Coronavirus (COVID-19) vaccine - Comirnaty® (mRNA Vaccine, Pfizer/BioNTech): national protocol

Annex A: Clinical Information

This Annex provides information about the clinical situation or condition and treatment in relation to the National Protocol.

Annex Version History

Version: 1.0 - 24 August 2021

Version 1.0 new Annex A

Version: 1.1 - 18 September 2021

The following sections have been updated:

• Indication section updated to include JCVI advice on third primary dose vaccination from 1st September 2021.
• Indication section updated to include JCVI statement on COVID-19 vaccination of children aged 12 to 15 years from 3rd September 2021.
• Indication section updated to include JCVI statement on COVID-19 booster vaccination from 14^th September 2021
• Inclusion section updated to include those aged from 12 years identified as meeting the definition for severe immunosuppression at the time of vaccination, in line with specialist advice, for a third primary dose in accordance with recommendations in the JCVI advice on third dose primary vaccine.
• Inclusion section updated to include those aged 12 – 15 years in line with Scottish Government policy.
• Inclusion section updated to include those as meeting the definition for a COVID-19 booster dose in line with JCVI advice.
• Inclusion section updated to include information about use of vaccine in different age groups in pregnancy.
• Frequency section updated with advice on third dose primary vaccine for those identified as meeting the definition for severe immunosuppression at the time of vaccination, in line with specialist advice, and recommendations in the JCVI advice.
• Frequency section updated to align with Scottish Government policy on vaccination of those aged 12 – 15 years.
• Frequency section updated to align with JCVI advice on COVID-19 booster vaccination
• Use outwith SPC section updated to highlight the marketing authorisation holder's summary of product characteristics states that the vaccine should be given as a series of two doses (0.3mL, each) 21 days apart. This is superseded by JCVI advice for third primary dose vaccination in those with severe immunosuppression at the time of vaccination and for a COVID-19 booster vaccine.

Version: 1.2 - 30 September 2021

The following sections have been updated:

• About the National Protocol updated to include paragraphs on consent for under 16s
• Approval and Clinical Authorisation – Competency updated to include section on consent for under 16's

• Exclusion criteria section updated to align with COVID-19 chapter of Green Book advice on contraindications and precautions in individuals with a history of allergy.
• Exclusion criteria section updated to include those who developed myocarditis or pericarditis following a previous COVID-19 vaccination.
• Cautions section updated to align with COVID-19 chapter of Green Book advice on contraindications and precautions in individuals with a history of allergy, including updated figure and flowchart.
• Cautions section updated to align with COVID-19 chapter of Green Book advice on co-administration with shingles vaccine and inactivated influenza vaccine
• Duration of treatment section updated to remove wording about booster doses.

• Frequency section updated with new flow and advice from Green Book chapter on vaccine choice for third primary dose for those with severe immunosuppression

• Frequency section updated to advise in those identified as requiring a booster vaccine dose the booster dose should be administered no earlier than six months after completion of the primary vaccine course.
• Duration of treatment updated to include information on Boosters
• Advice for parent / carer updated to include guidance for children and young people

Annex C updated to include line on capacity for under 16's

1. Clinical condition or situation to which this Protocol applies

Category: Indication

Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) is indicated for active immunisation against COVID-19 disease caused by SARS-CoV-2 virus in accordance with Scottish Government COVID-19 immunisation programme and recommendations given in

• Chapter 14a of the Immunisation Against Infectious Disease: the 'Green Book'
• JCVI statement on priority groups for COVID-19 vaccination from 30th December 2020;
• JCVI statement on phase 2 of the vaccination programme from 13th April 2021;
• JCVI statement on COVID-19 vaccination of children and young people aged 12 to 17 years from 15^th July 2021;
• JCVI statement on vaccination of 16 and 17 year olds from 4th August 2021 JCVI advice on third primary dose vaccination from 1st September 2021;
• JCVI statement on COVID-19 vaccination of children aged 12 to 15 years from 3^rd September 2021;
• JCVI statement regarding COVID-19 booster vaccination programme for winter 2021/22 from 14^th September 2021
• and subsequent correspondence/publications from Scottish Government.

Category: Inclusion criteria

National policy must be followed in relation to the priority groups eligible for vaccination at a particular point in time.

Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) should be offered to the following individuals:

• Residents in a care home for older adults and their carers
• All those 18 years of age and over
• Frontline health and social care workers (as included in COVID-19 –SARS-Cov-2 chapter of Green Book, JCVI statement and Scottish Government CMO letters)
• Clinically extremely vulnerable (CEV) individuals (not including those under 16 years) as defined by Scottish Government
• Individuals aged 16 years to 64 years with underlying health conditions which puts them at higher risk of serious disease and mortality included in Table 3 COVID-19 –SARS-Cov-2 chapter 14a of Green Book* this also includes adult household contacts of adults with severe immunosuppression
• All those aged 16 and 17 years of age (first dose only) unless they fall into one of the categories below
• All those aged 12 to 15 years of age (first dose only) unless they fall into one of the categories below
• Children and young people aged 12 years and over with specific underlying health conditions that put them at risk of serious COVID-19 in line with JCVI recommendations
• Children and young people aged 12 years and over who are household contacts of persons (adults or children) who are immunosuppressed
• Pregnant women should be offered vaccination at the same time as non-pregnant women, based on their age and clinical risk group. Pfizer and Moderna vaccines are the preferred vaccines for pregnant women, because of more extensive experience of their use in pregnancy.

Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) is authorised and recommended for use in those aged 12 years and over and COVID-19 vaccine Moderna while authorised for use from 12 years it is not recommended in those aged 12-17 years. Clinicians (such as obstetricians, mid-wives, GPs or other healthcare professionals authorised to offer COVID-19 vaccination) should discuss the risks and benefits of vaccination with the woman, who should be told about the limited evidence of safety for the vaccine in pregnancy.

• Those requiring a different type of COVID-19 vaccine for the second dose than that given as the first dose when clinically indicated.
• Those aged from 12 years identified as meeting the definition for severe immunosuppression in proximity of their first or second vaccine doses in the primary schedule, in line with specialist advice, for a third primary dose in accordance with recommendations in the JCVI advice on third dose primary vaccine.
• Those who received vaccination in phase 1 of the COVID-19 vaccination programme (priority groups 1-9) should be offered a COVID-19 booster vaccine in accordance with recommendations in the JCVI statement regarding a COVID-19 booster vaccine programme for winter 2021/22. This includes:

Those living in residential care homes for older adults

All adults aged 50 years or over

Frontline health and social care workers

All those aged 16 to 49 years with underlying health conditions that put them at higher risk of severe COVID-19 (as set out in the Green Book), and adult carers

Adult household contacts of immunosuppressed individuals

*This also includes 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.

The list above is not exhaustive, and clinician should apply clinical judgment to take into account the risk of COVID-19 exacerbating any underlying disease that a patient may have, as well as the risk of serious illness from COVID-19 itself. COVID-19 vaccine should be offered in such cases even if the individual is not in the clinical risk groups specified above, this may be provided under a Patient Specific Direction (PSD).

Category: Exclusion criteria

The vaccine should not be given to:

• Those who have had a previous systemic anaphylaxis reaction to any COVID-19 vaccine.
• Those who have had a prior systemic allergic reaction to any component (excipient) of Comirnaty® (COVID-19 mRNA vaccine, Pfizer/BioNTech) e.g. polyethylene glycol

• Those with a history of immediate anaphylaxis to multiple, different drug classes, with the trigger unidentified (this may indicate PEG allergy) unless the advice from relevant specialist, local immunisation or health protection team is that vaccination should proceed
• Those with a history of anaphylaxis to a vaccine, injected antibody preparation or a medicine likely to contain PEG (e.g. depot steroid injection, laxative) unless the advice from relevant specialist, local immunisation or health protection team is that vaccination should proceed
• Those with a history of idiopathic (unexplained) anaphylaxis unless the advice from relevant specialist, local immunisation or health protection team is that vaccination should proceed
• Those in whom no valid consent has been received
• Those who are under 12 years of age
• Those with confirmed COVID-19 infection to avoid confusing the differential diagnosis. As clinical deterioration can occur up to two weeks after infection, ideally vaccination should be deferred until around four weeks after onset of symptoms or from the first PCR positive specimen in those who are asymptomatic.
• Those with evidence of current deterioration of COVID-19 symptoms, deferral of vaccination may be considered to avoid incorrect attribution of any change in the person's underlying condition to the vaccine.
• Those who are participating in a clinical trial of COVID-19 vaccines
• Those with acute febrile illness – consider postponing immunisation until individual has fully recovered.
• Those bone marrow and peripheral blood stem cell donors who have commenced GCSF, the vaccination (first or second dose) must be delayed at least until 72 hours after stem cell collection (both peripheral blood stem cell and bone marrow donation). This is a precautionary advice to avoid vaccination when receiving Granulocyte-colony stimulating factor (GCSF) and allow for post donation recovery period.
• Those who developed myocarditis or pericarditis following a previous dose of COVID-19 vaccination

Category: Cautions/need for further advice/ circumstances when further advice should be sought from a doctor

The COVID-19 chapter of the Green Book advises that there are very few individuals who cannot receive COVID vaccine. Where there is doubt, rather than withholding vaccination, appropriate advice should be sought from the relevant specialist, or from the local immunisation or health protection team.

The Pfizer BioNTech (Comirnaty®) and Moderna mRNA vaccines contain polyethylene glycol (PEG). PEGs (also known as macrogols) are a group of known allergens commonly found in medicines, many household products and cosmetics. Medicines containing PEG include some tablets, laxatives, depot steroid injections, and some bowel preparations used for colonoscopy. Known allergy to PEG is rare but would contraindicate receipt of mRNA vaccines.

Published data now show that some individuals with prior allergic reaction to PEG containing medicines (e.g. PEG-asparaginase) can tolerate the PfizerBioNTech vaccine (although the historical reaction may have been due a non-PEG component). Expert advice should be obtained and if a decision is made to administer an mRNA vaccine, then this should only be done in hospital under medical supervision under a patient specific direction.

There is now evidence that many individuals with initial apparent allergic reaction to an mRNA vaccine can tolerate a second dose of the same vaccine. Where there were no objective signs of anaphylaxis and symptoms rapidly resolved (with no more than 1 dose of IM adrenaline), a further dose of the same vaccine can be given in any vaccination setting.

If the reaction might have been anaphylaxis, obtain expert advice; if a decision is made to administer the same vaccine, then this should be done under medical supervision in the hospital setting under a patient specific direction.

The COVID-19 chapter of the Green Book states 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.

Figure 1 summarises the management of patients with a history of allergy.

Graphic text below:

Green

Proceed with vaccinations

• Patient characteristics
  • previous allergic reactions (including anaphylaxis) to a food, insect sting and most medicines (where trigger has been identified)
  • Family history of allergies
  • Previous non-systemic reaction to a vaccine
  • Hypersensitivity to non-steroidal anti-inflammatory drug eg aspirin, ibuprofen
  • Mastocytosis
• Actions
  • Proceed with vaccination as normal, according to local guidelines

Amber

Special precautions

• Patient characteristics
  • History of immediate anaphylaxis to multiple different drug classes, with the trigger unidentified (this may indicate PEG allergy)
  • History of anaphylaxis to a vaccine, injected antibody preparation or a medicine likely to contain PEG (eg depot steroid injection laxative)
  • History of idiopathic anaphylaxis
• Actions
  • Discuss with allergy specialist and consider the possibility of PEG allergy
  • Consider observation of 30 minutes if vaccination proceeds (see precautions)
  • Some patients may benefit from pre-treatment with antihistamine, however this may mask initial symptoms of a reaction.

Red

Vaccination contra-indicated

• Patient characteristics
  • Prior systemic allergic reaction to the COVID-19 vaccine
  • For an mRNA-based COVID-19 vaccine, prior allergic reaction to another mRNA
  • Poor allergic reaction to a component of the vaccine including the PEG
• Actions
  • Do not give the vaccine in question
  • Refer to allergist

Figure 2 shows the Green Chapter flowchart for managing patients who have allergic reactions to the first dose of COVID-19 vaccine.

1 Consider pre-treatment with non-sedating antihistamine, at least 30 mins prior to vaccination

2 If reaction was to AstraZeneca vaccination, complete or boost with an mRNA vaccine. If reaction was to an mRNA vaccine, give the same or alternative mRNA vaccine in hospital setting.

Those with an anaphylaxis immediate-type allergic reaction are excluded from receiving vaccination under this protocol– a patient specific direction is required if further doses are offered.

Individuals with a bleeding disorder may develop a haematoma at the injection site (see Route of Administration).

As all of the early COVID-19 vaccines are considered inactivated, where individuals in an eligible cohort present having recently received another inactivated or live vaccine, COVID-19 vaccination should still be given. The same applies for most other live and inactivated vaccines where COVID-19 vaccination has been received first or where a patient presents requiring two or more vaccines. It is generally better for vaccination to proceed to avoid any further delay in protection and to avoid the risk of the patient not returning for a later appointment. An exception to this is shingles vaccination, where a seven-day interval should ideally be observed given the potential for an inflammatory response to COVID-19 vaccine to interfere with response to the live virus in the older population and because of the potential difficulty of attributing systemic side effects to the newer adjuvanted shingles vaccine.

A UK study of co-administration of AstraZeneca and Pfizer BioNTech COVID-19 vaccines with inactivated influenza vaccines confirmed acceptable immunogenicity and reactogenicity. Where co-administration does occur, patients should be informed about the likely timing of potential adverse events relating to each vaccine. If the vaccines are not given together, they can be administered at any interval, although separating the vaccines by a day or two will avoid confusion over systemic side effects.

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.

JCVI advise there is no known risk associated with giving these types of vaccines during pregnancy. These vaccines cannot replicate, so they cannot cause infection in either the woman or the unborn child.

Although clinical trials on the use of COVID-19 vaccines during pregnancy are not advanced, the available data do not indicate any harm to pregnancy. JCVI has therefore advised that women who are pregnant should be offered vaccination at the same time as non-pregnant women, based on their age and clinical risk group. There is now extensive post-marketing experience of the use of the Pfizer BioNTech (Comirnaty®) and Moderna vaccines in the USA with no safety signals so far. These vaccines are therefore the preferred vaccines to offer to pregnant women. Clinicians (such as obstetricians, mid-wives, GPs or other healthcare professionals authorised to offer COVID-19 vaccination) should discuss the risks and benefits of vaccination with the woman, who should be told about the limited evidence of safety for the vaccine in pregnancy.

There is no known risk associated with giving non-live vaccines whilst breastfeeding. JCVI advises that breastfeeding women may be offered vaccination with any suitable COVID-19 vaccine.

The developmental and health benefits of breastfeeding should be considered along with the woman'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.

Category: Action if excluded

Specialist advice should be sought on the vaccine and circumstances under which it could be given as vaccination using a patient specific direction may be indicated.

Individuals who are participating in a clinical trial of COVID-19 vaccines who present for vaccination should be referred back to the investigators.

In case of postponement due to acute illness advise when the individual can be vaccinated and ensure another appointment is arranged.

In case of postponement due to COVID-19 symptoms or positive COVID test in the last four weeks advise when the individual can be vaccinated and how future vaccination may be accessed.

Document the reason for exclusion and any action taken in accordance with local procedures.

Category: Action if patient declines

Advise the individual/carer about the protective effects of the vaccine, the risks of infection and potential complications if not immunised.

Advise how future immunisation may be accessed if they subsequently decide to receive the COVID-19 vaccine

Document patient's declined consent and advice given.

2. Description of treatment

Category: Name of medicine

Comirnaty® concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)

Comirnaty® (COVID-19 mRNA vaccine, Pfizer/BioNTech)

Category: Form/strength

Comirnaty® (COVID-19 mRNA vaccine, Pfizer/BioNTech) 30 micrograms/0.3mL dose concentrate for dispersion for injection multidose vials

Comirnaty® (COVID-19 mRNA vaccine, Pfizer/BioNTech) is a multidose vial and must be diluted with 1.8mL of 0.9% sodium chloride before use. 1 vial contains 6 doses of 30 micrograms of COVID-19 mRNA vaccine (embedded in lipid nanoparticles).

Category: Route of administration

After dilution, vials of Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) contain 6 doses of 0.3 mL of vaccine. In order to extract 6 doses from a single vial, low dead-volume syringes and/or needles should be used. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:

Each dose must contain 0.3 mL of vaccine.

If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3mL, discard the vial and any excess volume.

Do not pool excess vaccine from multiple vials.

Any unused vaccine should be discarded 6 hours after dilution.

Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) must be administered by intramuscular (IM) injection preferably into the deltoid area of the upper arm. Where administration into the deltoid is not possible the anterolateral thigh can be considered.

Inspect visually prior to administration and ensure appearance is consistent with the description in the manufacturer's product literature or summary of product characteristics.

Individuals with bleeding disorders may be vaccinated intramuscularly if, in the opinion of a doctor familiar with 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 is below the upper level of the therapeutic range, can receive intramuscular vaccination. A fine needle (23 or 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/parent/carer should be informed about the risk of haematoma from the injection.

The site at which each vaccine was given should be noted in the individual's records.

Category: Dosage

The dose of Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) is 30 micrograms contained in 0.3mL of the diluted vaccine.

Category: Frequency

Primary Vaccination

Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) course consists of two separate doses of 0.3ml each, a minimum of 21 days apart.

For both AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) and mRNA vaccines, there is evidence of better immune response and/or protection where longer intervals between doses in the primary schedule are used.

Based on this evidence, longer intervals are likely to provide more durable protection. JCVI is currently recommending a minimum interval of eight weeks between doses of all the available COVID-19 vaccines where a two-dose primary schedule is used. Operationally, this consistent interval should be used for all vaccines with a two-dose primary schedule to avoid confusion and simplify booking, and will help to ensure a good balance between achieving rapid and long-lasting protection.

If an interval longer than the recommended interval is left between doses in the two dose primary schedule, the second dose should still be given (preferably using the same vaccine as was given for the first dose if possible). The course does not need to be restarted.

The main exception to the eight-week lower interval would be those about to commence immunosuppressive treatment. In these individuals, the minimal intervals outlined above may be followed to enable the vaccine to be given whilst their immune system is better able to respond.

Individuals who are about to receive planned immunosuppressive therapy should be considered for vaccination prior to commencing therapy (ideally at least two weeks before), when their immune system is better able to make a response. Where possible, it would also be preferable for the 2-dose schedule to be completed prior to commencing immunosuppression. This would entail offering the second dose at the recommended minimum for that vaccine (three or four weeks from the first dose) to provide maximum benefit that may not be received if the second dose was given during the period of immunosuppression.

Evidence from trials of co-administration suggest that those who receive mixed schedules, including mRNA and AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) make a good immune response, although rates of side effects at the second dose are higher. Therefore, every effort should be made to determine which vaccine the individual received and to complete the two dose primary 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.

12-15 year olds

At this time, Scottish Government policy is that all 12-15 year olds should be offered a first dose of Comirnaty® COVID-19 mRNA vaccine. This is separate to the existing offer of two doses of vaccine to 12-15 year olds with specific underlying health conditions that put them at risk of serious COVID-19 in line with JCVI recommendations and to 12-15 year olds who are household contacts of persons (adults or children) who are immunosuppressed. Pending further evidence on effectiveness and safety in this age group, a second vaccine dose may be offered later to increase the level of protection and contribute towards longer term protection.

16-17 year olds

At this time, JCVI advises that all 16 -17 year olds should be offered a first dose of Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech). This is in addition to the existing offer of two doses of vaccine to 16 -17 year olds who are in 'at-risk' groups (including those clinically extremely vulnerable, with a specific underlying health condition, a frontline health or social care worker, an unpaid carer or within 3 months of their 18th birthday). Pending further evidence on effectiveness and safety in this age group, a second vaccine dose is anticipated to be offered later to increase the level of protection and contribute towards longer term protection.

People within 3 months of turning 18 will be offered two doses. Once an individual is 17 and 9 months, they will have entered the adult programme and therefore receive two doses.

Severely Immunosuppressed – Third Primary Dose

For those identified as meeting the definition for severe immunosuppression in proximity of their first or second vaccine doses in the primary schedule, in line with specialist advice, for a third primary dose in accordance with recommendations in the JCVI advice on third dose primary vaccine. The third primary dose should be given at least 8 weeks after the second dose, with special attention paid to current or planned immunosuppressive therapies guided by the following principles: a) where possible the third primary dose should be delayed until two weeks after the period of immunosuppression, in addition to the time period for clearance of the therapeutic agent, b) if not possible, consideration should be given to vaccination during a treatment 'holiday' or at a nadir of immunosuppression between doses of treatment.

For those aged over 18 years, JCVI advises a preference for mRNA vaccines - Pfizer BioNTech (Comirnaty®) or Moderna (Spikevax®) - for the third primary dose for those with severe immunosuppression. Pfizer BioNTech (Comirnaty®) is preferred for 12-17 year olds. AstraZeneca COVID-19 vaccine (Vaxzevria®) is an option for individuals who have received this vaccine previously where this would help to improve implementation. In exceptional circumstances, persons aged 40 years or over who received a mRNA COVID-19 vaccine previously may be offered a third dose of AstraZeneca Vaxzevria vaccine following a decision by a health professional on a case-by-case basis.

Booster vaccination

In those identified as requiring a booster vaccine dose, the booster dose should be administered no earlier than six months (24 weeks) after completion of the primary vaccine course.

JCVI advises a preference for the Pfizer-BioNTech (BNT162b2/ Comirnaty®) vaccine to be offered as the booster dose irrespective of which product was used in the primary schedule. There is good evidence that the Pfizer-BioNTech (BNT162b2/ Comirnaty®) vaccine is well tolerated as a third dose and will provide a strong booster response. Alternatively, individuals may be offered a half dose (50μg) of the Moderna (mRNA-1273/Spikevax®) vaccine, which should be well tolerated and is also likely to provide a strong booster response. A half dose (50μg) of Moderna (mRNA-1273/Spikevax®) vaccine is advised over a full dose due to the levels of reactogenicity seen following boosting with a full dose within the COV-BOOST trial. Where mRNA vaccines cannot be offered e.g. due to contraindication, vaccination with the AstraZeneca (ChAdOx1-S/Vaxzevria®) vaccine may be considered for those who received AstraZeneca (ChAdOx1-S/Vaxzevria®) vaccine in the primary course (please refer to the Green Book for further details)

Category: Duration of treatment

See Dose and frequency of administration above.

Category: Maximum or minimum treatment period

See Frequency of administration above.

Category: Quantity to supply/administer

Administer 30 micrograms in 0.3mL per administration.

Category: ▼ black triangle medicines

Yes, Comirnaty® (COVID-19 mRNA vaccine, Pfizer/BioNTech) has been designated ▼

All adverse reactions occurring in individuals of any age after vaccination should be reported to the MHRA using the Coronavirus Yellow Card Scheme. Anyone can report a suspected adverse reaction to the MHRA using the Coronavirus Yellow Card Reporting Scheme .

Category: Legal category

Prescription only medicine (POM).

Category: Is the use out with the SPC?

The vaccine marketing authorisation holder's summary of product characteristics states that the vaccine should be given as a series of two doses (0.3mL, each) 21 days apart.

This is superseded by the JCVI recommendation, as detailed in Chapter 14a of the green book, of a minimum interval of eight weeks between doses of all the available COVID-19 vaccines where a two-dose primary schedule is used.

And by JCVI advice, as detailed in Chapter 14a of the green book, for third primary dose vaccination in those with severe immunosuppression in proximity of their first or second doses in the primary schedule.

And by JCVI advice, as detailed in Chapter 14a of the green book, for COVID-19 booster vaccine which recommends a third dose at least six months after completion of the primary vaccine course.

Category: Storage requirements

Comirnaty® (COVID-19 mRNA vaccine, Pfizer/BioNTech) must be stored in accordance with manufacturer's advice.

Thawed vial

Once removed from the freezer unopened Comirnaty® COVID-19 mRNA vaccine vials can be stored for 31 days in a fridge between +2 to +8°C prior to dilution.

NHS Board guidance on Storage and Handling of vaccines should be observed.

Diluted Product

Comirnaty® (COVID-19 mRNA vaccine, Pfizer/BioNTech) should be diluted as close to use as possible. However, reconstituted vaccine which is not required immediately must be used within 6 hours from the time of dilution and stored between +2°C to +30°C.

The vaccine vial has space to write the date and time that the vial should be discarded following dilution (calculation: time of dilution + 6 hours); write this on the vial label.

Precautions for storage

During storage, minimise exposure to room light and avoid exposure to direct sunlight and ultraviolet light.

In the event of an inadvertent or unavoidable deviation of these conditions, vaccine that has been stored outside the conditions stated above should be quarantined and risk assessed for suitability of continued use or appropriate disposal.

The manufacturer may advise of updated storage requirements and product stability as new data becomes available, vaccine may be stored in accordance with updated recommendations from the manufacturer.

Category: Additional information

Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation should be postponed until they have fully recovered.

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. Inclusion of antibody positive individuals in the Pfizer phase 3 analysis did not give any safety signals.

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 confusing the differential diagnosis. As clinical deterioration can occur up to two weeks after infection, ideally vaccination should be deferred until around four weeks after onset of symptoms or from the first PCR 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.

3. Adverse reactions

Category: Warnings including possible adverse reactions and management of these

Local reactions at the injection site are fairly common after Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) primarily pain at the injection site, usually without redness and swelling. Systemic events reported were generally mild and short lived. In the final safety analysis of over 21,000 participants 16 years and older, the most common events were injection site pain (>80%), fatigue (>60%), and headache (>50%). Myalgia, arthralgia and chills were also common with fever in 10-20% mainly after the second dose. Most were classified as mild or moderate. Lymphadenopathy in the axillary, supraclavicular or cervical nodes on the same side as the injection was reported in less than 1%. Four cases of Bell's palsy were reported in vaccine recipients in the trial. Although within the expected background rate, this will be monitored closely post-implementation.

Side effects were less common in those aged over 55 than those aged 16 to 55 years. Severe systemic effects, defined as those that interfere with daily activity, included fatigue in 4% and headache in 2%. There was no signal to suggest that prior vaccination led to enhanced disease with only 1 case of severe COVID-19 in the 8 vaccine failures.

Recently a number of cases of myocarditis and pericarditis have been reported after Pfizer BioNTech (Comirnaty®) vaccine from Israel and the USA. The reported rate appears to be highest in those under 25 years of age and in males, and after the second dose. Onset is within a few days of vaccination and most cases are mild and have recovered without any sequalae. The MHRA has advised the benefits of vaccination still outweigh any risk in most individuals.

A protocol for the management of anaphylaxis and an anaphylaxis pack must always be available whenever Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) is given. 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. For children aged 12-17 years who are small or prepubertal administer 0.3mg intramuscular adrenaline (0.3mL of 1:1000 or 1mg/mL adrenaline), with an early call for help and further IM adrenaline every 5 minutes. 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.

In the event of a severe adverse reaction individual should be advised to seek medical advice.

For full details/information on possible adverse reaction, refer to manufacturer's product literature or summary of product characteristics.

Category: Reporting procedure for 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 .

As this vaccine is labelled with a black triangle, all adverse reactions occurring in individuals of any age after vaccination should be reported to the MHRA using the Coronavirus Yellow Card Scheme. Anyone can report a suspected adverse reaction to the MHRA using the Coronavirus Yellow Card Reporting Scheme .

Any adverse reaction to a vaccine should be documented in accordance with locally agreed procedures in the individual's record and the individual's GP should be informed.

Anaphylaxis is a very rare, recognised side effect of most vaccines and suspected cases should be reported via the Coronavirus Yellow Card Scheme. Chapter 8 of the Green Book gives detailed guidance on distinguishing between faints, panic attacks and the signs and symptoms of anaphylaxis. If a case of suspected anaphylaxis meets the clinical features described in Chapter 8, this should be reported via the Yellow Card Scheme as a case of 'anaphylaxis' (or if appropriate 'anaphylactoid reaction'). Cases of less severe allergic reactions (i.e. not including the clinical features of anaphylaxis) should not be reported as anaphylaxis but as 'allergic reaction'.

Programmatic Adverse Events should be recorded in line with local procedures and where appropriate escalated in accordance with the national framework.

Category: Advice to patient or carer including written information

Written information to be given to individual

• Provide manufacturer's consumer information leaflet/patient information leaflet (PIL) provided with the vaccine.
• Provide copy of Public Health Scotland post- vaccination leaflet
• Provide copy of Pregnant, planning a pregnancy or breastfeeding, a guide to COVID-19 vaccine to women of child bearing years
• For eligible children and young people under the age of 16, clear information on the potential risks and benefits of vaccination should be provided to the parent/carer of the eligible child or young person prior to vaccination. Information provided should be accessible for children and young people under the age of 16 should they wish to consent for vaccination.

Individual advice / follow up treatment

• Inform the individual/carer of possible side effects and their management.
• Vaccinated individuals should be advised that it is common to develop a fever after vaccination and that this normally happens within 48 hours after the vaccination and usually goes away within 48 hours. This is a common, expected reaction, and self-isolation and testing for COVID-19 are not required unless the individual has other COVID-19 symptoms; has been told by NHS Test and Protect they are a close contact of someone who has tested positive for COVID-19; they live with someone who has recently tested positive for COVID-19; or they live with someone who has symptoms of COVID-19.
• Vaccinated individuals should be advised that if the fever started 48 hours after the vaccination or lasts longer than 48 hours, they should self-isolate and book a test.
• Vaccinated individuals should be advised that feeling generally unwell, shivery, achy and tired were also symptoms commonly reported by vaccine recipients in the clinical trials. Generally, these symptoms were found to resolve within one to two days without treatment but paracetamol can be taken if necessary to relieve any of these symptoms.
• Inform the individual/carer that anyone who has any of the following symptoms after vaccination should seek medical advice urgently:

• chest pain
• shortness of breath
• feelings of having a fast-beating, fluttering, or pounding heart

• As has always been recommended, any fever after vaccination should be monitored and if individuals are concerned about their health at any time, they should seek advice from their GP or NHS24
• The individual should be advised to seek medical advice in the event of a severe adverse reaction.
• Inform the individual that they can report suspected adverse reactions to the MHRA using the Yellow Card reporting scheme on: http://yellowcard.mhra.gov.uk.
• Immunosuppressed individuals should be advised that they may not make a full immune response to the vaccine and they should continue to take appropriate measures to protect themselves against this infection.
• When administration is postponed advise the individual how future vaccination may be accessed.
• When applicable, advise the individual/carer when to return for vaccination or when a subsequent vaccine dose is due.

Category: Observation following vaccination

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

As syncope (fainting) can occur following vaccination, all vaccines should either be driven by someone else or should not drive for 15 minutes after vaccination.

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 any setting.

Category: Follow up

Not applicable

Category: Additional facilities

A protocol for the management of anaphylaxis and an anaphylaxis pack must always be available whenever Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) is given. 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. For children aged 12-17 years who are small or prepubertal administer 0.3mg intramuscular adrenaline (0.3mL of 1:1000 or 1mg/mL adrenaline), with an early call for help and further IM adrenaline every 5 minutes. 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.

4. Audit Trail/Records

Record/ audit trail

Record:

• that valid informed consent was given
• name of individual, address, date of birth and GP with whom the individual is registered
• name of person that undertook assessment of individual's clinical suitability for vaccine
• name of person that administered the vaccine
• name and brand of vaccine
• date of administration
• dose, form and route of administration of vaccine
• batch number
• where possible expiry date
• anatomical site of vaccination
• advice given, including advice given if excluded or declines immunisation
• details of any adverse drug reactions and actions taken
• administered under protocol

Records should kept in line with local procedures. Ideally records should be kept within the NHS Scotland COVID-19 vaccine administration app.

Local policy should be followed to encourage information sharing with the individual's General Practice.

All records should be clear, legible and contemporaneous.

5. References

Additional references

Immunisation against Infectious Disease [Green Book]

Immunisation against Infectious Disease [Green Book Chapter 14a] COVID-19

JCVI: advice on priority groups for COVID-19 vaccine 30th December 2020

Priority groups for phase 2 of the coronavirus (COVID-19) vaccination programme: advice from the JCVI 13 April 2021

JCVI statement on COVID-19 vaccination of children and young people aged 12 to 17 years: 15 July 2021

Updated JCVI statement on COVID-19 vaccination of children and young people aged 12 to 17 years: 04 August 2021

JCVI: Third primary COVID-19 vaccine dose for people who are immunosuppressed: 1st September 2021

JCVI: COVID-19 vaccination of children aged 12 to 15 years: 3rd September 2021

JCVI: Statement regarding a COVID-19 booster vaccine programme for winter 2021/22; 14th September 2021

Universal vaccination of children and young people aged 12 to 15 years against COVID-19. Letter from the UK Chief Medical Officers: 13th September.

Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

Educational resources for registered professionals produced by National Education for Scotland

Coronavirus (COVID-19) - vaccine: letter from the Chief Medical Officer updating on the vaccination programme - 1 January 2021