Vaccine update: issue 338, May 2023

Q: The EU Falsified Medicines Directive (FMD) and Delegated Regulation as applicable to UKHSA-supplied vaccines for the national immunisation programme

The EU Falsified Medicines Directive 2011/62/EU ( FMD ) and Delegated Regulation impose legal obligations on the EU medicines supply chain to prevent entry of falsified medicinal products into the supply chain. The Delegated Regulation was implemented in all EU Member States on 9 February 2019. Following the UK’s departure from the EU, the Delegated Regulation ceased to apply in Great Britain from 31 December 2020, but continues to apply in Northern Ireland. Information for customers in Northern Ireland FMD -barcoded packs of routine immunisation programme vaccines that are centrally supplied by UKHSA continue to be supplied with active FMD serialisation, and should be decommissioned by end users in Northern Ireland. Customers in Northern Ireland who access centrally supplied vaccines are encouraged to review local guidance on implementation of the EU Falsified Medicines Directive.

Question 1

UKHSA National Immunisation Network meeting: 13 and 14 June 2023

Accepted Answer

Immunisation is the single most effective way to help protect our population against infectious diseases, and is the right for every child, teenager and adult in the UK, and we strive to ensure everyone eligible is up to date with their routine immunisation schedule.

The theme for this year’s meeting is ‘Back to the future of immunisation 2.0’, focusing on the routine and selective programmes now we are living with coronavirus (COVID-19). The sessions including panels, workshops, opportunities for discussion and networking will provide all those in the field with up-to-date information on the emerging situation and support the recovery of uptake of the routine and selective immunisations.

Immunisation is a fast-moving area of expertise. Providing an annual 2 day conference to allow us to come together for a training and development meeting face to face, to share experiences, coverage and uptake data along with perspectives previously unpublished. We will be coming together with the national teams and representatives of the regional teams, with key stakeholders, SAIS teams, practice staff and practitioners who can implement behavioural change and strategies to improve uptake and address health inequalities, and maintain even increase immunisation rates in all settings.

NIN2023 is our opportunity to invite speakers to share their experiences of negotiating and using tools and methods to address underserved groups and knowledge of responding to outbreaks and improving coverage. This meeting will focus on current and emerging scientific issues in immunisation and implementation challenges relating to the UK Health Security Agency’s (UKHSA) national immunisation programme. Participants will learn the science and rationale behind the immunisation policy and decision making, and latest developments to better equip them in their public health roles. The meeting will provide a valuable opportunity to hear the most recent information and resources to support the programmes.

Question 2

Please join us and be a part of NIN2023

Accepted Answer

We have an exciting agenda of presentations and will be celebrating 10 years of the National Immunisation Network (NIN), 60 years of the JCVI and 75 years of both the NHS and the World Health Organization (WHO).

The event will be hosted in London at the Park Plaza Hotel in Westminster.

Places will be allocated on a first come, first serve basis. Please ensure you book your place by 4pm by Monday 5 June 2023.

Registration fees for public sector (including charities):

1 day attendance fee: £155
2 day attendance fee: £250

Registration fees for private and commercial organisations:

1 day attendance fee: £300
2 day attendance fee: £550

Registration fees for students:

1 day attendance fee: £100
2 day attendance fee: £150

Proof of student status will be expected on the day.

Exhibition stands:

commercial exhibition stand spaces are available, please email NIN2020@ukhsa.gov.uk before you register so we can confirm there is a space for you.
2 day attendance fee for 2 delegates with stand: £2500

No VAT is paid on delegates registration fees.

Question 3

Vaccine wastage

Accepted Answer

The importance of maintaining cold chain

During 2022, vaccine wastage incidents reported through ImmForm due to both avoidable and unavoidable incidents remained significant, at £5.7 million based on the list price. This is potentially an under-reporting of vaccine wastage and the true cost may be higher.

Please consider best practices around ordering, receipt and storage of vaccines which are provided centrally for the national immunisation programme. If vaccines are not stored correctly, it is not only wasteful and expensive for the NHS but vaccines may lose their effectiveness, and this could result in a failure of the vaccine to provide the required immune response.

The value of vaccine wastage due to avoidable reasons was £2.6 million. Just over half of the total value of reported causes of incidents were unavoidable (54%). The majority of unavoidable incidents were due to cold chain failures such as power cuts (contributing 50%, £2.9 million of the total). Expiring seasonal vaccines were the largest contributory factor (18% of the total cost of wastage, £1.1 million).

The next largest avoidable cause in 2022 was wastage caused by fridge malfunctions, fridge left open, or vaccine left out of fridge (16%, £896K). There continues to be a general downward trend in the overall number of doses reported as lost through incidents (180,000 in 2022 compared to 220,000 5 years ago). Incidents related to disposal of expired non seasonal vaccines continues to decline since a peak during the COVID-19 pandemic, £685K in 2022 compared to £2.8 million in 2020.

2022 had the lowest number of reported incidents and the lowest number of accounts reporting incidents in 5 years. Please continue to report incidents through ImmForm, to help us monitor and reduce the costs to the NHS.

Causes of vaccine wastage

50% Unavoidable – cold chain failure such as power cut
18% Expired seasonal such as influence vaccine
16% Cold chain failure such as fridge malfunction, fridge left open, vaccine left out of fridge
11% Expired non-seasonal vaccine
3% Unavoidable – vaccine not used due to change in programme
1% Vaccine preparation error
1% Unavoidable – vaccine prepared, but patient refused

Question 4

Reducing avoidable vaccine wastage

Accepted Answer

All healthcare providers should have their own local policies that describe how vaccines will be ordered, stored, handled, and disposed of correctly, and how to respond to vaccine storage failures. These local policies should reflect national policy and best practice recommendations which can be found in Chapter 3 of the green book.

Everyone who orders, stores or handles vaccines, should be trained and assessed as competent, before they undertake these tasks. Good practice in vaccine storage should be covered in all immunisation training courses. The Immunisation programme available on e-learning for healthcare includes an online training module and assessment about vaccine storage. It is suitable for both beginners and those wishing to refresh their knowledge.

Question 5

Responding to vaccine storage failures

Accepted Answer

To minimise wastage that may occur if there is a cold chain failure, healthcare providers should order little and often, and hold only enough routine vaccines for appointments that have been scheduled in the following 2 to 4 weeks. Particular attention should be paid to the stock holding of seasonal vaccines and it is recommended that only 2 weeks’ stock should be held in local fridges where possible, with stock levels regularly reviewed to be reflective of demand throughout the autumn and winter.

Please review the UKHSA published guidance on how to respond to errors in vaccine storage, handling and administration.

A poster and fridge magnet have also been produced and are available to order for free to help remind staff about cold chain and keeping vaccines healthy.

Question 6

New NHS England FutureNHS workspace for all vaccination and screening providers

Accepted Answer

NHS England has launched a new Vaccination and Screening FutureNHS workspace. The workspace houses content created by NHS England to support vaccination and screening providers, including datasets, guidance, communications materials, and shared learning. It also provides links to vaccination and screening information across various national websites.

This workspace combines the content from the previous workspaces linked below, which will be closed:

Note: the COVID-19 workspace and mpox workspace will remain open and separate.

All vaccination and screening providers with an NHS.net or other recognised healthcare and government email address, can join the workspace by visiting the workspace and selecting “Join”. More access guidance can be viewed at FutureNHS.

More content will be uploaded in the coming weeks and you can sign up to receive a weekly summary of all uploads to the workspace. NHS England will be running structured feedback in the coming weeks to hear your experience of the workspace and ideas for improvement. In the meantime, if you have comments, questions, or feedback about the workspace, please use the online form.

Question 7

Core programme leaflets

Accepted Answer

Available to order:

A guide to immunisations for babies up to 13 months - product code: C23IM13EN

A guide to pre-school immunisations for parents of children aged 2 to 5 years of age - product code: C22PSC34EN

A guide to immunisations for young people - product code: C22YPEN

Question 8

Vaccine supply

Accepted Answer

Routine vaccination programme

Expiry and disposal of vaccines supplied by UKHSA for the 2022 to 2023 children’s flu programme

All doses of the live attenuated influenza vaccine (LAIV) Fluenz® Tetra, and Quadrivalent Influenza Vaccine (split virion, inactivated) (QIVe) have now expired. The expiry date for the Cell Based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) (QIVc) supplied by UKHSA is 31 May 2023. Expired stock should be removed from fridges and disposed in line with local policies and recorded through the ImmForm stock incident page.

All influenza vaccines marketed in the UK for the 2023 to 2024 season

Information on all influenza vaccines that will be marketed in the UK for the 2023 to 2024 season, including ovalbumin content, is available to download.

Late May bank holiday deliveries warning notice

Late May bank holiday

Due to the late May Bank Holiday, there will be no deliveries or order processing by Movianto UK on Monday 29 May. Please see the table below for revised order cut-off and delivery dates. For customers with a standard delivery day of Monday, please be aware that after Monday 22 May, your next available delivery day will be Monday 5 June 2023. You are reminded to be prepared for the break in deliveries and to order accordingly. Please make sure you have sufficient room in your fridge for any additional vaccine you wish to stock over this holiday period. Please be advised that Emergency or “Out of Schedule” deliveries cannot be arranged for failure to place orders in good time.

Delivery day	Order cut off date	Order cut off time
Monday 22 May 2023	Thursday 18 May 2023	11.55am
Tuesday 23 May 2023	Friday 19 May 2023	11.55am
Wednesday 24 May 2023	Monday 22 May 2023	11.55am
Thursday 25 May 2023	Tuesday 23 May 2023	11.55am
Friday 26 May 2023	Wednesday 24 May 2023	11.55am
Monday 29 May 2023	Closed – no deliveries or order processing
Tuesday 30 May 2023	Thursday 25 May 2023	11.55am
Wednesday 31 May 2023	Friday 26 May 2023	11.55am
Thursday 1 June 2023	Tuesday 30 May 2023	11.55am
Friday 2 June 2023	Wednesday 31 May 2023	11.55am
Monday 5 June 2023	Thursday 1 June 2023	11.55am

Question 9

DTaP/IPV/Hib/HepB vaccine ordering

Accepted Answer

Supplies of DTaP/IPV/Hib/HepB vaccines Infanrix hexa® and Vaxelis® are available for the routine infant primary immunisations programme.

Orders for Infanrix hexa® remain unrestricted. Customers in England and Wales may order up to 20 packs of Vaxelis® per ImmForm account per week – this will vary for customers taking part in the Oxford Vaccine Group trial. Customers in Scotland should refer to their local ordering restrictions. Providers should not order more than 2 weeks’ worth of stock to minimise wastage due to fridge failures. For assistance, please contact the ImmForm Helpdesk at helpdesk@immform.org.uk

Question 10

Supply of vaccines with reduced shelf life

Accepted Answer

Vaccines supplied via ImmForm for the routine immunisation programme will usually have at least 3 months of shelf-life remaining at the time of delivery. Vaccines with reduced shelf life will occasionally be supplied. ImmForm customers will be informed of vaccines which have short shelf life via ImmForm news articles, updates on the particular ImmForm product page, or a click-thru pop-up message at the time of ordering.

ImmForm customers should order no more than 2 weeks’ worth of stock to minimise wastage due to fridge failures or failure to use stock before expiry. See Chapter 3 of the ‘Green Book’ (Immunisation against infectious disease) for further details on the storage and supply of vaccines.

Question 11

Update to Bexsero Patient Information Leaflet

Accepted Answer

Every pack of Bexsero (Meningitis B vaccine; 10 doses) issued via ImmForm in Great Britain, is supplied with a pad of 10 Patient Information Leaflets (PILs), as well as there being a single PIL inside each Bexsero pack. Since September 2020, an updated version of the PIL pad has been distributed with Bexsero orders. Please dispose of the single PIL from inside the pack and issue the updated PIL.

Question 12

Registering for a new or updating your existing ImmForm vaccine ordering account

Accepted Answer

When you register for or update an existing ImmForm account, UKHSA as a wholesaler of vaccines need to verify the requesting customer. Please ensure you have your professional regulatory body registration number or Wholesaler Dealer Licence and an organisation code which can be verified when requesting updates or requesting a new vaccine ordering account. For more information please see the ImmForm Helpsheet.

Question 13

The EU Falsified Medicines Directive (FMD) and Delegated Regulation as applicable to UKHSA-supplied vaccines for the national immunisation programme

Accepted Answer

The EU Falsified Medicines Directive 2011/62/EU (FMD) and Delegated Regulation impose legal obligations on the EU medicines supply chain to prevent entry of falsified medicinal products into the supply chain. The Delegated Regulation was implemented in all EU Member States on 9 February 2019. Following the UK’s departure from the EU, the Delegated Regulation ceased to apply in Great Britain from 31 December 2020, but continues to apply in Northern Ireland.

Information for customers in Northern Ireland

FMD-barcoded packs of routine immunisation programme vaccines that are centrally supplied by UKHSA continue to be supplied with active FMD serialisation, and should be decommissioned by end users in Northern Ireland. Customers in Northern Ireland who access centrally supplied vaccines are encouraged to review local guidance on implementation of the EU Falsified Medicines Directive.

Question 14

MMR vaccine ordering

Accepted Answer

To rebalance central supplies of both MMR vaccines please consider ordering M-M-RvaxPRO® as your first choice, which is available without restriction. Customers in England and Wales who require Priorix®, for example because you serve communities that do not accept vaccines containing porcine gelatine, may order up to 6 packs of Priorix® per ImmForm account per week. For assistance please contact the ImmForm Helpdesk at helpdesk@immform.org.uk

Question 15

Introduction of a London polio catch-up campaign 2023

Accepted Answer

Guidance on the introduction of a catch-up immunisation campaign in London to run until the end of the summer term 2023 has been published, please see IPV booster information. It includes information on:

background and summary of incident
information related to the 2022 London IPV booster campaign
London polio catch-up campaign 2023
routine IPV and measles, mumps and rubella (MMR) vaccination programmes and vaccines
vaccine ordering, supply and storage
vaccine administration queries
resources

Question 16

Non routine vaccine supply

Accepted Answer

Hepatitis A vaccine

Adult:

GSK: supply of Havrix Adult PFS singles and packs of 10 are currently available
Sanofi Pasteur: Avaxim PFS singles and packs of 10 are currently available
MSD: VAQTA Adult is available

Paediatric:

GSK: supply of Havrix Paediatric singles and packs of 10 are currently available
MSD: VAQTA Paediatric is available
Sanofi Pasteur: Avaxim Junior singles are currently available

Hepatitis B vaccine