Monday, May 24, 2021

Comparison of Diphtheria-Toxoid-Containing Vaccine

 

* Blue = For age < 7  

* Orange = For age ≥ 7

 

Comparing

1 dose = 0.5 ml each

Diphtheria Toxoid

Tetanus Toxoid

Alumiunum

Thiomersal

Pregnancy

Remarks

Diphtheria and Tetanus Vaccine Adsorbed (Pediatric)  Available in PKK Keningau

≤ 25 Lf

(≥ 30 IU)

≥ 5 Lf

(≥ 40 IU)

Al+++ ≤ 1.25 mg

0.005%

Not mentioned in product leaflet

 

 

·        Recommended for below 7 years old

·        For 7 years old and older, a special DT vaccine, containing a reduced amount of diphtheria toxoid is recommended.

Hexaxim

DTaP- IPV-HB-Hib

Available in PKK Keningau

≥ 20 IU

≥ 40 IU

Al(OH)3      0.6 mg Al3+

 

Not stated

Not applicable. Not intended for administration in women of child-bearing age

For primary and booster vaccination of hose 6 weeks to 24 months of age.

Adsorbed DT Vaccine (Malaysia)

20 Lf

7.5 Lf

Alumimium phosphate  1.5 mg

0.05 mg

Not applicable.

For below 7 years old

TDVAX™

Td (for age 7 and above in USA)

2 Lf

2 Lf

Less than 0.53 mg aluminium adjuvant

Trace amount, with ≤ 0.3 mcg mercury / dose

 

Animal reproduction studies have not been conducted with MassBiologics’ TDVAX. It is also not known whether MassBiologics’ TDVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MassBiologics’ TDVAX should be given to a pregnant woman only if clearly needed.

Td (for age 7 and above in USA)

Boostrix 

Tdap 

Agihan Khas JKNS

≥ 2 IU

(2.5 Lf)

≥ 20 IU

(5 Lf)

Al(OH)3      0.3 mg Al3+

AlPO4           0.2 mg Al3+

Not stated

·    The use of Boostrix may be considered during the third trimester of pregnancy.

·    Safety data from a prospective observational study where Boostrix was administered to pregnant women during the third trimester (793 pregnancy outcomes) as well as data from post-marketing surveillance where pregnant women were exposed to Boostrix or to Boostrix Polio (dTpa-IPV vaccine) have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child.

·    Human data from prospective clinical studies on the use of Boostrix during the first and second trimester of pregnancy are not available.

·    Limited data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born from mothers vaccinated with Boostrix during pregnancy. The clinical relevance of this observation is unknown.

·    Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development.

·   Boostrix should only be used during pregnancy when the possible advantages outweigh the possible risks for the foetus.

For booster vaccination against diphtheria, tetanus and pertussis for age 4 years and above.

 

https://www.who.int/vaccine_safety/initiative/tools/DTP_vaccine_rates_information_sheet.pdf

 

INFORMATION SHEET OBSERVED RATE OF VACCINE REACTIONS DIPHTHERIA, PERTUSSIS, TETANUS VACCINES

(WHO, 2014)

Diphtheria toxoid - Diphtheria toxoid is prepared by formalin inactivation of diphtheria toxin. Usually it is available as a preparation adsorbed with aluminium hydroxide or phosphate and combined with other toxoids or vaccine antigens. The potency of diphtheria vaccine used for the immunization of children should not be less than 30 IU per single human dose, while for adults; the potency is about a third of the dose for children. Monovalent single antigen diphtheria toxoid is currently commercially unavailable.

 

Tetanus toxoid - Tetanus toxoid is a preparation of formalin inactivated toxin. The toxoid is available adsorbed with aluminium phosphate or hydroxide, alone or in combination with other toxoids or vaccines. The potency of tetanus toxoid, expressed in International Units, varies widely according to the preparation and the manufacturer, but WHO stipulates the potency of tetanus vaccine used for the immunization of children should not be less than 40 IU per single human dose. The minimum potency specification for tetanus vaccine intended for booster immunization of older children and adults may be lower and should be approved by the National Regulatory Authority (NRA). Single antigen adsorbed tetanus toxoid is available with a toxoid content of 2 to 10 Lf/dose

 

Diphtheria and Tetanus (DT and Td) toxoid combination: DT vaccine used for primary immunisation and boosting in children contains 6.7-25Lf of diphtheria toxoid and 5 – 7.5 Lf of tetanus toxoid per dose. An adult combination, Td, is used for boosting and primary immunisation in adolescents and adults and contains a lower dose of diphtheria (less than 2 Lf/dose) but a similar dose of tetanus toxoid

UptoDate: Tetanus-diphtheria toxoid vaccination in adults

·         In the United States, a diphtheria-tetanus toxoid (DT and Td) or diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine (DTaP and Tdap; Adacel or Boostrix) vaccine 0.5 mL intramuscularly (IM) is recommended every 10 years for all adults with complete prior immunization against tetanus and diphtheria [2,4,5].

·         At least one of those doses should be with Tdap in adults aged 19 years and older who had not received Tdap previously.

·         When indicated, Tdap should be administered regardless of the interval since the last dose of Td.

·         Subsequently, booster doses with either Td or Tdap can be resumed 10 years later.

USA CDC 2021

·         If a tetanus-toxoid-containing vaccine is indicated for a pregnant woman, use Tdap.

·         Pregnancy: 1 dose Tdap during each pregnancy, preferably in early part of gestational weeks 27 to 36.

UptoDate: Immunizations during Pregnancy

Vaccination with the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) is routinely recommended during pregnancy [3]. Pregnant women who had not previously been fully vaccinated against tetanus and diphtheria should also receive a tetanus and diphtheria toxoid (Td) series.

UptoDate: Diphtheria and tetanus toxoid vaccines (DT [age <7 years] and Td [age ≥7 years]): Drug information

Td vaccines (eg, TDVax, Tenivac) are for use in patients ≥7 years of age; DT vaccines (generics) are for use in pediatric patients 6 weeks to <7 years of age. Td vaccines contain less diphtheria toxoid than DT vaccines; the vaccines are not interchangeable.

 

b Tetanus toxoid in this chart refers to a tetanus toxoid-containing vaccine.

·         For children <7 years of age, DTaP (DT, if pertussis vaccine contraindicated) is recommended.

·         For children 7 to 10 years of age who are not fully immunized against pertussis, diphtheria, or tetanus, Tdap should be used (followed by completion of catch-up series).

·         Tdap is preferred in patients ≥11 years of age if the patient has not previously been vaccinated with Tdap, if Tdap history is unknown, or if the patient is pregnant.

·         In patients who have previously been vaccinated with Tdap, either Td or Tdap may be used.

 

In general, maternal use of inactivated vaccines is not associated with increased risks to the fetus (ACIP [Kroger 2021]). Diphtheria toxoid and tetanus toxoid vaccines may be used during pregnancy (CDC/ACIP [Liang 2018]).

 

The Advisory Committee on Immunization Practices (ACIP) recommends a single Tdap vaccination during each pregnancy; ideally early in the period between 27 and 36 weeks' gestation to maximize passive antibody transfer to the fetus. Pregnant females who are not immunized or are only partially immunized should complete the primary series with Td or Tdap. Tetanus immune globulin and a tetanus toxoid containing vaccine are recommended by the ACIP as part of the standard wound management to prevent tetanus in pregnant females; the use of a tetanus-toxoid containing vaccine during pregnancy (with preference given to Tdap) is recommended for wound management if ≥5 years have passed since the last Td vaccination (CDC/ACIP [Havers 2020]); CDC/ACIP [Liang 2018]).

CDC: Tdap Vaccine Safety for Mother and Infant

 

 

Pregnant women have been getting both tetanus and diphtheria toxoids (Td) and tetanus toxoid (TT) vaccines worldwide since the 1960s to prevent neonatal tetanus. Td and TT vaccines administered during pregnancy have not been shown to harm either the mother or baby / fetus.

https://www.cdc.gov/pertussis/pregnant/hcp/vaccine-safety.html#:~:text=The%20tetanus%20toxoid%2C%20reduced%20diphtheria,administer%20any%20time%20during%20pregnancy.

American College of Obstetricians and Gynaegologists: Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination

In 2013, the Advisory Committee on Immunization Practices published its updated recommendation that a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) should be administered during each pregnancy, irrespective of the prior history of receiving Tdap. The recommended timing for maternal Tdap vaccination is between 27 weeks and 36 weeks of gestation. To maximize the maternal antibody response and passive antibody transfer and levels in the newborn, vaccination as early as possible in the 27–36-weeks-of-gestation window is recommended. However, the Tdap vaccine may be safely given at any time during pregnancy if needed for wound management, pertussis outbreaks, or other extenuating circumstances. There is no evidence of adverse fetal effects from vaccinating pregnant women with an inactivated virus or bacterial vaccine or toxoid, and a growing body of robust data demonstrate safety of such use.

 

A pregnant woman should not be revaccinated with Tdap in the same pregnancy if she received the vaccine in the first or second trimester.

 

https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/09/update-on-immunization-and-pregnancy-tetanus-diphtheria-and-pertussis-vaccination

 

Conclusion:

·         Only vaccines with reduced diphtheria component are recommended in adults (age 7 and above) and pregnancy.

·         Generally when comparing diphtheria/tetanus-covering vaccine, the tetanus toxoid component is similar, while the diphtheria toxoid content is about 3-15 times higher in < 7 years old formulation.

·         No information or recommendation can be found regarding use of paediatrics DT vaccine in population 7 years old and above.

·         No information can be found on the potential impact if population 7 years old and above given extra diphtheria toxoid.

 

Useful References / Further Reading:

1.        https://www.cdc.gov/vaccines/vpd/dtap-tdap-td/hcp/about-vaccine.html#:~:text=Diphtheria%20and%20Tetanus%20(DT%20and%20Td)%20Only%20Vaccines&text=Each%200.5%2Dmilliliter%20(mL),%2C%20is%20less%20than%200.02%25.

 

All information accessed on 19 May 2021 [J. Ho]

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