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U.S. Makes Second Agreement for Anti-Pandemic Flu
Vaccine
Developers targeting H5N1 virus that has caused Asian
epidemic
Sept. 28, 2005 – In the second announcement within
two weeks, Health and Human Services says an agreement has been signed
to develop vaccines against avain flu viruses that have the potential to
cause pandemics. Today, HHS Secretary Mike Leavitt said an agreement has
been signed with MedImmune of Gaithersburg, Md., to produce and test
these vaccines, including one for the H5N1 avian flu virus, which has
caused an epidemic in Asia.
In mid-September the government awarded a $100
million contract to sanofi pasteur, the vaccines business of the
sanofi-aventis Group, to manufacture avian influenza vaccine designed to
protect against H5N1.
The newest agreement is between the National
Institute of Allergy and Infectious Diseases (NIAID) and MedImmune Inc.
NIAID is part of the National Institutes of Health.
"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.
About NIAID:
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.
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