Boostrix®

• Recommended and offered free on the New Zealand Immunisation Schedule to all children at 11 years of age (in year 7 at school).
• Recommended, but not free, on the New Zealand Immunisation Catch Up Schedule to children from 7-10 years of age and adolescents from 18 years of age and adults who have not completed their primary course of three tetanus and diphtheria vaccinations. 
• From 1 January 2013 the vaccine is free for pregnant women between 28-38 weeks gestation.

• All adolescents at 11 years of age.
• Adolescents, up to their 18th birthday, who missed their 11 year old diphtheria, tetanus OR diphtheria, tetanus and pertussis booster vaccination.
• Recommended but only free when individual District Health Boards offer special programmes:
  • Pregnant women from 20 weeks of pregnancy (from 1 January 2013 the vaccine will be free for all pregnant women between 28-38 weeks gestation)
  • Health care staff who work with infants less than one year of age
  • Staff working in long term care facilities
  • Early childhood education staff
  • Students in training for occupations that work with children
  • Household and other close contacts of infants less than one year of age
  • Adults with an underlying medical condition in whom prevention of pertussis is important, e.g. those with chronic respiratory/lung disease

If children or adults have an evolving neurological disorder (e.g., uncontrolled epilepsy or deteriorating neurological state) there is the potential for confusion about the role of vaccination while clinically unstable. The risks and benefits of withholding vaccination until the clinical situation has stabilised should be considered on an individual basis.

• Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine; a previous dose of diphtheria, tetanus or pertussis vaccine or a component of the vaccine.
• Administration of Boostrix® should be postponed in individuals suffering from a fever over 38°C. The presence of a minor infection is not a reason to delay immunisation. 

Boostrix® is licensed as a booster vaccine and effectively increases a person’s existing immunity to tetanus, diphtheria and pertussis (whooping cough).

Unvaccinated children from 7 years of age and adults are expected to have some immunity to pertussis from exposure to the disease in the community. A single dose of Boostrix® is expected boost their existing protection to pertussis. However, a single dose of Boostrix® will not provide protection against tetanus and diphtheria in a previously unvaccinated person.

There is no published information on the effectiveness of Boostrix® when it is used for a primary immunisation course. However, based on the general principles of the human immune response to immunisation, a primary course of three Boostrix® vaccines is expected to result in protection from tetanus, diphtheria and pertussis.

After immunisation protection from pertussis lasts for 4-6 years (after the disease protection lasts 10-15 years).

For all vaccines, similar to most medications, an extremely rare allergic reaction called ‘anaphylaxis’ can occur. Anaphylaxis after immunisation occurs about 1-3 times in every one million vaccine doses. All vaccinators will have training and equipment to deal with this situation in the unlikely event of it occurring. No other serious responses to the vaccine have been identified.

Inactive vaccines, including tetanus, tetanus/diphtheria, hepatitis B and influenza vaccines have been administered during pregnancy for many years and no safety concerns have been identified.

Boostrix® is an inactive vaccine and also expected to be safe in pregnancy.

Adolescents, between 11 years of age and their 18th birthday, can catch up the missed dose of this vaccine at anytime.

• The Ministry of Health recommends that Boostrix® can be used for one, two or all three doses of a tetanus and diphtheria primary course for adults to offer additional pertussis protection.
• Boostrix® is not licensed for use as a primary series. However, there is no alternative non-booster strength vaccine available for adults and no safety concerns are expected when it is used in a primary series.
• Adacel® is an alternative vaccine to Boostrix®. It is also licensed as a booster immunisation for diphtheria, tetanus and pertussis protection. A link to the Adacel® data sheet lodged with Medsafe is on this page.
• Only the vaccine ADT™ Booster is funded for adults. Unless the adult requesting immunisation is pregnant at 28-38 weeks gestation or your local District Health Board (DHB) has a special programme in place Boostrix® OR Adacel® must be purchased from the manufacturer’s distributor for adults requesting it.
• When Boostrix® is administered outside of the National Immunisation Schedule or Catch Up Schedules a Doctor MUST prescribe the vaccine in the person's notes or a standing order must be in place.
• Adults requiring a boost of their pertussis immunity e.g., prior to travel, can receive either Boostrix® or Adacel®. A single dose of vaccine is usually enough to boost existing immunity to pertussis whether the adult has had a primary course of three pertussis containing vaccine doses in the past or not. This is because adults are expected to have had enough exposure to the disease in the community.

However, past exposure to pertussis cannot be guaranteed for every individual, to be confident that an adult does has the best protection against the disease a course of three Adacel® or Boostrix® immunisations.

Adacel®

• Boostrix® is only funded for the 11 year old schedule vaccine dose and for pregnant women between 28-38 weeks gestation. When a pertussis booster vaccine is requested for children, from 7 years of age and over, and other adults either Boostrix® or Adacel®must be purchased from the manufacturer's distributor.
• When Boostrix® is administered outside of the National Immunisation Schedule or Catch Up Schedules either a locally approved immunisation programme, doctor's prescription for the vaccine in the person's notes or a standing order must be in place.
• GSK is changingd the packaging for funded Boostrix® stock from ProPharma. The privaterly puchased stock from Healthcare Logistics has already changed. 
• A single dose of Boostrix® by deep intramuscular injection in children, 7 years of age and over, and adults is expected to provide protection against pertussis.
• A single dose of Boostrix® will not provide protection against tetanus and diphtheria in a previously unvaccinated person and two further diphtheria and tetanus containing vaccines must be administered at four weekly intervals.
• Boostrix® is licensed as a booster vaccine. It is used for primary vaccination out of licensure as there is no alternative primary vaccination strength vaccine available in New Zealand for these age groups. When the vaccine is used for a primary vaccination course use will be outside of current licensure and individuals need to be advised of this. No safety concerns are expected with use in these circumstances.

• The deltoid muscle is the preferred injection site.
• Boostrix® should be administered to children and adults with thrombocytopenia or bleeding disorders, e.g. haemophilia, in accordance with their haematologist's instructions. The vaccine may be given subcutaneously if the person's haematologist has advised against intramuscular injection of immunisations. Firm pressure should be applied to the injection site (without rubbing) for at least ten minutes following either intramuscular or subcutaneous injection.
• Women who are breast feeding can safely have Boostrix®. No adverse consequences for a breast feeding infant have been observed following vaccination of lactating women.
• Boostrix® can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.

• Boostrix® can be administered to pregnant women from 20 weeks gestation. From 1 January 2013 the vaccine will be funded for pregnant women between 28-38 weeks gestation.
  • For best protection of the newborn the booster immunisation would be given by the end of the 36th week of pregnancy:
    • This allows time for the woman's immune system to produce protection against whooping cough, reducing the risk she will have the disease when the baby is actually delivered and for the subsequent year when the baby's risk of complications from whooping cough is highest.
    • Circulating protection against whooping cough can also pass through the placenta into the baby and provide the baby with some of their own protection against severe disease for a short period of time (this varies between mothers and babies but is around 4-6 weeks).
  • After 36 weeks of pregnancy administering the booster immunisation:
    • Will increase the woman's protection against whooping cough, reducing the risk that she will have the disease during the baby's first year of life when their risk of complications from whooping cough is highest.
  • After delivery of the baby administering the booster immunisation:
    • Will increase the woman's protection against whooping cough, reducing the risk that she will have the disease during the baby's first year of life when their risk of complications from whooping cough is highest.

• Store between +2°C to +8°C. The expiry date of the vaccine is the last day of the month in the year indicated on the packaging.

After administration of Boostrix® to individuals who have previously completed a primary course of tetanus, diphtheria and pertussis immunisations serology of nine in 10 individuals demonstrated protection against tetanus and diphtheria.

Nine in 10 individuals also demonstrated an immune response to pertussis however studies have not yet established a correlation between serology results and protection against pertussis. However, it is expected that immunisation does reduce carriage of the Bordetella pertussis bacterium associated disease.

Unvaccinated children from 7 years of age and adults are expected to have some immunity to pertussis from exposure to the disease in the community. A single dose of Boostrix® is expected boost their existing protection against pertussis. A single dose of Boostrix® will not provide protection against tetanus and diphtheria in a previously unvaccinated person.

There is no published information on the effectiveness of Boostrix® when it is used for a primary immunisation course. However, based on the general principles of the human immune response to vaccination, a primary course of three Boostrix® vaccines is expected to result in protection from tetanus, diphtheria and pertussis.

After vaccination protection from pertussis lasts for 4-6 years (after the disease protection lasts 10-15 years).

Boostrix® is only funded for the 11 year old schedule vaccine dose or a catch up of this dose until the adolescent has their 18th birthday and pregnant women between 28-38 weeks gestation. Refer to the catch up section of the current Immunisation Handbook for age appropriate catch up schedules.

• A severe allergy (anaphylaxis) to a previous dose of this vaccine; a previous dose of diphtheria, tetanus or pertussis vaccine or a component of the vaccine.
• Administration of Boostrix® should be postponed in individuals suffering from acute severe febrile illness (fever over 38°C). The presence of a minor infection is not a contraindication.