COVID-19 vaccination programme

This guidance provides detail about what the CVP (COVID-19 vaccination programme) service in England involves, what is expected of practices, what you will get to support this work, and guidance on what to do now.

Location: England
Audience: GPs Practice managers
Updated: Tuesday 17 November 2020
Update

We're updating this page regularly with answers to your questions on the CVP.

The BMA GP committee England and NHSEI have agreed an ES (enhanced service), directed by NHSEI, for general practice in England to lead the delivery of the CVP (COVID-19 vaccination programme).

As an ES directed by NHSEI, it will be optional for practices to sign up to the service.

The intention is to prepare for a service to be delivered from 1 December, however the actual start date will depend on the availability of vaccines.

Similarly, we expect vaccine availability to be limited to begin with, meaning only small numbers of vaccine may be given in December and most vaccinations taking place in early 2021, giving practices more time to prepare.

 

What the service involves

At present, based on the information currently known to us, the vaccines being developed require two doses per patient, with a 21-28 day gap between doses.

Eligible patients will be confirmed soon, but are expected to be in line with the latest JCVI (joint committee on vaccination and immunisation) recommendations

Similar to the flu groups, they include:

  • all over the age of 50
  • those at high risk
  • care home residents and staff
  • all health and care workers (although it is unlikely that general practice will be required to deliver to all health and care staff who may get it from their employer).

The high priority groups will be vaccinated first, and as the vaccine becomes more available, practices will be able to provide this to increasing numbers.

The ES includes provision of vaccinations to housebound patients via home visits, as well as staff and residents of care homes. Community service providers will be expected to play a role in this service, particularly with housebound patients, as many do with flu immunisations using practice stocks.

Practices will be able to vaccinate their own staff and be paid for doing so.

Alongside the general practice-led service, other providers (likely to be NHS trusts) will be commissioned to provide the programme through other means, probably via regional vaccination centres in a similar way to the testing centres.

Local pharmacies may be commissioned where general practice coverage is not enough.

National and local public campaigns will advertise the services on offer, and which patients are eligible.

Why is this an enhanced service directed by NHSEI?

The CVP will be commissioned under section 7a of the 2006 NHS Act, as an enhanced service directed by NHSEI, using full delegated powers from the secretary of state.

This provides flexibility for necessary amendments to the specification to be made swiftly, by national agreement between NHSEI and GPCE only. This is crucial in such a fast moving environment where we will need to add in new information without delay as more vaccines are supplied with different requirements.

CCGs must offer this enhanced service to all practices, and they cannot make any amendments to it.

 

What is the role of CCGs and STPs?

Practices will need support from CCGs and ICSs, as well as local authorities, to relieve other pressures and assist in the preparation. However, the documentation is clear that this is general practice led – CCGs and ICSs cannot dictate how it should operate.

How the service will operate

Due to the logistics of delivery and characteristics of the vaccines, the service needs to be delivered at scale. The current assumption is that it will need to be done through groups of practices working together (likely along PCN (primary care network) geographies), with one designated vaccination site (ideally to be a GP practice). That would be determined by the practices involved.

As vaccines become more widely available it is possible that more than one site could be possible within each grouping.

Working together, practices will need to be prepared to offer vaccinations seven days a week so that the vaccine is delivered within its short shelf-life and so patients receive it as soon as possible. Specifics around delivery of the service will depend on matching patient demand and vaccine availability.

Call and recall system

A national call and recall system will be used, in addition to practices operating their own call and recall systems if they wish to do so.

Patients can choose to attend either their local general practice-led designated site, or a regional immunisation service. If patients choose the local site, practices will need to contact patients to book an appropriate time. Practices will be able to use the national booking system instead of their local booking system if they choose.

Administering the vaccine

A registered healthcare professional will need to carry out the clinical assessment and consent. A suitably trained non-registered member of staff will be able to administer the vaccine itself under clinical supervision.

This could include staff from the relevant practices, from the PCN, as well as volunteers and other NHS staff – as decided by the relevant practices. There is an expectation that staff will be required to undertake appropriate training in advance. Other staff assisting in an administrative capacity would not be required to undertake the training, but an information pack will be provided.

It will be for practices to determine how they work together to deliver the programme. For instance, practices could operate a rota using their teams to immunise their own registered patients in different sessions during the week. Or, they may wish to employ a dedicated team to do this on behalf of all practices, or for some practices to act on behalf of others.

The latest information on the vaccines suggests that patients do not need to be observed following administration of the vaccine, but patients must not drive for 15 minutes after.

Patients would need to be contacted again to book in their second appointment (or this could be done at the time of administering the first) allowing for the appropriate gap. Patients will need to receive the second dose from the same provider.

How many vaccines will practices have to give?

Using the JCVI interim recommendations on priorities, practices (in their groupings) can work out the total number in each priority group and will need to match supply to this. Flu immunisation groups can be used for reference.

They will then need to provide (to help with local planning) an indicative number of vaccinations they believe the site will be able to deliver each week (sites will not be held to this number). The minimum number required is 975 vaccinations per week.

What are the storage requirements for the vaccines?

We understand that local services will not need to store the vaccine in deep-freeze. It will have been defrosted by the time of delivery, but will then need to be used within a short time frame. We understand this vaccine has a 'fridge life' of five days out of the deep freeze and six hours once out of the fridge and diluted.

Other vaccines are being produced that should not need deep-freezing either. Every PCN should have routine cold storage, but if it does not then CCGs should be providing them (or funding for them) to ensure practices can deliver the programme.

Will practices need to be open over Christmas?

The ES requires the designated vaccination site to be able to deliver vaccines seven days a week, this includes Christmas. This is because of the characteristic of the vaccine – ie limited shelf life, space between doses etc – but will also depend on patient demand and vaccine supply.

It may be that very few patients want to receive the vaccine on Christmas Day, making delivery then impractical, or that the vaccine supply for the week has been expended before Christmas Day. Should a service take place, extended access services could be used.

Is there flexibility on the number of designated sites for PCNs?

Due to the logistics of transport and storage, initially only one site per PCN is going to be possible. If this presents serious problems then the CCG may be able to permit an additional site, but this will depend on the national logistics of delivery being able to do this.

The norm will be one site per PCN initially, but more sites may be possible in due course as more vaccine becomes available.

How will the vaccine be distributed to practices?

NHSEI will arrange logistics of deliveries to designated sites using refrigerated storage transport.

Practices will need to indicate how many vaccines they believe they will need on a weekly basis, and this will then be matched (as much as possible) to supply.

Can a practice refuse now but sign up after Christmas?

Unless the practice’s patients are already covered by another group providing the vaccination programme, then practices will be able to opt in at a later date.

However, practices are encouraged to sign up as soon as possible.

Safety and risk

The vaccines will be going through testing procedures and MHRA (medicines and healthcare products regulatory agency) licencing process.

Confirmation of the specific vaccines will be given following completion of trials and licencing/approval.

The JCVI and others will provide independent input and decisions will be made in the normal way. If the vaccine is not approved through the rigorous approvals process, then there will not be a programme. The NHS and practices must be prepared for rapid delivery in the event that the vaccine is approved.

The Government previously released the outcome of the human medicines regulations consultation. This outlines that the Government will be liable for any adverse implications from a vaccine being put into supply (both immediately and into the future).

Commissioning as an enhanced service ensures that all individuals delivering the services will have indemnity under the clinical negligence scheme for general practice.

Why is this being rushed for December 1?

Vaccine producers have suggested that they could be ready to transport vaccines as early as 1 December, pending the completion of testing and licencing/approval.

We must be prepared for the best case scenario of 1 December, however the actual start date will depend on the availability of vaccines.

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CVP funding

  • Practices will be provided with the vaccines, needles, syringes, diluents and PPE.
  • A £12.58 IOS (item of service) fee will be provided per dose.
  • This will be provided through a single payment of £25.16 upon completion of the second dose.
  • Should it not be possible to administer the second dose, one IOS can be claimed.
  • Additional local funding will be provided, in line with the additional funding for the flu programme arrangements (for example for hire of venues, additional storage, text message credits etc). This will need to be agreed locally.
  • Local enhanced services should be re-purposed by agreement with CCGs to make funded capacity available for the CVP.
  • There will be £150m of further support from NHSEI for additional capacity, ringfenced for general practice until the end of March 2021. This will be distributed nationally to ICSs and then CCGs and is meant for practices to increase workforce capacity, including GPs, to better manage workload pressures.
  • Extended access and hours capacity should similarly be reprioritised to provide additional capacity.
  • There will be parity of funding with other providers of the programme - with equivalence depending on the services given eg serving housebound patients is logistically more difficult than mobile patients, and we will be ensuring NHSEI lives up to this commitment.
  • Practices will be paid for the vaccines administered; if they withdraw from the programme they will receive payment for doses administered up to the point of withdrawal. They would need to ensure that any patient who had already received their first dose was provided with the second, before withdrawing the service.
How can we manage this without significant funding for additional staff?

Combining new funding for additional capacity with the vaccination item of service fee, and deploying the workforce to align with appropriate clinical prioritisation - including use of locums to provide additional capacity - practices and community teams can work together to successfully deliver the service.

QOF income protection will enable practices to prioritise COVID-19 vaccination activity, alongside those who would most benefit from review of their long-term condition

Can this be done with the proposed level of funding?

The payment of £12.58 per vaccine (£25.16 in total) is 25% higher than the IoS fee for flu and other vaccinations. This in turn was only increased two years ago from (EDIT). This is in addition to £150m invested to support workforce capacity, QOF income protection and the opportunity to use extended access services to expand the vaccination programme.

Economies of scale exist with large groups of the eligible population being general healthy mobile patients.

What if a patient only has the first dose?

If a patient doesn’t return for the second dose after appropriate invitations, practices will be paid for one dose only.

This includes (among other things) if the patient has chosen not to receive the second dose of the vaccine following a shared conversation, and if the patient did not respond to offers of receiving a second dose of the vaccine.

Practices are expected to make appropriate representations to patients who decide against the first or second dose. Where a patient declines or does not respond, the practice will record that on the system (no evidence required). If they decline the second dose only, the practice will be paid for the first dose.

Funding and prioritising workload

We expect the majority of patients will want to be vaccinated in general practice due to existing, trusted relationships. Practices participating in the CVP will need to accordingly prioritise their workload.

Other work and services can be deprioritised. GPCE and RCGP have revised our joint workload prioritisation guidance to assist practices in this.

This will be assisted by the QOF (quality and outcomes framework) income protection previously agreed, the streamlined and now optional appraisal system and other bureaucracy-reducing measures implemented early in the year remaining in place.

Changes to funding to help you prioritise CVP

  • The management of long term conditions should be managed on the basis of clinical prioritisation with continued recording patient contact, but this will not impact payment.
  • QI modules in QOF have been significantly revised, supporting essential activity.
  • ARRS (additional roles reimbursement scheme) staff can be deployed as required to vaccination as integral members of PCN teams. ARRS recruitment should continue with full funding entitlements remaining in place.
  • The network contract direct enhanced service makes clear the number of SMRs (structured medication reviews) to be delivered will be limited by PCN clinical pharmacist capacity. It's likely that the CVP is considered a priority for deploying available clinical pharmacists in the short term.
  • A PCN may use its additional roles reimbursement sum to reimburse extra hours worked by PCN staff, at plain time rates only, as long as the increase in whole time equivalent hours worked is clearly recorded on the PCN’s claim form and national workforce reporting system.

CQC have communicated about their approach to ease burden on providers in this period.

The funding and staff providing the improving access schemes can be utilised to deliver the service with local agreement, particularly in the evenings and at weekends. LMCs should discuss this with the local service providers to facilitate good collaboration.

Utilising the funding for additional capacity, the IoS fee and the clinical prioritisation of services, practices and community teams will be able to work together to successfully deliver the service.

GPCE will closely monitor the situation and work with NHSEI to ease further workload pressures where possible. With the prioritisation process in place, NHSEI and commissioners will be assured that practices are continuing to deliver what patients need.

Where will the workforce come from?

Staff may be moved from their regular commitments to provide the vaccines (remembering there will be staff from multiple practices). This will provide the staffing, without additional cost.

Most of the vaccine programme will be delivered by nurses, health care assistants and supported by PCN and practice pharmacists, assisted by practice staff, rather than GPs.

Practices will therefore need to reduce other nurse-led services. Practices will share with other practices in vaccination delivery in the designated centre, this may be on a rota basis, so could be one day a week, not seven days a week for a typical practice.

Any additional capacity required can be covered under the new £150m fund, through increasing hours of existing staff and/or engaging locums. Extended access services can also be used for vaccination delivery on evenings and weekends.

How can volunteers help?

Volunteers could also be used to help steward and supervise patients.

The Government previously released the outcome of the human medicines regulations consultation.

This suggested that legislation would be passed to permit non-registered individuals to be involved in the programme.

Volunteers engaged under a formal agreement and with appropriate checks (DBS etc) will be covered under the
clinical negligence scheme for general practice​.

How can other providers support practices?

Practices can use other providers (eg pharmacy and community providers) to assist with the programme, with their agreement.

They should use existing agreements for flu immunisation delivery (as is the case for many PCNs) or put in place similar arrangements if not already done. Practices will need to factor this into their considerations for workforce planning and funding distribution.

What about home visits?

Arrangements for home visits currently in place in many areas for flu vaccines, with providers working together to ensure coverage (for example community providers and district nurses) will be expected to be maintained, and if not in place to be put in place. NHSEI strongly encourages CCGs to work with community providers to assist general practice to deliver the service. We encourage LMCs to discuss this with their CCG and local community provider.

Will the additional income push me above the annual allowance?

The threshold for annual allowance in the pension scheme has been increased from 2020 onward.

Practical considerations for practices and PCNs

With the timeline being extremely tight, practices will have a short amount of time to make some key decisions, and will need to make rapid preparations to be ready to deliver from 1 December. Here are some pointers to help with the preparation.

  • Your target population

Firstly, think about who your target population is (based on JCVI recommendations).

  • How many of those you’re likely to receive to the vaccination site
  • How many will require a visit.

This will set the expectation of what you need to deliver. The unknown here is how many doses you’ll receive and when – could you vaccinate them all in the first week if enough vaccine were supplied?

  • What you need to practically deliver

Where

Which one practice (or another appropriate site) is used for the vaccination site? Remember that provision potentially needs to be available 8am - 8pm, seven days a week to all patients of the participating practices and considering storage facilities.

What are the implications for services at practices where their staff may be deployed instead to the designated vaccination site?

What happens at the designated site if it is a GP practice (for example is it just providing the CVP, or is it also providing other routine GP services too)?

Who

Vaccinators, diluters, ushers/admin, overseeing clinician. Who is going to staff the vaccination site, who is going to do visits?

Most of the programme should be delivered by staff other than GPs, who will be most useful in overseeing and in providing routine care to other patients as needed.

Running multiple vaccination lines under the supervision of one nurse will dramatically reduce the unit cost. These economies of scale have a large impact - hence the need for practices to cooperate.

  • Your existing workforce

Who can you redeploy to staff the vaccination site (practice staff and PCN staff)? If this is within their usual working hours then there will be no additional cost, and NHSEI has stated that you can prioritise the vaccination programme.

Remember too that you can use the staff who provide extended hours and extended access appointments (for example at evenings and weekends) so there should be no additional cost for these either.

You can also use other community providers (pharmacy, nursing etc) with their agreement, to deliver the service together remembering there may be costs involved with this.

  • What else you might need

Additional workforce

If you do need more people, then you can use volunteers and the £150m fund to create additional capacity (either to provide the CVP or to continue routine services while existing staff provide the CVP).

Visits

  • Housebound and care home patients will not be able to attend the vaccination site, so you’ll need to work out how to provide their vaccinations. It may be a practice nurse or other practice or PCN healthcare worker (during their normal working hours) or you might use the district nursing team.
  • How many patients can staff vaccinate a day, and what does this mean in terms of your total numbers?
  • It is worth being cautious at this stage as the first vaccine might not be practical to deliver in this way given its characteristics.

Additional costs

  • People who do not normally work evenings and weekends (could come from the £150m fund).
  • Additional staff to support existing staff (will come from the £150m fund).
  • Additional travel costs (using the IOS fee).
  • Additional venue hire (from local CCG funding).
  • Contingency costs (using the IOS fee).

Practicalities

Once you’ve worked all of this through you should be in a good position to start thinking about the specifics:

  • how to coordinate the appointment bookings for all patients (will all bookings be made through the designated vaccination site, or separately via individual practices, whether to use the national booking system)
  • what information to provide to patients about the service, including venue timings, patient eligibility
  • any approvals required for, and costs of, additional opening of the designated site premises
  • how additional staff or additional hours will be paid, and how funding will flow to ensure fair distribution depending on staffing and delivery decisions
  • setting up your vaccination site (patient flows, signage etc)
  • how to vaccinate your own staff.

 

Timeline

Task Date
Practices, in groups, to decide whether to deliver the service, and if so discuss practicalities (see below) Monday 10 to Tuesday 17 November
Practices to notify commissioners if they wish to participate in this ES and respond to the designation process Tuesday 17 November
Commissioners provisionally confirm designated sites Thursday 19 November
Formal offer to practices to deliver the ES Monday 23 November
Final enhanced service specification published to come into effect on specified date Late November
Administration of the vaccinations commences Start date to be confirmed, earliest will be 1 December

Delivery dates and volumes of the vaccine will be dependent on approvals and supply, which will be confirmed in due course.

 

The vaccines and their characteristics

At present, we understand there are two vaccines likely to be supplied in the UK initially. As these and other vaccines are developed and tested their characteristics might change.

The Pfizer vaccine The AstraZeneca vaccine
  • Acts via mRNA  and is likely to be the first vaccine available to practice.
  • Stored (at manufacturer) at about -75c.
  • Delivered to a practice in batches of 975 doses (195 vials each containing five doses), along with diluent, needles and syringes.
  • Once out of the freezer can be stored at 2-8c.
  • Needs to be used within five days.
  • Once diluted the vaccine must be used within six hours.
  • Not stable enough to transport a diluted solution to another venue.
  • Two doses required, 21 days apart and cannot be given within seven days of a flu vaccination.
  • Potential side-effects such as injection site discomfort and short lasting temperature, patients are not to drive for 15 minutes afterward.
  • Stored (at manufacturer) at -80c.
  • Delivered to practices in vials contain eight or 10.
  • doses and in batches of 10 vials, with syringes etc.
  • Does not require diluting.
  • Once out of the freezer can be stored at 2-8c, with a shelf life of about six months.
  • Once punctured the vials must be used within four hours.
  • Two doses required, 28 days apart and cannot be given within seven days of a flu vaccination.
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