New Drug Reviews
Tetravalent Meningococcal Conjugate Vaccine (Menactra) for the Prevention of Meningococcal Disease
Am Fam Physician. 2006 Nov 15;74(10):1771-1772.
Tetravalent meningococcal polysaccharide-protein conjugate vaccine (MCV4; Menactra) has joined the tetravalent meningococcal polysaccharide vaccine (MPSV4; Menomune) as the second vaccine labeled for the prevention of meningococcal disease caused by Neisseria meningitidis in persons 11 to 55 years of age. Like the older MPSV4, MCV4 is active against serotypes A, C, Y, and W-135 of the bacterium; it has no activity against serotype B. MCV4 should offer immunity longer than the three to five years provided by MPSV4.1
The Advisory Committee on Immunization Practices (ACIP) recommends that children 11 to 12 years of age, unvaccinated college freshman living in dormitories, military recruits, and other persons at high risk receive the MCV4 vaccine.2
|Name||Starting dosage||Dose form||Approximate monthly cost*|
Tetravalent meningococcal conjugate vaccine (Menactra)
0.5 mL once
*—Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2006.
In trials comparing MCV4 with the older MPSV4, serious adverse events were rare and occurred at approximately the same rates for both vaccines. These rates would normally be expected among healthy adolescent and adult populations.2 Several cases of Guillain-Barré syndrome have been reported in recipients of MCV4; however, data analysis suggests that the rate of Guillain-Barré syndrome, based on the number of cases reported within six weeks of MCV4 administration, is similar to that which would be expected to occur by chance.3 In its most recent update, the Centers for Disease Control and Prevention continues to recommend use of MCV4 in persons for whom it is indicated.4 MCV4 has not been tested for use during pregnancy; it is pregnancy category C.
MCV4 is well tolerated; most reactions are local and mild. Redness occurred in 11 to 14 percent of patients, swelling in 11 to 13 percent, induration in 16 to 17 percent, pain in 54 to 60 percent, and fever in 0.3 to 5.0 percent. These adverse effects occurred at rates similar to those with use of MPSV4.2
There are 1,400 to 2,800 cases of meningococcal disease annually in the United States, with a case-fatality ratio of 10 to 14 percent.2 Vaccination with MCV4 results in a protective rise in antibodies in 81 to 96 percent of persons 11 to 18 years of age, which is the main target group.2 Routine vaccination of U.S. adolescents is estimated to prevent 270 meningococcal cases and 36 deaths annually at a cost of $633,000 per case prevented and $121,000 per life year saved.5
Vaccination of all college freshmen who live in dormitories is calculated to prevent 16 to 30 meningococcal cases and one to three deaths yearly.2 The cost per case prevented is $617,000 to $1.85 million, and the cost per death prevented is $6.8 to $20.4 million.2
The cost for a 0.5-mL dose of MCV4 is $98. Many insurance plans cover this cost.
The vaccine is a single 0.5-mL dose administered intramuscularly into the deltoid muscle. It may be given along with other vaccines, although not at the same anatomic site. It is contraindicated in persons who are allergic to diphtheria toxoid or to latex (which is used as a bottle stopper), and in patients with previous Guillain-Barré syndrome.
MCV4 is as effective and as safe as the older MPSV4. It is recommended by the ACIP for children 11 to 12 years of age, college freshmen living in dormitories, and other high-risk populations. MCV4 should provide effective and longer-lasting immunity, but at significant expense to vaccinate the recommended target population.
1. Mitka M. New vaccine should ease meningitis fears. JAMA. 2005;293:1433–4.
2. Bilukha OO, Rosenstein N; for the National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC). Prevention and Control of Meningococcal Disease. Recommendations of the Advisory Committee on Immunization practices (ACIP). MMWR Recomm Rep 2005;54(RR-7):1–21. Accessed August 23, 2006, at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm.
3. CDC. Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine—United States, June–July 2005. MMWR Morb Mortal Wkly Rep 2005;54:1023–5. Accessed August 23, 2006, at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm54d1006a1.htm.
4. CDC. Update: Guillain-Barré Syndrome among recipients of Menactra meningococcal conjugate vaccine—United States, October 2005–February 2006. MMWR Morb Mortal Wkly Rep. 2006;55:364–6.
5. Shepard CW, Ortega–Sanchez IR, Scott RD II, Rosenstein NE. for the ABCs Team. Cost-effectiveness of conjugate meningococcal vaccination strategies in the United States. Pediatrics. 2005;115:1220–32.
STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.
The series coordinator for AFP is Allen F. Shaughnessy, Pharm. D., Tufts University Family Medicine Residency Program, Malden, Mass.
Copyright © 2006 by the American Academy of Family Physicians.
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