Sanofi Pasteur Begins Shipping Adacel Vaccine in the U.S. for Combined Protection Against Tetanus, Diphtheria, and Pertussis

SWIFTWATER, Pa. and LYON, France -- Sanofi Pasteur, the vaccines business of the sanofi-aventis Group, announces the availability of Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Absorbed) in the US for protection against tetanus, diphtheria, and pertussis from adolescence through adulthood. Adacel vaccine is the first booster to address pertussis--or whooping cough--protection across a wide range of ages (11 through 64 years) and the first and only such booster licensed for adults in the U.S. It was licensed by the Food and Drug Administration (FDA) on June 10, 2005. It has been a licensed product in Canada and Germany.

Adacel vaccine should be administered as a single, 0.5 mL dose by intramuscular injection. It is sold in packages of 10 single-dose vials.

At its June meeting, the Advisory Committee on Immunization Practices (ACIP) to the Centers for Disease Control and Prevention (CDC) voted to recommend that adolescents 11 and 12 years of age be given a tetanus-diphtheria-pertussis booster (Tdap) in place of the tetanus-diphtheria (Td) booster currently given to adolescents. The committee also recommended that Tdap be given to adolescents 13 through 18 who missed the 11 to 12 year dose of Td, and adolescents 11 to 18 who have already been vaccinated with Td are encouraged to receive a dose of Tdap to further protect against pertussis. The ACIP received additional background information on adult Tdap immunization and will consider adult recommendations at its October meeting.

The number of reported cases of pertussis continues to rise across the United States, raising concern in the public health and medical communities. Pertussis immunity from early childhood vaccinations wears off, leaving adults and adolescents susceptible to the disease, which they can then transmit to others. At particular risk are newborns who have not yet been fully vaccinated against pertussis[1], are more vulnerable to severe pertussis, and face the possibility of serious complications and even death.

Over the last decade, 80 percent of pertussis deaths have occurred in infants under six months of age.[2]

Adults often are the source of pertussis for infants and young children. A 2004 study sponsored by the Centers for Disease Control and Prevention (CDC) reported that in cases where the source of the disease was identifiable, adults were responsible for over half of pertussis cases in infants, with parents the source for 47 per cent and grandparents for 8 percent of cases.[3] Healthcare workers are of special concern for acquiring and transmitting the disease because of their exposure to both infected and susceptible individuals.

Data from the CDC indicate that pertussis case reports for 2004 are the highest number since 1959. Reports of pertussis have increased most dramatically among adolescents and adults.[4]

Pertussis also has a financial impact on the family. One study found that the average medical costs for an infant with pertussis was more than $2,800, while parents lost an average of six days of work to care for an ill child. This loss of productivity cost families an average of $767.[5] Another study, published in 2004, found that the majority of adults missed an average of 9.8 days of work due to their disease, while adolescents missed an average of 5.5 days of school.[6]

References

[1] Centers for Disease Control and Prevention (CDC). Outbreaks of Pertussis Associated with Hospitals - Kentucky, Pennsylvania, and Oregon, 2003. MMWR. 2004;54(3):67-71.

[2] Vitek CR, Pascual FR, Baugham, AL, Murphy TV. Increase in deaths from pertussis from young infants in the United States in the 1990s, Pediar Infect Dis J. 2003:22:628:634-636.

[3] Bisgard KM, et al. Infant Pertussis: Who Was the Source? Pediar Infect Dis J.. 2004;23(11):985-989.

[4] CDC. Division of Bacterial and Mycotic Diseases. Pertussis Disease Information. Available at http://www.cdc.gov/incidod/dbmd/diseaseinfo/pertussis_t.htm. Accessed April 8, 2005.

[5] Lee HL, Pichichero ME. Costs of Illness Due to Bordetella Pertussis in Families. Arch Fam Med. 2000;9:989-996.

[6] Lee GM, et al. Societal Costs and Morbidity of Pertussis in Adolescents and Adults. Clin Infect Dis. 2004;39(11):1572-1580.

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