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Bureau of Immunization: Immunizations Across the Lifespan
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Vaccine Topics

Diphtheria-Tetanus-Pertussis Vaccines

Recommendations for Tdap Vaccination of Pregnant Women and Others with Close Infant Contact

October 31, 2011 -- The CDC published Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months--Advisory Committee on Immunization Practices (ACIP), 2011 in the Morbidity and Mortality Weekly Report (MMWR);October 21, 2011;60/41;1424-1426.

The Guidance for Use section is reprinted below.

Maternal vaccination

The Advisory Committee on Immunization Practices (ACIP) recommends that women's healthcare personnel implement a Tdap vaccination program for pregnant women who previously have not received Tdap. Healthcare personnel should administer Tdap during pregnancy, preferably during the third or late second trimester (after 20 weeks' gestation). If not administered during pregnancy, Tdap should be administered immediately postpartum.

Cocooning

The ACIP recommends that adolescents and adults (e.g., parents, siblings, grandparents, childcare providers, and healthcare personnel) who have or anticipate having close contact with an infant less than 12 months of age should receive a single dose of Tdap to protect against pertussis if they have not previously received Tdap. Ideally, these adolescents and adults should receive Tdap at least 2 weeks before beginning close contact with the infant.

Expanded Age Indication for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine

September 29, 2011 -- We are pleased to draw your attention to the following article FDA Approval of Expanded Age Indication for a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine; Morbidity and Mortality Weekly Report (MMWR); September 23, 2011; 60(37); 1279-1280. These new recommendations will give our immunization partners more flexibility of product choice for those in their care. Excerpts are below:

  • On July 8, 2011, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) Boostrix® (GlaxoSmithKline Biologicals, Rixensart, Belgium). Boostrix® is now licensed for use in persons 10 years of age and older as a single-dose booster vaccination.
  • Recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been published previously. Publication of revised Tdap recommendations within the next year is anticipated.
  • The ACIP recommends that adolescents and adults receive a one-time booster dose of Tdap. For adults 19 through 64 years of age who previously have not received a dose of Tdap, a single dose of Tdap should replace a single decennial tetanus-diphtheria (Td) booster dose.
  • Persons 65 years of age and older (e.g., grandparents, childcare providers, and healthcare practitioners) who have or who anticipate having close contact with an infant less than 12 months of age and who previously have not received Tdap should receive a single dose of Tdap to protect against pertussis and reduce the likelihood of transmission.
  • Tdap can be administered regardless of interval since the last tetanus- or diphtheria-containing vaccine.
  • Currently, two Tdap products are licensed for use in the U.S., Boostrix® and Adacel® (Sanofi Pasteur, Toronto, Canada). Adacel® has been approved by the FDA as a single dose in persons 11 through 64 years of age. With the recent FDA expanded licensure for use of Boostrix®, the ACIP will be reviewing the current recommendations on use of Tdap in persons 65 years of age and older. At this time, either Tdap product may be used in persons 65 years of age and older.

Boostrix is Given FDA Approval for Use in Individuals Over 65

August 3, 2011 -- Recently, the Food and Drug Administration (FDA) approved the use of Boostrix® (GlaxoSmithKlein's Tetanus-diphtheria-acellular pertussis vaccine) in an expanded cohort including individuals over 65 years of age.

Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine from the Advisory Committee on Immunization Practices (ACIP), 2010 were published in Morbidity and Mortality Weekly Report (MMWR). January 14, 2011;60(01);13-15:

  • Adults age 65 years and older who have not previously received a dose of Tetanus-diphtheria-acellular pertussis vaccine (Tdap) and who have or anticipate having close contact with children younger than age 12 months of age (e.g., grandparents, other relatives, childcare providers, and healthcare personnel), should receive a one-time dose to protect themselves and infants.
  • Other adults 65 years and older who are not in contact with an infant and who have not previously received a dose of Tdap may receive a single dose of Tdap in place of a dose of tetanus-diphtheria vaccine (Td). Administration may be especially important during a community outbreak.

Vaccines for Children Program Resolution No. 6/11-2: Vaccines to Prevent Diphtheria, Tetanus, and Pertussis

July 7, 2011 -- The Bureau of Immunization is pleased to announce the release of the Vaccines for Children (VFC) Program Resolution No. 6/11-2, Vaccines to Prevent Diphtheria, Tetanus and Pertussis. Resolution 10/10-2 is repealed and replaced by this new resolution. Resolution No. 6/11-2 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 revise the previous resolution to incorporate new recommendations regarding the vaccination of pregnant adolescents.

The 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 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/ resolutions/0611dtap.pdf.

CDC Health Alert: Best Practices for Healthcare Professionals on the Use of Polymerase Chain Reaction (PCR) for Diagnosing Pertussis

February 16, 2011 -- The following CDC Health Alert Network (HAN) notice was issued February 16, 2011.

Summary: With the continuing resurgence of pertussis, healthcare professionals will likely see more patients with suspected pertussis. Proper testing criteria, timing of testing, specimen collection techniques, protocols for avoiding specimen contamination, and appropriate interpretation of test results are all necessary to ensure that Polymerase Chain Reaction (PCR) reliably informs patient diagnosis. PCR is an important tool for timely diagnosis of pertussis and is increasingly available to clinicians. PCR is a molecular technique used to detect DNA sequences of the Bordetella pertussis bacterium and unlike culture does not require viable (live) bacteria present in the specimen. Despite this advantage, PCR can give results that are falsely-negative or falsely-positive. The following compilation of best practices is intended to help healthcare professionals optimize the use of PCR testing for pertussis by avoiding some of the more common pitfalls leading to inaccurate results.

The HAN document includes information about recommendations for testing, including sections on whom to test and when they should be tested. Material concerning specimen collection and avoidance of sample contamination, and recommendation for interpretation are also presented.

For more information:

Monograph Aims to Increase Tdap Vaccination of Adults and Adolescents

February 10, 2011 -- The Joint Commission has released a monograph titled: Tdap Vaccination Strategies for Adults and Adolescents, including Health Care Personnel--Strategies from Research and Practice. The monograph can be downloaded at www.jointcommission.org.

The Summary of Key Points is presented below:

  • Pertussis (whooping cough) is on the rise. Rates have increased over the past two decades, primarily in adolescents and adults who have waning immunity from previous pertussis vaccinations or infection.
  • Infants who are too young to be vaccinated bear the burden of severe pertussis disease.
  • Most pertussis-related deaths occur in infants less than 4 months of age.
  • Adolescents and adults play a significant role in transmission of pertussis to vulnerable infants at home, in the community, and in healthcare and daycare settings.

For more detail, see the press release prepared by The Joint Commission.

Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine

January 20, 2011 -- The Bureau of Immunization would like to direct your attention to the January 14, 2011 Morbidity and Mortality Weekly Report, Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine from the Advisory Committee on Immunization Practices, 2010.

The Advisory Committee on Immunization Practices (ACIP) recommended in October 2010 to expand the use of Tdap vaccine to improve immunization coverage among adolescents and adults and close the age gaps (specifically, for children 7 through 10 years of age and adults 65 years of age and older) in the original licenses. This report provides the updated recommendations regarding intervals, age, safety and effectiveness data, and provides guidance for implementing the new recommendations.

Following review of published and unpublished Tdap safety and immunogenicity data, the Pertussis Working Group of ACIP has made additional recommendations to facilitate provision of Tdap to reduce the burden of pertussis disease and the risk for transmission to infants. The general recommendation for routine use continues to provide a single dose of Tdap to adolescents 11 to 12 years of age with catch-up for all adolescents and adults through 64 years of age who have not received a single dose of Tdap.

ACIP Recommendations

Timing of Tdap:

  • Tdap can be administered, when indicated, regardless of interval since the last tetanus- or diphtheria-toxoid containing vaccine. Changes are being made in the Florida SHOTS™ (Florida State Health Online Tracking System) to accommodate the change in intervals.

Adults Aged 65 years of age and Older:

  • Those who have or anticipate having close contact with an infant less than 12 months of age should receive a single dose of Tdap.
  • Other adults 65 years of age and older may be given a single dose of Tdap.

Children 7 through 10 years of age:

  • Those not fully vaccinated against pertussis and for whom no contraindication to pertussis vaccine exists should receive a single dose of Tdap.
  • Those never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status should receive a series of three vaccinations containing tetanus and diphtheria toxoids. The first of these three doses should be Tdap

Immunization Safety Update: Tetanus-Diphtheria-Pertussis-Containing Vaccines

September 22, 2010 -- This immunization update is a review of the administration/documentation of tetanus-diphtheria-pertussis-containing vaccines (Tdap/DTaP) in accordance with the Recommendations of the Advisory Committee on Immunization Practices (ACIP). There are four combination vaccines used to prevent diphtheria, tetanus and pertussis:

  • DTaP: diphtheria and tetanus toxoid, acellular pertussis
  • Tdap: tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine
  • DT: diphtheria and tetanus toxoid
  • Td: tetanus toxoid and reduced diphtheria toxoid

Two of these (DTaP and DT) are given to children younger than 7 years of age, Td is given to children 7 years of age and older and Tdap is given to those 10 to 64 years of age. Children need 4-5 doses of DTaP by kindergarten (4 to 6 years of age) and a Tdap booster by age 11. All teens and adults are also recommended to receive one Tdap booster in place of a Td.

It is important to note that there have been reported/documented vaccine administration errors/mix-ups regarding the inadvertent administration of Tdap/DTaP to children/adults in the wrong age-groups. Every step should be taken to avoid improper administration of vaccines. DTaP should not be confused with Tdap.

Appropriate vaccine administration is critical to patient safety and vaccine effectiveness. Staff should be fully trained in the administration of immunizations and provided with all resources regarding the vaccines they will be administering. Steps should be taken to prevent product mix-ups including careful storage of similar looking vaccines. Reference documents are linked below:

Questions have surfaced regarding the recommendations in relation to the inadvertent administration of Tdap/DTaP. What are the recommendations if a dose of DTaP or Tdap is administered to a patient for whom the product is not indicated (such as wrong age-group)?

Most important: the parent or patient should be informed that the incorrect vaccine was administered and internal policies be followed for medication errors.

The following should provide guidance as to whether the inadvertent dose is valid or needs to be repeated:

  • Tdap given to a child younger than age 7 years as either dose 1, 2, or 3, is NOT valid. Repeat with DTaP as soon as feasible
  • Tdap given to a child younger than age 7 years as either dose 4 or 5, can be counted as valid for DTaP dose 4 or 5
  • Tdap given to a child age 7 through 9 years can be counted as valid for the one-time Tdap dose
  • DTaP given to patients age 7 or older can be counted as valid for the one-time Tdap dose

Please refer to the February 23, 2006 MMWR: Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines and the Immunization Action Coalition: Ask the Experts: for further guidance.

Requirement for Tetanus/Diphtheria/Pertussis (Tdap) for Entry and Attendance in 7th Grade

February 13, 2009 -- The Florida Department of Health, Bureau of Immunization would like to remind all immunization partners about the upcoming school immunization requirement effective for the 2009/2010 school year for students entering 7th grade.

Effective School Year 2009/2010:

Students entering, repeating, or transferring into 7th grade will need to provide documentation for the tetanus-diphtheria-pertussis (Tdap) vaccine.

This requirement is in addition to the previous immunization requirements that are grade-appropriate.

Students who received a dose of tetanus-diphtherial (Td) vaccine 2 to 5 years prior to entering 7th grade should be given a Temporary Medical Exemption (TME) and immunized at the appropriate time. The timeline for the TME must be no longer than 5 years from the last tetanus-diphtheria-containing vaccine. Please note: a dose of Tdap can be given within 2 years of receiving a dose of Td vaccine, regardless of a child’s TME status, if there is a risk of exposure to pertussis.

Tdap can be administered to students 10 years of age and above if prior Td booster was given at least 2 years ago. Recommendations for provision of the Tdap vaccine are in accordance with the recommendations of the Advisory Committee on Immunization Practices (ACIP).

The Department of Education is updating their electronic system to incorporate the following: In order to assist districts in recording the needed immunization information, two codes (P and Q) have been added to the Vaccine Status element. The element can be viewed at http://www.fldoe.org/eias/dataweb/database_0809/st293_1.pdf. These codes should be useful as staff prepare for the requirements of 2009/2010. Therefore, for the 2009/2010 school year, only codes ‘P’ (Tdap) and ‘Q’ (Td) will be acceptable for students entering 7th grade.

The updated codes will also be reflected in the Florida State Health Online Tracking System (SHOTS) as well as on the updated Certificate of Immunization (DH 680).

New Indication for Boostrix® Vaccine (Tdap) Expands Disease Protection to Individuals 10 Through 64 Years of Age

January 07, 2009 -- The Bureau of Immunization wishes to make you aware that BOOSTRIX® vaccine has now been licensed for use in an expanded age group that includes adults 19 through 64 years of age.

The U.S. Food and Drug Administration (FDA) has approved BOOSTRIX® [Tetanus Toxoid-Reduced Diphtheria Toxoid-Acellular Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 19 through 64 years of age. BOOSTRIX® offers protection against tetanus, diphtheria and pertussis (whooping cough) to individuals 10 through 64 years of age – the broadest age range for any Tdap vaccine. BOOSTRIX was previously approved as a booster vaccine for preteens and teens.

The CDC recommends a single Tdap vaccination for adults 19 through 64 years of age in place of a Td booster, if the last dose of the Td vaccine was received 10 or more years prior in individuals who have not already received a Tdap vaccine. This includes healthcare personnel who have direct patient contact, as well as adults younger than 65 years of age who have or anticipate having contact with infants younger than 12 months (e.g., parents, grandparents, childcare providers).

While this new approval does not affect provision of VFC vaccines, it does afford consumers and providers with another option for protection against Bordatello pertussis infection and complications in adolescents and adults.

Combined Tdap/Td Vaccine Information Statement

November 20, 2008 -- The Centers for Disease Control and Prevention (CDC) published a new interim Vaccine Information Statement (VIS) that can be used for both tetanus-diphtheria-pertussis (Tdap) and tetanus-diphtheria (Td) vaccines and is now available. It replaces the Tdap VIS dated July 12, 2006 and the Td VIS dated June 10, 1994. These older VIS forms 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 VISs 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.

The new VIS is available at http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-td-tdap.pdf. For the latest information concerning VIS updates, visit the CDC's VIS News website. Many VISs are available in other languages. As new editions are translated, they are also posted on the Immunization Action Coalition's website.

ACIP Recommendations for New Pentacel® and Kinrix™ Combination Vaccines

September 10, 2008 -- The Centers for Disease Control and Prevention (CDC) has published indications and guidance for use for the new diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), inactivated poliovirus vaccine (IPV), and Haemophilus influenzae type b conjugate (Hib) combination vaccine (DTaP-IPV-Hib), Pentacel®, and the new diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP) and inactivated poliovirus (IPV) combination vaccine (DTaP-IPV), Kinrix™.

Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, and Haemophilus b Conjugate Vaccine and Guidance for Use in Infants and Children

On June 20, 2008 the Food and Drug Administration (FDA) licensed a combined vaccine, DTaP-IPV/Hib (Pentacel®, Sanofi Pasteur), for use as a four-dose series in infants and children 2, 4, 6, and 15 through 18 months of age. This report summarizes the indications for Pentacel® and provides guidance from the Advisory Committee on Immunization Practices (ACIP) for its use.

***It is important to note that the 4th dose should be deferred until there is an ample supply of Hib vaccine. Single antigen products can be used for the 4th dose.

Additionally, the Morbidity and Mortality Weekly Report (MMWR) discusses the documentation of the lot numbers. Different lot numbers for the different components of DTaP-IPV/Hib are included on the DTaP-IPV vial and on the Hib powder vial.

While it is recommended that providers should record lot numbers separately for the DTaP-IPV and Hib components, Florida SHOTS has not yet been modified to accept two vaccine lot numbers for the same combined vaccine. At a minimum, providers must record the lot number located on the outside of the box. We will notify you when there are any changes to this process.

The recommendations can be accessed online at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5739a5.htm

Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine and Guidance for Use as a Booster Dose

On June 24, 2008, the Food and Drug Administration licensed a combined vaccine, DTaP-IPV (Kinrix™, GlaxoSmithKline Biologicals, Rixensart, Belgium). Kinrix™ is licensed for use as the fifth dose of the DTaP vaccine series and the fourth dose of the IPV series in children 4 through 6 years of age. DTaP-IPV administered to children 4 through 6 years of age would reduce by one the number of injections needed to complete DTaP and IPV immunization. This report summarizes the indications for Kinrix™ and provides guidance from the Advisory Committee on Immunization Practices (ACIP) for its use.

The recommendations can be accessed online at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5739a4.htm

Data are limited on the safety and immunogenicity of interchanging DTaP vaccines from different manufacturers. The ACIP recommends that, whenever feasible, the same manufacturer's DTaP product should be used for the pertussis series; however, that vaccination should not be deferred if the specific DTaP vaccine brand previously administered is unavailable or unknown.

Prevention of Pertussis, Tetanus, and Diphtheria Among Pregnant and Postpartum Women and Their Infants: Recommendations of the Advisory Committee on Immunization Practices

May 28, 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 Early Release (MMWR) 2008; volume 57, 1-47 on May 14, 2008 concerning tetanus-diphtheria-pertussis (Tdap) vaccine use among pregnant and postpartum women.

The CDC's Advisory Committee on Immunization Practices (ACIP) recommends that pregnant women who were not vaccinated previously with Tdap:

  • Receive Tdap in the immediate postpartum period before discharge from hospital or birthing center.
  • May receive Tdap at an interval as short as two years since the most recent tetanus-diphtheria (Td) vaccine.
  • Receive Td during pregnancy for tetanus and diphtheria protection when indicated.
  • Defer the Td vaccine indicated during pregnancy to substitute Tdap vaccine in the immediate postpartum period if the woman is likely to have sufficient protection against tetanus and diphtheria.

This report:

  • Describes the clinical features of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants.
  • Reviews available evidence of pertussis vaccination during pregnancy as a strategy to prevent infant pertussis.
  • Summarizes Tdap vaccination policy in the United States.
  • Presents recommendations for use of Td and Tdap vaccines among pregnant and postpartum women.

Vaccine Packaging Update for Sanofi Pasteur Products

The Bureau of Immunization provides this important notice to alert you regarding packaging changes to two Sanofi Pasteur vaccine products: DAPTACEL® - Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP), licensed for children up to 7 years of age; and ADACEL® - Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), licensed for persons 11 through 64 years of age. These changes will help avoid confusion in the marketplace between the two vaccines. Please see the packaging document from Sanofi Pasteur Inc. for more details.

Please Note: The Bureau of lmmunization will continue to provide DAPTACEL® and ADACEL® vaccines to all Vaccines for Children (VFC)-eligible children for whom the vaccine is indicated. More information is available at http://www.sanofipasteur.us.

If you have any questions concerning recommendations for the DTaP vaccine or Tdap vaccine, please contact the Bureau of lmmunization, at (850) 245-4342. For information regarding the VFC vaccine supply, contact Robert Griffin at (850) 245-4342.

Combination Vaccines to Help Protect Adolescents Against Pertussis

The Food and Drug Administration (FDA) approved the first combination vaccines that provide a booster immunization against pertussis (whooping cough), in combination with tetanus and diphtheria for adolescents. The vaccines will be marketed as Boostrix® by GlaxoSmithKline (GSK) and Adacel® by Sanofi Pasteur.

Pertussis is a highly communicable disease of the respiratory tract that can be especially serious for infants less than one year old, and may even be fatal. Pertussis can cause coughing and choking spells that make breathing difficult. It is thought that adolescents might transmit the disease to susceptible infants and other family members. Rates of pertussis infection have been increasing in very young infants who have not received all of their immunizations, and in adolescents and adults.

Boostrix® and Adacel® are Tetanus Toxoid (T), Reduced Diphtheria Toxoid (d) and Acellular Pertussis Vaccines (ap), Adsorbed. Although booster vaccines for adolescents containing T and d are currently licensed and marketed for use in these age groups, none contain a pertussis component. Boostrix® is licensed for use in adolescents 10 through 18 years of age and Adacel® for persons 11 through 64 years of age.