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No Routine MCV4 in 2- to 10-Year-Olds, ACIP Says


 

ATLANTA — Routine use of the conjugate meningococcal vaccine is not recommended for children aged 2–10 years, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention decided at its winter meeting.

Currently recommended for routine use in adolescents aged 11–18 years, the quadrivalent meningococcal conjugate vaccine (MCV4) (Sanofi Pasteur Inc.'s Menactra) was approved by the Food and Drug Administration for use in children aged 2–10 years on Oct. 17, 2007. Prior to that, it had been licensed for use in persons aged 11–55 years. Also in October, the ACIP recommended MCV4 instead of the old meningococcal polysaccharide vaccine (Sanofi Pasteur's Menomune) for children aged 2–10 years who are at high risk for meningococcal disease. These include travelers to or residents of countries in which meningococcal disease is hyperendemic or epidemic, children who have terminal complement component deficiencies, and children who have anatomic or functional asplenia (MMWR 2007;56:1265–6).

After considering data on the burden of disease, population impact, economic analysis, and other factors, an ACIP working group determined that routine vaccination against meningococcal disease in children aged 2–10 years should not be recommended at this time, other than for the children at high risk.

However, if providers or parents choose to vaccinate children in that age group, MCV4 is preferred over the polysaccharide vaccine. After hearing an outline of the rationale for this recommendation, the full committee voted unanimously (with one abstention) to support it.

Dr. Amanda Cohn of the CDC's National Center for Immunization and Respiratory Diseases' Division of Bacterial Diseases presented the working group's conclusions. Overall, the incidence of meningococcal disease is at a “historic low,” having decreased or remained stable each year for the last decade.

In the year 2006, the most recent for which data are available, the overall incidence in the population was 0.3/100,000, compared with 1.3/100,000 10 years earlier. “Being at this nadir did impact the working group's decision,” she said.

In most studies, young children have a low prevalence of Neisseria meningitidis carriage, compared with adolescents. While the current recommendation to give the vaccine to children aged 11–18 years is expected to protect them before they enter college, a time of high risk/incidence, giving the vaccine to 2-year-olds would be “catching the downslope.” Moreover, the proportion of disease caused by the serogroups contained in the vaccine—A, C, Y, and W-135—is just 59% in 2- to 10-year-olds, compared with 75% of the disease in adolescents.

An estimated 160 cases per year of meningococcal disease caused by serotypes A, C, Y, and W-135 occur among 2- to 10-year-olds, of which the majority (50%) are in children aged 2–4 years. Among 11- to 19-year-olds, approximately 250 cases occur annually, she said.

Cost-effectiveness analyses place the cost per quality-adjusted life-year (QALY) of giving MCV4 to all 2-year-olds at $160,000, compared with $90,000/QALY for the current adolescent immunization strategy, assuming the same duration of immunity. On top of that, there are currently no vaccines recommended to be given at the 2-year-old well-child visit, so such a recommendation would add programmatic concerns as well, Dr. Cohn pointed out.

Dr. Cohn suggested—and several panel members agreed—that it would be best to wait for the licensure of meningococcal vaccines for infants and/or toddlers, who have the highest meningococcal disease rates in the population (3.9/100,000). Several companies are working on this, and data thus far are positive (JAMA 2008;299:173–84).

Meanwhile, for those who still choose to immunize 2- to 10-year-olds, data do support the use of MCV4 rather than the polysaccharide vaccine (Pediatr. Infect. Dis. J. 2005;24:57–62).

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