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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 Fourth Acellular Pertussis Vaccine for Use Among Infants and Young ChildrenOn July 29, 1998, the Food and Drug Administration (FDA) licensed North American Vaccine, Inc. (Beltsville, Maryland) to distribute a combined diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) (CertivaTM *) ** for the first four doses of the diphtheria and tetanus toxoids and pertussis vaccination series administered to infants and children aged 6 weeks-6 years. CertivaTM is the fourth acellular pertussis vaccine to be licensed for use in infants and young children in the United States (1). Vaccine doses should be administered at ages 2, 4, 6, and 15-20 months. Data are insufficient to evaluate the use of CertivaTM as a fifth dose among children aged 4-6 years who have received CertivaTM for the previous four doses. Additional information about the immunogenicity and safety of a fifth dose following four previous doses of the same acellular pertussis vaccine is being collected and should be available before these infants are aged 4-6 years and require a fifth dose. The Advisory Committee on Immunization Practices (ACIP), the Committee on Infectious Diseases, the American Academy of Pediatrics, and the 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 (1,2). 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 CertivaTM for the first four doses of the diphtheria, tetanus, and 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 received previously, any of the licensed DTaP vaccines may be used to complete the vaccination series (1). References
* Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed, CertivaTM, manufactured and distributed by North American Vaccine, Inc., Beltsville, Maryland. Marketed by Ross Products Division, Abbott Laboratories, Inc. The diphtheria and tetanus toxoid components are produced by the Statens Seruminstitut, Copenhagen, Denmark. Final formulation and release of CertivaTM are conducted by North American Vaccine, Inc. ** Use of trade names and commercial sources is for identification only and does not imply endorsement by CDC or 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: 11/10/98 |
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