COVID-19 Vaccine Administrative Protocol (CVAP) - NT Health
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CVAP – Pfizer (Comirnaty®)
COVID-19 Vaccine Administrative
Protocol (CVAP)
BNT162b2 [mRNA]) Comirnaty ® COVID-19
Vaccine - Pfizer
Drug Comirnaty ® COVID-19 Vaccine (BNT162b2 [mRNA]) multidose vial containing up
to 6 doses of 30 micrograms after dilution
Indication Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by
SARS-CoV-2, in individuals 12 years of age and older who meet the eligibility
criteria under the National COVID-19 vaccination implementation phases, including
in pregnancy.
Comirnaty® COVID-19 Vaccine is provisionally registered in people aged 12
years of age and older and is given in a two-dose schedule.
mRNA vaccines (i.e., Comirnaty® or Spikevax® COVID-19 Vaccines) are the
preferred vaccines over Vaxzevria® (formerly AstraZeneca) COVID-19
Vaccine in people aged under 60 years, and in pregnant women.
Second dose for people who develop thrombosis with thrombocytopenia
syndrome after their first dose of Vaxzevria® COVID-19 Vaccine or who
otherwise have a contraindication for the Vaxzevria® COVID-19 Vaccine.
Clinical guidance on use of COVID-19 vaccine in Australia in 2021 (health.gov.au)
The following groups of children among those aged 12–15 years be prioritised for
vaccination:
ATAGI recommended priority categories found
at https://www.health.gov.au/news/atagi-statement-regarding-
vaccination-of-adolescents-aged-12-15-years
Children with rheumatic heart disease.
NOTE:
Women at any stage of pregnancy are recommended to receive Comirnaty.
Pregnant women (category B1 - limited experience in humans, animal studies do not
indicate harmful effects).
People who are on secondary prophylaxis for Rheumatic Heart Disease
recommended to receive Comirnaty®
Department of Health
Page 1 of 7CVAP – Pfizer (Comirnaty®)
Contraindications Contraindications
and/or People under 12 years old
Exclusions*
Anaphylaxis to the active substance or to any of the excipients (including
Polyethylene Glycol)
Any person who has an episode of rheumatic fever within the last 3 months
or has current active inflammatory markers
Exclusions
Ensure there is a minimal interval of 7 days between the COVID-19
vaccines and any other vaccine, including the seasonal influenza vaccine)
https://www.health.gov.au/resources/publications/atagi-advice-on-influenza-and-
covid-19-vaccines
Administration of vaccine to individuals with an acute severe febrile illness
or acute infection (minor infection or low grade fever should not delay
vaccination) should be deferred until they are symptom-free.
Precautions
Specific allergies - some individuals may need prior assessment before receiving a
COVID-19 vaccine, including:
people with immediate (within 4 hours) and generalised symptoms of a
possible allergic reaction (e.g. urticaria/hives) to a previous dose of a
COVID-19 vaccine
people with a generalised allergic reaction (without anaphylaxis) to any
component of the COVID-19 vaccine to be administered (e.g. PEG in
Comirnaty)
people with a history of anaphylaxis to previous vaccines and/or multiple
drugs (injectable and/or oral) where ingredients such as PEG or polysorbate
80 may conceivably be the cause
people with a known systemic mast cell activation disorder with raised mast
cell tryptase that requires treatment.
Consult with medical officer or cardiologist about people with
Inflammatory cardiac illness e.g., myocarditis, pericarditis, endocarditis
within the last 6 months
Acute rheumatic fever (i.e., with active myocardial inflammation) or acute
rheumatic heart disease
Acute decompensated heart failure
Pericarditis / myocarditis to previous dose of Pfizer vaccine
Please refer to the Product Information of list of precautions
Comirnaty-BNT162b2-PI Template (tga.gov.au)
Dose and Route* 30 micrograms (0.3mL after dilution) given intramuscularly in the deltoid muscle of
the upper arm
Department of Health
Page 2 of 7CVAP – Pfizer (Comirnaty®)
Dose Frequency* 2 dose course given at least 21 days apart
If the second dose is administered later than the recommended interval, no
additional vaccine doses needs to be given.
Dilution Please follow instructions in the product information for dilution
Comirnaty-BNT162b2-PI Template (tga.gov.au)
Syringe 1. In community clinics
Preparation Prepare a single dose from the multi-dose vial as per ATAGI Guidelines
2. In mass vaccination clinics
Prepare in accordance from multi-dose vials as per ATAGI Guidelines
Label each syringe indicating the medicine name, batch number, date and
time of preparation if not being used immediately
Place in a cardboard tray with lid to protect from light until given
Administration* Intramuscular injection after dilution into the deltoid muscle of the upper arm.
Drug No interaction studies have been performed.
Interactions* An interval of 7 days between COVID 19 vaccine and other vaccines including
influenza is recommended.
Monitoring Ensure vaccines are not expired and have been stored in accordance to Product
requirements* Information.
Once removed from the freezer, the unopened thawed vial can be stored at
2-8°C for up to one month (31 days). and up to 2 hours at temperatures 30
°C or lower, prior to use.
Discard any unused vaccine 6 hours after dilution.
Assess patient suitability for vaccination with pre vaccination questionnaire.
Obtain informed patient consent to be vaccinated.
Provide advice to the patient about possible adverse events following immunisation
and what to do if they occur.
Patients should be kept under close observation for at least 15 minutes following
vaccination and for 30 minutes if have previous history of allergies.
Adverse events following vaccination are notifiable conditions in the NT and need
to be reported to Public Health Unit.
Follow established procedure if an adverse reaction occurs.
https://www.health.gov.au/health-topics/immunisation/health-
professionals/reporting-and-managing-adverse-vaccination-events
Health Health professional using this guideline must:
professional 1. Meet the requirements outlined by the NT Chief Health Officer:
Accreditation
Requirements Nurses and Midwives:
Department of Health
Page 3 of 7CVAP – Pfizer (Comirnaty®)
Be registered with the Australian Health Practitioner Regulation Agency
with no conditions or undertakings which may limit delivery of clinical
services directly to patients
Adhere to S25 2017 Prescribed Qualifications for Nurses and Midwives to
Supply, Administer or Possess Vaccines (p 4-6)
• https://nt.gov.au/__data/assets/pdf_file/0006/424914/s25.pdf
Adhere to this COVID-19 vaccine Protocol
Hold a current Basic Life Support Certificate or Provide First Aid Certificate
and provide documentary evidence of the qualifications when required
Hold a current vaccine provider qualification from an approved provider
Provide documentary evidence of the vaccine provider qualification when
required, including the date on which the qualification was obtained
Maintain continuing professional development related to skills and
competencies required for delivery of immunisation services.
Aboriginal Health Practitioners:
Be registered with the Australian Health Practitioner Regulation Agency
with no conditions or undertakings which may limit delivery of clinical
services directly to patients
Adhere to Gazette Notice G21 2019 - Prescribed Qualifications for
Aboriginal and Torres Strait Islander Health Practitioners to Supply,
Administer or Possess Vaccines and Gazette Notice S25 2017
• https://nt.gov.au/__data/assets/pdf_file/0010/694531/g21.pdf
Adhere to this COVID-19 vaccine Protocol
Hold a current Basic Life Support Certificate or Provide First Aid Certificate
and provide documentary evidence of the qualifications when required
Hold a current vaccine provider qualification from an approved provider
Provide documentary evidence of the vaccine provider qualification when
required, including the date on which the qualification was obtained
Maintain continuing professional development related to skills and
competencies required for delivery of immunisation services.
Registered Pharmacists
Be registered with the Australian Health Practitioner Regulation Agency
with no conditions or undertakings which may limit delivery of clinical
services directly to patients
Adhere to Gazette Notice S30 2020 - Qualifications Prescribed for
Pharmacist to Supply and Administer Schedule 4 Vaccine
• https://nt.gov.au/__data/assets/pdf_file/0003/882327/s30.pdf
Adhere to this COVID-19 vaccine Protocol
Hold a current Basic Life Support Certificate or Provide First Aid Certificate
and provide documentary evidence of the qualifications when required
Hold a current vaccine provider qualification from an approved provider:
Department of Health
Page 4 of 7CVAP – Pfizer (Comirnaty®)
Provide documentary evidence of the vaccine provider qualification when
required, including the date on which the qualification was obtained,
Maintain continuing professional development related to skills and
competencies required for delivery of immunisation services.
AND ALL Health Professional, including medical officers, must:
Have completed the national COVID19 Vaccination Training Program including all
SIX core modules and the vaccine specific modules relating to the vaccine the
Health professional will be administering or handling.
COVID-19 an introduction
Handling and Storage
Communication and purpose
Multi-dose vial training and delivery
Documentation and reporting
Safety surveillance and reporting of adverse events following immunisation
The training modules can be accessed here:
https://covid19vaccinationtraining.org.au/login/index.php
AND
Provide documentary evidence of the vaccine provider qualification when
required, including the date on which the qualification was obtained
Documentation The health professional must:
Record the patient’s appointment in the organisation’s COVID-19 vaccine
booking/clinical system and set up a recall for the second dose
Complete pre-vaccination checklist, including precautions and
contraindications (please refer to medical officer if required)
Enter the patient details and vaccine brand name, dose, site of
administration and batch number in the Australian Immunisation Register in
real time
o If this is not possible due to ICT outages then within 24 hours
Record any Adverse Events Following Immunisation as per established
procedures
Provide information on vaccination and post vaccination care to the
individual in an appropriate form
Provide proof of vaccination to the individual as required
Document informed consent if providing the vaccine to people with capacity
aged over 16 years
Document of parental/carer informed consent for children aged 12 - 15
years.
Service Health Services providing COVID-19 vaccination must meet the:
requirements NT COVID-19 vaccine clinic practice standards for NT Government run
services
Department of Health
Page 5 of 7CVAP – Pfizer (Comirnaty®)
Australian Government Requirements for all other clinics.
Managing Adrenaline (epinephrine) (1:1000) for injection ampoules
Anaphylactic Give if there are any respiratory and/or cardiovascular symptoms or signs of
reactions anaphylaxis.
following vaccine
Adrenaline is not required for generalised non-anaphylactic reactions (such
administration
as skin rash or angioedema).
Dose
Adult: 0.5 mL for average adult
Child: 12-15 years calculate 1:1000 adrenaline dose according to weight –
Refer to Doses of intramuscular 1:1000 adrenaline for anaphylaxis | The
Australian Immunisation Handbook (health.gov.au)
Route
Given by deep intramuscular injection preferably in the anterolateral (upper
outer) thigh.
Frequency
Repeat every 5 minutes if required until medical help arrives.
Contraindications
There are no absolute contraindications to adrenaline in anaphylactic
reactions; adrenaline is often life-saving.
Monitoring
Follow DRSABCD.
Call for medical assistance.
If the patient is unconscious, lie him/her on the left side and position to
keep the airway clear.
If the patient is conscious, lie him/her supine in ‘head-down and feet-up’
position (unless this results in breathing difficulties).
If oxygen is available, administer by facemask at a high flow rate.
Check breathing; if absent, commence basic life support or appropriate
cardiopulmonary resuscitation (CPR).
Document Dose and frequency in medication record.
Documentation of adverse drug reaction should be documented according to local
procedures Adverse events following vaccination are notifiable conditions in the NT
and need to be reported to the Public Health Unit.
Follow established procedure if an adverse reaction occurs.
https://www.health.gov.au/health-topics/immunisation/health-
professionals/reporting-and-managing-adverse-vaccination-events
Related Australian Product Information – COMIRNATY ® (BNT162b2 [mRNA]) COVID-19
Documents VACCINE
Comirnaty-BNT162b2-PI Template (tga.gov.au)
https://www.health.gov.au/resources/collections/covid-19-vaccination-provider-
resources
Department of Health
Page 6 of 7CVAP – Pfizer (Comirnaty®)
ATAGI Clinical guidance on use of COVID-19 vaccine in Australia (most recent
version)
ATAGI check list for administration sites
Australian Immunisation Handbook
Pre Vaccination Screening Checklist
Immunisation: Health Professionals; NT Upskilling Courses
Australian Immunisation Handbook: After Vaccination
Australian Government COVID 19 Vaccination Training Program
COVID-19 vaccination decision guide for women who are pregnant, breastfeeding
or planning pregnancy
References:
* The drug information provided is to act as a guide only, for further information reference should be
made to the full manufacturer’s product info and other reliable sources of medicines information. If
contraindications or interactions are present refer to medical officer before administration.
Approved by Name Signature Date
Chief Health Dr Hugh Heggie EDOC2021/0320750 16 September 2021
Officer
Department of Health
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