The value of the Vaccine Update resources

In this month's Travel health update, Jane examines why we should be avid readers of the Vaccine Update newsletters 

I’m sure many of you subscribe to Vaccine Update but opening up the document and having time to read it when we are all so busy can be a challenge. However, it may be useful to remind you how valuable this publication is in keeping you up to date on all immunisation issues.

For example, the last two months’ Vaccine Updates notified us of some excellent resources useful in a travel health context. The history of vaccine development and introduction of vaccines in the UK was updated to include the addition of influenza for four-year-old children in 2014. I find this chart a helpful aide-memoire when determining whether or not travellers are up to date on the national immunisation schedule for life in the UK prior to their trip. See http://tinyurl.com/kho9547

OFF-LABEL VACCINES

Three new documents have been created on the topic of off-label vaccines:

1. Off-label vaccines: a guide for parents (http://tinyurl.com/nr97cjl)

2. Off label vaccines: a guide for healthcare professionals (http://tinyurl.com/nr97cjl)

3. The use of vaccines that have been stored temporarily outside the recommended temperature range (http://tinyurl.com/opaelcc)

When a vaccine is introduced to the market, it has to have a licence for use in humans. This process is undertaken by the Medicines and Healthcare Regulatory Authority, and there will be strict terms for use in its licence, which are explained in the Summary of Product Characteristics (SPC) of the vaccine. If a vaccine is ‘off-label’ it means it is still authorised for use, but it is being used in a slightly different way to that specified in the SPC. In clinical practice, a healthcare professional often prescribes a medicine for use in a different way to the licence, based on additional information on that medicine or based on professional judgement of the patient’s best interest. An example of this in a travel context is Engerix B vaccine on a rapid schedule of days 0, 7 and 28 with a fourth reinforcing dose at 12 months. The SPC states this is a course that can be given to people aged 18 years and above in circumstances where a person is at immediate risk, including travel to areas of high endemicity, and a more rapid induction of protection is required. However, Public Health England guidance on hepatitis B (Chapter 18 of Immunisation against infectious diseases – the ‘Green Book’), states that although not licenced, Engerix B can be given on this schedule to those aged 16 to 18 years where it is important to provide rapid protection. This would be an off-label vaccine use. If administering a vaccine off-label we are obliged to explain this to the patient. Reading the guide is both useful and important.

Cold chain

If the cold chain is breached and a vaccine has been exposed to a temperature outside the 2 -8°C that the licence requires, advice has to be taken as to whether or not it can still be used. (See the ImmForm Helpsheet no. 18, available at http://tinyurl.com/mu227vo, which tells you what to do in the event of a fridge failure, other breach of the cold chain, or any incident leading to wastage of vaccine stock) It may be established that the vaccine can still be used, but in this situation it would be an off-label vaccine. The leaflet on the use of vaccines that have been stored temporarily outside the recommended temperature range helps to explain the situation to the patient.

Lastly, the leaflet and patient alert card for a patient who is asplenic, has had a splenectomy or has a dysfunctional spleen has been redesigned, and you can find it at https://www.gov.uk/government/publications/splenectomy-leaflet-and-card?ghgh

It is important to give this information to any patients in this category, whether they are travelling or not, and to instill the importance of carrying the alert card. Also to remember such patients now need to be given meningitis B in addition to pneumoccal, Hib/MenC, Meningococcal ACWY and an annual influenza vaccination. (See chapter 7 of the Green Book). These vaccines should all be provided ‘on the NHS’. There is space on the alert card to include this information.•