NIAID and MedImmune Join Forces to Develop Potential Pandemic Influenza Vaccines

28 Sep, 2005, 01:00 ET from U.S. Department of Health and Human Services

    WASHINGTON, Sept. 28 /PRNewswire/ -- HHS Secretary Mike Leavitt today
 announced that the National Institute of Allergy and Infectious Diseases
 (NIAID) and MedImmune Inc. have signed a cooperative research and development
 agreement for the development of vaccines against avian influenza viruses that
 have the potential to cause pandemics.  Under the agreement, NIAID, part of
 the National Institutes of Health, and MedImmune of Gaithersburg, Md., will
 produce and test multiple vaccines against potential pandemic flu strains,
 including the H5N1 avian influenza virus.
     "The threat of pandemic flu is an urgent health challenge," HHS Secretary
 Mike Leavitt said.  "This agreement will help speed the process of developing
 vaccines we will need to fight an outbreak if the avian flu starts to spread
 rapidly through the human population."
     Kanta Subbarao, M.D. M.P.H, and Brian Murphy, M.D., of NIAID's Laboratory
 of Infectious Diseases will lead NIAID's part in this collaboration.  The
 agreement specifies that the scientists will add selected genes from avian flu
 viruses with pandemic potential into a weakened human flu virus to create
 several attenuated, live virus vaccines candidates.
     "Our agreement with MedImmune coordinates public and private resources and
 brings a deeper pool of talent to bear on the urgent need for vaccines to
 combat the threat of an influenza pandemic," said NIAID director Anthony S.
 Fauci, M.D.  "It is an example of the many productive public-private
 partnerships upon which we depend in our quest to develop vaccines, drugs and
 diagnostics for myriad infectious disease threats."
     Infectious disease experts worry that avian influenza viruses, which until
 recently have rarely infected people, could trigger a devastating global flu
 outbreak.  The H5N1 avian influenza is especially troubling as it has spread
 rapidly among birds and other animals in Asia since late 2003, and more
 recently has been found in birds in Russia and Kazakhstan.  According to the
 World Health Organization, of the 115 people in four Asian countries who have
 been infected with H5N1 from late 2003 through 2005, 59 have died.  While this
 virus currently is not known to spread efficiently from person to person, it
 could trigger a human influenza pandemic if it acquires that ability.
     NIAID and MedImmune will develop at least one vaccine for each of the 16
 variations of a key influenza surface protein known as hemagglutinin
 (represented by the letter "H" in the names of influenza strains, such as
 H5N1).  NIAID and MedImmune will develop vaccines for the highest priority
 hemagglutinin subtypes first.  The researchers say it will take years to
 systematically develop vaccines for all the hemagglutinin subtypes.  Having
 effective vaccines against all subtypes will help us prepare for influenza
 pandemics in the future, explains NIAID's Dr. Subbarao.
     Human influenza viruses that have circulated in the last century contain
 one of three possible hemagglutinin proteins (H1, H2 and H3); potential
 pandemic viruses contain one of the others to which humans have never been
 exposed.  Not having any prior exposure to the hemagglutinin in H5N1 avian
 influenza virus currently spreading in Asia, the human immune system is
 unprepared to fight it.  For that reason, developing an H5N1 vaccine is a high
 priority for the NIAID/MedImmune collaboration.
     Under the agreement, NIAID and MedImmune will use methods such as reverse
 genetics and classical reassortment to place hemagglutinin genes with pandemic
 potential into an attenuated human flu virus.  Reverse genetics is a
 laboratory method by which researchers can custom make a flu vaccine by
 assembling genes that code for the desired features.  Reassortment is the
 swapping and mixing of gene segments between two different viral strains
 inside a chicken cell to create a new vaccine.
     The NIAID/MedImmune agreement builds on research pioneered by NIAID's Dr.
 Murphy beginning in the 1970s.  Working with the developer of the attenuated
 influenza virus -- John Maassab, Ph.D., of the University of Michigan School
 of Public Health -- Dr. Murphy and colleagues created a flu vaccine from a
 live flu virus weakened so that it would not cause disease.  As an extra
 measure of safety, the researchers grew the live virus vaccine in
 progressively colder temperatures to prevent it from spreading beyond the
 relatively cool upper respiratory tract.  This "cold-adapted" virus is
 proprietary to MedImmune and is the basis of MedImmune's FluMist(R) flu
 vaccine, also a product of a public-private partnership between NIAID and
 MedImmune.  The researchers will use the same cold-adapted virus as the
 backbone for the pandemic influenza vaccines.
     NIAID and MedImmune will generate many of the vaccines in NIAID's
 Bethesda, Md., labs.  Both NIAID and MedImmune will initially conduct
 laboratory studies of the vaccines.  MedImmune then will manufacture the
 vaccines for human clinical trials, which NIAID will run through a contract
 facility, pending Food and Drug Administration approval.  These studies will
 assess vaccine safety and immunogenicity.
     NIAID is a component of the National Institutes of Health, an agency of
 the U.S. Department of Health and Human Services.  NIAID supports 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.
 
     Note: All HHS press releases, fact sheets and other press materials are
 available at http://www.hhs.gov/news.
 
 

SOURCE U.S. Department of Health and Human Services
    WASHINGTON, Sept. 28 /PRNewswire/ -- HHS Secretary Mike Leavitt today
 announced that the National Institute of Allergy and Infectious Diseases
 (NIAID) and MedImmune Inc. have signed a cooperative research and development
 agreement for the development of vaccines against avian influenza viruses that
 have the potential to cause pandemics.  Under the agreement, NIAID, part of
 the National Institutes of Health, and MedImmune of Gaithersburg, Md., will
 produce and test multiple vaccines against potential pandemic flu strains,
 including the H5N1 avian influenza virus.
     "The threat of pandemic flu is an urgent health challenge," HHS Secretary
 Mike Leavitt said.  "This agreement will help speed the process of developing
 vaccines we will need to fight an outbreak if the avian flu starts to spread
 rapidly through the human population."
     Kanta Subbarao, M.D. M.P.H, and Brian Murphy, M.D., of NIAID's Laboratory
 of Infectious Diseases will lead NIAID's part in this collaboration.  The
 agreement specifies that the scientists will add selected genes from avian flu
 viruses with pandemic potential into a weakened human flu virus to create
 several attenuated, live virus vaccines candidates.
     "Our agreement with MedImmune coordinates public and private resources and
 brings a deeper pool of talent to bear on the urgent need for vaccines to
 combat the threat of an influenza pandemic," said NIAID director Anthony S.
 Fauci, M.D.  "It is an example of the many productive public-private
 partnerships upon which we depend in our quest to develop vaccines, drugs and
 diagnostics for myriad infectious disease threats."
     Infectious disease experts worry that avian influenza viruses, which until
 recently have rarely infected people, could trigger a devastating global flu
 outbreak.  The H5N1 avian influenza is especially troubling as it has spread
 rapidly among birds and other animals in Asia since late 2003, and more
 recently has been found in birds in Russia and Kazakhstan.  According to the
 World Health Organization, of the 115 people in four Asian countries who have
 been infected with H5N1 from late 2003 through 2005, 59 have died.  While this
 virus currently is not known to spread efficiently from person to person, it
 could trigger a human influenza pandemic if it acquires that ability.
     NIAID and MedImmune will develop at least one vaccine for each of the 16
 variations of a key influenza surface protein known as hemagglutinin
 (represented by the letter "H" in the names of influenza strains, such as
 H5N1).  NIAID and MedImmune will develop vaccines for the highest priority
 hemagglutinin subtypes first.  The researchers say it will take years to
 systematically develop vaccines for all the hemagglutinin subtypes.  Having
 effective vaccines against all subtypes will help us prepare for influenza
 pandemics in the future, explains NIAID's Dr. Subbarao.
     Human influenza viruses that have circulated in the last century contain
 one of three possible hemagglutinin proteins (H1, H2 and H3); potential
 pandemic viruses contain one of the others to which humans have never been
 exposed.  Not having any prior exposure to the hemagglutinin in H5N1 avian
 influenza virus currently spreading in Asia, the human immune system is
 unprepared to fight it.  For that reason, developing an H5N1 vaccine is a high
 priority for the NIAID/MedImmune collaboration.
     Under the agreement, NIAID and MedImmune will use methods such as reverse
 genetics and classical reassortment to place hemagglutinin genes with pandemic
 potential into an attenuated human flu virus.  Reverse genetics is a
 laboratory method by which researchers can custom make a flu vaccine by
 assembling genes that code for the desired features.  Reassortment is the
 swapping and mixing of gene segments between two different viral strains
 inside a chicken cell to create a new vaccine.
     The NIAID/MedImmune agreement builds on research pioneered by NIAID's Dr.
 Murphy beginning in the 1970s.  Working with the developer of the attenuated
 influenza virus -- John Maassab, Ph.D., of the University of Michigan School
 of Public Health -- Dr. Murphy and colleagues created a flu vaccine from a
 live flu virus weakened so that it would not cause disease.  As an extra
 measure of safety, the researchers grew the live virus vaccine in
 progressively colder temperatures to prevent it from spreading beyond the
 relatively cool upper respiratory tract.  This "cold-adapted" virus is
 proprietary to MedImmune and is the basis of MedImmune's FluMist(R) flu
 vaccine, also a product of a public-private partnership between NIAID and
 MedImmune.  The researchers will use the same cold-adapted virus as the
 backbone for the pandemic influenza vaccines.
     NIAID and MedImmune will generate many of the vaccines in NIAID's
 Bethesda, Md., labs.  Both NIAID and MedImmune will initially conduct
 laboratory studies of the vaccines.  MedImmune then will manufacture the
 vaccines for human clinical trials, which NIAID will run through a contract
 facility, pending Food and Drug Administration approval.  These studies will
 assess vaccine safety and immunogenicity.
     NIAID is a component of the National Institutes of Health, an agency of
 the U.S. Department of Health and Human Services.  NIAID supports 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.
 
     Note: All HHS press releases, fact sheets and other press materials are
 available at http://www.hhs.gov/news.
 
 SOURCE  U.S. Department of Health and Human Services