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).
The CVP is delivered by groups of practices, generally covering an area conterminous with PCN (primary care network) footprints.
The first wave of GP-led vaccinations commenced on 14 December, with more GP groups coming online throughout December and beyond. The GP-led programme sits alongside the programme being rolled out through hospital hubs, which commenced 8 December.
- Implications of the Government’s decision to change the dosing schedule of the vaccines from three to four weeks to 12, and support available to help practices manage this change in policy.
- Details of a transitional arrangement for second dose appointments already scheduled to take place up until 10 January.
- Approval of the Oxford AstraZeneca (AZ) vaccine, and the ability for practices to transport and administer the AZ vaccine from sites other than the practice grouping’s designated site.
- Access to vaccines for all frontline health and social care workers.
- Further support the BMA secured to enable practices to prioritise vaccine delivery, including additional payments for care home vaccinations.
What the service involves
Eligible patients will 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.
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.
It also allows PCNs to vaccinate the patients of non-participating practices and to unregistered patients.
All frontline health and social care workers are eligible to receive the vaccine, regardless of what sector and setting they work in. This includes locums and private health and social care workers. Practices are able to vaccinate their own staff and other health and care workers be paid for doing so.
Local pharmacies have been commissioned where general practice coverage is not enough.
The BMA has made it clear that the vaccination of frontline HCW (health and care workers) must take place as soon as possible.
CCGs should be contacting all healthcare providers to make them aware of how to book an appointment for frontline HCWs.
Those healthcare providers should pass the message on to their employees and others they are engaged with. Practices should reach out to the frontline HCW they know to book them in.
In turn, frontline HCWs should contact their registered GP, a practice they are engaged with, or their local vaccination site, to book an appointment.
For the avoidance of doubt, frontline HCWs include those workers who would ordinarily have frontline responsibilities but for reasons outside their control are currently working in a non-frontline setting.
Read our guidance on vaccine provision for HCWs.
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, which should be by national agreement between NHSEI and GPCE. 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.
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.
Practices should not feel pressured or coerced into signing up to the ES, but if this occurs practices should escalate this to NHSEI via GPC England or relevant LMC. Similarly, NHSEI has been clear that CCGs should not micromanage the operational elements of the CVP as this service is practice-led.
If practices know that they do not wish to sign up to the ES they should communicate this to CCGs to support local planning.
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 model for delivery is through groups of practices working together (along PCN geographies), with one designated vaccination site (ideally to be a GP practice).
NHS England has published a SOP (standard operating procedure) for vaccination deployment in community settings, including general practice.
NHS England has also published a collaborative agreement for use by practice groups, which our legal team has reviewed further. This is a template that practices could adapt further if they wanted to, but this should not be necessary.
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 is operating, 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.
- Pfizer vaccine patient group direction
- Pfizer vaccine national protocol
- AstraZeneca vaccine patient group direction
- AstraZeneca vaccine national protocol
The current national protocol for the Pfizer vaccine includes the need for vaccine recipients to be monitored for 15 minutes after vaccination, with a longer observation period when indicated after clinical assessment. For more information, see the MHRA urgent precautionary advice for healthcare professionals.
A SOP (standard operation procedure) for the management of COVID-19 vaccination clinical incidents and enquiries has also been published.
We have created additional guidance on how you can utilise extra workforce to deliver the vaccination programme.
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.
Administering the second dose
Patients will 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 practice grouping. In some cases, patients receiving a second AZ dose may do so at their own practice (as opposed to the original designated site), but only where their practice is part of their original practice grouping that delivered the first dose.
At present, available vaccines require a two-dose schedule.
The MHRA, JCVI and chief medical officers announced that the gap between doses should be extended from three to four weeks (for Pfizer and the AZ vaccines, respectively) to 12 weeks in order to offer a first dose of the vaccine to more people in priority cohorts.
This recommendation was made on the basis that “models suggest that initially vaccinating a greater number of people with a single dose will prevent more deaths and hospitalisations than vaccinating a smaller number of people with two doses”.
The BMA recognises this presents enormous difficulties to practice groupings who have already made hundreds or thousands of appointments with patients to receive the second dose within the original dosing schedule.
After lobbying from the BMA, we can confirm that, as a transitional arrangement, pre-arranged appointments for the administering of second doses up to and including 10 January 2020 can still take place with written notification of clinical judgement.
Appointments for second doses due to take place after that date should be rescheduled to reflect the current guidance to delay for up to 12 weeks.
We have also negotiated additional support available to practice groupings to implement this change, including:
- a patient letter and script explaining the changes
- a one-off £1,000 payment to support administrative efforts
- an offer of support from North of England CSU, which is operating a call centre free-of-charge to contact patients to postpone appointments.
Using the JCVI 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 Pfizer vaccine
- Minimum supply to practices of 975 per week.
- Practices can draw five or six doses from each vial.
- Packs of 75 supplied for vaccination of care home residents and staff.
The AstraZeneca vaccine
- All sites will get an initial 400 doses.
- Delivered to practices in vials containing eight or 10 doses and in batches of 10 vials, with syringes etc.
- Subsequent deliveries will be determined by supply and availability of the vaccine.
The Pfizer vaccine
- Stored (at manufacturer) at around -75c.
- Once out of the freezer can be stored at 2-8c.
- Needs to be used within three and a half days from delivery.
- Once diluted the vaccine must be used within six hours.
The AstraZeneca vaccine
- Stored (at manufacturer) at -80c.
- Can be stored at practices sites at 2-8c, with a shelf life of about six months.
- Does not require diluting.
- Once punctured the vials must be used within four hours.
Practice groupings should be able to use ordinary cold storage for these vaccines, and there should be no need for practices to use deep-freezing.
Refrigeration units or funding will be made available to practices to ensure they have sufficient storage to deliver the programme.
NHSEI will arrange logistics of deliveries to designated sites using refrigerated storage transport.
The AstraZeneca vaccine is easier to store and transport. As a result, practices are able to transport the AZ vaccine from the designated site, to their own practices, or care homes or patients’ homes, to administer at those sites.
Deliveries of the vaccine will still be made to the designated site, and practices will be responsible for any onward transport.
Pfizer vaccines must be administered from the designated site. There is a lack of flexibility associated with this vaccine due to the logistics of transport and storage.
Unless the practice’s patients are already covered by another group providing the vaccination programme, then practices should be able to opt in at a later date.
However, practices are encouraged to sign up as soon as possible.
Practice groups must prioritise the delivery of vaccines to eligible patients, and should plan accordingly. In some instances, surplus vaccine supply may nonetheless result – for example, where fewer patients attend vaccination clinics than was anticipated.
In these instances, the overriding principle will be to avoid wastage, so NHSEI has advised that the residual vaccines may be administered to vaccinate wider frontline HCWs.
If a practice group is no longer able to deliver the ES it should notify the CCG at the first possible opportunity, which will work in concert with NHSEI to identify logistical support available to enable the group to deliver the ES.
In instances where the group is still unable to deliver the ES, NHSEI will redirect the delivery of vaccine supplies to avoid wastage.
CVP funding and resources
- Practices will be provided with the vaccines, needles, syringes, diluents, fridges and PPE.
- Practices will also be provided with relevant 4G-capable IT equipment as well as any barcode scanner that may be required.
- Public Health England has published consent forms and letters for use by practices, as well as a range of patient leaflets.
- Participating groups of practices will receive an initial batch of leaflets.
- A £12.58 IOS (item of service) fee will be provided per dose.
- NHSEI has agreed to increase the supplementary funding available for care home vaccinations (residents and staff) to support the vaccination of all care home residents and staff by the end of:
- £30 for first doses administered Monday 14 December - Sunday 17 January
- £20 for first doses administered Monday 18 - Sunday 24 January
- £10 for first doses administered Monday 25 - Sunday 31 January
- £10 for all second doses administered
- PCNs bringing in additional workforce until the end of January to ensure that all records for vaccination of priority cohorts are up to date and recorded properly in Pinnacle will be eligible to claim up to £950 per week (a maximum of £2500 per PCN grouping) of funding support. Vaccination must be recorded immediately in Pinnacle to ensure the record is updated and that PCNs are paid.
- 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, coverings for outdoor waiting areas, 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.
- £150m of further support is available 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.
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
The payment of £12.58 per vaccine (£25.16 in total) is 25% higher than the IoS fee for flu and other vaccinations. This is in addition to:
- £150m invested to support workforce capacity
- QOF income protection
- the opportunity to use extended access services to expand the vaccination programme
- Additional payments for vaccinating care home residents and staff.
Economies of scale exist with large groups of the eligible population being general healthy mobile patients.
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.
In most instances practice groups should use existing estates or premises to deliver vaccination clinics. If this is not possible, available NHS vacant space should be considered – this should be free of charge, brokered by your CCG.
If these options are not possible, third-party venues can be considered. Practice groups and CCGs can agree one-off setup costs to be met by NHS, and up to £20m has been made available to systems to meet these expenses.
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 and NHS England has now been clear that they can offer an urgent-only service while vaccinating practice teams are involved in the programme.
Other work and services can be deprioritised. GPCE and RCGP have revised our joint workload prioritisation guidance to assist practices in this.
GPCE has worked closely with NHSEI to identify further measures to free up practices to support COVID-19 vaccination efforts. NHSEI has instructed CCGs to:
- take a supportive approach to minimise local contract enforcement across routine care
- suspend any locally commissioned services except where these are specifically in support of vaccination or other COVID-related support to the local system.
- consider whether clinical staff involved in CCG management could be made available to support practices.
The BMA has also secured NHSEI agreement that appraisals can be declined during this period. Other bureaucracy-reducing measures implemented earlier in the year also remain in place.
Changes to funding to help you prioritise CVP
- QOF (quality and outcomes framework) income protection is in place - in addition to the existing protections for 310 QOF points, we have successfully negotiated for the protection of the eight prescribing indicators (to be paid on the basis of historical performance), as well as full income protection for all 74 points in QI modules, to apply from January to March 2021.
- Additional funding has been made available for PCN clinical directors in those PCNs where at least one practice is participating in the CVP, to apply from January to March 2021.
- Minor surgery DES (directed enhanced service) income will be income protected until March 2021.
- 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.
- 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.
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.
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.
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.
The threshold for annual allowance in the pension scheme has been increased from 2020 onward.
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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 a vaccine. 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.
What you need to practically deliver
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)?
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
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).
- 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.
- 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).
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 ensure your own staff are vaccinated.
The vaccines and their characteristics
At present, there are two vaccines 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|
* at the end of December, the MHRA, JCVI and chief medical officers decided that the interval between doses (for both vaccines) should be extended to 12 weeks, so that more people can be offered a first dose sooner.
Safety and risk
The vaccines go through testing procedures and MHRA's (medicines and healthcare products regulatory agency) licencing process. Confirmation of the specific vaccines is given following completion of trials and licencing/approval. The JCVI and others will provide independent input and decisions are made in the normal way.
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.