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Bureau of Immunization: Immunizations Across the Lifespan
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Vaccine Topics

Diphtheria-Tetanus-Pertussis Vaccines

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.