SOURCE: GlaxoSmithKline
December 08, 2008 09:05 ET
FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough Vaccine, BOOSTRIX®, for Adults
New Indication for Booster Vaccine Expands Disease Protection to Individuals Aged 10-64 Years
PHILADELPHIA, PA--(Marketwire - December 8, 2008) - GlaxoSmithKline (NYSE: GSK) announced
today that the U.S. Food and Drug Administration (FDA) has approved
BOOSTRIX® [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular
Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 19-64 years of age.
BOOSTRIX offers protection against tetanus, diphtheria and pertussis
(whooping cough) to individuals 10-64 years of age -- the broadest age
range for any Tdap vaccine. BOOSTRIX was previously approved as a booster
vaccine for preteens and teens.
"Whooping cough is a highly contagious respiratory disease that can be
prevented through vaccination, yet, according to the Centers for Disease
Control and Prevention (CDC), most adolescents and adults have not received
the recommended booster shot," said Andrew C. Eisenberg MD, MHA, FAAFP,
Associate Professor, Department of Public Health and Policy, Texas A&M
School of Rural Public Health. "BOOSTRIX can be given in place of one
tetanus diphtheria (Td) booster for adolescents and adults, in accordance
with the CDC recommendation for whooping cough protection."
The approval of BOOSTRIX in adults was based on two clinical trials in
which nearly 3,000 U.S. subjects 19-64 years of age were vaccinated with
BOOSTRIX. The data demonstrate the overall safety and immunogenicity of
BOOSTRIX in providing booster protection against tetanus, diphtheria and
whooping cough in adults.
The CDC recommends a single Tdap vaccination for adults aged 19-64 years,
in place of a Td booster if the last dose of the Td vaccine was received 10
or more years prior in individuals who have not already received a Tdap
vaccine. This includes healthcare personnel who have direct patient
contact, as well as adults younger than 65 years of age who have or
anticipate having contact with infants younger than 12 months (e.g.,
parents, grandparents, childcare providers).
"This approval extends the whooping cough protection afforded by BOOSTRIX
in adolescents to adults 19-64, expanding options for adult Tdap
vaccination," said Wayde M. Weston, Ph.D., Director, U.S. Clinical Research
and Development/Medical Affairs, GlaxoSmithKline.
The approval of BOOSTRIX in adults expands the GSK Vaccines portfolio,
making it the only company in the country to offer a full line of vaccines
to protect adults from pertussis, hepatitis A & B and flu.
About Pertussis (Whooping Cough)
Whooping cough, also known as pertussis, is a serious and highly contagious
respiratory disease characterized by severe coughing fits. Whooping cough
may lead to complications such as pneumonia or rib fracture in adolescents
and adults. The illness may last for more than 100 days and can lead to
lost time at work or school. Babies who have not received all of their
shots for whooping cough are at risk of catching the illness. Preteens,
teens and adults are often the source of infection for infants.
Whooping cough starts off like the common cold, and may include symptoms
such as a runny nose, sneezing, mild fever and severe coughing fits. While
more than 3,500 cases of whooping cough were reported in U.S. adults ages
20 years and older in 2007, many more cases may go unreported. In fact, it
is estimated that over 600,000 cases occur in adults annually. According to
the CDC's 2007 National Immunization Survey, an estimated 98 percent of
adults aged 18-64 years reported that they have not received the whooping
cough booster shot.
About BOOSTRIX
BOOSTRIX is approved as a booster vaccination for the prevention of
tetanus, diphtheria and pertussis in individuals 10-64 years of age. Since
2005, more than 7.5 million doses of BOOSTRIX have been distributed in the
US to protect adolescents from whooping cough.
This press release contains general information about pertussis infection
and the potential impact of vaccination. It also contains information about
BOOSTRIX which is presented separately. Approval of BOOSTRIX for use in
preventing tetanus, diphtheria and pertussis in adults 19-64 was based on
immune response data and not on data concerning effect of vaccination with
BOOSTRIX on these diseases or outcomes of these diseases (such as pneumonia
or rib fracture, nor of transmission of disease). For additional
information about BOOSTRIX, please see the complete Prescribing Information
accompanying this material.
Important Safety Information
In clinical studies, common adverse events were injection-site reactions
(pain, redness, swelling, or increase in arm circumference), headache,
fatigue, and gastrointestinal symptoms. Severe allergic reaction after a
previous dose of BOOSTRIX or encephalopathy within 7 days of a previous
pertussis antigen-containing vaccine is a contraindication. The decision to
give BOOSTRIX should be based on benefits and risks if Guillain-Barré
syndrome has occurred within 6 weeks of receipt of a prior tetanus
toxoid-containing vaccine, or if progressive or unstable neurologic
disorders exist. Persons who experienced an Arthus-type hypersensitivity
reaction following a previous dose of tetanus toxoid-containing vaccine
should not receive BOOSTRIX unless 10 years have elapsed. The prefilled
syringes contain dry natural latex rubber that may cause allergic
reactions.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline Biologicals (GSK Biologicals) is a leading global vaccine
manufacturer committed to preventing disease in people of all ages with
innovative vaccines and delivery systems. The division, headquartered in
Belgium, is active in vaccine research, development and production with
more than 30 vaccines currently available globally and 20 more in
development. In 2007 GSK Biologicals distributed 1.1 billion doses of
vaccines -- an average of 3 million doses a day.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical
and health care companies. GlaxoSmithKline is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit www.gsk.com.
Boostrix is a registered trademark of the GlaxoSmithKline group of
companies.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors that may affect
GSK' s operations are described under 'Risk Factors' in the 'Business
Review' in the company' s Annual Report on Form 20-F for 2007.
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