sanofi pasteur Seeks to Broaden Age Group for New Vaccine to Protect Against Meningococcal Disease

SWIFTWATER, Pa. -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group, is seeking U.S. government approval to broaden the age indication for its new meningococcal vaccine Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine). The company has filed a supplemental application with the U.S. Food and Drug Administration (FDA) to amend the vaccine's license to include children aged 2 through 10 years. The FDA licensed Menactra vaccine on Jan. 14, 2005 for use among 11 through 55 year olds.

Menactra vaccine is the world's first quadrivalent conjugate vaccine

licensed for the prevention of meningococcal disease and is designed to offer

protection against four serogroups of Neisseria meningitidis (A, C, Y, and

W-135), the bacterium that causes meningococcal infection.

"The additional age indication would help protect a younger segment of the

population against a serious and devastating disease," said Michael Decker,

MD, MPH, vice president of scientific and medical affairs at sanofi pasteur. "At

the same time, it has the potential benefit of increasing meningococcal

immunization rates because the 2-10 age group generally are seen by a

pediatrician on a regular basis for the recommended schedule of childhood

vaccinations."

Studies have demonstrated that serogroups C, Y and W-135 account for about

48 percent of meningococcal disease in 2 through 5 year-olds and 65 percent in 5 through 11 year-olds.

On Feb. 10, 2005, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommended immunization with Menactra vaccine for young adolescents at the pre-adolescent visit (11-12 year old), adolescents at high school entry (15-year-old) and college freshmen living in dormitories. The committee recognized the need to reduce the threat of this potentially fatal bacterial infection among segments of the population found to be at increased risk of infection

relative to the general population.

Immunization providers can order Menactra vaccine by visiting

http://www.vaccineshoppe.com or calling 1-800-VACCINE (1-800-822-2463).

The supplemental license application is based upon three clinical studies.

Two were randomized, multi-center, active-controlled, modified double-blind

clinical studies of children aged 2 through 10 years comparing the safety and

immunogenicity of Menactra vaccine to Menomune-A/C/Y/W-135 (Meningococcal

Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined), sanofi pasteur's

currently-licensed polysaccharide meningococcal vaccine. The third was a Phase

2, controlled, multi-center, open-label study of children aged 3 through 5

years who had been vaccinated previously with Menactra vaccine approximately

two years earlier. The objective of this study was to evaluate the antibody

memory response to the vaccine.

Overall, data presented in the studies demonstrated that for children aged

2 through 10 years Menactra vaccine is safe and immunogenic. In addition,

compared to Menomune vaccine, Menactra vaccine resulted in longer-term

persistence of bactericidal antibody, improved production of high avidity

antibody, and the establishment of immune memory. No clinically significant

adverse events were identified after a six-month controlled follow-up.

There are risks associated with all vaccines.  In the studies, the

immediate reactions were uncommon and consisted primarily of local redness at

or near the injection site. They were reported for the most part as mild

reactions and were reversible. Solicited systemic reactions were similar among

the study groups and were described for the most part as mild, reversible, and

of short duration. The most common complaints were irritability and

drowsiness. In general, the benefits of a successful conjugate vaccine include

longer-lasting immune responses and boostable memory responses.  Sanofi

pasteur is the sole supplier of Menactra vaccine.

Meningococcal disease is a rare but serious bacterial infection that

strikes between 1,500 and 3,400 Americans every year, causing meningitis or

sepsis in the majority of cases. Approximately 10 percent of individuals who

contract meningococcal disease will die.  Of those who survive, up to one in

five suffer permanent disabilities such as hearing loss, neurological damage

and limb amputations.  Meningococcal disease often begins with symptoms that

can be mistaken for common viral illnesses, such as the flu.  However, unlike

more common infections, meningococcal disease can progress very rapidly and

kill an otherwise healthy young person in 48 hours or less.

The sanofi-aventis Group is the world's third-largest pharmaceutical

company, ranking No. 1 in Europe.