COVID-19 Vaccination Service

During the COVID-19 pandemic, over 1,500 community pharmacy sites were involved in vaccinating patients and health and care workers under a Local Enhanced Service against coronavirus alongside vaccination centres, hospitals and Primary Care Network (PCN) sites.

In December 2020, the NHS commenced its COVID-19 vaccination programme. There have been three types of vaccination site:

• Vaccination centres, using large-scale venues;
• Hospital hubs, using NHS Trusts across the country; and
• Local vaccination services, made up of sites led by general practice teams working together in primary care networks (PCN) and community pharmacy sites.

Through each of the previous phases of the vaccination programme, each NHS region, working with their integrated care systems (ICS), has defined the mix and number of sites required based on local demographics.

Pharmacies have been central to the Government’s COVID-19 response, and figures from NHS England, in January 2022, show just how significant a contribution they have made to the vaccination efforts. In the previous 12 month to January 2022, which marked the one-year anniversary of the sector providing COVID-19 vaccinations, more than 22 million vaccinations were administered by community pharmacy-led COVID vaccination sites. NHS England also highlighted a 50% increase in the number of pharmacies delivering COVID-19 boosters since October 2021.

The vaccination service was first commissioned as a Local Enhanced Service by NHS England regional teams in consultation with Local Pharmaceutical Committees. It was commissioned where there was a local need, for example where there was a gap in service provision or a need for additional capacity, and where pharmacy owners were able to meet the key designation requirements.

Those pharmacy owners selected as designated sites played a critical role in the success of Phase 1 (the vaccination of patient JCVI cohorts 1-9) and Phase 2 (the vaccination of patient JCVI cohorts 10-12) of the COVID-19 vaccination programme. Through their strong local relationships, community pharmacies have helped to tackle vaccine inequalities and improve vaccination take-up.

The Phase 3 programme in 2021, was provided alongside the seasonal influenza vaccination programme, which runs each autumn.

In December 2021, provisions were made within the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 for a new type of Enhanced service, the National Enhanced Service (NES). Under this type of service, NHS England commissions an Enhanced service that is nationally specified. This requires NHS England to consult with Community Pharmacy England on matters relating to the service specification and remuneration for the service.

This differs from a LES that is locally developed and designed to meet local health needs and for which NHS England would consult with Local Pharmaceutical Committees. A NES allows the agreement of standard conditions nationally, while still allowing the flexibility for local decisions to commission the service to meet local population needs, as part of a nationally coordinated programme.

Phase 5 of the vaccination service, the autumn 2022 and spring 2023 booster programmes, were commissioned as a NES.

For the autumn/winter 2023/24 booster programme, NHS England will commission a vaccination service directly from community pharmacies.

Provision of the service at the pharmacy

Pharmacy owners who wish to participate in the service at their pharmacy can opt-in to the service, subject to meeting the minimum requirements. These are detailed in the NHSE guidance document, but the following summarises the key points. Pharmacy owners:

• Need to read the Enhanced service specification and be confident that they will be able to meet its requirements, including being able to commence vaccinating within four weeks of notification of contract award or by the start date of the vaccination programme (whichever is later)
• Must also provide the Flu Vaccination Advanced Service from September 2023 to 31st March 2024
• Must be able to offer at least 100 COVID-19 vaccinations per week
• Be ‘in good standing’ from a regulatory perspective with the NHS and other organisations such as the General Pharmaceutical Council

Pharmacy owners who submit an EOI for a site at their pharmacy will not be required to administer all vaccinations from the pharmacy; they must also vaccinate eligible housebound/care home patients if requested by NHSE and they may also provide outreach services if agreed with NHSE.

This new EOI process marks a significant change from the approach used by NHSE in previous EOI processes. Previously, EOIs from pharmacies were only granted if there was a population need for a new provider to offer the service, e.g. if there was a perceived gap in COVID-19 vaccination provision in the services being offered by other vaccination providers or if there was a need for additional capacity. That requirement is removed from the new EOI process for pharmacies wishing to provide the service on the pharmacy premises (but not for those that want to provide the service solely at an off-site location, away from the pharmacy premises).

Additionally, the new EOI process is being hosted on a new platform, which NHSE expect will provide a much improved experience for users.

Provision of the service away from the pharmacy

Pharmacy owners can also express an interest in providing the service from a location away from their pharmacy. However, NHSE will usually only approve requests to operate services in the vicinity of the pharmacy where there is a population need, for example within the same Integrated Care System.

These decisions will be taken once the provisional network of pharmacies wanting to vaccinate patients on their premises, primary care network sites and other providers (such as NHS Trusts) has been identified.

These expressions of interest must also meet the minimum requirements set out in the NHSE guidance. The process NHSE will follow in determining whether these off the pharmacy premises applications will be approved is described in the NHSE guidance.

Eligible patients

In early August, the Government accepted the final Joint Committee for Vaccination and Immunisation (JCVI) advice for the COVID-19 Autumn 2023 seasonal campaign. The groups to be offered a COVID-19 booster vaccine are:

• Residents in a care home for older adults
• All adults aged 65 years and over
• Persons aged 6 months to 64 years in a clinical risk group, as laid out in the Immunisation Green Book, COVID-19 Chapter (Green Book)
• Frontline health and social care workers
• Persons aged 12 to 64 years who are household contacts (as defined in the Green Book) of people with immunosuppression
• Persons aged 16 to 64 years who are carers (as defined in the Green Book) and staff working in care homes for older adults.

The JCVI also advised that primary course vaccination for individuals in the above cohorts who have not had any previous doses should be offered. They should receive a single dose of COVID-19 vaccine during the campaign period.

Timing of the campaign

Originally, NHS England’s letter to systems, community pharmacies and general practices (published on 10th August 2023) advised that COVID-19 vaccinations (and flu vaccinations – but see further information here) would commence from 2nd October 2023 for care home residents and care home staff and from 7th October 2023 for all other eligible patient cohorts. However, following guidance from the UKHSA, the Government has asked NHS England to bring forward the start of the COVID-19 autumn/winter booster programme due to the risks presented by the new BA.2.86 variant of COVID-19.

On 30th August 2023, NHS England’s letter to systems, community pharmacies and general practices (published in the Primary Care Bulletin on 1st September 2023), which now supersedes the previous letter, advised that COVID-19 vaccinations (and flu vaccinations – but see further information here) can commence:

• for care home residents, care home staff and those that are housebound from 11th September 2023;
• for all other eligible patient cohorts, vaccination can commence via Local Booking Systems (LBS) from 11th September 2023; and
• from 18th September 2023, LBS will be complemented by the National Booking System (NBS) which will become available to allow eligible patient cohorts to book a COVID-19 or flu vaccination online (using NHS.uk), via the NHS App or by calling 119.

National COVID-19 vaccination invitations will also start being issued to eligible patients from 18th September 2023.

Systems have been asked to ensure that all care home residents are vaccinated by 22nd October 2023 with vaccination for all other cohorts completed by 15th December 2023.

Key documents

Pharmacy owners who want to be considered as a provider for the service should, first, read the following documents prior to completion of an expression of interest (EOI):

Service specification for the autumn/winter 2023/24 Community Pharmacy National Enhanced Service COVID-19 vaccination programme (updated 5th September 2023)

Community Pharmacy Expression of Interest Guidance (published 4th August 2023)

JCVI update statement on the COVID-19 vaccination programme for autumn 2023 (published 30th August 2023)

JCVI statement on the COVID-19 vaccination programme for autumn 2023 (published 8th August 2023)

NHS England’s letter on the BA2.86 risk and changes to autumn/winter 2023/24 vaccination delivery programme (published 30th August 2023)

NHS England’s letter on the Autumn/Winter 2023-24 flu and COVID-19 seasonal campaign (published 10th August 2023)

Patient Group Directions for COVID-19 vaccines (published 7th September 2023)
These PGDs provide one of the legal mechanisms for administration of COVID-19 vaccines under the service.

National Protocols for COVID-19 vaccines (published 8th September 2023)
These protocols provide the legal mechanisms for the administration of COVID-19 vaccines by appropriately trained persons in accordance with regulation 247A of the Human Medicines Regulations 2012 (HMR 2012), inserted by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020.

Further information on the service is available on the FutureNHS platform (login required). If you do not have access to the Future NHS platform, you can register directly on the site using an NHSmail email address or using a similar professional email address by emailing P_C_N-manager@future.nhs.uk.

The Expression of Interest process and site designation

The EoI process is fully explained in NHS England’s Community Pharmacy Expression of Interest Guidance, but the process for designation of vaccination sites is summarised in the process chart below.  A Designated Site is a site nominated by a pharmacy owner and selected (in the case of those away from the pharmacy) and/or approved by NHS England as the premises from which the COVID-19 vaccine will be administered to patients.

NHS England Regional Teams will work with local authorities and ICSs to consider and manage the site designation process.

NHS England has published (initially in draft) the Enhanced services specification for the autumn service and comprehensive guidance on the EOI process:

COVID-19 autumn vaccination Enhanced service specification and guidance on the Community Pharmacy Expression of Interest Process

Any pharmacy owners interested in submitting an expression of interest should start by reviewing the content of both these documents.

The EOI process opened on 4th August 2023 on the Health-Family Portal and the deadline for submissions (which was originally due to close on 29th August) was 5pm on Monday 4th September 2023.

The key points to consider before submitting an EOI include:

• The economic viability of the service, considering the 25% fee decrease imposed by NHS England
• Suitability of the location of the pharmacy or vaccination site for easy patient access, including availability of car parking and public transport links and disabled access;
• The need for sufficient space for the administration of vaccines, e.g. second consultation room, or a clear plan as to how the service will be provided while still providing access to a consultation room for other patients who may need to use it,  or areas within the pharmacy which can be screened off for sole use in the vaccination service;
• The need for clear signage and marked pathways to guide patients;
• Adequate fridge space and the ability to ensure the security of stored vaccine;
• A clear understanding of the legal route which will be used for vaccination (Patient Group Direction (PGD) or national protocol) and the operational consequences of this;
• Availability of appropriate staff to operate the vaccination service, all with appropriate training completed and competence evidenced. Ensure staff workloads and pressures have been considered and mitigated, including the ability to have sufficient breaks (mental and physical);
• Ability to support patients with additional needs, e.g., accessible information, staff members with language skills relevant to the local population; and
• Availability of adequate IT infrastructure and equipment, e.g. Wi-Fi, tablet devices.

Department of Health and Social Care

Press release – Flu and COVID autumn vaccine programmes brought forward (30th August 2023)

Suspension of the 15-minute wait for vaccination with mRNA vaccine for COVID-19: UK CMOs’ opinion
UK Chief Medical Officers’ and lead Deputy Chief Medical Officers for vaccines’ opinion on the 15-minute wait after vaccination with mRNA vaccine for COVID-19.

NHS England

BA2.86 risk and changes to autumn/winter 2023/24 vaccination delivery programme
Letter setting out next steps on the risks presented by the new BA.2.86 variant of COVID-19.

Autumn/Winter 2023-24 flu and COVID-19 seasonal campaign
Letter setting out next steps for flu and COVID-19 delivery for Autumn/Winter 2023/24.

COVID-19 vaccination guidance
This page provides vaccination centres, hospital hubs and primary care services with a list of guidance about the COVID-19 vaccination programme.

COVID-19 vaccination programme hub (FutureNHS collaboration platform)
If you do not have access to the Future NHS platform, you can register directly on the site using an NHSmail email address or using a similar professional email address by emailing P_C_N-manager@future.nhs.uk.

Summary of the legal mechanisms for administering the COVID-19 vaccine(s) (25th March 2022)
These summaries help to identify which legal mechanism is most suitable based on the local staffing mix and models for delivery based on the legal framework they must be used within.

Operational Bulletins (Future NHS platform – login required)
These bulletins provide a weekly summary of key operational information for the COVID-19 Vaccination Programme.

Clinical Bulletins (Future NHS platform – login required)
These bulletins provide a summary of key clinical information to assist providers with the COVID-19 Vaccination Programme.

NHS England Primary care guidance hub page

NHS England COVID-19 vaccination hub page

NHS England coronavirus documents hub page

UK Health Security Agency

COVID-19: the green book, chapter 14a
COVID-19 vaccination information for public health professionals.

COVID-19 vaccination: information for healthcare practitioners
Guidance for healthcare practitioners about the COVID-19 vaccination programme. (Updated 9th May 2023)

Vaccine incident guidance: responding to errors in vaccine storage, handling and administration (Updated 7th July 2022)

Vaccine Update

COVID-19 vaccination: vaccine product information (Updated 31st March 2023)
Information on the presentation, doses and storage of COVID-19 vaccines.

Other resources

The following links provide access to further information on the vaccination programme.

Anaphylaxis telephone card (PDF)
Personalise this card and keep it by the phone to guide staff on calling an ambulance if a patient has an anaphylactic reaction to a vaccination.

Anaphylactic reactions – Initial treatment poster (Resuscitation Council UK)

General Pharmaceutical Council guidance for pharmacy professionals involved in the COVID-19 vaccination programme

NHS website information for patients

The National Minimum Standards and Core Curriculum for Immunisation Training for Registered Healthcare Practitioners sets the standards and lists the essential topics which should be incorporated into immunisation training for registered healthcare practitioners.

People who will provide the COVID-19 Vaccination Service must have completed practical training in vaccination that meets these requirements. There are a number of organisations that provide vaccination training for pharmacists and those that we have been made aware of are listed on our flu vaccination webpage.

Pharmacy owners will be expected to oversee and keep a record to confirm that all staff have undertaken training prior to participating in the administration of vaccinations. This includes any additional training associated with new vaccines that become available during the period of the service.

All persons involved in the preparation of vaccine must be appropriately trained in this and have appropriate workspace to do so. This process may vary dependent upon the vaccine in use and may include dilution using standard aseptic technique and drawing up of multi-dose vials.

All persons involved in the administration of the vaccine must have:

• Completed the additional online COVID-19 specific training modules available on the e-learning for healthcare website;
• The necessary experience, skills and training to administer vaccines in general, including completion of the general immunisation training available on e-learning for healthcare and face-to-face administration training, where relevant;
• The necessary experience, skills and training, including training with regard to the recognition and initial treatment of anaphylaxis;
• Where a healthcare professional is administering the vaccine, they must have:
  • Read and understood the clinical guidance available and ensure they keep up to date with new and stay updated guidance as it is published; and
  • Understood and be familiar with the Patient Group Directions and/or the national protocol for the COVID-19 vaccines, including guidance on who can use them.
• Where any other persons are administering the vaccine, they must be familiar with, understand and act within the scope of the national protocol for the COVID-19 vaccines.

Pharmacy owners must ensure that staff are familiar with all guidance relating to the administration of the different types of vaccine and are capable of the provision of vaccinations using the different types of vaccine.

A COVID-19 vaccination training slide set, e-learning programme, vaccinator training requirements and a vaccinator competency assessment tool have also been published and they can be accessed from the GOV.UK COVID-19 vaccination programme hub page.

Patient consent

As with the provision of any pharmacy service, the patient must consent to being vaccinated.

Patient consent should be obtained verbally and that be recorded in the clinical record for the service.

The patient should also be advised of the information sharing that will take place, for the appropriate recording of the vaccination in their GP practice record and  with the NHS England (or the NHS Business Services Authority acting on their behalf) for the purposes of payment, post-payment verification, supply management and planning of future vaccination requirements.

Clinical records

There are several point of care (POC) IT systems, made available by NHS England, that pharmacy owners can choose to use to record the vaccination event.

Access information on the available POC systems

Pharmacy owners should ensure that clinical records are made on the system as soon is reasonably possible after the vaccination is administered and before the end of the same day that the vaccination was administered. The service specification provides further information on what to do where that is not possible.

A range of communication packs and toolkits, including key messages, information, translations, Easy Read formats and letter templates has been published on the FutureNHS platform. These can be found on the appropriate Programme Documents section of the COVID-19 Programme Updates and Resources hub page.

The UKHSA has also published an information leaflet and sticker for the COVID-19 autumn vaccination programme. These can be found at:
COVID-19 vaccination: autumn programme resources – GOV.UK (www.gov.uk)

Equalities community of practice

A range of bespoke tools, resources and content for your engagement and practice in supporting and learning from people and partners within underserved communities and equalities groups has been published on the FutureNHS platform.

Funding

For the autumn 2023/24 booster programme, pharmacy owners will be paid £7.54 for each vaccine administered.

This vaccination fee is 25% lower than the previously paid fee and pharmacy owners will need to carefully consider the economics of providing the service prior to submitting an EOI.

Read our comment on the reduced fee

There is an additional financial supplement of £10 per dose for the vaccination of housebound people (cannot be claimed for vaccinations given in care homes).

These fees are funded from the NHS vaccination budget, not from the pharmacy global sum.

The vaccines will be provided to the designated pharmacy owners free of charge and therefore, no reimbursement of the cost of the vaccine will be payable.

Accelerated provision fees

To support acceleration of the vaccination programme, NHS England is putting in place interim financial arrangements, recognising the additional administrative, organisational and delivery costs which pharmacy owners will incur.

Pharmacies commissioned to provide COVID-19 vaccinations will now be eligible to claim:

• An additional acceleration payment of £10 (in addition to the item of service (IoS) fee) for each COVID-19 vaccination administered to care home residents between 11th September and Sunday 22nd October 2023 inclusive.
• An additional acceleration payment of £5.00 (in addition to the IoS) for each COVID-19 vaccination administered to care home residents between 23rd October  and 31st October.
• A separate one-off additional payment of £200 for each completed care home by 23:59 on Sunday 22nd October 2023 that is confirmed to the commissioner by the submission of a live time survey no later than 23:59 on Sunday 29th October 2023.

To support the acceleration of COVID-19 vaccinations to other eligible cohorts:

• An additional £5 acceleration payment (in addition to the IoS fee) will be paid for each COVID-19 vaccination administered to other eligible people (i.e. excluding care home residents and housebound people, who are covered by the above arrangements) between 11th September and 31st October 2023.

Additional funding

NHS England regional teams and ICS will use locally available funding to support improvement to access to vaccinations and help tackle health inequalities.

Claiming payment

COVID-19 vaccination data is transferred between the pharmacy’s PoC system and the MYS portal throughout the month to support payment. This data transfer concludes on the last day of each calendar month. Where vaccinations have been administered to housebound or care home residents, pharmacy owners must have recorded the status of the patient in the point of care system prior to making the claim for payment.

Claims should be made by the 5th of the month following the activity, as is normal for pharmacy services.

Pharmacy owners will need to log on to MYS to declare that the information is correct and to submit the claims for payment.

Claims will be accepted by the NHSBSA within three months of the expected claim date. Later claims will not be processed.

Payments to pharmacy owners will be made monthly as part of their normal payment schedule. Claims will show on payment schedules under the ‘COVID Vaccine’ header.

National Booking System (NBS) and Q-Flow Support (FutureNHS login required)

Point of Care Systems (FutureNHS login required)

Autumn / Winter 23-24 COVID-19 and Flu Vaccination Campaign – acceleration of programme for new variant (FutureNHS login required)

Vaccination FAQs to support conversations with the public (FutureNHS login required)