Friday, August 12, 2011

ACIP Updates Guidelines for Meningococcal Conjugate Vaccine

From Medscape Medical News

Laurie Barclay, MD

August 5, 2011 — An Advisory Committee on Immunization Practices (ACIP) report in the August 5 issue of the Morbidity and Mortality Weekly Report reviews data underlying the extended age indication for quadrivalent meningococcal conjugate vaccine and the interchangeability of both licensed meningococcal vaccines. The report describes licensure of a meningococcal conjugate vaccine for children aged 2 through 10 years and updated booster dose guidance for adolescents as well as for other persons at greater risk for meningococcal disease.

As previously reported by Medscape in January 2011, the US Food and Drug Administration (FDA) approved an extended, lower age range for the quadrivalent meningococcal conjugate vaccine MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics) to include persons 2 through 55 years of age. The FDA first approved MenACWY-CRM in February 2010 for the prevention of invasive disease caused by Neisseria meningitides serogroups A, C, Y, and W-135 in persons 11 to 55 years of age.
The other FDA-approved quadrivalent meningococcal conjugate vaccine is MenACWY-D (Menactra, Sanofi Pasteur). Like MenACWY-CRM, MenACWY-D is intended to prevent meningococcal disease caused by serogroups A, C, Y, and W-135 among people 2 through 55 years of age.
In addition, MenACWY-D is FDA-approved as a 2-dose series for children 9 months through 23 months of age.
"The [ACIP] recommends that persons aged 2 through 55 years at increased risk for meningococcal disease and all adolescents aged 11 through 18 years be immunized with meningococcal conjugate vaccine," the report states. "
ACIP further recommended, in January 2011, that all adolescents receive a booster dose of quadrivalent meningococcal conjugate vaccine at age 16 years. This report summarizes data supporting the extended age indication for MenACWY-CRM and the interchangeability of the two licensed meningococcal conjugate vaccines."
A multicenter, randomized, controlled trial assessed the safety and immunogenicity of MenACWY-CRM in children 2 through 10 years of age. Seroresponses to groups C, Y, and W-135 after a single MenACWY-CRM dose in children aged 2 through 5 years and 6 through 10 years were noninferior to responses after a single MenACWY-D dose, measured using a human complement serum bactericidal assay (hSBA) . The proportions of children aged 2 through 10 years with hSBA titers 8 or higher after receiving MenACWY-CRM and MenACWY-D were, respectively, 75% and 80% for serogroup A, 72% and 68% for serogroup C, 90% and 79% for serogroup W-135, and 77% and 60% for serogroup Y.
In that trial, headache and irritability were the most common systemic adverse effects with MenACWY-CRM, and rates of adverse effects were similar to those seen after MenACWY-D vaccination. Pain was the most common injection-site reaction, reported within 7 days after vaccination; erythema and induration were also frequently reported. Less than 1% of persons receiving MenACWY-CRM had serious adverse events, and the vaccine was not thought to be responsible for any of these.
The ACIP now recommends that either meningococcal conjugate vaccine can be used in children 2 through 10 years of age who are at increased risk for meningococcal disease. This recommendation supersedes the previous recommendation that children in this age group should receive only MenACWY-D when meningococcal vaccination is indicated. Either meningococcal conjugate vaccine is preferred over quadrivalent meningococcal polysaccharide vaccine.
Children with terminal complement deficiencies or anatomic or functional asplenia should receive a 2-dose primary series, whereas children with increased risk for disease because they are travelers to or residents of countries in which meningococcal disease is hyperendemic or epidemic should receive a single primary dose.
In January 2011, ACIP recommended that adolescents given a previous dose of meningococcal conjugate vaccine before 16 years of age should be given a single booster dose. ACIP now also recommends a booster dose for persons 2 through 55 years of age who continue to be at increased risk for meningococcal disease, including laboratory workers who work with N. meningitides.
Either meningococcal conjugate vaccine is suitable for revaccination, based on a postlicensure study assessing persistence of hSBA antibodies and the safety and immunogenicity of MenACWY-CRM vaccination 3 years after receipt of a single dose of MenACWY-CRM or MenACWY-D. For all serogroups, the percentage of participants with hSBA titers 8 or higher was similar at 36 months after receipt of a single dose of MenACWY-CRM or MenACWY-D at ages 11 through 18 years. After receiving the booster dose of MenACWY-CRM, more than 99% of persons previously given MenACWY-CRM or MenACWY-D had hSBA titers 8 or higher.
Rates of injection-site reactions and systemic adverse events reported after revaccination were similar to those rates reported after the first vaccination. There are currently no available data on the safety or immunogenicity of booster vaccination with MenACWY-D after primary vaccination with MenACWY-CRM.
"Health-care providers should use every opportunity to provide the booster dose when indicated, regardless of the vaccine brand used for the previous dose or doses," the report authors conclude.
MMWR Morb Mortal Wkly Rep. 2011;60:1018-1019. Full text.

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