FDA Approves GlaxoSmithKline's PEDIARIX(TM) First U.S. Combination Vaccine to Protect Infants Against Five Diseases
Monday December 16, 8:02 am ET
New Vaccine Results In Up To Six Fewer Injections For Infants
RESEARCH TRIANGLE PARK, N.C., Dec. 16 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK - News) announced today that its combination vaccine, PEDIARIX(TM)[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. |
