Coronavirus (COVID-19): guidance for use of Pfizer BioNTech vaccine in care homes

Introduction - Aim of the vaccination programme

The aim of the current COVID-19 vaccination programme is to protect those who are at most risk from serious illness or death from COVID-19.

The Joint Committee on Vaccination and Immunisation (JCVI) therefore considered the available epidemiological, microbiological and clinical information on the impact of COVID-19 in the UK and provided the Government with advice to support the development of a vaccine strategy in keeping with the above aim.

This advice said vaccination should be initially prioritised in this order:

• residents in a care home for older adults and their carers
• all those 80 years of age and over and frontline health and social care workers
• all those 75 years of age and over
• all those 70 years of age and over and clinically extremely vulnerable individuals
• all those 65 years of age and over
• all individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
• all those 60 years of age and over
• all those 55 years of age and over
• all those 50 years of age and over

Vaccine Supply

The vaccine is supplied to pharmacy departments at -75°C±15°C. Pharmacy departments will store the vaccines in an ultra-low temperature freezer and when the vaccine is ready to be used, thaw the vaccine. The vaccine is stable at 5 days at +2-8°C from the point of being taken out of an ultra-low temperature freezer.

Health and social care workers and vaccinators

The vaccine will be diluted and administered by appropriately trained healthcare professionals employed by the Health Board in hospital vaccine clinics under occupational health arrangements. The vaccine will be administered either by healthcare professionals already authorised to vaccinate or in accordance with a patient group direction. The dilution and administration will be undertaken by the same person.

Care Home residents and staff

Packing down

Given the large pack size (975 doses), hospital pharmacy departments will pack down the vaccine into a smaller pack size under Section 10 of the Medicines Act 1968 as agreed by MRHA.

A packaging solution has been identified and tested to ensure that the vials can be held securely in transit. The Scottish Pharmacy Quality Assurance Group (Scotland’s network of quality assurance pharmacists) have produced a national template protocol for retrieval of the vaccines from freezers, packing and labelling the container for onward storage and distribution.

An appropriate quantity of vials to cover patients and staff working in these settings will be supplied to NHS nurses employed by the relevant Health Board, from the hospital pharmacy and will be transported to the Care Home on that same day for administration to staff and patients. A Health Board can pack-down a quantity of vials for administration to patients by nurses employed by the Health Board. However it is not legally permissible for the Health Board to supply another legal entity with a quantity of vials packed down in the hospital pharmacy unless the Health Board has a license known as a Marketing and Import Authorisation (MIA). No territorial Boards hold this licence. This is why it is not possible for the Health Board to supply a quantity of vaccine to leave at a care home for care home staff to administer.

Transporting the Vaccine to the Care Home

NHS employed qualified health professionals will carry the undiluted vaccine vials in validated vaccine porters at +2 oC to +8oC to a Care Home. Stability data currently indicates that the undiluted Pfizer BioNTech COVID-19 vaccine will remain stable for 5 days (120 hours) when stored in a fridge with a temperature range of +2°C to +8°C.

At the Care Home

Preparation of the Environment

Vaccines should remain in the porter and there should be sufficient space for the vaccine porters to be stored. The area should be secure and suitable for vaccine preparation. There should be sufficient secure storage space for the vaccine consumables and waste generated by the vaccination service.

Preparation of the vaccine

Once removed from +2°C to +8°C the vaccine should be diluted immediately, and within a maximum of two hours. The vaccine is stable for six hours at room temperature after dilution. The vaccine will be diluted and drawn up in accordance with national and locally agreed Health Board standard operating procedures. Detailed and up to date Pfizer BioNTech Covid-19 Vaccine details can be accessed on TURAS learn.

Only NHS qualified health professionals should administer the Pfizer BioNTech vaccine to care home residents and staff. The following has been written under the assumption that informed consent has been provided by residents or staff.

Mobile residents and staff

Those residents who are mobile, or can be assisted should receive their vaccine in a prepared vaccination communal area. This area must adhere to Infection Prevention and Control (IPC), social distancing and patient flow guidelines.

NHS qualified health professionals should administer vaccines to mobile residents and staff as per guidelines for walkthrough / occupational health clinical setting guidelines, described in the Flu and Covid 19 Service Delivery Manual. Consider measures such as asking staff to wait in private vehicles (for the avoidance of doubt, only wait in private vehicles BEFORE vaccination, not for the 15 minutes post vaccination) or designated external waiting areas, where possible, to reduce numbers in communal spaces during busy periods.

Immobile Residents

Where residents are immobile and cannot be moved to the vaccination area, an NHS qualified health professionals should vaccinate residents in their room, setting up a mobile vaccination station at the door to the resident’s bedroom. This  vaccination station should consist of a trolley (wipeable with an appropriate disinfectant solution or clinical wipe), appropriate clinical waste system, appropriate sharps unit, PPE, alcohol based hand rub, vaccines and vaccination supplies.

The following provides a guide to the steps required:

1. With clean hands, clean the mobile vaccination station with an appropriate disinfectant solution or clinical wipe and put supplies on bottom of trolley.
2. Perform Hand hygiene in line with section 1.2 of Standard Infection Control Precautions (SICPs)
3. Don appropriate PPE in line with section 1.4 of SICPs
4. On the mobile vaccination station [1] at the resident’s bedroom door, dilute the vial of vaccine, following the agreed standard operating procedure. Place on the single use tray on the mobile vaccination station.
5. Draw up one dose of vaccine. Place the syringe of vaccine along with post vaccination consumables i.e. cotton wool on a second sterile disposable or wipe able tray, along with a sharps container.
6. Enter the resident’s room, leave the mobile vaccination station on the corridor side of the door, with waste bags facing the resident’s door, but not touching.
7. Place the sharps container on a clean surface or clean paper towel, in reach of where you are vaccinating the resident.
8. Place the tray with vaccine and equipment next to the resident.
9. Prepare the resident for vaccination.
10. Administer the vaccine to the resident. All steps in the administration standard operating procedure should be followed.
11. On resident side of door, doff PPE, placing PPE and vaccine equipment waste in appropriate waste management streams (in line with 1.9 waste management SICPs), perform hand hygiene (in line with section 1.2 of SICPs), pick up sharps container and exit the room. Place sharps bin on bottom of trolley.
12. If a wipeable tray was used, this should be cleaned with an appropriate disinfectant solution or clinical wipe prior to being placed back on bottom of trolley.
13. Clean trolley top with an appropriate disinfectant solution or clinical wipe.
14. Perform Hand hygiene in line with section 1.2 of SICPs
15. Ensure recording of vaccination on Vaccination App.
16. Remain with the resident, or ensure the resident is observed for any adverse effects by a member of staff [2] 15 minutes following vaccination. 
17. Move the mobile vaccination station to the next immobile residents room and repeat the steps [3].

[1] The MHRA have advised (15th December 2020) 

"The diluted vaccine vial cannot be exposed to excess vibration once diluted and therefore transportation by motor vehicle is prohibited. Carrying vials or moving on a trolley may be acceptable providing the vials always remain upright and protected from excess vibration (for example do not push trolley across cobbled surface)."

[2] NHS Scotland has adopted the Northern Ireland delegation framework, registered nurses are responsible for ensuring that the staff member delegated to is competent and confident.

[3] "There is no data to support storage of the vaccine within the syringes for any length of time for microbiological impact. This is an unpreserved vaccine and should be used as soon as is practicable once drawn into the syringe in line with good clinical practices”.

Disposal of the vaccine and consumables

Any unused vaccine should be disposed of in a yellow, blue lidded puncture resistant sharps bin, along with used needles and syringes. Used PPE which may pose a risk of infection and soft waste which poses a risk of infection, such as used cotton wool should be disposed of in an orange clinical waste bag.

The white cardboard packaging that the vials were provided in by the pharmacy department can be placed in dry mixed recycling.

Any Wastepaper with confidential patient information should be placed in confidential waste. Any non-infectious waste (residual waste) such as general waste, including PPE that does not pose a risk of infection can be placed in a black bin bag.

Vaccinators

Qualified health professionals (i.e. individuals employed or contracted by a Scottish Health Board) who are vaccinating care home staff and residents will have been vaccinated themselves. Qualified health professionals who are vaccinating care home staff and residents will be tested regularly (see section 15 below on Lateral Flow Testing for Vaccinators).

Healthcare workers should wear the appropriate PPE, and pay attention to social distancing with each other. Healthcare workers will be working under the overarching corporate and clinical governance frameworks of their Health Board.

Procedures should be in place to limit the number of different visiting healthcare professionals attending these sites to minimise any risk of transmission of COVID-19. 

Completed Vaccination Session

Feedback and update Care Home staff on all residents vaccinated.

Inform care home staff of post vaccine advice and how to escalate any vaccination related adverse events, no matter how significant or insignificant, in and out of hours as appropriate. 

COVID Vaccination when there are suspected or confirmed COVID cases in care home residents

Green Book advice (COVID-19 Greenbook Chapter 14a suggests there is currently limited evidence to support the use of COVID-19 vaccines as post-exposure prophylaxis or to interrupt transmission during outbreaks. The use of vaccine to provide direct protection to vulnerable individuals in prolonged community outbreaks should be discussed with the local health protection teams taking into account all the circumstances including the number of cases in a home, ‘Think Covid’ and ability to vaccinate maintaining IPC procedure. 

If a care home has only one case of COVID-19 infection in a resident or staff member, other residents and care home staff may be offered vaccination as long as they have not been deemed close contacts of the case requiring self-isolation.

If a care home has more than one case in an ongoing outbreak or incident, residents who are symptomatic, positive or close contacts who are self-isolating would not be eligible for vaccination as above. A risk assessment would need to be undertaken to assess whether or not the outbreak / incident cases are segregated sufficiently for other residents and care home staff to be offered vaccination or if safer to schedule the vaccinations post end of the outbreak / incident i.e. 14 days after the last positive test or symptoms, and following a further risk assessment.

COVID-19 precautions

Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. However, if an individual is acutely unwell, (for non COVID reasons or if they are experiencing COVID-19 symptoms), they should not receive the vaccine until they have fully recovered. This is to avoid confusing the differential diagnosis of any acute illness (including COVID-19) by wrongly attributing any signs or symptoms of the illness as being possible reactions to the vaccine.

Current or previous history of COVID-19 disease

As deterioration in some people with COVID-19 can occur up to two weeks after infection, ideally vaccination should be deferred until they have recovered and at least four weeks after onset of COVID-19 symptoms or four weeks from the first PCR positive specimen in those who are asymptomatic. 

Lateral Flow Testing (LFT) for Vaccinators

Given all vaccinators working within health and social care/community settings will be NHS Board employees, it has been agreed that they will be included within the hospital LFD testing roll-out/pathway. With this addition, twice weekly LFT will be offered to all patient-facing staff in NHS Scotland hospitals, C-19 Assessment Centres, SAS and all COVID-19 vaccinators. Board LFT Leads and guidance – including Standard Operating Procedures, FAQs etc. – are being updated to reflect this change.