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Q&A: What we know about the Covid vaccine DES (Updated 7 January)

Q&A: What we know about the Covid vaccine DES (Updated 7 January)

Pulse’s Q&A focuses on what the Covid vaccine DES means for GPs based on what we know. This will be updated constantly. If you have any questions, please contact newsdesk@pulsetoday.co.uk or comment at the bottom of this article. Last updated 7 January 2021.


Payments and the DES

Money

How much will practices be paid?

Practices in England will be paid £12.58 per dose administered of whichever vaccine they have. The vaccines that have been approved so far have two doses.

Practices were originally told they would be paid £25.16 after the second dose is administered.

However, a change in guidance to delay the second dose by 12 weeks means NHS England is now consulting with the BMA so that GPs will be paid after each separate dose instead.

For vaccinations given to care home residents and staff, an extra £10 per dose will be paid – on top of the £12.58 fee.

Updated 4 January

What happens if you are unable to administer the second dose of the vaccine?

Under the original proposals – in which doses would be delivered just three weeks apart – practices were told they would still be paid the £12.58 if patients did not have the second dose for the following reasons:

(a) unsuitability for the patient:

(i) because of medicine intolerance or allergy discovered during administration of the first dose

(ii) if the patient has commenced end of life care before a second dose of the vaccine could be provided

(iii) if the patient has died before a second dose could be provided.

(b) the patient has chosen not to receive the second dose of the vaccine following a shared decision making conversation

(c) the patient did not respond to offers of receiving a second dose of the vaccine

(d) if the patient has moved out of the area covered by the PCN grouping (see below);

 (e) if the patient has moved in to the area covered by the PCN grouping after receiving the first dose of the vaccine from another provider.

How will practices have to organise themselves?

The first deadline for the programme will be for ‘PCN groupings’ to inform their CCG about their nominated vaccination site by Tuesday 17 November.

Practices will need to organise themselves into groupings, which will broadly align to their primary care networks. However, there are exceptions to this, such as PCNs with populations larger than 100,000 patients, or for PCNs smaller than 30,000 patients. Practices who are not part of a PCN will also be able to sign up in collaboration with their local PCN.

Each grouping will have to designate a single premises as a vaccination site. This will then have to be approved by the CCG. The CCG will rank the nominated sites. If there are too many sites, they will cut the number according to the ranked list.

NHS England estimate that there will be 1,000 to 1,500 sites in all.

Updated 17:50, 11 November

When will practices have to sign up?

GPs were instructed to sign up to the enhanced service by the end of 7 December, with the contract becoming effective on 8 December.

NHS England announced GPs would begin delivering the vaccination programme from 14 December.

Updated 4 January

When will practices have to start vaccinations?

The MHRA has now approved the Pfizer vaccine for use in the UK, as well as the Oxford/AstraZeneca vaccine, with both being rolled out across the country.

GPs were not required to deliver the majority of vaccinations given at the end of 2020, when only the Pfizer vaccine was available and hospital hubs were the first settings to start the programme.

However, GPs are expected to administer the ‘bulk’ of the first wave of the Oxford/Astra Zeneca vaccine in early 2021.

Updated 4 January

Who will be able to administer the vaccinations?

Registered healthcare professionals will need to carry out the clinical assessment, consent and preparation of the vaccine.

However, the vaccine itself can be administered by a suitably trained non-registered staff member – while under the clinical supervision of a registered healthcare professional.

A national protocol lays out what registered and unregistered practitioners are allowed to do at different stages of delivering the vaccine.

Updated 4 January

What training will staff need?

Practices will need to oversee and keep a record confirming all staff have undertaken training prior to vaccination.

Training will be provided by Public Health England / Health Education England.

Practice staff are likely to have to take part in specific e-learning chapters – with each one taking up to 1.5 hours to complete.

Additional chapters of e-learning will be provided if new vaccines become available.

How will patients be notified?

Patients will be sent a letter by the national call/recall service telling them they are eligible for vaccination and that they have a choice of where they can get their vaccine.

Meanwhile, PCN groupings will also be expected to contact patients eligible for vaccination, using nationally agreed wording.

Patients will be given the choice to either book at a GP-led vaccination centre or use the national booking service to be vaccinated by another provider.

PCNs will be given the option to use the national booking service – or they can use their own appointment booking systems and schedule clinics in line with vaccine supply.

Currently there is no way of informing practices automatically when a patient books a vaccination with another provider via the national booking system, but this is being looked into further.  

Practices will not be contractually obliged to offer call and recall for patient cohorts that they are unable to reliably identify from their records, eg, health and social care workers – but are encouraged to do so if they can identify them.

Is this actually a Directed Enhanced Service?

It became apparent on 13 November that this may not actually be a DES, despite the BMA calling it such. It has been called an ‘enhanced service directed by NHS England’.

In reality, this probably won’t mean much for GP practices. It allows NHS England to change the requirements – or maintain ‘flexibility – but this was inevitable as we don’t know the characteristics of every vaccine as yet. And as there is no core payment involved – only item of service fees – PCN are in effect able to opt out whenever they like by simply deciding not to continue administering vaccines: there is no contratual mechanism that NHS England can use to punish them.

Another advantage of a DES is that it gives GPs preferred provider status. This might be a problem in future, but with such a vast vaccination programme, it is highliy unlikely that GPs will be discouraged from giving out the vaccination to as many patients as they can.

Added 8:45, 16 November

Will practices have to open on bank holidays, as well as evenings and weekends?

There is a requirement that practices must ‘be able to deliver a vaccination service seven days per week including bank holidays between 8am and 8pm’. NHS England said that because of the nature of the Pfizer vaccine – with GPs having to be administer it within a few days of receiving the batches of 975 doses – and the unknown delivery times, it may be the case that vaccinations could take place on bank holidays, evenings and weekends.

Updated 4 January

What is the case if no practice in a PCN area is willing to lead on the vaccinations?

This is the nightmare scenario for the Government, and one that hasn’t been fully answered. There will be ‘Nightingale’ style mass vaccination centres that could take up the slack. But it is unclear how many, and they won’t be able to vaccinate care homes or housebound patients.

We have seen this problem with test and trace, with people needing to travel long distances in order to get tested. This still needs to be clarified.

Added 18:00, 11 November

Is payment to the practice or the PCN grouping?

This is not yet completely clear, but we know it is a requirement of the DES to have a ‘vaccination collaboration agreement’ in place, designed ‘to support practices to put in place appropriate arrangements under the Enhanced Service for premises, data sharing, financial arrangements, subcontracting arrangements’.

Added 18:30, 11 November

Will we be paid for vaccinating our own staff if they are not registered with us?

Yes. The BMA has said: ‘Practices will be able to vaccinate their own staff and be paid for doing so.’

Added 18:30, 11 November

What is happening in the devolved nations?

Most of the information in this Q&A relates to what is happening in England. Few details have been released for other parts of the UK so far, although in Scotland health boards will take the lead in running the programme.

Northern Ireland is expected to draw up an agreement with GPs that is similar to England’s contract.

In Wales, health boards and trusts will also be in charge of the vaccination programme.

However, following the MHRA’s approval of the Pfizer vaccine for UK use, the Welsh Government said practical constraints meant it will not be possible to vaccinate care home residents with the Pfizer vaccine.

Updated 11:30, 2 December


Patient care

Patient care

Will patients need to be monitored after being given the vaccine?

Yes, if they receive the Pfizer vaccination they will need to be observed for 15 minutes afterwards.

But patients receiving the Oxford/AstraZeneca vaccine will not need to be monitored.

The guidance on this has changed a few times. Originally it was proposed there should be a 15-minute observation requirement, but that was later clarified as only applying if the patient were driving.

However, the original advice for patients to be monitored for 15 minutes was reinstated for the Pfizer vaccine after two healthcare professionals had reactions to the jab. There have been no anaphylactic adverse reactions to the Oxford jab so far.

Updated 7 January

What is the time needed between the two doses, and how soon after the flu vaccine can we start administering them?

The Joint Committee on Vaccination and Immunisation (JCVI) has confirmed that for both the Pfizer and Oxford/AstraZeneca vaccine it recommends two doses.

The Government originally said the Pfizer vaccine doses would be given three weeks apart, and was expected to confirm a similar interval for the Oxford/AstraZeneca vaccine.

However, the JCVI has changed its advice. It says the second dose of the Pfizer vaccine may be given between three to 12 weeks following the first dose. The second dose of the AstraZeneca vaccine may be given between four to 12 weeks following the first dose.

The advice was changed to give more people a chance of receiving the first dose and gaining some immunity.

The MHRA has said the AstraZeneca vaccine is more effective when the second dose is given eight to 12 weeks after the first. The JCVI has meanwhile said there is ‘no strong reason’ to believe the Pfizer/BioNTech vaccine would be any different.

There needs to be at least seven days between the flu vaccination and Covid-19 vaccinations.

But Public Health England guidance says while coronavirus jabs should ideally be separated from other non-Covid vaccinations by seven days, vaccination can still be considered within a shorter time period.

Updated 7 January

Is the Pfizer vaccine the only one practices will be administering?

The Pfizer vaccine was the first to be authorised and rolled out in hospitals and at GP sites, but practices will largely be administering the Oxford AstraZeneca vaccine now it has also been approved.

The two vaccines both have high levels of efficacy.

Pfizer announced that its vaccine is 90% effective – later revised to 95% following full analysis.

The University of Oxford vaccine has been shown to be 90% effective when given as a half dose followed by a full dose. But the two full-dose approach is what has been authorised by the MHRA, which has a 70% efficacy.

US biotech firm Moderna has also shown its vaccine to be 95% effective – but it is at a later stage of development and has not yet been approved for use in the UK.

The UK has secured 355 million doses of six different vaccines in development worldwide (although does not expect all to be effective).

This includes 100 million doses of the Oxford vaccine, 40 million doses of Pfizer’s and five million doses of the Moderna vaccine.

Updated 4 January

Can two different types of Covid vaccine be used with the same patient?

Yes – though Public Health England says every effort should be made to complete both doses with the same vaccine where possible.

That is because there is currently no evidence on the interchangeability of vaccines. But PHE says since both frontrunners are based on the spike protein of the virus, it is likely the second dose will help to boost the response to the first dose even if a different vaccine candidate is used.

Added 2 December

Which patients will practices need to vaccinate?

The Joint Committee on Vaccinations and Immunisations has recommended the following order for administering the two authorised vaccines:

  1. Residents in a care home for older adults and their carers
  2. All those 80 years of age and over. Frontline health and social care workers
  3. All those 75 years of age and over
  4. All those 70 years of age and over. Clinically extremely vulnerable individuals
  5. All those 65 years of age and over
  6. All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
  7. All those 60 years of age and over
  8. All those 55 years of age and over
  9. All those 50 years of age and over

The JCVI at first stressed it did not recommend giving the vaccine to any pregnant women.

However, it has updated its advice on giving the vaccine to pregnant women, saying they should in fact be offered it if they meet the definition of being clinically extremely vulnerable.

The JCVI has updated its guidance on giving the vaccines to children. It said the Pfizer-BioNTech vaccine is authorised in those aged 16 years and over. But the AstraZeneca vaccine is only authorised for use in those aged 18 years and over.

Meanwhile, Public Health England initially said Covid-19 vaccines are not routinely recommended for those under 18 years of age, but has since updated its guidance to say children under 16 years of age should not be routinely given the vaccine.

Updated 7 January

Will the vaccine work for immunosuppressed patients?

The JCVI says they ‘may not respond as well to the vaccine’, so clinically extremely vulnerable patients are advised to continue following Government advice on reducing infection risk, even if vaccinated.

The committee says it will review the evidence on whether the vaccine stops transmission and whether it is beneficial to vaccinate people living in the same household of immunosuppressed patients as part of a ‘cocooning’ strategy.

Added 4 January

Will practices have to provide visits to care homes and housebound patients?

Yes. Under the DES, practice groups will be responsible for both care home staff and residents, and will need to provide home visits for housebound patients.

NHS England has said it expects GP teams to visit care homes a ‘minimum’ of four times to provide vaccines.

When will GPs get vaccinated?

The Joint Committee on Vaccination and Immunisation (JCVI) said GPs would be prioritised for Covid vaccination based on their personal risk level, exposure and amount of contact with vulnerable people.

Overall, frontline health and social care staff are in the JCVI’s second priority group for vaccine.

As of early January, NHS England said the vaccination programme should now be expanded to ensure vulnerable GPs and practice staff receive the jab as a priority.

Updated 4 January


Non-Covid vaccine workload

What work will practices be able to stop doing in order to carry out this programme?

At the end of 2020 NHS England initially said practices giving the vaccines ‘must demonstrate ability to coordinate clinical capacity in line with cohort prioritisation and national/practice call/recall schedules and in alignment with national communications guidance, whilst maintaining appropriate levels of wider general practice capacity’.

However, at the start of 2021 when the vaccine programme gathered pace it laid out measures for CCGs, designed to cut GP workload:

  • Suspension of locally commissioned services, except ‘where these are specifically in support of vaccination’ or other Covid-related support, including reducing admissions;
  • A review of whether clinical CCG management could support practices or PCN work;
  • To take a ‘supportive and pragmatic approach’ to GP contract enforcement across routine care.

Updated 7 January

What support will practices receive to do all their other work?

There will be a £150m general practice Covid fund available until March (but no other Covid funding) to keep normal services running. It will be up to CCGs and ICSs to decide how this money is used, but they have been given suggestions including hiring pools of extra salaried GPs.

The conditions attached to the £150m Covid support fund also suggest that practices will need to increase their achievements for the learning disabilities DES, and will need to help clear backlogs in long-term conditions and other vaccinations.

How will GPs access the £150m fund to keep normal services running?

It will be for integrated care systems and CCGs to determine how best it is spent within general practice. NHS England said it should have ‘a focus on simplicity and speed of deployment’.

However, they say: ‘Accessing the fund will be conditional on practices and PCNs continuing to complete national appointment and workforce data in line with existing contractual requirements.’

They have also said that there will be no extra money given to practices to support them through Covid until April.

What will the £150m be used for?

NHS England say that it should be used to help ‘stimulate the creation of additional salaried GP roles that are attractive to practices and locums alike’. This includes the employment of staff returning to help with Covid, or to increase the time commitment of existing salaried staff.

It will also be used to:

  • Support the establishment of the simple Covid oximetry@home model – with details to be announced shortly;
  • Help identify and support patients with Long Covid;
  • Continue to support clinically extremely vulnerable patients and maintain the shielding list;
  • Help with the backlog of appointments including for chronic disease management and routine vaccinations and immunisations;
  • Make ‘significant progress on learning disability health checks’, with an expectation that all CCGs will without exception reach the target of 67% by March 2021. Current achievement is one fifth lower than the equivalent position last year; and actions to improve ethnicity data recording in GP records
  • Potentially offering backfill for staff absences where this is agreed by the CCG, required to meet demand, and the individual is not able to work remotely.

What additional workforce will be available to general practice to deliver the vaccine?

NHS England at first said that the vaccinations would need to be carried out with existing staff. However, they claim that the £150m can be used to help extend the hours of salaried staff and to attract people back into general practice.

However it has since gone on to say that free extra staff will be available to GP networks vaccinating in care homes.

Updated 4 January


The vaccine characteristics

How will the Pfizer vaccines need to be stored and where will practices be able to get fridges and other necessary resources for storing a vaccine at below 70 degrees?

The Pfizer vaccine will initially need to be stored at minus 70 degrees. However, it will not be practice groupings who will need to do this.

NHS England’s specifications call on groupings to have refrigeration to store vaccinations at 2-8 degrees. Vaccines are delivered in batches of 975, which will have to be used within 3.5 days of delivery – marking a change from the original five days.

The vials will come in vials of five doses, not 1,000 as Pulse had reported.

Updated 4 January

Do they come in huge vials?

Pulse originally reported that the vaccines will come in vials of 1,000. However, this is not the case (and we apologise). The vials come in doses of five, NHS England has confirmed.

Updated, 18:00, 11 November

How is the Oxford vaccine stored and supplied?

In contrast to the Pfizer vaccine, Oxford/AstraZeneca’s vaccine must not be frozen and can be stored in the fridge at 2-8 degrees. The unopened vials have a shelf life of six months.

Once opened the vaccine should be used as soon as possible and within six hours. The vaccine may be stored between 2 and 25 degrees while being used.

The Oxford/AstraZeneca vaccine is supplied in packs of 10 vials. Each vial contains 8 or 10 doses of the vaccine.

Added 4 January

Can an extra dose be taken from leftover liquid in the vials?

Yes, guidance states both the Pfizer and Oxford vaccines come in vials that might allow for an extra dose to be extracted on top of the standard amount.

Added 7 January

How quickly does immunity kick in?

The Pfizer vaccine provides immunity seven days after the second dose is administered.

The Commission on Human Medicine (CHM), which advises the Government, says partial immunity does occur after the first dose but two doses guarantees the best immunity.

Oxford University says its vaccine provides protection for a ‘short period’ between the first and second dose but that the second dose is expected to provide a more durable immune response. 

It says partial immunity occurs beyond day 22 of the first dose with its initial results showing that two doses provide more robust protection beyond three months. 

Updated 4 January

Are there any side effects of the vaccines?

The MHRA has confirmed both the Pfizer and Oxford/ AstraZeneca vaccines have met its regulatory standards for being deployed across the UK.

When the Pfizer vaccine was first rolled out in December, two healthcare professionals receiving the jab had anaphylactoid reactions. Both had a ‘strong past history’ of allergic reactions and each carried an adrenaline auto injector.

The MHRA went on to revise its advice on monitoring patients, stating they should be watched for 15 minutes after receiving the Pfizer jab.

Updated 4 January

Can I give the vaccine to patients with a history of anaphylaxis?

NHS England says patients can receive ‘any’ Covid vaccine as long as they are not allergic to any specific vaccine ingredients.

This is an update to prior guidance in which GPs were advised not to give the Pfizer vaccine to patients with a history of ‘significant’ allergic reaction to a vaccine, medicine or food, following two incidents related to the vaccine.

Added 7 January

Will patients need to self-isolate if they experience side effects?

Public Health England has said patients may experience a mild fever for 48 hours but that they should only be advised to isolate – and take a Covid-19 test – if it lasts longer than two days.

Updated 11:30, 2 December


Questions needing to be clarified

Question marks

How long will protection last and will there be annual vaccinations?  

This is still unclear, though both authorised vaccine candidates have said better protection is guaranteed after two doses.

Will patients still able to pass the virus on even after vaccination

This is the $64,000 question. We don’t know whether either of the vaccines prevents people from being infected or just stops them from getting ill.

Will practices even break even from this, when taxation, wages and claw backs are taken into account?

Various groups are currently modelling this and we will update when we have more info.

What happens if we fail to book in the requisite minimum 975 patients per week – do we have to cancel the clinic or waste vaccine?

This is a major part of the DES that hasn’t yet been clarified.

If vaccinated, will people no longer have to self-isolate if they’re exposed to Covid?

Are there any groups that aren’t eligible for the vaccine, or for whom it wouldn’t be safe?

Will GPs be required to provide proof to workplaces, schools etc that patients have been vaccinated?

Will those with positive antibody Covid results be treated the same way – ie, do they need the vaccination at all, or the two doses?


Please comment if you have any more questions or email editor@pulsetoday.co.uk


          

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READERS' COMMENTS [11]

Please note, only GPs are permitted to add comments to articles

John Oldring 10 November, 2020 2:37 pm

1.Is it known how good an antibody response the older pts will have to each vaccine
2.Will pts still able to pass the virus on even after vaccination
3.What is the risk of the virus mutating and hence making the vaccine less effective
4There will be various types of vaccine produced will there be patient exclusions for each type of vaccine.especially for those will already vulnerable immune systems as a result of illness or its treatment

Reply moderated
Jonathan Heatley 10 November, 2020 3:02 pm

I can imagine some of my families will not want their elderly severely demented relative to have this life prolonging vaccine. They are allowed to opt out of flu vaccine. Is the covid one voluntary?

Reply moderated
Robert James Andrew Mackenzie Koefman 10 November, 2020 3:02 pm

What is so manipulative about this is the headlines today say Matt Hancock says GPs are getting £150million for this which of course is not true as the above document explains.

Reply moderated
Huw Williams 10 November, 2020 6:25 pm

I suggest NHSE keep their £150m and £12.58 per immunisation and see if they can deliver a comprehensive, safe, timely vaccination program while still providing all of their routine services and managing a pandemic

Ashley Krotosky 11 November, 2020 11:47 am

Can someone explain how the single site per PCN works?
Do the fees go to practice of patient even if they are given elsewhere?
Are practices expected to second staff to participate in the process at the chosen site?
Will a PCN hire staff specifically for the process and distribute any profit among practices in proportion to patients attending?
If the host site doesn’t get all the income , will they be expected to receive compensation for hosting?

Reply moderated
Helen Crawley 11 November, 2020 9:19 pm

Question and reply from above leads to further queries:
Q: What additional workforce will be available to general practice to deliver the vaccine?
A: NHS England says that the vaccinations will need to be carried out with existing staff. However, they claim that the £150m can be used to help extend the hours of salaried staff and to attract people back into general practice.

My queries:
What are medical defence organisations going to charge to cover the additional sessions provided by doctors currently paying to cover less than full time work?

Can retired GPs be part of this workforce? How will this happen? Will they be working as doctors or as medical support workers (a key question if they have been sent the GMC letter stating that they are back on the MPL).

David jenkins 12 November, 2020 11:02 am

surely it is obvious that healthcare workers need to be done first:

a – you know where they all are, and it is easier to get in touch with them and organise it

b – the very last thing you want is a load of unimmunised, and possibly infected, healthworkers going around nursing homes infecting all the residents

c – you don’t want loads of staff going off with covid, or self isolating because they have potentially been exposed to anyone infected.

Guy Wilkinson 20 November, 2020 4:47 pm

Agree David Jenkins

Monica Stevens 20 November, 2020 5:58 pm

Before Public Health was decimated, this was their Raison d’etre. They should be vaccinating the public in large public spaces. That way, no vaccine doses will be wasted, staff can be in full PPE, with as little mixing as possible of people. The administration details will then be held centrally and then their GPs can be informed. They can train anyone to give the vaccine, under medical supervision. It does not have to be individual GPs.

It is not that we GPs are work shy, but that we are still looking after the general health of patients. We cannot discharge those duties and immunise as well. We do not want to become conduits for infection in the local community.

terry sullivan 6 January, 2021 11:07 pm

dr heatley–i am not aware flu jab can be compulsory?

coronajabs life-prolonging? evidence?

Joanna Rudnicka 11 January, 2021 11:18 am

Jonathan Heatley – Covid vaccine is most definitely not compulsory and life prolonging?? – definitely no evidence for that yet!!