World now at the start of 2009 influenza pandemic

[Luke_Wilbur]

World now at the start of 2009 influenza pandemic

Dr Margaret Chan

Director-General of the World Health Organization

 

Statement to the press by WHO Director-General Dr Margaret Chan

11 June 2009

 

Ladies and gentlemen, In late April, WHO announced the emergence of a novel influenza A virus.

 

This particular H1N1 strain has not circulated previously in humans. The virus is entirely new.

 

The virus is contagious, spreading easily from one person to another, and from one country to another. As of today, nearly 30,000 confirmed cases have been reported in 74 countries.

 

This is only part of the picture. With few exceptions, countries with large numbers of cases are those with good surveillance and testing procedures in place.

 

Spread in several countries can no longer be traced to clearly-defined chains of human-to-human transmission. Further spread is considered inevitable.

 

I have conferred with leading influenza experts, virologists, and public health officials. In line with procedures set out in the International Health Regulations, I have sought guidance and advice from an Emergency Committee established for this purpose.

 

On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met.

 

I have therefore decided to raise the level of influenza pandemic alert from phase 5 to phase 6.

 

The world is now at the start of the 2009 influenza pandemic.

 

We are in the earliest days of the pandemic. The virus is spreading under a close and careful watch.

 

No previous pandemic has been detected so early or watched so closely, in real-time, right at the very beginning. The world can now reap the benefits of investments, over the last five years, in pandemic preparedness.

 

We have a head start. This places us in a strong position. But it also creates a demand for advice and reassurance in the midst of limited data and considerable scientific uncertainty.

 

Thanks to close monitoring, thorough investigations, and frank reporting from countries, we have some early snapshots depicting spread of the virus and the range of illness it can cause.

 

We know, too, that this early, patchy picture can change very quickly. The virus writes the rules and this one, like all influenza viruses, can change the rules, without rhyme or reason, at any time.

 

Globally, we have good reason to believe that this pandemic, at least in its early days, will be of moderate severity. As we know from experience, severity can vary, depending on many factors, from one country to another.

 

On present evidence, the overwhelming majority of patients experience mild symptoms and make a rapid and full recovery, often in the absence of any form of medical treatment.

 

Worldwide, the number of deaths is small. Each and every one of these deaths is tragic, and we have to brace ourselves to see more. However, we do not expect to see a sudden and dramatic jump in the number of severe or fatal infections.

 

We know that the novel H1N1 virus preferentially infects younger people. In nearly all areas with large and sustained outbreaks, the majority of cases have occurred in people under the age of 25 years.

 

In some of these countries, around 2% of cases have developed severe illness, often with very rapid progression to life-threatening pneumonia.

 

Most cases of severe and fatal infections have been in adults between the ages of 30 and 50 years.

 

This pattern is significantly different from that seen during epidemics of seasonal influenza, when most deaths occur in frail elderly people.

 

Many, though not all, severe cases have occurred in people with underlying chronic conditions. Based on limited, preliminary data, conditions most frequently seen include respiratory diseases, notably asthma, cardiovascular disease, diabetes, autoimmune disorders, and obesity.

 

At the same time, it is important to note that around one third to half of the severe and fatal infections are occurring in previously healthy young and middle-aged people.

 

Without question, pregnant women are at increased risk of complications. This heightened risk takes on added importance for a virus, like this one, that preferentially infects younger age groups.

 

Finally, and perhaps of greatest concern, we do not know how this virus will behave under conditions typically found in the developing world. To date, the vast majority of cases have been detected and investigated in comparatively well-off countries.

 

Let me underscore two of many reasons for this concern. First, more than 99% of maternal deaths, which are a marker of poor quality care during pregnancy and childbirth, occurs in the developing world.

 

Second, around 85% of the burden of chronic diseases is concentrated in low- and middle-income countries.

 

Although the pandemic appears to have moderate severity in comparatively well-off countries, it is prudent to anticipate a bleaker picture as the virus spreads to areas with limited resources, poor health care, and a high prevalence of underlying medical problems.

 

Ladies and gentlemen,

 

A characteristic feature of pandemics is their rapid spread to all parts of the world. In the previous century, this spread has typically taken around 6 to 9 months, even during times when most international travel was by ship or rail.

 

Countries should prepare to see cases, or the further spread of cases, in the near future. Countries where outbreaks appear to have peaked should prepare for a second wave of infection.

 

Guidance on specific protective and precautionary measures has been sent to ministries of health in all countries. Countries with no or only a few cases should remain vigilant.

 

Countries with widespread transmission should focus on the appropriate management of patients. The testing and investigation of patients should be limited, as such measures are resource intensive and can very quickly strain capacities.

 

WHO has been in close dialogue with influenza vaccine manufacturers. I understand that production of vaccines for seasonal influenza will be completed soon, and that full capacity will be available to ensure the largest possible supply of pandemic vaccine in the months to come.

 

Pending the availability of vaccines, several non-pharmaceutical interventions can confer some protection.

 

WHO continues to recommend no restrictions on travel and no border closures.

 

Influenza pandemics, whether moderate or severe, are remarkable events because of the almost universal susceptibility of the world’s population to infection.

 

We are all in this together, and we will all get through this, together.

 

Thank you.

Edited June 11, 2009 by Luke_Wilbur

[Guest Balintfy Fauci]

Understanding Influenza, Pandemic Flu

Right Click to Download MP3 File

 

 

Brief Description:

Influenza, or flu, is a respiratory infection caused by several flu viruses. Pandemic flu refers to particularly virulent strains of flu that spread rapidly from person to person to create a world-wide epidemic (pandemic).

 

 

 

Transcript:

 

Balintfy: The flu, like the common cold, is a respiratory infection caused by viruses. But the flu differs in several ways from the common cold. For example, people with colds rarely get fevers or headaches or suffer from the extreme exhaustion that flu viruses cause. The most familiar aspect of the flu is the way it can "knock you off your feet" as it sweeps through entire communities.

 

Fauci: There are two reasons to be concerned about the flu.

 

Balintfy: Dr. Anthony Fauci is the director of the National Institute of Allergy and Infectious Diseases. He explains that one concern is that seasonal flu — a flu outbreak that occurs yearly — is itself a serious disease, killing more than a quarter of a million people worldwide.

 

Fauci: There’s also the threat of having what we call a pandemic flu.

 

Balintfy: Pandemic flu refers to particularly virulent strains of flu that spread rapidly from person to person to create a world-wide epidemic.

 

Fauci: One of the best weapons against influenza is a vaccine that induces what we call neutralizing antibody. And a neutralizing antibody is an antibody that can actually block the virus in question. The trouble with the induction of neutralizing antibodies with flu is that they are usually directed against a component or portion of the virus that changes readily from strain to strain, and certainly changes when you have a pandemic virus or a pandemic strain. That’s the reason why each year we have to revaccinate people so that you can keep up with the drifting of the strains by mutations that occur.

 

Balintfy: The influenza virus is one of the most changeable of viruses with genes known for "drifting and shifting." These genetic changes may be small and continuous or large and abrupt. Dr. Fauci points to a universal vaccine as a research target.

 

Fauci: The universal vaccine is one that you can give to an individual that would protect against an entire menu, as it were, of different strains of influenza.

 

Balintfy: For more information about flu viruses and the latest research on influenza, visit www.niaid.nih.gov. This is Joe Balintfy, National Institutes of Health, Bethesda, Maryland.

[Guest LAW_*]

Anthony S. Fauci, M.D.

NIAID Director

 

 

Dr. Anthony S. Fauci, a native of Brooklyn, New York, received his M.D. degree from Cornell University Medical College in 1966. He then completed an internship and residency at The New York Hospital-Cornell Medical Center. In 1968, Dr. Fauci came to the National Institutes of Health (NIH) as a clinical associate in the Laboratory of Clinical Investigation (LCI) at the National Institute of Allergy and Infectious Diseases (NIAID). In 1980, he was appointed Chief of the NIAID Laboratory of Immunoregulation, a position he still holds. In 1984, Dr. Fauci became Director of NIAID, where he oversees an extensive research portfolio of basic and applied research to prevent, diagnose, and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. The NIAID budget for fiscal year 2009 is approximately $4.7 billion. Dr. Fauci serves as one of the key advisors to the White House and Department of Health and Human Services on global AIDS issues, and on initiatives to bolster medical and public health preparedness against emerging infectious disease threats such as pandemic influenza.

 

Dr. Fauci has made many contributions to basic and clinical research on the pathogenesis and treatment of immune-mediated and infectious diseases. He has pioneered the field of human immunoregulation by making a number of basic scientific observations that serve as the basis for current understanding of the regulation of the human immune response. In addition, Dr. Fauci is widely recognized for delineating the precise mechanisms whereby immunosuppressive agents modulate the human immune response. He has developed effective therapies for formerly fatal inflammatory and immune-mediated diseases such as polyarteritis nodosa, Wegener's granulomatosis, and lymphomatoid granulomatosis. A 1985 Stanford University Arthritis Center Survey of the American Rheumatism Association membership ranked the work of Dr. Fauci on the treatment of polyarteritis nodosa and Wegener's granulomatosis as one of the most important advances in patient management in rheumatology over the previous 20 years.

 

Dr. Fauci has made seminal contributions to the understanding of how the AIDS virus destroys the body's defenses leading to its susceptibility to deadly infections. He also has delineated the mechanisms of induction of HIV expression by endogenous cytokines. Furthermore, he has been instrumental in developing highly effective strategies for the therapy of patients with this serious disease, as well as for a vaccine to prevent HIV infection. He continues to devote much of his research time to identifying the nature of the immunopathogenic mechanisms of HIV infection and the scope of the body's immune responses to the AIDS retrovirus.

 

In 2003, an Institute for Scientific Information study indicated that in the twenty year period from 1983 to 2002, Dr. Fauci was the 13th most-cited scientist among the 2.5 to 3 million authors in all disciplines throughout the world who published articles in scientific journals during that time frame. Dr. Fauci was the world's 10th most-cited HIV/AIDS researcher in the period 1996-2006.

 

Through the years, Dr. Fauci has served as Visiting Professor at major medical centers throughout the country. He has delivered many major lectureships all over the world and is the recipient of numerous prestigious awards for his scientific accomplishments, including the Presidential Medal of Freedom, the National Medal of Science, the George M. Kober Medal of the Association of American Physicians, the Mary Woodard Lasker Award for Public Service, the Albany Medical Center Prize in Medicine and Biomedical Research, and 35 honorary doctorate degrees from universities in the United States and abroad.

 

Dr. Fauci is a member of the National Academy of Sciences, the American Academy of Arts and Sciences, the Institute of Medicine (Council Member), the American Philosophical Society, and the Royal Danish Academy of Science and Letters, as well as a number of other professional societies including the American College of Physicians, the American Society for Clinical Investigation, the Association of American Physicians, the Infectious Diseases Society of America, the American Association of Immunologists, and the American Academy of Allergy Asthma and Immunology. He serves on the editorial boards of many scientific journals; as an editor of Harrison's Principles of Internal Medicine; and as author, coauthor, or editor of more than 1,100 scientific publications, including several textbooks.

[Guest LAW_*]

HHS To Acquire New Anthrax Therapeutic Treatment For Stockpile

 

The Department of Health and Human Services (HHS) announced today it will purchase 20,000 treatment courses of ABthrax, an anthrax therapeutic treatment, from Human Genome Sciences of Rockville, Md. for $165,205,217. Delivery is expected to begin in 2009. Under the terms of the agreement, full payment to Human Genome Sciences is contingent on the product receiving licensure from the Food and Drug Administration.

 

“This important addition to the Strategic National Stockpile will provide physicians a way to neutralize the deadly toxin anthrax bacteria produces,” said Dr. Gerald Parker, HHS Acting Assistant Secretary for Public Health Emergency Preparedness. “And we found it is the toxin which accounted for the majority of anthrax-related deaths during the anthrax attacks of 2001.”

 

The Department of Homeland Security has determined that anthrax poses a threat to the U.S. population and the interagency Weapons of Mass Destruction Medical Countermeasures Subcommittee has recommended that anthrax therapeutics be acquired to improve the nation’s biodefense preparedness and response capabilities and protect civilians from a potentially lethal exposure to anthrax spores.

 

In September 2005, HHS awarded a base contract to Human Genome Sciences for acquisition of a small amount of ABthrax, their antitoxin product, for independent government analysis and testing. The base contract included an option to acquire additional product following the testing and HHS is now exercising that option.

 

HHS’ Office of Public Health Emergency Preparedness, which oversees the advanced research and procurement efforts under the Project BioShield program through its Office of Research and Development Coordination, manages the contract with Human Genome Sciences.

[Guest America]

Influenza virus causes significant morbidity and mortality in humans and domestic animals; annual epidemics of influenza are responsible for over 40,000 deaths every year in the United States alone. Infrequent pandemics caused by the H1N1, H2N2, and H3N2 subtypes of influenza A virus during the 20th century resulted in significantly higher rates of influenza-related morbidity and mortality. The virulent nature of potential pandemic strains such as these requires the virus to be handled under conditions involving higher levels of biosafety containment and requires significant changes for the safe production of vaccines against the pandemic strains.

 

There’s no time to waste, given the threat of a global pandemic triggered by mutations in the deadly bird flu virus that have emerged in Asia, Africa, and Europe. Wherry and co-workers are racing to create a prototype for the vaccine by 2011.

[Guest Wherry]

If we can train the T cells to effectively recognize the internal proteins for influenza virus and be maintained long term, it might be possible to create a vaccine that protects against all strains of flu. We’re starting to see promising hints in mice. But translating these things to humans takes a tremendous amount of time and effort.

[Guest Grant E. Pickering]

Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines and immunotherapeutics for infectious diseases and cancer, today announced clinical results demonstrating that its vaccine adjuvant, JVRS-100, when combined with a trivalent inactivated seasonal flu vaccine, generated robust T-cell mediated immune responses and antibody responses. Strong T-cell responses to influenza vaccine in humans have not been evidenced to date and remain an important goal for improved influenza vaccines particularly in elderly subjects. T-cell responses are critical to protection against influenza disease and recovery from infection.

 

Detailed results of the randomized, double-blind, multi-center Phase 1 clinical study will be presented at a podium presentation at the National Foundation for Infectious Diseases 12th Annual Conference on Vaccine Research meeting in Baltimore, MD, on April 27th, 2009 by Dr. Jeff Fairman, Vice-President of Research at Juvaris.

 

"The results from this trial confirm the results seen with JVRS-100 in pre-clinical studies, and the clinical data clearly support the broad potential benefits of an adjuvanted vaccine approach via the stimulation of both antibodies and T-cells, antigen dose reduction, single-dose administration, rapid immunity and improved cross-protection," said Grant Pickering, President and CEO of Juvaris. "We believe that JVRS-100 is ideally suited to address the unmet needs in the influenza market, including emerging threats such as the currently circulating swine flu, as well as to adjuvant other vaccines to treat infectious diseases where strong T-cell immunity is required."

 

In the Phase 1 study, 128 young adult subjects in groups of 20-24 were vaccinated with a licensed trivalent influenza vaccine with or without JVRS-100. The trial was designed to compare safety and immunogenicity 28 days after a single intramuscular immunization.

 

The efficacy endpoints were antibody measurements based on neutralizing and hemagglutination inhibiting (HAI) antibodies against the relevant flu virus strains, as well as T-cell responses measured by intracellular cytokine staining. Subjects receiving JVRS-100 adjuvanted vaccine were shown to have antibody responses to influenza A that were approximately two-fold higher than recipients of unadjuvanted vaccine. Importantly, significant T-cell responses, including polyfunctional T cells secreting multiple cytokines (interferon- , interleukin-2, and tumor necrosis factor- ) were observed in subjects receiving JVRS-100 adjuvant but not in subjects who received vaccine alone.

 

The primary safety objective of the study compared the safety and tolerability of JVRS-100 with vaccine vs. vaccine alone. The adjuvant was very well tolerated. The incidence of adverse events following vaccination with JVRS-100 at effective dose levels was similar to that in the vaccine-alone groups.

 

"The promising results from this clinical trial indicate that JVRS-100 can increase the immune response generated by existing vaccines without additional toxicity," said Thomas P. Monath, M.D., acting Chief Medical Officer at Juvaris. "We look forward to advancing JVRS-100 into Phase 2 clinical development in the elderly patient population and into trials with a pandemic (avian) influenza vaccine. The elderly appear to have functional defects in plasmacytoid dendritic cell (pDC) responses during immune stimulation. Recent research data from Juvaris indicate that JVRS-100 can increase immune responses in the absence of pDCs, suggesting that the adjuvant will be effective in the elderly."

 

Seasonal influenza affects approximately one billion people worldwide each year, and results in 5 million severe illnesses and 500,000 deaths. Approximately 90 percent of the deaths occur in the elderly, where flu infection can lead to severe complications from underlying diseases, pneumonia and death. Seasonal influenza vaccines, which are widely used in the U.S. and developed countries, are effective in approximately one-third of the elderly population. The emergence of new, highly pathogenic strains, like the swine influenza virus currently affecting Mexico and the U.S., illustrate the need for improved vaccines. Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines to improve efficacy and reduce vaccine dosage requirements.

 

About JVRS-100

JVRS-100 is a cationic lipid-DNA complex that is being developed as an adjuvant to improve the effectiveness of existing vaccines and to develop new vaccines against a variety of infectious diseases. Research indicates that the mechanism of action of JVRS-100 is distinct from other known adjuvants. The adjuvant complex self-assembles with disease-specific antigens and induces substantial antibody- and cell-mediated immune responses, particularly induction of CD4+ and CD8+ T lymphocytes. Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic vaccine settings in multiple species. This platform provides the opportunity to develop many disease-specific immunotherapy products for which there are significant unmet medical needs.

 

About Juvaris

Juvaris BioTherapeutics is a clinical stage company developing adjuvanted vaccines and immunotherapeutics to treat infectious diseases and cancer. The Company's lead product candidate, JVRS-100, is currently in clinical development as an adjuvant to improve the efficacy of seasonal influenza vaccines in the elderly population. The Company is also developing vaccines for HSV-2, universal flu and pandemic flu and has initiated clinical development of an immunotherapeutic to treat acute leukemia with grant funding from a leading academic institution. Juvaris completed a Series A financing led by Kleiner Perkins Caufield & Byers and has been awarded multiple NIH grants. More information about the Company and its technology can be obtained at its website: www.juvaris.com.

[Guest CDC]

Now our challenge is to prepare for a possible return in the fall,” said Secretary Napolitano. “The Obama Administration has been working together across the government and will continue to do so over the weeks and months ahead to keep the American people safe. We are reaching out to our partners in state and local government, in school districts and the private sector to urge them to modify and update their pandemic plans. We are working with our scientists to test and prepare a possible vaccine. And we are working with governments around the world to share what we know and learn from what is happening in their countries.”