Vaccine TopicsPneumococcal VaccinesNew Information Resource Regarding Pneumococcal Vaccine Use in ChildrenJune 03, 2010 -- The Bureau of Immunization would like to direct your attention to a particularly timely and useful document developed by the Immunization Action Coalition (IAC). This document, directed towards a healthcare provider audience, is a concise “one-pager” presenting recommendations, schedules, and answers to questions concerning pneumococcal vaccine use in children. This document was promoted in a recent IAC Express (#870) as follows: Many healthcare providers have questions about the use of the new 13-valent pneumococcal conjugate vaccine (PCV13), especially when dealing with catch-up vaccination and children with medical conditions that are indications for both PCV and pneumococcal polysaccharide vaccine (PPSV23). To help answer such questions, the IAC has developed a new handout, Recommendations for Pneumococcal Vaccine Use in Children, that spells out the recommendations for every scenario. This new resource includes three tables. The first table provides the recommended PCV13 schedule based on the child's age and PCV7 and/or PCV13 vaccination history. The second table provides the recommended schedule for administering PPSV23 vaccine to children. The third table lists the underlying medical conditions that are indications for pneumococcal vaccination among children. The IAC's Handouts for Patients and Staff web section offers healthcare professionals and the public approximately 250 FREE English-language handouts (many also available in translation), which we encourage website users to print out, copy, and distribute widely.
Vaccine Information Statement NewsThe Bureau of Immunization is pleased to highlight the recent publication of the 13-valent pneumococcal conjugate vaccine (PCV13). Details can be found at www.cdc.gov/vaccines/pubs/vis/vis-news.htm. It may be used immediately, and is preferred over the previous PCV VIS. The new VIS is located at www.cdc.gov/vaccines/pubs/vis/default.htm#pcv. Many VIS are available in Spanish and other languages at www.immunize.org/vis. 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. Please contact my staff. Links to the latest vaccine information statements can be found at:
ACIP Recommendations for Pneumococcal Conjugate and Meningococcal VaccinesMarch 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 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Recommendations for Use Among Children — Advisory Committee on Immunization Practices (ACIP), 2010On February 24, 2010, a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13™, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.]) was licensed by the Food and Drug Administration (FDA) for prevention of invasive pneumococcal disease (IPD) caused by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes in the 7-valent pneumococcal conjugate vaccine formulation (PCV7 [Prevnar®, Wyeth]). PCV13 is approved for use among children 6 weeks to 71 months of age and succeeds PCV7, which was licensed by FDA in 2000. The Pneumococcal Vaccines Work Group of the ACIP reviewed available data on the immunogenicity, safety, and cost-effectiveness of PCV13, and on estimates of the vaccine-preventable pneumococcal disease burden. The working group then presented policy options for consideration of the full ACIP. This report summarizes recommendations approved by ACIP on February 24, 2010, for:
The CDC's guidance for vaccination providers regarding transition from PCV7 to the PCV13 immunization program also is included. PCV13 is available for ordering through the Vaccines for Children (VFC) Program on March 18, 2010. The VFC Program will provide program specific ordering information. Providers should return unused Prevnar® 7 remaining in their offices, after the receipt of Prevnar 13™, as quickly as possible. Each provider office will receive return labels from McKesson Customer Service for return of unused doses of Prevnar® 7. Once the provider office receives a shipment of Prevnar 13™, the remaining Prevnar® 7 doses should be boxed and returned to McKesson. These doses do not need to be shipped as viable vaccine. Only public-purchased doses should be returned to McKesson. Please direct any questions regarding ordering and returning of Prevnar® products to the VFC Program staff at (800) 483-2543. IMPORTANT: Wyeth Recalls 4 Lots of Privately Sold Prevnar® Pneumococcal 7-Valent Conjugate VaccineMarch 23, 2010 -- The Bureau of Immunization, as part of our commitment to our partners, brings to your attention the following Centers for Disease Control and Prevention (CDC) information distributed on March 23, 2010, regarding Wyeth's voluntary recall of 4 lots of privately sold Prevnar® pneumococcal 7-valent conjugate vaccine. This recall does not involve vaccines distributed through the Vaccines for Children (VFC) Program. During a routine physical inspection of Prevnar® pre-filled syringes, Wyeth determined that a potential exists for syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with Prevnar®. Wyeth performed a medical assessment and has concluded that the affected syringes present no health or safety risk to patients. Further, there would be no expected loss of potency and there is no need to revaccinate children who may have received a dose of Prevnar® from an affected syringe. There is no safety concern with the lots that are being recalled and therefore no need to revaccinate anyone who had been immunized with vaccines from these specific lot numbers:
These lots were distributed January 9 through March 3, 2010. If you have any product from the above lots, please remove it immediately from use. Contact Stericycle Inc. at 1-800-668-4391 and request a Return Kit from the Customer Service agent. Stericycle Inc. will subsequently send you a Return Kit with preprinted return address label(s), packing slip and instructions for returning the recalled product. You will receive credit for the returned merchandise. A copy of the letter Wyeth distributed to their customers is linked for your reference. New Vaccines to Prevent Invasive Pneumococcal and Meningococcal DiseasePrevnar 13™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:
PCV13 will replace PCV7.
Menveo®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:
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 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®. Vaccine Information Statement UpdatesOctober 12, 2009 -- The Bureau of Immunization is pleased to highlight recent updates to three Vaccine Information Statements (VIS): pneumococcal (PPSV), rabies, and zoster (shingles). Existing stocks may be used up, but be prepared to explain the changes to patients when appropriate. PPSV: The paragraph on pregnancy under section 5 has received a minor update. In the previous edition, the term "is not recommended" was used in a way that could be misinterpreted to mean "should never be given." In fact, while PPSV is not routinely recommended for pregnant women, it may be given under some circumstances. This VIS is available at www.cdc.gov/vaccines/pubs/vis/default.htm#ppv23. Rabies: This update incorporates the new 4-dose post-exposure regimen and makes minor updates throughout. This VIS is available at www.cdc.gov/vaccines/pubs/vis/default.htm#rabies. Zoster: This change removes active, untreated tuberculosis as a contraindication, which had been erroneously included in the previous editions. Several minor changes were also made. These involve changes in numbers (number of annual cases, age over which the disease is more common, and duration of rash) to make the VIS more consistent with other published materials. The edition date has not changed. This VIS is available at www.cdc.gov/vaccines/pubs/vis/default.htm#shingles. Healthcare providers should periodically access VISs electronically and print out a supply for routine distribution. If necessary, bureau staff can fax copies to providers without internet access. Please contact the bureau by calling 850-245-4342. For the latest information concerning VIS updates, visit the CDC's VIS News website. Many VIS forms are available in other languages. As new editions are translated, they are posted on the Immunization Action Coalition's website. Vaccine Information Statement (VIS) NewsApril 29, 2009 -- The Bureau of Immunization requests that all providers read the following information carefully regarding Vaccine Information Statement (VIS) updates and development, released April 16, 2009, by the Centers for Disease Control and Prevention (CDC). Updated Pneumococcal Polysaccharide (PPSV23) VIS: The PPSV VIS has been updated, mainly to reflect new indications for smokers and adults with asthma, but also to get a general facelift. 2009-2010 Influenza VIS under development: For 2009-2010, the CDC is proposing a single influenza VIS that will cover both trivalent inactivated influenza vaccine (TIV) and live attenuated influenza vaccine (LAIV ). It is being developed now, and will ideally be released at the same time as the 2009-2010 ACIP influenza recommendations. Given the frequency with which VIS forms are updated, the ease of access to them on the internet and through the Florida State Health Online Tracking System (SHOTS), the requirement for healthcare providers to use only the current version, and the fiscal/temporal impracticality of having a consistently up-to-date supply available for the state, the Bureau of Immunization will neither print nor store any vaccine information statements in the State Distribution Center. 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. By Federal law, all vaccine providers must give patients, their parents, and/or legal representatives the appropriate VIS whenever a vaccination is given. As needed, providers should supplement VIS forms orally, with videotapes, with additional printed material, or in any other way that will help recipients understand the disease and vaccine. Sufficient time should be allotted to review the VIS and discuss:
A contact number should be provided to the parent or guardian in the event there are questions or medical concerns. For the latest information concerning VIS updates, visit the CDC's VIS News website. Many VIS forms are available in other languages. As new editions are translated, they are posted on the Immunization Action Coalition's website. VFC Resolution No. 02/09-1: Vaccines to Prevent Pneumococcal DiseaseMarch 13, 2009 -- Resolution No. 02/09-1: Advisory Committee on Immunization Practices: Vaccines for Children Program Vaccines to Prevent Pneumococcal Disease. VFC Resolution 10/08-1 is repealed and replaced by Resolution No. 02/09-1, adopted and effective: February 25, 2009, the purpose of this resolution is to correct errors in the eligible groups and dose intervals for pneumococcal conjugate vaccine, and to streamline the resolution through the use of links to published documents. The document can be viewed online at www.cdc.gov/vaccines/programs/vfc/downloads/ To view other Resolutions, or request email notification of updates, visit www.cdc.gov/vaccines/programs/vfc/acip-vfc-resolutions.htm Pneumonia Hospitalizations Among Young Children After Introduction of Pneumococcal Conjugate Vaccine 1997--2006January 29, 2009 -- The Centers for Disease Control and Prevention (CDC) has released information regarding Pneumonia Hospitalizations Among Young Children After Introduction of Pneumococcal Conjugate Vaccine (United States 1997--2006). The report can be viewed online at www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a1.htm?s_cid=mm5801a1_e . The updated findings from national hospital discharge data suggest that previously observed reductions in all–cause pneumonia hospitalizations after routine pneumococcal conjugate vaccine (PCV7) use among U.S. children less than 2 years of age have been sustained. These results also confirm that pneumococcus is a major cause of childhood pneumonia and indicate the need for continued monitoring of the immunization program’s effects on pneumonia hospitalizations in children. Pneumonia accounts for an estimated 8% of all childhood hospital admissions. The bacteria, Streptococcus pneumoniae (pneumococcus) is a leading bacterial cause of childhood pneumonias. Routine childhood immunization with the PCV7 began in 2000, and substantial declines in hospital admissions for pneumonia in young children were previously reported through 2004. The CDC monitors the effects of PCV7 immunization on pneumonia hospitalizations using data from the Nationwide Inpatient Sample. This report provides an updated analysis through 2006. In 2006, the rate for all-cause pneumonia hospitalizations among children less than 2 years of age was 8.1 per 1,000 children, 35% lower than the rate before the introduction of PCV7 vaccine. This reduction represents an estimated 36,300 fewer annual pneumonia hospitalizations in 2006, compared with the average annual number of hospitalizations during 1997-1999. Updated Pneumococcal Conjugate Vaccine Information Statement-- SUPERSEDED INFORMATION -- HISTORICAL USE ONLY -- SEE UPDATED INFORMATION ABOVE -- December 11, 2008 -- The Centers for Disease Control and Prevention (CDC) published a new interim Vaccine Information Statement (VIS) for Pneumococcal Conjugate Vaccine (PCV). It incorporates recent updates in recommendations for healthy children 2 through 4 years of age, as well as miscellaneous minor changes. The previous VIS may still be used until stocks are depleted. By Federal law, all vaccine providers must give patients, their parents, and/or legal representatives the appropriate VIS whenever a vaccination is given. As needed, providers should supplement VIS forms orally, with videotapes, with additional printed material, or in any other way that will help recipients understand the disease and vaccine. Sufficient time should be allotted to review the VIS and discuss:
A contact number should be provided to the parent or guardian in the event there are questions or medical concerns. The new VIS is available at www.cdc.gov/vaccines/pubs/vis/default.htm#pcv7. For the latest information concerning VIS updates, visit the CDC's VIS News website. Many VIS forms are available in other languages. As new editions are translated, they are also posted on the Immunization Action Coalition's website. Percentage of Adults Aged > 65 Years Who Ever Received a Pneumococcal VaccinationJuly 30, 2008 -- The Florida Department of Health, Bureau of Immunization announces publication of the Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR);July 4, 2008 / Vol. 57 / No. 26/page 723 - QuickStats: Percentage of Adults Aged >65 Years Who Ever Received a Pneumococcal Vaccination. The report notes that in 2007, approximately 58% of adults older than 65 years of age had ever received a pneumococcal vaccination. In this population, statistically significant differences by sex, age group, and race/ethnicity were observed. Women were more likely than men to have ever received a pneumococcal vaccination. Adults older than 75 years of age were more likely to have ever received a pneumococcal vaccination, compared with adults 65 to 74 years of age. Non-Hispanic white adults older than 65 years of age were more likely than Hispanic and non-Hispanic black adults in that age group to have received the vaccination. The MMWR can be accessed on the web at www.cdc.gov/mmwr/preview/mmwrhtml/mm5726a4.htm?s_cid=mm5726a4_e. Updated Recommendation for Use of 7-Valent Pneumococcal Conjugate vaccine-- SUPERSEDED INFORMATION -- HISTORICAL USE ONLY -- SEE UPDATED INFORMATION ABOVE -- April 7, 2008 -- The Florida Department of Health, Bureau of Immunization announces publication of the Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 2008; volume 57, number 13 on April 4, 2008, concerning 7-valent pneumococcal conjugate vaccine (PCV7). The complete MMWR can be accessed on the web at www.cdc.gov/mmwr/preview/mmwrhtml/mm5713a4.htm This notice updates the recommendation for use of PCV7 vaccine among children 24 to 59 months of age, who are either unvaccinated or who have a lapse in PCV7 administration. The Advisory Committee on Immunization Practices (ACIP) Pneumococcal Vaccines Work Group reviewed data on PCV7, and on the basis of that review, the ACIP approved the following revised recommendation for use of PCV7 in children 24 to 59 months of age:
No changes were made to previously published recommendations regarding the use of PCV7 in children 24 to 59 months of age; the list of underlying medical or immunocompromising conditions; or the use of 23-valent pneumococcal polysaccharide vaccine in children over 2 years of age, who have previously received PCV7. The childhood immunization schedule is found at www.cdc.gov/vaccines/recs/schedules/default.htm
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