FDA Approves GlaxoSmithKline’s Pediarix(TM) First U.S. Combination
Vaccine To Protect Infants Against Five Diseases
New Vaccine Results In Up To Six Fewer Injections For
Infants
RESEARCH TRIANGLE PARK, NC -- (INTERNET WIRE)
-- 12/16/2002 -- GlaxoSmithKline (NYSE:
GSK) announced today that its combination vaccine, PEDIARIX™
[Diphtheria and Tetanus Toxoids and Acellular Pertussis
Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus
Vaccine Combined], received approval from the U.S. Food and Drug
Administration (FDA) to be given to infants at 2, 4 and 6 months
of age for the prevention of diphtheria, tetanus, pertussis,
hepatitis B and polio.* PEDIARIX is the first five-in-one
U.S.-licensed vaccine to offer protection against five serious
diseases in a three-dose vaccination series. This combination
vaccine results in up to six fewer injections for infants, which
may reduce infants’ pain and discomfort.
“The introduction of a combination vaccine like PEDIARIX
marks a milestone for the United States immunization program,”
said Joel Ward, M.D., director of the University of California,
Los Angeles (UCLA) Center for Vaccine Research, Research and
Education Institute at Harbor-UCLA Medical Center and principal
clinical trial investigator. “Combination vaccines make it
easier to comply with the implementation of a complicated
immunization schedule and reduce the number of injections and
office visits compared with separately administered vaccines.”
Currently, children receive approximately twenty injections
in the first two years of life and with the development and
introduction of new vaccines, that number will continue to
increase. Nine injections are presently recommended to protect
the more than four million babies born in the United States each
year against diphtheria, tetanus, pertussis (whooping cough),
hepatitis B and polio. PEDIARIX protects against these diseases
with only three injections in the primary series, which could
result in as many as 24 million fewer injections per year for
infants in the United States.
“GlaxoSmithKline is proud to bring PEDIARIX to the United
States,” said Barbara Howe, M.D., vice president, Clinical
Research and Development and Medical Affairs, Vaccines North
America, GlaxoSmithKline. “PEDIARIX is approved in many other
countries. We believe this combination vaccine will not only
help ease the United States immunization process for both
parents and healthcare professionals, but may also reduce parent
anxiety and infant pain and discomfort associated with multiple
injections.”
Proven Immunogenicity and Established Safety
The development of combination vaccines includes trials that
are designed to demonstrate safety and immunogenicity of the
combination vaccine as compared to the separate administration
of individual U.S.-licensed vaccines. PEDIARIX was proven safe
and effective in numerous clinical trials worldwide, where
20,739 doses of PEDIARIX were administered to 7,028 infants.
In clinical studies, adverse events in infants receiving
PEDIARIX included injection-site reactions (pain, redness, or
swelling), fever, and fussiness. Administration of PEDIARIX was
associated with higher rates of fever relative to separately
administered vaccines (see Adverse Reactions section of the
package insert). PEDIARIX is contraindicated in infants with
known hypersensitivity to any component of the vaccine including
yeast, neomycin, and polymyxin B. As with any vaccine,
vaccination with PEDIARIX may not protect 100% of susceptible
individuals.
Combination Vaccines
Vaccines have been heralded as one of the greatest public
health achievements of the 20th century because they have helped
protect children and eradicate diseases. Life-threatening
diseases, such as polio which affected 20,000 people in the
United States in the early 1950’s alone, are nearly eradicated
as a result of widespread vaccination. Today, infants may
receive approximately 20 injections in the first two years of
life, which protect them against many serious diseases including
diphtheria, tetanus, pertussis, mumps, measles, rubella, polio,
hepatitis B, Haemophilus influenzae type b and
Streptococcus pneumoniae.
Combination vaccines, such as DTP [diphtheria, tetanus and
pertussis], have been available and effectively used for 56
years. In fact, the Advisory Committee on Immunization Practices
(ACIP), the American Academy of Pediatrics (AAP) and the
American Academy of Family Physicians (AAFP) prefer the use of
licensed combination vaccines versus separate injections of
their equivalent component vaccines. This preference is based on
the rationale that the use of combination vaccines is a
practical way to overcome the constraints of multiple
injections. To minimize the number of injections children
receive, parenteral combination vaccines should be used, if
licensed and indicated for the patient’s age, instead of their
equivalent component vaccines. Combination vaccines also help
reduce costs for parents and physicians, may reduce the number
of office visits, and help facilitate the addition of new
vaccines into the immunization schedule.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA,
and Research Triangle Park, N.C., is one of the world's leading
research-based pharmaceutical and healthcare companies and is
committed to improving the quality of human life by enabling
people to do more, feel better and live longer.
Web site address:
www.GSKVaccines.com
* See complete prescribing information for indication.
Contact: Ramona DuBose
Phone: 919-483-2391
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