human malaria:

• Plasmodium falciparum
• Plasmodium vivax
• Plasmodium malariae
• Plasmodium ovale.

Plasmodium falciparum and Plasmodium vivax are the most common. Plasmodium falciparum is the most deadly.

Transmission

Malaria transmission rates can differ depending on local factors such as rainfall patterns (mosquitoes breed in wet conditions), the proximity of mosquito breeding sites to people, and types of mosquito species in the area. Some regions have a fairly constant number of cases throughout the year - these countries are termed "malaria endemic". In other areas there are "malaria seasons" usually coinciding with the rainy season.

Large and devastating epidemics can occur when the mosquito-borne parasite is introduced into areas where people have had little prior contact with the infecting parasite and have little or no immunity to malaria, or when people with low immunity move into areas where malaria cases are constant. These epidemics can be triggered by wet weather conditions and further aggravated by floods or mass population movements driven by conflict.

Symptoms

The common first symptoms – fever, headache, chills and vomiting – usually appear 10 to 15 days after a person is infected. If not treated promptly with effective medicines, malaria can cause severe illness and is often fatal.

Who is at risk?

Most cases and deaths are in sub-Saharan Africa. However, Asia, Latin America, the Middle East and parts of Europe are also affected. In 2006, malaria was present in 109 countries and territories.

Specific risks follow.

• Travellers from malaria-free regions, with little or no immunity, who go to areas with high disease rates are very vulnerable.
• Non-immune pregnant women are at high risk of malaria. The illness can result in high rates of miscarriage and cause over 10% of maternal deaths (soaring to a 50% death rate in cases of severe disease) annually.
• Semi-immune pregnant women risk severe anaemia and impaired fetal growth even if they show no signs of acute disease. An estimated 200 000 of their infants die annually as a result of malaria infection during pregnancy.
• HIV-infected pregnant women are also at increased risk.

Treatment

Early treatment of malaria will shorten its duration, prevent complications and avoid a majority of deaths. Because of its considerable drag on health in low-income countries, malaria disease management is an essential part of global health development. Treatment aims to cure patients of the disease rather than to diminish the number of parasites carried by an infected person.

The best available treatment, particularly for P. falciparum malaria, is a combination of drugs known as artemisinin-based combination therapies (ACTs). However, the growing potential for parasite resistance to these medicines is undermining malaria control efforts (see below). There are no effective alternatives to artemisinins for the treatment of malaria either on the market or nearing the end of the drug development process.

WHO recommends:

• prompt treatment for all episodes of disease (within 24 hours of the onset of symptoms if possible);
• use of insecticide-treated nets for night-time prevention of mosquito bites;
• for pregnant women in highly endemic areas, preventive doses of sulfadoxine–pyrimethamine (IPT/SP) to periodically clear the placenta of parasites;
• indoor residual spraying to kill mosquitoes that rest on the walls and roofs of houses.

WHO guidelines for the treatment of malaria [pdf 1.85Mb]

Drug resistance

Drug resistance to commonly used antimalarial drugs has spread very rapidly. In order to avoid this for artemisinins, they should be used in combination as ACTs, and artemisinin monotherapy (use of one artemisinin drug versus the more effective combination pill) should not be used. The less effective single-drug treatment increases the chance for parasites to evolve and become resistant to the medicine. Intensive monitoring of drug potency is essential to protect against the spread of resistant malaria strains to other parts of the world.

WHO recommends continuous monitoring and is assisting countries as they work to strengthen drug observation efforts.

More information on resistance

Prevention

Prevention focuses on reducing the transmission of the disease by controlling the malaria-bearing mosquito. Two main interventions for vector control are:

• use of mosquito nets treated with long-lasting insecticide, a very cost-effective method;
• indoor residual spraying of insecticides.

These core interventions can be locally complemented by other mosquito vector control methods (for example, reducing standing water habitats where insects breed, among other approaches).

Insecticide resistance

Mosquito control efforts are being strengthened in many areas, but there are significant challenges, including:

• increasing mosquito resistance to key insecticides DDT and pyrethroids, particularly in Africa;
• a lack of alternative, effective insecticides;
• changing behaviours of local malaria-bearing mosquitoes, which can result from vector control efforts (as insects move to more hospitable areas).

There are no equally effective and efficient insecticide alternatives to DDT and pyrethroids, and the development of new pesticides is an expensive, long-term endeavour. Vector management practices that enforce the sound management of insecticides are essential.

Insecticide resistance detection should be a routine feature of national control efforts to ensure that the most effective vector control methods are being used.

More information on vector control

Economic impact

Beyond the human toll, malaria wreaks significant economic havoc in high-rate areas, decreasing Gross Domestic Product (GDP) by as much as 1.3% in countries with high levels of transmission. Over the long-term, these aggregated annual losses have resulted in substantial differences in GDP between countries with and without malaria (particularly in Africa).

Malaria’s health costs include both personal and public expenditures on prevention and treatment. In some heavy-burden countries, the disease accounts for:

• up to 40% of public health expenditures
• 30% to 50% of inpatient hospital admissions
• up to 60% of outpatient health clinic visits.

Malaria disproportionately affects poor people who cannot afford treatment or have limited access to health care, and traps families and communities in a downward spiral of poverty.

Elimination

Recent data shows that large-scale use of WHO recommended strategies could rapidly reduce malaria, especially in areas of high transmission such as Africa. WHO and Member States have made significant gains in malaria elimination efforts. For example, the Maldives, Tunisia and the United Arab Emirates have eliminated malaria. Country successes are due to intense national commitments and coordinated efforts with partners.

Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.

“HHS/FDA has helped save lives by making high quality, anti-retroviral generic drugs available quickly, at a lower cost, for those most in need under the President’s Emergency Plan," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "As we grant tentative approval for the 75th product, our efforts won't stop: we will continue to provide review of applications for safe and effective treatments for AIDS to combat this global concern."

“Tentative approval" means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of HHS/FDA's normal requirements for manufacturing quality and clinical safety and efficacy.

HHS/FDA performs all of its reviews of applications received in association with the Emergency Plan on an expedited basis; the agency reviewed this application for lamivudine tablets in less than six months. After receiving approval or tentative approval from HHS/FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows HHS/FDA to share data from its evaluations with the WHO team in Geneva. Generic anti-retrovirals given approval or tentative approval by HHS/FDA are also immediately eligible for procurement by recipients of grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria.

In 2003, President George W. Bush launched his Emergency Plan for AIDS Relief to combat global HIV/AIDS – the largest commitment by any nation to combat a single disease in history. At that time, about 50,000 people in sub-Saharan Africa were receiving anti-retroviral treatment. Today, the Emergency Plan reaches more than 1.7 million worldwide with anti-retroviral treatment, the vast majority of them in sub-Saharan Africa, and supports care for more than 6.6 million people, including 2.7 million orphans and vulnerable children. To date, interventions funded by the Emergency Plan have allowed mothers to give birth to nearly 200,000 HIV-free children.

In 2004, HHS/FDA implemented an expedited process under the Emergency Plan to review individual, generic anti-retroviral (ARV) drug formulations, co-packaged versions of individual ARV drug formulations, and fixed-dose ARV combinations. The expedited process includes a commitment by HHS/FDA and the Office of the U.S. Global AIDS Coordinator to work closely with manufacturers before they submit a marketing application to HHS/FDA, especially those firms that have never previously submitted to the agency, and to conduct a priority assessment of those applications.

On July 30, 2008, President Bush signed into law the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008, which reauthorized and expanded the Emergency Plan for five additional years, from 2009 through 2013. The legislation authorizes up to $38 billion over five years for bilateral HIV/AIDS programs under the Emergency Plan, activities under the President’s Malaria Initiative, and bilateral U.S. Government international work against tuberculosis, as well as contributions to the Global Fund.

For more information

PEPFAR on the Web
www.pepfar.gov
http://www.fda.gov/oia/pepfar.htm

To see a consumer article called "Improving Access to HIV/AIDS Drugs Abroad," visit http://www.fda.gov/consumer/updates/pepfar081307.html

FDA Generic Drugs
http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm

 http://www.fda.gov/bbs/topics/NEWS/2008/NEW01909.html

--Prepandrix™, Europe’s only approved pre-pandemic influenza vaccine, confers persistent immune response against a number of H5N1 strains--

Issued: 16th September 2008, Third European Influenza Conference (ESWI), Vilamoura, Portugal

Results from two new clinical studies announced at the Third European Influenza Conference (ESWI) demonstrate that Prepandrix™, GlaxoSmithKline’s (GSK) H5N1 adjuvanted pre-pandemic influenza vaccine, confers broad cross-clade immunity that is maintained when the second dose is given many months after the first dose, and even if the second dose is formulated from a different H5N1 strain. Greater administration flexibility, adaptable to local pre-pandemic vaccination policies, could potentially reduce the impact on vital healthcare resources during the first intensive months of a pandemic.

“When indeed H5N1 would be at the basis of the next influenza pandemic, it is critical that a pre-pandemic H5N1 influenza vaccine provides broad and persistent immunity, also against drifted H5N1 strains.” said Professor Albert Osterhaus, Head Department of Virology, Institute of Virology Erasmus Medical Centre Rotterdam. “GSK’s pre-pandemic influenza vaccine has repeatedly demonstrated and now confirmed that this level of immunity can be maintained when the second dose is given many months after the first, even with a different H5N1 strain.”

The World Health Organization (WHO) considers that the world is now closer to another influenza pandemic than at any time since the last one in 1968,1 with the virus currently threatening to trigger a pandemic (H5N1) having a potential reported case fatality rate above 60%.2 The WHO has highlighted that vaccines are the most important intervention for preventing influenza and reducing its health consequences during a pandemic1.

A pre-pandemic influenza vaccine is the only vaccine which can be produced in advance and stockpiled today, allowing immediate availability in the event of a WHO declared pandemic. In contrast, a pandemic influenza vaccine can only go into production once the exact pandemic influenza strain is determined and declared, with the first doses being available a minimum of four months after the onset of a pandemic.2

The pre-pandemic influenza vaccine concept is based on using a currently circulating avian influenza virus likely to cause a pandemic, such as H5N1, to make a vaccine with the ability to raise immune protection against potential drift H5N1 strains. With experts citing immunisation with stockpiled pre-pandemic influenza vaccine as the most effective strategy for protecting entire populations,3,4 GSK’s pre-pandemic vaccine will play a critical role in pandemic preparedness planning.

“These new data show that GSK’s pre-pandemic influenza vaccine, is highly adaptable to local pandemic policies. Stockpiling of H5N1 vaccine and use of this vaccine is anticipated to provide the ability to offer protection to vaccinated individuals as well as to slow down the spread of the disease. New developments such as this make it vital for governments to continually evaluate their pandemic preparedness plans,” said Jean Stéphenne, President and General Manager GSK Biologicals. “We are actively working with governments and other organisations across the world to ensure the most effective pre-pandemic influenza vaccine is available to help protect against an influenza pandemic.”

Study Results from ESWI

AS03 adjuvanted pre-pandemic H5N1 vaccine allows highly flexible prime-boost vaccination strategy

The phase II, open, randomised study (in adults aged 18-60 years) evaluated the impact on the reactogenicity and immunogenicity when the second dose is administered between 21 days and up to six months after the first dose using GSK’s adjuvanted pre-pandemic influenza vaccine. A single booster dose of Prepandrix was administered six months after primary vaccination with either one or two dose(s) of the same adjuvanted vaccine. The results show that two vaccination doses, whether given 21 days or six months apart, elicit a comparable immune response against the vaccine strain. This confirms that the timing of administration with the second dose can be flexible and undertaken up to six months after first immunisation while maintaining the quality of the immune response. This highlights the robustness of the immunity achieved with the adjuvanted vaccine.

AS03 adjuvanted pre-pandemic H5N1 vaccine: single dose primary vaccination with clade 1 vaccine strain leads to strong immune responsiveness to clade 2 strain booster vaccination.

The phase II, open, randomised study (in adults aged 18-60 years) evaluated the cross-clade* immunity with a two dose vaccination schedule using GSK’s adjuvanted pre-pandemic H5N1 influenza vaccine. A single booster dose of the pre-pandemic influenza vaccine containing a clade 2.1 strain (drifted* H5N1 strain) was administered six months after primary vaccination with either one or two dose(s) of the pre-pandemic vaccine containing a clade 1 strain (Prepandrix). The clinical trial results show that a single dose primary vaccination with a clade 1 vaccine strain leads to strong immune responsiveness to the clade 2 strain booster vaccination. In addition, re-vaccination provides rapid and notable cross-clade immune responses against both strains.

*A clade is the name given to groups of viral variants that are closely related from an evolutionary standpoint

*Drift strains are the result of small, gradual changes in the genetic material that occur through point mutations (which are random and unpredictable) resulting in alterations to the main surface proteins, haemagglutinin, and neuraminidase

About GSK’s Adjuvanted Pre-Pandemic Influenza Vaccine

GSK's H5N1 adjuvanted pre-pandemic influenza vaccine is the first and only pre-pandemic influenza vaccine to be granted marketing authorisation by the European Commission (in 30 European states).The vaccine is an H5N1 adjuvanted pre-pandemic influenza vaccine, designed to be given before or at the onset of a declared influenza pandemic to prevent influenza caused by the H5N1 virus type (avian influenza or ‘bird flu’). GSK’s vaccine is formulated with a novel proprietary adjuvant system, which is designed to achieve a high immune response at a low dose of antigen, and to be long-lasting and active against a broad range of H5N1 strains.      

GSK is the world leader in pandemic influenza product development as it is the only company to operate a flexible portfolio of licensed pandemic products, including the pre-pandemic influenza vaccine (Prepandrix), a pandemic influenza vaccine (Pandemrix) and an influenza antiviral (Relenza®). 

GlaxoSmithKline Supporting Pandemic Preparedness Plans

GSK has previously announced its intention to donate 50 million doses of its H5N1 adjuvanted pre-pandemic influenza vaccine to the WHO in support of its stockpile initiative. The intended donation would help establish a much needed stockpile of pre-pandemic vaccines that can be distributed to the world’s poorest countries at short notice by the WHO. Delivered over a three-year period, it would provide enough doses of vaccine for 25 million people at two injections per person. GSK supports this proactive strategy of worldwide stockpiling of H5N1 pre-pandemic vaccine which may be able to save millions of lives by protecting some of the most vulnerable populations in the world at the outbreak of a pandemic.

GSK has already signed contracts with the US and several European countries, such as Switzerland and Finland, for the supply of its pre-pandemic vaccine and bulk antigen.

Prepandrix™, Pandemrix™ andRelenza® are trade marks of the GlaxoSmithKline group of companies.

GlaxoSmithKline (GSK) – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For company information, visit GlaxoSmithKline at www.gsk.com.

GlaxoSmithKline Biologicals (GSK Bio) – one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GSK’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2007, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, more than one in every ten doses delivered were combination vaccines intended to prevent up to six diseases in one vaccine.

Prepandrix™, Pandemrix™ andRelenza® are trade marks of the GlaxoSmithKline group of companies.

 References

1. WHO. Influenza Pandemic Preparedness and Response. Report by the Secretariat. EB115/44. 20 January 2005. (Accessed Aug 08)

2. Osterhaus Albert. Pre- or post-pandemic influenza vaccine? Editorial. Vaccine 2007; 25: 4983-4984.

3. Gambotto A, Barratt-Boyes SM, de Jong MD, Neumann G, Kawaoka Y. Human infection with highly pathogenic H5N1 influenza virus. Lancet 2008; 371; 1464–75

Source: GSK Press Release

--Important New Treatment Option for Millions in United States Affected by Life-Threatening Liver Disease--

FOSTER CITY, Calif--Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Viread(R) (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B, a serious liver disease caused by the hepatitis B virus (HBV). Chronic hepatitis B is the leading cause of liver cancer worldwide and affects an estimated two million individuals in the United States.

Viread is now also indicated for the treatment of chronic hepatitis B in adults. The drug is administered as a once-daily tablet, and works by blocking HBV DNA polymerase, the enzyme that is necessary for the virus to replicate in liver cells. Viread has been available in the United States as a treatment for HIV infection in adults since 2001.

"Viread will be an important new treatment option and its approval represents a significant step forward in the fight against chronic hepatitis B," said Ira Jacobson, M.D., Chief, Division of Gastroenterology and Hepatology, Weill Cornell Medical College.

Pivotal Clinical Trials

This approval is based on data from two ongoing, randomized and double-blind Phase III clinical trials, Studies 102 and 103, which compared Viread to Gilead's Hepsera(R) (adefovir dipivoxil) over 48 weeks of treatment. Results from both studies show that a significantly greater percentage of patients with chronic hepatitis B who received Viread achieved a complete response to treatment compared to those who received Hepsera. A complete response was defined as serum HBV DNA levels below 400 copies/mL and histologic improvement characterized by at least a two point reduction in the Knodell necroinflammatory score (a measure of necro-inflammation - an inflammatory process in the liver including or leading to death of liver cells) with no concurrent worsening of fibrosis (scarring of liver tissue). Trial participants included both patients new to HBV therapy (n=375) and patients (n=51) who had received prior nucleoside treatment. To date, more than 400 chronic hepatitis B patients have been treated with Viread in these studies.

"The approval of Viread for hepatitis B represents more than a decade of work in both the fields of HIV and hepatitis B to develop a medication that offers significant viral suppression, once-daily dosing and a well-established safety profile," said Kevin Young, Executive Vice President, Commercial Operations, Gilead Sciences. "We extend our thanks to the investigators and patients who participated in the clinical trials that support today's approval, and we look forward to partnering with community members to increase disease awareness and expand access to treatment for those patients in need."

Because chronic HBV infection can persist for years without causing any noticeable symptoms, many people are unaware they are infected and do not seek treatment. The disease disproportionately affects Asian Americans: One in 10 foreign-born Asian Americans is estimated to be living with chronic HBV infection, a rate 100 times greater than that of the non-Asian U.S. population, which reflects the high prevalence of HBV in many Asian countries.

"Although we've made great strides in reducing the overall incidence of chronic hepatitis B in the United States, the disease still takes a devastating toll in Asian-American communities," said Danny Chu, M.D., Community Physician, New York. "Greater public awareness and effective new treatment options are urgently needed to help reduce this significant health disparity."

The approval of Viread expands Gilead's hepatic health franchise. The company's first treatment for chronic hepatitis B, Hepsera, is currently the most widely prescribed oral agent for the disease in the United States. The company is also developing small-molecule compounds for the treatment of hepatitis C and a hepatoprotectant for multiple forms of hepatitis-related liver fibrosis, including nonalcoholic steatohepatitis (also known as NASH).

Viread was approved for the treatment of chronic hepatitis B in the European Union, Turkey, Australia and New Zealand earlier this year, and a marketing application is currently pending in Canada.

Important Information About Viread for Chronic Hepatitis B

 Viread (tenofovir disoproxil fumarate) is indicated for the treatment of chronic hepatitis B in adults.

The following points should be considered when initiating therapy with Viread for the treatment of HBV infection:

    --  This indication is based on data from one year of treatment in

        primarily nucleoside-treatment-naive adult patients with

        HBeAg-positive and HBeAg-negative chronic hepatitis B with

        compensated liver disease.

    --  The numbers of patients in clinical trials who were

        nucleoside-experienced or who had lamivudine-associated

        mutations at baseline was too small to reach conclusions of

        efficacy.

    --  Viread has not been evaluated in patients with decompensated

        liver disease.

The recommended dose for the treatment of chronic hepatitis B is 300 mg once daily taken orally without regard to food. Dose interval adjustment is recommended in renal impairment.

LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS AND POST TREATMENT EXACERBATION OF HEPATITIS

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.

Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including Viread. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

New onset or worsening of renal impairment including cases of acute renal failure and Fanconi syndrome have been reported with the use of Viread. It is recommended to assess creatinine clearance (CrCl) before initiating treatment with Viread and monitor CrCl and serum phosphorus in patients at risk. Administering Viread with concurrent or recent use of nephrotoxic drugs, including Hepsera should be avoided.

HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with Viread. Viread should only be used as part of an appropriate antiretroviral combination regimen in HIV-infected patients with or without HBV coinfection.

Decreases in bone mineral density (BMD) have been observed in HIV-infected patients. It is recommended that BMD monitoring be considered for patients with a history of pathologic fracture or who are at risk for osteopenia. The bone effects of Viread have not been studies in patients with chronic HBV infection.

In controlled clinical trials in patients with chronic hepatitis B, the most common adverse reaction (all grades) is nausea. Other treatment-emergent adverse reactions reported in greater than 5 percent of patients treated with Viread included: abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain and skin rash.

About Chronic Hepatitis B

The hepatitis B virus (HBV) is up to 100 times more easily transmitted than HIV. While most new cases of HBV infection in previously healthy adults are cleared by the immune system within a few months, many people - especially those infected as newborns and young children - will develop chronic, lifelong infections. In these cases, chronic hepatitis B can slowly destroy the liver, causing scarring (cirrhosis), liver disease, or liver cancer over many years or decades. Because it is believed to be the cause of 80 percent of all liver cancer cases worldwide, HBV is second only to tobacco among known human carcinogens.

The hepatitis B virus can be transmitted by any activity that involves exposure to blood and other body fluids, including sexual contact and use of contaminated needles during injection drug use. It can also be transmitted from mother to child at birth, which is the primary transmission route among Asian Americans. Asian Americans are one of the fastest-growing minority groups in the United States, numbering approximately 15 million people in 2007. A recent study showed that up to two-thirds of Asian Americans with chronic hepatitis B did not know they were infected.

Although there is no simple cure for chronic hepatitis B, antiviral treatment can slow viral replication and therefore reduce liver inflammation and liver injury.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

Source: Gilead Press Release

WHITEHOUSE STATION, N.J., July 23, 2008 - ISENTRESS® (raltegravir), Merck's first-in-class HIV-1 integrase inhibitor, suppressed HIV-1 viral load and increased CD4 cell counts through 48 weeks of combination therapy with other anti-HIV medicines compared to placebo in combination with other anti-HIV medicines in HIV-infected patients with triple-class resistant virus failing current therapy. These results from two pivotal Phase III studies of 699 treatment-experienced patients who were failing other antiretroviral therapies (ARTs) were published today in the New England Journal of Medicine.

In October 2007, the U.S. Food and Drug Administration (FDA) granted ISENTRESS accelerated approval for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication with HIV-1 strains resistant to multiple antiretroviral agents. The approval was based on analyses of viral load reductions and CD4 cell count increases from baseline through 24 weeks in two Phase III studies of ISENTRESS, which are ongoing. The 48-week data reported today in the New England Journal of Medicine represent additional data from those studies.

The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response. The safety and efficacy of ISENTRESS have not been established in treatment-naïve adult patients or pediatric patients. There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.

"HIV disease is very complex and is especially difficult to manage in patients whose virus has become resistant to therapy. The 48-week results for ISENTRESS show that when paired with other anti-HIV medicines, ISENTRESS effectively lowered the amount of virus in the blood to undetectable levels in 62 percent of patients versus 33 percent of patients receiving placebo plus other anti-HIV medicines. Also, combination therapy with ISENTRESS helped the immune system to rebound. ISENTRESS acts at a step in HIV replication that's different from the targets of prior drugs," said Roy Steigbigel M.D., professor of medicine, pathology, microbiology and pharmacology, Stony Brook University School of Medicine and lead study investigator for one of the studies.

ISENTRESS studied in nearly 700 patients with virus resistant to multiple anti-HIV medicines

The data published today in the New England Journal of Medicine are Week 48 results from two identical ongoing multi-center, double-blind, randomized, placebo-controlled Phase III studies (BENCHMRK-1 and BENCHMRK-2) that compare ISENTRESS in combination with optimized background therapy (OBT) to placebo plus OBT. The primary endpoint of this ongoing study is the percentage of patients that achieve HIV RNA virus levels less than 400 copies/mL at Week 16. Patients in the studies had HIV resistant to at least one drug in each of three classes [nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)] of oral ARTs.

Patients in BENCHMRK-1 were enrolled in Europe, Asia, Australia and South America (Peru). The baseline viral load (geometric mean) was approximately 41,000 copies/mL for patients treated with ISENTRESS and 32,000 copies/mL for patients treated with the placebo regimen. The median baseline CD4 cell counts were 140 cells/mm³ for patients treated with ISENTRESS and 105 cells/mm³ for patients treated with the placebo regimen.

Patients in BENCHMRK-2 were enrolled in North and South America. The baseline viral load (geometric mean) was approximately 48,000 copies/mL for patients in both groups. The median baseline CD4 cell counts were 102 cells/mm³ for patients treated with ISENTRESS and 132 cells/mm³ for patients treated with the placebo regimen.

Patients received ISENTRESS 400 mg or placebo, each dosed orally twice daily in combination with OBT. OBT was determined based on each patient's prior treatment history and results from HIV resistance testing; and represents the best available antiviral drug combination individualized for each patient. In order to allow for the best possible treatment regimen to be constructed for each patient, darunavir and tipranavir, which were investigational medicines in many countries at the time of this study, were permitted for use in OBT.

Consistent suppression of viral load and increase in CD4 cell counts observed through 48 weeks of treatment with ISENTRESS

Results at Week 48 were consistent across both BENCHMRK studies. The results reported in the New England Journal of Medicine include both individual study results and a combined analysis of both studies at 48 weeks. At 48 weeks, the percentage of patients who achieved HIV RNA levels below 400 copies/mL were nearly two times greater for patients receiving ISENTRESS plus OBT (72 percent of patients; 332 of 459) compared to patients receiving placebo plus OBT (37 percent of patients; 88 of 237); p<0.001. In addition, ISENTRESS plus OBT suppressed viral load to undetectable levels (below 50 copies/mL) in significantly more patients compared to placebo plus OBT; 62 percent of patients (285 of 459) versus 33 percent of patients (78 of 237), respectively; p<0.001.

After 48 weeks, mean CD4 cell counts were more than doubled in patients receiving ISENTRESS plus OBT compared to patients receiving placebo plus OBT. Specifically, patients receiving ISENTRESS plus OBT achieved mean increases in CD4 cell counts from baseline of 109 cells/mm³ compared to 45 cells/mm³ for patients receiving placebo plus OBT; p<0.001.

"The efficacy results shown after 48 weeks of treatment with ISENTRESS when used in combination with other anti-HIV medicines are consistent with observations at 24 weeks," said David Cooper M.D., D.Sc., professor of medicine and director of the National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia.

Safety results at 48 weeks

Also, the combined analysis showed that 4 of 462 patients (0.9 percent) receiving ISENTRESS plus OBT and 1 of 237 patients (0.4 percent) receiving placebo plus OBT discontinued therapy due to drug-related adverse experiences. Overall, 11 of 462 patients (2.4 percent) receiving ISENTRESS plus OBT and 7 of 237 patients (3.0 percent) receiving placebo plus OBT experienced serious drug-related adverse events. The most commonly reported (reported in at least two percent of patients) study drug-related side effects in patients receiving raltegravir plus OBT were diarrhea, nausea, injection site pain or reaction (due to enfuvirtide) and headache.

Study results also showed that at 48 weeks, 16 of 462 patients (3.5 percent) receiving ISENTRESS plus OBT and 4 of 237 (1.7 percent) patients receiving placebo plus OBT were diagnosed as having new, recurrent or progressive cancer. Statistical analysis indicated these rates, adjusted for how much time the patients were on treatment, were not different, with relative risk of 1.54 and 95 percent confidence interval including 1 (0.50 to 6.34).

Subgroup analyses of patients with predicted poor response to antiretroviral therapy

Results from subgroup exploratory analyses examining factors that would predict disease progression due to poor response to antiretroviral therapy were also published in the same issue of the New England Journal of Medicine. The combined data from both studies showed that, after 48 weeks, ISENTRESS in combination with OBT showed greater response rates for lowering HIV viral load and increasing CD4 cell count over placebo plus OBT in patients with high levels of HIV-1 RNA (>100,000 copies/mL), very low CD4 cell counts (<50 cells/mm³) or low Phenotypic or Genotypic Sensitivity Scores [(PSS or GSS) for OBT < 1] at study enrollment.

PSS and GSS scores help report the number of anti-HIV medicines in the OBT regimen to which a patient's HIV is susceptible, and represents the number of active agents in the OBT at the beginning of the study. A low PSS or GSS indicates that there are few or no active agents in the patients OBT regimen, and is a reflection that a patient's HIV had developed resistance to a greater number of anti-HIV medicines prior to the study.

Study results showed that in patients with the fewest active drugs in their OBT, those with a GSS of 0, the virus was suppressed to undetectable levels in more patients receiving ISENTRESS plus OBT compared to patients receiving placebo plus OBT, 45 percent versus 3 percent, respectively; and mean increases in CD4 cell counts from baseline in these patients were 81 and 11 cells/mm³, respectively. In patients who were more likely to respond to treatment, those with more active OBT (GSS of 2), 77 percent of patients receiving ISENTRESS plus OBT achieved undetectable viral loads versus 62 percent of patients receiving placebo plus OBT; and mean increases in CD4 cell counts were 145 and 87 cells/mm³, respectively.

By week 48, 23 percent of patients (105 of 462) receiving ISENTRESS plus OBT had virologic failure (HIV viral RNA greater than 400 copies/mL). Resistance testing done on viruses isolated from 94 of the 105 patients with virologic failure showed that 68 percent (64) had genotypic evidence of resistance to ISENTRESS. Seventy-five percent of the patients with evidence of genotypic resistance (48) had two or more ISENTRESS resistance-associated mutations.

Important safety information about ISENTRESS after 24 weeks of therapy

ISENTRESS does not cure HIV or AIDS and does not prevent passing HIV to others. Healthcare providers should know that immune reconstitution syndrome has been reported in patients treated with ART, which may necessitate further evaluation and treatment.

At 24 weeks, the most commonly reported adverse experiences of any severity (mild, moderate or severe) for ISENTRESS plus OBT versus placebo plus OBT, respectively, regardless of drug relationship were diarrhea (16.6 percent vs. 19.5 percent), nausea (9.9 percent vs. 14.2 percent), headache (9.7 percent vs. 11.7 percent) and fever (4.9 percent vs. 10.3 percent).

Creatine kinase elevations were observed in subjects who received ISENTRESS. Myopathy and rhabdomyolysis have been reported; however, the relationship of ISENTRESS to these events is not known. ISENTRESS should be used with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medication known to cause these conditions.

Results from pooled safety analyses from three separate studies (BENCHMRK-1, BENCHMRK-2 and a Phase II dose ranging study) in treatment-experienced patients taking 400 mg of ISENTRESS dosed twice daily plus OBT or placebo plus OBT showed that after 24 weeks of therapy the rates of discontinuation of therapy due to adverse experiences were 2.0 percent in patients receiving ISENTRESS plus OBT and 1.4 percent in patients receiving placebo plus OBT. In addition, drug-related clinical adverse events of moderate to severe intensity occurring in greater than or equal to 2.0 percent of patients were diarrhea (3.7 percent vs. 4.6 percent), nausea (2.2 percent vs. 3.2 percent) and headache (2.4 percent vs. 1.4 percent) for ISENTRESS plus OBT and placebo plus OBT, respectively.

Drug interactions

Based on the results of drug interaction studies and the clinical trials data, no dose adjustment of ISENTRESS is required when coadministered with other antiretroviral agents. Preclinical studies showed that ISENTRESS is not metabolized by cytochrome P450 enzymes, but is primarily metabolized by uridine diphosphate glucuronosyltransferase (UGT) 1A1; therefore, caution should be used when coadministering ISENTRESS with strong inducers of UGT 1A1 (e.g., rifampin), which may reduce plasma concentrations of ISENTRESS.

About ISENTRESS

ISENTRESS is a single 400 mg tablet taken twice daily without regard to food. ISENTRESS does not require boosting with ritonavir.

ISENTRESS is the first medicine to be approved in a new class of antiretroviral drugs called integrase inhibitors. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit two other enzymes critical to the HIV-1 replication process – protease and reverse transcriptase – but ISENTRESS is the only drug approved that inhibits the integrase enzyme.

Merck HIV research

Merck is committed to developing innovative therapies that offer advances in the treatment of infectious diseases – including HIV. Merck's efforts to develop investigational treatments for HIV and AIDS have been under way for more than 20 years and continue today. Merck began its HIV integrase inhibitor research in 1993 and was the first to demonstrate inhibition of HIV integrase in vitro and in vivo.

Prevalence of HIV and AIDS

In 2006, more than one million Americans were living with HIV and AIDS, and it is estimated that approximately 40,000 new cases of HIV and AIDS are diagnosed each year in the United States. Worldwide, an estimated 33 million people are infected with HIV and AIDS, and more than two million new infections occurred in 2007.

Merck's commitment to providing access to treatment

Merck is committed to ensuring access to our antiretroviral medicines (ARVs) through a differential pricing policy that provides our ARVs at dramatically lower prices-at which Merck does not profit-to people living in the world's least developed countries and those hardest hit by the pandemic, as defined by various United Nations indices.

Also, Merck is committed to seeking additional ways to reduce the cost of its ARVs for people living in the world's poorest countries and those hardest hit by the pandemic, including through partnering with external manufacturers and suppliers to achieve incremental efficiencies and cost savings.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Source: Merck Press Release

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

-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

--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

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 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

--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.

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)

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:

1. Fluarix, for use by people ages 18 and older.
2. FluLaval, for use by people ages 18 and older
3. Afluria, for use by people ages 18 and older
4. Fluvirin, for people ages 4 and older.
5. Fluzone, for people 6 months and older.
6. 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

---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.

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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."

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.
• The diluted broth is spread onto solid agar media in Petri plates (drug plates) that contain the drugs used for tuberculosis. There is also a growth control (a plate with no drug) included.
• The drug plates and growth control plates are kept warm for 21 days and then examined for growth. The number of colonies on the growth control plate and on each drug plates is determined. A sample is resistant to a drug when the number of colonies that grow on the drug-containing agar are greater than 1% of the colonies that grow on the growth control.

What does CDC do to ensure laboratory quality control for drug susceptibility testing?

• The CDC drug susceptibility testing is performed using standard techniques with quality control and data review before results are released.
• CDC uses a standardized inoculum with quality control testing to confirm that the correct drugs and drug concentrations are used.
• Quality control testing is also performed on the culture media used to grow the TB bacteria to ensure consistency.
• The CDC laboratory performs M. tuberculosis drug susceptibility testing as described by the Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards). Testing is performed and results are reported in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations.

What are the first- and second-line drugs used to treat TB?

• 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.
• There are 10 drugs currently approved by the U.S. Food and Drug Administration (FDA) for treating TB. Of the approved drugs, the first-line anti-TB agents that form the core of treatment regimens include
• isoniazid (INH)
• rifampin (RIF)
• ethambutol (EMB)
• pyrazinamide (PZA)
• Second-line drugs used to treat TB include
• fluoroquinolones (levofloxacin, moxifloxacin, gatifloxacin)
• three injectable drugs (amikacin, kanamycin, or capreomycin)
• ethionamide
• cycloserine
• Second-line drugs are less effective and more toxic than first-line drugs used to treat TB.

What can be done to improve our ability to prevent and reduce the numbers and cases of TB?
New tools for TB diagnosis, treatment, and prevention are needed to achieve the goal of TB elimination. New diagnostic tools for TB detection, especially drug-resistant TB, are needed. Rapid diagnostic tests, such as those that have been developed for HIV, are still unavailable for drug-resistant TB.

 Source: CDC http://www.cdc.gov

May 29, 2007. The Centers for Disease Control and Prevention (CDC) is working with a number of international, state, and local partners on an investigation involving a U.S. citizen recently diagnosed with extensively drug-resistant tuberculosis (XDR TB).  XDR TB has been recently defined as a subtype of multidrug-resistant tuberculosis (MDR TB) with additional resistance to the two most important second-line antibiotics (i.e., a fluoroquinolone and an injectable agent [amikacin, kanamycin, or capreomycin]) in addition to the two most important first-line drugs (i.e., isoniazid and rifampin).

CDC learned that a patient with XDR TB traveled to Europe via commercial airline (Air France # 385) departing Atlanta on May 12 and arriving in Paris on May 13, 2007, and returned to the United States after taking a commercial flight on May 24 from Prague, Czech Republic to Montreal, Canada (Czech Air # 410). The patient re-entered the U.S. on May 24 via automobile.  Since May 25, the patient has been hospitalized in respiratory isolation and is undergoing additional medical evaluation.

CDC is collaborating with U.S. state and local health departments, international Ministries of Health, the airline industry, and the World Health Organization (WHO) regarding appropriate notification and follow up of passengers and crew potentially at risk for exposure to XDR TB. Each country involved in the investigation is determining the most appropriate guidance for its residents. The following recommendations have been developed for U.S. residents who may have been exposed to this patient. 

This patient has radiographic evidence of pulmonary TB, is culture-positive for XDR TB, but is sputum smear negative for acid fast bacilli and is relatively asymptomatic.  On the basis of the patient’s clinical and laboratory status, and lack of receiving adequate treatment for XDR TB, this patient was considered potentially infectious at the time of his airline travel, and meets the criteria in the WHO guidelines for initiating an airline contact investigation.  http://whqlibdoc.who.int/hq/2006/WHO_HTM_TB_2006.363_eng.pdf  

In accordance with the WHO TB and Airline Travel Guidelines, to ensure appropriate follow-up and care for persons who may have been exposed to XDR TB, CDC is recommending the following for passengers and crew onboard Air France # 385 departing Atlanta on May 12 and arriving in Paris on May 13, and on Czech Air # 410 departing from Prague and arriving in Montreal on May 24: passengers seated in the same row as the index patient and those seated in the two rows ahead and the two rows behind, as well as the cabin crew members working in the same cabin should be evaluated for TB infection. This includes initial evaluation and testing with follow up  8-10 weeks later for re-evaluation.

As there has never been an airline contact investigation for XDR TB, it is not known if the current recommendations are adequate to determine the possible range and risk of transmission of infection. Because of the serious consequences of XDR TB and anticipated public concern, in addition to the contacts listed above, all U.S. residents and citizens on these flights should be notified and encouraged to seek TB testing and evaluation.  

Drug-susceptible (regular) TB and XDR TB are thought to be spread the same way.  TB bacilli become aerosolized when a person with TB disease of the lungs or throat coughs, sneezes, speaks, or sings. These bacilli can float in the air for several hours, depending on the environment.  Persons who breathe air containing these TB bacilli can become infected.  

The risk of acquiring any type of TB appears to depend on several factors, such as extent of disease in the source patient, duration of exposure, and ventilation.  Transmission has been documented in association with patients who have lung disease, and bacteria seen or cultured in sputum. Persons who become infected usually have been exposed for several hours (or days) in poorly ventilated or crowded environments. An important way to prevent the spread and transmission is by limiting an infectious person’s contact with other people.  Thus, people who have a confirmed diagnosis of TB or XDR TB are placed on treatment and kept isolated until they are no longer infectious.

Persons who believe they may have been exposed to TB or XDR TB can call 1-800 CDC INFO for further information.

Where to go for information about:  

Tuberculosis: http://www.cdc.gov/tb/default.htm

XDR TB: http://www.cdc.gov/tb/pubs/tbfactsheets/xdrtb.htm http://www.cdc.gov/tb/pubs/tbfactsheets/xdrtb.htm  and http://www.cdc.gov/tb/pubs/tbfactsheets/cdcandxdrtb.htm http://www.cdc.gov/tb/pubs/tbfactsheets/cdcandxdrtb.htm

TB Testing: http://www.cdc.gov/tb/pubs/tbfactsheets/skintesting.htm http://www.cdc.gov/tb/pubs/tbfactsheets/skintesting.htm and http://www.cdc.gov/tb/pubs/tbfactsheets/QFT.htm http://www.cdc.gov/tb/pubs/tbfactsheets/QFT.htm

Infection control: http://www.cdc.gov/tb/pubs/tbfactsheets/ichcs.htm http://www.cdc.gov/tb/pubs/tbfactsheets/ichcs.htm  and http://www.cdc.gov/tb/pubs/tbfactsheets/rphcs.htm http://www.cdc.gov/tb/pubs/tbfactsheets/rphcs.htm

Tuberculosis and Air Travel:

http://whqlibdoc.who.int/hq/2006/WHO_HTM_TB_2006.363_eng.pdf

##This Message was distributed to State and Local Health Officers, Public Information Officers, Epidemiologists, State Laboratory Directors, BT Coordinators and HAN Coordinators, as well as Public Health Associations and Clinician organizations##

 NEW YORK—April 30, 2007----The Pfizer Foundation today announced the names of 20 U.S. community-based AIDS service organizations (ASOs) chosen to participate in ConnectHIV, the Foundation’s latest initiative to support organizations working to stop the spread and impact of HIV/AIDS. ConnectHIV integrates lessons learned from the Southern HIV/AIDS Prevention Initiative, the Foundation’s recently completed 3-year prevention initiative to support small-to-mid-sized organizations in multicultural communities in the South. Through ConnectHIV, the Foundation is providing $7.5 million in grants, technical assistance and networking resources over three years to ASOs that take a comprehensive approach to HIV prevention, access to care and treatment.

ASOs chosen to receive grants through ConnectHIV serve communities that are disproportionately affected by HIV/AIDS and are based in the 10 states with the highest number of new AIDS cases as reported by the CDC in 2004: New York, Florida, California, Texas, New Jersey, Illinois, Georgia, Pennsylvania, Maryland and North Carolina.

“The Pfizer Foundation is providing national leadership by promoting evidence-based approaches and is strongly supporting community leadership by granting funds to community-based service providers that know best how to reach those most at risk for infection and those most in need of care-related services,” said Frank Beadle de Palomo, senior vice president and director, global HIV/AIDS programs, Academy for Educational Development (AED). “AED is proud to be an evaluation partner for such a visionary program”.

To measure the impact of ConnectHIV, AED and the Johns Hopkins Bloomberg School of Public Health are partnering with the Pfizer Foundation to evaluate behavior change within the ASO communities. Behaviors that will be evaluated include actions around HIV testing, safe sex negotiation, disclosure of HIV status, condom use, access to substance abuse treatment services and support, adherence to medication and regular visits to healthcare providers. The evaluation will also measure cost-effectiveness of program interventions to understand how to maximize the health benefits of any given investment in the HIV prevention and care continuum.

“The HIV epidemic is far from over in the U.S., and comprehensive approaches to HIV/AIDS care and prevention are needed. The Pfizer Foundation model is to be strongly commended in this regard, and I am pleased to be an evaluation partner in this very important project,” said David Holtgrave, PhD, professor and chair of the Department of Health, Behavior & Society at the Johns Hopkins Bloomberg School of Public Health.

HIV/AIDS remains an urgent domestic health crisis with HIV infection rates in the U.S. remaining steady over the past 15 years. The CDC reports that approximately 40,000 Americans become HIV-positive each year and one-quarter of HIV-infected Americans do not yet know they are infected. Infections from this group are believed to account for more than half of new HIV infections each year. The Institute of Medicine estimates that up to approximately 49 percent of the people with HIV/AIDS in the U.S. do not receive regular care for the disease.

“These organizations are leaders in the HIV/AIDS community,” said Robert Mallett, president of the Pfizer Foundation. “We are pleased that the grants will support their outstanding work in providing much-needed care and services. Pfizer understands that prevention and care efforts need to target both HIV+ and high-risk HIV- individuals, and is critical in decreasing new infections.”

ConnectHIV Grantees

ASOs awarded ConnectHIV funding  City  State 

Foothill AIDS Project  Claremont  CA 

Cal-Pep  Oakland  CA 

Black Coalition on AIDS  San Francisco  CA 

STOP AIDS Project  San Francisco  CA 

Shanti Project  San Francisco  CA 

NFAN  Jacksonville  FL 

Positive Impact, Inc.  Atlanta  GA 

Chicago House and Social Service Agency  Chicago  IL 

Test Positive Aware Network  Chicago  IL 

AIDS Interfaith Residential  Baltimore  MD 

Piedmont Health Care Consortium  Durham  NC 

AIDS Care Service, Inc  Winston-Salem  NC 

Hyacinth AIDS Foundation  New Brunswick  NJ 

NY Harm Reduction Educators  Bronx  NY 

Latino Commission on AIDS  New York  NY 

The Family Center  New York  NY 

BEBASHI  Philadelphia  PA 

Prevention Point Philadelphia  Philadelphia  PA 

Philadelphia FIGHT  Philadelphia  PA 

St. Hope Foundation  Houston  TX 

ConnectHIV Partners

Academy for Educational Development is an independent, nonprofit organization committed to solving critical social problems and building the capacity of individuals, communities, and institutions to become more self-sufficient. AED works in all the major areas of human development, with a focus on improving education, health, and economic opportunities for the least advantaged people in the United States and developing countries throughout the world. AED is a leader in applying lessons learned in fighting the HIV/AIDS epidemic internationally to prevention efforts in the United States. AED has been a key partner with community-based organizations, researchers, health departments, national and regional organizations, academic institutions and many other key stakeholders to focus on reducing the spread of the epidemic in most at-risk groups, especially communities of color.

As a leading international authority on public health, the Johns Hopkins Bloomberg School of Public Health is dedicated to protecting health and saving lives. Every day, the School works to keep millions around the world safe from illness and injury by pioneering new research, deploying its knowledge and expertise in the field and educating tomorrow's scientists and practitioners in the global defense of human life. The School was founded in 1916, and the Department of Health, Behavior & Society, chaired by Dr. Holtgrave, was launched in 2005 to address behavioral and societal issues in public health.

Pfizer Foundation – a Legacy in HIV Prevention

The Pfizer Foundation has worked in partnership with community-based organizations for a half a century to ensure access to quality healthcare for those individuals most in need. Beginning in 2004, the Pfizer Foundation and Pfizer committed a total of $6 million over 3 years to support a network of more than 55 innovative HIV/AIDS prevention program across 9 Southern states.

After three years of intensive grant and capacity building support, the majority of Southern HIV/AIDS Prevention Initiative grantees have demonstrated stronger service delivery, improved organizational capacity, and expanded networks with local and regional AIDS service organizations. In addition, the social impact of the Initiative has been significant, including training more than 1,000 individuals as peer educators or mentors and reaching more than 50,000 community members with prevention materials.

The Pfizer Foundation is a charitable organization established by Pfizer Inc. The Foundation is a separate and independent tax-exempt organization. The Foundation’s mission is “to promote access to quality health care and education, to nurture innovation, and to support the community involvement of Pfizer people.”

Under the deal, two Indian companies will supply 19 antiretroviral drugs and their cost will be reduced by 45%, a statement by the foundation says.

More than 40m people worldwide are infected with HIV/AIDS, the UN says.

The cheap drugs, according to the statement, will be available in 62 developing countries in Africa, Asia, Latin American and the Caribbean.

One of the drugs, made by leading Indian pharmaceutical companies, Cipla and Ranbaxy, is described as a "new child-friendly product" and will cost less than $60 per year per child.

The international drug-buying facility, UNITAID, set up by France, Brazil, Chile, Norway and the UK, is subsidizing the program by $35m, the Clinton Foundation says.

"Though the world has made progress in expanding HIV/AIDS treatment to adults, children have been left behind. Only one in 10 children who needs treatment is getting it," Mr. Clinton said in his speech at the Delhi hospital.

He was there to launch the federal government's national program to treat children with HIV.

The program aims to increase the number of children on treatment in India from less than 2,000 in September to 10,000 by the end of March by making pediatric care available at all centers treating adults, the statement by the foundation says.

More than five million Indians are infected with HIV and the UN says India now has more people with the virus than any other country in the world.

The Clinton Foundation, set up in 2002, aims to provide technical and financial help to poorer countries struggling to stop the spread of HIV/AIDS.

Summary: If an influenza pandemic struck today, borders would close, the global economy would shut down, international vaccine supplies and health-care systems would be overwhelmed, and panic would reign. To limit the fallout, the industrialized world must create a detailed response strategy involving the public and private sectors…

The Lancet Neurology said incubation periods could be longer for some. To date, 161 cases of vCJD (variant Creutzfeld Jakob disease) have been reported in the UK, 18 in France and 12 in the rest of the world - most of those of UK origin.

At present, it is not clear how susceptible people might be to transmission of vCJD through routes such as blood transfusions. As there is currently no test for the disease, this could potentially mean that someone receives blood or blood products from someone who is carrying vCJD but does not know it.

A laboratory is to be set up to improve early diagnosis in Uige province, where most of the cases have been recorded. A second lab will be opened in the capital Luanda as authorities fear the highly-contagious virus could spread. The toll now exceeds the previous worst outbreak recorded in Angola's neighbor, the Democratic Republic of Congo, in 1998, when 123 died.

Several countries have taken measures to try to halt the spread of the virus. "We have recorded a total of 132 cases between 13 October 2004 and 30 March 2005, of whom 126 have died," a joint statement by Angola's health ministry and the World Health Organization (WHO) said.

Early symptoms of Marburg are diarrhea, stomach pains, nausea and vomiting, which give way to bleeding. The WHO said most of the Angolan deaths occurred between three and seven days after the onset of symptoms. Marburg, a severe form of hemorrhage fever, has no known vaccine or medical treatment. Three-quarters of Marburg's victims have been children, according to the WHO.