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FDA Approval of a Second Acellular Pertussis Vaccine for Use Among Infants and Young Children

JAMA. 1997;277(10):783. doi:10.1001/jama.1997.03540340017009.
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ON DECEMBER 30, 1996, the Food and Drug Administration (FDA) licensed Wyeth-Lederle Vaccines and Pediatrics to distribute a combined diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) (ACEL-IMUNE®*) for all five doses of the diphtheria, tetanus, and pertussis vaccination series administered to infants and children aged 6 weeks-6 years (before the seventh birthday). Since December 1991, ACEL-IMUNE® has been licensed for use as the fourth and fifth doses of the vaccination series among children aged 15 months-6 years who previously received three or four doses of diphtheria and tetanus toxoids combined with wholecell pertussis vaccine (DTP). ACEL-IMUNE® is the second acellular pertussis-containing vaccine to be licensed for use in infants in the United States.1

The Advisory Committee on Immunization Practices (ACIP); Committee on Infectious Diseases, American Academy of Pediatrics; and American Academy of Family Physicians recommend that children routinely receive a series


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