New
Vaccine to Help Infants
The combination vaccine, Pediarix™ [Diphtheria and Tetanus
Toxoids and Accellular Pertussis Adsorbed, Hepatitis B
(Recombinant) and Inactivated Poliovirus Vaccine Combined]
recently 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 with the development and introduction
of new vaccines, that number will continue to increase. Nine
injections are presently recommended to protect 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 does
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. Pediarix™ is contraindicated in infants
with known hypersensitivity to any component of the vaccine
including yeast, neomycin and polynyxin-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, rubella, polio, hepatitis B, Haemophilus
influenza type b, and Streptoccoccus 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. Their web address
is www.GSKVaccines.com.
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