Sanofi pasteur, the vaccines business of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for protection against meningococcal disease in adolescents and adults aged 11-55 years.
Menactra vaccine is the first quadrivalent conjugate vaccine licensed in the U.S. for the prevention of meningococcal disease and is designed to offer protection against four serogroups of Neisseria meningitidis (A, C, Y, W-135), the bacterium that causes meningococcal infection.
The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has formed a working group that is updating the recommendations for the prevention and control of meningococcal disease, including routine meningococcal vaccination of one or more birth cohorts (e.g., 11-12 year olds) and of selected college students. The ACIP is expected to approve any changes in recommendations during the February 2005 committee meeting.
"Adolescents and young adults are at increased risk for contracting meningococcal disease. I'm very pleased that pediatricians and family physicians in the United States now have a new tool to reduce the number of cases among this age group," said Michael Pichichero, MD, professor of microbiology/immunology, pediatrics and medicine, University of Rochester Medical Center. "The FDA licensure of Menactra vaccine, if it is coupled with wide-spread meningococcal immunization, represents a significant step toward eradicating this devastating disease."
Although meningococcal disease rates are highest in infants, rates begin to rise again in early adolescence and peak between the ages of 15 and 24. During the 1990s, one study reported substantially increased incidence among 15- to 24-year-olds. In addition to the increased incidence, the fatality rate was over 22 percent in this age group, over five times that seen in younger persons. Up to 83 percent of the cases reported in this study were caused by the potentially vaccine-preventable serogroups that are included in Menactra vaccine.
"In 2001, members of the CDC's Active Bacterial Core Surveillance Team called upon the pharmaceutical industry to create a conjugate vaccine for protection against multiple serogroups of Neisseria meningitidis to combat the increased risk for disease in the adolescent population," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at sanofi pasteur, the human vaccines business of sanofi-aventis Group. "We are pleased to respond to their challenge with the licensure of Menactra vaccine. All evidence indicates that widespread use of Menactra vaccine will help to reduce invasive meningococcal disease in the United States, thereby preventing many deaths and anguish for thousands of families."
The FDA's decision to license Menactra vaccine was based on safety and immunogenicity data from six pivotal studies, which included more than 7,500 adolescents and adults receiving Menactra vaccine. Menactra vaccine induced the production of functional antibodies specific to the capsular polysaccharides of the four serogroups (A, C, Y and W-135) found in the vaccine. All vaccine immunogenicity measurements demonstrated strong immune responses to a single dose of Menactra vaccine that were equivalent to a single dose of sanofi pasteur's Menomune-A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined).
Additional findings demonstrated 98 to 100 percent of seronegative adolescents were found to elicit four-fold increases in antibody titers to all four meningococcal serogroups. In seronegative adults, this range was 91 to 100 percent.
There are risks associated with all vaccines. The most common adverse reactions to Menactra vaccine may include pain, redness, and induration at the site of injection, headache, fatigue and malaise. Menactra vaccine is contraindicated in persons with known hypersensitivity to any component of the vaccine or to latex, which is used in the vial stopper.