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FDA advisory panel recommends licensing of Adacel Vaccine for combined protection against tetanus, diphtheria and pertussis

SWIFTWATER, PA., March 15, 2005 -- Sanofi Pasteur announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA voted unanimously to recommend licensing of Adacel (tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) Vaccine for protection against tetanus, diphtheria and pertussis in adolescents and adults aged 11-64 years.

Adacelvaccine is the first booster to address pertussis protection across a wide range of ages including adolescents and adults. These age groups are at a growing risk of contracting and transmitting the disease.

The number of reported cases of pertussis -- commonly known as whooping cough -- continues to rise at a rate of great concern to the public health and medical communities. The U.S. Centers for Disease Control and Prevention (CDC) has received 19,000 case reports for 2004, a nearly 40 percent increase over 2003, and the highest number in four decades. Various studies indicate that the actual number of pertussis cases is many times greater than what is reported.

Approximately two-thirds of all cases occur in adolescents and adults. Although pertussis in adolescents and adults is often thought of as relatively mild, many in these age groups who contract the disease experience prolonged coughing, vomiting, missed school or work, and various complications. Due to similarities of symptoms, pertussis may initially be mistaken for other viral illnesses such as bronchitis, influenza, or even the common cold. In fact, it is within the first two weeks, often before a noticeable cough develops, when pertussis is most contagious.

Additionally, pertussis is easily transmitted to unimmunized or partially immunized infants and young children who are more vulnerable to serious pertussis-related complications or death. In effect, preventing pertussis in adolescents and adults could provide another means of preventing the spread of the disease, particularly to infants and young children.

lthough the FDA is not bound by the Advisory Committee's recommendation, the agency considers it carefully when deciding whether to license a vaccine for marketing. In making its recommendation, the FDA Advisory Committee reviewed the results of four principal clinical studies that included more than 7200 individuals who were evaluated for safety. The immunogenicity profile of Adacel vaccine was documented in a randomized subset of participants enrolled in the studies. Across the four trials, a total of 4,342 Adacel and Td vaccine recipients were evaluated for their immune responses to vaccination.

Adacel vaccine is currently licensed and marketed in Canada and Germany.

Source: Sanofi-Aventis

Posted: March 2005

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