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Guidance for practice nurses on using unlicensed TB vaccine

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Nurses and other healthcare professionals are to receive new guidance on the unlicensed BCG jab that is being used in response to the current global shortage of the tuberculosis vaccine.

A new guide has been produced on the administration and storage of the unlicensed BCG vaccine, which is supplied by Canadian firm Intervax Ltd but manufactured in Bulgaria by BB NCIPD Ltd.

The information, published online by Public Health England, will also be supplied with the delivery of the vaccine and should be used instead of the information insert inside the pack.

It covers how to reconstitute the paediatric and adult dose, how to store the vaccine, how to administer the vaccine and also important eligibility criteria.

PHE is importing the InterVax product due to the ongoing shortage of BCG vaccine and delays in receiving the vaccine from its usual supplier in Denmark, the Statens Serum Institute.

The agency noted that, while the vaccine does not have a UK license, it has been used widely around the world for many years and is the only suitable alternative BCG vaccine currently available.

The guide highlighted the following four points as “important to note” for health professionals.

  • The presentation in each pack is 20 x 1ml amber glass ampoules of lyophilised powder. A separate pack of 20 x 1ml clear glass ampoules of diluent will also be supplied.
  • The BCG vaccine should be reconstituted only with the diluent supplied which is labelled “DILUENT FOR BCG VACCINE (SALINE)”. No other diluent should be used.
  • The vaccine is to be administered by intradermal injection only.
  • Ideally the reconstituted vaccine should be used immediately or within a short period of time. However, if not used immediately, the reconstituted vaccine should be stored away from light, at between 2° and 8°C and must discarded after 6 hours. Care should be taken when storing the reconstituted vaccine to ensure it remains upright.

PHE added that, as the product does not have a marketing authorisation for use in the UK, a Patient Group Direction cannot be used to supply or administer this vaccine.

The vaccine will, therefore, need to be prescribed by using a Patient Specific Direction, prescription or patient medicines administration chart.

Public Health England has also published a guide for parents and carers, explaining the decision to use the InterVax product – titled Why is my child being offered unlicensed BCG (TB) vaccine?

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