Vaccine Information

Entry last updated: 09/22/2006

- Understanding the Disease
- Available Vaccines
- History of the Vaccine
- Who Should and Should Not Receive the Vaccine
- Dose Schedule
- Effectiveness of the Vaccine
- Known Side Effects
- Related Issues
- Key References and Sources of Additional Information
- State Vaccine Requirements
- Important Facts for Parents to Know
- Frequently Asked Questions
- CDC Vaccine Information Statement

Understanding the Disease

Neisseria meningitidis, or the meningococcus, is a bacterium that can cause a life-threatening infection of the bloodstream, meningitis (infection of the brain and spinal cord coverings), or both. Symptoms may include fever, stiff neck, sore throat, headache, muscle aches, joint pain and swelling, shock, and seizures. Complications—in 11-19% of survivors—may include deafness and other neurologic impairment, and impaired circulation leading to gangrene and amputation of limbs. Death occurs in 10% to 14% of people with meningococcal disease, and is highest in infants and adolescents.

There are approximately 2,600 cases of meningococcal meningitis in the U.S. each year, mostly in children less than five years old. Children younger than two years old have the highest incidence, with a second peak incidence between 15 to 24 years of age. Close contacts of a person with meningococcal disease have a higher rate of infection and are at greatest risk in the first week of contact. Depending on the type of exposure some of these persons may be given antibiotics to prevent infection. Studies report that first-year college students living in dormitories have a somewhat elevated risk for meningococcal disease when compared with other undergraduate students (See Related Issues).

Large outbreaks of the disease are rare in the United States, but not in some countries. It is recommended that travelers to certain areas, particularly sub-Saharan Africa during the dry season (December through June) and travelers to Mecca during Hajj receive the vaccine.

Available Vaccines

Product: Menomune® A/C/Y/W-135
(Meningococcal polysaccharide vaccine, Groups A, C, Y and
W-135 combination)
Manufacturer: Aventis Pasteur
Year licensed: 1981

Vaccine to be available soon:

Product: Menactra®
(Meningococcal polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine)
Manufacturer: Aventis Pasteur
Year licensed: 2005

MPSV4 is both available as single dose which is thimerosal preservative-free and is also available in 10 dose vials that contain 25 mcg of thimerosal/0.5 ml. MCV4 will be available as a single dose that is thimerosal preservative free. For information on the thimerosal content in this vaccine, see the Food and Drug Administration at www.fda.gov/cber/vaccine/thimerosal.htm#t3 or Johns Hopkins University's Institute for Vaccine Safety at
www.vaccinesafety.edu/thi-table.htm

History of the Vaccine

In the U.S., meningococcal disease is usually caused by groups A, B, C, Y, and W-135 of the meningococcus bacteria. In 1978, the first meningococcal vaccines were licensed in the United States and were effective against only two of the major groups of meningoccocus. Currently, licensed vaccines provide some protection against all groups except B; there is no licensed vaccine for group B in the U.S.

Originally, the vaccines were developed to control meningococcal disease in the armed forces. All U.S. military recruits are given meningococcal polysaccharide vaccine prior to induction.

In 2005, a new meningococcal conjugate vaccine, MCV4, was licensed for people 11-55 years of age. When it becomes available, it will likely be in short supply initially. As a consequence, recommendations for its use will evolve depending on vaccine availability.

Who Should and Should Not Receive this Vaccine

Who should receive these vaccines?

• MCV4 will be the preferred vaccine for individuals 11-55 years of age who are at increased risk for meningococcal disease. If MCV4 is unavailable, MPSV4 is an acceptable alternative for this age group.
• MPS4 is the only vaccine licensed for children 2 to10 years of age and for adults older than 55 years of age who are at risk for meningococcal disease.

Routine Vaccination of Adolescents

• MCV4 is recommended for children 11 - 12 years of age. 
• For the next 3 years, in order to more rapidly reduce disease among older adolescents, MCV4 is also recommended at high school entry (15 years old).

Other populations at increased risk for meningococcal disease should also receive the vaccine. Populations at increased risk include:

• Students living in close contact, such as in dormitories. Many colleges elect to target meningococcal immunization for all matriculating freshman. Vaccination ideally should precede entering school by two or more weeks. Other students wishing to reduce their risk of meningococcal disease can also choose to be vaccinated and vaccine should be made easily available to these students. Some colleges and some states now require college students to be vaccinated against the meningococcus. 
• U.S. military recruits
• Certain people who might be affected during a meningococcal disease outbreak 
• Travelers to certain parts of Africa and other locations where meningococcal disease is common 
• People with immune system disorders (e.g., spleen has been removed or damaged, disorder known as terminal complement component deficiency, or properdin deficiencies) 
• Laboratory personnel who are routinely exposed to the meningococcus 
• If at risk, MPSV4 can likely be safely given to pregnant women; there is no data for MCV4 given during pregnancy.

Who should not receive the meningococcal vaccines?

• People who had a serious reaction to a previous dose of the meningococcal vaccine. 
• Vaccination is contraindicated for people who are known to be hypersensitive to any component of the vaccine or latex. MCV4 should not be given to someone known to be hypersensitive to diphtheria toxoid. 
• It is not recommended that children less than 11 years of age routinely receive the meningococcal vaccine because the infection rate among children is low, their immunity may be short-lived, and if they receive the vaccine early, subsequent doses of the vaccine may not protect them as well. 
• People who are moderately or severely ill should consult with their physician before receiving any vaccine.

Dose Schedule

For children and adults 11-55 years of age, MCV4 will be administered as a single 0.5 ml dose intramuscularly. MPSV4 is administered 0.5 ml subcutaneously.

Revaccination with MCV4 should be considered for persons previously immunized with MPSV4, if they remain at increased risk for infection. If needed, children under 11 years of age may be revaccinated with MPSV4 in two to three years if they were first vaccinated before four years of age.

There is insufficient data available yet to guide recommendations on revaccination of persons who were previously vaccinated with MCV4.

MCV4 and MPSV4 may be administered concomitantly with other vaccines but at a different site of the body.

Effectiveness of the Vaccine

In older children and adults, the MPSV4 vaccine is 85% to 100% effective at preventing infection from the strains of the meningococcus used in the vaccine, and protection lasts for at least three years. Children under two years of age respond poorly to the vaccine.

Compared to MPSV4, MCV4 induces higher production of antibodies and protection is expected to last longer.

Neither MPSV4 or MCV4 would be expected to prevent serogroups B disease.

Known Side Effects

More than half of those immunized with MPSV4 experience no adverse reactions. Mild reactions are experienced by up to 40% of those immunized and include pain and redness at the site of injection. Also, recipients may develop a fever after immunization.

Local adverse reactions are more common among MCV4 recipients than among persons vaccinated with MPSV4.

In very rare cases (far less than 1 person out of 10,000 shots given), a more serious reaction to MPSV4, such as paresthesia (a burning, prickling, or sensation of numbness), or an allergic response that can cause difficulty breathing, can occur.

Adverse events, whether felt to be due to the vaccine or not, should be reported to the Vaccine Adverse Events Reporting System.

Related Issues

MPSV4 is to be administered subcutaneously whereas MCV4 is to be administered intramuscularly. More than 100 persons have inadvertently received the MCV4 vaccine by the subcutaneous route, however. For a subset of these individuals, CDC determined that—although the serologic responses were lower after MCV4 was administered SC compared to IM—the proportions of individuals who achieved antibody levels felt to be protective were similar. Therefore CDC did not recommend that those who had received MCV4 needed to be re-immunized (see MMWR report).

Five cases of Guillain-Barré Syndrome have been reported in recipients of MCV4 (See report on MMWR) but it is uncertain if they were causally related or coincidental.

Meningococcal outbreak control is discussed in detail in CDC publications.

Key References and Sources of Additional Information

• American Academy of Pediatrics, Committee on Infectious Diseases. (2003). Meningococcal infections. In LK Pickering (Ed.), Red Book: Report of the Committee on Infectious Diseases (26th ed., pp. 430-436). Elk Grove Village, IL: Author.
• American College Health Association. (2000). Recommendations on meningococcal vaccination from ACHA, CDC, and AAP. 
• Bruce MG, Rosenstein NE, Capparella JM, Shutt KA, Perkins BA, and Collins M. (2001). Risk factors for meningococcal disease in college students. JAMA, 286(6), 688-693.
• Centers for Disease Control and Prevention (CDC). (1997). Control and prevention of serogroup C meningococcal disease: Evaluation and management of suspected outbreaks: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report, 46(RR-5), 13-21.
• CDC. (2000). Meningococcal disease and college students: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report, 49(RR-7), 13-20.
• CDC. (2000). Meningococcal vaccine: What you need to know [Vaccine Information Statement (VIS)].
• CDC. (2000). Prevention and control of meningococcal disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report, 49(RR-7), 1-10. 
• Food and Drug Administration, Vaccine Adverse Event Reporting System Working Group. (2001). Safety data on the meningoccocal polysaccharide vaccine from the vaccine adverse event reporting system. Clinical Infectious Diseases, 32(9), 1273-1280.
• Harrison LH. (2000). Preventing meningococcal infections in college students. Clinical Infectious Diseases, 30(4), 648-651.
• Humiston SG and Good C. (2000). Vaccinating your child: Questions and answers for the concerned parent. Atlanta: Peachtree Publishers.
• Offit PA and Bell LM. (1999). Vaccines: What every parent should know (Rev. ed.). New York: IDG Books.
• Plotkin SA and Orenstein WA (Eds.). (2004). Vaccines (4th ed.). Philadelphia: W. B. Saunders.
• Wang VJ, Kupperman N, Malley R, Barnett ED, Meissner HC, Schmidt EV, and Fleisher GR. (2001). Meningoccocal disease among children who live in a large metropolitan area, 1981-1996. Clinical Infectious Diseases, 32(7),1004-1009.

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