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From the Department of State Health Services Immunization Branch
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January 13, 2012
Broadened Recommendations for Meningococcal Conjugate Vaccine (MCV4) for Certain Children
The goal of the Vaccine Advisory is to disseminate, in a timely manner, practical information related to vaccines, vaccine-preventable diseases, and the vaccine programs managed by the Immunization Branch. The Immunization Branch welcomes readers’ input to improve the contents of this document.
To view past issues, go to: www.dshs.state.tx.us/immunize/vacadvise/
At its June 2011 meeting, the Advisory Committee on Immunization Practices (ACIP) voted to recommend that specific groups of children ages 9 through 23 months at increased risk for meningococcal disease receive a 2 dose series of quadrivalent meningococcal conjugate vaccine (MCV4) MenACWY-D (Menactra®, sanofi pasteur).
This advisory summarizes the new recommendation published in the October 14, 2011 issue of the Morbidity and Mortality Weekly Report (MMWR). To read the full report, visit http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6040a4.htm?s_cid=mm6040a4_e%0d%0a.
This advisory contains:
- Background information
- Summary of ACIP‘s recommendations for meningococcal vaccine
- Texas Vaccines for Children program (TVFC)
- Texas school and child-care facilities requirements for meningococcal vaccine
- Epidemiology and surveillance
- Reporting vaccine adverse events
1) Background Information
There are currently two licensed quadrivalent meningococcal vaccine (MCV4) products; MenACWY-D (Menactra®, sanofi pasteur) and MenACWY-CRM (Menveo®, Novartis Vaccines and Diagnostics, Inc.).
In April 2011, the Food and Drug Administration (FDA) expanded Menactra® meningococcal vaccine licensure to include infants and toddlers 9 through 23 months of age. Menactra® was already approved for use in persons 2 through 55 years of age. The other MCV4 product, Menveo®, is licensed for use in persons 2 through 55 years of age and has not been FDA-approved for children younger than age 2.
Both vaccines protect against invasive meningococcal disease caused by Neisseria meningitides serotypes A, C, Y and W-135.
The ACIP Meningococcal Vaccine Workgroup reviewed data from clinical studies on the safety and immunogenicity of MenACWY-D in healthy children 9 through 23 months of age at its June 2011 meeting. After review of these clinical data, ACIP recommended that children 9 through 23 months of age with certain risk factors for meningococcal disease receive a 2-dose series of MenACWY-D taken 3 months apart.
2) Summary of New ACIP Recommendations
The ACIP recommends a two-dose series of Menactra® for infants 9 through 23 months of age, 3 months apart, who have the following risk factors for meningococcal disease:
- Children needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.
- Children with complement component deficiencies such as C5-9, properidin, factor H, and factor D deficiencies.
- Children in a defined risk group during a community or institutional meningococcal outbreak.
A two-dose series is required for any child whose first dose was received prior to their second birthday. Those who remain at risk for meningococcal disease should receive a booster dose 3 years after the primary series.
Recommendations for use of Menactra®, among persons 2 through 55 years of age have been published previously and remain the same.
3) Texas Vaccines for Children program (TVFC)
Eligible groups for meningococcal vaccine include:
- Children age 9 months through 10 years who are at increased risk for meningococcal disease, including:
- children who have complement deficiencies (e.g., C5-C9, properidin, factor H, or factor D);
- children with HIV infection;
- travelers to or residents of countries in which meningococcal disease is hyperendemic or epidemic;
- children who are part of an outbreak of a vaccine-preventable serogroup.
- Children age 2 through 10 years who have anatomic or functional asplenia.
- All children age 11 through 18 years.
ImmTrac users can report quadrivalent (serogroups A, C, Y & W-135 (tetravalent) meningococcal conjugate vaccines using CPT code 90734 and brand names Menactra® or Menveo®.
For more information about ImmTrac, please refer to: www.ImmTrac.com.
5) Texas school and child-care facilities requirement for meningococcal vaccine
In August 2009, Texas adopted a new meningococcal vaccine requirement. All students entering 7th grade are required to have a dose of meningococcal vaccine. This requirement is being phased in by grades through school year 2014-2015. Click on the following link to view the phase-in schedule: 2009-10 Immunization Requirements Phase-In Schedule (Rev. 12/2010).
In addition, as of January 1, 2012, all first-time college students, transfer students, or returning students enrolling in public or private or independent institutions of higher education must show evidence of vaccination against bacterial meningitis within the last 5 years. The meningococcal vaccine must be received at least 10 days before classes begin (State of Texas law SB 1107).
6) Epidemiology and surveillance
Meningococcal disease is a potentially life threatening illness caused by the bacterium Neisseria meningitidis. The case fatality rate of invasive meningococcal disease is 9-12% even with appropriate antibiotic therapy. Of the survivors, 10-20% suffer from serious sequelae such as neurologic damage, hearing loss or loss of limbs. Meningitis (meningococcal meningitis) and septicemia (meningococcemia) are the most common presentations of meningococcal disease. Less common presentations can include pneumonia, conjunctivitis, septic arthritis, and pericarditis.
There are five serogroups of N. meningitidis responsible for almost all invasive cases: A, B, C, Y and W-135 Four of the five serogroups can be prevented with vaccination. The first meningococcal polysaccharide vaccine was licensed in the United States in 1974. The first meningococcal conjugate vaccine was licensed in the United States in 2005. The current polysaccharide and conjugate meningococcal vaccines cover serogroups A, C, Y and W-135. No vaccine is available in the United States for serogroup B.
Invasive meningococcal disease is a reportable condition in Texas. An average of 57 cases of invasive meningococcal disease were reported in Texas annually (range 45 to 70) from 2005-2010.
7) Reporting Vaccine Adverse Events
An adverse event is a health problem that is reported after someone gets a vaccine or medicine.
Adverse events from privately purchased vaccine should be reported directly to VAERS at http://vaers.hhs.gov/. Secure web-based reporting is available on the VAERS website. You may also contact VAERS at (800) 822-7967 for forms and information.
In Texas, reports of adverse events following vaccination at public health clinics or with vaccine provided through public funding such as the Texas Vaccines for Children (TVFC) program should be reported through the Texas Department of State Health Services, Immunization Branch via fax or mail.
- Fax a completed VAERS Form to: (866) 624-0180 (toll-free)
- Mail a completed VAERS form to DSHS, Immunization Branch, MC-1946, P.O. Box 149347, Austin, TX 78714-9347
A copy of the form is also available in the TVFC Toolkit. For more information about VAERS or for a pre-addressed postage-paid VAERS form, you can contact DSHS at (800) 252-9152.
We hope you generously forward this advisory to others who may benefit from this information.
Texas Department of State Health Services Immunization Branch (MC-1946)
P.O. Box 149347, Austin, Texas 78714-9347. (512) 458-7284 or (800) 252-9152
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