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.
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
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.
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
MMWR Morb Mortal Wkly Rep. 2011;60:1018-1019.