Administration of COVID 19 mRNA Vaccine BNT162b2 by a ...

COVID-19 mRNA Vaccine BNT162b2 by a Healthcare Professional in the form of a Patient Specific Direction; Administration of

Reference Number: NCADP010(20) Version: 1.3 Issue Date: 11/01/2021 Page 1 of 22 It is your responsibility to check on the intranet that this printed copy is the latest version

Administration of COVID-19 mRNA Vaccine BNT162b2 by a Healthcare Professional in the form of

a Patient Specific Direction

Lead Author: Sarah Boulger, Senior Medicines Information Pharmacist PAT

Additional author(s) Lindsay Harper, Director of Pharmacy NCA

Division/ Department: Diagnostics and Pharmacy

Applies to: (Please delete) Salford Royal Care Organisation,

Royal Oldham Care Organisation,

Bury Care Organisation

Rochdale Care Organisation

Approving Committee: NCA Covid Clinical Advisory Group

Date approved V1: 07/12/2020

Date approved V1.1 11/12/2020



Review date: 07/12/2021

Contents

Contents

Section Page

Document summary sheet

1 Overview 3

2 Scope & Associated Documents 3

3 Background 3

4 What is new in this version? 3

5 Policy 4

5.1 Characteristics of Staff 4

5.2 Authority to Proceed 6

5.3 Patient Information and Consent 9

5.4 Treatment, route, administration and legal status 9

5.5 Actions in the event of an adverse reaction 11

5.6 Record of administration 12

5.7 Patient advice and follow up treatment 12

6 Roles and responsibilities 14

7 Monitoring document effectiveness 15

Group arrangements:

Salford Royal NHS Foundation Trust (SRFT)

Pennine Acute Hospitals NHS Trust (PAT)



8 Abbreviations and definitions 15

9 References 15

10 Document Control Information 17

11 Equality Impact Assessment (EqIA) tool 18

12 Appendices

Appendix 1: Patient assessment and consent form 21

Appendix 2: Patient Specific Direction 22



1. Overview (What is this policy about?) This policy describes how qualified healthcare professionals administer the COVID-19 mRNA Vaccine BNT162b2 to patients within the Northern Care Alliance (NCA), in the form of a Patient Specific Direction (PSD).

If you have any concerns about the content of this document please contact the author or advise the Document Control Administrator.

2. Scope (Where will this document be used?)

The following staff groups must read this policy:

Registered healthcare professionals employed by the NCA that have undertaken relevant training and competency assessments to administer the COVID-19 mRNA Vaccine BNT162b2 to adults aged 16 years and over.

Prescribers employed by the NCA who are competent to prescribe the COVID-19 mRNA Vaccine BNT162b2 to adults aged 16 years and over and will write the PSD.

Associated Documents

A full list of SOPs and QRGs for the storage, preparation and administration of COVID-19 mRNA Vaccine BNT162b2 will be available on the intranet and in all vaccination sites

SRFT

163TD(C)(33)SRFT Medicines Policy

TC23(05)SRFT Non-Medical Prescribing (NMP) Policy

MM13(05)SRFT Anaphylaxis Protocol for Adults and Children

RM3(09)SRFT Mental Capacity Act Policy PAT

EDC018 Medicines Policy

EDQ029 Mental Capacity Act (2005) Policy and Procedures

EDC033 Non-Medical Prescribing Policy

3. Background (Why is this document important?) The advice and guidance contained within this policy is based upon the latest research-based evidence in Public Health England Immunisation against Infectious Disease (Green Book) and JCVI recommendations for the purpose of protection against COVID-19. https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

4. What is new in this version?

Amendments made to V1.1 from V1:

Group arrangements:

Salford Royal NHS Foundation Trust (SRFT)

Pennine Acute Hospitals NHS Trust (PAT)

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book



Amendment to the exclusion criteria and consent form questions, to states that ‘staff with

a history of immediate-onset anaphylaxis to a vaccine, medicine or food that required

Emergency Admission and treatment with adrenaline should not receive the Pfizer

BioNtech vaccine’, in line with MHRA guidance issued on the evening of 9/12/20 and on

the advice of the Immunology team at Salford.

Update of wording, throughout on managing anaphylaxis, to match advice issued on the

evening of 9/12/20 by the MHRA

Updated information throughout on post-vaccination observation, to match advice issued

on the evening of 9/12/20 by the MHRA

Amendments made to V1.2 from V1.1:

Update to section 5.1 to widen the list of healthcare professionals authorised to administer the Covid-19 vaccine under this PSD, following appropriate training and competency assessment.

Update to the additional training requirements to include the Immunisation ELfH modules and provide external links to the e-learning packages.

Amendments made to V1.3 from V1.2:

Use extended to other Care Organisations across the NCA

Updated information on vaccination in pregnancy and removal of breastfeeding as an exclusion criteria, in-line with new advice from MHRA 31/12/20

Additional training requirements for prescribers in section 5.1

New section on ‘cautions’ in section 5.2 to incorporate additional information relating to allergies and pregnancy/breastfeeding.

Allergies information updated in line with recommendations in the Green Book

Timing of second dose increased to 4-12 weeks as per national guidance

5. Policy A PSD is a written instruction by an independent prescriber for a medicine to be supplied or administered for a named patient. The PSD may take the form of a list of patients (several named patients) who require vaccination. The COVID-19 mRNA Vaccine BNT162b2 whilst authorised is still not fully licensed. Therefore, the types of prescribers that can issue a patient specific direction for the vaccine are medical doctors and independent nurse or pharmacist prescribers only. PSDs do not limit those who can supply or administer the medicine. For example, a suitably trained health care assistant can do so, even though they cannot work under a PGD. Healthcare professionals undertaking the administration of COVID-19 mRNA Vaccine BNT162b2 via a PSD will receive training as developed by the Care Organisation’s Vaccination and Immunisation Training Lead, and using the national PHE training documents.

5.1 Characteristics of staff

Healthcare professional administering the vaccine(s)



Qualifications required Registered nurse registered with the NMC Physiotherapists registered with the HCPC Podiatrists registered with the HCPC Occupational Therapists registered with the HCPC ODPs registered with the HCPC Paramedics registered with the HCPC Radiographers registered with the HCPC Pharmacists registered with the GPhC

Additional requirements Completion of specific training relating to the Covid-19 vaccine, in order to deliver COVID-19 mRNA Vaccine BNT162b2 immunisation under this PSD. Training must be tailored to the skills and competencies required for the safe and effective delivery of COVID-19 mRNA Vaccine BNT162b2 immunisation, including peer to peer immunisation. Therefore, all vaccinators must:

Read and understand The Green Book, Chapter 14a – Covid-19 – SARS-Cov-2

Read and understand PHEs Covid-19 vaccination guidance for healthcare practitioners

Read and understand PHEs Covid-19 vaccination training slide set

Complete the E-LfH COVID-19 Vaccination e-learning programme and assessment

Complete the E-LfH Immunisation e-learning programmes and assessments – Legal Aspects, Vaccine Storage, Vaccine administration

All vaccinators must be competent in the storage, handling, reconstitution and disposal of COVID-19 mRNA Vaccine BNT162b2 as well as management of the cold chain and must have read all associated Trust guidance and procedures relating to COVID-19 mRNA Vaccine BNT162b2.

Continued Training Requirements

Ensure that all mandatory training, including Basic Life Support, treatment of anaphylaxis, Infection Control and Medicines Management is up to date. Any CPD required is fulfilled and update training attended

https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a


https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941236/COVID-19_vaccination_programme_guidance_for_healthcare_workers_December_2020_V2.pdf


https://portal.e-lfh.org.uk/Component/Details/514308





Independent Prescribers

Qualifications required Medical Doctor registered with the GMC. Nurse or pharmacist with non-medical independent prescribing (NMP) qualification and registered with the NMC / GPhC respectively. All prescribers should:

Read and understand The Green Book, Chapter 14a –

Covid-19 – SARS-Cov-2

Read and understand PHEs Covid-19 vaccination guidance for healthcare practitioners

Read and understand PHEs Covid-19 vaccination training slide set

Complete the E-LfH COVID-19 Vaccination e-learning programme and assessment

Complete the E-LfH Immunisation e-learning programmes and assessments – Legal Aspects, Vaccine Storage, Vaccine administration

Additional requirements Employed by the NCA, and (where applicable) listed on the Care Organisation’s NMP register and up to date with all requirements as laid out in the Care Organisation’s NMP policy. Ensure that all mandatory training, including Basic Life Support, Treatment of Anaphylaxis and Infection Control is up to date. All prescribers are required to work within their own area of competence, and only those who are familiar with immunisations may be deemed competent. In order to be able to issue a patient specific direction the prescriber must have sufficient information on the vaccine to enable them to confidently write the instruction and prescribe the vaccine for each patient. There are additional competencies and assessments for staff who will be reconstituting and/or administering the vaccine.

5.2 Authority to proceed

Recommended inclusion and exclusion criteria and additional prescribing information for COVID-19 mRNA Vaccine BNT162b2 can be found in Chapter 14a of the Immunisation Against Infectious Disease: ‘The Green Book’, and subsequent correspondence/publications from PHE and/or NHS England.

Patient eligibility The Individual Patient Assessment Form in appendix 1 will need to be completed by the prescriber to confirm patient eligibility

Criteria for exclusion Individuals who:

Have not provided valid consent (see appendix 1)

Are under 16 years of age












Have had a previous systemic allergic reaction (including immediate onset anaphylaxis) to a previous dose of COVID-19 mRNA vaccine BNT162b2 or to any component of the vaccine or residues from the manufacturing process (e.g. polyethylene glycol – PEG; refer to Regulation 174 Information for UK Healthcare Professionals for a full list of excipients)

Have a history of immediate-onset anaphylaxis to multiple classes of drugs or unexplained anaphylaxis that required Emergency Admission and treatment with adrenaline

Are suffering from acute severe febrile illness (the presence of a minor infection is not a contraindication for immunisation)

Pregnancy, unless at very high risk of catching the infection or those with clinical conditions that put them at high risk of suffering serious complications from COVID-19 (see cautions).

Have a bleeding disorder, unless 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.

Cautions Allergy A very small number of individuals have experienced anaphylaxis when vaccinated with the COVID-19 mRNA vaccine BNT162b2. Following close surveillance of the initial roll-out, the MHRA has advised that individuals with a history of anaphylaxis to food, an identified drug or vaccine, or an insect sting can receive any COVID-19 vaccine, as long as they are not known to be allergic to any component (excipient) of the vaccine. All recipients of the COVID-19 mRNA vaccine BNT162b2 should be kept for observation and monitored for a minimum of 15 minutes. The British Society for Allergy and Clinical Immunology (BSACI) has advised that:

individuals with a localised urticarial (itchy) skin reaction

(without systemic symptoms) to the first dose of a COVID-

19 vaccine should receive the second dose of vaccine with

prolonged observation (30 minutes) in a setting with full

resuscitation facilities (such as a hospital)

individuals with non-allergic reactions (vasovagal

episodes, non-urticarial skin reaction or non-specific

symptoms) to the first dose of a COVID-19 vaccine can

receive the second dose of vaccine in any vaccination

setting

Pregnancy and Breastfeeding There is no known risk associated with giving non-live vaccines during pregnancy or whilst breast-feeding. Since non-live



vaccines cannot replicate, they cannot cause infection in either the mother or the fetus. Developmental and reproductivity testing of the Pfizer BioNTech and AstraZeneca COVID-19 vaccines in animals have not raised any concerns. Although the available data do not indicate any harm, women who are pregnant should not routinely be offered COVID-19 mRNA vaccine BNT162b2 during pregnancy and should postpone vaccination until completion of pregnancy. JCVI has advised that vaccination in pregnancy should be considered, where the risk of exposure to SARS-CoV2 infection is high and cannot be avoided, or where the woman has underlying conditions that put them at very high risk of serious complications of COVID-19. If a woman finds out she is pregnant after she has started a course of vaccine, routine advice is to complete her pregnancy before finishing the recommended schedule. Women should be offered vaccine as soon as possible after pregnancy. JCVI advises that breastfeeding women may be offered vaccination with the Pfizer BioNTech COVID-19 mRNA vaccine BNT162b2. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for immunisation against COVID-19, and the woman should be informed about the absence of safety data for the vaccine in breastfeeding women. Anticoagulation 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 Covid-19 vaccination. If in any doubt, consult with the clinician responsible for prescribing or monitoring the individual’s anticoagulant therapy.

Patient Specific Directive (PSD)

A valid PSD must be obtained. A PSD is a written instruction from an independent prescriber (doctor or independent nurse/pharmacist prescriber) to another healthcare professional, to supply and/or administer a medicine directly to a named patient, or to several named patients. This must be obtained prior to administration of the COVID-19 mRNA Vaccine BNT162b2. The PSD must state the patients name and NHS number, the date of administration, the name and signature of the Prescriber, the name, form and strength of vaccine (generic or brand name where appropriate), route of administration, frequency and dose.



The PSD will take the form of a proforma (see Appendix 2) placed in the patient’s medical record and signed by the Prescriber.

5.3 Patient information and consent forms

Patient Information Leaflet A Patient Information Leaflet and a Record of Administration card will be provided to the patient at point of administration.

Patient Consent Form Consent must be obtained prior to vaccination (see appendix 1). Consent forms must be signed and placed in the patient’s medical notes. The interpretation services must be used where necessary. Where a patient with capacity refuses to consent, counsel with regards to the risks of COVID infection and the protective effect of the vaccine. Document advice given. The healthcare professional must inform the Independent Prescriber and in turn the patient’s GP must be informed. Where a patient does not have capacity and is unable to consent to having their COVID vaccine administered, refer to the Trust Mental Capacity Act Policy. Where necessary, for patients with learning difficulties, any written or verbal information may need to be adapted in order to provide support.

5.4 Treatment, route, administration and legal status

Vaccine Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection. Each multidose vial contains 5 doses of 30micrograms of BNT162b2 RNA embedded in lipid nanoparticles. The vaccine does not contain a preservative.

Indication Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older in accordance with the recommendations given in Chapter 14a of the Immunisation Against Infectious Disease: ‘The Green Book’, JVCVI recommendations for the purpose of protection against COVID-19 and subsequent correspondence/publications from PHE and/or NHS England.

Legal Status Prescription Only Medicine (POM)

Route and method of administration

COVID-19 mRNA Vaccine BNT162b2 is to be administered by intramuscular injection into the deltoid region of the upper arm.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940566/Information_for_UK_recipients_on_Pfizer_BioNTech_COVID-19_vaccine.pdf



A 1ml syringe with a 23g x 25mm needle will be provided for administration. The site at which each vaccine was given should be noted in the patient’s records. The vaccine requires dilution prior to administration, and should be prepared and administered in line with the recommendations contained in the product information and QRG for Preparation of Pfizer-BioNTech COVID-19 Vaccine syringes for Administration.

Dose and frequency of administration

30micrograms contained in 0.3ml of the diluted vaccine. The vaccine should be administered in 2 doses, between 4 and 12 weeks apart.

Storage The COVID-19 mRNA Vaccine BNT162b2 should be stored at -70°C +/- 10°C and has shelf life of 6months. Store in the original package in order to protect from light. After thawing, the vaccine should be diluted and used immediately. However, in-use stability data have demonstrated that once thawed, the undiluted vaccine can be stored for up to 5 days at 2°C to 8°C, or up to 2 hours at temperatures up to 25°C, prior to use. After dilution, store the vaccine at 2°C to 25°C and use immediately and within 6 hours. Once diluted, the vials should be marked with the new discard date and time. Once thawed, the vaccine cannot be re-frozen.

Disposal Equipment used for immunisation, including used vials, ampoules, or discharged vaccines in a syringe or applicator, should be disposed of safely in a UN-approved puncture-resistant ‘sharps’ box according to NCA policy

Identification & management of adverse reactions

Anaphylaxis is a very rare, recognised side effect of most vaccines

A protocol for the management of anaphylaxis and an anaphylaxis pack containing adrenaline 1:1000 must always be available whenever the Pfizer BioNtech vaccine is given. Ensure there is access to a telephone

The health professionals overseeing the immunisation service must be trained to recognise an anaphylactic reaction and be familiar with techniques for resuscitation of a patient with anaphylaxis

Vaccine recipients should be monitored for 15 mins after vaccination, with a longer observation period when indicated after clinical assessment

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941452/Information_for_healthcare_professionals.pdf



Pain at the injection site is fairly common with the COVID-19 mRNA Vaccine BNT162b2, sometimes with redness or swelling. The most common systemic effects reported in trials were fatigue, headache, myalgia, chills, arthralgia and pyrexia, which were usually mild and resolved within a few days after vaccination. If required, symptomatic treatment with analgesic and/or anti-pyretic medicinal products (e.g. paracetamol-containing products) may be used.

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.

Other considerations Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation may be postponed until they have fully recovered to avoid confusing symptoms of acute illness with adverse effects of the vaccine.

5.5 Actions in the event of an adverse reaction

A protocol for the management of anaphylaxis and an anaphylaxis pack containing adrenaline 1:1000 must always be available whenever the Pfizer BioNtech vaccine is given. Ensure there is access to a telephone

If general adverse reaction occurs

As these vaccines are labelled with a black triangle, all adverse reactions occurring after vaccination should be reported to the MHRA via the Coronavirus Yellow Card Scheme (www.coronavirus-yellowcard.mhra.gov.uk). Anyone can report a suspected adverse reaction to the Medical and Healthcare products Regulatory Agency (MHRA) using this scheme, including patients. In addition:

Record in patient’s notes, including updating any the allergies/intolerances sections of the notes/drug charts

Inform patient’s GP as soon as possible

Complete DATIX incident form

http://www.coronavirus-yellowcard.mhra.gov.uk/



If anaphylactic reaction occurs

Immediate treatment should include early treatment with 0.5mg intramuscular adrenaline (0.5ml of 1:1000 or 1mg/ml adrenaline), with an early call for help and further IM adrenaline every 5 minutes, according to policy on anaphylaxis and BLS training.

Record in patient’s notes, including updating any the allergies/intolerances sections of the notes/drug charts

Inform patient’s GP as soon as possible

Complete DATIX incident form

Suspected cases should be reported via the Coronavirus Yellow Card Scheme (www.coronavirus-yellowcard.mhra.gov.uk)

5.6 Record of administration

PSD proforma All COVID vaccines administered to a patient will be documented on the proforma (Appendix 2). This will be filed in the patient’s medical records

Patient’s Medical Records The following information should be recorded

Name and brand of vaccine

Dose, route and site of administration

Date of administration

Legible batch number/s and expiry date (from vaccine packaging)

Printed name and legible signature of person administrating drug and designation

Contraindications checked

Action taken if patient refuses vaccine

Reactions to vaccination and action taken (see section 5.4)

As there is likely to be different COVID-19 vaccines available on the UK market, it is especially important that the exact brand of vaccine, batch number and site at which each vaccine is given is accurately recorded in the individual’s records.





5.7 Patient advice and follow up treatment

Patient advice / follow up treatment

Patients should be given:

Patient Information Leaflet

Vaccination record card

‘What to Expect After Your Covid-19 Vaccination’ leaflet Individuals should be advised regarding adverse reactions to vaccination and reassured that this COVID-19 mRNA Vaccine BNT162b2 cannot cause COVID-19. As with all vaccines, immunisation may not result in protection in all individuals, and COVID-19 vaccination does not protect against other respiratory viruses that may be in circulation. Immunosuppressed individuals should be advised that they may not make a full immune response to the vaccine. Inform the individual that they should continue to follow current advice regarding social distancing, wearing a face mask and washing their hands thoroughly and frequently. The individual/parent/carer should be advised to seek medical advice in the event of an adverse reaction. When applicable, advise the individual/parent/carer when a subsequent vaccine dose is due.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940566/Information_for_UK_recipients_on_Pfizer_BioNTech_COVID-19_vaccine.pdf

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941469/PHE_11843_Covid-19_what_to_expect_leaflet.pdf



Patient’s Medical Records Record:

that valid informed consent was given;

name of individual, address, date of birth and GP with whom the individual is registered

name of immuniser

name and brand of vaccine

date of administration

dose, route and site of administration of vaccine

batch number and expiry date

when next dose is due

advice given, including advice given if excluded or declines immunisation

details of any adverse drug reactions and actions taken

Supplied via PSD All records should be clear, legible and contemporaneous. As there is likely to be different COVID-19 vaccines available on the UK market, it is especially important that the exact brand of vaccine, batch number and site at which each vaccine is given is accurately recorded in the individual’s records. A record of vaccination should be returned to the individual’s general practice to allow clinical follow up and to avoid duplicate vaccination. A record of all individuals receiving treatment under a PSD should also be kept for audit purposes in accordance with local policy.

6. Roles & responsibilities

6.1 Prescribers employed by the NCA Prescribers writing the PSD for COVID-19 mRNA Vaccine BNT162b2 must read and follow this policy as well as any other relevant advice and prescribing information related to the vaccine. Prescribers must ensure that the healthcare professional administering the COVID-19 vaccine under the PSD has received adequate training and successfully completed any competency assessments prior to delegating the task of administration. 6.2 Registered Healthcare Professionals Registered healthcare professionals involved in the administration of the COVID-19 vaccination are to read and follow this policy. Healthcare professionals involved in the administration of the COVID-19 vaccination must complete the appropriate training and competency assessment prior to administration.



6.3 Nursing Leads Nursing leads should ensure that all nursing staff involved in the administration of the COVID-19 vaccination have completed the appropriate training and competency assessment, and read and follow this policy.

Any near misses, accidents and/or incidents are reported via Datix as per the Trust’s Incident Reporting and Investigation Policy.

6.4 Pharmacy Staff All pharmacy staff involved in the provision of the COVID-19 vaccination are aware of this guideline and follow appropriate procedures

All information within this guidance is current and evidence-based

Any near misses, accidents and/or incidents are reported via Datix as per the Trust’s Incident Reporting and Investigation Policy.

7. Monitoring document effectiveness

The Trust Director of Pharmacy will monitor the safe administration of COVID-19 vaccine by reviewing incidents reported through the Trust’s Adverse Incident Reporting system (Datix). Where a lack of compliance is found, the identified group, committee or individual will identify required actions, allocate responsible leads, target completion dates and ensure an assurance report is represented showing how any gaps have been addressed. Assurance reports will be fed through the appropriate governance channels such as Medicines Safety and Medicines Management Group as appropriate.

8. Abbreviations and definitions

NCA Northern Care Alliance NMP Non-Medical Prescriber mRNA Messenger ribonucleic acid JCVI Joint Committee on Vaccination and Immunisation

9. References

References: Immunisation Against Infections Disease (The Green Book) Chapter 14a COVID-19 - SARS-CoV-2. Public Health England (https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a) Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 Vaccine (https://coronavirus-yellowcard.mhra.gov.uk/productinformation) Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine (https://coronavirus-yellowcard.mhra.gov.uk/productinformation) Public Health England COVID-19 vaccination programme. Information for healthcare practitioners December 2020 (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/



https://coronavirus-yellowcard.mhra.gov.uk/productinformation






file/941236/COVID-19_vaccination_programme_guidance_for_healthcare_workers_December_2020_V2.pdf) MHRA press release - Confirmation of guidance to vaccination centres on managing allergic reactions following COVID-19 vaccination with the Pfizer BioNTech vaccine. Accessed 10/12/20



https://www.gov.uk/government/news/confirmation-of-guidance-to-vaccination-centres-on-managing-allergic-reactions-following-covid-19-vaccination-with-the-pfizer-biontech-vaccine



10. Document Control Information

Part 1 Must be fully completed by the Author prior to submission for approval

Name of lead author: Sarah Boulger

Job Title: Senior Medicines Information Pharmacist

Contact number: 0161 720 2152

Email address: [email protected]

Consultation: List persons/groups included in consultation. N.B Include Pharmacy/PADAT/D&T/MMG for

documents containing drugs.

Indicate whether feedback used (FU), not used (FNU) or not-received (NR)

Name of person or group Role / Department / Service / Committee /

Corporate Service

Date Response:

FU / FNU / NR

Lindsay Harper Director of Pharmacy, NCA Dec 2020

EqIA sign off: See Appendix 11

Name: (Insert named lead from EDI Team) Date:

Tara Hewitt 09/12/2020

Communication plan:

The document will be circulated to all staff involved in the vaccination programme. The document will be placed on

the Document Control system for SRFT.

Part 2 Must be fully completed by the Author following committee approval.

Failure to complete fully will potentially delay publication of the document.

Submit to Document Control/Policy Support for publication.

Approval date: Method of document approval:

Formal Committee decision

07/12/2020 – V1

11/12/2020 – V1.1

18/12/2020 – v1.2

08/01/21 – V1.3

Chairperson’s approval

Name of Approving

Committee

NCA Covid Clinical Advisory Group

Chairperson Name/Role Simon Featherstone, NCA Director of Nursing

Amendments approval: Name of approver, version number and date. Do not amend above details.

Part 3 Must be fully completed by the Author prior to publication

Keywords & phrases: Covid-19 vaccination coronavirus vaccine

Document review

arrangements

Review will occur by the author, or a nominated person, within one year or earlier

should a change in legislation, best practice or other change in circumstance

dictate.



11. Equality Impact Assessment (EqIA) tool

1. Possible Negative Impacts

Protected Characteristic Possible Impact Action/Mitigation

Age Patients under the age of 16 not eligible for the vaccine

Policy refers to national guidance and legislation around eligibility criteria and vaccine authorisation

Disability Patients with learning disabilities may not have capacity to consent to have the vaccine The Patient Information Leaflets may not be suitable for patients with learning difficulties or cognitive impairment Patients may have a physical disability that affects where the vaccine may be administered

Policy refers to need for assessment in line with MCA 2005 and Trust policy Provide links in policy (where available) to available resources in an easy read format, aimed at patients with learning difficulties Information in policy referring to training that should include other possible injection sites if the patient has any physical disability e.g. amputation

Ethnicity Potential language barrier Use of interpretation services referenced within relevant sections of the policy

Gender None

Marriage/Civil Partnership None

Pregnancy/Maternity Persons who are pregnant are excluded from receiving the vaccination unless at very high risk of catching the infection or those with clinical conditions that put them at high risk of suffering serious complications from COVID-19.

Vaccination is delayed in this cohort until safe to administer. Await national guidance on how to capture eligible people who had their vaccination delayed due to pregnancy/breastfeeding.

Religion & Belief None

Sexual Orientation None

Trans None

Other Under Served Communities (Including Carers, Low Income, Veterans)

None

2. Possible Opportunity for Positive Impacts

Protected Characteristic Possible Impact Action/Mitigation

Age None

Disability None

Ethnicity None

Gender None



3. Combined Action Plan

Action (List all actions & mitigation below)

Due Date Lead

(Name & Job Role)

From Negative or Positive Impact?

Policy refers to need for capacity assessment and best interest meetings in line with MCA 2005 and Trust policy

Actioned NCA Covid CAG recommendation

Negative

Use of interpretation services referenced within relevant sections of the protocol

Actioned Author Negative

Provide links in policy (where available) to available resources in an easy read format, aimed at patients with learning difficulties

Jan 2021 Author to update when Public Health England resources become available

Negative

Vaccination is delayed in pregnancy (unless at very high risk of catching the infection or those with clinical conditions that put them at high risk of suffering serious complications from COVID-19) until safe to administer. Await national guidance on how to capture eligible people who had their vaccination delayed due to pregnancy/breastfeeding.

Jun 2021 Author to update as per national recommendations

Negative

Ensure the pregnancy element is adequately communicated to Trans men. Investigate resources used at other Acute Hospitals

Jun2021 Author with support from Equality and Inclusion team

Negative

Information in policy referring to training that should include other possible injection sites if the patient has any physical disability e.g. amputation

Actioned

Author Positive

Policy refers to national guidance and legislation around eligibility criteria and vaccine authorisation

Actioned Author Negative

Marriage/Civil Partnership None

Pregnancy/Maternity None

Religion & Belief None

Sexual Orientation None

Trans None


None

4. Information Consulted and Evidence Base (Including any consultation)

Protected Characteristic Name of Source

Summary of Areas Covered

Web link/contact info

Age Product literature and Public Health England (PHE)

Product literature PHE

Disability

Ethnicity

Gender

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940565/Information_for_Healthcare_Professionals_on_Pfizer_BioNTech_COVID-19_vaccine.pdf

https://www.gov.uk/government/collections/covid-19-vaccination-programme



5. EqIA Update Log (Detail any changes made to EqIA as policy has developed and any additional impacts included)

Date of Update Author of Update Change Made

Marriage/Civil Partnership

Pregnancy/Maternity Product literature and Public Health England (PHE)

Product literature PHE

Religion & Belief

Sexual Orientation

Trans


6. Have all of the negative impacts you have considered been fully mitigated or resolved? Impacts have been mitigated as per sections 1 and 2

7. Please explain how you have considered the duties under the accessible information standard if your document relates to patients? Carers would be involved in all communication and written information leaflets are available on the internet (links provided within body of document)

8. Equality Impact Assessment completed and signed off? (Insert named lead from EDI Team below). Please also add this information within Section 11. Name: Tara Hewitt Date: 09/12/2020 Nil changes to EqIA assessment in following amendments made in V1.1 Nil changes to EqIA assessment in following amendments made in V1.2

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940565/Information_for_Healthcare_Professionals_on_Pfizer_BioNTech_COVID-19_vaccine.pdf

https://www.gov.uk/government/collections/covid-19-vaccination-programme



12. Appendices

Appendix 1 Individual Patient Assessment and Consent Form to assist the creation of Patient Specific Direction for the administration of Pfizer BioNTech COVID-19 mRNA Vaccine BNT 162b2

Name of patient:

Ethnicity: Gender: Male Female Prefer not to say

Date of birth: NHS number:

Address:

Assessor’s Name: Role:

Are you currently unwell with fever? No Yes

Have you had an allergic reaction to a previous dose of COVID-19 mRNA vaccine BNT162b2 or to any component of the vaccine - e.g. polyethylene glycol (PEG)?

No Yes

Do you have a history of immediate-onset anaphylaxis to a vaccine or medicine that required Emergency Admission and/or treatment with adrenaline?

No Yes

Are you pregnant or planning to be pregnant in the next 3 months?

No Yes

Are you breast-feeding? No Yes

Do you have a bleeding disorder? No Yes

Are you currently taking an anticoagulant? E.g. warfarin, apixaban, dabigatran, rivaroxaban or a low molecular weight heparin injection?

No Yes

If any of the YES boxes in red are ticked, then a further review by the prescriber must take place

To be completed by the person presenting for vaccination:

Please confirm that you have received and read the COVID-19 vaccination leaflet and understand the benefits and risks of the vaccination being offered

Yes No

Do you consent for the full course of COVID-19 vaccination? Yes No

Signature …………………………………………………………………….. Date ………/………/……… Time ………………………



Appendix 2 Patient Specific Direction (PSD) for the administration of Pfizer BioNTech Coronavirus Vaccine BNT 162b2 to Adults by healthcare professionals suitably trained in Vaccination

To be completed by the Independent Prescriber:

Name of patient:

Ethnicity: Gender: Male Female Prefer not to say

Date of birth: NHS number:

Address:

I authorise for the above named patient to receive the following vaccination:

Name of vaccination:

Pfizer BioNTech COVID-19 mRNA Vaccine BNT 162b2

First dose: Second dose:

Strength of vaccination:

30micrograms

Dose:

0.3ml (30 micrograms) Route of administration:

Intramuscular (IM) Injection

Frequency: Single dose to be repeated once, between 4 and12 weeks later

I confirm that this can be administrated by a healthcare professional who is suitably trained and qualified to do so and is employed by the Northern Care Alliance Signature:

Name of Independent Prescriber:

Date: Expiry date of PSD: (7 days after PSD is signed)

To be completed by the vaccine administrator: Date administered:

Time of administration:

Vaccine Batch Number:

Vaccine expiry date:

Site of administration:

Right upper arm Left upper arm

Signature of vaccine administrator:

Name of vaccine administrator: