03 Feb 2017
Vaccine supply, shortages and use of unlicensed medicinesHelpful links to further information on vaccines and use of unlicensed products
Vaccine shortages occur from time to time for a variety of reasons. Health professionals who are having difficulties obtaining vaccines are encouraged to contact their supplier for more information.
In some vaccine shortage situations, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health (DH) allow vaccine companies to import alternative vaccine products for use. These products may not have a UK marketing authorisation (formerly a product license), and should only be used where no suitable UK 'licensed' product is available.
Health professionals who are not independent prescribers must use a Patient Specific Direction to supply or administer these products, in addition to following any local guidelines. Guidance on prescribing unlicensed medicines can be found in the resources section below.
Sources of information on the use of vaccines
For vaccines with a UK marketing authorisation, information and recommendations for use are available in Public Health England’s ‘Green book’ Immunisation against infectious disease. Health professionals should monitor for updates to the Green Book, it is possible to subscribe to email alerts so you will be notified when chapters are amended.
Public Health England regularly publish Vaccine Update, describing the latest developments in vaccines and vaccination programmes including supply updates; you can subscribe to get these by email.
The manufacturer’s marketing authorisation information can be found in the Summary of Product Characteristics (SPC) on the electronic Medicines Compendium (eMC).
For products without a UK marketing authorisation, prescribing information, produced in English should be available from the supplier. Where, unavailable, this information should be sought directly from the manufacturer.
Updates to marketing authorisations
Changes to vaccine marketing authorisations are published on the eMC. Recommendations for the use of vaccinations are considered and made by Joint Committee on Vaccination and Immunisation (JCVI), and thereafter published in the relevant chapter of Immunisation against infectious disease the ‘Green Book’. While the JCVI meet on a regular basis, there may be a time lag between updates to the manufacturers marketing authorisation and updates being made to the Green Book. In these situations, where the Green Book and marketing authorisation differ, health professionals should make a clinical decision if they wish to follow information provided by the manufacturer.
- Electronic Medicines Compendium (eMC)
- General Medical Council: Prescribing unlicensed medicines
- Joint Committee on Vaccination and Immunisation (JCVI)
- MHRA: Off-label or unlicensed use of medicines: prescribers’ responsibilities
- Nursing and Midwifery Council: Nurse and midwife independent prescribing of unlicensed medicines
- Public Health England: Immunisation against infectious disease - the Green Book
- Public Health England: Vaccine Update