New Vaccine to Help Infants

The combination vaccine, Pediarix™ [Diphtheria and TetanusToxoids and Accellular Pertussis Adsorbed, Hepatitis B(Recombinant) and Inactivated Poliovirus Vaccine Combined]recently received approval from the U.S. Food and DrugAdministration (FDA) to be given to infants at 2, 4 and 6 monthsof 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 diseasesin a three-dose vaccination series. This combination vaccineresults in up to six fewer injections for infants, which mayreduce infants’ pain and discomfort.

“The introduction of a combination vaccine like Pediarix™marks a milestone for the United States immunizationprogram,” said Joel Ward, M.D., director of the University ofCalifornia, Los Angeles (UCLA) Center for Vaccine Research,Research and Education Institute at Harbor-UCLA Medical Center andprincipal clinical trial investigator. “Combination vaccinesmake it easier to comply with the implementation of a complicatedimmunization schedule and reduce the number of injections andoffice visits compared with separately administeredvaccines.”

Currently, children receive approximately twenty injections inthe first two years of life with the development and introductionof new vaccines, that number will continue to increase. Nineinjections are presently recommended to protect more than fourmillion babies born in the United States each year againstdiphtheria, tetanus, pertussis (whooping cough), hepatitis B, andpolio. Pediarix™ protects against these diseases with only threeinjections in the primary series, which could result in as many as24 million fewer injections per year for infants in the UnitedStates.

“GlaxoSmithKline is proud to bring Pediarix™ to theUnited States,” said Barbara Howe, M.D., vice president,Clinical Research and Development and Medical Affairs, VaccinesNorth America, GlaxoSmithKline. “Pediarix™ is approved inmany other countries. We believe this combination vaccine will notonly help ease the United States immunization process for bothparents and healthcare professionals, but may also reduce parentanxiety and infant pain and discomfort associated with multipleinjections.”

Proven Immunogenicity and Established Safety

The development of combination vaccines includes trials that aredesigned to demonstrate safety and immunogenicity of thecombination vaccine as compared to the separate administration ofindividual U.S. licensed vaccines. Pediarix™ was proven safe andeffective in numerous clinical trials worldwide, where 20,739 doesof Pediarix™ were administered to 7,028 infants.

In clinical studies, adverse events in infants receivingPediarix™ included injection-site reactions (pain, redness orswelling), fever and fussiness. Administration of Pediarix ™wasassociated with higher rates of fever relative to separatelyadministered vaccines. Pediarix™ is contraindicated in infantswith known hypersensitivity to any component of the vaccineincluding yeast, neomycin and polynyxin-B. As with any vaccine,vaccination with Pediarix may not protect 100% of susceptibleindividuals.

Combination Vaccines

Vaccines have been heralded as one of the greatest public healthachievements of the 20th century because they have helped protectchildren and eradicate diseases. Life-threatening diseases, suchas polio which affected 20,000 people in the United States in theearly 1950’s alone, are nearly eradicated as a result ofwidespread vaccination. Today, infants may receive approximately20 injections in the first two years of life, which protect themagainst many serious diseases including diphtheria, tetanus,pertussis, mumps, rubella, polio, hepatitis B, Haemophilusinfluenza type b, and Streptoccoccus pneumoniae.

Combination vaccines, such as DTP, [diphtheria, tetanus andpertussis], 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 Academyof Family Physicians (AAFP) prefer the use of licensed combinationvaccines versus separate injections of their equivalent componentvaccines. This preference is based on the rationale that the useof combination vaccines is a practical way to overcome theconstraints of multiple injections. To minimize the number ofinjections children receive, parenteral combination vaccinesshould be used, if licensed and indicated for the patient’s age,instead of their equivalent component vaccines. Combinationvaccines also help reduce costs for parents and physicians, mayreduce the number of office visits and help facilitate theaddition of new vaccines into the immunization schedule.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, andResearch Triangle Park, N.C., is one of the world’s leadingresearch-based pharmaceutical and healthcare companies and iscommitted to improving the quality of human life by enablingpeople to do more, feel better and live longer. Their web addressis www.GSKVaccines.com.

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