Dr Claire Davies outlines some practical points and challenges for primary care involvement in the national COVID-19 vaccination campaign

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Dr Claire Davies 

Read this article to learn more about:

  • aims of the current COVID-19 vaccination programme
  • vaccine storage, administration, and staffing requirements
  • patient communication and advice.

The information in this article is correct as of 13 January 2021. For more up-to-date information, please refer to:

In December 2020, NHS England announced the launch of phase 2 of the much-anticipated mass vaccination campaign against COVID-19.1 General practice has an important role in the campaign, described by NHS chief Sir Simon Stevens as ’a decisive turning point in the pandemic’.2 Successful in flu vaccination programmes, and located within communities, primary care is trusted to be able to deliver the vaccine, including to the most vulnerable and hard-to-reach people.3

The UK Government has stated that they have secured enough vaccine to vaccinate the people most vulnerable to COVID-19.3 The Joint Committee on Vaccination and Immunisation (JCVI) priority for the campaign is the prevention of COVID-19 mortality and the protection of health and social care staff and systems. Later phases of the vaccination programme may include targeting persons at increased risk of exposure and/or hospitalisation.4 Mathematical modelling indicates that a large proportion of the population would need to be vaccinated with a vaccine that is highly effective at preventing infection in order to interrupt transmission. At present, there are insufficient data to confirm or refute whether mass vaccination can interrupt transmission of COVID-19; therefore, the target is to reduce mortality and morbidity in individuals in high-risk groups.4

At the time of writing (January 2021), the COVID-19 vaccines manufactured by Pfizer/BioNTech,5 Oxford University/AstraZeneca,6 and Moderna have been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK. Supplies of the Moderna vaccine are expected to be delivered to the UK from spring 2021, once Moderna expands its production capability.8 This article focuses on the Pfizer/BioNTech and the Oxford University/AstraZeneca COVID-19 vaccines, as both of these vaccines are currently available for administration in the UK.

Clinical trials for the vaccines produced by both Pfizer/BioNTech and Oxford University/AstraZeneca showed high levels of efficacy following a two-dose schedule, with the second dose at 3 weeks for the Pfizer/BioNTech vaccine and at 4 weeks for the Oxford University/AstraZeneca vaccine. However, on the 31 December 2020, the JCVI released a statement recommending that vaccinating more people with their first dose of vaccination is prioritised above offering others their second dose, in order to maximise the public health benefits of the programme, with the second dose to be administered within 12 weeks of the first dose.9

How is the vaccine being rolled out?

GP practices have been asked if they wish to sign up to the vaccination programme as part of an Enhanced Service via Primary Care Networks (PCNs).10 Practices can prioritise the vaccination programme above other services, apart from urgent care.10

Patients may also book into other national mass vaccination centres via a national call and recall system once further supplies of vaccine become available.2

Hospital staff will be able to access the vaccine via NHS Trust Vaccination Hubs.11

Which patients will be eligible for vaccination?

The JCVI has issued an order of priority for vaccination as follows:4

  1. residents in a care home for older adults and their carers
  2. all those 80 years of age and over and front-line health and social care workers
  3. all those 75 years of age and over
  4. all those 70 years of age and over and clinically extremely vulnerable individuals12
  5. all those 65 years of age and over
  6. all individuals aged 16 years to 64 years with underlying health conditions that 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.

What are the key considerations for the COVID-19 vaccines?

The Pfizer/BioNTech13 and Oxford University/AstraZeneca14 COVID-19 vaccines currently approved for UK use have different characteristics and requirements (see Table 1). There are also some special considerations for specific groups (see Table 2). See Box 1 for a number of practical considerations for delivering the COVID-19 vaccination programme in primary care.

Table 1: Characteristics and requirements of the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines
CharacteristicPfizer/BioNTech vaccine13
Oxford University/AstraZeneca vaccine14

Vaccine form

Supplied as a concentrate for solution for injection (must be diluted before use[A])

Supplied as solution for injection

Number of vials per pack

195 vials per pack

10 vials per pack

Number of doses per vial

1 vial (0.45 ml) contains 5 doses, supplied in a 2 ml vial to allow for dilution[A]

Available in:

  • 10-dose vials (5 ml)
  • 8-dose vials (4 ml)

Volume of 1 dose

0.3 ml (of diluted vaccine[A])

0.5 ml

Doses and scheduling

Two doses required, at least 21 days apart

(Note: the JCVI recommends giving the second dose between 3 to 12 weeks after the first dose9)

Two doses required. The second dose should be administered between 4 and 12 weeks after the first dose

(Note: the JCVI recommends giving the second dose 4 to 12 weeks after the first dose9)

Shelf life and special precautions for storage

  • Shelf life is 6 months at –80°C to –60°C.

Thawed, undiluted vaccine

  • Store for up to 5 days at 2°C to 8°C, and up to 2 hours at temperatures up to 25°C, prior to use
  • During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light
  • Thawed vials can be handled in room light conditions
  • Once thawed, the vaccine cannot be re-frozen.

Diluted vaccine

  • Store the vaccine at 2°C to 25°C and use as soon as practically possible and within 6 hours
  • Discard any unused vaccine.

Unopened multidose vial

  • Store in a refrigerator (2°C to 8°C) for up to 6 months
  • Do not freeze
  • Keep vials in outer carton to protect from light.

After first use

  • Use as soon as practically possible and within 6 hours
  • The vaccine may be stored between 2°C and 25°C during the in-use period
  • Discard any unused vaccine.

 

 

[A] For details about how to dilute the Pfizer/BioNTech COVID-19 vaccine, refer to section 4.2 of reference 13. 

JCVI=Joint Committee on Vaccination and Immunisation

Table 2: Special considerations for specific groups
GroupConsiderations

Bleeding disorders

 

Individuals with bleeding disorders may receive the vaccine intramuscularly, if a doctor familiar with their bleeding risk deems it suitably safe for the patient. Firm pressure should be applied after the vaccination. Further information on individual bleeding disorders is given in COVID 19: the green brook, chapter 14a.15

Pregnancy and Breastfeeding

 

Specific trials in pregnancy have not been carried out. The available data does not indicate any specific risk to pregnancy; however, there is insufficient evidence to recommend routine use. The JCVI recommends that pregnant women at very high risk of either catching COVID-19 or developing complications should discuss the risks and benefits of the vaccine with their doctor.16

Although there is no data on COVID-19 vaccination in breastfeeding, the JCVI states there is not thought to be a risk to the breastfeeding infant and so the vaccine may be given to breastfeeding women.16

Children

 

Vaccine trials have only just commenced in children. Data collected so far during the pandemic indicates children are at less risk of complications of COVID-19 compared with adults and so COVID-19 vaccines are not routinely recommended for children and young people under 16 years of age.15 Immunisation may be given to older children deemed at high risk of COVID-19 complications on a case-by-case basis—as this would be outside the terms of the MHRA approval, this would be considered unlicensed use.15,[A]

Immunosuppression and HIV

People who have immunosuppression due to disease or treatment are included in the list of at-risk groups who should receive COVID-19 immunisation.15 Individuals with immunosuppression and HIV may be given COVID-19 vaccination (regardless of CD4 count).15

Current or previous infection with COVID-19

For people with confirmed infection, vaccination should be deferred until clinical recovery to around 4 weeks after onset of symptoms (or 4 weeks from the first confirmed positive specimen in those who are asymptomatic).15

[A] For off-licence use of medicines, the prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council’s Good practice in prescribing and managing medicines and devices for further information.17

JCVI=Joint Committee on Vaccination and Immunisation; MHRA=Medicines and Healthcare products Regulatory Agency

Box 1: Practical considerations for COVID-19 vaccination

  • Practices will need to:10
    • identify a site to deliver the programme, bearing in mind that provision is required potentially from 8.00 to 20.00, 7 days a week
    • work out the total number of patients in their priority groups, which will be similar to the flu groups
    • factor in how many patients will need a home visit
    • consider how to cover any care homes in the area
    • factor social distancing requirements into the appointments
    • consider how to make vaccination sites accessible to communities of socioeconomic deprivation
    • consider how to continue to deliver urgent primary care services during the vaccination programme
  • Booking can be via a national call and recall system if practices choose, or via practice booking. Costs and workforce requirements will need to be calculated; several Local Medical Committees have produced tools to help with these18
  • All staff are required to do a 1.5-hour online training course delivered by e-Learning for Healthcare19
    • this e-learning programme provides theoretical training. Those who are new, or returning, to vaccination after a prolonged period will also require face-to-face practical training in vaccine administration and assessment and competency sign-off before administering the COVID-19 vaccine. Vaccinators should also have completed basic life support and anaphylaxis training and any statutory and mandatory training required by their employer
  • Practices may need to vaccinate over bank holidays; however, this depends if there is still any vaccine left to be used and also on patient demand. Extended access services can be used if necessary10
  • Practices will be reimbursed for vaccinating their own staff
  • NHS England have now produced a standard operating procedure for the primary care programme.20

Patients should not be offered an appointment for a COVID-19 vaccine at the same time as other vaccines because there is currently no data for co-administration of COVID-19 vaccines with other vaccines. Scheduling of other immunisations should be a minimum of 7 days apart to avoid inappropriate attribution of adverse events.15

Side-effects such as mild pain and tenderness are common at the site of injection with either of the vaccines. Fever, headache, and fatigue are also common.13,15

Following cases of anaphylaxis in health workers who received the Pfizer/BioNTech vaccine, the MHRA initially stated that the vaccine should not be given to anyone with a history of immediate-onset anaphylaxis to a vaccine, medicine, or food.21 After monitoring of the initial roll-out, the COVID-19: the green book, chapter 14a now states:15

  • ‘the vaccine should not be given to those who have had a previous systemic allergic reaction (including immediate-onset anaphylaxis) to:
    • a previous dose of the same COVID-19 vaccine
    • any component (excipient) of the COVID-19 vaccine.’

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

What is the communication plan for patients?

Patients will be invited for vaccination individually according to their risk category as a vaccine becomes available for their group. A national call and recall system is planned; however, PCNs may also choose to contact their own patients individually.10

The UK government has a produced a range of patient information leaflets and consent forms for people in care homes, social care staff, and adults.22

Funding

Practices will be reimbursed at £12.58 as an item of service fee per dose. This is claimable even if the patient does not receive the second dose.10

NHS England have also ring-fenced £150 million of support for additional workforce capacity for primary care until the end of March 2021.23

Staffing

A GP must be accountable for the programme, but it is not essential that GPs themselves draw up the vaccine. A registered health professional must do this, along with consenting the patient.24

At the time of writing (January 2021), Patient Group Directions have been produced for thePfizer/BioNTech and the Oxford University/AstraZeneca COVID-19 vaccines.25

Liability and indemnity

Where vaccinations are administered in line with the General Practice Enhanced Service specification, indemnity for clinical negligence will be provided under the Clinical Negligence Scheme for General Practice.26,27 This applies to all staff who are employed or engaged by a general practice to deliver the vaccination programme.

Controversies

The mass vaccination programme against COVID-19 is launching at a time when winter pressures are traditionally high for primary care. Although quality and outcomes framework requirements have been eased during the pandemic,28  an additional campaign to offer influenza vaccination to people aged 50–64 years is now underway,29  putting further pressure on practices. In addition, many practices have stated that demand for services has been higher than ever during the pandemic.30 Funding for the primary care vaccination has been noted to be small, particularly in comparison to that given to the private sector test and trace services.31

Primary care networks are facing significant challenges with the task of vaccinating 300 patients against COVID-19 per day, as it is often complicated by the need to socially distance, the 15 minutes observation required following the Pfizer/BioNTech vaccination, and the need for home visits for some patients. The approval of the Oxford University/AstraZeneca vaccine, which comes in vials ready to use similar to the influenza vaccination, will make the logistics easier for primary care.

At present, there are no long-term data on how long immunity will last and when vaccination will need repeating.

Despite the barriers, around 280 PCNs were due to join the vaccination programme commencing on 15 December 2020.32 The strategy of prioritising a single dose of vaccine has caused consternation for some primary care clinicians, who have expressed unease at the decision, having consented patients who have already received the vaccine for the original two-dose schedule, and now face large amounts of work postponing patients already booked in for their second dose. The JCVI has responded with a fuller explanation of the public health benefits of this approach, indicating they are confident a single dose of either of the available vaccines gives good protection against severe COVID-19 disease within 2 to 3 weeks of vaccination, with subsequent doses being more relevant for longer term protection rather than increasing initial vaccine efficacy.33

Summary

With a new, more transmissible strain of COVID-19 now rampant in the UK, the welcome arrival of efficacious vaccines is, at present, the key hope for a way out of the pandemic. Many PCNs have stepped up to join the vaccination programme. As of 10 January 2021, over 2.2 million people in the UK had already received their first dose of vaccination,34 via both primary and secondary care networks. With new cases of COVID-19 at well over 50,000 per day over the Christmas period, the case for mass vaccination of vulnerable groups has never been more urgent.

Dr Claire Davies

GP, London

The information in this article is correct as of 13 January 2021. For more up-to-date information, please refer to:

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References

  1. NHS England and NHS Improvement. Letter to GP practices. Wave 1 mobilisation of the primary care COVID-19 vaccination programme 2020/21. 4 December 2020. Available at: www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/12/C0938_PCN-notice-letter-4-December-2020.pdf
  2. NHS. News. NHS vaccine programme ‘turning point’ in battle against the pandemic. 8 December 2020. Available at: www.england.nhs.uk/2020/12/nhs-vaccine-programme-turning-point-in-battle-against-the-pandemic/ (accessed 7 January 2021).
  3. NHS. Letter to GPs, general practice teams, and CCGs. Urgent preparing for general practice to contribute to a potential COVID-19 vaccination programme. 9 November 2020. Available at: www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/C0856_COVID-19-vaccineletter_9-Novrevb.pdf
  4. Department of Health and Social Care. Joint Committee on Vaccination and Immunisation: advice on priority groups for COVID-19 vaccination, 30 December 2020. Updated 6 January 2021. Available at: www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020 (accessed 7 January 2021).
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  14. Medicines and Healthcare products Regulatory Agency. Decision. Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca. Updated 7 January 2021. www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca (accessed 7 January 2021).
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  22. Public Health England. Collection. COVID-19 vaccination programme: leaflets and posters.  Available at: www.gov.uk/government/collections/covid-19-vaccination-programme?utm_source=The%20British%20Medical%20Association&utm_medium=email&utm_campaign=12036693_GP%20ENEWSLETTER%20101220%20-%20ENGLAND&utm_content=PHE%20resources&dm_t=0,0,0,0,0#leaflets-and-posters (accessed 7 January 2021).
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