Clinical Context

There are approximately 800 to 1200 cases of meningococcal disease per year in the United States, according to vaccine recommendations by Cohn and colleagues in the March 2013 issue of Morbidity and Mortality Weekly Report. This translates into a disease incidence of only 0.3 cases per 100,000 population. The risk for meningococcal disease has decreased during the past 15 years, and this decline predated the widespread use of the meningococcal vaccine. Nearly all cases of meningococcal disease are sporadic, but outbreaks still occur. Serogroups C, Y, and W Neisseria meningitidis account for 73% of infections among adolescents and adults, and these serogroups are included in available vaccines. However, serogroup B N meningitidis comprises approximately 60% of infections among children younger than 6 years, and serogroup B is not included in available meningococcal vaccines.

The quadrivalent meningococcal vaccine is currently recommended for children 11 or 12 years old, with a booster vaccine at age 16 years. The US Food and Drug Administration (FDA) recently approved the quadrivalent meningococcal vaccine for application among infants as young as age 2 months.

Study Synopsis and Perspective

The FDA has expanded the indication for the quadrivalent meningococcal vaccine (Menveo) to infants and toddlers from age 2 months, according to an August 2 announcement.

The vaccine protects against invasive disease caused by common N meningitidis serogroups A, C, Y, and W-135.

As previously reported by Medscape Medical News, the quadrivalent meningococcal vaccine has been available for use in adolescents and adults (ages 11 - 55 years) since February 2010 and in children (ages 2 - 10 years) since January 2011.

A Deadly Disease

"Each year, more children in the US die or are left with permanent disability from meningococcal disease than from 2 other diseases combined that we routinely vaccinate infants against — rotavirus and varicella," Steve Black, MD, from the Center for Global Health at University of Cincinnati Children's Hospital in Ohio, commented.

With the expanded indication, "we now have the opportunity to help protect our infants against 4 strains of meningococcal disease earlier, when they are most vulnerable," he said.

Studies show that infants younger than 7 months are the age group most vulnerable to meningococcal disease in the United States. In their first year of life, infants are more than 7 times more likely to contract the disease than 14- to 24-year-olds. Of the infants who contract the disease, more than 10% will die from it, and of those who do survive, roughly 1 in 5 will have permanent adverse effects.

The FDA's decision to expand use of the vaccine to infants from age 2 months was based on data from 3 randomized studies involving more than 8700 infants, conducted in Australia, Canada, Latin America, Taiwan, and the United States.

The quadrivalent meningococcal vaccine is currently registered in more than 50 countries for active immunization to prevent invasive meningococcal disease caused by N meningitidis serogroups A, C, W-135, and Y. (In the United States, no vaccine is approved to protect against meningitis serogroup B infection.)

More information on the expanded indication for the quadrivalent meningococcal vaccine is available on the FDA Web site.

Highlights

• A randomized trial of the quadrivalent meningococcal vaccine among infants demonstrated good immunogenicity after vaccination, particularly for meningococcal serotypes C, W-135, and Y.
• Another study of children between ages 2 and 10 years demonstrated noninferiority of the quadrivalent meningococcal vaccine compared with meningococcal polysaccharide-protein conjugate vaccine (Menactra) for meningococcal serotypes C, W-135, and Y.
• Syncope has been reported after administration of the quadrivalent meningococcal vaccine. Patients should be monitored for 15 minutes after the administration of the vaccine.
• 3 randomized trials have examined the safety of the quadrivalent meningococcal vaccine among infants, and 4 trials have evaluated the vaccine among children through age 10 years. Common adverse events associated with the quadrivalent meningococcal vaccine include tenderness at the injection site and irritability. The addition of this vaccine did not promote a substantial increase in the incidence of fever compared with routine vaccinations.
• Serious adverse events were reported at rates of 0.3% to 2.7% among infants receiving the quadrivalent meningococcal vaccine. It is unclear if this vaccine had a role in causing these events, which included wheezing, pneumonia, gastroenteritis, and convulsions.
• It does not appear that the quadrivalent meningococcal vaccine significantly decreases the efficacy of other routine vaccinations during concomitant administration.
• The safety of the quadrivalent meningococcal vaccine during pregnancy has not been established.

Clinical Implications

• A quadrivalent meningococcal vaccine was recently approved by the FDA for use among children as young as age 2 months.
• The dosing schedule for this vaccine among infants is a total of 4 injections provided at ages 2, 4, 6, and 12 months. In children beginning vaccination at ages 7 months through 23 months, the quadrivalent meningococcal vaccine is to be given in 2 doses; the second dose should be given in the second year of life and at least 3 months after the first dose. High-risk children younger than 5 years may receive a booster dose of the vaccine 2 months after the first dose. Adolescents age 11 years and older and adults up to age 55 years may receive a single dose of this vaccine.
• Syncope has been reported after administration of the quadrivalent meningococcal vaccine. Patients should be monitored for 15 minutes after administration of the vaccine.

CME Test