Vaccine development There is no vaccine yet available for the H5N1 virus but several companies in the US and Europe are racing to develop one




IP/CPSD NEWSLETTER 
 

Page  
 
 

 
 

Page  
 

ip/CPSD NEWSLETTER 
 
 

 
 
 
 
 
 
 

Message from the President 
 
 
 
 

DHS Pandemic Influenza Newsletter 
 
 
 
 

Ip/CPSD issue 5 
 
 
 
 
 

09 May 2006

 
 
 

In this image provided by ABC, chickens are confiscated in a scene from “Fatal Contact: Bird Flu in America.”  The ABC made-for-movie follows an outbreak of an Avian Flu from its origins in a Hong Kong market through its mutation into a virus transmittable from human to human around the world and aired May 09 in the U.S, just as scientists are to begin testing of wild birds in Alaska that could herald the arrival of bird flu in North America. (AP Photo/ABC,Ken George, HO) 
 
 

STAKEHOLDERS NEWS 
 

Although there were many important issues/events going on simultaneously this week in the PanFlu world, one notable event was the airing of the ABC-TV drama “Fatal Conflict:  Bird in America.”  Health and Human Services Secretary Michael Leavitt saw the movie and described it as "a fictional account designed to entertain.  "It was not a factual presentation of a real-life situation. It's obviously depicting events that have occurred in the past and could occur in the future," he said.  Following the airing of this ABC –TV drama, "Nightline" examined the difference between fact and fiction; included in this Newsletter is a list of “Fast Facts on Avian Flu” compiled by WHO, NIH, CDC and DOS. 

The topic of vaccination came up several times this week in the PanFlu world; it was one of the most worrisome issue raised by the movie, that is the speed at which a vaccine can be produced, manufactured in large quantities and then delivered to the public. During the Policy Paper Task Force meeting this week, two of the policy papers reviewed revolved around vaccination and there was much thought provoking discussions on this topic including who gets priority for vaccination in a Pandemic Influenza environment, “exposure risk personnel” or “mission essential personnel.”  A decision has not been met, since these policy papers are still under review by the Policy Paper Task Force group.  For additional information on vaccination, see section on “Vaccination Policy for DHS” and  the attachment, “HHS Viewer Guide: Question and Answers.”

Other notable events going on in the PanFlu world include the Department’s Chief Medical Officer, Dr Runge’s testimony on Thursday before the House Government Reform Committee on “Pandemic Influenza: Roles and Responsibilities of DHS and HHS.”   Work group representatives discussed during the prep PCC meeting that their components were still receiving questions regarding PanFlu following the announcement of the Implementation Plan For The National Strategy For Pandemic Influenza which took place on 03 May 2006.  As a reminder, the Department’s Office of Public Affairs guidance is as follows: Direct all public or press inquiries to DHS OPA HQ @ 202-282-8010.   
 
 
 

Inside This Issue

    1 Stakeholder News

    2 HHS Viewer Guide to “Fatal Contact: Bird Flu in America.”

3 Vaccination Policy for DHS

4 Fast Facts on Avian Flu

5 Policy Paper Task Force Work Group

Upcoming Events        

Web Pages of Note

 
 

HHS Viewer Guide to “Fatal Contact:  Bird Flu in America.”

On Tuesday, May 9 at 8 p.m., the ABC television network air a made-for-TV movie titled "Fatal Contact: Bird Flu in America."  The movie follows an outbreak of the H5N1 avian flu virus from its origins in a Hong Kong market through its mutation into a pandemic virus that becomes easily transmittable from human to human and spreads rapidly around the world.  Among the story lines featured, several of the movie's key characters are the Secretary of Health & Human Services, a CDC Epidemic Intelligence Service officer, and the Governor of Virginia.  More information on the film can be found on the ABC-TV Website at: http://abc.go.com/movies/birdflu.html.  Below are talking points and a set of questions and answers based on the film, which has been previewed by a number of HHS staff.

TALKING POINTS 
 
 
 
 

  • The ABC Movie "Fatal Contact: Bird Flu in America" is a movie, not a documentary.  It is a work of fiction designed to entertain and not a factual accounting of a real world event.
  • There is no influenza pandemic in the world at this time.
  • Also, it is important to remember that H5N1 avian influenza is almost exclusively a disease of birds.  The H5N1 virus has not yet appeared in the U.S.
  • Should the H5N1 virus appear in the U.S., it does not mean the start of a pandemic.
  • An additional point to remember is that the next influenza pandemic could be substantially less severe than what the movie depicts or that occurred in 1918.  For example, the influenza pandemics of 1957/58 and 1968/69 caused so much less illness and death than did the 1918/19 pandemic that many Americans at that time did not distinguish them from seasonal influenza and were unaware that a pandemic was underway.
  • While the movie does serve to raise awareness about avian and pandemic flu, we hope it will inspire preparation - not panic.  There are steps individuals, families and communities can take to prepare.  You can keep a supply of food and medicines on hand in case you have to stay home, you can practice good public health measures like frequent hand washing and staying home when sick. There is good information available on www.pandemicflu.gov. 
  • The film does depict scenarios that could unfold should a severe pandemic ever develop, including limited availability of antivirals and vaccines as well as the potential for disruption of supplies, medicines and other essential services. 
  • The film also illustrates the expected months-long delay in developing an effective vaccine against a pandemic strain of influenza once it emerges.  This is why, at the President's request, the Congress approved funding for the Department of Health and Human Services to make significant financial investments to improve the technology for vaccine development and to build up our domestic vaccine production capacity, to ensure more rapid availability of vaccine for the population in a pandemic.
  • The film highlights an important aspect of planning - individual and community planning and cooperation that will be so vital to sustaining communities and neighborhoods during an extended wave of an influenza pandemic.   HHS has developed an extensive set of planning documents, including planning checklists for businesses, schools, health care providers, community organizations and states as well as an individual and family planning guide.  All of these materials are available at www.pandemicflu.gov.
  • While the H5N1 virus has not yet appeared in the U.S., and there is no influenza pandemic in the world at this time, it is important for all Americans to be informed about this potential public health threat and some of the steps individual Americans can take to protect themselves and their families in the event of a pandemic.

 
 

VACCINATION POLICY FOR DHS

There are various pharmacologic and non-pharmacologic countermeasures the DHS workforce can utilize to protect themselves against a potential influenza pandemic.  One of the most important pharmacologic countermeasures in protecting the workforce is the timely development, distribution, and administration of an influenza vaccine that is specific to the pandemic strain.   Scientists have been developing a vaccine against the avian influenza (H5N1) virus that has the potential of becoming the next pandemic strain.  Recently, the National Institute of Allergy and Infectious Diseases (NIAID) funded an avian influenza (H5N1) vaccine trial that revealed limited results.  Infectious disease experts have commented that if avian influenza (H5N1) mutates and becomes the next pandemic strain, the current experimental H5N1 vaccine may not be effective.   In fact a new vaccine will need to be developed for that particular strain and this process could take 6 to 8 months.   Despite these limitations, scientists are optimistic that with increased funding and advancing technology, vaccine production will become more efficient and timely.  

To prepare the DHS workforce for the possible vaccine contingency, the DHS Workforce Assurance Working Group, headed by Coast Guard Rear Admiral Paul Higgins, is currently developing policies that would require DHS Components to prioritize vaccine administration (when available), based upon personnel exposure risk and based upon the critical nature of the DHS mission. The proposed DHS vaccine prioritization policy will require DHS components to place DHS personnel into two tiers: (1) Tier 1 -Exposure Risk and (2) Tier 2 - Mission-Criticality.  Exposure risk will be defined by guidelines set forth by the Department of Health and Human Services. Mission-Criticality will be determined by each DHS component.   In the event, there is an FDA-approved vaccine for the specific pandemic strain,  vaccine administration for the DHS workforce will be done on a voluntary basis with appropriate Medical disclosures and informed consent.

Due to the uncertain nature of pharmacologic countermeasures, the DHS Workforce Assurance Working Group is placing their primary emphasis on non-pharmacologic countermeasures (e.g. personal protective equipment, social distancing, cough etiquette).  Specific details on DHS non-pharmacologic countermeasures will be delineated in upcoming DHS policy decision papers. 

Specific DHS questions on Workforce Assurance may be sent to CDR McConnell at WMcConnell@comdt.uscg.mil or the author of this article, CDR Ignacio at JIgnacio@comdt.uscg.mil.  For component specific policy questions on Pandemic Influenza (PI) or Avian Influenza (AI) please contact the component-specific PI / AI point of contact. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Infectious disease experts have commented that if avian influenza (H5N1) mutates and becomes the next pandemic strain, the current experimental H5N1 vaccine may not be effective. 
 

 
 
 
 
 
 
 
 

 
                                           

 
 

 
 

 

FAST FACTS ON AVIAN FLU

Public health officials are concerned that the avian flu, or "bird flu," could easily become a serious threat to human health worldwide. The following are some fast facts on this deadly disease.

 
 

  • Experts fear that if the H5N1 virus mutates to a form that does pass from human to human, it could set off an international pandemic.
  • The standard measures taken to control an outbreak of avian flu include quarantine of an infected flock, the destruction of entire flocks and the proper disposal of carcasses.
  • Unless prompt and consistently strict controls are implemented, epidemics can take years to contain – a 1992 epidemic in Mexico was not controlled until 1995.
  • The first known human cases of avian flu occurred in 1997 in Hong Kong, when the H5N1 virus infected 18 people, six of whom died.
  • A rapid response by Hong Kong authorities – some 1.5 million birds were destroyed in three days – averted what might have become a public health catastrophe.
  • Since then, deadly avian flu outbreaks among humans have occurred in the Netherlands, Indonesia, Thailand, Cambodia and Vietnam. At least 60 people worldwide have died of the H5N1 virus since 2003.
  • Other forms of the avian flu (not H5N1) have occurred in humans in Virginia and New York.
  • In humans, the avian flu is marked by fever, sore throat, cough, muscle aches, eye infections and, in fatal cases, severe respiratory distress and viral pneumonia.
  • There is no vaccine yet available for the H5N1 virus, but several companies in the U.S. and Europe are racing to develop one.
  • Two antiviral drugs are currently available that have been shown in laboratory settings to be effective against avian flu: Tamiflu (oseltamivir) and Relenza (zanamivir). Their possible effectiveness against the deadly H5N1 strain of avian flu is currently being studied.
  • The U.S. Department of State has decided to stock Tamiflu for eligible U.S. government employees and their families at its embassies and consulates in Southeast Asia.
  • Influenza strains can quickly become resistant to these antiviral drugs, and therefore the drugs may not always be effective.
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    Vaccine development There is no vaccine yet available for the H5N1 virus but several companies in the US and Europe are racing to develop one

    IP/CPSD NEWSLETTER 
     

    Page  
     
     

     
     

    Page  
     

    ip/CPSD NEWSLETTER 
     
     

     
     
     
     
     
     
     

    Message from the President 
     
     
     
     

    DHS Pandemic Influenza Newsletter 
     
     
     
     

    Ip/CPSD issue 5 
     
     
     
     
     

    09 May 2006

     
     
     

    In this image provided by ABC, chickens are confiscated in a scene from “Fatal Contact: Bird Flu in America.”  The ABC made-for-movie follows an outbreak of an Avian Flu from its origins in a Hong Kong market through its mutation into a virus transmittable from human to human around the world and aired May 09 in the U.S, just as scientists are to begin testing of wild birds in Alaska that could herald the arrival of bird flu in North America. (AP Photo/ABC,Ken George, HO) 
     
     

    STAKEHOLDERS NEWS 
     

    Although there were many important issues/events going on simultaneously this week in the PanFlu world, one notable event was the airing of the ABC-TV drama “Fatal Conflict:  Bird in America.”  Health and Human Services Secretary Michael Leavitt saw the movie and described it as "a fictional account designed to entertain.  "It was not a factual presentation of a real-life situation. It's obviously depicting events that have occurred in the past and could occur in the future," he said.  Following the airing of this ABC –TV drama, "Nightline" examined the difference between fact and fiction; included in this Newsletter is a list of “Fast Facts on Avian Flu” compiled by WHO, NIH, CDC and DOS. 

    The topic of vaccination came up several times this week in the PanFlu world; it was one of the most worrisome issue raised by the movie, that is the speed at which a vaccine can be produced, manufactured in large quantities and then delivered to the public. During the Policy Paper Task Force meeting this week, two of the policy papers reviewed revolved around vaccination and there was much thought provoking discussions on this topic including who gets priority for vaccination in a Pandemic Influenza environment, “exposure risk personnel” or “mission essential personnel.”  A decision has not been met, since these policy papers are still under review by the Policy Paper Task Force group.  For additional information on vaccination, see section on “Vaccination Policy for DHS” and  the attachment, “HHS Viewer Guide: Question and Answers.”

    Other notable events going on in the PanFlu world include the Department’s Chief Medical Officer, Dr Runge’s testimony on Thursday before the House Government Reform Committee on “Pandemic Influenza: Roles and Responsibilities of DHS and HHS.”   Work group representatives discussed during the prep PCC meeting that their components were still receiving questions regarding PanFlu following the announcement of the Implementation Plan For The National Strategy For Pandemic Influenza which took place on 03 May 2006.  As a reminder, the Department’s Office of Public Affairs guidance is as follows: Direct all public or press inquiries to DHS OPA HQ @ 202-282-8010.   
     
     
     

    Inside This Issue

      1 Stakeholder News

      2 HHS Viewer Guide to “Fatal Contact: Bird Flu in America.”

    3 Vaccination Policy for DHS

    4 Fast Facts on Avian Flu

    5 Policy Paper Task Force Work Group

    Upcoming Events        

    Web Pages of Note

     
     

    HHS Viewer Guide to “Fatal Contact:  Bird Flu in America.”

    On Tuesday, May 9 at 8 p.m., the ABC television network air a made-for-TV movie titled "Fatal Contact: Bird Flu in America."  The movie follows an outbreak of the H5N1 avian flu virus from its origins in a Hong Kong market through its mutation into a pandemic virus that becomes easily transmittable from human to human and spreads rapidly around the world.  Among the story lines featured, several of the movie's key characters are the Secretary of Health & Human Services, a CDC Epidemic Intelligence Service officer, and the Governor of Virginia.  More information on the film can be found on the ABC-TV Website at: http://abc.go.com/movies/birdflu.html.  Below are talking points and a set of questions and answers based on the film, which has been previewed by a number of HHS staff.

    TALKING POINTS 
     
     
     
     

    • The ABC Movie "Fatal Contact: Bird Flu in America" is a movie, not a documentary.  It is a work of fiction designed to entertain and not a factual accounting of a real world event.
    • There is no influenza pandemic in the world at this time.
    • Also, it is important to remember that H5N1 avian influenza is almost exclusively a disease of birds.  The H5N1 virus has not yet appeared in the U.S.
    • Should the H5N1 virus appear in the U.S., it does not mean the start of a pandemic.
    • An additional point to remember is that the next influenza pandemic could be substantially less severe than what the movie depicts or that occurred in 1918.  For example, the influenza pandemics of 1957/58 and 1968/69 caused so much less illness and death than did the 1918/19 pandemic that many Americans at that time did not distinguish them from seasonal influenza and were unaware that a pandemic was underway.
    • While the movie does serve to raise awareness about avian and pandemic flu, we hope it will inspire preparation - not panic.  There are steps individuals, families and communities can take to prepare.  You can keep a supply of food and medicines on hand in case you have to stay home, you can practice good public health measures like frequent hand washing and staying home when sick. There is good information available on www.pandemicflu.gov. 
    • The film does depict scenarios that could unfold should a severe pandemic ever develop, including limited availability of antivirals and vaccines as well as the potential for disruption of supplies, medicines and other essential services. 
    • The film also illustrates the expected months-long delay in developing an effective vaccine against a pandemic strain of influenza once it emerges.  This is why, at the President's request, the Congress approved funding for the Department of Health and Human Services to make significant financial investments to improve the technology for vaccine development and to build up our domestic vaccine production capacity, to ensure more rapid availability of vaccine for the population in a pandemic.
    • The film highlights an important aspect of planning - individual and community planning and cooperation that will be so vital to sustaining communities and neighborhoods during an extended wave of an influenza pandemic.   HHS has developed an extensive set of planning documents, including planning checklists for businesses, schools, health care providers, community organizations and states as well as an individual and family planning guide.  All of these materials are available at www.pandemicflu.gov.
    • While the H5N1 virus has not yet appeared in the U.S., and there is no influenza pandemic in the world at this time, it is important for all Americans to be informed about this potential public health threat and some of the steps individual Americans can take to protect themselves and their families in the event of a pandemic.

     
     

    VACCINATION POLICY FOR DHS

    There are various pharmacologic and non-pharmacologic countermeasures the DHS workforce can utilize to protect themselves against a potential influenza pandemic.  One of the most important pharmacologic countermeasures in protecting the workforce is the timely development, distribution, and administration of an influenza vaccine that is specific to the pandemic strain.   Scientists have been developing a vaccine against the avian influenza (H5N1) virus that has the potential of becoming the next pandemic strain.  Recently, the National Institute of Allergy and Infectious Diseases (NIAID) funded an avian influenza (H5N1) vaccine trial that revealed limited results.  Infectious disease experts have commented that if avian influenza (H5N1) mutates and becomes the next pandemic strain, the current experimental H5N1 vaccine may not be effective.   In fact a new vaccine will need to be developed for that particular strain and this process could take 6 to 8 months.   Despite these limitations, scientists are optimistic that with increased funding and advancing technology, vaccine production will become more efficient and timely.  

    To prepare the DHS workforce for the possible vaccine contingency, the DHS Workforce Assurance Working Group, headed by Coast Guard Rear Admiral Paul Higgins, is currently developing policies that would require DHS Components to prioritize vaccine administration (when available), based upon personnel exposure risk and based upon the critical nature of the DHS mission. The proposed DHS vaccine prioritization policy will require DHS components to place DHS personnel into two tiers: (1) Tier 1 -Exposure Risk and (2) Tier 2 - Mission-Criticality.  Exposure risk will be defined by guidelines set forth by the Department of Health and Human Services. Mission-Criticality will be determined by each DHS component.   In the event, there is an FDA-approved vaccine for the specific pandemic strain,  vaccine administration for the DHS workforce will be done on a voluntary basis with appropriate Medical disclosures and informed consent.

    Due to the uncertain nature of pharmacologic countermeasures, the DHS Workforce Assurance Working Group is placing their primary emphasis on non-pharmacologic countermeasures (e.g. personal protective equipment, social distancing, cough etiquette).  Specific details on DHS non-pharmacologic countermeasures will be delineated in upcoming DHS policy decision papers. 

    Specific DHS questions on Workforce Assurance may be sent to CDR McConnell at WMcConnell@comdt.uscg.mil or the author of this article, CDR Ignacio at JIgnacio@comdt.uscg.mil.  For component specific policy questions on Pandemic Influenza (PI) or Avian Influenza (AI) please contact the component-specific PI / AI point of contact. 
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     

    Infectious disease experts have commented that if avian influenza (H5N1) mutates and becomes the next pandemic strain, the current experimental H5N1 vaccine may not be effective. 
     

     
     
     
     
     
     
     
     

     
                                               

     
     

     
     

     

    FAST FACTS ON AVIAN FLU

    Public health officials are concerned that the avian flu, or "bird flu," could easily become a serious threat to human health worldwide. The following are some fast facts on this deadly disease.

     
     

    • Experts fear that if the H5N1 virus mutates to a form that does pass from human to human, it could set off an international pandemic.
    • The standard measures taken to control an outbreak of avian flu include quarantine of an infected flock, the destruction of entire flocks and the proper disposal of carcasses.
    • Unless prompt and consistently strict controls are implemented, epidemics can take years to contain – a 1992 epidemic in Mexico was not controlled until 1995.
    • The first known human cases of avian flu occurred in 1997 in Hong Kong, when the H5N1 virus infected 18 people, six of whom died.
    • A rapid response by Hong Kong authorities – some 1.5 million birds were destroyed in three days – averted what might have become a public health catastrophe.
    • Since then, deadly avian flu outbreaks among humans have occurred in the Netherlands, Indonesia, Thailand, Cambodia and Vietnam. At least 60 people worldwide have died of the H5N1 virus since 2003.
    • Other forms of the avian flu (not H5N1) have occurred in humans in Virginia and New York.
    • In humans, the avian flu is marked by fever, sore throat, cough, muscle aches, eye infections and, in fatal cases, severe respiratory distress and viral pneumonia.
    • There is no vaccine yet available for the H5N1 virus, but several companies in the U.S. and Europe are racing to develop one.
    • Two antiviral drugs are currently available that have been shown in laboratory settings to be effective against avian flu: Tamiflu (oseltamivir) and Relenza (zanamivir). Their possible effectiveness against the deadly H5N1 strain of avian flu is currently being studied.
    • The U.S. Department of State has decided to stock Tamiflu for eligible U.S. government employees and their families at its embassies and consulates in Southeast Asia.
    • Influenza strains can quickly become resistant to these antiviral drugs, and therefore the drugs may not always be effective.