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Persons using assistive technology might not be able to fully access information in this file. For assistance, please send e-mail to: mmwrq@cdc.gov. Type 508 Accommodation and the title of the report in the subject line of e-mail. Notice to Readers FDA Approval of a Second Acellular Pertussis Vaccine for Use Among Infants and Young ChildrenOn 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{Registered} *) ** 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{Registered} 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 whole-cell pertussis vaccine (DTP). ACEL-IMUNE{Registered} 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 of five doses of vaccine against diphtheria, tetanus, and pertussis before age 7 years (2-5). The first four doses should be administered at ages 2, 4, 6, and 15-18 months and the fifth dose at age 4-6 years. The following evidence supports the use of ACEL-IMUNE{Registered} for the diphtheria, tetanus, and pertussis vaccination series:
Because of the reduced frequency of adverse reactions and high efficacy, the ACIP recommends DTaP (either ACEL-IMUNE{Registered} or Tripedia{Registered} {Connaught Laboratories, Inc., Swiftwater, Pennsylvania}) for all doses of the routine diphtheria, tetanus, and pertussis vaccination series (1). DTaP also is recommended for all remaining doses in the schedule for children who have started the vaccination series with one, two, three, or four doses of DTP. During the transition period from use of whole-cell DTP to DTaP, vaccines containing a whole-cell pertussis component continue to be an acceptable alternative for all doses in the pertussis vaccination series. Whenever feasible, the same DTaP vaccine should be used throughout the entire vaccination series. No data exist on the safety, immunogenicity, or efficacy of different DTaP vaccines when administered interchangeably in the primary or booster vaccination of a child. However, if the vaccine provider does not know or have available the type of DTaP vaccine the child to be vaccinated had previously received, any of the licensed DTaP vaccines may be used to complete the vaccination series. ACIP is developing recommendations for use of DTaP among infants. References
* Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, ACEL-IMUNE{Registered}, manufactured by Lederle Laboratories and distributed by Wyeth-Lederle Vaccines and Pediatrics (Pearl River, New York). The acellular pertussis vaccine component is produced by Takeda Chemical Industries, Ltd. (Osaka, Japan), and is combined with diphtheria and tetanus toxoids manufactured by Lederle Laboratories. ** Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services. Disclaimer All MMWR HTML versions of articles are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the electronic PDF version and/or the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices. **Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.Page converted: 09/19/98 |
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