How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2 (Oct 17, 2011 - Nov 25, 2012)

Laidback Al · Sep 12, 2012

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Is the USA taking steps to prepare for an H5N1 pandemic?

On June 7, 2012, the Public Health Emergency section of the Department of Health and Human Services made a low-key press release on the funding of human trials for a live attenuated H5N1 vaccine.

BARDA Contract 1

HHS support results in international influenza vaccine milestone Clinical trial among first in the world for live attenuated influenza vaccine for avian influenza

Thailand today became one of the first countries in the world to test an H5N1 avian, or bird, influenza vaccine in a needle-free, nasal spray formulation. This Phase I clinical trial of a live attenuated influenza vaccine, known as LAIV, to protect people from the H5N1 virus, resulted from international collaboration with health agencies around the world, including the U.S. Department of Health and Human Services? Biomedical Advanced Research and Development Authority (BARDA). A Phase I clinical trial is the first step in testing new vaccines in humans. . . .

Through a grant to the WHO, BARDA has provided funding and technical assistance to support Thailand?s GPO as well as other developing countries. The grant supported building pilot scale manufacturing facilities to produce the vaccine, devising a clinical trial process to study the vaccine?s effectiveness in protecting people against avian influenza and a regulatory process to evaluate the vaccine, as well as conducting clinical trials in humans. . . .

The study and data analysis for this clinical trial are expected to be completed by May 2013.

Certainly, Thailand is an excellent choice for trials. Between 2004-2006, Thailand reported 25 human H5N1 cases. Also, given the anti-vaccine sentiment in the USA, clinical trials of a live attenuated H5N1 vaccine would probably not be popular, especially given the media storm over the recent H5N1 ferret tests and arguments over potential laboratory escapes.

BARDA Contract 2

Recently, on September 6, 2012, the Public Health Emergency section of the Department of Health and Human Services provided another press release relating to pandemic vaccine production.

New HHS contracts enhance pandemic preparedness BARDA takes historic steps with master vaccine seed lots, vaccines for pre-pandemic stockpile

The U.S. Department of Health and Human Services has awarded three-year contracts to all five U.S.-licensed influenza vaccine manufacturers to produce master vaccine seed stocks for viruses with pandemic potential before a pandemic occurs. The contracts also allow HHS to purchase cell-based vaccine in addition to conventional egg-based vaccine in a pandemic. Both steps are new in the department?s pandemic preparedness efforts. . . .

Since 2010, HHS has taken steps to increase national vaccine manufacturing capacity with nimble and flexible technologies, such as cell-based vaccine technologies. These technologies may assist HHS in providing more pandemic influenza vaccine sooner. Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic, or developed rapidly in response to an epidemic.

The contracts will be overseen by the HHS Biomedical Advanced Research and Development Authority (BARDA) and are awarded to Sanofi Pasteur of Swiftwater, Pa., Novartis in Cambridge, Mass. and Holly Springs, N.C., GlaxoSmithKline of Philadelphia, Pa., CSL Biotherapies of King of Prussia, Pa., and MedImmune of Gaithersburg, Md.

The contracts also support clinical trials and stockpiling of vaccine and adjuvants, enabling HHS to respond quickly to flu outbreaks and pandemics. Although current licensed seasonal flu vaccines do not contain adjuvants, clinical trials using adjuvants is an important part of pandemic preparedness. Adjuvants can be added to influenza vaccine to lower the amount of the active ingredient in vaccine, called antigen, needed for the vaccine to produce an immune system response. Adding adjuvant results in more doses of vaccine being available during a pandemic.

Initially HHS will commit a total of $4.4 million for the companies to produce master vaccine seed stocks and $7.3 million for the companies to store pre-pandemic vaccines.

Similar to these previous contracts, today?s contracts are flexible enough to be used to develop vaccine for emerging influenza strains. In addition to being used for the 2009 H1N1 vaccine, the previous contracts were used earlier this year to develop a vaccine against the new H3N2v influenza virus which has infected people coming in contact with pigs carrying the virus.

Human influenza pandemics continue to be a public health concern. An influenza pandemic occurs when a novel virus emerges in the human population, with no or low levels of pre-existing immunity, is readily transmissible from person to person. Since 2004, HHS has purchased and stockpiled H5N1 avian flu vaccine and new oil-in-water adjuvants from manufacturers based on annual assessments of novel influenza viruses with pandemic potential. . . .

This press release is vague regarding the actual contracts for pandemic virus research and development. On a blog from a web site that tracks USA military and defense issues, another perspective on these contracts emerges.

Posted on September 10, 2012

U.S. government takes threat of bird flu pandemic seriously; spends $25 billion for medical countermeasures

By John Keller

Evidently the U.S. government is taking the threat of a global bird flu pandemic very seriously, as the U.S. Department of Health and Human Services (HHS) has awarded five contracts collectively worth as much as $25.36 billion for medical countermeasures to the H5N1 avian influenza virus. . . .

To keep any potential H5N1 bird flu pandemic in check, HHS officials on 4 Sept. awarded contracts potentially worth $9 billion to Novartis Vaccines and Diagonostics Inc. in Boston; $8.2 billion to MedImmune LLC in Gaithersburg, Md.; $4.7 billion to Sanofi Pasteur Inc. in Swiftwater, Pa.; $2 billion to GlaxoSmithKline LLC in Philadelphia; and $1.5 billion to CSL Biotherapies Inc. in King of Prussia, Pa.

All contract awards are the maximum amount possible. The contract duration is three years with options for two additional years. Awarding the contracts was the HHS Biomedical Advanced Research and Development Authority (BARDA).

The companies will provide the U.S. government with vaccines, support, and medical storage not only for pre-pandemic medicine to help prevent the spread of the H5N1 virus, but also for medicines to treat the virus after it is contracted to alleviate symptoms and prevent deaths. . . .

So the question remains, Is the USA taking steps to prepare for an H5N1 pandemic or is it just being prudent?

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Laidback Al · Sep 23, 2012

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Pandemic triage should be a part of disaster medicine training

Tetano posted an abstract today for an article entitled "Disaster Curricula in Medical Education: Pilot Survey" (link). The authors conducted this study to evaluate the inclusion of disaster medicine in core curricula in medical training. The authors provide a disappointing conclusion.

tetano said:
. . . Only a small percentage of US medical schools currently include disaster medicine in their core curriculum, and even fewer medical schools have incorporated or adopted competency-based training within their disaster medicine lecture topics and curricula.

Smith J, Levy MJ, Hsu EB, Levy JL. Disaster curricula in medical education: pilot survey. Prehosp Disaster Med. 2012;27(5):1-3.

link: http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=8676183

Treating patients during the next pandemic would qualify as disaster medicine if the CFR begins to approach the CFR level from the 1918 pandemic. Every HCW and medical professional should receive training in disaster medicine. Every HCW and medical professional should understand that in the wake of a virulent pandemic, medical facilities will be strained to the limits, medicine will be in short supply, relief staff nonexistent, and a vaccine months away.

Medical educators owe it to their students to adequately prepared them for the next pandemic.

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Laidback Al · Oct 31, 2012

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Which country has the highest number of reported human cases of H5N1?

The second annual International Society for Influenza and other Respiratory Virus Diseases (ISIRV) conference entitled ?Severe Influenza: Burden, Pathogenesis and Management? wrapped today in Hanoi, Vietnam. The program for the three day conference can be found at this link.

Earlier this week on Monday there was a general press release from the conference regarding the number of human H5N1 cases in Vietnam (FT link).

Shiloh said:
Vietnam ranks third in world in human A/H5N1 cases
Tuoitrenews
Updated : Tue, October 30, 2012,1:00 PM (GMT+0700)

With 123 human cases of A/H5N1 avian flu confirmed since 2003, 61 of whom have died, Vietnam now ranks third in the number of flu patients in the world, the Health Ministry reported. . .

Actually, Vietnam dropped to third place in 2011.

Through the end of 2005, Vietnam ranked first with the most confirmed human cases of H5N1 (93). Surprisingly, in the following year, 2006, Vietnam did not record any human cases of H5N1 even though more than 60% of all previous world-wide confirmed cases were reported by Vietnam. It was almost as if Vietnam decided not to have any more human cases of H5N1 in 2006.

In 2006, Vietnam continued to lead the world in number of reported cases with 93, although the count in Indonesia was increasing rapidly. By 2007, Indonesia became the world leader in confirmed H5N1 cases with 117. At that time, Vietnam was second with a total count of 98. Since 2008, Indonesia continues to rank first in the number of WHO-reported H5N1 cases with a total of 191 through October 30, 2012.

Meanwhile, the official case count in Egypt continues to grow since 2006 when the first cases were reported. In 2011, the official cumulative H5N1 count was 158 for Egypt. That number exceeded the cumulative count for Vietnam that year by 39 cases. By the end of 2011, Vietnam had fallen to third among world countries in the cumulative total H5N1 cases reported to WHO.

Is there any significance to ranking countries based on the cumulative number of WHO-reported H5N1 cases?

The WHO data set for H5N1 is small for the 9 year period between 2003 and 2012. But a skeptical interpretation suggests that over the past few years countries with a high incidence of endemic bird flu are becoming more and more reluctant to report or even identify human cases of H5N1. There seems to be tendency among these countries to report fewer and fewer cases with the hope that another county will become the front runner in leading the world in the number of officially reported cases of H5N1.

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Laidback Al · Nov 14, 2012

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Egypt - Do Poultry Rearing and Slaughtering Practices Increase Local Human and Poultry Infections?

Egypt has the second highest number of confirmed human cases of H5N1, 168 as of August 10, 2012. Most of these cases were believed to result from non-compliant poultry rearing and slaughtering practices.

An abstract posted by tetano today, entitled Poultry rearing and slaughtering practices in rural Egypt: an exploration of risk factors for H5N1 virus human transmission, suggests that H5N1 transmission between poultry and poultry and humans in Egypt is more complicated.

From the abstract . . .

H5N1 virus prevention in Egypt represents both an epidemiological and socio-cultural challenge. Traditional poultry-rearing practices that likely increase exposures to H5N1-infected poultry are common throughout Egypt. Despite education campaigns following sporadic H5N1 outbreaks, no differences in these practices could be detected between households with previous H5N1 human or poultry cases and those households with any previous experience with H5N1.

The study found that poultry rearing and slaughtering practices did not differ between households experiencing human and poultry H5N1 infections and those households that did not.

It is not clear why H5N1 infections occur in some households and not others, even though H5N1 is endemic in poultry populations in Egypt and the same poultry rearing and slaughtering practices are widespread among the population.
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Gert van der Hoek · Nov 18, 2012

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2

Did not see this Dutch study before, no new conclusion, but IMHO another confirmation from real life, something like a smoking gun:

Conclusion from an analysis of avian influenza virus during a HP H7N7 outbreak:

This implies that HPAI viruses with pandemic potential can emerge directly from poultry.

Comparative analysis of avian influenza virus diversity in poultry and humans during a highly pathogenic avian influenza A (H7N7) virus outbreak.

J Virol. 2011 Oct;85(20):10598-604. Epub 2011 Aug 17.

Abstract

Although increasing data have become available that link human adaptation with specific molecular changes in nonhuman influenza viruses, the molecular changes of these viruses during a large highly pathogenic avian influenza virus (HPAI) outbreak in poultry along with avian-to-human transmission have never been documented.

By comprehensive virologic analysis of combined veterinary and human samples obtained during a large HPAI A (H7N7) outbreak in the Netherlands in 2003, we mapped the acquisition of human adaptation markers to identify the public health risk associated with an HPAI outbreak in poultry.

Full-length hemagglutinin (HA), neuraminidase (NA), and PB2 sequencing of A (H7N7) viruses obtained from 45 human cases showed amino acid variations at different codons in HA (n=20), NA (n=23), and PB2 (n=23).

Identification of the avian sources of human virus infections based on 232 farm sequences demonstrated that for each gene about 50% of the variation was already present in poultry.

Polygenic accumulation and farm-to-farm spread of known virulence and human adaptation markers in A (H7N7) virus-infected poultry occurred prior to farm-to-human transmission. These include the independent emergence of HA A143T mutants, accumulation of four NA mutations, and farm-to-farm spread of virus variants harboring mammalian host determinants D701N and S714I in PB2.

This implies that HPAI viruses with pandemic potential can emerge directly from poultry. Since the public health risk of an avian influenza virus outbreak in poultry can rapidly change, we recommend virologic monitoring for human adaptation markers among poultry as well as among humans during the course of an outbreak in poultry.

Pubmed

Laidback Al · Nov 25, 2012

Re: How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2 (Oct 17, 2011 - Nov 25, 2012)

This thread is now closed.

Please make additional posts in the thread entitled -

Discussion - Is Bird Flu (H5N1) Still a Global Public Health Threat? (Nov 25, 2012+)
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How Dangerous is Bird Flu (H5N1) to Global Public Health? Part 2 (Oct 17, 2011 - Nov 25, 2012)

Laidback Al

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Laidback Al

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Laidback Al

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Laidback Al

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Gert van der Hoek

In Memoriam - Editor, Senior Moderator

Laidback Al

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