Guidance

Guidance for NHS providers in England on accessing DHSC centrally supplied flu vaccines

Published 8 October 2021

Applies to England

Summary

Following the success of the 2020 to 2021 seasonal flu immunisation programme, the Department of Health and Social Care (DHSC) has announced its intention to continue with the expanded flu programme in the 2021 to 2022 flu season as part of its continued response to the COVID-19 pandemic. This includes a drive to increase uptake in existing cohorts eligible for a free vaccine under the NHS programme, and also expansion to new groups, such as secondary school children up to year 11.

In order to support the expanded vaccination programme and achieve even higher vaccine uptake rates compared to last year, DHSC has secured an additional supply of influenza vaccines. These vaccines will be available for providers of the NHS flu vaccination programme, to top up local supplies once they run low. Additional supply arrives later in the season and is intended to complement existing supply, so providers should have exhausted local supplies before accessing central supply.

We are now able to confirm the process by which NHS providers will be able to access this additional stock. For the purposes of this guidance NHS providers are defined by those providing NHS services under the NHS Standard Contract. For the avoidance of doubt, this stock is only available for the vaccination of frontline healthcare workers, and additional eligible cohorts, such as pregnant women and clinically at risk patients as described in the National Service Specification and where commissioned by NHS England and NHS Improvement (NHSEI) to provide that service.

Primary care guidance has been released separately.

Please note that the stock arrives from early November onwards. Expected first delivery dates are included within the detailed guidance below.

In designing the process for accessing additional stock, consideration has been given to how NHS providers currently source and administer flu vaccinations. It has been purposefully designed to limit the impact on business as usual vaccinations and supply chains. We also have a responsibility to balance this with the need to protect and mitigate risks of unintended use, as this is a taxpayer funded programme, while acknowledging the exceptional circumstances that has warranted the programme’s expansion.

NHS providers will be provided the additional vaccines free of charge. All frontline health and social care workers should receive a vaccination this season which should – in the case of NHS providers – be provided and funded by their employer, in order to meet their responsibility to protect their staff and patients and ensure the overall safe running of services. It is expected that all NHS providers should vaccinate frontline healthcare workers with locally procured stock first before accessing additional stock.

Some staff may be eligible for a free NHS vaccine, which they can access at their registered practice or a community pharmacy, if they fall within one of the eligible cohorts set out in the updated annual flu letter.

The additional vaccine supply may also be used to vaccinate eligible patients under National service specification. In these cases the NHS England and NHS Improvement (NHSEI) Public Health Commissioner and NHS providers will need to agree the impact of any additional activity on agreed payment mechanisms taking into account whether providers have utilised free of charge vaccines.

JCVI have set out the recommended vaccines for each cohort, this is set out in appendix C: recommended influenza vaccines of the national flu immunisation programme 2021 to 2022 letter. The product which is available for NHS providers, QIVr, is suitable for adults 18 to 64 years old, and suitable for adults over 65 years where aQIV is not available.

The majority of the additional stock will arrive from November onwards, and NHS providers will be able to access this only once their own local stocks are depleted. The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a dispensation to allow movement of vaccines locally between other NHS provider organisations and we would encourage you to work with regional NHSEI Public Health Commissioning team to understand what stock is available locally before accessing the national additional supply.

As part of the process for NHS providers to access free additional flu vaccines, NHS providers will be required to capture and record details of the vaccinations given to aid the management of the national flu programme. As you will be aware, the method to record the vaccine event is to use the National Immunisation and Vaccine System (NIVS) digital solution. NIVS is being used in multiple service provider settings to capture flu vaccination event information. This system is the requisite submission tool for flu vaccination data for all healthcare workers and also where NHS providers are administering the vaccine in other settings including under 65 clinical at-risk groups (for example maternity departments or through other in and outpatients setting for clinical at-risk cohorts).

Please note as in previous seasons, the routine monthly UK Health Security Agency (UKHSA) data collection for healthcare workers will operate using the ImmForm website. Data reported through ImmForm continues in parallel and remain the official statistics for the influenza immunisation programme.

How to order additional DHSC stock

This guidance covers NHS providers (as defined above) in England. Guidance for primary care has been issued separately.

Assess if there is a need for further flu vaccines by comparing current and expected uptake rates in eligible cohorts compared with your current vaccine supply .

Providers should order additional vaccines only when they have allocated all of their locally procured stock. Providers should only be using additional stock to vaccinate patients or frontline healthcare workers once they are sure that their local order will not be sufficient to achieve the uptake ambitions for each cohort that they are commissioned to vaccinate.

Providers may need to register an account with the manufacturer of additional stock, for information, accounts may take a week or more to set up, and providers should also familiarise themselves with the ordering process. DHSC may provide periodic updates on central stock levels available from suppliers to the regional NHSEI commissioner, so you should keep in regular contact with your regional team. The manufacturer has indicated estimated delivery times however this may change.

In order to access additional stock, providers will be required to agree all the following terms:

• the provider have allocated all of the locally procured flu vaccines and any additional flu vaccines they have previously ordered, including any vaccines yet to be delivered, for the cohorts that they require additional vaccine for

• the provider agrees not to return any of their local stock order for those cohorts to manufacturers, as additional stock is only to be used after all local stocks for a particular cohort has been exhausted

• the provider will only use additional stock to vaccinate frontline healthcare workers and patients who they have been contracted to vaccinate. This will include those frontline healthcare workers and patients who fall into eligible groups included in the national flu immunisation programme, as set out in the National flu immunisation programme 2021 to 2022 letter, that they have been commissioned to vaccinate

• if applicable, they will claim the correct fees for additional flu vaccines administered

• information on orders will be retained by DHSC, and shared with NHSEI and flu vaccine manufacturers

Providers should only order enough vaccines to cover your expected demand as you will not be able to return unused additional flu vaccines. DHSC will monitor orders as the season progresses and may update ordering limits to manage supply. Ordering too frequently may limit the availability of delivery slots and may require DHSC to alter the ordering policy to ensure all appropriate providers have access to stock. As stock and delivery slots are limited, orders and stock levels will be closely monitored by DHSC to understand local demand, prevent supply issues and ensure the appropriate use of central stock.

NHS providers will have systems in place to store and administer locally and additional supplied stock in such a way to support accurate record keeping and financial claims.

Providers will not be able to return any unused stock to manufacturers. Towards the end of the season, if providers find themselves with an excess of additional stock that will not be used we advise you to contact your regional NHSEI Public Health Commissioning team for support in the re-distribution of the stock to another local provider in the first instance.

In the very unlikely circumstance that a provider finds themselves with a small amount of unused additional stock and only after notifying the regional NHSEI Public Health Commissioning team and making every effort to redistribute the stock, then the provider will be required to dispose of any unused additional stock themselves. Disposal must be conducted in line with standard procedures. Providers will keep clear records as to the amount, type of vaccines and batch numbers redistributed or disposed of.

NHS providers are prohibited from supplying additional supplied stock to a third party in exchange for payment.

Additional vaccines available to order

Manufacturer	Product	Vaccine type	Ovalbumin content micrograms per dose	Availability
Sanofi Pasteur	Supemtek®	QIVr (recombinant quadrivalent influenza vaccine)	Egg-free	From early November

Please note Supemtek® does not come with needles and you will be required to provide your own needles.

Chapter 4 of the Green Book on immunisation procedures recommends a 25mm 23G (blue) or 25mm 25G (orange) needle should be used for intramuscular injections in infants, children and adults. The syringe Supemtek® is provided in has a luer-lock adapter, these luer-lock syringes can accommodate either a luer-lock or luer-slip needle.

Appendix A: manufacturer ordering process – Sanofi Pasteur

Manufacturer	Product	Minimum order	Availability	Delivery time
Sanofi Pasteur	Supemtek (QIVr)	50	From early November	Within 7 business days of ordering, providing you already hold an account with the supplier and vaccines are available

Please note Supemtek® does not come with needles and you will be required to provide your own needles.

Chapter 4 of the Green Book on immunisation procedures recommends a 25mm 23G (blue) or 25mm 25G (orange) needle should be used for intramuscular injections in infants, children and adults. The syringe Supemtek® is provided in has a luer-lock adapter, these luer-lock syringes can accommodate either a luer-lock or luer-slip needle.

If you wish to place an order for QIVr Supemtek® please follow these steps – If you already have a Sanofi Pasteur account number and you are a user of Vaxishop, skip to step 5:

1. Create a Sanofi Pasteur account if you do not already have one.
2. Complete all relevant details and submit.
3. Sanofi will create your account and will be in touch with your new account number within 5 working days.
4. Once you have your new active Sanofi Pasteur account number, register as a user with Vaxishop using your account number and postcode.
5. Log in to Vaxishop with your username and password.
6. Go to the ‘Influenza’ tab and select ‘Order national flu stock’ and follow the steps from here.

Appendix B: frequently asked questions

What stock is available?

Enough stock is available for eligible groups. The department has worked with manufacturers of adult flu vaccines to increase supply for use in England. QIVr has been made available to NHS providers as it has been agreed with NHSEI that QIVr meets their vaccine requirements. If additional or alternate products are required, DHSC will work with NHSEI to make these available and update guidance accordingly.

Who can be immunised with vaccine from additional stock?

In line with the aim of the national flu immunisation programme, the additional stock can be used to vaccinate frontline healthcare workers and patients for whom you have a contract in place to vaccinate. This will include those frontline healthcare workers and patients who fall into eligible groups included in the national flu immunisation programme, as set out in the National flu immunisation programme 2021 to 2022 letter and for whom you have been specifically commissioned to vaccinate.

Can I use additional stock to vaccinate frontline healthcare volunteer workers if I have run out of my local stock?

You should vaccinate all frontline health care workers working in your organisation as appropriate, this will include those directly employed, those who are sub-contracted or on honorary contracts (for example bank and agency staff) and those who are working unpaid unless you are assured that they have been vaccinated elsewhere this season.

What are the requirements for recording the use of vaccines?

As part of the process for accessing free additional vaccines, you will be required to capture and record details of the vaccinations to aid the management of the national flu programme. As you will be aware, the NIVS digital solution is being used in multiple settings to capture flu vaccination information. The system is the requisite submission tool for flu vaccination data for all healthcare workers and also where NHS providers are administering the vaccine in other settings (for example maternity departments or through other in and outpatients setting for clinical at-risk cohorts). Further communications on the system will be sent shortly which will cover secondary care settings and healthcare workers. If you have any questions regarding the system or require further information, please contact agem.nivs@nhs.net.

Please note as in previous seasons, the routine monthly UKHSA data collection for healthcare workers will operate using the ImmForm website. Data reported through ImmForm continues in parallel and remain the official statistics for the influenza immunisation programme.

If an NHS provider finds itself with a small amount of unused additional stock and only after notifying your regional NHSEI Public Health Commissioning team and making every effort to redistribute the stock, providers will be required to dispose of any unused additional stock themselves. Disposal should be conducted in line with standard procedures. Providers should keep clear records as to the amount, type of vaccines and batch numbers redistributed or disposed of. NHS providers are also prohibited from supplying additional supplied stock to a third party in exchange for payment.

Can I use additional stock to vaccinate social care workers who are eligible for a free vaccine?

Social care staff can obtain the flu vaccine for free from their GP or at a community pharmacy, you should refer to the flu immunisation for social care staff guidance.

Which brand of vaccine are available? Are they suitable for all ages and clinical needs?

Vaccines have been ordered by DHSC from a number of manufacturers. This was done to reduce the likelihood of the additional stock being seriously affected should a problem occur with a single manufacturer. QIVr has been made available to NHS providers as it has been agreed with NHSEI that QIVr meets their vaccine requirements. If additional or alternate products are required, DHSC will work with NHSEI to make these available and update guidance accordingly.

Health professionals accessing additional stock should use the vaccines best suited to their patient population in line with Joint Committee on Vaccination and Immunisation (JCVI) guidance as set out in the national flu immunisation programme 2021 to 2022 letter and in the green book on suitability of each product for different age groups, and clinical needs such as severe egg allergy (anaphylaxis). More detailed information is available from the manufacturers’ summaries of product characteristics.

QIVr is suitable for adults 18 to 64 years old, and suitable for adults over 65 years where aQIV is not available.

Can multiple orders for additional stock be placed at the same time?

We ask NHS providers to order stock only when they are sure they will be able to use it. Ordering too much stock may lead to shortages for other providers. NHS providers will be able to make additional orders if they run out from of their additional stock order. Ordering too frequently may limit the availability of delivery slots and may require DHSC to alter the ordering policy to ensure all providers have access to stock.

Do I have to pay for additional stock?

No, DHSC stock has been paid for by the department and will be provided to NHS providers free of charge. Commissioners and NHS providers will need to agree the impact of any additional activity on block payments taking into account whether providers have had to pay for additional vaccine.

How will payments for vaccinations administered work?

The additional vaccine supply may also be used to vaccinate eligible patients where NHS providers are commissioned to do so. In these cases the NHSEI Public Health Commissioner and NHS providers will need to agree the impact of any additional activity on agreed payment mechanisms taking into account whether providers have had to pay for additional vaccine.

What do I do with unused stock at the end of the season?

If you have accessed additional stock, you should have exhausted all of your local stock first. It is therefore not anticipated that providers will have any unused local stock if you have accessed additional stock. Manufacturers will also require you to confirm as part of the declaration process for ordering additional stock that you will not return any local stock. In light of high demand for flu vaccine this season and the significant expansion of the programme – along with the ability to redistribute stock locally – it is not expected that any additional stock will go unused.

However, in the very unlikely circumstance that an NHS provider finds itself with a small amount of unused additional stock and only after notifying your regional NHSEI Public Health Commissioning team and making every effort to redistribute the stock, providers will be required to dispose of any unused additional stock themselves. Disposal must be conducted in line with standard procedures. Providers should keep clear records as to the amount, type of vaccines and batch numbers redistributed or disposed of. NHS providers are prohibited from supplying DHSC supplied stock to a third party in exchange for payment.

What if, even after accessing additional stock, I still have insufficient stock to meet demand?

You should speak to your regional NHSEI Public Health Commissioning teams to determine if any other providers have surplus stock that you can access. In addition, for eligible patients outside of your frontline healthcare worker commitments, you could re-direct patients to their registered GP or local community pharmacies (aged over 18 years only) if they have stock available.

Will I easily be able to distinguish between locally procured stock and centrally procured stock so I can ensure I claim the correct payment?

In most (but not all cases), the additional centrally procured stock will have different batch numbers to locally procured stock. NHS providers should put in place arrangements to clearly label and if possible, store additional stock separately to locally procured stock to ensure NHS block payment adjustments for additional activity can be justified. NHS providers should be accessing additional stock only when they are no longer expecting to receive any more locally procured stock for that particular vaccine.

Further information

Throughout the season, information and updates will be shared with Regional NHSEI Commissioning Teams.

In addition, if there are further questions not addressed in this document, please contact your Regional NHSEI Commissioning Team in the first instance.