Pneumococcal Vaccines
Immunization Update -- Pneumococcal Conjugate Vaccine
April 10, 2012 -- The Bureau of Immunization would like to review the recommendations for the pneumococcal conjugate vaccine as detailed in the Recommended Immunization Schedule for Persons Aged 0 through 6 years—United States, 2012 and the Prevention of Pneumococcal Disease Among Infants and Children --- Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine; Morbidity and Mortality Weekly Report (MMRW); Recommendations and Reports; December 10, 2012 / 59(RR11);1-18.
The 13-valent pneumococcal conjugate vaccine (PCV13) replaces the 7-valent (PCV7) for all doses. PCV13 is routinely given to infants as a 4-dose series at 2, 4, 6, and 12 to 15 months of age. Infants and children who have received 1 dose or more of PCV7 should complete the immunization series with PCV13. For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age and children 2 to 18 years of age with underlying medical conditions also should receive 23-valent pneumococcal polysaccharide vaccine (PPSV23) after completing all recommended doses of PCV13.
**Please note: A single supplemental dose of PCV13 is recommended for all children aged 14 through 59 months who have received 4 doses of PCV7 or another age-appropriate, complete PCV7 schedule.
Updated Recommendations for the Use of Pneumococcal Conjugate and Polysaccharide Vaccines
December 16, 2010 -- The Bureau of Immunization wishes to call to your attention the following article, Prevention of Pneumococcal Disease Among Infants and Children --- Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine, published December 10, 2010 in Morbidity and Mortality Weekly Report (MMWR) Recommendations and Reports 59(RR11);1-18. This release updates the provisional recommendations previously released.
This report summarizes recommendations approved by the Advisory Committee on Immunization Practices (ACIP) on February 24, 2010, for the use of 13-valent pneumococcal conjugate vaccine (PCV13) to prevent pneumococcal disease in infants and young children under 6 years of age.
Recommendations include
- Routine vaccination of all children 2 through 59 months of age.
- Vaccination of children 60 through 71 months of age with underlying medical conditions.
- Vaccination of children who received 1 or more doses of 7-valent pneumococcal conjugate vaccine (PCV7) previously.
Recommendations also are provided for targeted use of the
The ACIP recommendation for routine vaccination with PCV13 and the immunization schedules for children up to 59 months of age who have not received any previous PCV7 or PCV13 doses are the same as those published previously for PCV7 (CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2000;49[No. RR-9]; CDC. Updated recommendation from the Advisory Committee on Immunization Practices [ACIP] for use of 7-valent pneumococcal conjugate vaccine [PCV7] in children aged 24--59 months who are not completely vaccinated. MMWR 2008;57:343--4), with PCV13 replacing PCV7 for all doses. For routine immunization of infants, PCV13 is recommended as a 4-dose series at 2, 4, 6, and 12 to 15 months of age. Infants and children who have received 1 dose or more of PCV7 should complete the immunization series with PCV13. A single supplemental dose of PCV13 is recommended for all children aged 14 through 59 months who have received 4 doses of PCV7 or another age-appropriate, complete PCV7 schedule. For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age. Children 2 to 18 years of age with underlying medical conditions also should receive PPSV23 after completing all recommended doses of PCV13.
IMPORTANT: Wyeth Recalls 4 Lots of Privately Sold Prevnar® Pneumococcal 7-Valent Conjugate Vaccine
March 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:
- E25197 (EXP 10/13)
- E28211 (EXP 10/13)
- E37556 (EXP 10/13)
- E38749 (EXP 11/13)
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 Disease
Prevnar 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:
- 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.
PCV13 will replace 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/
ApprovedProducts/UCM201669.pdf. - The FDA approval letter can be viewed at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm.
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:
- 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/
ApprovedProducts/UCM201349.pdf.
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 Updates
October 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) News
April 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:
- Benefits of the vaccines
- Diseases they prevent
- Any contraindications or possible known risks from the vaccines
- What to expect following the immunization
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 Disease
March 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.
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--2006
January 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 allâcause 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
Percentage of Adults Aged > 65 Years Who Ever Received a Pneumococcal Vaccination
July 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.
