NI COVID-19 Booster & Flu Vaccination Programme & Vaccinator Training Resources
Introduction & Key Links
Welcome to the GPNI COVID-19 Booster & Flu Vaccination Programme hub – if you have feedback or suggestions / corrections let us know at hello@gpni.co.uk
Spring Booster Campaign Update
- GPs Responsibilities
- Everyone aged 75 and older living at home.
- Practices without capacity to offer the vaccination will be asked to identify and inform patients that they are eligible and can attend participating pharmacies for their vaccination.
- Housebound over 75s – GPs to identify and inform the Trust who will arrange vaccination through District Nursing or vaccination teams
- Care home residents will have vaccination through community pharmacies attending homes
- Any new residents or those unable to be vaccinated on the date of the pharmacy visit will need referred to Trust district nursing/vaccination teams.
- Trusts will have responsibility for immunosuppressed.
Timing
- Booster to be given 6 months after last vaccination
- People who took the offer of a booster in Autumn in 21 will be eligible in May or June
- The Green Book allows some operational flexibility for people who have had a least 3 months since their last dose.
- In expectation of the wider Autumn programme it would be ideal to give the spring booster early enough to allow a six month interval before autumn programme
- Expectation of ‘short burst’ vaccination in late April and early May
All practices will be supplied with Moderna
- Packs of 10 vials
- Each Vial will have 20 doses
- I.e. 200 booster doses
- Use by 30 days from defrost
- HSCB expect practices will be able to place orders from mid-April. Delivery can be expected within 5 days of ordering and it will have a use by period of 25 days from delivery
Vaccinators
The national protocol will include a role for Health Care Assistants to administer the vaccine as part of a wider team that includes registered healthcare professionals. HCAs will need either NVQ qualification or 2 years’ experience, and have completed appropriate vaccination training. Colleagues in PHA, DoH and the clinical education centre are working to finalise advice on training and appropriate tasks for HCAs.
The PHA support vaccinators will continue to be available, but this is a limited pool and PHA will endeavour to provide support fairly across all practices which request it.
Training
Most training is available on line, including PHA Professional information | HSC Public Health Agency (hscni.net) e-learning for health Home – elearning for healthcare (e-lfh.org.uk) and through the Clinical Education Centre Clinical Education Centre | Clinical Education Centre (hscni.net)
- Anaphylaxis Module- CEC e-learning or www.e-lfh.org.uk
- PGD Training Module- CEC e-learning or www.e-lfh.org.uk
- Intramuscular Injection Administration Update CEC e-learning or www.e-lfh.org.uk
- Medicines Management CEC e-learning or www.e-lfh.org.uk
- Current BLS e-learning on CEC or www.e-lfh.org.uk
· Infection Prevention & Control (Level 3) – CEC e-learning or www.e-lfh.org.uk
· Storage Maintenance of cold chain/disposal of vaccines – Chapters 3 & 14a of the Green book
· Core Knowledge for Covid-19 vaccinators- www.e-lfh.org.uk
· Moderna Module – www.e-lfh.org.uk
Key Links
VACCINE SUPPLY FOR THE COVID-19 BOOSTER VACCINATION PROGRAMME
- Following on from HSS 69/2021 https://www.health-ni.gov.uk/sites/default/files/publications/health/doh-hss-md-69-2021_0.pdf
This letter sets out the position regarding the availability of COVID-19 vaccines and provides advice for GPs to consider before they organise their COVID-19 booster clinics. - JCVI have recommended that an mRNA vaccine is the preferred vaccine for the vast majority of people eligible to receive a booster dose. Evidence indicates that the effectiveness of the Pfizer-BioNTech or Moderna vaccines are equally high.
- The main rate limiting factor in the booster programme is the requirement that there has to be a minimum of 6 months from the date of receipt of the 2nd primary dose. The digital team are working with a number of GP practice managers to develop a process for automated searches to enable identification of those patients who need to be called for a booster. This will be progressed as rapidly as possible, working with the practice managers, to determine the optimal solution.
- Orders for the Pfizer-BioNTech vaccine can be placed with Movianto via the web based ordering system from w/c 4 October. It should be noted however that at present the Pfizer-BioNTech vaccine can only be supplied in a tray containing 1,170 doses (195 vials, each containing 6 doses of 0.3ML per vial). The vaccine is defrosted to order prior to delivery to the practice and so orders could take up to 5 working days before they will be received by a practice. All the doses must be administered within the expiry date indicated on the label attached to the pack by Movianto – typically 27 or 28 days, but a minimum of 25 days. Only practices able to use these doses should order these large packs. Other smaller practices should consider if they need to wait for the Moderna vaccine or smaller Pfizer packs when they become available later in the month, see below.
Consumables will also need to be ordered in addition to the vaccine, practices ordering a full pack of Pfizer-BioNTech vaccine must also order
- 12 packs of combined 23G (25mm / 1 inch) needles and 1ml syringes for administration (100 in pack)
- 2 packs of needles for dilution (100 in pack)
– 10 packs of 0.9% sodium chloride 5ml ampoules for dilution (20 in pack)
– 1 pack of Patient Information Leaflets (1,200 leaflets per box)
Practices should be advised that existing supplies of 38mm (1.5inch) combined needles and syringes ordered and held by practices for administration of the AstraZeneca vaccine to morbidly obese individuals can also be used for administration of the Pfizer/BioNTech vaccine to morbidly obese individuals.
Revised vaccination cards are being produced by the Public Health Agency and practices will be advised when these are available to order from Movianto. In the interim, practices are advised to continue use the current vaccination cards and write booster against the 1st dose entry. - The Moderna vaccine will be available to order from w/c 11 October however due to limited supplies GPs are encouraged to use a full tray of the Pfizer vaccine, where possible. The Moderna vaccine comes in packs of 100 doses, which will allow for approximately 170 half doses (10 vials, each containing 17 half doses of 0.25ML per vial) to be administered. The vaccine is defrosted to order prior to delivery to the practice and so orders could take up to 5 working days before they will be received by a practice. All the doses must be administered within the expiry date indicated on the label attached to the pack by Movianto – typically 26 or 27 days, but a minimum of 24 days.
Initial orders of the Moderna vaccine in October will be capped at 2 packs per practice, with a minimum of two weeks interval before further deliveries will be available to the practice. Consumables will also need to be ordered in addition to the vaccine, and practices ordering a full pack of Moderna vaccine must also order:
- 1 pack of combined 23G (25mm / 1 inch) needles and 1ml syringes for administration (200 in pack)
– 2 packs of Patient Information Leaflets (100 leaflets per box)
Practices should be advised that existing supplies of 38mm (1.5inch) combined needles and syringes ordered and held by practices for administration of the AstraZeneca vaccine to morbidly obese individuals can also be used for administration of the Moderna vaccine to morbidly obese individuals. - Revised vaccination cards are being produced by the Public Health Agency and practices will be advised when these are available to order from Movianto. In the interim, practices are advised to continue use the current vaccination cards and write booster against the 1st dose entry.
- It is intended that by late October smaller pack sizes of the Pfizer vaccine will be available which will enable packs of 30 vials (180 doses) to be issued. Unlike the flu vaccine it will not be possible to order on a daily basis and therefore a minimum of two packs per practice would have to be ordered, with a minimum of two weeks interval before further deliveries will be available to the practice. It is expected that all GP practices will use some of the Pfizer vaccine at some stage during the booster programme.
- Practices are therefore asked to consider their requirements based on the number of eligible patients they will have throughout October and into November reaching the 6 month mark since receipt of their 2nd COVID-19 vaccine before placing an order via the Movianto NI online ordering page.
Vaccine Management System
Login : https://vms.healthandcareni.net/gp
An updated version of VMS allowing recording of COVID-19 booster dose, as well as 3rd primary dose for immunosuppressed patients and influenza vaccinations will be available on 6th October.
VMS Users may need to refresh their browser once they log in to ensure they are logging on to the new version. This will only need to be done if you have bookmarked the VMS URL.
All previous URLs lead to the new app. GPs can use this URL https://vms.healthandcareni.net/gp/ and be taken to the new app.
Please be advised that the “save for later” function should not be used at this time.
HSCB Update 2nd December 2021
The COVID-19 vaccination programme continues to move rapidly. Please see updates about several issues:
Recent JCVI advice
We are awaiting Department of Health guidance and will be issuing a LES addendum when this has been received.
The JCVI advice is that boosters are to be offered to all adults over 18 and interval has been reduced to 3 months.
Departmental priority is initially those over 50 or with clinical risks and more than 3 months since 2nd dose, GPs should continue to actively call this group. GPs are not required to actively call younger people, but where operationally prudent GPs can vaccinate any eligible adult, for example if they are attending for flu vaccination or for a clinical consultation or to minimise wastage.
Where practices are calling patients to minimise wastage they should focus on the Departmental next priority group, those 40-49 more than 6 months since 2nd dose
VMS & PHA Admin Support
Thank you for continuing to record all flu and covid vaccines on VMS. With multiple options for people to get vaccines it is very important that VMS is updated promptly after vaccinations. Please be aware the write back to the clinical system is not live and ideally VMS should be checked, particularly if the patient is uncertain about having had vaccinations elsewhere. Flu vaccinations administered to all practice patients will shortly be available on a downloadable report available on VMS. Attached memo contains helpful advice about VMS.
PHA admin support All practices have been given the offer of admin support to clear any backlog of VMS data upload. This support does not replace the requirement for practises to input their own VMS data.
Vaccine Dosing & Pack Sizes
Moderna (Spikevax)
Booster dose is smaller than primary dose
Booster dose is 0.25ml. A vial contains 20 booster doses
The primary dose (1st & 2nd doses for all patients and 3rd dose for those with immunosuppression) is 0.5ml
Pfizer -BioNTech (Comirnaty)
Booster dose is same as primary dose
Booster dose is 0.3ml. A vial contains 6 booster doses
The primary dose (1st & 2nd doses for all patients and 3rd dose for those with immunosuppression) is also 0.3ml
Please see HSS (MD) 71/2021 for full details about booster vaccines.
Moderna Booster The Department of Health has directed that 20 (previously 17) Booster doses of 0.25mls of Moderna vaccine should be used per vial to avoid unnecessary wastage. (Alternatively the vial contains 10 primary doses of 0.5mls)
Please be aware of the vaccine packs available when ordering – Pfizer tray 1170 doses, Pfizer pack down 360 doses, Moderna 200 doses
Smaller packs of Pfizer 360 dose packs of Pfizer pack downs are available to order through Movianto. The minimum expiry will be 14 days after delivery, but many packs will have longer expiry up to 25 days. The limit on the number of 360 dose packs that practices can order is currently 2 packs every 2 weeks
Recent Adverse Incidents (Learning from)
- vaccines should be drawn up and used immediately. We have seen incidents where large numbers of vaccines have been drawn up and either used outside cold chain limits or wasted
- please see attached reminder about use by dates after defrost and batch numbers after Pfizr pack down
- please see attached reminder about COVID-19 booster doses – this is particularly important if vaccinators are using both Pfizer (booster dose 0.3ml) and Moderna (booster dose 0.25ml)
“Use by dates” and batch numbers on Booster doses of COVID-19 vaccines
Practices must urgently ensure that all staff involved in the vaccination programme are aware of the importance of checking use by dates on COVID-19 boosters.
Both Moderna (Spikevax) and Pfizer -BioNTech (Comirnaty) are transported to the wholesaler/distributor in the frozen state. The wholesaler/distributor defrosts the vaccine when it is ordered by the practice and it is then transported to practices with the normal “cold chain” requirements.
All vaccines have a manufacturer’s expiry date on the boxes and on each individual vial. When the vaccine is defrosted a label with a “use by date” is added to the box. This date will be 31 days from defrosting and will be earlier than the manufacturer’s expiry date.
The individual vials do not have a new use by date added. Images of blank “use by date” labels attached for information.
Where the Pfizer -BioNTech (Comirnaty) is “packed down” from the full tray into smaller packs, they are first defrosted and then sent to a different site for pack down. These smaller packs get a new batch number and use by date applied. The use by date is the same as the one applied at defrost, the batch number will be in the format VPxxxxxxxx.
VMS recording
For full packs of Moderna(Spikevax) or Pfizer -BioNTech (Comirnaty) enter the manufacturers batch number and the use by date applied at defrost.
For “pack down” packs of Pfizer -BioNTech (Comirnaty) use the VPxxxxxxxx batch number and the use by date applied at defrost.
Practices must ensure that all vaccinators are aware of the use by date added after defrosting and that this is checked on the box before vaccinations are administered.
Please see HSS(MD)71/2021 for full details about booster vaccines. Yours sincerely,
Third Primary Doses
Further advice will be issued soon. In the meantime:
- Some patients who present to their GP or community pharmacy for a booster vaccine who are found during the consent process to require a 3rd primary dose. In the interim, practices using Pfizer could vaccinate and record on VMS as a 3rd primary dose. Practices using Moderna, who administer a 0.5ml dose should record as a 3rdPrimary Dose. However, if a 0.25ml booster dose is administered this should be recorded as a booster dose, not a 3rd primary dose.
- Some patients have been given a booster and then get a letter saying they need a 3rd dose. For Pfizer the dose is the same for booster and 3rd primary. Practices can change the VMS from booster to 3rd dose. For Moderna the booster is 0.25ml and the 3rd primary is 0.5ml. Please don’t change the VMs recording for these patients as it would read back with the wrong dose
- An amended claim form for Primary Covid boosters which will include 3rd doses and also simplify the patient groups is being finalised
SUSPENSION OF THE 15 MINUTE WITH MRNA VACCINE FOR COVID 19
The four Chief Medical Officers of the UK and lead DCMOs for vaccines have considered whether, in the light of the very considerable need to speed up vaccination and boosting in the light of the omicron variant the 15 minute wait for some mRNA Covid-19 vaccines should be temporally suspended.
Primary vaccination in children aged 5 to 11 years
JCVI have now recommended that children aged five to 11 years in a clinical risk group (as defined in the Green Book); or children who are a household contact of someone who is immunosuppressed (as defined in the Green Book), should be offered two 10 micrograms doses of the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) with an interval of 8 weeks between the first and second doses. The minimum interval between any vaccine dose and recent COVID-19 infection should be four weeks.
Booster vaccinations in persons aged 12 to 17 years
I. All children and young people aged 16 to 17 years;
II. Children and young people aged 12 to 15 who are in a clinical risk group or who are a household contact of someone who is
immunosuppressed; and
Second primary dose for young people aged 12-17 *Updated December 21*
Childrens 2nd doses JCVI have recently advised children aged over 12 should be offered 2 doses of COVID-19 vaccine, with a 12 week interval. The intention is that this will be available though Trust run vaccination centres
Following recent JCVI advice and Departmental circulars HSS(MD)54/2021, and HSS(MD) 70/2021 a single primary dose of COVID-19 vaccination should be offered to young people aged 12-15. Only Pfizer is currently suitable for this age group.
Children aged 12- 15 will be offered COVID-19 vaccination in school, but a small number may miss the opportunity to be vaccinated in school due to absence, illness etc.
In line with HSS(MD)56/2021 young people aged 16 & 17 are currently being encouraged to attend Trust run clinics, but these are expected to close in coming weeks. Pfizer is the recommended vaccine for this age group
Community pharmacies will continue to provide 1st and 2nd doses of COVID-19 vaccination for adults, but they are using Aztra Zeneca and Moderna vaccies.
GPs will have Pfizer available to them for the booster programme.
GPs are therefore asked to facilitate requests from children/young people for COVID-19 vaccination if the practice has Pfizer vaccine available. Practices are not required to actively call young people, but the claim form will be amended to allow practices to claim for vaccinating them
Anti-Vaccination Protests
A small number of practices have had protests at clinics. HSCB appreciate this is very disruptive and potentially distressing for staff and patients . PSNI are aware of this problem and will respond as quickly as possible. Practices should contact 101 to report incidents or 999 if urgent assistance is required. Practices can also inform PSNI of upcoming clinics using 101 if they would value their advice.
Schools programme
All schools will have at least 1 visit to offer COVID-19 vaccinations. Children who have been unable to receive the vaccine in school (e.g. through sickness absence or self-isolation) should be encouraged to attend a Trust vaccination clinic (scheduled at weekends or mass vaccination centres) in the first instance. Details are available on nidirect here: Get a COVID-19 vaccination in Northern Ireland | nidirect. GPs should not be actively calling children, but can vaccinate children at the parents request if the practice has capacity and is offering the Pfizer vaccine.
Haemophilia & Thrombosis Patients and IM injection
COVID-19 vaccination and rare side effects
Guidance relating to blood clotting, myocarditis and Guillain-Barre Syndrome (GBS) after COVID-19 vaccination.
Information and guidance for health professionals on very rare conditions reported after COVID-19 vaccination.
Blood clotting
If you have any clinical concerns, patients should be urgently referred to hospital and to appropriate specialist services for further assessment, particularly if the symptoms are unexplained and present in combination with thrombocytopaenia.
The recommended management of this rare presenting condition is available from the British Society of Haematologists (BSH) here with specific guidance produced from the Royal College of Emergency Medicine (RCEM) here Emergency Departments and Acute Medical Units
A brief guidance document on the primary care management of suspected thromboembolism with thrombocytopenia after COVID-19 vaccination has been produced by the Royal College of General Practitioners (RCGP).
Myocarditis and Guillain-Barre Syndrome (GBS)
If you have any clinical concerns, patients should be urgently referred to appropriate specialist services for further assessment. Further information and guidance will be added as it becomes available.
Guidance, training and resources relating to the COVID-19 vaccination programme are available.
Guidance on blood clotting
Leaflets on blood clotting
Guidance on myocarditis and pericarditis
Guidance on Guillain-Barre Syndrome
A 3rd primary dose for immunosuppressed patients *Updated December 21*
Third Primary Doses Further advice will be issued soon. In the meantime:
1. Some patients who present to their GP or community pharmacy for a booster vaccine who are found during the consent process to require a 3rd primary dose. In the interim, practices using Pfizer could vaccinate and record on VMS as a 3rd primary dose. Practices using Moderna, who administer a 0.5ml dose should record as a 3rdPrimary Dose. However, if a 0.25ml booster dose is administered this should be recorded as a booster dose, not a 3rd primary dose.
2. Some patients have been given a booster and then get a letter saying they need a 3rd dose. For Pfizer the dose is the same for booster and 3rd primary. Practices can change the VMS from booster to 3rd dose. For Moderna the booster is 0.25ml and the 3rd primary is 0.5ml. Please don’t change the VMs recording for these patients as it would read back with the wrong dose
3. An amended claim form for Primary Covid boosters which will include 3rd doses and also simplify the patient groups is being finalised
Following recent JCVI advice and Departmental circular HSS(MD) 66/2021 a 3rd primary dose of COVID-19 vaccination should be offered to immunosuppressed patients.
The majority of these patients will be under secondary care and Trusts have been asked to identify these patients and make arrangements for them to have the 3rd dose vaccination. If these patients approach the practice they should be directed to their consultant for advice.
It is possible that some patients who are not under ongoing secondary care management will have been prescribed high dose steroids by their GP. The JCVI have said this is individuals who had received high-dose steroids (equivalent to >40mg prednisolone per day for more than a week) for any reason in the month before vaccination. Individuals who had received brief immunosuppression (≤40mg prednisolone per day) for an acute episode (for example, asthma / COPD / COVID-19) and individuals on replacement corticosteroids for adrenal insufficiency are not considered severely immunosuppressed sufficient to have prevented response to the primary vaccination
The extended LES will fund:
- Practices completing a search of their clinical systems to identify patients aged 12 or older where the GP has prescribed high-dose steroids (equivalent to >40mg prednisolone per day for more than a week) for any reason in the month before vaccination.
- If any of the identified patients are adults (18 years or older) are not currently receiving treatment via secondary care, they should be issued with a letter recommending that they receive a 3rd primary dose via a local community pharmacy using the Moderna vaccine. Draft letters are attached at Annex B and C of HSS(MD) 66/2021which GPs may wish to adapt and use.
- If any of the identified patients are under 18 years and are not currently receiving treatment via secondary care, they should be referred to their local Trust via the CCG route to be considered for vaccination.
HSCB & PHA Public FAQs
HSCB is maintaining a FAQ for the public regarding the GP COVID-19 vaccine rollout and you may find this helpful where patients have questions. The link is http://www.hscboard.hscni.net/coronavirus/covid-19-vaccination-programme/.
The PHA also have some helpful FAQs for the public at https://www.publichealth.hscni.net/covid-19-coronavirus/northern-ireland-covid-19-vaccination-programme/covid-19-vaccination-programme
Public Health Agency Updates
COVID-19 & Influenza vaccination in nursing homes
Care homes residents and staff are vulnerable to both COVID-19 and influenza, and were amongst the first to be offered COVID-19 vaccination using Trust teams. Trust teams have been re-established to offer COVID-19 booster vaccination to care home residents and staff.
Trusts have indicated that while the mobile teams providing COVID-19 boosters will be co-administering influenza vaccine to residents in residential homes, they will not be providing influenza vaccination in nursing homes. Practices should ensure they retain sufficient vaccine for their patients in nursing homes, and arrange for their vaccination using their own staff, nursing home staff or district nurses, in line with previous years.
GOV.UK - COVID-19 vaccination programme Resources
https://www.gov.uk/government/collections/covid-19-vaccination-programme
**This relates to PHE guidance but some information / resources may be transferrable**
Housebound Patients
ny Housebound patient who has missed (for example due to hospitalisation) or now consents to or requires a first, second or third primary does of covid vaccine or a booster dose should be referred to the Trust District Nursing teams for administration as per local arrangements. Trusts are providing the vaccines directly to the district nursing/vaccination teams. Mostly they will be using Pfizer. Where AstraZeneca is needed for clinical reasons please make this clear in the referral
PHA admin support
All practices have been given the offer of admin support to clear any backlog of VMS data upload. This support does not replace the requirement for practises to input their own VMS data.
Vaccine Management System
Login : https://vms.healthandcareni.net/gp
An updated version of VMS allowing recording of COVID-19 booster dose, as well as 3rd primary dose for immunosuppressed patients and influenza vaccinations will be available on 6th October.
VMS Users may need to refresh their browser once they log in to ensure they are logging on to the new version. This will only need to be done if you have bookmarked the VMS URL.
All previous URLs lead to the new app. GPs can use this URL https://vms.healthandcareni.net/gp/ and be taken to the new app.
Please be advised that the “save for later” function should not be used at this time.
GOVERNANCE, HANDLING & PREPARATION REQUIREMENTS
DEPLOYMENT OF THE PFIZER AND MODERNA COVID-19 VACCINES IN GENERAL PRACTICE - HSS(MD)68/2021
Both vaccines are inherently “fragile” in nature and so must be handled carefully. The key component is messenger Ribonucleic Acid (mRNA) which is a delicate substance. The mRNA is encased in microscopic lipid nanoparticles both to protect it and to help it get into cells. Once inside the cell, the mRNA instructs the cell to produce particular coronavirus proteins, and it is this that leads to the immune response that protects us. These nanoparticles are delicate and so this is why the vaccine is distributed in the frozen state so that the nanoparticles do not degrade, including when being transported. Similarly, if the thawed vial is shaken rather than gently inverted during preparation, the lipid nanoparticles may again degrade, or release the mRNA which is destroyed and therefore deactivated.
Pfizer / BioNTech have been granted a Conditional Marketing Authorisation (CMA) for their vaccine by the European Medicines Agency (EMA), branded as Comirnaty®. The Summary of Product Characteristics (SmPC) for Comirnaty® is available on the EMA website.
The COVID-19 Vaccine Moderna (Spikevax®) vaccine is also authorised for use in Northern Ireland in line with a Conditional Marketing Authorisation issued by the EMA. The SmPC for the Spikevax® product is available on the EMA website.
Both vaccines have specific requirements for their preparation, including the need for aseptic non-touch technique (ANTT) when preparing doses for administration, as well as defined time limitations for onward transport once thawed and for administration once the vial is first punctured. These requirements are likely to be updated as more information becomes available, and so practices should always refer to the relevant SmPC which contains the most up to date information about the characteristics of each vaccine to inform local planning.
Technical Standard Operating Procedures (SOP)
To mitigate the risks of inadvertently inactivating the vaccines, a suite of technical SOPs and other resources has been developed by the NHS Specialist Pharmacy Service (SPS) which general practice pharmacy teams may find useful.
Both the Comirnaty® and Spikevax® vaccines are sensitive to light and movement and so have specific transport requirements including temperature and time constraints which may impact on the ability to deploy the vaccine in off-site locations. Practices considering the use of mRNA vaccines in off-site locations should refer to the NHS SPS resources developed to support the appropriate use of COVID-19 vaccines in temporary vaccination sites. Due to the characteristics of the Pfizer (Comirnaty®) and Moderna (Spikevax®) vaccines, which require dedicated areas for preparation of the vaccine and observation following administration, the use of “drive-through” temporary vaccination site models is not appropriate.
Training resources
The Public Health Agency (PHA) has developed a range of professional guidance and information resources on the COVID-19 vaccination programme, including a detailed training resource with vaccine specific information for each of the approved COVID-19 vaccines in use in Northern Ireland.
In addition, Pfizer has produced an online educational resource containing bespoke information for healthcare professionals in Northern Ireland, including a video demonstrating the handling and preparation of the Comirnaty® vaccine.
Handling multiple vaccines
As more COVID-19 vaccines become available, it is important to ensure procedures are in place to make certain that each person gets the right dose of the right vaccine at the right time and that the vaccine has been stored and handled as specified in the product’s authorisation documentation.
The different COVID-19 vaccines have different storage, handling and preparation requirements, different dosages and different observation periods following vaccination. There may also be differences in the contraindications for each vaccine and in the advice that should be given about possible anticipated side effects.
The NHS Specialist Pharmacy Service has put together guidance on safe practice for handling multiple vaccines from receipt through to administration. Vaccinators are encouraged to read through this guidance in order to minimise the risk of errors where multiple vaccines are available.
Support from HSC Trust Medicines Information service
Senior pharmacy leaders and their teams within HSC Trusts have considerable experience and working knowledge of both the Pfizer / BioNTech and Moderna vaccines. General practice teams may contact the Regional Medicines and Poisons Information Centre in the Belfast HSC Trust on 028 9504 0558 (Monday to Friday9.00am to 5.00pm) or by email at medicineinfo@belfasttrust.hscni.net for advice and support with any specific queries. Please note, the resources highlighted above must be referred to before contacting the Regional MI service.
Ordering and distribution - Comirnaty® & Spikevax®
As with the AstraZeneca vaccine used in the primary vaccination programme, arrangements are being put in place for practices to order supplies of the Comirnaty® and Spikevax® vaccines via the Movianto web based ordering system. The Health and Social Care Board will work with the Public Health Agency and with practices to agree quantities that will be available for practices to order, and further details will be provided in the coming days.
Vaccines, consumables and associated equipment will be delivered to base sites. Due to the fragile nature of mRNA vaccines, onward transport should be minimised where possible. Where transport to an off-site location is required, practices should ensure that processes are in place to support the appropriate transport of the vaccine to the end-user location in line with the requirements outlined in the relevant SmPC. Cold-chain requirements and the advice provided in the NHS SPS resources highlighted above must be adhered to in order to preserve the nature of the vaccines. Care should be taken to pack vaccines securely to minimise movement during transit. It is recommended that only the quantities of vaccine required for a particular off-site clinic are transported to the end location.
Comirnaty®
At this time the Comirnaty® vaccine is currently supplied to practices in packs of 195 vials, with 6 doses available from each vial. This is a total of 1170 doses per pack. Practices will also need to order the required consumables from Movianto along with the required quantities of vaccine – combined needles and syringes for dilution, combined needles and syringes for administration, sodium chloride 0.9% injection for dilution and the relevant Patient Information Leaflet (PIL). Comirnaty® is currently distributed in packs measuring approximately 229mm x 229mm x 40mm, and practices should ensure that there is sufficient refrigerated storage available to accommodate this.
As outlined above, any supply of stock from one practice to another would constitute wholesale supply and necessitate the supplying practice to hold a WDA. We recognise that the need to apply for and hold a WDA is not likely to be feasible for most general practices and so the Department is actively working to put a solution in place to provide smaller packs for use by general practices. At this time it is envisaged that smaller pack sizes will be made available to support practices from the end of October 2021. Further information will be made available in due course.
The vaccine will be delivered to practices designated to receive Comirnaty® at a temperature of 2-8°C following defrosting by Movianto. The process of defrosting and distribution may take 3 to 5 days. The vaccine has a 1 month expiry date following defrosting when stored at 2-8°C. Therefore, it is important to note that on receipt by the practice, the actual expiry date will be less than 1 month due to the time required for the defrosting and distribution process. This will be clearly indicated on a label added by Movianto and will typically be 27 to 28 days (but with a minimum of 25 days) available to practices on delivery.
Following defrosting, within the 1 month expiry date at 2-8°C, the Comirnaty® vaccine can be transported for up to 12 hours. This will include the transport time to deliver the vaccine to practices from Movianto. Practices should plan any further transport to off-site locations on the basis that there is a maximum of 2 hours available for onward transport following initial delivery from Movianto.
Spikevax®
The Spikevax® vaccine is supplied in packs of 10 vials, each containing 10 full doses of 0.5mL. Each pack measures approximately 60mm x 51mm x 126mm. JCVI have recommended administration of a half dose of 0.25mL as part of the COVID-19 booster programme. Actions are progressing to support administration of a half dose of the Moderna vaccine, including updating the regional Vaccine Management System (VMS), training and PIL. We will issue further advice on this as soon as possible. NOTE Practices should not administer a half dose Moderna booster to patients until instructed to do so.
The vaccine will be delivered to practices designated to receive Spikevax® at a temperature of 2-8°C following defrosting by Movianto. The vaccine has a 30 day expiry date following defrosting when stored at 2-8°C. However the actual expiry date will be less than this due to the time required for the defrosting and distribution process and this will be indicated on a label added by Movianto. The process of defrosting and distribution may take 3 to 5 days and so the actual expiry date will typically be 26 to 27 days from delivery, with a minimum of 24 days available to practices on delivery.
Following defrosting, the Spikevax® vaccine can be transported for up to 12 hours at 2-8°C, within the 30 day expiry date. This will include the transport time to deliver the vaccine to practices from Movianto. Practices should plan any further transport to off-site locations on the basis that there is a maximum of 2 hours available for onward transport following initial delivery from Movianto.
While every effort is being made to ensure timely delivery of orders that are placed with Movianto, practices should not schedule vaccination clinics before deliveries of vaccine have been confirmed.
Monitoring and reporting
Healthcare professionals are reminded that all suspected adverse reactions to medicines or devices related to the management of COVID-19 should be reported to the MHRA via the Yellow Card Scheme https://coronavirus-yellowcard.mhra.gov.uk/
Conclusion
We would like to offer our sincere thanks to general practice teams across Northern Ireland for their efforts in delivering the primary COVID-19 vaccination programme. Your efforts have been instrumental in the delivery of a programme that has been successful in protecting people from serious illness and has ultimately saved many, many lives.
Introducing a booster programme this autumn will help to prolong protection from COVID-19 in those most at risk from this virus and will help to reduce hospitalisations as we head into colder weather and what will be a challenging period for our health service.
Yours sincerely
PROF SIR MICHAEL McBRIDE / Chief Medical Officer
MRS CATHY HARRISON /Chief Pharmaceutical Officer
Pfizer / Comirnaty
Information for practices using Pfizer / Comirnaty
Iinformation for practices using PFIZER / COMIRNATY
COMIRNATY Northern Ireland Handling, Preparation & Administration Poster
Both vaccines have specific requirements for their preparation, including the need for aseptic non-touch technique (ANTT) when preparing doses for administration, as well as defined time limitations for onward transport once thawed and for administration once the vial is first punctured. These requirements are likely to be updated as more information becomes available, and so practices should always refer to the relevant SmPC which contains the most up to date information about the characteristics of each vaccine to inform local planning.
Training for Vaccinators - PFIZER / COMIRNATY
All vaccinators must be registered health care professionals. Health care assistants may support vaccinators including post vaccination observation but may not administer the vaccine as part of this service.
All vaccinators should complete the COVID-19 vaccinator competency assessment tool Any training needs identified by the COVID-19 vaccinator competency assessment tool should be addressed. Copies of the assessments should be held in the practice. Additional training and information is available on the PHA website.
All vaccinators should complete the e-learning for health module on COVID-19.
In addition they shoould complete the eLearning Pfize
This e-learning course provides specific information about the Pfizer-BioNTech COVID-19 vaccine (Comirnaty). It is designed to provide healthcare workers involved in delivering the vaccine with the knowledge they need to safely and effectively deliver this vaccine.
Preparing doses of vaccines using aseptic non-touch technique (ANTT)
https://www.sps.nhs.uk/articles/preparing-doses-of-vaccines-using-aseptic-non-touch-technique-antt/
This page should be read in conjunction with other material on vaccine preparation, in particular their Standard Operating Procedures.
Anaphylaxis
HSS-MD-85-2020-ADRENALINE-FOR-ANAPHYLAXIS-KITS-A-REMINDER-TO-HEALTH-CARE-PROFESSIONALS
RCUK’s expert anaphylaxis group is currently updating the anaphylaxis guidelines for 2021. In light of the current mass vaccination programme they have provided updated information for use in any vaccination setting to give clear guidance to healthcare professionals involved. We have also produced a poster of the algorithm for the management of anaphylaxis in the vaccination setting.
e-LFT Recognising and Managing Anaphylaxis Training
Basic Life Support
RCGP : Community CPR in the COVID-19 world
Additional Resources
Supply & Ordering - PFIZER / COMIRNATY
The Pfizer-BioNTech vaccine can only be supplied in a tray containing 1,170 doses (195 vials, each containing 6 doses of 0.3ML per vial). The vaccine is defrosted to order prior to delivery to the practice and so orders could take up to 5 working days before they will be received by a practice.
All the doses must be administered within the expiry date indicated on the label attached to the pack by Movianto – typically 27 or 28 days, but a minimum of 25 days.
Only practices able to use these doses should order these large packs. Other smaller practices should consider if they need to wait for the Moderna vaccine or smaller Pfizer packs when they become available later in the month, see below.
Consumables will also need to be ordered in addition to the vaccine, practices ordering a full pack of Pfizer-BioNTech vaccine must also order
– 12 packs of combined 23G (25mm / 1 inch) needles and 1ml syringes for administration (100 in pack)
– 2 packs of needles for dilution (100 in pack)
– 10 packs of 0.9% sodium chloride 5ml ampoules for dilution (20 in pack)
– 1 pack of Patient Information Leaflets (1,200 leaflets per box)
Practices should be advised that existing supplies of 38mm (1.5inch) combined needles and syringes ordered and held by practices for administration of the AstraZeneca vaccine to morbidly obese individuals can also be used for administration of the Pfizer/BioNTech vaccine to morbidly obese individuals.
Revised vaccination cards are being produced by the Public Health Agency and practices will be advised when these are available to order from Movianto. In the interim, practices are advised to continue use the current vaccination cards and write booster against the 1st dose entry.
Storage - PFIZER / COMIRNATY
The vaccine will be delivered to practices designated to receive Comirnaty® at a temperature of 2-8°C following defrosting by Movianto. The process of defrosting and distribution may take 3 to 5 days. The vaccine has a 1 month expiry date following defrosting when stored at 2-8°C. Therefore, it is important to note that on receipt by the practice, the actual expiry date will be less than 1 month due to the time required for the defrosting and distribution process. This will be clearly indicated on a label added by Movianto and will typically be 27 to 28 days (but with a minimum of 25 days) available to practices on delivery.
Following defrosting, within the 1 month expiry date at 2-8°C, the Comirnaty® vaccine can be transported for up to 12 hours. This will include the transport time to deliver the vaccine to practices from Movianto. Practices should plan any further transport to off-site locations on the basis that there is a maximum of 2 hours available for onward transport following initial delivery from Movianto.
Moderna / SpikeVax
Information for practices using Moderna / SpikeVax
Both vaccines have specific requirements for their preparation, including the need for aseptic non-touch technique (ANTT) when preparing doses for administration, as well as defined time limitations for onward transport once thawed and for administration once the vial is first punctured. These requirements are likely to be updated as more information becomes available, and so practices should always refer to the relevant SmPC which contains the most up to date information about the characteristics of each vaccine to inform local planning.
Training for Vaccinators - MODERNA / SPIKEVAX
All vaccinators must be registered health care professionals. Health care assistants may support vaccinators including post vaccination observation but may not administer the vaccine as part of this service.
All vaccinators should complete the COVID-19 vaccinator competency assessment tool Any training needs identified by the COVID-19 vaccinator competency assessment tool should be addressed. Copies of the assessments should be held in the practice. Additional training and information is available on the PHA website.
All vaccinators should complete the e-learning for health module on COVID-19.
In addition they shoould complete the eLearning Moderna COVID-19 vaccine (SpikeVax)
This e-learning course provides specific information about the ModernaCOVID-19 vaccine (SpikeVax). It is designed to provide healthcare workers involved in delivering the vaccine with the knowledge they need to safely and effectively deliver this vaccine.
Preparing doses of vaccines using aseptic non-touch technique (ANTT)
https://www.sps.nhs.uk/articles/preparing-doses-of-vaccines-using-aseptic-non-touch-technique-antt/
This page should be read in conjunction with other material on vaccine preparation, in particular their Standard Operating Procedures.
Anaphylaxis
HSS-MD-85-2020-ADRENALINE-FOR-ANAPHYLAXIS-KITS-A-REMINDER-TO-HEALTH-CARE-PROFESSIONALS
RCUK’s expert anaphylaxis group is currently updating the anaphylaxis guidelines for 2021. In light of the current mass vaccination programme they have provided updated information for use in any vaccination setting to give clear guidance to healthcare professionals involved. We have also produced a poster of the algorithm for the management of anaphylaxis in the vaccination setting.
e-LFT Recognising and Managing Anaphylaxis Training
Basic Life Support
RCGP : Community CPR in the COVID-19 world
Additional Resources
Supply & Ordering - MODERNA / SPIKEVAX
The Moderna vaccine will be available to order from w/c 11 October however due to limited supplies GPs are encouraged to use a full tray of the Pfizer vaccine, where possible.
The Moderna vaccine comes in packs of 100 doses, which will allow for approximately 170 half doses (10 vials, each containing 17 half doses of 0.25ML per vial) to be administered.
The vaccine is defrosted to order prior to delivery to the practice and so orders could take up to 5 working days before they will be received by a practice. All the doses must be administered within the expiry date indicated on the label attached to the pack by Movianto – typically 26 or 27 days, but a minimum of 24 days.
Initial orders of the Moderna vaccine in October will be capped at 2 packs per practice, with a minimum of two weeks interval before further deliveries will be available to the practice. Consumables will also need to be ordered in addition to the vaccine, and practices ordering a full pack of Moderna vaccine must also order:
– 1 pack of combined 23G (25mm / 1 inch) needles and 1ml syringes for administration (200 in pack)
– 2 packs of Patient Information Leaflets (100 leaflets per box)
Practices should be advised that existing supplies of 38mm (1.5inch) combined needles and syringes ordered and held by practices for administration of the AstraZeneca vaccine to morbidly obese individuals can also be used for administration of the Moderna vaccine to morbidly obese individuals.
Storage - MODERNA / SPIKEVAX
temperature of 2-8°C following defrosting by Movianto. The vaccine has a 30 day expiry date following defrosting when stored at 2-8°C. However the actual expiry date will be less than this due to the time required for the defrosting and distribution process and this will be indicated on a label added by Movianto. The process of defrosting and distribution may take 3 to 5 days and so the actual expiry date will typically be 26 to 27 days from delivery, with a minimum of 24 days available to practices on delivery.
Following defrosting, the Spikevax® vaccine can be transported for up to 12 hours at 2-8°C, within the 30 day expiry date. This will include the transport time to deliver the vaccine to practices from Movianto. Practices should plan any further transport to off-site locations on the basis that there is a maximum of 2 hours available for onward transport following initial delivery from Movianto.
While every effort is being made to ensure timely delivery of orders that are placed with Movianto, practices should not schedule vaccination clinics before deliveries of vaccine have been confirmed.
SPS PREPARING DOSES OF VACCINES USING ASEPTIC NON-TOUCH TECHNIQUE (ANTT)
SPS Preparing doses of vaccines using aseptic non-touch technique (ANTT)
https://www.sps.nhs.uk/articles/preparing-doses-of-vaccines-using-aseptic-non-touch-technique-antt/
This page should be read in conjunction with other material on vaccine preparation, in particular their Standard Operating Procedures. enc below
Implementing aseptic non-touch technique
Aseptic non-touch technique (ANTT) minimises the risk of contamination transfer to critical surfaces during manipulations. It is achieved by disinfecting sites and ensuring equipment is removed from protective packaging immediately before use.
In all cases operators should sanitise their hands prior to commencing vaccine preparation and follow local guidance around use of gloves.
Using trays for assembly of consumables
If a tray is used as the preparation work area it should be disinfected on all sides with alcohol wipes before starting preparation.
If trays are only being used to hold the vials and equipment before preparation there is no need to disinfect the tray surface. In this case, the bench area should be disinfected.
Disinfecting vial bungs and ampoule necks with alcohol wipes
Vial bungs and ampoule necks should be disinfected and allowed to dry before the bung is punctured or the ampoule opened.
Handling syringes and needles
The outer packaging does not require disinfection if preparation is in a clinical area. The packaging should be opened immediately before the connection between needle and syringe is made.
- Open the needle packaging by peeling the packaging apart to only expose the needle connection. Do not remove the needle from the packaging and place on the surface as this risks contaminating the hub.
- Open the syringe packaging by peeling apart and removing the syringe. Avoid touching the syringe tip.
- Connect the syringe and needle immediately before placing in the work area.
- Only remove needle sheath immediately before use for vaccine reconstitution/dose withdrawal.
Information and guidance specific to COVID-19 Vaccine Pfizer-BioNTech
Resources covering pharmaceutical aspects of the vaccination programme specific to COVID-19 Vaccine Pfizer-BioNTech
SPS Standard Operating Procedures.
Information and guidance specific to COVID-19 Vaccine AstraZeneca
Information and guidance specific to COVID-19 Vaccine Pfizer-BioNTech
Information and guidance specific to COVID-19 Vaccine Moderna
COVID-19 Vaccine Pfizer-BioNTech Handling and Preparation Video
Running a vaccination clinic
Resources for Running a Clinic
PHA Guidance
Infection control guidance for adult COVID-19 vaccination clinics
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RCGP Guidance
Delivering Mass Vaccinations during COVID 19 : Standard Operating Procedures
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PHE (England) Guidance
COVID-19 local vaccination services deployment in community settings
Larger or offsite clinics
Our colleagues in regional emergency planning want to ensure that the emergency services, DfI Roads and councils are aware of the locations of larger or off-site COVID-19 vaccination clinics in case there are steps that can be taken to aid the clinics or if you need emergency assistance, for example:
o If you need to seek help from NIAS e.g. anaphylaxis
o If you need to seek help from PSNI re traffic issues or other problems
o So DfI Roads can consider their winter gritting programme in these areas
HSCB would be grateful if you would let your PSM know as soon as possible please about any large or off-site clinics being planned
Leaflets & Posters
COVID-19 Vaccination Programme information materials | HSC Public Health Agency (hscni.net)
COVID-19 vaccination – protection for health and social care workers
A guide to COVID-19 vaccination – all women of childbearing age
What to expect after your COVID-19 vaccination
COVID-19 vaccination – a guide for adults
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