GlaxoSmithKline’s PEDIARIX now Available Nationwide
New Interactive Website Provides Parents With the
Immunization Tools They Need
RESEARCH TRIANGLE PARK, NC -- (INTERNET WIRE)
-- 01/09/2003 -- GlaxoSmithKline announced today that its
pediatric combination vaccine, PEDIARIX(TM) [Diphtheria and
Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B
(Recombinant) and Inactivated Poliovirus Vaccine Combined], is
now available. PEDIARIX, approved by the U.S. Food and Drug
Administration in December 2002, is the first U.S.-licensed
vaccine to offer protection against five serious diseases
simultaneously, reducing the total number of shots infants
receive by up to six. With more than four million births every
year in this country, the use of PEDIARIX could spare infants as
many as 24 million injections per year. The company also
launched
www.PEDIARIX.com, a website dedicated to providing parents
with information on childhood vaccines.
“GlaxoSmithKline is proud to be the first company in the
United States to offer a single vaccine that provides protection
against five serious childhood diseases,” said Barbara Howe,
M.D., vice president, Clinical Research and Development and
Medical Affairs, Vaccines North America, GlaxoSmithKline. “We
were encouraged by the excitement expressed by so many in the
medical community last month when PEDIARIX was approved. We
anticipate a successful launch as people begin to realize and
experience the advantages PEDIARIX offers.”
The current childhood immunization schedule calls for
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. By reducing the number of
shots, combination vaccines help facilitate the addition of new
immunizations into the crowded pediatric immunization schedule,
help reduce costs for parents and physicians and may reduce the
number of office visits.
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. These groups have stated that, 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.
Nine injections for the primary series are currently
recommended to protect infants against diphtheria, tetanus,
pertussis (whooping cough), hepatitis B and polio. The use of
PEDIARIX will require only three shots to achieve this
protection at 2, 4 and 6 months of age.* PEDIARIX has been
proven safe and effective in numerous clinical trials, where
20,739 doses of PEDIARIX were administered to 7,028 infants.
PEDIARIX.com: Helping Parents Make Sense of Immunizations
To help educate parents about the diseases their children
should be protected against and about the importance of
childhood vaccination, GlaxoSmithKline has launched a new
website,
www.PEDIARIX.com. This interactive educational website
provides parents with the tools they need to prepare for their
child’s healthcare professional visit, including an immunization
schedule, doctor’s office checklist, benefits of combination
vaccines, and a backgrounder on the diseases against which
childhood vaccinations protect. Healthcare professionals are
encouraged to direct parents to
www.PEDIARIX.com as a way to help eliminate parental anxiety
and confusion about immunizations.
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.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA and
Research Triangle Park, NC, 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.
For more information on PEDIARIX, please visit
www.PEDIARIX.com or call toll-free at 1-866-PEDIARIX
(1-866-733-4274).
* See complete prescribing information for
indication.
PED210R0
Contact: Ramona DuBose
Phone: 919-483-2839
|