June 20, 2012 -- The Bureau of Immunization would like to share the following information about a newly licensed vaccine: GlaxoSmithKline (GSK) received approval from the Food and Drug Administration (FDA) on June 14, 2012 for the vaccine MenHibrix® [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine]. MenHibrix® is a vaccine indicated to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. MenHibrix® is approved for use in children 6 weeks through 18 months of age. The press release can be accessed at GSK's website. GSK will provide additional details when MenHibrix® will be available in the near future.
MenHibrix® was developed to align with the Centers for Disease Control and Prevention's (CDC) recommended infant immunization schedule for Hib vaccination to allow for vaccination against meningococcal groups C & Y without adding additional shots. The vaccination schedule for MenHibrix® is a 4-dose series given at 2, 4, 6, and 12 through 15 months of age. The first dose can be given as early as 6 weeks of age and the last as late as 18 months of age. Prescribing information is available.
The Bureau will notify providers when the Advisory Committee on Immunization Practices (ACIP) provides vaccine recommendations and when it will be available through the Vaccine for Children (VFC) Program. Notification will also be sent out when MenHibrix® has been added to the Florida SHOTS™ (Florida State Health Online Tracking System).
January 10, 2012 -- The Immunization Action Coalition (IAC) recently posted the updated Meningococcal Vaccine Information Statements (VIS) in Haitian Creole.
VIS 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 VIS be handed out when (before each dose) certain vaccinations are given. You are encouraged to distribute the up-to-date English-language version at the same time as you distribute the translation.
October 17, 2011 -- The Bureau of Immunization wishes to announce the availability of the updated (interim) Meningococcal Vaccine Information Statement (VIS). An updated (interim) VIS was posted on October 14, 2011. It incorporates changes in the routine schedule and indications, as well as in the precautions and adverse events sections. Mainly because of these latter changes, providers should begin using this updated (interim) VIS as soon as possible.
Vaccine Information Statements are information sheets produced by the Centers for Disease Control and Prevention (CDC) that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that VIS be handed out when (before each dose) certain vaccinations are given.
This updated VIS has been integrated into the Florida State Health Online Tracking System (SHOTS), so registry users can access them electronically.
Healthcare providers should periodically access the VIS electronically and print out a supply for routine distribution. If necessary, bureau staff can FAX copies to providers without internet access.
July 25, 2011 -- The Bureau of Immunization is pleased to announce the release of the Vaccines for Children (VFC) Program Resolution No. 6/11-1, Vaccines to Prevent Meningococcal Disease. Resolution 10/10-1 is repealed and replaced by this new resolution. Resolution No. 6/11-1 was adopted and became effective at the Advisory Committee on Immunization Practices (ACIP) meeting held on June 22, 2011. The purpose of this resolution is to update the eligible groups for meningococcal vaccination to include children 9 to 23 months of age at increased risk of meningococcal disease, to update the intervals for booster doses, and to add information about the meningococcal polysaccharide vaccine back into the VFC Program resolution.
VFC Program 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 resolutions.
Updated Recommendations for Use of Meningococcal Conjugate Vaccines — Advisory Committee on Immunization Practices (ACIP)
February 28, 2011 -- The Bureau of Immunization would like to provide the following updated recommendations for use of meningococcal conjugate vaccines as published in the Morbidity and Mortality Weekly Report, January 28, 2011 / 60(03);72-76.
This report summarizes two recommendations approved by the ACIP:
- Routine vaccination of adolescents, preferably at 11 or 12 years of age, with a booster dose at 16 years of age. Adolescents who receive the first dose at 13 through 15 years of age, a one-time booster dose should be administered, preferably at 16 through 18 years of age, before the peak in increased risk. Persons who receive their first dose of meningococcal conjugate vaccine at or after 16 years of age do not need a booster dose.
- A 2-dose primary series administered 2 months apart for persons 2 through 54 years of age with persistent complement component deficiency (e.g., C5-C9, properidin, factor H, or factor D) and functional or anatomic asplenia. A booster dose should be provided every 5 years, thereafter.
Teenagers who are 16 through 18 years of age should make sure they get either a booster dose or their first dose of meningococcal conjugate vaccine to protect against meningococcal disease. Meningococcal conjugate vaccines were licensed in 2005 based on immunogenicity (because a surrogate of protection had been defined) and safety data. After licensure, additional data on bactericidal antibody persistence, trends in meningococcal disease epidemiology in the U.S, and vaccine effectiveness have indicated many adolescents might not be protected for more than 5 years. Therefore, persons immunized at 11 or 12 years of age may have decreased protective immunity by 16 through 21 years of age, when their risk for disease is greatest.
The report discusses the rationale for the updated recommendations, revisits the current recommendations, and offers some guidance from the Centers for Disease Control and Prevention (CDC) for the transition to the adolescent dose.
These updated meningococcal conjugate vaccine recommendations from the ACIP have been summarized (see table 2 of the recommendation). The document is available at www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a3.htm?s_cid=mm6003a3_e. Details regarding the routine meningococcal conjugate vaccination schedule are available at www.cdc.gov/vaccines/recs/schedules/. Adverse events after receipt of any vaccine should be reported to the Vaccine Adverse Event Reporting System at vaers.hhs.gov.
March 9, 2010 -- Wyeth received Food and Drug Administration (FDA) approval for a 13-valent pneumococcal conjugate vaccine (PCV13) known as Prevnar 13™. Additionally, on February 24, the CDC's Advisory Committee on Immunization Practices (ACIP) voted to recommend replacing the 7-valent pneumococcal conjugate vaccine (PCV7) with PCV13. Indications include the following:
- For use in children 6 weeks through 59 months of age.
- For use in children 60 through 71 months of age who have underlying medical conditions that increase their risk of pneumococcal disease or complications.
- Children 6 through 18 years of age who are at increased risk for invasive pneumococcal disease because of sickle cell disease, HIV-infection or other immunocompromising conditions, cochlear implant or cerebrospinal fluid leaks.
- For active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
The 13-valent Pneumococcal Conjugate vaccine (PCV13) will replace the 7-valent Pneumococcal Conjugate Vaccine (PCV7).
- The ACIP Provisional Recommendations for Use of 13-Valent Pneumococcal Conjugate Vaccine (PCV 13) Among Infants and Children were published March 3, 2010. The Provisional Recommendations detail the routine schedule for unimmunized infants and children, a catch-up schedule as well as the recommended PCV13 doses for children who received 4 doses of PCV7.
- The prescribing information can be accessed at the following website: www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/
- The FDA approval letter can be viewed at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm.
March 9, 2010 -- Novartis received FDA approval of Menveo® (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). Indications include the following:
- For use in individuals 11 through 55 years of age.
- For active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.
The prescribing information can be accessed at the following web site: www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/
The FDA approval letter can be viewed at: www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201343.htm.
The vaccine is not presently available for private-provider purchase or through the Florida Vaccines for Children (VFC) Program. Availability is anticipated early to mid April. The Bureau of Immunization will notify providers when the vaccine is available.
Florida SHOTS™ is incorporating the necessary updates to accommodate the vaccines.
Please note: The Bureau of Immunization will keep providers updated as to the availability of both vaccines, the ACIP recommendations and the Vaccine Information Statements (VIS). The ACIP recommendations do not become official until approved by the CDC Director, Department of Health and Human Services and publication in the Morbidity and Mortality Weekly Report (MMWR). Additionally, the Red Book Online, Vaccine Status Table has been updated to include both Prevnar 13™ and Menveo®.
Report from the Advisory Committee on Immunization Practices: Decision Not to Recommend Routine Vaccination of All Children 2 to 10 Years of Age with Quadrivalent Meningococcal Conjugate Vaccine
At its February 2008 meeting, the Advisory Committee on Immunization Practices (ACIP) decided not to recommend routine vaccination of children 2 to 10 years of age against meningococcal disease, unless the child is at increased risk for the disease. This report summarizes the deliberations of the ACIP and the rationale for its decision, and restates existing recommendations for meningococcal vaccination among children 2 to 10 years of age at increased risk for meningococcal disease. The ACIP continues to recommend routine vaccination against meningococcal disease for all persons 11 to 18 years of age and those persons 2 to 55 years who are at increased risk for meningococcal disease.
The Morbidity and Mortality Weekly Report; volume 57, number 12, released on May 2, 2008, can be accessed at: www.cdc.gov/mmwr/preview/mmwrhtml/mm5717a4.htm.
October 18, 2007 -- On October 18, the Food and Drug Administration (FDA) issued a press release announcing that it approved the use of Menactra® bacterial meningitis vaccine (Sanofi Pasteur) to include children 2 to 10 years of age. Previously, the vaccine was licensed for use in persons 11 to 55 years of age. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) currently recommends meningococcal vaccination for children 2 to 10 years of age who are at increased risk of developing meningococcal disease, such as those who have had their spleen removed or whose spleen is not functioning; those with a medical condition called terminal complement component deficiency, which makes it difficult to fight infection; and those who expect to travel to areas outside of the U.S. where the disease is common. Vaccination also is used to control outbreaks of bacterial meningitis.
Please Note: While the CDC recommends provision of Menactra® to at-risk children 2 to 10 years of age, the CDC continues to recommend routine immunization with Menactra® to persons 11 to 18 years of age.