New Five-in-One Vaccine for Infants and Children

By madeline_ellis


In the United States, thanks to years of immunization, the number of cases of formerly common childhood illnesses such as measles, polio and tetanus are now at their lowest levels in history. Vaccines are one of the most effective weapons we have against disease, and although not 100 percent, they do work in 85 to 99 percent of cases. It can be difficult to watch your children get a shot, but the short-term pain is nothing compared with the suffering they could encounter with a potentially deadly bout of measles, diphtheria, or pertussis (commonly known as whooping cough). The U.S. Centers for Disease Control and Prevention (CDC) currently recommend up to 23 single-entity injections by the time a child reaches 18 months of age, but the approval of a new 5-in-1 vaccine by the FDA could reduce that number of shots by as much as one-third.

Pentacel is a combination vaccine for immunization against diphtheria, tetanus, pertussis, polio and Haemophilus influenza type b (Hib). It contains no thimerosal, a controversial mercury-containing organic compound previously used in childhood vaccines as a preservative. Pentacel is approved for administration as a four-dose series at two, four, six and 15 to 18 months of age. However, the first dose may be given as early as six weeks of age. "The FDA approval of Pentacel vaccine is great news for parents and pediatricians who want to reduce the stress of well-baby visits," said Tina Q. Tan, M.D., infectious disease specialist at Children's Memorial Hospital in Chicago. "Pertussis disease continues to remain a threat to young infants, who are at the highest risk for severe complications and death. With a four-dose primary series of Pentacel vaccine, pediatricians can reduce the number of vaccination shots while providing protection against five diseases, including pertussis."

Approval of the vaccine was based upon the results of clinical studies conducted in the U.S. and Canada involving more than 5,000 children showing the vaccine to be safe and effective. The most common adverse reactions to Pentacel include injection site redness, swelling and tenderness; fever, fussiness and crying. However, the company does stress that some people may be allergic to parts of the Pentacel vaccine. The vaccine should not be given to infants who have had adverse reactions to prior tetanus or pertussis-containing vaccines.

Pentacel has been used in Canada since 1997, and is licensed in seven other countries. "We are pleased that the U.S. FDA has now taken this important step to make the convenience of Pentacel vaccine available to health-care providers and parents in the U.S.," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur, manufacturer of the vaccine. The company's U.S. operations in Swiftwater, Pennsylvania have long provided vaccines to prevent childhood diseases. In 1987, it licensed the first Hib conjugate vaccine, and in 1996 it was the first company to license a DTaP vaccine for use in infants. In 2005, Sanofi introduced Menactra'Of vaccine to protect against meningococcal disease, and Adacel vaccine as a booster dose for protection against tetanus, diphtheria and pertussis in both adults and adolescents 11 to 64 years of age.

Pentacel is expected to be available for distribution in the U.S. this summer.