An acellular vaccine recently licensed by FDA protects infants against pertussis, or "whooping cough," while causing fewer side effects than whole-cell pertussis vaccines.
Acellular pertussis vaccines contain only parts of the pertussis bacterium thought to be important for immunity, while whole-cell vaccines contain the whole, killed bacterium.
Currently, children in the United States receive a whole-cell pertussis vaccine in combination with diphtheria-tetanus toxoid, or DTP, at 2, 4 and 6 months of age, with additional doses of either a DTP or DT vaccine with an acellular pertussis component (DTaP) between 12 and 18 months and before entering elementary school.
The acellular vaccine licensed July 31 for the first three doses is one of two DTaP vaccines already approved for the fourth and fifth doses.
Pertussis is a highly communicable respiratory disease that can be especially serious for infants. The coughing and choking that occur make breathing difficult and can last for several weeks. Occasionally, infants can die from the disease.
According to the national Centers for Disease Control and Prevention, in 1994 and 1995 a total of approximately 9,500 cases of pertussis were reported in the United States. The World Health Organization reports that pertussis causes approximately 350,000 deaths worldwide.
Safety data from a number of studies indicate that the DTaP vaccines cause fewer adverse reactions than DTP vaccines in the first three doses. Reactions can include local redness or swelling, as well as fever, drowsiness, irritability, or prolonged, high-pitched crying. Studies are in progress to help determine the extent of these reactions when children receive the acellular pertussis vaccine for all five doses. Infrequent, serious events such as seizures have been reported after immunizations with both DTP and DTaP.
Two clinical studies were conducted to assess the efficacy of the pertussis component of this DTaP vaccine for infants. In these studies, the acellular pertussis vaccine was estimated to be between 69 and 80 percent effective in preventing pertussis, depending on the way the study was designed and completed. (The whole-cell vaccine is about 80 percent effective.)
Children who have begun their immunizations with DTP should continue to receive their fourth and fifth doses as DTaP. For those children who will now receive DTaP at 2, 4 and 6 months, a fourth dose of DTaP is recommended in the second year of life. Studies are being planned to help determine recommendations for the fifth dose.
The acellular pertussis component of the vaccine is produced by the Research Foundation for Microbial Diseases of Osaka University in Japan. It is combined with diphtheria and tetanus toxoids by Connaught Laboratories, Inc., Swiftwater, Pa., and is sold under the trade name Tripedia.
(See also "New Pertussis Vaccine Offers Prevention Alternative," in the September 1992 FDA Consumer.)
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