FDA NEWS RELEASE
For Immediate Release: Nov. 22, 2013
Media Inquiries: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez(at)fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA,OCOD(at)fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA,OCOD(at)fda.hhs.gov
Vaccine to supplement National Stockpile, not intended for commercial availability
The
U.S. Food and Drug Administration today approved the first adjuvanted
vaccine for the prevention of H5N1 influenza, commonly known as avian or
bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine,
Adjuvanted, is for use in people 18 years of age and older who are at
increased risk of exposure to the H5N1 influenza virus.
Avian
influenza is an infectious disease of birds caused by certain influenza
A viruses. Most avian influenza A viruses do not infect people. However
some viruses, such as H5N1, have caused serious illness and death in
people outside of the U.S., mostly among people who have been in close
contact with infected and ill poultry. When people do become infected
with H5N1, about 60 percent die, according to the World Health
Organization. H5N1 is an influenza virus with pandemic potential because
it continues to infect wild birds with occasional outbreaks of
influenza disease in poultry populations, and most humans have no
immunity to it.
“This vaccine could be used in the
event that the H5N1 avian influenza virus develops the capability to
spread efficiently from human to human, resulting in the rapid spread of
disease across the globe,” said Karen Midthun, M.D., director of the
FDA’s Center for Biologics Evaluation and Research. “Vaccines are
critical to protecting public health by helping to counter the
transmission of influenza disease during a pandemic.”
The
H5N1 avian influenza vaccine is not intended for commercial
availability. The U.S. Department of Health and Human Services has
purchased the vaccine from the manufacturer, ID Biomedical Corporation
of Quebec, Quebec City, Canada (a subsidiary of GlaxoSmithKline
Biologicals), for inclusion within the National Stockpile for
distribution by public health officials if needed.
The
vaccine is made using an egg-based manufacturing process, which is also
used for ID Biomedical Corporation’s seasonal influenza vaccine,
FluLaval. It contains the adjuvant AS03, an oil-in-water emulsion. An
adjuvant is a substance incorporated into some vaccines to enhance or
direct the immune response of the vaccinated individual. The adjuvant
makes it possible to use a small amount of influenza protein per dose of
vaccine to elicit the desired immune response in an individual to
prevent influenza disease. Reducing the amount of influenza protein per
dose helps to increase the total number of doses of a safe and effective
vaccine available for the public during a pandemic.
The
H5N1 component and the AS03 adjuvant component are supplied in two
separate vials, which must be combined prior to use. The vaccine is
administered via intramuscular injection in two doses, 21 days apart.
The
evaluation of safety compared approximately 3,400 adults 18 years of
age and older who received the vaccine to about 1,100 adults who
received placebo in a multi-center study. The most common side effect
reported during the clinical studies among the vaccine recipients was
injection site pain. Muscle aches, headache, fatigue and injection site
redness and swelling were also common. To determine how well the vaccine
works, the immune response was evaluated in about 2,000 of the
vaccinated adults. The results showed that 91 percent of individuals
between the ages of 18 and 64 years and 74 percent of individuals 65
years and older who received the two-dose regimen developed antibodies
at a level that is expected to reduce the risk of getting influenza.
The
manufacturer will collaborate with the FDA and other U.S. governmental
agencies on plans to collect additional safety and effectiveness data
through U.S. government-sponsored studies of the vaccine, in the event
that it is used during an H5N1 influenza virus pandemic.
For more information:
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
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