Single antigen tetanus vaccine has now been replaced by combined tetanus and low dose diphtheria vaccine in adults and adolescents, explains Jane Chiodini

Tetanus is induced by the toxin of the tetanus bacillus, Clostridium tetani. Bacilli are harboured in the intestine of many vertebrates, including man, and their spores are widely distributed in the environment, particularly in soil.

Infection usually results when a wound is inoculated by spores at the time of injury. Inoculation can occur via burns and more trivial injuries as well as puncture wounds.1 Immunisation against tetanus was introduced in the 1950s and became part of the national programme in 1961.

Diphtheria, a bacterial infection caused by Corynebacterium diphtheriae, is spread by droplet infection. It usually affects the tonsils, pharynx, larynx and occasionally the skin. Symptoms vary from a sore throat to life-threatening diphtheria of the larynx or the lower and upper respiratory tract. Mortality from the disease is 5-10% even if properly treated and higher if untreated.2 Effective protection is by mass immunisation.

Immunisation against diphtheria began in the UK in 1940, resulting in a dramatic fall in the number of cases and deaths from the disease.1 However, since 1991 there has been an epidemic of diphtheria in Russia and the former Soviet states, with mortality rates as high as 17-23% in Azerbaijan, Georgia and Turkmenistan.2

Immunisation is now part of the UK childhood immunisation programme; the schedule is outlined in Table 1 (below).

Table 1: Schedule for tetanus and diphtheria immunisation 4
Schedule Children Adults
Primary course 3 doses of vaccine (usually as DTP) at 2,3 and 4 months of age 3 doses of vaccine (as Td) each one month apart
4th dose At least 3 years after the primary course, usually pre-school entry (as DTaP) 10 years after primary course (as Td)
5th dose At 13-18 years before leaving school (as Td) 10 years after 4th dose (as Td)

In May 2002 the Department of Health announced that single antigen tetanus vaccine (T) was to be replaced by the combined tetanus and low dose diphtheria vaccine (Td) for routine use in adults and adolescents.3

The change was made on the advice of the Joint Committee on Vaccination and Immunisation because there was concern about the low levels of immunity to diphtheria in older people in the United Kingdom.4 It also brought us into line with recommendations from the World Health Organization.4

Figure 1: Sample group direction for tetanus and low dose diphtheria vaccine, Diftavax ®

Diftavax ® © Jane Chiodini 10/2002

Figure 1 (cont'd): Sample group direction for tetanus and low dose diphtheria vaccine, Diftavax ®
Diftavax ® © Jane Chiodini 10/2002
Figure 1 (cont'd): Sample group direction for tetanus and low dose diphtheria vaccine, Diftavax ®

Diftavax ® © Jane Chiodini 10/2002

For both tetanus and diphtheria, a total of five doses of vaccine at the appropriate intervals are considered to give lifelong immunity.

However, the guidance also documents for the first time that travellers going to areas where medical facilities may not be accessible should be given a booster dose of Td if they have not been vaccinated against tetanus in the past 10 years.

Giving tetanus vaccine at the time of an injury when lifelong protection has been established may not boost immunity early enough. If the risk is especially high, for example if the wound is contaminated with stable manure, human tetanus immunoglobulin should be given to provide immediate additional protection.4 This may be obtained from Baxter Healthcare (tel: 01635 206140).

Practices are beginning to keep minimal doses in stock in case of emergencies as it may take 24 hours to obtain the product. Stock should also be available in the local accident and emergency department but it would seem appropriate to manage this situation in primary care where possible.

Drawing up a PGD

Patient Group Directions (PGDs) have been a legal requirement in the NHS throughout the UK since 9 August 2000. National guidance is now available in England,5 Wales6 and Scotland.7 PGDs should be in place for the administration of prescription only medicines (POM) to groups of patients who may not be individually identified before presentation at the surgery. Therefore nurses administering these vaccines must only do so if there is an appropriate PGD in place. To do otherwise would be to act illegally and could result in a criminal prosecution under the Medicines Act.5,6,7

To work in accordance with a PGD, the nurse administering the POM must be named within the document and must sign it, as must the senior doctor giving his/her authorisation for the nurse to work within the PGD. To do this, however, the senior doctor within the practice must be satisfied that the nurse has adequate knowledge and is competent to administer the immunisation in line with the Nursing and Midwifery Council (NMC) Code of Professional Conduct8 and NMC Standards for the Administration of Medicines.9

It is useful to gather together all the information you need before starting work on a PGD, and it is essential to have access to the Summary of Product Characteristics (SPC) for the vaccine. SPCs are available directly from the drug manufacturers and on the internet at

The PGD should include:

  • The name of the business to which the direction applies
  • The date the direction comes into force and the date it expires
  • A description of the medicine(s) to which the direction applies
  • Class of health professional who may supply or administer the vaccine
  • Signature of a senior doctor or dentist and a pharmacist
  • Signature of an appropriate health organisation
  • The clinical condition or situation to which the direction applies
  • A description of those patients excluded from treatment under the direction
  • A description of the circumstances in which further advice should be sought from a doctor (or dentist, as appropriate) and arrangements for referral
  • Details of the appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration and minimum or maximum period over which the medicine should be administered
  • Relevant warnings including potential side-effects
  • Details of any necessary follow up action and the circumstances
  • A statement of the records to be kept for audit purposes.

Diftavax is the only combined tetanus and low dose diphtheria vaccine available in the UK. It may be ordered from Farillon on an allocated stock order for school leavers only. Practices should send a fax to Gary Talbot, Customer Care Supervisor, on 01708 378771 stating how much they need allocated on a fortnightly basis. Diftavax required for other circumstances must be obtained directly from the manufacturer or a wholesale supplier.


  1. Salisbury DM, Begg NT (eds). Immunisation against Infectious Disease. London: Department of Health,1996.
  2. World Health Organization. Factsheet No 89 - Diphtheria. Geneva: WHO, 2000.
  3. Department of Health. Replacement of single antigen tetanus vaccine by combined tetanus/ low dose diphtheria vaccine for adults and adolescents. London: DoH, 16 May 2002 (Letter).
  4. Department of Health. Update on Immunisation Issues PL/CMO/2002/4, PL/CNO/2002/4, PL/CPHO/2002/2. August 2002.
  5. NHS Executive. Patient Group Directions (England Only). HSC 2000/026. Leeds: NHSE, 2000.
  6. The National Welsh Assembly. Review of Prescribing, Supply and Administration of Medicines - Sale, Supply and Administration of Medicines by Health Professionals Under Patient Group Directions (PGD). COCNOCDOC SOCPhA-SALEMED3. 22 December 2000.
  7. Scottish Executive Health Department. NHS HDL (2001)7. Patient Group Directions. January 2001.
  8. Nursing and Midwifery Council. Code of Professional Conduct. London: NMC, 2002.
  9. Nursing and Midwifery Council. Standards for the Administration of Medicines. London: NMC, 2002.

Guidelines in Practice, December 2002, Volume 5(12)
© 2002 MGP Ltd
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