Summary of tetanus immunisation policy

In this summary

 

The disease

• Tetanus is an acute disease caused by the action of tetanus toxin, released following infection by the bacterium Clostridium tetani
• Tetanus spores are present in soil or manure and may be introduced into the body through a puncture wound, burn, or scratch—which may go unnoticed
• Neonatal tetanus is due to infection of the baby’s umbilical stump. The bacteria grow anaerobically at the site of the injury and have an incubation period of between 4 and 21 days (most commonly about 10 days)
• The disease is characterised by generalised rigidity and spasms of skeletal muscles. The muscle stiffness usually involves the jaw (lockjaw) and neck and then becomes generalised
• Tetanus can never be eradicated because the spores are commonly present in the environment, including soil
• Tetanus is not spread from person to person

The tetanus vaccination

• The vaccine is made from a cell-free purified toxin extracted from a strain of C. tetani. This is treated with formaldehyde that converts it into tetanus toxoid. This is adsorbed onto an adjuvant, either aluminium phosphate or aluminium hydroxide, to improve its immunogenicity
• Tetanus vaccines contain not less than 20 international units (IU) of tetanus toxoid
• The tetanus vaccine is only given as part of combined products for the UK national vaccination programme: 
  • diphtheria/tetanus/acellular pertussis/inactivated polio vaccine/Haemophilus influenzae type b/Hepatitis B (DTaP/IPV/Hib/HepB)
  • diphtheria/tetanus/acellular pertussis/inactivated polio vaccine (DTaP/IPV or dTaP/IPV)
  • tetanus/diphtheria/inactivated polio vaccine (Td/IPV)
• The above vaccines are thiomersal-free. They are inactivated, do not contain live organisms, and cannot cause the diseases against which they protect
• The combined vaccines above should be used where protection is required against tetanus, diphtheria, or polio in order to provide comprehensive, long-term protection against all three diseases

Storage

• Vaccines should be stored in the original packaging at +2˚C to +8˚C and protected from light. All vaccines are sensitive to some extent to heat and cold
• Heat speeds up the decline in potency of most vaccines, thus reducing their shelf life. Effectiveness cannot be guaranteed for vaccines unless they have been stored at the correct temperature
• Freezing may cause increased reactogenicity and loss of potency for some vaccines. It can also cause hairline cracks in the container, leading to contamination of the contents

Presentation

• Tetanus vaccine should only be used as part of combined products. DTaP/IPV, dTaP/IPV, and Td/IPV are supplied as a pre-filled syringe. DTaP/IPV/Hib/HepB is supplied as a pre-filled syringe, or a single dose ampoule, plus a separate vial containing a powder. Prefilled syringes/ampoules should have a uniform cloudy white suspension. The suspension may sediment during storage and should be shaken to distribute the suspension uniformly before use

Administration

• Vaccines are routinely given intramuscularly into the upper arm or anterolateral thigh. This is to reduce the risk of localised reactions, which are more common when vaccines are given subcutaneously
• For individuals with a bleeding disorder, vaccines should be given by deep subcutaneous injection to reduce the risk of bleeding
• Tetanus-containing vaccines can be given at the same time as other vaccines such as MMR, MenC, and hepatitis B
• The vaccines should be given at a separate site, preferably in a different limb. If given in the same limb, they should be given at least 2.5 cm apart
• The site at which each vaccine was given should be noted in the child’s records

Dosage and schedule

• First dose of 0.5 ml of a tetanus-containing vaccine
• Second dose of 0.5 ml, 1 month after the first dose
• Third dose of 0.5 ml, 1 month after the second dose
• Fourth and fifth doses of 0.5 ml should be given at the recommended intervals (see below)

Disposal

• Equipment used for immunisation, including used vials, ampoules, or discharged vaccines in a syringe, should be disposed of safely in a UN-approved puncture-resistant ‘sharps’ box, according to local authority regulations and guidance in the technical memorandum 07-01: Safe management of healthcare waste

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Recommendations for the use of the vaccine

• The objective of the immunisation programme is to provide a minimum of five doses of tetanus-containing vaccine at appropriate intervals for all individuals
• In most circumstances, a total of five doses of vaccine at the appropriate intervals are considered to give satisfactory long-term protection
• To fulfil this objective, the appropriate vaccine for each age group is determined also by the need to protect individuals against diphtheria, pertussis, Hib, hepatitis B, and polio

Primary immunisation

Infants and children under 10 years of age

• The primary course of tetanus vaccination consists of three doses of a tetanus-containing vaccine with an interval of 1 month between each dose
• DTaP/IPV/Hib/HepB is recommended to be given at 2, 3, and 4 months of age but can be given at any stage from 2 months up to 10 years of age
• If the primary course is interrupted it should be resumed but not repeated, allowing an interval of 1 month between the remaining doses

Children aged 10 years or over, and adults

• The primary course of tetanus vaccination consists of three doses of a tetanus-containing vaccine with an interval of 1 month between each dose
• Td/IPV is recommended for all individuals aged 10 years or over
• If the primary course is interrupted it should be resumed but not repeated, allowing an interval of 1 month between the remaining doses

Reinforcing immunisation

Children under 10 years of age

• Children under 10 years should receive the first tetanus booster combined with diphtheria, pertussis, and polio vaccines
• The first booster of a tetanus-containing vaccine should ideally be given 3 years after completion of the primary course, normally between 3.5 and 5 years of age
• When primary vaccination has been delayed, this first booster dose may be given at the scheduled visit provided it is 1 year since the third primary dose. This will re-establish the child on the routine schedule
  • DTaP/IPV or dTaP/IPV should be used in this age group
  • Td/IPV should not be used routinely for this purpose in this age group because it has been shown not to give equivalent diphtheria antitoxin response when compared with other recommended preparations

Children aged 10 years or over

• Individuals aged 10 years or over who have only had three doses of a tetanus-containing vaccine, with the last dose at least 5 years ago, should receive the first tetanus booster combined with diphtheria and polio vaccines (Td/IPV)
• The second booster dose of Td/IPV should be given to all individuals ideally 10 years after the first booster dose

All patients

• When the previous doses have been delayed, the second booster should be given at the school session or scheduled appointment provided a minimum of 5 years have lapsed between the first and second boosters. This will be the last scheduled opportunity to ensure long-term protection
• If a person attends for a routine booster dose and has a history of receiving a vaccine following a tetanus-prone wound, attempts should be made to identify which vaccine was given
• If the vaccine given at thetime of the injury was the same as that due at the current visit and was given after an appropriate interval, then the routine booster dose is not required. Otherwise, the dose given at the time of injury should be discounted as it may not provide long-term protection against all antigens, and the scheduled immunisation should be given. Such additional doses are unlikely to produce an unacceptable rate of reactions
• People who inject drugs (PWID) are at greater risk of tetanus. Every opportunity should be taken to ensure that they are fully protected against tetanus. Booster doses should be given if there is any doubt about their immunisation status

Vaccination of children with unknown or incomplete immunisation status

• Where a child born in the UK presents with an inadequate immunisation history, every effort should be made to clarify what immunisations they may have had (see Chapter 11 on vaccination schedules)
• A child who has not completed the primary course should have the outstanding doses at monthly intervals
• Children may receive the first booster dose as early as 1 year after the third primary dose to re-establish them on the routine schedule
• The second booster should be given at the time of leaving school to ensure long-term protection by this time, provided a minimum of 5 years is left between the first and second boosters
• Children coming from developing countries, from areas of conflict, or from hard-to-reach population groups may not have been fully immunised. Where there is no reliable history of previous immunisation, it should be assumed that they are unimmunised, and the full UK recommendations should be followed (see Chapter 11)
• Children coming to the UK may have had a fourth dose of a tetanus-containing vaccine that is given at around 18 months in some countries. This dose should be discounted as it may not provide satisfactory protection until the time of the teenage booster. The routine pre-school and subsequent boosters should be given according to the UK schedule
• Further advice on vaccination of children with unknown or incomplete immunisation status is published by Public Health England

Travellers and those going to reside abroad

• All travellers should ensure that they are fully immunised according to the UK schedule (see above). Additional doses of vaccines may be required according to the destination and the nature of travel intended (see the National Travel Health Network and Centre)
• For travellers to areas where medical attention may not be accessible and whose last dose of a tetanus-containing vaccine was more than 10 years previously, a booster dose should be given prior to travelling, even if the individual has received five doses of vaccine previously. This is a precautionary measure in case immunoglobulin is not available to the individual should a tetanus-prone injury occur
• Where tetanus, diphtheria, or polio protection is required and the final dose of the relevant antigen was received more than 10 years ago, Td/IPV should be given

Tetanus vaccination in laboratory workers

• Individuals who may be exposed to tetanus in the course of their work, in microbiology laboratories, are at risk and must be protected (see Chapter 12)

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Contraindications

• There are very few individuals who cannot receive tetanus-containing vaccines. When there is doubt, appropriate advice should be sought from the relevant specialist consultant, the local screening and immunisation team, or local Health Protection Team rather than withholding the vaccine
• The vaccines should not be given to those who have had:
  • a confirmed anaphylactic reaction to a previous dose of a tetanus-containing vaccine, or
  • a confirmed anaphylactic reaction to neomycin, streptomycin, or polymyxin B (which may be present in trace amounts)

Precautions

• Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation
• If an individual is acutely unwell, immunisation should be postponed until they have fully recovered. This is to avoid wrongly attributing any new symptom or the progression of symptoms to the vaccine

Systemic and local reactions following a previous immunisation

• This section gives advice on the immunisation of children with a history of a severe or mild systemic or local reaction within 72 hours of a preceding vaccine. Immunisation with tetanus-containing vaccine should continue following a history of:
  • fever, irrespective of its severity
  • hypotonic-hyporesponsive episodes (HHE)
  • persistent crying or screaming for more than 3 hours
  • severe local reaction, irrespective of extent

Pregnancy and breast-feeding

• Tetanus-containing vaccines may be given to pregnant women when protection is required without delay

Premature infants

• Premature infants should be vaccinated in accordance with the national routine immunisation schedule according to their chronological age
• Very premature infants (born ≤28 weeks of gestation) who are in hospital should have respiratory monitoring for 48–72 hours when given their first immunisation, particularly those with a previous history of respiratory immaturity
  • if the child has apnoea, bradycardia, or desaturations after the first immunisation, the second immunisation should also be given in hospital, with respiratory monitoring for 48–72 hours
• As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed

Immunosuppression and HIV infection

• Individuals with immunosuppression or HIV infection (regardless of CD4 count) should be given tetanus-containing vaccines in accordance with the recommendations above. These individuals may not make a full antibody response. Re-immunisation should be considered after treatment is finished and recovery has occurred. Specialist advice may be required

Neurological conditions

• The presence of a neurological condition is not a contraindication to immunisation but if there is evidence of current neurological deterioration, deferral of vaccination may be considered, to avoid incorrect attribution of any change in the underlying condition
  • the risk of such deferral should be balanced against the risk of the preventable infection, and vaccination should be promptly given once the diagnosis and/or the expected course of the condition becomes clear
• If a child has experienced encephalopathy or encephalitis within seven days of immunisation, it is unlikely that these conditions will have been caused by the vaccine and they should be investigated by a specialist
  • if a cause is identified or the child recovered within seven days, immunisation should proceed as recommended
• In children where no underlying cause was found and the child did not recover completely within 7 days, immunisation should be deferred until the condition has stabilised or the expected course of the condition becomes clear
• If a seizure associated with a fever occurred within 72 hours of a previous immunisation with tetanus containing vaccine, immunisation should continue as recommended if a cause is identified or the child recovers within 24 hours
  • if no underlying cause has been found and the child did not recover completely within 24 hours, further immunisation should be deferred until the condition is stable

Deferral of immunisation

• There will be very few occasions when deferral of immunisation is required. Deferral leaves the child unprotected; the period of deferral should be minimised so that immunisation can commence as soon as possible
• If a specialist recommends deferral this should be clearly communicated to the general practitioner, who must be informed as soon as the child is fit for immunisation

Adverse reactions

• Pain, swelling, or redness at the injection site are common and may occur more frequently following subsequent doses. A small painless nodule may form at the injection site; this usually disappears and is of no consequence
• Fever, convulsions, high-pitched screaming, and episodes of pallor, cyanosis, and limpness (HHE) occur with equal frequency after both DTaP and TD vaccines
• Confirmed anaphylaxis occurs extremely rarely
• Other allergic conditions may occur more commonly and are not contraindications to further immunisation
• All suspected adverse reactions to vaccines occurring in children, or adults, to vaccines should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card scheme

Management of patients with tetanus-prone wounds

• Tetanus-prone wounds include:
  • puncture-type injuries acquired in a contaminated environment and likely therefore to contain tetanus spores e.g. gardening injuries
  • wounds containing foreign bodies
  • compound fractures
  • wounds or burns with systemic sepsis
  • certain animal bites and scratches—although smaller bites from domestic pets are generally puncture injuries animal saliva should not contain tetanus spores unless the animal has been routing in soil or lives in an agricultural setting
• Note: individual risk assessment is required and this list is not exhaustive e.g. a wound from discarded needle found in a park may a tetanus-prone injury but a needle stick injury in a medical environment is not
• High-risk tetanus-prone wounds include any of the above with either:
  • heavy contamination with material likely to contain tetanus spores e.g. soil, manure
  • wounds or burns that show extensive devitalised tissue
  • wounds or burns that require surgical intervention that is delayed for more than six
  • hours are high risk even if the contamination was not initially heavy
• Thorough cleaning of wounds is essential

Immunisation recommendations for clean and tetanus-prone wounds

Immunisation status	Immediate treatment			Later treatment
	Clean wound*	Tetanus prone	High risk tetanus prone
Those aged 11 years and over, who have received an adequate priming course of tetanus vaccine† with the last dose within 10 years Children aged 5–10 years who have received priming course and preschool booster Children under 5 years who have received an adequate priming course	None required	None required	None required	Further doses as required to complete the recommended schedule (to ensure future immunity)
Received adequate priming course of tetanus vaccine† but last dose more than 10 years ago Children aged 5–10 years who have received an adequate priming course but no preschool booster Includes UK born after 1961 with history of accepting vaccinations	None required	Immediate reinforcing dose of vaccine	Immediate reinforcing dose of vaccine One dose of human tetanus immunoglobulin‡ in a different site
Not received adequate priming course of tetanus vaccine† Includes uncertain immunisation status and/or born before 1961	Immediate reinforcing dose of vaccine	Immediate reinforcing dose of vaccine One dose of human tetanus immunoglobulin‡ in a different site	Immediate reinforcing dose of vaccine One dose of human tetanus immunoglobulin‡ in a different site
* Clean wound is defined as wounds less than 6 hours old, non-penetrating with negligible tissue damage † At least three doses of tetanus vaccine at appropriate intervals. This definition of ‘adequate course’ is for the risk assessment of tetanus-prone wounds only. The full UK schedule is five doses of tetanus containing vaccine at appropriate intervals ‡ If tetanus immunoglobulin is not available, human normal immunoglobulin may be used as an alternative

Supplies of vaccines

• Infanrix hexa (diphtheria/tetanus/3-component acellular pertussis/inactivated polio vaccine/Haemophilus influenzae type b/Hepatitis B (DTaP/IPV/Hib/HepB))—manufactured by GlaxoSmithKline
• Repevax (diphtheria/tetanus/5-component acellular pertussis/inactivated polio vaccine (dTaP/IPV))—manufactured by Sanofi Pasteur
• Infanrix IPV (diphtheria/tetanus/3-component acellular pertussis/inactivated polio vaccine (DTaP/IPV))—manufactured by GlaxoSmithKline
• Revaxis (diphtheria/tetanus/inactivated polio vaccine (Td/IPV))—manufactured by Sanofi Pasteur
• Boostrix IPV (diphtheria/tetanus/5-component acellular pertussis/inactivated polio vaccine (dTaP/IPV))—manufactured by GlaxoSmithKline