The requester asked for a signed copy of the Patient Group Direction (PGD) for the rollout of COVID-19 vaccinations on the Isle of Man. Manx Care disclosed the full information, including the PGD for the AstraZeneca vaccine and a covering letter confirming its endorsement and legal status under Isle of Man legislation.
Key Facts
The Patient Group Direction (PGD) was developed by Public Health England for the UK vaccination programme but endorsed by the Isle of Man Department of Health and Social Care.
The specific PGD provided covers the administration of the COVID-19 Vaccine AstraZeneca (ChAdOx1-S [recombinant]).
Registered practitioners must individually sign section 7 of the PGD, and an authorising manager must counter-sign to administer the vaccine.
Isle of Man legislation (Medicines for Human Use (Amendment) Regulations 2020) provides immunity from civil liability for practitioners using the vaccine in accordance with MHRA conditions.
The PGD version v01.00 was valid from 06 January 2021 with an expiry date of 05 January 2022.
Data Disclosed
2022-03-17
2022-04-13
52
5
001559
v01.00
06 January 2021
05 January 2022
06 July 2021
18 November 2020
20 November 2020
2005
2020
Original Request
please can you provide a signed copy of the Patient Group Direction for the roll out of the Covid vaccinations.
Data Tables (61)
Version
number
Change details
Date
V01.00
New COVID-19 Vaccine AstraZeneca PGD
05 January 2021
Vanessa MacGregor
Consultant in Communicable Disease Control, Public Health England,
East Midlands Health Protection Team
Alison MacKenzie
Consultant in Public Health Medicine, Screening and Immunisation Lead,
Public Health England (South West) / NHS England and NHS
Improvement South (South West)
Gill Marsh
Senior Screening and Immunisation Manager, Public Health England /
NHS England and NHS Improvement (North West)
Lesley McFarlane
Screening and Immunisation Co-ordinator, Public Health England / NHS
England and NHS Improvement Midlands (Central Midlands)
Tushar Shah
Lead Pharmacy Advisor, NHS England and NHS Improvement (London
Region)
Qualifications and
professional registration
Practitioners must only work under this PGD where they are
competent to do so. Practitioners working to this PGD must also be
one of the following registered professionals who can legally supply
and administer under a PGD (see Patient Group Directions: who can
administer them):
• nurses and midwives currently registered with the Nursing and
Midwifery Council (NMC)
• pharmacists currently registered with the General Pharmaceutical
Council (GPhC)
• chiropodists/podiatrists, dieticians, occupational therapists,
orthoptists, orthotists/prosthetists, paramedics, physiotherapists,
radiographers and speech and language therapists currently
registered with the Health and Care Professions Council (HCPC)
• dental hygienists and dental therapists registered with the
General Dental Council
• optometrists registered with the General Optical Council.
Practitioners must also fulfil all the Additional requirements.
Additional requirements
Continued over page
Additionally, practitioners:
• must be authorised by name as an approved practitioner under
the current terms of this PGD before working to it
• must have undertaken appropriate training for working under
PGDs for supply/administration of medicines
• must be competent in the use of PGDs (see NICE Competency
framework for health professionals using PGDs)
• must be familiar with the vaccine product and alert to changes in
the Summary of Product Characteristics (SPC), should it become
licensed, or the Regulation 174 Information for UK Healthcare
Professionals for the vaccine and familiar with the national
recommendations for the use of this vaccine
• must be familiar with, and alert to changes in relevant chapters of
Immunisation Against Infectious Disease: the Green Book
• must be familiar with, and alert to changes in the relevant NHS
standard operating procedures (SOPs) and commissioning
arrangements for the national COVID-19 vaccination programme
• must have undertaken training appropriate to this PGD as
required by local policy and national NHS standard operating
procedures and in line with the Training recommendations for
COVID-19 vaccinators.
• must have completed the national COVID-19 vaccination e-
learning programme, including the relevant vaccine specific
session, and/or locally-provided COVID-19 vaccine training
• must be competent to assess individuals for suitability for
vaccination, identify any contraindications or precautions, obtain
informed consent (or ‘best interests’ decision in accordance with
the Mental Capacity Act 2005) and to discuss issues related to
vaccination
• must be competent in the correct handling and storage of
vaccines, and management of the cold chain
• must be competent in the handling of the vaccine product and
use of aseptic technique for drawing up the correct dose
• must be competent in the intramuscular injection technique
Additional requirements
(continued)
• must be competent in the recognition and management of
anaphylaxis, have completed basic life support training and be
able to respond appropriately to immediate adverse reactions
• must have access to the PGD and relevant COVID-19
vaccination programme online resources such as the Green Book
and PHE COVID-19 vaccination programme: Information for
healthcare practitioners
• must have been signed off as competent using the COVID-19
vaccinator competency assessment tool if new to or returning to
immunisation after a prolonged period (more than 12 months) or
have used the tool for self-assessment if experienced vaccinator
(vaccinated within past 12 month)
• should fulfil any additional requirements defined by local policy
The individual practitioner must be authorised by name, under
the current version of this PGD before working according to it.
Continued training
requirements
Practitioners must ensure they are up to date with relevant issues
and clinical skills relating to vaccination and management of
anaphylaxis.
Practitioners should be constantly alert to any subsequent
recommendations from Public Health England and/or NHS England
and NHS Improvement and other sources of medicines information.
Clinical condition or
situation to which this
PGD applies
COVID-19 Vaccine AstraZeneca is indicated for the active immunisation
of individuals for the prevention of COVID-19 caused by coronavirus
(SARS-CoV-2) infection, in accordance with the national COVID-19
vaccination programme (see COVID-19 vaccination programme page)
and recommendations given in Chapter 14a of the Immunisation Against
Infectious Disease: the ‘Green Book’, and subsequent
correspondence/publications from PHE and/or NHS England and NHS
Improvement.
Criteria for inclusion
COVID-19 Vaccine AstraZeneca should be offered to individuals, aged
18 years and over, in accordance with Joint Committee on Vaccination
and Immunisation (JCVI) guidance on ‘Priority groups for coronavirus
(COVID-19) vaccination’ in the following order of priority, starting with
those to be vaccinated first:
Priority Risk group
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 (see Chapter 14a)
3 All those 75 years of age and over
4 All those 70 years of age and over
Clinically extremely vulnerable2 individuals (see Definition of
clinically extremely vulnerable groups)
5 All those 65 years of age and over
6 All individuals aged 16 years3 to 64 years with underlying
health conditions which put them at higher risk of serious
disease and mortality (see Appendix A or Chapter 14a)4
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
Only individuals aged 18 years and over and included in one or more of
the priority groups tabled above may be vaccinated in accordance with
this PGD.
Implementation of the COVID-19 vaccination programme should aim to
achieve high vaccine uptake whilst prioritising those most at risk.
Implementation should also involve flexibility in vaccine deployment at a
local level. Operational considerations, such as minimising wastage, may
require a flexible approach to prioritisation, where decisions are taken in
consultation with national or local public health experts. However, the
priority order in the table above should be followed if it is reasonably
practicable to do so.
Priority
Risk group
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 (see Chapter 14a)
3
All those 75 years of age and over
4
All those 70 years of age and over
Clinically extremely vulnerable2 individuals (see Definition of
clinically extremely vulnerable groups)
5
All those 65 years of age and over
6
All individuals aged 16 years3 to 64 years with underlying
health conditions which put them at higher risk of serious
disease and mortality (see Appendix A or Chapter 14a)4
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
Criteria for exclusion5
Individuals for whom valid consent, or a ‘best-interests’ decision in
accordance with the Mental Capacity Act 2005, has not been obtained..
Individuals who:
• are less than 18 years of age
• have had a previous systemic allergic reaction (including immediate
onset anaphylaxis) to a previous dose of COVID-19 Vaccine
AstraZeneca or to any component of the vaccine or residues from the
manufacturing process6
• are pregnant (see Additional Information)
• are suffering from acute severe febrile illness (the presence of a
minor infection is not a contraindication for vaccination)
• are participating in a clinical trial of COVID-19 vaccines
• have received a dose of COVID-19 vaccine in the preceding 28 days
• have completed a course of COVID-19 vaccination
Cautions, including
any relevant action to
be taken
Syncope (fainting) can occur following, or even before, any vaccination
especially in adolescents as a psychogenic response to the needle
injection. This can be accompanied by several neurological signs such
as transient visual disturbance, paraesthesia and tonic-clonic limb
movements during recovery. It is important that procedures are in place
to avoid injury from faints.
Individuals with a bleeding disorder may develop a haematoma at the
injection site (see Route of Administration).
Past history of COVID-19 infection
There is no evidence of any safety concerns from vaccinating individuals
with a past history of COVID-19 infection, or with detectable COVID-19
antibody.
Vaccination of individuals who may be infected but asymptomatic or
incubating COVID-19 infection is unlikely to have a detrimental effect on
the illness. Vaccination should be deferred in those with confirmed
infection to avoid onward transmission and confusing the differential
diagnosis. As clinical deterioration can occur up to two weeks after
infection, ideally vaccination should be deferred until clinical recovery to
around four weeks after onset of symptoms or four weeks from the first
confirmed positive specimen in those who are asymptomatic.
Having prolonged COVID-19 symptoms is not a contraindication to
receiving COVID-19 vaccine but if the individual is seriously debilitated,
still under active investigation, or has evidence of recent deterioration,
deferral of vaccination may be considered to avoid incorrect attribution of
any change in the person’s underlying condition to the vaccine.
Vaccine Surveillance
The UK regulator will maintain real-time surveillance post deployment of
COVID-19 vaccines in the UK. In response to any safety signals, MHRA
may provide temporary advice or make substantive amendments to the
authorised conditions of the vaccine product’s supply in the UK. Supply
under this PGD must be in accordance with the most up-to-date advice or
amendments (see Green Book Chapter 14a and Regulatory approval of
COVID-19 Vaccine AstraZeneca).
Action to be taken if
the patient is
excluded
The risk to the individual of not being immunised must be considered.
The indications for risk groups are not exhaustive, and the healthcare
practitioner should consider the risk of COVID-19 exacerbating any
underlying disease that an individual may have, as well as the risk of
serious illness from coronavirus (SARS-CoV-2) itself. Where appropriate,
such individuals should be referred for assessment of clinical risk. Where
risk is identified as equivalent to those currently eligible for immunisation,
vaccination may be provided by an appropriate prescriber or on a patient
specific basis, under a PSD.
Children at very high risk of exposure and serious outcomes such as
older children with severe neuro-disabilities that require residential care
should be referred to specialists for consideration for vaccination, by an
appropriate prescriber or under PSD, following assessment of the
individual’s risk.
Individuals who have had a previous systemic allergic reaction (including
immediate onset anaphylaxis) to a previous dose of COVID-19 Vaccine
AstraZeneca or any component of the vaccine should not receive further
COVID-19 Vaccine AstraZeneca.
Women who are pregnant should not routinely be offered COVID-19
Vaccine AstraZeneca during pregnancy and should postpone vaccination
until completion of pregnancy. Vaccination may be considered for those
at high risk of exposure or very high risk of serious complications of
COVID-19 (see Additional Information). An appropriate prescriber or a
PSD would be required.
In case of postponement due to acute illness, advise when the individual
can be vaccinated and, if possible, ensure another appointment is
arranged.
Individuals who are participating in a clinical trial of COVID-19 vaccines
who present for vaccination should be referred back to the investigators.
Document the reason for exclusion and any action taken.
Action to be taken if
the patient or carer
declines treatment
Informed consent, from the individual or a person legally able to act on
the person’s behalf, must be obtained for each administration and
recorded appropriately. Where a person lacks the capacity, in
accordance with the Mental Capacity Act 2005, a decision to vaccinate
may be made in the individual’s best interests.
Advise the individual/carer about the protective effects of the vaccine, the
risks of infection and potential complications if not immunised.
Document advice given and the decision reached.
Arrangements for
referral for medical
advice
As per local policy.
Name, strength &
formulation of drug
COVID-19 Vaccine AstraZeneca, solution for injection in multidose
container COVID-19 Vaccine (ChAdOx1-S [recombinant]):
• 5ml of solution in a 10-dose vial
• 4ml of solution in an 8-dose vial
One dose (0.5 ml) contains COVID-19 Vaccine (ChAdOx1-S*
recombinant) 5 x 1010 viral particles.
*Recombinant, replication-deficient chimpanzee adenovirus vector
encoding the SARS-CoV-2 Spike (S) glycoprotein. Produced in
genetically modified human embryonic kidney (HEK) 293 cells.
Legal category
COVID-19 Vaccine AstraZeneca did not have a UK marketing
authorisation at the time of writing this PGD.
COVID-19 Vaccine AstraZeneca has been provided temporary
authorisation by the Medicines & Healthcare products Regulatory
Agency (MHRA) for supply in the UK under regulation 174 and 174A
of HMR 2012, see
https://www.gov.uk/government/publications/regulatory-approval-of-
covid-19-vaccine-astrazeneca
In accordance with the UK Statutory Instrument 2020 No. 1125, The
Human Medicines (Coronavirus and Influenza) (Amendment)
Regulations 2020, a PGD may now be used to supply and/or
administer a medicine authorised under regulation 174.
The regulation 174 authorised product is categorised as a prescription
only medicine (POM).
Black triangle
COVID-19 Vaccine AstraZeneca is authorised for temporary supply in
the UK in accordance with a Regulation 174 authorisation.
As a new vaccine product, MHRA has a specific interest in the
reporting of adverse drug reactions for this product.
Off-label use
COVID-19 Vaccine AstraZeneca is supplied in the UK in accordance
with regulation 174 and did not have a UK marketing authorisation at
the time of writing this PGD.
As part of the consent process, healthcare professionals must inform
the individual/carer that this vaccine has been authorised for
temporary supply in the UK by the regulator, MHRA, and that it is
being offered in accordance with national guidance. The Regulation
174 Information for UK recipients for COVID-19 Vaccine AstraZeneca
should be available to inform consent
Route / method of
administration
Continued over page
COVID-19 Vaccine AstraZeneca is for administration by intramuscular
injection only, preferably into deltoid region of the upper arm.
Vaccine should be prepared in accordance with the manufacturer’s
recommendations (see Regulation 174 Information for UK Healthcare
Professionals) and NHS standard operating procedures for the
service.
Inspect visually prior to administration and ensure appearance is
consistent with the description in the Regulation 174 Information for
UK Healthcare Professionals, that is a colourless to slightly brown,
clear to slightly opaque solution. Discard the vaccine if particulate
COVID-19 Vaccine AstraZeneca, solution for injection in multidose
encoding the SARS-CoV-2 Spike (S) glycoprotein. Produced in
genetically modified human embryonic kidney (HEK) 293 cells.
COVID-19 Vaccine AstraZeneca is for administration by intramuscular
injection only, preferably into deltoid region of the upper arm.
Vaccine should be prepared in accordance with the manufacturer’s
recommendations (see Regulation 174 Information for UK Healthcare
Professionals) and NHS standard operating procedures for the
service.
Route / method of
administration
(continued)
matter or differences to the described appearance are observed. Do
not shake the vial.
Check product name, batch number and expiry date prior to
administration.
Aseptic technique should be used for withdrawing each vaccine dose
of 0.5ml into a syringe for injection to be administered intramuscularly.
Use a separate sterile needle and syringe for each individual.
Each vial contains at least the number of doses stated. It is normal for
liquid to remain in the vial after withdrawing the final dose. When low
dead volume syringes and/or needles are used, the amount remaining
in the vial may be sufficient for an additional dose. Care should be
taken to ensure a full 0.5ml dose is administered. Where a full 0.5ml
dose cannot be extracted, the remaining volume should be discarded.
The vaccine does not contain any preservative. After first dose
withdrawal, use the vial as soon as practically possible and within 6
hours (stored at 2°C to 25°C). Discard any unused vaccine.
Individuals with bleeding disorders may be vaccinated intramuscularly
if, in the opinion of a doctor familiar with the individual's bleeding risk,
vaccines or similar small volume intramuscular injections can be
administered with reasonable safety by this route. If the individual
receives medication/treatment to reduce bleeding, for example
treatment for haemophilia, intramuscular vaccination can be
scheduled shortly after such medication/treatment is administered.
Individuals on stable anticoagulation therapy, including individuals on
warfarin who are up to date with their scheduled International
Normalised Ratio (INR) testing and whose latest INR was below the
upper threshold of their therapeutic range, can receive intramuscular
vaccination. A fine needle (equal to 23 gauge or finer calibre such as
25 gauge) should be used for the vaccination, followed by firm
pressure applied to the site (without rubbing) for at least 2 minutes.
The individual/carer should be informed about the risk of haematoma
from the injection.
Dose and frequency of
administration
A two-dose course should be administered consisting of 0.5ml
followed by a second dose of 0.5ml administered between 4 to 12
weeks after the first dose, or in accordance with official guidance at
the time.
If an interval longer than the recommended interval is left between
doses, the second dose should still be given (using the same vaccine
as was given for the first dose if possible, see Additional Information).
The course does not need to be restarted.
Duration of treatment
See Dose and frequency of administration above.
Booster doses of COVID-19 vaccines are not yet recommended
because the need for, and timing of, boosters has not yet been
determined.
Quantity to be supplied /
administered
Administer 0.5ml
A two-dose course should be completed.
Supplies
Continued over page
Providers should order COVID-19 vaccines via the national appointed
supply route for the provider.
Aseptic technique should be used for withdrawing each vaccine dose
of 0.5ml into a syringe for injection to be administered intramuscularly.
Use a separate sterile needle and syringe for each individual.
Each vial contains at least the number of doses stated. It is normal for
liquid to remain in the vial after withdrawing the final dose. When low
dead volume syringes and/or needles are used, the amount remaining
in the vial may be sufficient for an additional dose. Care should be
taken to ensure a full 0.5ml dose is administered. Where a full 0.5ml
dose cannot be extracted, the remaining volume should be discarded.
The vaccine does not contain any preservative. After first dose
withdrawal, use the vial as soon as practically possible and within 6
hours (stored at 2°C to 25°C). Discard any unused vaccine.
Providers should order COVID-19 vaccines via the national appointed
supply route for the provider.
Supplies
(continued)
COVID-19 vaccines for the national COVID-19 vaccination
programme will be made available for ordering on the ImmForm
website: https://portal.immform.phe.gov.uk/
NHS standard operating procedures should be followed for
appropriate ordering, storage, handling, preparation, administration
and waste minimisation of COVID-19 Vaccine AstraZeneca, which
ensure use is in accordance with Regulation 174 Information for UK
Healthcare Professionals and Conditions of Authorisation for COVID-
19 Vaccine AstraZeneca.
Storage
COVID-19 Vaccine AstraZeneca unopened multidose vial:
• Store in a refrigerator (2 to 8°C).
• Do not freeze.
• Keep vials in outer carton to protect from light.
• Shelf life is 6 months.
After first dose withdrawn, administer remaining doses from the vial as
soon as practically possible and within 6 hours of first use of the vial.
The vaccine may be stored between 2°C and 25°C during this in-use
period.
Label vial with the expiry time after first use.
Once a dose is withdrawn from the vial it should be administered
immediately.
The vaccine does not contain preservative.
Disposal
Follow local clinical waste policy and NHS standard operating
procedures and ensure safe and secure waste disposal.
Equipment used for vaccination, including used vials, ampoules, or
discharged vaccines in a syringe or applicator, should be disposed of
safely and securely according to local authority regulations and
guidance in the technical memorandum 07-01: Safe management of
healthcare waste (Department of Health, 2013).
AstraZeneca COVID-19 Vaccine contains genetically modified
organisms (GMOs). Sharps waste and empty vials should be placed
into yellow lidded waste bins and sent for incineration; there is no
need for specific designation as GMO waste. An appropriate virucidal
disinfectant should be available for managing spills in all settings
where vaccination is administered.
Drug interactions
Continued over page
Immunological response may be diminished in those receiving
immunosuppressive treatment, but it is important to still immunise this
group.
Although no data for co-administration of COVID-19 vaccine with
other vaccines exists, in the absence of such data, first principles
would suggest that interference between inactivated vaccines with
different antigenic content is likely to be limited. Based on experience
with other vaccines, any potential interference is most likely to result
in a slightly attenuated immune response to one of the vaccines.
There is no evidence of any safety concerns, although it may make
the attribution of any adverse events more difficult.
It should not be routine to offer appointments to give this vaccine at
the same time as other vaccines. Scheduling should ideally be
separated by an interval of at least 7 days to avoid incorrect attribution
of potential adverse events.
COVID-19 vaccines for the national COVID-19 vaccination
programme will be made available for ordering on the ImmForm
website: https://portal.immform.phe.gov.uk/
• Store in a refrigerator (2 to 8°C).
• Do not freeze.
• Keep vials in outer carton to protect from light.
• Shelf life is 6 months.
After first dose withdrawn, administer remaining doses from the vial as
soon as practically possible and within 6 hours of first use of the vial.
The vaccine may be stored between 2°C and 25°C during this in-use
period.
Immunological response may be diminished in those receiving
immunosuppressive treatment, but it is important to still immunise this
group.
Drug interactions
(continued)
Where individuals in an eligible cohort present having received
another inactivated or live vaccine, COVID-19 vaccination should still
be considered. The same applies for other live and inactivated
vaccines where COVID-19 vaccination has been received first or
where an individual presents requiring two vaccines. In most cases,
vaccination should proceed, and may be provided under the PGD, to
avoid any further delay in protection and to avoid the risk of the
individual not returning for a later appointment. In such circumstances,
individuals should be informed about the likely timing of potential
adverse events relating to each vaccine.
Identification &
management of adverse
reactions
The most frequently reported adverse reactions were injection site
tenderness (>60%); injection site pain, headache, fatigue (>50%);
myalgia, malaise (>40%); pyrexia, chills (>30%); and arthralgia,
nausea (>20%). The majority of adverse reactions were mild to
moderate in severity and usually resolved within a few days of
vaccination. By day 7 the incidence of subjects with at least one local
or systemic reaction was 4% and 13% respectively. When compared
with the first dose, adverse reactions reported after the second dose
were milder and reported less frequently.
Adverse reactions were generally milder and reported less frequently
in older adults (≥65 years old).
A detailed list of adverse reactions is available in the Regulation 174
Information for UK Healthcare Professionals
Individuals should be provided with the advice within the leaflet What
to expect after your COVID-19 vaccination, which covers the
reporting of adverse reactions and their management, such as with
analgesic and/or antipyretic medication.
Reporting procedure of
adverse reactions
Healthcare professionals and individuals/carers should report
suspected adverse reactions to the Medicines and Healthcare
products Regulatory Agency (MHRA) using the Coronavirus Yellow
Card reporting scheme on:
https://coronavirus-yellowcard.mhra.gov.uk/. Or search for MHRA
Yellow Card in the Google Play or Apple App Store.
As a new vaccine product, MHRA hasa specific interest in the
reporting of all adverse drug reactions for this product, see
https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
Any adverse reaction to a vaccine should also be documented in the
individual’s record and the individual’s GP should be informed.
The Green Book Chapter 14a and Chapter 8 provide further details
regarding the clinical features of reactions to be reported as
‘anaphylaxis’. Allergic reactions that do not include the clinical
features of anaphylaxis should be reported as ‘allergic reaction’.
Written information to be
given to patient or carer
Ensure the individual has been provided appropriate written
information such as the:
• Regulation 174 Information for UK recipients for COVID-19
Vaccine AstraZeneca
• COVID-19 Vaccination Record Card
• What to expect after your COVID-19 vaccination
• COVID-19 vaccination: women of childbearing age, currently
pregnant, or breastfeeding
The most frequently reported adverse reactions were injection site
tenderness (>60%); injection site pain, headache, fatigue (>50%);
myalgia, malaise (>40%); pyrexia, chills (>30%); and arthralgia,
nausea (>20%). The majority of adverse reactions were mild to
moderate in severity and usually resolved within a few days of
vaccination. By day 7 the incidence of subjects with at least one local
or systemic reaction was 4% and 13% respectively. When compared
with the first dose, adverse reactions reported after the second dose
were milder and reported less frequently.
Adverse reactions were generally milder and reported less frequently
in older adults (≥65 years old).
A detailed list of adverse reactions is available in the Regulation 174
Information for UK Healthcare Professionals
Patient advice / follow up
treatment
As with all vaccines, immunisation may not result in protection in all
individuals. Immunosuppressed individuals should be advised that
they may not make a full immune response to the vaccine. Nationally
recommended protective measures should still be followed.
Individuals should be provided with the advice within the leaflet What
to expect after your COVID-19 vaccination, which covers the
reporting of adverse reactions and their management, such as with
analgesic and/or antipyretic medication.
The individual/carer should be advised to seek appropriate advice
from a healthcare professional in the event of an adverse reaction.
Vaccinated individuals should be advised that the COVID-19 vaccine
may cause a mild fever, which usually resolves within 48 hours. This
is a common, expected reaction and isolation is not required unless
COVID-19 is suspected.
Advise the individual/carer that they can report side effects directly via
the national reporting system run by the MHRA known as the
Coronavirus Yellow Card reporting scheme on:
https://coronavirus-yellowcard.mhra.gov.uk/ . Or search for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting side
effects, they can help provide more information on the safety of
medicines.
When applicable, advise the individual/carer when to return for
vaccination or when a subsequent vaccine dose is due.
Special considerations /
additional information
Continued over page
Ensure there is immediate access to adrenaline (epinephrine) 1 in
1,000 injection and access to a telephone at the time of vaccination.
A protocol for the management of anaphylaxis and an anaphylaxis
pack must be readily available in case of an anaphylactic event.
Immediate treatment should include early treatment with 500
micrograms intramuscular adrenaline (0.5ml of 1:1000 or 1mg/ml
adrenaline), with an early call for help and further IM adrenaline every
5 minutes if features of anaphylaxis do not resolve.
Minor illnesses without fever or systemic upset are not valid reasons
to postpone vaccination. If an individual is acutely unwell, vaccination
should be postponed 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 to the
adverse effects of the vaccine.
Pregnancy
There is no known risk associated with giving inactivated,
recombinant viral or bacterial vaccines or toxoids during pregnancy or
whilst breast-feeding. Since inactivated vaccines cannot replicate,
they cannot cause infection in either the mother or the fetus. Although
AstraZeneca COVID-19 vaccine contains a live adenovirus vector,
this virus is not replicating so will not cause infection in the mother or
the fetus. As with most pharmaceutical products, specific clinical trials
of COVID-19 vaccine in pregnancy have not been carried out.
Developmental and reproductivity testing of the Pfizer BioNTech and
AstraZeneca COVID-19 vaccines in animals have not raised any
concerns. Adenovirus vectors, similar to those used in the
• Priority groups for coronavirus (COVID-19) vaccination: advice
I confirm that I have read and understood the content of this PGD and that I am willing
and competent to work to it within my professional code of conduct.
Name
Designation
Signature
Date
I confirm that the registered healthcare professionals named above have declared
themselves suitably trained and competent to work under this PGD. I give
authorisation on behalf of insert name of organisation
for the above named healthcare professionals who have signed the PGD to work
under it.
Name
Designation
Signature
Date
Chronic respiratory
disease
Individuals with a severe lung condition, including those with asthma that
requires continuous or repeated use of systemic steroids or with previous
exacerbations requiring hospital admission, and chronic obstructive pulmonary
disease (COPD) including chronic bronchitis and emphysema; bronchiectasis,
cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary
dysplasia (BPD).
Chronic heart disease
and vascular disease
Congenital heart disease, hypertension with cardiac complications, chronic heart
failure, individuals requiring regular medication and/or follow-up for ischaemic
heart disease. This includes individuals with atrial fibrillation, peripheral vascular
disease or a history of venous thromboembolism.
Chronic kidney
disease
Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic
syndrome, kidney transplantation.
Chronic liver disease
Cirrhosis, biliary atresia, chronic hepatitis.
Chronic neurological
disease
Stroke, transient ischaemic attack (TIA). Conditions in which respiratory function
may be compromised due to neurological disease (e.g. polio syndrome
sufferers). This includes individuals with cerebral palsy, severe or profound
learning disabilities, Down’s Syndrome, multiple sclerosis, epilepsy, dementia,
Parkinson’s disease, motor neurone disease and related or similar conditions; or
hereditary and degenerative disease of the nervous system or muscles; or
severe neurological disability.
Diabetes mellitus
Any diabetes, including diet-controlled diabetes.
Immunosuppression
Immunosuppression due to disease or treatment, including patients undergoing
chemotherapy leading to immunosuppression, patients undergoing radical
radiotherapy, solid organ transplant recipients, bone marrow or stem cell
transplant recipients, HIV infection at all stages, multiple myeloma or genetic
disorders affecting the immune system (e.g. IRAK-4, NEMO, complement
disorder, SCID).
Individuals who are receiving immunosuppressive or immunomodulating
biological therapy including, but not limited to, anti-TNF, alemtuzumab,
ofatumumab, rituximab, patients receiving protein kinase inhibitors or PARP
inhibitors, and individuals treated with steroid sparing agents such as
cyclophosphamide and mycophenolate mofetil.
Individuals treated with or likely to be treated with systemic steroids for more
than a month at a dose equivalent to prednisolone at 20mg or more per day.
Anyone with a history of haematological malignancy, including leukaemia,
lymphoma, and myeloma and those with systemic lupus erythematosus and
rheumatoid arthritis, and psoriasis who may require long term
immunosuppressive treatments.
Some immunosuppressed patients may have a suboptimal immunological
response to the vaccine.
Asplenia or
dysfunction of the
spleen
This also includes conditions that may lead to splenic dysfunction, such as
homozygous sickle cell disease, thalassemia major and coeliac syndrome.
Morbid obesity
Adults with a Body Mass Index ≥40 kg/m².
Severe mental illness
Individuals with schizophrenia or bipolar disorder, or any mental illness that
causes severe functional impairment.
Adult carers
Those who are in receipt of a carer’s allowance, or those who are the main carer
of an elderly or disabled person whose welfare may be at risk if the carer falls ill.
Younger adults in
long-stay nursing and
residential care
settings
Many younger adults in residential care settings will be eligible for vaccination
because they fall into one of the clinical risk groups above.
Given the likely high risk of exposure in these settings, where a high proportion
of the population would be considered eligible, vaccination of the whole resident
population is recommended.
Younger residents in care homes for the elderly will be at high risk of exposure
and, although they may be at lower risk of mortality than older residents, should
not be excluded from vaccination programmes (see priority 1 above).
For consideration of children under 16 see Action to be taken if the patient is
excluded
Version
number
Change details
Date
V01.00
New PHE PGD template for COVID-19 mRNA vaccine
BNT162b2.
1 O December 2020
Vanessa MacGregor
Consultant in Communicable Disease Control, Public Health England,
East Midlands Health Protection Team
Alison Mackenzie
Consultant in Public Health Medicine, Screening and Immunisation Lead,
Public Health England (South West) / NHS England and NHS
Improvement South (South West)
Gill Marsh
Senior Screening and Immunisation Manager, Public Health England /
NHS England and NHS Improvement (North West)
Lesley McFarlane
Screening and Immunisation Co-ordinator, Public Health England / NHS
England and NHS Improvement Midlands (Central Midlands)
Tushar Shah
Lead Pharmacy Advisor, NHS England and NHS Improvement (London
Region)
Qualifications and
professional registration
Practitioners must only work under this PGD where they are
competent to do so. Practitioners working to this PGD must also be
one of the following registered professionals who can legally supply
and administer under a PGD (see Patient Group Directions: who can
administer them):
• nurses and midwives currently registered with the Nursing and
Midwifery Council (NMC)
• pharmacists currently registered with the General Pharmaceutical
Council (GPhC)
• chiropodists/podiatrists, dieticians, occupational therapists,
orthoptists, orthotists/prosthetists, paramedics, physiotherapists,
radiographers and speech and language therapists currently
registered with the Health and Care Professions Council (HCPC)
• dental hygienists and dental therapists registered with the
General Dental Council
• optometrists registered with the General Optical Council.
Practitioners must also fulfil all the Additional requirements.
Additional requirements
Continued over page
Additionally, practitioners:
• must be authorised by name as an approved practitioner under
the current terms of this PGD before working to it
• must have undertaken appropriate training for working under
PGDs for supply/administration of medicines
• must be competent in the use of PGDs (see NICE Competency
framework for health professionals using PGDs)
• must be familiar with the vaccine product and alert to changes in
the Summary of Product Characteristics (SPC), should it become
licensed or the Regulation 174 Information for UK Healthcare
Professionals for the vaccine and familiar with the national
recommendations for the use of this vaccine
• must be familiar with, and alert to changes in relevant chapters of
Immunisation Against Infectious Disease: the Green Book
• must be familiar with, and alert to changes in the relevant NHS
standard operating procedures (SOPs) and commissioning
arrangements for the national COVID-19 vaccination programme
• must have undertaken training appropriate to this PGD as
required by local policy and national NHS standard operating
procedures and in line with the Training recommendations for
COVID-19 vaccinators.
• must have completed the national COVID-19 vaccination e-
learning programme, including the relevant vaccine specific
session, and/or locally-provided COVID-19 vaccine training
• must be competent to assess individuals for suitability for
vaccination, identify any contraindications or precautions, obtain
informed consent and to discuss issues related to vaccination
• must be competent in the correct handling and storage of
vaccines, and management of the cold chain
• must be competent in the handling of the vaccine product,
procedure for dilution of the vaccine and use of the correct
technique for drawing up the correct dose
• must be competent in the intramuscular injection technique
Additional requirements
(continued)
• must be competent in the recognition and management of
anaphylaxis, have completed basic life support training and be
able to respond appropriately to immediate adverse reactions
• must have access to the PGD and relevant COVID-19
vaccination programme online resources such as the Green Book
and PHE COVID-19 vaccination programme: Information for
healthcare practitioners
• must have been signed off as competent using the COVID-19
vaccinator competency assessment tool if new to or returning to
immunisation after a prolonged period (more than 12 months) or
have used the tool for self-assessment if experienced vaccinator
(vaccinated within past 12 month)
• should fulfil any additional requirements defined by local policy
The individual practitioner must be authorised by name, under
the current version of this PGD before working according to it.
Continued training
requirements
Practitioners must ensure they are up to date with relevant issues
and clinical skills relating to vaccination and management of
anaphylaxis.
Practitioners should be constantly alert to any subsequent
recommendations from Public Health England and/or NHS England
and NHS Improvement and other sources of medicines information.
Clinical condition or
situation to which this
PGD applies
COVID-19 mRNA vaccine BNT162b2 is indicated for the active
immunisation of individuals for the prevention of coronavirus (SARS-
CoV-2) infection and subsequent COVID-19, in accordance with the
national COVID-19 vaccination programme (see COVID-19
vaccination programme page) and recommendations given in Chapter
14a of the Immunisation Against Infectious Disease: the ‘Green Book’,
and subsequent correspondence/publications from PHE and/or NHS
England and NHS Improvement.
Criteria for inclusion
COVID-19 mRNA vaccine BNT162b2 should be offered to individuals
in accordance with Joint Committee on Vaccination and Immunisation
(JCVI) guidance on ‘Priority groups for coronavirus (COVID-19)
vaccination’ in the following order of priority, starting with those to be
vaccinated first:
Priority Risk group
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 (see Chapter
14a)
3 All those 75 years of age and over
4 All those 70 years of age and over
Clinically extremely vulnerable2 individuals (see
Definition of clinically extremely vulnerable groups)
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 (see Appendix A or
Chapter 14a)
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
Only individuals included in one or more of the priority groups tabled
above may be vaccinated in accordance with this PGD.
Implementation of the COVID-19 vaccination programme should aim
to achieve high vaccine uptake whilst prioritising those most at risk.
Implementation should also involve flexibility in vaccine deployment at
a local level. Operational considerations, such as minimising wastage,
may require a flexible approach to prioritisation, where decisions are
taken in consultation with national or local public health experts.
However, the priority order in the table above should be followed if it is
reasonably practicable to do so.
Priority
Risk group
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 (see Chapter
14a)
3
All those 75 years of age and over
4
All those 70 years of age and over
Clinically extremely vulnerable2 individuals (see
Definition of clinically extremely vulnerable groups)
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 (see Appendix A or
Chapter 14a)
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
Cautions, including any
relevant action to be
taken
Appropriate medical treatment, such as an anaphylaxis kit including
adrenaline 1 in 1000, should be readily available in case of an
anaphylactic event.
Syncope (fainting) can occur following, or even before, any
vaccination especially in adolescents as a psychogenic response to
the needle injection. This can be accompanied by several neurological
signs such as transient visual disturbance, paraesthesia and tonic-
clonic limb movements during recovery. It is important that procedures
are in place to avoid injury from faints.
Individuals with a bleeding disorder may develop a haematoma at the
injection site (see Route of Administration).
All women of childbearing age should be provided the advice in the
leaflet 'COVID-19 vaccination: a guide for women of childbearing age,
pregnant, planning a pregnancy or breastfeeding’ and their
understanding checked as part of the consent process. They should
be advised that pregnancy should be avoided until 2 months after the
second dose of vaccine (see Additional Information below).
Past history of COVID-19 infection
There is no evidence of any safety concerns from vaccinating
individuals with a past history of COVID-19 infection, or with
detectable COVID-19 antibody.
Vaccination of individuals who may be infected but asymptomatic or
incubating COVID-19 infection is unlikely to have a detrimental effect
on the illness. Vaccination should be deferred in those with confirmed
infection to avoid onward transmission and confusing the differential
diagnosis. As clinical deterioration can occur up to two weeks after
infection, ideally vaccination should be deferred until clinical recovery
and at least four weeks after onset of symptoms or four weeks from
the first positive specimen in those who are asymptomatic.
Having prolonged COVID-19 symptoms is not a contraindication to
receiving COVID-19 vaccine but if the patient is seriously debilitated,
still under active investigation, or has evidence of recent deterioration,
deferral of vaccination may be considered to avoid incorrect attribution
of any change in the person’s underlying condition to the vaccine.
Vaccine Surveillance
The UK regulator will maintain real-time surveillance post deployment
of COVID-19 vaccines in the UK. In response to any safety signals,
MHRA may provide temporary advice or make substantive
amendments to the authorised conditions of the vaccine product’s
supply in the UK. Supply under this PGD must be in accordance with
any such advice or amendments (see Regulatory approval of
Pfizer/BioNTech vaccine for COVID-19 and for an example of such
advice see Criteria for exclusion.
Action to be taken if the
patient is excluded
Continued over page
The risk to the individual of not being immunised must be
considered. The indications for risk groups are not exhaustive, and
the healthcare practitioner should consider the risk of COVID-19
exacerbating any underlying disease that an individual may have, as
well as the risk of serious illness from coronavirus (SARS-CoV-2)
itself. Where appropriate, such individuals should be referred for
assessment of clinical risk. Where risk is identified as equivalent to
those currently eligible for immunisation, vaccination may be provided
All women of childbearing age should be provided the advice in the
leaflet 'COVID-19 vaccination: a guide for women of childbearing age,
pregnant, planning a pregnancy or breastfeeding’ and their
understanding checked as part of the consent process. They should
be advised that pregnancy should be avoided until 2 months after the
second dose of vaccine (see Additional Information below).
Action to be taken if the
patient is excluded
(continued)
by an appropriate prescriber or on a patient specific basis, under a
PSD.
Children at very high risk of exposure and serious outcomes such as
older children with severe neuro-disabilities that require residential
care should be referred to specialists for consideration for vaccination,
under PSD, following assessment of the individual’s risk.
Women who are pregnant, planning to get pregnant or breastfeeding
must postpone COVID-19 vaccination until completion of pregnancy
and breastfeeding. Individuals who think they may be pregnant should
delay vaccination until they are sure they are not. Pregnancy should
be avoided until 2 months after the second dose of vaccine.
Individuals should be provided the advice in the leaflet 'COVID-19
vaccination: a guide for women of childbearing age, pregnant,
planning a pregnancy or breastfeeding’.
In case of postponement due to acute illness, advise when the
individual can be vaccinated and if possible ensure another
appointment is arranged.
Individuals with confirmed COVID-19 infection in the preceding 4
weeks should postpone vaccination until clinical recovery and at least
four weeks after onset of symptoms or four weeks from the first
positive specimen in those who are asymptomatic.
Individuals who are participating in a clinical trial of COVID-19
vaccines who present for vaccination should be referred back to the
investigators.
Document the reason for exclusion and any action taken.
Action to be taken if the
patient or carer declines
treatment
Informed consent, from the individual or a person legally able to act
on the person’s behalf, must be obtained for each administration and
recorded appropriately.
Advise the individual/carer about the protective effects of the vaccine,
the risks of infection and potential complications if not immunised.
Document advice given and the decision reached.
Arrangements for
referral for medical
advice
As per local policy.
Name, strength &
formulation of drug
COVID-19 mRNA vaccine BNT162b2 concentrate for solution for
injection, presented as a multidose vial.
1 vial (0.45ml) contains 5 doses of 30 micrograms of BNT162b2 RNA
(embedded in lipid nanoparticles).
Vials may alternatively be labelled:
• BNT162b2 (SARS-COV-2-mRNA vaccine), or
• Pfizer-BioNTech COVID-19 vaccine
Legal category
COVID-19 mRNA vaccine BNT162b2 did not have a UK marketing
authorisation at the time of writing this PGD.
COVID-19 mRNA vaccine BNT162b2 has been provided temporary
authorisation by the Medicines & Healthcare products Regulatory
Agency (MHRA) for supply in the UK under regulation 174 and 174A
of HMR 2012, see
https://www.gov.uk/government/publications/regulatory-approval-of-
pfizer-biontech-vaccine-for-covid-19
In accordance with the UK Statutory Instrument 2020 No. 1125, The
Human Medicines (Coronavirus and Influenza) (Amendment)
Regulations 2020, a PGD may now be used to supply and/or
administer a medicine authorised under regulation 174.
The regulation 174 authorised product is categorised as a prescription
only medicine (POM).
Black triangle
COVID-19 mRNA vaccine BNT162b2 is authorised for temporary
supply in the UK in accordance with a Regulation 174 authorisation.
As a new vaccine product, MHRA have a specific interest in the
reporting of adverse drug reactions for this product, see
https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
Off-label use
COVID-19 mRNA vaccine BNT162b2 is supplied in the UK in
accordance with regulation 174 and did not have a UK marketing
authorisation at the time of writing this PGD.
As part of the consent process, healthcare professionals must inform
the individual/carer that this vaccine has been authorised for
temporary supply in the UK by the regulator, MHRA, and that it is
being offered in accordance with national guidance.
Route / method of
administration
Continued over page
Thawed COVID-19 mRNA vaccine BNT162b2 requires dilution in its
original vial with 1.8ml of unpreserved sodium chloride 0.9% solution
for injection, prior to withdrawing a 0.3ml dose.
COVID-19 mRNA vaccine BNT162b2 is for administration by
intramuscular injection only, preferably into deltoid region of the upper
arm.
Vaccine should be prepared in accordance with the manufacturer’s
recommendations (see Regulation 174 Information for UK Healthcare
Professionals) and NHS standard operating procedures for the
service.
Gently invert the diluted solution 10 times. Do not shake the vaccine.
COVID-19 mRNA vaccine BNT162b2 concentrate for solution for
injection, presented as a multidose vial.
1 vial (0.45ml) contains 5 doses of 30 micrograms of BNT162b2 RNA
(embedded in lipid nanoparticles).
Vials may alternatively be labelled:
Thawed COVID-19 mRNA vaccine BNT162b2 requires dilution in its
original vial with 1.8ml of unpreserved sodium chloride 0.9% solution
for injection, prior to withdrawing a 0.3ml dose.
COVID-19 mRNA vaccine BNT162b2 is for administration by
intramuscular injection only, preferably into deltoid region of the upper
arm.
Vaccine should be prepared in accordance with the manufacturer’s
recommendations (see Regulation 174 Information for UK Healthcare
Professionals) and NHS standard operating procedures for the
service.
Gently invert the diluted solution 10 times. Do not shake the vaccine.
Route / method of
administration
(continued)
Inspect visually prior to administration and ensure appearance is
consistent with the description in the Regulation 174 Information for
UK Healthcare Professionals, that is an off-white solution with no
particulates visible. Discard the vaccine if particulates or
discolouration are present.
Check product name, batch number and expiry date prior to
administration.
Individuals with bleeding disorders may be vaccinated intramuscularly
if, in the opinion of a doctor familiar with the individual's bleeding risk,
vaccines or similar small volume intramuscular injections can be
administered with reasonable safety by this route. If the individual
receives medication/treatment to reduce bleeding, for example
treatment for haemophilia, intramuscular vaccination can be
scheduled shortly after such medication/treatment is administered.
Individuals on stable anticoagulation therapy, including individuals on
warfarin who are up to date with their scheduled INR testing and
whose latest INR was below the upper threshold of their therapeutic
range, can receive intramuscular vaccination. A fine needle (equal to
23 gauge or finer calibre such as 25 gauge) should be used for the
vaccination, followed by firm pressure applied to the site (without
rubbing) for at least 2 minutes. The individual/carer should be
informed about the risk of haematoma from the injection.
Each vial contains 5 doses. It is normal for a small amount of liquid to
remain in the vial after withdrawing the final dose.
Dose and frequency of
administration
A two-dose course should be administered consisting of
30micrograms in 0.3ml followed by a second dose of 30micrograms in
0.3ml after an interval of 21 days. For operational purposes the
second dose may be routinely scheduled at 28 days.
If the course is interrupted or delayed, it should be resumed using the
same vaccine (see Additional Information) but the first dose should
not be repeated.
Duration of treatment
See Dose and frequency of administration above.
Booster doses of COVID-19 vaccines are not yet recommended
because the need for, and timing of, boosters has not yet been
determined.
Quantity to be supplied /
administered
Administer 30micrograms in 0.3ml
A two-dose course should be completed.
Supplies
Covid-19 vaccines for the national COVID-19 vaccination programme
will be made available for ordering on the ImmForm website:
https://portal.immform.phe.gov.uk/
NHS standard operating procedures should be followed for
appropriate storage, handling, preparation, administration and waste
minimisation of COVID-19 mRNA Vaccine BNT162b2, which ensure
use is in accordance with Regulation 174 Information for UK
Healthcare Professionals and Conditions of Authorisation for
Pfizer/BioNTech COVID-19 vaccine BNT162b2.
Covid-19 vaccines for the national COVID-19 vaccination programme
will be made available for ordering on the ImmForm website:
https://portal.immform.phe.gov.uk/
Storage
COVID-19 mRNA vaccine BNT162b2 is supplied from the
manufacturer as a multiple-dose (5-dose) vial of frozen, preservative-
free concentrate, which requires storage in an ultra-low temperature
freezer at -80°C to -60°C or a thermal container at -90°C to -60°C.
Shelf life is 6 months at -80°C to -60°C.
Store in original packaging in order to protect from light.
The undiluted vaccine can be stored for up to 5 days (120 hours) at 2-
8°C, or 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.
After aseptic dilution, vials should be marked with the dilution date
and time, stored at 2°C to 25°C and used within 6 hours from the time
of dilution. The vaccine does not contain preservative.
Once the dose is drawn from the vial it should be administered
immediately.
The above details relate to storage requirements and available
stability data at the time of product authorisation. This may be subject
to amendment as more data becomes available. Refer to NHS
standard operating procedures for the service and the most up to date
manufacturer’s recommendations in the Conditions of Authorisation
for Pfizer/BioNTech COVID-19 vaccine BNT162b2 and Regulation
174 Information for UK Healthcare Professionals.
Disposal
Follow local clinical waste policy and NHS standard operating
procedures and ensure safe and secure waste disposal.
Equipment used for vaccination, including used vials, ampoules, or
discharged vaccines in a syringe or applicator, should be disposed of
safely and securely according to local authority regulations and
guidance in the technical memorandum 07-01: Safe management of
healthcare waste (Department of Health, 2013).
Drug interactions
Continued over page
Immunological response may be diminished in those receiving
immunosuppressive treatment, but it is important to still immunise this
group.
Although no data for co-administration of COVID-19 vaccine with
other vaccines exists, in the absence of such data, first principles
would suggest that interference between inactivated vaccines with
different antigenic content is likely to be limited. Based on experience
with other vaccines, any potential interference is most likely to result
in a slightly attenuated immune response to one of the vaccines.
There is no evidence of any safety concerns, although it may make
the attribution of any adverse events more difficult.
It should not be routine to offer appointments to give this vaccine at
the same time as other vaccines. Scheduling should ideally be
separated by an interval of at least 7 days to avoid incorrect attribution
of potential adverse events.
Where individuals in an eligible cohort present having received
another inactivated or live vaccine, COVID-19 vaccination should still
be considered. The same applies for other live and inactivated
Immunological response may be diminished in those receiving
immunosuppressive treatment, but it is important to still immunise this
group.
Drug interactions
(continued)
vaccines where COVID-19 vaccination has been received first. In
many cases vaccination should proceed, and may be provided under
the PGD, to avoid any further delay in protection and to avoid the risk
of the individual not returning for a later appointment. In such
circumstances, individuals should be informed about the likely timing
of potential adverse events relating to each vaccine.
Identification &
management of adverse
reactions
The most frequent adverse reactions in participants 16 years of age
and older were pain at the injection site (> 80%), fatigue (> 60%),
headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (>
20%) and pyrexia (> 10%) and were usually mild or moderate in
intensity and resolved within a few days after vaccination. Redness at
the injection site, injection site swelling, and nausea are reported as
common. Lymphadenopathy was reported in less than 1%.
Individuals should be provided with the advice within the leaflet What
to expect after your COVID-19 vaccination, which covers the
reporting of adverse reactions and their management, such as with
analgesic and/or antipyretic medication.
Vaccinated individuals should be advised that the COVID-19 vaccine
may cause a mild fever, which usually resolves within 48 hours. This
is a common, expected reaction and isolation is not required unless
COVID-19 is suspected.
A detailed list of adverse reactions is available in the Regulation 174
Information for UK Healthcare Professionals
Reporting procedure of
adverse reactions
Healthcare professionals and individuals/carers should report
suspected adverse reactions to the Medicines and Healthcare
products Regulatory Agency (MHRA) using the Coronavirus Yellow
Card reporting scheme on:
https://coronavirus-yellowcard.mhra.gov.uk/. Or search for MHRA
Yellow Card in the Google Play or Apple App Store.
As a new vaccine product, MHRA have a specific interest in the
reporting of all adverse drug reactions for this product, see
https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
Any adverse reaction to a vaccine should also be documented in the
individual’s record and the individual’s GP should be informed.
The Green Book Chapter 14a and Chapter 8 provide further details
regarding the clinical features of reactions to be reported as
‘anaphylaxis’. Allergic reactions that do not include the clinical
features of anaphylaxis should be reported as ‘allergic reaction’.
Written information to be
given to patient or carer
Ensure the individual has been provided appropriate written
information such as the:
• Regulation 174 Information for UK recipients for COVID-19
mRNA vaccine BNT162b2
• COVID-19 Vaccination Record Card (Product code:
COV2020311)
• What to expect after your COVID-19 vaccination (Product code:
COV2020307)
• COVID-19 vaccination: a guide for women of childbearing age,
pregnant, planning a pregnancy or breastfeeding (Product code
COV2020374)
Patient advice / follow up
treatment
As with all vaccines, immunisation may not result in protection in all
individuals. Individuals may not be protected until at least 7 days after
their second dose of the vaccine. Immunosuppressed individuals
should be advised that they may not make a full immune response to
the vaccine. Nationally recommended protective measures should still
be followed.
Inform the individual/carer of possible side effects and their
management.
The individual/carer should be advised to seek appropriate advice
from a healthcare professional in the event of an adverse reaction.
Advise the individual/carer that they can report side effects directly via
the national reporting system run by the MHRA known as the
Coronavirus Yellow Card reporting scheme on:
https://coronavirus-yellowcard.mhra.gov.uk/ . Or search for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting side
effects, they can help provide more information on the safety of
medicines.
All women of childbearing age should be provided the advice in the
leaflet 'COVID-19 vaccination: a guide for women of childbearing age,
pregnant, planning a pregnancy or breastfeeding’ and their
understanding checked as part of the consent process. They should
be advised that pregnancy should be avoided until 2 months after the
second dose of vaccine (see Additional Information below).
Vaccine recipients should be monitored for 15 mins after vaccination,
with a longer observation period when indicated after clinical
assessment.
When applicable, advise the individual/carer when to return for
vaccination or when a subsequent vaccine dose is due.
Special considerations /
additional information
Continued over page
Ensure there is immediate access to adrenaline (epinephrine) 1 in
1,000 injection and access to a telephone at the time of vaccination.
Minor illnesses without fever or systemic upset are not valid reasons
to postpone vaccination. If an individual is acutely unwell, vaccination
should be postponed 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 to the
adverse effects of the vaccine.
Women of child-bearing age, currently pregnant, planning a
pregnancy or breastfeeding
As with most pharmaceutical products, specific clinical trials in
pregnant women have not been carried out for this vaccine.
Because of the new formulation of this particular vaccine, the MHRA
wants to see more non-clinical data before finalising the advice in
pregnancy. It is standard practice when waiting for such data on any
medicine, to avoid its use in those who may become pregnant or who
are breastfeeding. Women should be advised that they should not
receive a COVID-19 vaccine if they are breastfeeding, pregnant, may
be pregnant or are planning a pregnancy. Vaccination should be
postponed until completion of pregnancy and, if relevant, until finished
breastfeeding.
All women of childbearing age should be provided the advice in the
leaflet 'COVID-19 vaccination: a guide for women of childbearing age,
pregnant, planning a pregnancy or breastfeeding’ and their
understanding checked as part of the consent process. They should
be advised that pregnancy should be avoided until 2 months after the
second dose of vaccine (see Additional Information below).
Special considerations /
additional information
(continued)
Pregnancy should be avoided until 2 months after the second dose of
vaccine.
This advice is precautionary until additional evidence is available to
support the use of this vaccine in pregnancy and breastfeeding.
JCVI have advised that routine questioning about last menstrual
period and/or pregnancy testing is not required before offering the
vaccine. Those being invited for vaccination should be able to access
the advice in the leaflet 'COVID-19 vaccination: a guide for women of
childbearing age, pregnant, planning a pregnancy or breastfeeding’
and their understanding checked as part of the consent process.
Additional measures may need to be considered for potential
recipients who are unable to access the information in written or
online form.
If a woman finds out she is pregnant after she has started a course of
vaccine, she should complete her pregnancy and breastfeeding, if
relevant, before finishing the recommended schedule. Termination of
pregnancy following inadvertent vaccination should not be
recommended. Surveillance of inadvertent administration in
pregnancy is being conducted by the PHE Immunisation Department,
to whom such cases should be reported (Tel: 020 8200 4400).
Previous incomplete vaccination
Other COVID-19 vaccines may become available after this PGD has
been written. There is no evidence on the interchangeability of the
COVID-19 vaccines although studies are underway. Therefore, every
effort should be made to determine which vaccine the individual
received and to complete the course with the same vaccine. For
individuals who started the schedule and who attend for vaccination at
a site where the same vaccine is not available, or if the first product
received is unknown, it is reasonable to offer one dose of the locally
available product to complete the schedule. This option is preferred if
the individual is likely to be at immediate high risk or is considered
unlikely to attend again. In these circumstances, as COVID-19
vaccines are based on the spike protein, it is likely the second dose
will help to boost the response to the first dose.
Records
Continued over page
Record:
• that valid informed consent was given;
• name of individual, address, date of birth and GP with whom the
individual is registered (or record where an individual is not
registered with a GP and that appropriate advice has been
given)
• name of immuniser
• name and brand of vaccine
• date of administration
• dose, form and route of administration of vaccine
• quantity administered
• batch number and expiry date
• anatomical site of vaccination
• advice given, including advice given if excluded or declines
vaccination
• details of any adverse drug reactions and actions taken
• supplied via PGD
Pregnancy should be avoided until 2 months after the second dose of
vaccine.
This advice is precautionary until additional evidence is available to
support the use of this vaccine in pregnancy and breastfeeding.
JCVI have advised that routine questioning about last menstrual
period and/or pregnancy testing is not required before offering the
vaccine. Those being invited for vaccination should be able to access
the advice in the leaflet 'COVID-19 vaccination: a guide for women of
childbearing age, pregnant, planning a pregnancy or breastfeeding’
and their understanding checked as part of the consent process.
Additional measures may need to be considered for potential
recipients who are unable to access the information in written or
online form.
• Priority groups for coronavirus (COVID-19) vaccination: advice
I confirm that I have read and understood the content of this PGD and that I am willing
and competent to work to it within my professional code of conduct.
Name
Designation
Signature
Date
I confirm that the registered healthcare professionals named above have declared
themselves suitably trained and competent to work under this PGD. I give
authorisation on behalf of insert name of organisation
for the above named healthcare professionals who have signed the PGD to work
under it.
Name
Designation
Signature
Date
Chronic respiratory
disease
Individuals with a severe lung condition, including those with asthma that
requires continuous or repeated use of systemic steroids or with previous
exacerbations requiring hospital admission, and chronic obstructive pulmonary
disease (COPD) including chronic bronchitis and emphysema; bronchiectasis,
cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary
dysplasia (BPD).
Chronic heart disease
and vascular disease
Congenital heart disease, hypertension with cardiac complications, chronic heart
failure, individuals requiring regular medication and/or follow-up for ischaemic
heart disease. This includes individuals with atrial fibrillation, peripheral vascular
disease or a history of venous thromboembolism.
Chronic kidney
disease
Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic
syndrome, kidney transplantation.
Chronic liver disease
Cirrhosis, biliary atresia, chronic hepatitis.
Chronic neurological
disease
Stroke, transient ischaemic attack (TIA). Conditions in which respiratory function
may be compromised due to neurological disease (e.g. polio syndrome
sufferers). This includes individuals with cerebral palsy, severe or profound
learning disabilities, Down’s Syndrome, multiple sclerosis, epilepsy, dementia,
Parkinson’s disease, motor neurone disease and related or similar conditions; or
hereditary and degenerative disease of the nervous system or muscles; or
severe neurological disability.
Diabetes
Any diabetes, including diet-controlled diabetes.
Immunosuppression
Immunosuppression due to disease or treatment, including patients undergoing
chemotherapy leading to immunosuppression, patients undergoing radical
radiotherapy, solid organ transplant recipients, bone marrow or stem cell
transplant recipients, HIV infection at all stages, multiple myeloma or genetic
disorders affecting the immune system (e.g. IRAK-4, NEMO, complement
disorder, SCID).
Individuals who are receiving immunosuppressive or immunomodulating
biological therapy including, but not limited to, anti-TNF, alemtuzumab,
ofatumumab, rituximab, patients receiving protein kinase inhibitors or PARP
inhibitors, and individuals treated with steroid sparing agents such as
cyclophosphamide and mycophenolate mofetil.
Individuals treated with or likely to be treated with systemic steroids for more
than a month at a dose equivalent to prednisolone at 20mg or more per day.
Anyone with a history of haematological malignancy, including leukaemia,
lymphoma, and myeloma and those with systemic lupus erythematosus and
rheumatoid arthritis, and psoriasis who may require long term
immunosuppressive treatments.
Some immunosuppressed patients may have a suboptimal immunological
response to the vaccine.
Asplenia or
dysfunction of the
spleen
This also includes conditions that may lead to splenic dysfunction, such as
homozygous sickle cell disease, thalassemia major and coeliac syndrome.
Morbid obesity
Adults with a Body Mass Index ≥40 kg/m².
Severe mental illness
Individuals with schizophrenia or bipolar disorder, or any mental illness that
causes severe functional impairment.
Adult carers
Those who are in receipt of a carer’s allowance, or those who are the main carer
of an elderly or disabled person whose welfare may be at risk if the carer falls ill.
Younger adults in
long-stay nursing and
Many younger adults in residential care settings will be eligible for vaccination
because they fall into one of the clinical risk groups above.
Full Response Text
1
Patient Group Direction for COVID-19 Vaccine AstraZeneca, (ChAdOx1-S
[recombinant])
Publications approval reference 001559
(“the PGD”)
Reference no:
COVID-19 Vaccine AstraZeneca PGD
Version no:
v01.00
Valid from:
06 January 2021
Status
This document is to be read in conjunction with the PGD and shall not be deemed or implied
to alter or amend the terms of the PGD in any way.
This document seeks to explain and confirm certain parts of the PGD in the context of the Isle
of Man and sets out guidance for practitioners intending to sign the PGD and working within
it in order to mitigate any risks of non-compliance which would invalidate the cover provided
for practitioners working to the PGD.
Background to the PGD
The PGD has been developed by Public Health England (“PHE”) for authorisation by NHS
England and NHS Improvement (together “NHS”) to facilitate the delivery of the United
Kingdom’s COVID-19 vaccination programme. PHE and the NHS have developed and obtained
organisational authorisation under the terms of the PGD to issue it.
The PGD has not been adapted for use in the Isle of Man, instead the Department of Health
and Social Care (“Department”) will follow the PGD for the purposes of the Island’s COVID-19
vaccination programme (“vaccination programme”) from the date of the issue of this letter
until any new or revised PGD comes into force.
The PGD is therefore endorsed by the Department for practitioners to adhere to in the
vaccination programme, subject to the matters set out in this letter. Using the PGD authorises
practitioners to administer the COVID-19 Vaccine AstraZeneca, (ChAdOx1-S [recombinant])
vaccine (“vaccine”).
2
Signing the PGD
All registered practitioners working under the PGD are required individually to sign section 7
of the PGD. An authorising manager must also sign as a counter-signatory.
Such signature provides the authority for the practitioner to administer the vaccination
programme subject to the terms of the PGD. Persons qualified to administer, and additional
requirements are set out in section 3 of the PGD which practitioners should ensure that they
are aware of, and can comply with, prior to signing the PGD. Only those authorised by name
can work according to the PGD.
Note that in accordance with the PGD, versions of it may be updated, and in that case the
Department will use all reasonable endeavours to notify all practitioners of any updates.
However practitioners must assure themselves that they are working on the current version.
Practitioners and authorising managers are responsible for compliance with the terms of the
PGD. Indemnity will be addressed under separate cover.
PGD conditions
There are conditions for administering the vaccine under the PGD. In summary, these are:
1. That current UK national recommendations should be followed – this means
recommendations by PHE or the NHS;
2. That additional requirements, which include all those set out in section 3 of the PGD
are satisfied; and
3. That the practitioner ensures the clinical conditions set out in section 4 of the PGD are
met.
In relation to the additional requirements, particularly those relating to training,
recommendations or other clinical conditions, contact can be made with any of the signatories
detailed below.
Isle of Man Legal Position
Section 5 of the PGD sets out the status of the marketing authorisation for the vaccine;
specifically that the vaccine has been granted a temporary authorisation by the Medicines &
Healthcare products Regulatory Agency (MHRA) for supply in the United Kingdom.
The Department confirms that equivalent legislation is in place in the Isle of Man, i.e. that
vaccines granted a temporary authorisation by the MHRA can be supplied in the Island. Our
equivalent legislation also provides immunity from civil liability provided that the practitioner
uses the product in accordance with any condition attached to the authorisation and in
accordance with any recommendation or requirement of the MHRA1. This requires all
practitioners working to the PGD to administer the vaccine in accordance with the
manufacturer’s instructions.
1 The Medicines for Human Use (Amendment) Regulations 2020 were approved by Tynwald on 18 November
2020 and came into operation on 20 November 2020. These Regulations inserted a new regulation 4A
(immunity from civil liability) into the Medicines for Human Use Regulations 2005.
COVID-19 Vaccine AstraZeneca PGD v01.00 Valid from: 06/01/2021 Expiry: 05/01/2022 Page 1 of 22
Publications approval reference: 001559
Patient Group Direction for COVID-19 Vaccine AstraZeneca,
(ChAdOx1-S [recombinant])
This Patient Group Direction (PGD) is for the administration of COVID-19 Vaccine
AstraZeneca (ChAdOx1-S [recombinant]) to individuals in accordance with the national
COVID-19 vaccination programme.
This PGD is for the administration of COVID-19 Vaccine AstraZeneca by registered
healthcare practitioners identified in Section 3.
Reference no:
COVID-19 Vaccine AstraZeneca PGD
Version no:
v01.00
Valid from:
06 January 2021
Review date:
06 July 2021
Expiry date:
05 January 2022
Public Health England (PHE) has developed this PGD for authorisation by NHS
England and NHS Improvement to facilitate the delivery of the national COVID-19
vaccination programme.
NHS England and NHS Improvement and those providing services in accordance with this
PGD must not alter, amend or add to the clinical content of this document (sections 3, 4, 5
and 6); such action will invalidate the clinical sign-off with which it is provided. Section 2 may
be amended only by the person(s) authorising the PGD, in accordance with Human
Medicines Regulations 2012 (HMR2012)1 Schedule 16 Part 2, on behalf of NHS England
and NHS Improvement. Section 7 is to be completed by registered practitioners providing the
service and their authorising/line manager.
Operation of this PGD is the responsibility of NHS England and NHS Improvement and
service providers. The final authorised copy of this PGD should be kept by NHS England and
NHS Improvement for 8 years after the PGD expires. Provider organisations adopting
authorised versions of this PGD should also retain copies for 8 years.
Individual registered practitioners must be authorised by name to work according to
the current version of this PGD by signing section 7. A manager with the relevant level
of authority should also provide a counter signature, unless there are contractual
arrangements for self-declaration.
Providers must check that they are using the current version of the PGD. Amendments may
become necessary prior to the published expiry date. Current versions of PHE developed
COVID-19 vaccine PGDs can be found via:
https://www.gov.uk/government/collections/covid-19-vaccination-programme
The most current national recommendations should be followed. This may mean that a
Patient Specific Direction (PSD) is required to administer the vaccine in line with updated
recommendations that are outside the criteria specified in this PGD.
Any concerns regarding the content of this PGD should be addressed to:
immunisation@phe.gov.uk
1 This includes any relevant amendments to legislation (such as 2013 No.235, 2015 No.178, 2015 No.323 and
2020 No.1125).
Change history
Version
Change details
Date
number
V01.00
New COVID-19 Vaccine AstraZeneca PGD
05 January 2021
COVID-19 Vaccine AstraZeneca PGD v01.00 Valid from: 06/01/2021 Expiry: 05/01/2022
Page 2 of 22
COVID-19 Vaccine AstraZeneca PGD v01.00 Valid from: 06/01/2021 Expiry: 05/01/2022 Page 4 of 22
Vanessa MacGregor
Consultant in Communicable Disease Control, Public Health England,
East Midlands Health Protection Team
Alison MacKenzie
Consultant in Public Health Medicine, Screening and Immunisation Lead,
Public Health England (South West) / NHS England and NHS
Improvement South (South West)
Gill Marsh
Senior Screening and Immunisation Manager, Public Health England /
NHS England and NHS Improvement (North West)
Lesley McFarlane
Screening and Immunisation Co-ordinator, Public Health England / NHS
England and NHS Improvement Midlands (Central Midlands)
Tushar Shah
Lead Pharmacy Advisor, NHS England and NHS Improvement (London
Region)
COVID-19 Vaccine AstraZeneca PGD v01.00 Valid from: 06/01/2021 Expiry: 05/01/2022 Page 6 of 22
3. Characteristics of staff
Qualifications and
professional registration
Practitioners must only work under this PGD where they are
competent to do so. Practitioners working to this PGD must also be
one of the following registered professionals who can legally supply
and administer under a PGD (see Patient Group Directions: who can
administer them):
•
nurses and midwives currently registered with the Nursing and
Midwifery Council (NMC)
•
pharmacists currently registered with the General Pharmaceutical
Council (GPhC)
•
chiropodists/podiatrists, dieticians, occupational therapists,
orthoptists, orthotists/prosthetists, paramedics, physiotherapists,
radiographers and speech and language therapists currently
registered with the Health and Care Professions Council (HCPC)
•
dental hygienists and dental therapists registered with the
General Dental Council
•
optometrists registered with the General Optical Council.
Practitioners must also fulfil all the Additional requirements.
Additional requirements
Continued over page
Additionally, practitioners:
•
must be authorised by name as an approved practitioner under
the current terms of this PGD before working to it
•
must have undertaken appropriate training for working under
PGDs for supply/administration of medicines
•
must be competent in the use of PGDs (see NICE Competency
framework for health professionals using PGDs)
•
must be familiar with the vaccine product and alert to changes in
the Summary of Product Characteristics (SPC), should it become
licensed, or the Regulation 174 Information for UK Healthcare
Professionals for the vaccine and familiar with the national
recommendations for the use of this vaccine
•
must be familiar with, and alert to changes in relevant chapters of
Immunisation Against Infectious Disease: the Green Book
•
must be familiar with, and alert to changes in the relevant NHS
standard operating procedures (SOPs) and commissioning
arrangements for the national COVID-19 vaccination programme
•
must have undertaken training appropriate to this PGD as
required by local policy and national NHS standard operating
procedures and in line with the Training recommendations for
COVID-19 vaccinators.
•
must have completed the national COVID-19 vaccination e-
learning programme, including the relevant vaccine specific
session, and/or locally-provided COVID-19 vaccine training
•
must be competent to assess individuals for suitability for
vaccination, identify any contraindications or precautions, obtain
informed consent (or ‘best interests’ decision in accordance with
the Mental Capacity Act 2005) and to discuss issues related to
vaccination
•
must be competent in the correct handling and storage of
vaccines, and management of the cold chain
•
must be competent in the handling of the vaccine product and
use of aseptic technique for drawing up the correct dose
•
must be competent in the intramuscular injection technique
COVID-19 Vaccine AstraZeneca PGD v01.00 Valid from: 06/01/2021 Expiry: 05/01/2022 Page 7 of 22
Additional requirements
(continued)
•
must be competent in the recognition and management of
anaphylaxis, have completed basic life support training and be
able to respond appropriately to immediate adverse reactions
•
must have access to the PGD and relevant COVID-19
vaccination programme online resources such as the Green Book
and PHE COVID-19 vaccination programme: Information for
healthcare practitioners
•
must have been signed off as competent using the COVID-19
vaccinator competency assessment tool if new to or returning to
immunisation after a prolonged period (more than 12 months) or
have used the tool for self-assessment if experienced vaccinator
(vaccinated within past 12 month)
•
should fulfil any additional requirements defined by local policy
The individual practitioner must be authorised by name, under
the current version of this PGD before working according to it.
Continued training
requirements
Practitioners must ensure they are up to date with relevant issues
and clinical skills relating to vaccination and management of
anaphylaxis.
Practitioners should be constantly alert to any subsequent
recommendations from Public Health England and/or NHS England
and NHS Improvement and other sources of medicines information.
COVID-19 Vaccine AstraZeneca PGD v01.00 Valid from: 06/01/2021 Expiry: 05/01/2022 Page 8 of 22
4. Clinical condition or situation to which this PGD applies
Clinical condition or
situation to which this
PGD applies
COVID-19 Vaccine AstraZeneca is indicated for the active immunisation
of individuals for the prevention of COVID-19 caused by coronavirus
(SARS-CoV-2) infection, in accordance with the national COVID-19
vaccination programme (see COVID-19 vaccination programme page)
and recommendations given in Chapter 14a of the Immunisation Against
Infectious Disease: the ‘Green Book’, and subsequent
correspondence/publications from PHE and/or NHS England and NHS
Improvement.
Criteria for inclusion
COVID-19 Vaccine AstraZeneca should be offered to individuals, aged
18 years and over, in accordance with Joint Committee on Vaccination
and Immunisation (JCVI) guidance on ‘Priority groups for coronavirus
(COVID-19) vaccination’ in the following order of priority, starting with
those to be vaccinated first:
Priority
Risk group
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 (see Chapter 14a)
3
All those 75 years of age and over
4
All those 70 years of age and over
Clinically extremely vulnerable2 individuals (see Definition of
clinically extremely vulnerable groups)
5
All those 65 years of age and over
6
All individuals aged 16 years3 to 64 years with underlying
health conditions which put them at higher risk of serious
disease and mortality (see Appendix A or Chapter 14a)4
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
Only individuals aged 18 years and over and included in one or more of
the priority groups tabled above may be vaccinated in accordance with
this PGD.
Implementation of the COVID-19 vaccination programme should aim to
achieve high vaccine uptake whilst prioritising those most at risk.
Implementation should also involve flexibility in vaccine deployment at a
local level. Operational considerations, such as minimising wastage, may
require a flexible approach to prioritisation, where decisions are taken i
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