CVAP - ASTRAZENECA COVID-19 Vaccine Administrative Protocol (CVAP) - NT Department of Health
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CVAP - ASTRAZENECA
COVID-19 Vaccine Administrative
Protocol (CVAP)
(ChAdOx1-S) SOLUTION FOR INJECTION
COVID-19 VACCINE ASTRAZENECA®
Drug COVID-19 VACCINE ASTRAZENECA® (ChAdOx1-S) SOLUTION FOR INJECTION
multi-dose vial containing up to 10 doses of 5 x 1010 viral particles (vp) of
(ChAdOx1-Sa,b)
Indication Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by
SARS-CoV-2, in individuals 18 years of age and older who meet the eligibility criteria
under the National COVID-19 vaccination implementation phases.
Contraindication Contraindications
s and/or • People under 18 years old.
Exclusions*
• Hypersensitivity to the active substance or to any of the excipients including
polysorbate 80
• People who have received the influenza or any other vaccine within the past
14 days
https://www.health.gov.au/resources/publications/atagi-advice-on-influenza-and-
covid-19-vaccines
Refer the following people to a medical officer for further assessment:
• Pregnant Women (category B2 - limited experience in humans, animal
reproductive toxicity studies have not been completed).
• Individuals with any severe allergies (to anything), history of anaphylaxis to any
substance, or carries or has been prescribed an adrenaline auto injector (EpiPen)
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.
26th March 2021
COVID-19 vaccine should be deferred for people who have a history of the
following rare conditions:
1. people with a confirmed medical history of Cerebral Venous Sinus
Thombosis (SVST;) and/or
2. people with a confirmed medical history of heparin induced
thrombocytopenia (HIT).
Department of Health Page 1 of 6CVAP - ASTRAZENECA
This is until further information from ongoing investigations in Europe is available
and is only a precautionary measure:
Precautions
Please refer to the Product Information for list of precautions
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-
2021-PI-01194-1&d=202103011016933
Please check vial size (4mL or 5mL) which contain 8 and 10 doses respectively
Dose and Route* 5 x 1010 vp (0.5mL) given intramuscularly in the deltoid muscle of the upper arm
Dose Frequency* A 2 dose course with second dose administered 12 weeks apart (minimum interval
4 weeks apart).
• Vaccine efficacy increases with a longer interval between doses.
If the second dose of COVID-19 Vaccine AstraZeneca is administered later than the
recommended interval, no additional vaccine doses need to be given.
Preparation 1. In community clinics
• Prepare a single dose from the multi-dose vial as per ATAGI Guidelines
2. In mass vaccination clinics
• Prepare and label in accordance from multi-dose vials as per ATAGI
Guidelines
• Place in a cardboard tray with lid to protect from light until given.
Administration* Intramuscular injection into the deltoid muscle of the upper arm.
Drug No interaction studies have been performed.
Interactions* Do not give within 14 days of influenza or any other vaccine.
Monitoring Ensure vaccines are not expired and have been stored in accordance to the Product
requirements* Information
Opened multi-dose vial
After first opening, chemical and physical in-use stability has been demonstrated
from the time of vial puncture to administration for
• no more than 6 hours at room temperature up to 30°C, or
• 48 hours in a refrigerator (2°C to 8°C)
The vial can be re-refrigerated, but after first opening the cumulative storage time
at room temperature must not exceed 6 hours, and the total cumulative storage
time must not exceed 48 hours.
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.
Department of Health
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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:
• 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.
Department of Health
Page 3 of 6CVAP - ASTRAZENECA
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:
• 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:
2. 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 attendance 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
Department of Health
Page 4 of 6CVAP - ASTRAZENECA
• 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
Service Health Services providing COVID-19 vaccination must meet the
requirements • NT COVID-19 vaccine clinic practice standards for NT Government run
services
• 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
• 0.5 mL
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 of adrenaline (epinephrine) 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
Department of Health
Page 5 of 6CVAP - ASTRAZENECA
Related Australian Product Information – COVID-19 VACCINE ASTRAZENECA®
Documents (ChAdOx1-S) SOLUTION FOR INJECTION
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=C
P-2021-PI-01194-1&d=202103011016933
ATAGI clinical guidance on COVID-19 Vaccine in Australia in 2021
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
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 Chief Name Signature Date
Health Officer Document
Dr Hugh Heggie EDOC2021/115412 29 March 2021
Department of Health
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