Off-Label Vaccines: An Introductory Guide for Healthcare Professionals

Overview

This Guidelines summary contains advice for healthcare professionals on circumstances that can lead to vaccines being used 'off label', when vaccines could be used off label, and addressing patient concerns about off-label vaccine use. This summary does not include information from the full guideline on how a vaccine gets a licence, or examples of successful off-label vaccine use. For information in these areas, refer to the full guideline.

Reflecting on your Learnings

Reflection is important for continuous learning and development, and a critical part of the revalidation process for UK healthcare professionals. Click here to access the Guidelines Reflection Record.

Use of Vaccines in Ways Not Specified in the Licence

• A medicine or vaccine can only be marketed and promoted for use by the licence-holder in accordance with the specifications of the licence
• However, it is common in clinical practice for healthcare professionals to prescribe a medicine for use in a different way from that stated in its licence. This is because the health professional has additional information about the medicine or has exercised their professional judgement, and decided that the medicine would still be appropriate for an individual patient
• This is often referred to as off-label use. The responsibility for such use rests with the healthcare professional
• Off-label use of medicines is fairly common, particularly in children, as most medicines are tested first in adults and conducting studies in large numbers of children can be difficult
• Many vaccines are designed to be used in children and have been tested in this age group, and so off-label use of vaccines is much less common but does occur from time to time
• Vaccine use is usually based on the recommendation of the Joint Committee on Immunisation and Vaccination (JCVI).

Reasons Patient May be Offered Off-Label Vaccines

• All routine vaccines currently used in the UK are licensed to be placed on the market
  • as well as having the data to support their safety and efficacy in accordance with the licence, it means they have been manufactured to a high standard and have undergone independent batch testing before release
  • sometimes clinical experts on the JCVI recommend that the vaccine should be used in people who were not included in the initial trials, or recommend that the number or timing of the doses is different from that used in the trials
  • as these situations were not specified in the licence, this would mean the vaccine was being used off label
• This recommendation is normally based on additional evidence presented to the committee that may have been obtained by a research group independent from the manufacturer
  • sometimes it reflects the expert clinical judgement of the members based on their understanding of how vaccines work in different patient groups
  • when a vaccine is being used off label, it means that experts have advised that there are clear benefits of using the vaccine in this way and that the vaccine is still considered to be safe and effective
  • off-label use of vaccines does not mean they are unlicensed—they are licensed for use in different people or to be used in a slightly different way from the licence recommendation
• Often, the information gained from off-label use is then used by the manufacturer to apply to modify the license to include these different uses.

Deciding When Off-Label Vaccines Should be Used

• Sometimes, after the European Medicines Agency or Medicines and Healthcare products Regulatory Agency (MHRA) has licensed a vaccine, circumstances change—such as an outbreak of a disease, which necessitates the vaccine being used in a different population. Sometimes new data emerges, which the manufacturer may not have produced themselves, and so it is not yet reflected in the licence
• Such studies are often conducted independently to ensure that the vaccine fits into the existing UK schedule, avoiding additional visits or unnecessary injections. In these situations, a recommendation may need to be made that is different from the terms of the licence, so that as many people as possible can benefit from the protection offered by the vaccine
• For the national vaccine programme, these decisions are usually taken by the JCVI. Most commonly, they involve recommending that a vaccine that is licensed for one group of patients can be used off label in another age group, or that a vaccine may be used at a different schedule from that in the licence.

Patient Concerns About Off-Label Vaccine Use

• If individuals or parents have concerns about receiving an off-label vaccine, they should be reassured that the vaccine is being given in this way following expert consideration by the JCVI or their healthcare professional that it is safe and effective to give it in this way, and that there is a good reason to do so
• Not receiving a recommended vaccine could put themselves or their child at risk of contracting a serious infection.

Further Information

• The MHRA has comprehensive information on this topic, available via GOV.UK
• The General Medical Council also provides information about prescribing in its ethical guidance.