Information

Coronavirus (COVID-19) vaccine - Comirnaty® 10 micrograms/dose (mRNA, Pfizer/BioNTech): national protocol v1.0

Protocol for the supply and administration of Comirnaty® 10 micrograms/dose (COVID-19 mRNAVaccine, Pfizer/BioNTech) national protocol v1.0.


Annex A: Clinical Information

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

Most Recent Changes

Version: 1.0

Date: 25/01/22

Summary of changes:

The following sections have been updated:

Frequency section updated to include course consisting of two separate doses of 0.2ml each, a minimum of 21 days apart.

1. Clinical condition or situation to which this Protocol applies

Indication

Comirnaty® 10 micrograms/dose (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’; statements from Joint Committee on Vaccination and Immunisation (JCVI); and subsequent correspondence/publications from Scottish Government.

Inclusion criteria

Comirnaty® 10 micrograms/dose (COVID-19 mRNA vaccine, Pfizer/BioNTech should be offered to individuals aged 5-11 years in accordance with the recommendations in Chapter 14a of the Green Book and JCVI advice.

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

Individuals are eligible for different dose schedules based on their age and recognised risk group (see the frequency section).

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® 10 micrograms/dose (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 5 years of age or over 12 years of age
  • 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 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

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.

Individuals with a history of allergy

The Pfizer BioNTech (Comirnaty® 10 micrograms/dose) 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. Observe for 30 minutes.

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. Observation for 15 minutes is recommended.

No specific management is required for individuals with a family history of allergies.

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

Figure 1: Management of patients with a history of allergy

Green

Proceed with vaccinations

Patent characteristics

  • previous allergic reactions including anaphylaxis to a food, incest 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

  • 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

  • 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.

Figure 2: Flowchart for managing patients who have allergic reactions to the first dose of COVID-19 vaccine
This figure is a flowchart for managing patients who have allergic reactions to the first dose of COVID-19 vaccine. It provides advice on the circumstances which require specialist advice and on when vaccination may proceed in any vaccination setting.

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 history

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

Co-administration with other vaccines

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. This includes but is not limited to vaccines commonly administered around the same time or in the same settings (including influenza and pneumococcal polysaccharide vaccine in those aged over 65 years, pertussis-containing vaccines and influenza vaccines in pregnancy, and LAIV, HPV, MenACWY and Td-IPV vaccines in the schools programmes).

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

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.

Clinical trial participants

Individuals who have participated in a clinical trial of COVID-19 vaccines should be provided with written advice on whether and when they should be safely vaccinated in the routine programme. Advice should also be provided from the trial investigators on whether any individual could receive additional doses for the purposes of vaccine certification. Trial participants who are eligible for boosters should be offered vaccination in line with the general population, at least three months after the dose considered as the final primary dose or the final revaccination (if the latter is required for certification purposes).

Individuals with a past history of COVID-19 infection

There is no convincing 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 or asymptomatic or incubating COVID-19 infection is unlikely to have a detrimental effect on the illness.

Vaccination should ideally be deferred in those with confirmed infection to avoid confusing the differential diagnosis. As clinical deterioration can occur up to two weeks after infection, vaccination of adults and high risk children should be deferred until clinical recovery to around four weeks after onset of symptoms or four weeks from the first confirmed positive specimen for that episode in those who are asymptomatic. The four-week interval may be reduced in periods of high incidence or where there is concern about vaccine effectiveness (for example a new variant).

In younger people, protection from serious complications of COVID-19 infection is likely to be high for a period of months. Limited evidence suggests that countries with longer intervals between primary doses (eight to twelve weeks) may have a lower rate of myocarditis after the second dose. Based on extrapolation from this limited evidence, JCVI have taken a precautionary approach to mitigate the very rare risk of post-vaccine myocarditis. Therefore, vaccination should ideally be deferred until twelve weeks from onset (or sample date) in children and young people under 18 years who are not in high risk groups. This interval may be reduced to eight weeks in healthy under 18 year olds during periods of high incidence or where there is concern about vaccine effectiveness (for example a new variant). Current advice in PIMS-TS cases also suggests that an interval of 12 weeks should be observed, although earlier administration can be considered in those at risk of infection and/or who are fully recovered.

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.

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

In case of deferral due to COVID-19 symptoms or recent positive COVID test 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.

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

Name of medicine

Comirnaty® 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)

Comirnaty® 10 micrograms/dose (COVID-19 mRNA vaccine, Pfizer/BioNTech)

Form/strength

Comirnaty® 10 micrograms/dose (COVID-19 mRNA vaccine, Pfizer/BioNTech) 10 micrograms/0.2mL dose concentrate for dispersion for injection multidose vials

Comirnaty® 10 micrograms/dose (COVID-19 mRNA vaccine, Pfizer/BioNTech) is a multidose vial and must be diluted with 1.3mL of 0.9% sodium chloride before use. 1 vial contains 10 doses of 10 micrograms of COVID-19 mRNA vaccine (embedded in lipid nanoparticles).

Route ofadministration

After dilution, vials of Comirnaty® 10 micrograms/dose (COVID-19 mRNA vaccine, Pfizer/BioNTech) contain 10 doses of 0.2 mL of vaccine. In order to extract 10 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 ten doses from a single vial.

Each dose must contain 0.2 mL of vaccine.

If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.

Any unused vaccine should be discarded 12 hours after dilution.

Comirnaty® 10 micrograms/dose (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.

Dosage

The dose of Comirnaty® 10 micrograms/dose COVID-19 mRNA vaccine is 10 micrograms contained in 0.2 mL of the diluted vaccine

Frequency

Primary Vaccination

Comirnaty® 10 micrograms/dose (COVID-19 mRNA Vaccine, Pfizer/BioNTech) course consists of two separate doses of 0.2ml each, a minimum of 21 days apart.

For Comirnaty® 10 micrograms/dose (COVID-19 mRNA vaccine, Pfizer/BioNTech), 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, using the same minimum interval for all products will 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.

5-11 year olds

Children aged 5 - 11 years in a clinical risk group (as defined in the COVID-19 chapter of Green Book), or who are about to commence immunosuppression or who are a household contact of someone who is immunosuppressed (as defined in the Green Book), should be offered two 10 micrograms doses of Comirnaty® (COVID-19 mRNA vaccine, Pfizer/BioNTech) with an interval of 8 weeks between the first and second doses.

Children aged 5-11 years who have commenced immunisation with the 10 microgram paediatric dose of Pfizer BioNTech should complete vaccination with the paediatric dose (although an adult/ adolescent dose is an alternate in those who turn 12 years of age between doses). Those who present for the second dose over the age of 12 years should be given an adult/ adolescent dose of vaccine.

Severe immunosuppression

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 (as defined in COVID-19 chapter of Green Book) 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® 10 micrograms/dose) is preferred for 5-11 year olds.

Duration of treatment

See Dose and frequency of administration above.

Maximum or minimum treatment period

See Frequency of administration above.

Quantity to supply/administer

Administer 10 micrograms in 0.2mL per administration.

▼ black triangle medicines

Yes, Comirnaty® 10 micrograms/dose (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

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

Legal category

Prescription only medicine (POM).

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 (0.2mL, each) 21 days apart.

This is superseded by the JCVI recommendation of a minimum interval of eight weeks between doses of all the available COVID-19 vaccines where a two-dose primary schedule is used.

The vaccine marketing authorisation holder’s summary of product characteristics states that close observation for at least 15 minutes is recommended following vaccination. In recognition of the need to accelerate delivery of the programme in response to the emergence of the Omicron variant, the UK Chief Medical Officers have recommended temporary suspension of this requirement. This temporary suspension in individuals without a history of allergy has also been agreed by the Commission on Human Medicines

The Scottish Government has made further recommendations that all doses of COVID-19 vaccines be followed by a 5 minute observation period.

The vaccine marketing authorisation holder’s summary of product characteristics states that the vaccine is indicated in children aged 5 to 11 years. The use in children aged 5-11 years who commence immunisation with the 10 microgram paediatric dose of Pfizer BioNTech and then turn 12 years of age should complete vaccination with the 10 microgram paediatric dose is outwith the SPC but is aligned with advice from JCVI.

Vaccine should be stored according to the conditions detailed below. However, in the event of a deviation of these conditions where vaccine is assessed as appropriate for continued use, administration under this PGD is allowed.

Storage requirements

Comirnaty® 10 micrograms/dose (COVID-19 mRNA vaccine, Pfizer/BioNTech) must be stored in accordance with manufacturer’s advice.

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

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 12 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 + 12 hours); write this on the vial label.

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.

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.

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

Warnings including possible adverse reactions and management of these

The overall safety profile of Comirnaty in participants 5 to 15 years of age was similar to that seen in participants 16 years of age and older.

The most frequent adverse reactions in children 5 to 11 years of age were injection site pain (>80%), fatigue (>50%), headache (>30%), injection site redness and swelling (>20%), myalgia and chills (>10%).

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. Individuals who have had myocarditis or pericarditis should be investigated, and a second or booster dose can be given once they are fully recovered in line with advice in the COVID-19 chapter of the Green Book, under a PSD.

A protocol for the management of anaphylaxis and an anaphylaxis pack must always be available whenever vaccines are given. Immediate treatment should include early treatment with intramuscular 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.

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

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

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.

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
  • 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.

Observation following vaccination

Following COVID-19 vaccine administration, individuals should be observed for any immediate reactions whilst they are receiving any verbal post vaccination information and exiting the centre.

According to the Summaries of Product Characteristics, it is recommended that all recipients of the Pfizer BioNTech and Moderna vaccines are kept for observation and monitored for a minimum of 15 minutes. In recognition of the need to accelerate delivery of the programme in response to the emergence of the Omicron variant, the UK Chief Medical Officers have recommended suspension of this requirement. This temporary suspension in individuals without a history of allergy has also been agreed by the Commission on Human Medicines. There is no routine requirement for observation following COVID-19 Vaccine AstraZeneca.

The Scottish Government has made further recommendations that all doses of mRNA COVID-19 vaccines be followed by a 5 minute observation period.

A longer observation period should be observed when indicated after clinical assessment as set out in Figure 1 and Figure 2 (above).

Vaccinated individuals should be informed about how to access immediate healthcare advice in the event of displaying any symptoms. In some settings, for example domiciliary vaccination, this may require a responsible adult to be present for at least 15 minutes after vaccination.

Follow up

Not applicable

Additional facilities

A protocol for the management of anaphylaxis and an anaphylaxis pack must always be available whenever vaccines are given. Immediate treatment should include early treatment with intramuscular 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] https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book

Immunisation against Infectious Disease [Green Book] COVID-19 https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a

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

https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020

JCVI: Final statement on phase 2 of the COVID-19 vaccination programme: 13 April 2021 JCVI final statement on phase 2 of the COVID-19 vaccination programme: 13 April 2021

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

https://www.gov.uk/government/publications/covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-jcvi-statement/jvci-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

https://www.gov.uk/government/publications/jcvi-statement-august-2021-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years/jcvi-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-4-august-2021

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

https://www.gov.uk/government/publications/third-primary-covid-19-vaccine-dose-for-people-who-are-immunosuppressed-jcvi-advice

JCVI: COVID-19 vaccination of children aged 12 to 15 years: 3rd September 2021 https://www.gov.uk/government/publications/jcvi-statement-september-2021-covid-19-vaccination-of-children-aged-12-to-15-years

JCVI: Statement regarding a COVID-19 booster vaccine programme for winter 2021/22; 14th September 2021 https://www.gov.uk/government/publications/jcvi-statement-september-2021-covid-19-booster-vaccine-programme-for-winter-2021-to-2022/jcvi-statement-regarding-a-covid-19-booster-vaccine-programme-for-winter-2021-to-2022

Universal vaccination of children and young people aged 12 to 15 years against COVID-19. Letter from the UK Chief Medical Officers: 13th September. https://www.gov.uk/government/publications/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19

JCVI advice on the UK vaccine response to the Omicron variant: 29 November 2021 https://www.gov.uk/government/publications/uk-vaccine-response-to-the-omicron-variant-jcvi-advice

JCVI statement on COVID-19 vaccination of children and young people: 22 December 2021: https://www.gov.uk/government/publications/jcvi-update-on-advice-for-covid-19-vaccination-of-children-and-young-people/jcvi-statement-on-covid-19-vaccination-of-children-and-young-people-22-december-2021

Manufacturer’s product information/ Summary of Product Characteristics https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

Educational resources for registered professionals produced by National Education for Scotland

https://learn.nes.nhs.scot/37676/immunisation/covid-19-vaccines

All relevant Scottish Government advice including the relevant CMO letter(s)

Contact

Email: CEU@gov.scot

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