By IDSE News Staff
The FDA expanded the indication for the meningococcal conjugate (meningococcal ACWY; Menactra, Sanofi Pasteur) vaccine to include children 24 months to 10 years of age.
The FDA first approved meningococcal ACWY vaccine in 2005 for immunization of adolescents and adults between 11 and 55 years of age. Meningococcal ACWY vaccine offers protection against four of the five most common serogroups of bacteria that cause meningococcal infection, Neisseria meningitidis serogroups A, C, Y and W-135.
Clinical Studies
The FDA’s decision to license meningococcal ACWY vaccine for children as young as 24 months was based on safety and immunogenicity data from two large clinical studies. Both studies were randomized, multicenter, active-controlled, modified double-blind clinical studies of children 24 months through 10 years of age comparing the safety and immunogenicity of meningococcal ACWY vaccine with Sanofi Pasteur’s Menomune – A/C/Y/W-135, meningococcal polysaccharide vaccine, groups A, C, Y and W-135 combined. A third multicenter, open-label study of children 4 through 6 years of age evaluated the antibody memory response to the vaccine in those who had been vaccinated previously with meningococcal ACWY vaccine approximately two years earlier.
Data from the studies indicated that the vaccine was safe and immunogenic for children 24 months through 10 years of age. Immune responses were significantly greater for all four serogroups in those who received Menactra vaccine than those who received Menomune – A/C/Y/W-135 vaccine. Compared with Menomune – A/C/Y/W-135 vaccine, Menactra vaccine resulted in long-term persistence of bactericidal antibody, 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. In the studies, immediate reactions were uncommon and consisted primarily of local redness at or near the injection site. Reactions were reported, for the most part, as mild and of short duration. Solicited systemic reactions were similar among the study groups and described, for the most part, as mild, reversible and of short duration. The most common solicited complaints among children 2 through 10 years of age were injection site pain and irritability.
“We have been waiting for this expansion of use of Menactra to younger children, since they too are at risk and may benefit from the vaccine. Meningococcal disease is serious, and no healthy child should have to risk permanent disability, or even death, from this vaccine-preventable disease,” said Michael Pichichero, MD, a professor of microbiology/immunology, pediatrics and medicine, University of Rochester Medical Center, in New York.
About half of the cases in children 24 months through 5 years of age and two-thirds in those 6 through 11 years potentially could be prevented through vaccination, he added.
The most common local and systemic adverse reactions to Menactra vaccine include injection site pain, redness and induration, headache, fatigue, and malaise. Menactra vaccine is contraindicated in people with known hypersensitivity to any component of the product or to latex, which is used in the vial stopper. Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of Menactra vaccine. Those previously diagnosed with GBS should not receive the vaccine. See the package insert for more information.
Sanofi Pasteur said it would work closely with the CDC’s Advisory Committee on Immunization Practices regarding recommendations for children younger than 11 years of age, now that the indication has changed.
Meningococcal disease is a rare but serious bacterial infection that strikes between 1,400 and 2,800 Americans every year, causing meningitis or sepsis in the majority of cases.
Approximately 10% of individuals who contract meningococcal disease will die. Of those who survive, up to 1 in 5 suffer permanent disabilities such as hearing loss, neurologic damage and limb amputations. Meningococcal disease often begins with symptoms that can be mistaken for common viral illnesses, such as the flu. But unlike more common infections, meningococcal disease can progress rapidly and kill an otherwise healthy young person in 48 hours or less.
