Vaccines and medicines: availability, supply, shortages and use of unlicensed medicines

Information for health professionals on availability of vaccines and use of unlicensed products

Vaccines with UK marketing authorisation

For vaccines with a UK marketing authorisation (i.e. UK product license), information and recommendations for use are available in the '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.

The UK Health Security Agency (UKHSA) regularly publish Vaccine update, describing the latest developments in vaccines and vaccination programmes in the UK including supply updates; you can subscribe to get these by email.

Summary vaccine information is available in the Topics in Brief and Factsheets & Resources section of our website.

The manufacturer’s marketing authorisation information can be found in the Summary of Product Characteristics (SmPC) on the electronic medicines compendium (emc).

Vaccine and medicines shortages

Vaccine shortages occur from time to time for a variety of reasons. Health professionals who are having difficulties obtaining vaccines or medicines are encouraged to contact their supplier for more information.

When vaccine supplies are restricted, health professionals should prioritise vaccine use; an effective risk assessment will ensure vaccine recommendations are appropriate, help identify higher risk travellers, and give priority to those who are most vulnerable.

In some vaccine shortage situations, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health & Social Care (DHSC) grant approval for vaccine companies to import alternative vaccine products. These products may not have a UK marketing authorisation and preference is that they should only be used where no suitable UK 'licensed' product is available. Temporary recommendations for administration of vaccines (including information on dose sparing) and travel-related medicines may be provided by UKHSA.

Health professionals who are not independent prescribers must use a Patient Specific Direction (PSD) to supply or administer these products, in addition to following any local guidelines. Prescribing information, produced in English should be available from the supplier. Where, unavailable, this information should be sought directly from the manufacturer. Additional resources for guidance on prescribing products without a UK marketing authorisation can be found in the resources section below.

Table 1 below contains information on vaccines (related to travel health) supply shortages/discontinuations.

Table 1. Vaccines supply status

Please note: This table is updated monthly and only covers vaccines discontinued or in short supply. It does NOT replace information obtained from the respective manufacturers.

*not suitable for individuals with severe egg allergies or other contraindications, consult The Green Book: Rabies Chapter 27.

Information on vaccine supply is available from UK Health Security Agency: Vaccine Update.

Table 2. Antimalarial(s) supply status

Please note: This table is updated monthly and does NOT replace information obtained from the respective manufacturers.

Updates to marketing authorisations

Changes to vaccine and medicines marketing authorisations are published on the electronic medicines compendium (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. Guidelines for use of antimalarials are updated annually by the UKHSA Advisory Committee on Malaria Prevention (ACMP).

Resources

• NHS Travel Vaccinations
• electronic medicines compendium (emc)
• General Medical Council: Good practice in prescribing and managing medicines and devices
• 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
• UK Health Security Agency: Immunisation against infectious disease - the Green Book
• UK Health Security Agency: Vaccine Update
• Travax
• Royal Pharmaceutical Society: Competency framework for all prescribers