Meningococcal Vaccines Archives-- Superseded Information -- HISTORICAL USE ONLY -- See Current Information --
March 29, 2011 -- The Bureau of Immunization is pleased to announce the release of the Vaccines for Children (VFC) Program Resolution No. 10/10-1, Vaccines to Prevent Meningococcal Disease. Resolution 06/09-2 is repealed and replaced by this new resolution. Resolution No. 10/10-1 was adopted and became effective at the Advisory Committee on Immunization Practices (ACIP) meeting held on October 27, 2010. The purpose of this resolution is to clarify eligible groups for meningococcal vaccination, update primary vaccination recommendations for high risk children, update recommendations regarding vaccination of adolescents and revaccination, and clarify use of conjugate versus polysaccharide meningococcal vaccines.
VFC resolutions passed by the ACIP form the basis for VFC Program policies on vaccine availability and usage. VFC Program vaccine must be administered according to the guidelines outlined by the ACIP in the VFC Program resolutions.
This document can be found on the Centers for Disease Control and Prevention (CDC) website at http://www.cdc.gov/vaccines/programs/vfc/downloads/
March 18, 2010 -- The Bureau of Immunization is pleased to bring to your attention two important articles published by the Centers for Disease Control and Prevention (CDC) on March 12, 2010, in the Morbidity and Mortality Weekly Report (MMWR Weekly / Vol. 59 / No. 9). These two articles, Licensure of a 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Recommendations for Use Among Children -- Advisory Committee on Immunization Practices (ACIP), 2010 (page 258) and Licensure of a Meningococcal Conjugate Vaccine (Menveo®) and Guidance for Use -- Advisory Committee on Immunization Practices (ACIP), 2010 (page 273), describe the recommendations and use of two important vaccines in the healthcare provider's disease prevention plan.
Please be sure to check for published updates and errata.
We encourage providers to read these recommendations and guidance carefully, since we include only excerpts here.
Licensure of a Meningococcal Conjugate Vaccine (Menveo®) and Guidance for Use -- Advisory Committee on Immunization Practices (ACIP), 2010
On February 19, 2010, the Food and Drug Administration (FDA) licensed a quadrivalent meningococcal conjugate vaccine, MenACWY-CRM (Menveo®, Novartis Vaccines and Diagnostics). MenACWY-CRM is licensed as a single dose for use among persons 11 through 55 years of age. The ACIP reviewed data from prelicensure clinical trials on the safety and immunogenicity of MenACWY-CRM. This report summarizes the approved indications for MenACWY-CRM and provides guidance from ACIP for its use. The following guidance for use of MenACWY-CRM is consistent with licensed indications and ACIP recommendations for meningococcal conjugate vaccines.
GUIDANCE FOR USE OF MenACWY-CRM: MenACWY-CRM is licensed by the FDA as a single dose in persons 11 through 55 years of age. The ACIP recommends quadrivalent meningococcal conjugate vaccine for all persons 11 through 18 years of age and for persons 2 through 55 years of age who are at increased risk for meningococcal disease.
Persons at increased risk for meningococcal disease include:
- College freshmen living in dormitories.
- Microbiologists who are exposed routinely to isolates of Neisseria meningitidis.
- Military recruits.
- Persons who travel to or reside in countries where meningococcal disease is hyperendemic or epidemic.
- Persons who have persistent complement component deficiencies.
- Persons with anatomic or functional asplenia.
MenACWY-CRM or MCV4 may be used in persons 11 through 55 years of age, and are preferred to quadrivalent meningococcal polysaccharide vaccine (MPSV4). Persons 2 through 10 years of age who are recommended to receive a meningococcal vaccine should receive MCV4, and persons more than 55 years of age should receive MPSV4. Meningococcal conjugate vaccine (Menactra® Sanofi-Pasteur) is licensed as a single dose for use among persons 2 through 55 years of age.
The Bureau will notify our partners once Menveo® is available for ordering through the Vaccines for Children Program.
February 8, 2008 -- The Vaccine Information Statement (VIS) for meningococcal conjugate vaccine (MCV) has been updated to incorporate the recent licensure of MCV for children 2 to 10 years of age, who are at increased risk from meningococcal disease. The new edition is dated January 28, 2008. Existing stocks of the last version can be used up, although the new version should be used when administering MCV to anyone in the 2 to 10 age group.
The new VIS is available at: www.cdc.gov/vaccines/pubs/vis/default.htm#mening.
See the complete list of available VISs on the CDC's VIS webpage: www.cdc.gov/vaccines/pubs/vis/default.htm.
Recommendation from the Advisory Committee on Immunization Practices Regarding Quadrivalent Meningococcal Conjugate Vaccine
December 7, 2007 -- The Bureau of Immunization is pleased to announce the release of the Centers for Disease Control and Prevention (CDC) notice, Recommendation from the Advisory Committee on Immunization Practices (ACIP) for Use of Quadrivalent Meningococcal Conjugate Vaccine (MCV4) in Children Aged 2--10 Years at Increased Risk for Invasive Meningococcal Disease, issued on December 7, 2007 in the Morbidity and Mortality Weekly Report (MMWR). On October 17, 2007, the Food and Drug Administration approved quadrivalent meningococcal conjugate vaccine (MCV4) (Menactra®, Sanofi Pasteur) for use in children 2 to 10 years of age, in addition to its prior approval for use in persons 11 to 55 years of age. This notice provides updated recommendations for meningococcal vaccination among children 2 to 10 years of age at increased risk for meningococcal disease. The recommendations were approved by the ACIP at its October 24, 2007 meeting. You may access the full recommendation at: www.cdc.gov/mmwr/preview/mmwrhtml/mm5648a4.htm?s_cid=mm5648a4_e.
The ACIP revised recommendation states that Menactra® is preferable to meningococcal polysaccharide vaccine, (MPSV4) (Menomune®, Sanofi Pasteur) for vaccination of children 2 to 10 years of age who are at increased risk for meningococcal disease. These children include travelers to or residents of countries in which meningococcal disease is hyperendemic or epidemic, children who have terminal complement component deficiencies, and children who have anatomic or functional asplenia.
Additionally, the conjugate product (Menactra®) is preferred to the polysaccharide product (Menomune®) for use among children 2 to 10 years of age, for control of meningococcal disease outbreaks. Recommendations for use of Menactra® in persons 11 to 55 years of age, including a recommendation for routine vaccination with MCV4 of persons 11 to 18 years of age, have been published previously and remain unchanged.
Revised Recommendations of the Advisory Committee on Immunization Practices Regarding Meningococcal Conjugate Vaccine
The Centers for Disease Control and Prevention (CDC) published the Revised Recommendations of the Advisory Committee on Immunization Practices (ACIP) to Vaccinate All Persons Aged 11--18 Years with Meningococcal Conjugate Vaccine on August 10, 2007 in the Morbidity and Mortality Weekly Report (MMWR) Series, Vol 56, #31. In June 2007, the ACIP revised its recommendation to include routine vaccination of all persons 11 to 18 years of age with one dose of meningococcal conjugate vaccine (MCV4) at the earliest opportunity. Persons 11 to 12 years of age should be routinely vaccinated at the 11 to 12 years healthcare visit, as recommended by the ACIP. The ACIP continues to recommend routine vaccination for persons 19 to 55 years of age who are at increased risk for meningococcal disease: college freshmen living in dormitories, microbiologists routinely exposed to isolates of Neisseria meningitidis, military recruits, travelers to or residents of countries in which Neisseria meningitidis is hyperendemic or epidemic, persons with terminal complement component deficiencies, and persons with anatomic or functional asplenia. The recommendation is available online at: www.cdc.gov/mmwr/preview/mmwrhtml/mm5631a3.htm.
The Bureau of Immunization is pleased to announce the release of the revised Meningococcal Vaccine Information Statement (VIS). Several additional cases of Guillain-BarrÃ© Syndrome (GBS) have been associated with meningococcal conjugate vaccine (see Morbidity and Mortality Weekly Report (MMWR) Update from October 2006). The VIS reflects the statement that "some" cases have been reported, rather than "a few" cases. The VIS has a new date (November 16, 2006), but existing stocks of the October 7, 2005 edition may be used up. No other changes were made. Once a VIS is available, it should be used effective immediately. The VIS can be viewed online at: www.cdc.gov/vaccines/pubs/vis/default.htm#mening. To access the VIS from the Immunization Action Coalition (IAC) VIS web section, go to: www.immunize.org/vis/vis_menin.asp.
Reminder - Vaccine Information Statements: A federal statute requires all healthcare providers who administer vaccines covered by the National Vaccine Injury Compensation Program (NVICP) to give patients or parents a copy of the relevant VIS. The VIS must be provided prior to vaccination. While the CDC develops VIS statements for all vaccines and encourages their use, it is a legal requirement that healthcare providers give patients or parents a VIS only if the vaccine is covered by the NVICP. Also, the name of the statute, the National Childhood Vaccine Injury Act (NCVIA), can be confusing because the statute is not focused just on children. A vaccine receives coverage when CDC recommends a particular vaccine for routine administration to children. However, once the vaccine is in the program, the NVICP covers injuries to anyone who receives it, child or adult. More information about VIS statements can be found on the CDC's website at www.cdc.gov/vaccines/pubs/vis/vis-facts.htm.
MMWR: Notice to Readers - Improved Supply of Meningococcal Conjugate Vaccine, Recommendation to Resume Vaccination of Children 11 to 12 Years of Age
At the request of the Centers for Disease Control and Prevention (CDC) and the National Immunization Program (NIP), please ensure that Morbidity and Mortality Weekly Report (MMWR): November 3, 2006/55(43);1177, regarding the supply of and recommendations for Meningococcal Conjugate Vaccine (MCV4), is shared with colleagues, members, coalitions, and partners with an interest in the administration of meningococcal vaccine.
In May 2006, the CDC, in consultation with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics, American Academy of Family Physicians, American College Health Association, and Society for Adolescent Medicine, recommended deferral of MCV4 vaccination of children 11 to 12 years of age in response to vaccine supply limitations. Currently, Sanofi Pasteur reports that limitations in the MCV4 supply have been resolved.
Therefore, the CDC recommends resuming routine vaccination of all recommended groups according to ACIP recommendations, including children 11 to 12 years of age and, if not previously vaccinated with MCV4, of adolescents at high school entry (at approximately 15 years of age), of college freshmen living in dormitories, and of other persons at increased risk for meningococcal disease. Where possible, providers who deferred vaccination of children 11 to 12 years of age should recall those patients for vaccination. This MMWR can be viewed online at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5543a5.htm.
Please note: The Bureau of Immunization will provide the MCV4 (Menactra™) to all Vaccines for Children Program-eligible adolescents 11 to 18 years of age. We will monitor usage in order to assure an adequate supply to all of the age groups.
On October 7th, 2005, the Centers for Disease Control and Prevention (CDC) National Immunization Program (NIP) issued the Meningococcal 10/7/05 Vaccine Information Statement (Interim). The interim Vaccine Information Statement (VIS) is revised to reflect Guillain-Barr Syndrome (GBS) risk. In light of reports of several cases of GBS following vaccination with meningococcal conjugate vaccine (Menactra®), the VIS has been revised to include information about the potential association between the vaccine and the disease.
The revised VIS should be used. To access the interim VIS (dated October 7, 2005) from the NIP website, go to:www.cdc.gov/vaccines/pubs/vis/#menin. Vaccine Information Statements (VISs) are information sheets produced by the CDC that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that VISs be handed out whenever (before each dose) certain vaccinations are given. For information about the use of VISs, and for VISs in a total of 33 languages, visit the NIP and Immunization Action Coalition (IAC) VIS web section at: www.immunize.org/vis/vis_menin.asp.
Please report all cases of GBS and other significant events following administration of MCV4 to the Vaccine Adverse Event Reporting System (VAERS) at www.vaers.hhs.gov or by phone (800) 822-7967. In addition, prior to submitting the report electronically, please fax a copy of the VAERS report to the Bureau of Immunization at: 850-922-4195.
Alert on Menactra® Meningococcal Vaccine and Guillain Barre Syndrome