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Pediarix vaccine now available nationwide, supported by new interactive website

RESEARCH TRIANGLE PARK, N.C., January 9, 2003 -- GlaxoSmithKline announced that its pediatric combination vaccine, Pediarix [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, 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.

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, 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 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.

Source: GlaxoSmithKline

Posted: January 2003