Chilhood immunisations: Dealing with the out of the ordinary

Most routine childhood immunisations are just that – routine. But to keep us on our toes, situations crop up from time to time when we need to exercise both wisdom and knowledge, and to ensure that whatever crops up, our practice is evidence-based

General practice nurses have a responsibility to promote the benefits of childhood immunisation and any opportunity to immunise should not be missed. To remain competent and confident in our immunisation knowledge and skills, it is vital that we keep up to date with national policy and changes to vaccination programmes, to ensure our practice is evidence-based and current. Our ‘go-to’ resource is ‘The Green Book’ – the Public Health England (PHE) publication ‘Immunisation against Infectious Disease’ – and having ready online access to it at work is paramount.¹

The routine schedule for childhood immunisations ensures that very young children are protected against disease at the earliest opportunity and should be followed as closely as possible.^2,3 However, although we have this ‘routine’ schedule, sometimes life is everything but routine. What do we do if a child hasn’t had any of their primary vaccinations? How do we deal with parents who demand to have the 12 months immunisations spread over several visits? What do we do if the vaccine fridge door has been left ajar overnight? Which preschool vaccines can you give a child who is about to have chemotherapy for acute lymphoblastic leukaemia? Fortunately, we have ready access to numerous evidenced-based resources to deal with not just the essentials of immunisation but the answers to more unusual situations which may present themselves. Box 1 provides a list of fundamental resources to underpin our practice.

A BREAK IN THE COLD CHAIN

Maintenance of the cold chain is essential for vaccine safety and efficacy, and forms part of the vaccine’s product licence. From their manufacture, transportation and distribution to final refrigeration within the surgery vaccines must be stored between +2oc and +8oc. Should storage temperatures fall outside these parameters at any point along this process it is classified as a break in the cold chain, with ensuing consequences. If vaccines freeze, it can reduce their efficacy, exacerbate local reactions and risk contamination should the vial or syringe crack from the effects of low temperatures.⁴ Equally, warmed vaccines may be less effective.⁵ Our responsibility, therefore, is to ensure that the cold chain is maintained from receipt of the vaccines at the surgery right up to preparing it to give to the patient. The resources in Box 1 provide links for good practice recommendations for storage, specifications for refrigeration, calibration of thermometers, recording devices, frequency of recording, documentation and action to be taken in view of a cold chain breach.4–7 A nominated member of staff should be responsible for vaccine management, which includes storage, ordering, monitoring, maintaining records as well as ensuring all staff know how to report a cold chain failure – from the receptionist who receives the parcel from the delivery driver to the clinical staff who administer the vaccines.

So what are our responsibilities on discovering a break in the cold chain?

• Quarantine the vaccines to a fridge where the cold chain is maintained
• Label the quarantined vaccines – neither use or destroy at this point until guidance is sought
• Report to your Immunisation co-ordinator as per your local policy and to ImmForm (in England)
• Investigate

– what monitoring has taken place

– when was the temperature of the fridge last between +2 - +8oc

– how long the fridge was outside of these temperature parameters

– what was the temperature range within this period

• Identify all of the vaccines potentially affected

– Have any vaccines already been given to patients?

• Contact each vaccine’s manufacturer for advice on specific vaccines affected
• Seek expert advice and guidance as per your local practice policy
• Following risk assessment and expert guidance, decide whether the vaccines are still safe to be used on a case-by-case basis
• Ensure clear documentation is kept of the incident and action taken

Each practice must ensure it has its own policy and operating procedures, including managing incidents, based on national guidance.4–7 Appropriate management of such incidents can also reduce the amount of unnecessary wastage of vaccines and significant costs to the NHS.

OFF-LABEL VACCINES

Following a minor breach in the cold chain, some vaccines may be deemed suitable to use, once advice has been sought.⁸ In these circumstances, expert opinion from PHE and/or the vaccine manufacturer(s) will determine whether the efficacy and safety of vaccine has been maintained and it can be used. Due to the interruption in the cold chain, the vaccine is now deemed ‘off-label’, i.e. outside the manufacturer’s marketing authorisation. The implications for practice are that, in order for a parent/guardian to give fully informed consent before the vaccine is administered, the following must be discussed:

• Inform parent/guardian that the vaccine is ‘off-label’ and why
• Advise that expert opinion has been sought to reassure parents that the safety and efficacy of the vaccine is maintained
• Advise that receiving/delaying a vaccine could potentially put a child at risk
• Advise that the parent/guardian has a choice as to whether their child receives the vaccine in this instance
• Obtain verbal consent before any vaccine is given
• Provide a leaflet explaining ‘off-label’ use of vaccines

As the vaccine is now outside the product licence, it can no longer be given under a Patient Group Direction (PGD).⁹ Instead, a Patient Specific Direction (PSD) must be used and scanned in with the patient records. It must be documented in the patient’s records that the vaccine was used ‘off-label’ and that the parent/guardian consented to it being given following full disclosure and discussion. It is the responsibility of the immunising practitioner when any vaccines are used outside of the cold chain.

PGD or PSD?

A Patient Specific Direction (PSD) is a written instruction from a qualified and registered prescriber for a medicine, which details the dose, route and frequency, to be administered to an individually named patient or several named patients.Patient Group Directions (PGDs) are written instructions to enable the administration of licensed medicines by qualified healthcare professionals to groups of patients who may not be individually identified in advance.

INCOMPLETE OR UNCERTAIN IMMUNISATION STATUS

Vaccination uptake in the UK for the under 5s remains high, with many regions meeting the WHO uptake target of 95%.¹⁰ However, many children remain un-immunised or partially immunised. The reasons are multifactorial, and may include parental choice, deprivation, immigration, no permanent address (e.g. refugees, travelling communities), lost records. Where there is no evidence of previous immunisation history, it has to be assumed that the child is un-immunised. Public Health England’s algorithm to determine which vaccines need to be given to children with uncertain or incomplete immunisation status is invaluable in practice.^2,11

In essence, the guidance suggests:

• Children without a reliable vaccine history should be assumed ‘vaccine naive’ i.e. not immunised and therefore a schedule for full immunisation planned
• Children who come to reside in the UK who are part way through their immunisations from another country should be transferred onto the UK schedule
• Once a primary course has been started, simply resume the course – there is no need to repeat doses or restart the course
• Aim to protect children in the shortest time possible and plan the catch-up schedule with the minimal number of visits

In some countries, children receive a 4th dose of tetanus at the age of 18 months. In this instance, as there is no evidence to suggest this booster will provide sufficient protection until the teenage booster, this 4th dose is ignored and the child should be given the DTaP/IPV as per the schedule for preschool immunisation and the subsequent school-leavers booster at 14 years.¹² Equally, in some countries where MMR is given before the age of 12 months the immune response could be sub-optimal.¹³ In this instance, ignore any doses given under 1 year and immunise as per the UK schedule.

COMBINATION VACCINES AND MULTIPLE VACCINATION

Parents/carers may ask whether it is ‘safe’ for their infants and children to receive multiple vaccines in one appointment as recommended in the UK immunisation schedule. These concerns must be addressed and reassurance given to the huge benefits of providing adequate protection for their babies and children in one visit.¹⁴ From the day a child is born it is exposed to hundreds and hundreds of antigens from viruses and bacteria in the environment on a daily basis as part of normal living. In comparison, vaccines provide very little challenge to the immune system and are certainly not an additional burden.^15,16 Some vaccines have been manufactured specifically to reduce the number of injections a baby receives, such as the 6-in-1 DTaP/IPV/Hib/Hep B and the MMR, to ensure best possible protection. Studies have shown that vaccines are as effective in combination as they are individually with no greater risk of side-effects.¹⁶ Delaying vaccination by ‘spreading the load’ leaves very young children unprotected for longer and it is more traumatic for the child to keep bringing them back for more injections. Increasing the number of visits also increases time and efforts for parents (and nurses!). It also risks further vaccines being missed and risks ill-health. All this for no good reason. Separating appointments should therefore be avoided at all costs. It is also worth noting that there is no need to postpone the 8 week immunisations until after a GP baby check.

RECORDING BATCH NUMBERS

Recent discussion in the GPN community has highlighted concerns as to which batch number and expiry date to record for vaccines that are reconstituted, such as Infanrix-Hexa DTaP/IPV/Hib/HepB), Menitorix Hib/MenC, Priorix MMR vaccine and MenACWY vaccines. The issue is that the different components of the vaccine – the powder and the solvent/suspension – each have a different batch number. So which one to record? PHE recommends in this instance that the batch number and expiry date on the vaccine’s box is the batch number for the entire product and this is the one which should be recorded on both the child’s record and on the child health IT system.¹⁷ To further complicate matters, on the boxes of Menitorix there are also two batch numbers, for example A76CA352A and A76DA352A. In this instance, the one to record is the batch number with ‘C’ in the middle, i.e. ‘C’ for combined powder and solvent. The D represents the diluent.¹⁷

SPECIAL CONSIDERATIONS

There are very few circumstances where an individual can’t be immunised and referring for specialist advice in certain situations may be more appropriate than automatically withholding a vaccine.¹⁸

Immunosuppression and immunodeficiency

Inactivated vaccines cannot replicate and can therefore be given to children with immunosuppression or immunodeficiency although the response to the vaccine may be lower. However, in the case of live vaccines, depending on the severity of the child’s immunosuppression, there is a risk of severe and even fatal infections as would be the case for children with acute or chronic leukaemia, for example.¹⁸ MMR, Rotarix rotavirus vaccine and live attenuated influenza vaccine (LAIV) are live vaccines, and although their use may be considered if the risk of disease outweighs the risk from the vaccine, depending on the level of immunosuppression, but specialist advice MUST be sought.^18,19 Children who are about to undergo immunosuppressive therapy should ideally be vaccinated with their inactivated vaccines two weeks prior to commencing their treatment but may need repeat doses once treatment is completed.

Household contacts of patients with immunosuppression/deficiency should ensure their immunisation status is up to date as per the UK immunisation schedule.³ But should we be concerned about the use of live vaccines in this instance? Evidence suggests that in respect to MMR there is no risk to the immunosuppressed contacts of MMR vaccines.¹⁹ With regards to Rotarix, there is viral antigen shedding in the stools of infants after rotavirus vaccination, and attention to hand hygiene after nappy changing, before food preparation and before any direct contact with individuals with immunosuppression reduces any risk of virus transmission. Children should be immunised against influenza in line with the UK schedule and recommendations, but those children who are unable to avoid contact with very severely immunocompromised patients i.e. bone marrow patients and patients requiring isolation, should be given an inactivated vaccine instead of the LAIV.

Prematurity

Babies who are born prematurely should not have their vaccines withheld or delayed as they are more susceptible to infectious disease. Therefore premature babies should be given their vaccinations at the appropriate chronological age, according to the UK schedule, irrespective of their gestational age at birth. The Green Book recommends that very premature babies (under 28 weeks) should have their first vaccines in hospital and will require respiratory monitoring for the first 48-72 hours following immunisation due to the small increased risk of apnoea in premature infants.¹⁹ The Green Book recommendation for needle length for intramuscular injections in infants and children is to use a 25mm 23G (blue) or 25mm 25G (orange) needle. However, in preterm infants, a shorter 16mm 25G (orange) needle may be considered for tiny legs in such special circumstances.¹⁹ Following meningitis B vaccine, babies born before 32 weeks gestation should be prescribed post-vaccination prophylactic doses of infant paracetamol, calculated by their current weight.

Early childhood vaccination in travellers

MMR: In the UK, the first dose of MMR is given at 12 months of age, with a further dose at 3 years and 4 months (or soon after).³ Children travelling to areas where disease is endemic or where there is an epidemic, may need earlier protection prior to travel. In this instance, the Green Book says MMR vaccine can be given from 6 months of age.^2,20 This may differ from the recommendations in the vaccines’ Summary of Product Characteristics (SmPCs) but the advice in the Green Book overrides the SmPCs in line with recommendations from the Joint Committee on Vaccination and Immunisation (JCVI).21–23 As previously mentioned, infants under 12 months may have sub-optimal response to the vaccine so any dose of MMR given before they are one year old is discounted and the child should still be immunised at the appropriate times with the two doses as per the UK schedule.

Children who have already had their first dose of MMR at the scheduled age (12 months) but are travelling to risk areas before they receive their second dose (3y4m) should be given the second dose prior to travel as long as it is 1 month after their first dose. Furthermore, if a child has received 2 doses of MMR within 3 months of each other and is under 18 months of age, they will then need another dose of MMR when they are 3y4m for optimal protection.²⁰

Primary immunisations: For travel purposes to endemic areas, the first dose of primary immunisations can be given to infants from 6 weeks old.² If given early, the 4 week interval between each dose of the primary course of DTaP-containing vaccine should still be adhered to. However, if, for exceptional travel purposes, one of the subsequent doses needs to be given up to a week before it is scheduled (i.e. from 3 weeks after the previous dose) only one dose of the primary course can be brought forward in this way.²

’I DON’T WANT MY CHILD VACCINATED!’

Parents who choose not to immunise their children may do so for many reasons but part of a GPN’s role is to understand their concerns and beliefs about vaccination and address misunderstandings, challenge views and allay unfounded fears. Parents sometimes question why their child is being immunised against a disease that is rarely seen in the UK.²⁴ But vaccination is vital if we want to protect not just ourselves, but also those around us. People travel, outbreaks occur, and throughout the world children are still infected, become seriously ill and still die of preventable infections. It is everyone’s responsibility to reduce the spread of disease, and vaccination lies at the very heart of that responsibility.

CONCLUSION

Vaccinating children can be both straightforward and complicated. As GPNs we need the wisdom and resources to tackle the challenges that present themselves, to ensure that our practice is evidenced-based and to use the plethora of resources available to us to share and discuss with our colleagues within the GPN community to inform us when we’re not quite sure.

ACTIVITY – CHILDHOOD IMMUNISATIONS AND CONSENT

Using Chapter 2 of ‘The Green Book’ for reference consider the following:²⁵

• Should consent be verbal or written?
• What constitutes fully informed consent?
• What supportive materials do you have in your practice for parents?
• How do you manage parents who do not speak English?
• Who has automatic parental responsibility for their child?
• What do you do if the parents disagree on whether their child should receive a vaccine or not?

RESOURCES FOR PROFESSIONALS

NHS Health Protection Scotland. Guidance on vaccine storage and handling, version 3http://www.hps.scot.nhs.uk/resourcedocument.aspx?id=6330Public Health England. Immunisation against infectious disease – ‘The Green Book’www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-bookPublic Health England. Immunisationhttps://www.gov.uk/government/collections/immunisationRCN Immunisation (including vaccine storage)https://www.rcn.org.uk/clinical-topics/public-health/specialist-areas/immunisationPHE. The Routine Immunisation Schedule, from Autumn 2017https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/633693/Complete_imm_schedule_2017.pdfPHE. Vaccine Updatehttps://www.gov.uk/government/collections/vaccine-updatePHE. Vaccination of individuals with uncertain or incomplete immunisation status (updated November 2017)https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/658744/Algorithm_of_individuals_with_uncertain_or_incomplete_vaccine_status.pdf

RESOURCES FOR PARENTS AND CARERS

NHS Choices Childhood Immunisationshttps://www.nhs.uk/conditions/vaccinations/childhood-vaccines-timeline/?Public Health Matters Blog 14: Questions new parents ask about vaccinationhttps://publichealthmatters.blog.gov.uk/2016/04/25/14-questions-new-parents-ask-about-vaccination/Oxford Vaccine Group. The Vaccine Knowledge Projecthttp://vk.ovg.ox.ac.ukNHS Scotland. What to expect after immunisation: Babies and children up to 5 years, 2017 (Available in various languages)http://www.immunisationscotland.org.uk/documents/6122.aspx

REFERENCES

1. Public Health England (PHE). Immunisation Against Infectious Disease. September 2014.

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

2. PHE. Immunisation Against Infectious Disease. Chapter 11: The UK Immunisation Schedule. September 2016. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/554298/Green_Book_Chapter_11.pdf

3. PHE. The routine immunisation schedule from Autumn 2017. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/633693/Complete_imm_schedule_2017.pdf

4. PHE. Protocol for ordering, storing and handling vaccines. March 2014

5. NHS Health Protection Scotland. Guidance on vaccine storage and handling. Version 3, 2017 Available at: http://www.hps.scot.nhs.uk/resourcedocument.aspx?id=6330

6. PHE. Immunisation Against Infectious Disease. Chapter 3: Storage, distribution and disposal of vaccines, March 2013 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/223753/Green_Book_Chapter_3_v3_0W.pdf

7. Chiodini J. Safe storage and handling of vaccines. Nursing Standard. 2014; 28 (25) 45-52. https://www.rcn.org.uk/clinical-topics/public-health/specialist-areas/immunisation

8. Health Protection Agency. Vaccine incident guidance. October 2011.

https://www.gov.uk/government/publications/vaccine-incident-guidance-responding-to-vaccine-errors

9. PHE. Immunisation Against Infectious Disease. Chapter 5: Immunisation by nurses and other healthcare professionals. March 2013.

10. PHE. Latest UK vaccine coverage figures for children up to five years of age published. Vaccine Update Issue 271, 6. October 2017

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/653401/VU_271_october_2017.pdf

11. PHE. Vaccination of individuals with uncertain or incomplete immunisation status. November 2017.

12. PHE. Immunisation Against Infectious Disease. Chapter 30: Tetanus. Updated April 2013.

13. European Centre for Disease Prevention and Control. Vaccine scheduler. https://vaccine-schedule.ecdc.europa.eu

14. PHE. Administering four vaccines in one year olds at one visit. Vaccine update: Issue 264 June 2017.

15. World Health Organization. Global Vaccine Safety Six common misconceptions about immunisation. http://www.who.int/vaccine_safety/initiative/detection/immunization_misconceptions/en/index6.html

16. Oxford Vaccine Group. Vaccine Knowledge Project Combination vaccines and multiple vaccinations. http://vk.ovg.ox.ac.uk/combination-vaccines-and-multiple-vaccinations

17.PHE. Vaccine Update Issue 241, 5 February 2016

18. PHE. Immunisation Against Infectious Disease. Chapter 6: Contraindications and special considerations. August 2017.

19. PHE. Immunisation Against Infectious Disease. Chapter 7 Immunisation of individuals with underlying medical conditions October 2016.

20. PHE. Immunisation Against Infectious Disease. Chapter 21 Measles. January 2013.

21. PHE. Immunisation Against Infectious Disease. Chapter 4: Immunisation Procedure March 2013

22. electronic Medicines Companion (eMC). SmPC: MMR VAX Pro. Updated June 2017. https://www.medicines.org.uk/emc/product/6307

23. eMC. SmPC: Priorix. Updated November 207. https://www.medicines.org.uk/emc/product/1159

24. WHO. Questions and answers on immunization and vaccine safety. http://www.who.int/features/qa/84/en/

25. PHE. Immunisation Against Infectious Disease.Chapter 2: Consent, the Green Book. March 2013.