Tetanus Vaccines

The majority of children who received the tetanus vaccine will get it through the DTaP shot.  However, if parents choose to have their child receive the tetanus shot separately, they will receive the DT shot, which is given to individuals up to seven years of age.  For persons older than seven, the Td or TENIVAC shot is used.

An excellent 7-minute presentation on Tetanus can be seen at:
Think Twice Global Vaccine Institute: Tetanus Vaccine Powerpoint Presentation
http://thinktwice.com/tet_show.htm
 

Sanofi Pasteur DT

DT package insert Sanofi Pasteur https://www.vaccineshoppe.com/image.cfm?doc_id=12617&image_type=product_pdf

Three safety studies were cited. (p.2)  The first had 163 infants given DT at 2, 4 and 6 months and acellular pertussis vaccine (aP) at 3, 5, and 7 months.  One control group (n=85) received DT and aP at 2, 4, and 6 months while the other control (n=85) received DTwP at 2, 4, and 6 months and a placebo (undisclosed) at 3, 5, and 7 months.

The second trial had 52 children who had previously received 3 doses of DTP. 
They received either aP (25) or wP (25) given at the same time at a separate site.

The third trial had 99 children who had received 4 doses of DTP.  They received DT in one arm and wP in the other.

The first study followed the infants for only 24 hours and looked for and reported only for fever, crying, loss of appetite and injection site reactions.  The latter two studies only observed for injection site reactions.

The DT evaluated in the clinical trials contained thimerosal.

DT has not been evaluated for carcinogenicity, mutagenic potential, or impairment of fertility (p.3)

Apnea following intramuscular vaccination has been observed in some infants born prematurely. (p.2)

Syncope (fainting) has been reported following vaccination with DT. (p.2)

Animal reproduction studies have not been conducted with DT. It is also not known whether DT can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. (p.3)

Adverse Reactions from Post-Marketing Experience (p.4)

 

In the previous package insert, only two studies were done, one with 20 subjects and the other with 40.  The second study, compared infants given DTP, DT, DTP at 2,4, and 6 months, compared to infants  who were give vaccine to kids who were given DTP, DTP, DT at the same ages. (The order of shots was varied.)  They found the incidence of adverse reactions was significantly lower following the DT administration.  Therefore it was claimed “safe” based on 60 infants and no placebo.

Sanofi Pasteur’s DT contains aluminum potassium sulfate, peptone, bovine extract, formaldehyde, thimerosal (in trace amounts), modified Mueller and Miller medium, and ammonium sulfate.
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
 

Sanofi Pasteur - TENIVAC

Sanofi Pasteur - TENIVAC Package Insert (for ages 7 and older)  https://www.vaccineshoppe.com/image.cfm?doc_id=12609&image_type=product_pdf

TENIVAC is a vaccine indicated for active immunization for the prevention
of tetanus and diphtheria in persons 7 years of age and older.
A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (page 6)
Vaccination with TENIVAC vaccine may not protect all individuals.  If TENIVAC vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. (page 6)
Adverse Reactions (p. 7-11)
Clinical studies compared TENIVAC to the vaccine it replaced – DECAVAC.  No placebo control was used.  
One study followed subjects for only 3 days.  Common adverse reactions included pain, headache, injection site redness, injection site swelling, malaise, muscle weakness and pain in joints.  (p. 8-9)
Another study followed subjects for 30 days.  Serious adverse events included localized infection, asthma, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, cholecystitis, chest pain and cerebrovascular accident. (page 10)
From post-marketing experience, the following adverse events were included based on severity, frequency of reporting or the strength of causal association to TENIVAC vaccine:  Lymphadenopathy, allergic reactions (such as erythematous rash, maculopapular rash, urticaria and pruritus); anaphylactic reaction (bronchospasm and angioedema), paresthesia, dizziness, syncope, Guillain Barré syndrome, vomiting, myalgia, pain in extremities, Injection site reactions (including inflammation, mass, edema, induration, warmth, pruritus, cellulitis, discomfort) fatigue, edema peripheral (page 11)
TENIVAC Ingredients: aluminum phosphate, formaldehyde, modiefied Meuller-Miller casamino acid medium (without beef heart infusion), and ammonium sulfate.  http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

 

 
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