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August 21, 1996

Acellular Pertussis Vaccine is Licensed for Infants

JAMA. 1996;276(7):516-518. doi:10.1001/jama.1996.03540070012006

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AFTER 15 YEARS of development and extensive field trials in Europe and the United States, the Food and Drug Administration (FDA) has licensed an acellular pertussis vaccine for use in the primary diphtheria-tetanus-pertussis (DTP) immunization series at age 2, 4, and 6 months, when most serious complications of the disease occur.

The new licensure does not require a new product to be manufactured. The acellular version has been licensed since 1992 for use in the fourth and fifth doses of DTP given to children up to 6 years of age. The vaccine, manufactured by Connaught Laboratories, Inc, Swiftwater, Pa, is available now to physicians for use in their pediatric practices. Marketed under the trade name Tripedia, the vaccine contains 2 antigens: pertussis toxin and filamentous hemagglutinin.

Acellular vaccines were originally developed in Japan. The principle was further developed by several US manufacturers, including Connaught, in response to concerns over adverse