Document text
National Center for Immunization & Respiratory Diseases
VFC Resolution Update: Tetanus and Diphtheria Toxoid Containing Vaccines
Michelle Hughes
Division of Bacterial Diseases
National Center for Immunization and
Respiratory DiseasesJeanne Santoli
Immunization Services Division
National Center for Immunization and
Respiratory Diseases
February 2024
Background
Background
•CDC recommends a primary series of 5 DTaP vaccines for children <7
years
•For children aged <7 years who developed a contraindication to pertussis -containing vaccines, CDC previously recommended DT instead
of DTaP
•The sole DT vaccine manufacturer in the U nited States discontinued DT
production
•Last lot expired in April 2023
•No DT vaccin e is av ailable in the United States
Contraindication specific to pertussis vaccine
component
•The only contraindication specific to the pertussis component in DTaP is
encephalopathy within 7 days of vaccination, not attributed to another cause.
•Exact numbers are unknown, but occurrence of this adverse reaction is extremely rare.
•CDC issued updated vaccination guidance for young children with a contraindication to pertussis -containing vaccines.
Guidance
•CDC recommends young children receive DTaP as the first dose in the
diphtheria, tetanus, and pertussis childhood vaccination series.
•CDC recommends continued use of DTaP unless a contraindication to pertussis -containing vaccines develops.
•For young children who develop a contraindication to pertussis -
containing vaccines, vaccine providers may administer Td for all recommended remaining doses in place of DTaP .
Uncertain impact on diphtheria protection
•Td is licensed for ages ≥7 years
•Td contains a lower dose of diphtheria toxoid compared to DT
•Limited data suggest that low -dose diphtheria toxoid -containing
vaccines may not reliably generate a protective diphtheria
seroresponse.
https://www.cdc.gov/vaccines/vpd/dtap- tdap -td/hcp/td- offlabel.html
VFC Resolution Updates
•MassBiologics has discontinued production of their Td vaccine, TdVax.TM Grifols, who is the
exclusive distributor for TdVax,TM expects to have product available through approximately
June 2024.
•Sanofi, who manufacturers Tenivac ,® the only other US- licensed Td vaccine, is taking steps to
augment their available supply of Td for the US. However, it is anticipated that the supply of
Td vaccine in the US market will be constrained during 2024. Temporary ordering controls
have been put into place in the public and private sectors to help manage the gap in supply.
•Tdap vaccine is available from both US- licensed manufacturers without supply constraints at
this time.
•Based on the rarity of developing a contraindication to pertussis -containing vaccines, the
temporarily constrained supply of Td vaccine is not anticipated to prevent providers from
utilizing Td vaccine for these children in the VFC program. Td Vaccine Supply Update
The purpose of this resolution is to (1) add Td vaccine for use in children < 7 years of
age for whom receipt of the pertussis component is contraindicated and to (2) update the language regarding the Tdap booster to align with ACIP recommendations. Purpose of the Resolution
Children and adolescents aged 6 weeks through 18 years. Eligible Groups
Vaccines containing tetanus toxoid, diphtheria toxoid, and acellular pertussis antigens
recommend for use in persons aged <7 years.Recommended Schedule and Intervals (1)
Vaccine Type Vaccine Brand (1) Age for approved use in the
routine schedule (2)
2 mos 4
mos6
mos15-18
mos4-6 yrs
(3)
DTaP DTaP (4) Daptacel X X X X X
DTaP (4) Infanrix X X X X X
Combination
vaccines with
DTaPDTaP -HepB- IPV (4, 5) Pediarix X X X
DTaP -IPV/Hib (4, 6) Pentacel X X X X
DTaP -IPV-Hib-HepB (4,
7) Vaxelis X X X
DTaP -IPV (8) Kinrix X
DTaP -IPV (8) Quadracel X
Td Td (9) Tenivac X X X X
Td Td (9) TdVax X X X X
(1)The use of brand names is not meant to preclude the use of other comparable licensed
vaccines.
(2)Minimal intervals: Dose 1 to 2: 4 weeks. Dose 2 to 3: 4 weeks. Dose 3 to 4: 6 months. Dose 4 to 5: 6 months. For more information on age for use in catch -up immunization schedules please
see: https://www.cdc.gov/vaccines/schedules/hcp/imz/catchup.html
(3)The fifth dose is not necessary if the fourth dose was given after the fourth birthday.
(4)FDA-approved for use in infants as young as 6 weeks.
(5)FDA-approved for use through age 6 years (prior to 7th birthday). The combined DTaP-HepB -IPV
vaccine may be used when any component of the combination is indicated, and if the other
components are not contraindicated. Approved for the primary series only (Doses 1 -3). For
adequate immune response, the last dose of hepatitis B vaccine should be given at ≥24 weeks
of age and therefore this combination vaccine should not be administered as a complete
primary series on an accelerated schedule at 4 -week intervals for prevention of pertussis. Recommended Schedule and Intervals (2)
(6) FDA-approved for use through age 4 years (prior to 5th birthday). The combined DTaP-IPV/Hib
vaccine may be used when any component of the combination is indicated, and if the other
components are not contraindicated. Approved for the primary series and first booster dose (Doses
1-4). The combined DTaP -IPV/Hib vaccine is not indicated for children 5 years of age and older.
(7) FDA-approved for use through age 4 years (prior to 5th birthday). The combined DTaP-IPV -Hib-
HepB vaccine may be used when any component of the combination is indicated, and if other
components are not contraindicated. Approved for the primary series only (Doses 1 -3). For
adequate immune response, the last dose of hepatitis B vaccine should be given >24 weeks of age
and therefore this combination vaccine should not be administered as a complete primary series
on an accelerated schedule at 4 -week intervals for prevention of pertussis.
(8) The combined DTaP -IPV vaccines may be used when any component of the combination is
indicated, and if the other components are not contraindicated. Only approved for the booster
dose at age 4 through 6 years. Earlier doses should use another vaccine.
(9) Use tetanus toxoid - and diphtheria toxoid-containing vaccine if encephalopathy not attributable to
another identifiable cause occurs within 7 days of administration of previous dose of pertussis -
containing vaccine. For more information on the use of Td in children <7 please see: About Young
Children with a Contraindication to Pertussis -Containing Vaccines | CDCRecommended Schedule and Intervals (3)
Vaccines containing tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis
antigens recommended for use in persons aged 7– 18 years. Recommended Schedule and Intervals (4)
Vaccine Type Brand
Tdap (1, 2, 3, 4) Adacel
Boostrix
Td (4, 5, 6) Tenivac
TdVax
(1)The use of brand names is not meant to preclude the use of other comparable licensed
vaccines.
(2)Persons aged 11 -18 years should receive a single booster dose of Tdap, preferably at a
preventive care visit at ages 11- 12 years. The booster dose is not necessary if the Tdap
dose was given after the ninth birthday.
(3)Catch -up immunization: Persons aged 7- 18 years who have never been vaccinated
against pertussis, tetanus, or diphtheria should receive a series of three tetanus and
diphtheria toxoid -containing vaccines, which includes at least 1 dose of Tdap. The
preferred schedule is a dose of Tdap, followed by a dose of either Td or Tdap at least 4
weeks afterward and another dose of either Td or Tdap 6 to 12 months later. Persons
aged 7- 18 years who are not fully immunized against pertussis, tetanus, or diphtheria
should receive one dose of Tdap (preferably the first) in the catch -up series; if
additional tetanus toxoid -containing doses are required, either Td or Tdap vaccine can
be used. The catch -up immunization schedule and minimum intervals between doses
are available at: https://www.cdc.gov/vaccines/schedules/hcp/child- adolescent.html Recommended Schedule and Intervals (5)
(4) Adolescents who are pregnant should receive Tdap, irrespective of past history of Tdap receipt.
Tdap should be administered from 27 through 36 weeks’ gestation, preferably during the earlier part of this time period, although it may be administered at any time during pregnancy. If an adolescent did not receive Tdap during her current pregnancy and did not receive a prior dose of Tdap ever, then Tdap should be administered immediately postpartum. If an adolescent did not receive Tdap during her current pregnancy but did receive a prior dose of Tdap, then she should not receive a dose of Tdap postpartum.
(5) Tetanus prophylaxis for wound management: A tetanus toxoid –containing vaccine is indicated as
part of wound management if more than five years has passed since the last tetanus toxoid –
containing vaccine dose. If a tetanus toxoid –containing vaccine is indicated for persons aged ≥11
years, Tdap is preferred for persons who have not previously received Tdap or whose Tdap history is unknown. If a tetanus toxoid–containing vaccine is indicated for a pregnant woman,
Tdap should be used. For nonpregnant persons with documentation of previous vaccination with
Tdap, either Td or Tdap can be used if a tetanus toxoid–containing vaccine is indicated.
(6) Td should be used if encephalopathy not attributable to another identifiable cause occurs within
7 days of administration of a previous dose of pertussis -containing vaccine. Recommended Schedule and Intervals (6)
Recommended Dosage
Refer to product package inserts available at:
https://www.fda.gov/vaccines -blood- biologics/vaccines/vaccines -licensed- use- united -
states
Contraindications/PrecautionsContraindications and precautions can be found at: https://www.cdc.gov/mmwr/volumes/67/rr/rr6702a1.htm
Dosage and Contraindications/Precautions
[If an ACIP recommendation regarding diphtheria, tetanus, and pertussis vaccination is
published within 6 months following this resolution, the relevant language above (except in the eligible groups sections) will be replaced with the language in the
recommendation and incorporated by reference to the publication URL.] Statement Regarding Update Based on Published
Documents