Monkeypox state-wide protocol for the supply and administration of the JYNNEOS vaccine.
Last updated: 27 October 2022
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Version Date Areas updated
2 2 September 2022

1.3 Training requirements
3.4 Record keeping for LHD mass vaccination clinics
4.3 Locations where vaccine can be administered expanded
4.4 Addition of intradermal route of administration
7. Revised to include intradermal route, additional precautions for all
Appendix F included – post-exposure prophylaxis

312 September 2022 Update to links in Appendices
Update to consideration around immunocompromised
​4​10 October 20222.1 Medical practitioner can provide supervision via Telehealth
527 October 2022

3.4 Reporting daily data to NSW Health
4.1 Expanded eligibility criteria for the vaccine
4.3 Adding additional designated clinics
7 Additional guidance on use of insulin syringes

On this page

1. Background

1.1. About this document

This Protocol provides information on JYNNEOS, a vaccine indicated for the prevention of smallpox and monkeypox disease in adults 18 years of age and older. JYNNEOS has been made available in Australia under Section 18A of the Therapeutic Goods Act 1989 (Cth).

Vaccination will be offered to those who are determined to be at high risk of monkeypox infection, or susceptible to detrimental sequelae should they develop disease. At the direction of the NSW Chief Health Officer (CHO), vaccination may be advised for those at occupational risk of smallpox or monkeypox exposure, including staff working in high level biocontainment facilities or laboratory workers who are likely to be in close contact / care of patients or handling biohazardous samples from infected patients.

This Protocol is for use by health practitioners who have been identified by the CHO as vaccination providers and will order or administer the vaccine. Compliance with this Protocol is mandatory.

Authorised settings for administration of the vaccine are limited to those designated by the CHO. Vaccination in other settings is not legally permitted.

This Protocol contains protocols for JYNNEOS vaccine administration.

The requirements set out in this Protocol are directions of the CHO for the purposes of the Therapeutic Goods (Medicines – MVA-BN) (Emergency) Exemption) (No.3) 2022 (as amended from time to time).

1.2. Key definitions

  • CHO: The New South Wales Chief Health Officer.
  • Medication: Used singularly throughout the Protocol to describe a drug, medicine, pharmaceutical preparation, therapeutic substance, and vaccine.
  • Public Health Organisation: A local health district, or statutory health corporation, or an affiliated health organisation in respect of its recognised establishments and recognised services.
  • Public Hospital: Any public hospital as defined in the Health Services Act 1997 (NSW)
  • S100 Prescriber: A medical practitioner authorised to prescribe section 100 highly specialised drugs under the National Health Act 1953, including but not limited to HIV and hepatitis B & C therapeutics.
  • Supply: Includes to administer medications to a group or a specific patient and is consistent with the definition of supply in section 4 of the Poisons and Therapeutic Goods Act 1966. Includes administration of a single dose for prophylaxis by an authorised health practitioner.
  • Vaccine: The JYNNEOS vaccine, a 3rdgeneration smallpox vaccine manufactured by Bavarian Nordic.

1.3. Training requirements

The following training requirements must be met by medical practitioners and any registered nurses acting under the direction of a medical practitioner prior to administration of the JYNNEOS vaccine:

  • current cardio-pulmonary resuscitation (Basic Life Support) competency
  • received prior training to recognise and manage anaphylaxis including the use of adrenaline (epinephrine)
  • remain up to date on any new advice from the Australian Technical Advisory Group on Immunisation (ATAGI) or Therapeutic Goods Administration (TGA) regarding additional precautions or consent requirements. The Public Health Organisation or sexual health service will ensure up to date resources are provided to the service.

For intradermal administration, registered nurses acting under the direction of an authorised medical practitioner and medical practitioners prior to administration of the JYNNEOS vaccine must ensure that they have reviewed relevant information for intra-dermal administration of the vaccine and completed any training mandated by their relevant local health district.

2. Implementation of protocol

2.1. Prerequisites for medical practitioners administering the vaccine

Medical practitioners operating under this Protocol must:

  • have read and understood this Protocol and comply with the Protocol in relation to the administration of the vaccine and the selection of targeted persons to receive the vaccine
  • practice in accordance with any practice conditions imposed by the person’s place of employment and the endorsements, notations and conditions on the person’s registration
  • ensure informed consent is obtained from the patient by a medical practitioner prior to vaccine administration. The medical practitioner may direct a registered nurse to conduct consenting procedures on their behalf where the medical practitioner supervises and ensures that the consent was properly obtained. For the avoidance of doubt, supervision by the medical practitioner can occur by telehealth.
  • ensure records relating to the administration of the vaccine are retained in the medical record and are uploaded to the Australian Immunisation Register (AIR) (unless the patient makes a specific request that their vaccination is not recorded in the AIR).

2.2. Public Health Organisations and S100 prescribers

The vaccine may be administered by registered nurses only at the direction and under the authority of a medical practitioner.

Public Health Organisations and S100 prescriber settings must ensure that consent has been obtained from the patient and that the registered nurse administers a vaccine on the direction of a medical practitioner.

Public Health Organisations and S100 prescriber settings must have processes in place to periodically assess compliance with this Protocol and take appropriate action where any aspect of non-compliance is identified. The CHO may request evidence of the compliance with this Protocol and relevant records which Public Health Organisations and S100 prescribers are required to keep under this Protocol.

3. Vaccine information

3.1 General information

JYNNEOS is a 3rdgeneration smallpox vaccine. It is a live vaccine produced from the strain modified vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus, and cannot replicate in the human body. The vaccine is expected to protect against both the smallpox and monkeypox viruses.

JYNNEOS is considered safe to use in people who are immunocompromised, in pregnant women and while breastfeeding. It is indicated for use in adults aged 18 years and older considered at risk for monkeypox infection.

JYNNEOS has not been formally studied in children aged under 18 years. However, there are trial data on safety in children of MVA-BN used as the vaccine delivery platform for a small number of childhood vaccines.

The Australian Technical Advisory Group on Immunisation (ATAGI) advises that vaccination with JYNNEOS in children can be considered, especially for individuals in high-risk groups aged 16 years and older, after discussing the benefits and the potential harms of vaccination with their immunisation provider.

Vaccination with JYNNEOS may be used for both pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

Standard administration of JYNNEOS is by subcutaneous injection.

JYNNEOS may be administered by intradermal injection as an alternative route for PrEP. The intradermal route is not recommended for people with severe immunocompromise and is not the preferred route for post-exposure prophylaxis. These groups should have subcutaneous administration.

For PrEP, a complete vaccination course with JYNNEOS requires two doses, which must be given at least 28 days apart.

If a vaccine course is commenced using the subcutaneous route for the first dose, it can be completed by intradermal injection for the second dose, and vice versa.

There is evidence showing that the first dose may provide a moderate level of protection after around two weeks. Optimal coverage is reached two weeks after the second dose.

People who have previously had a smallpox vaccine, including any doses of JYNNEOS may still get monkeypox if they are exposed to an infected person. People at high risk of monkeypox infection who have received a smallpox vaccine dose more than ten years prior are recommended to receive a booster dose. JYNNEOS may be administered via either the subcutaneous or intradermal route as a booster.

For PEP, a single dose is recommended for protection against contracting monkeypox infection and attenuating disease/symptoms. It is ideally offered within 4 days of last exposure, although may be offered up to 14 days in those at ongoing risk, or those who are at higher risk of the complications of monkeypox. The subcutaneous route is currently recommended for PEP.

3.2. Supply and use

JYNNEOS is supplied with a package of 20 single-dose vials. The dimensions of the pack are: L: 9.8 x W: 12.90 x H: 4.7 cm.

JYNNEOS must be supplied and used ONLY at the direction of the CHO in accordance with this Protocol. The requirements set out in this Protocol are the directions of the CHO for the purposes of the Therapeutic Goods (Medicines – MVA-BN) (Emergency) Exemption) (No.3) 2022 (as amended from time to time).

3.3. Storage, distribution and handling

JYNNEOS will either be stored frozen or at +2°C to +8°C prior to distribution. It should be stored in its original packaging to protect from light. Once de-frosted it must not be re-frozen.

JYNNEOS will be distributed at the direction of the CHO to locations within NSW.

For distribution, the vaccine will be transported either frozen or at +2°C to +8°C to designated vaccination providers.

If received frozen, the vaccine can be stored frozen at -20°C or -50°C. Otherwise the vaccine must be stored at +2°C to +8°C, it must not be re-frozen. It is stable for 24 weeks if it is brought to this temperature directly from prior storage at -50°C. [Note: storage for 24 weeks at +2°C to +8°C is based on advice from officers of the Commonwealth Department of Health, and it is different to advice in the JYNNEOS® Package Insert FDA (appendix A) which advises that once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 12 hours.]

If frozen, before use the vaccine must be thawed at room temperature for approximately 10 minutes. Vials must not be re-frozen once they have been thawed.

The vaccine must not be used after the expiration date shown on the vial label, nor beyond 24 weeks after thawing from -50°C (or 12 hours if thawed from -20°C).

If there is a cold chain breach, contact the public health unit (PHU) on 1300 066 055. Where the event is specifically related to monkeypox vaccine, public health units are asked to send the details of the event including a contact name and number at the site to MoH-VaccReports@health.nsw.gov.au and Health Protection NSW will liaise with the Commonwealth regarding further advice.

3.4. Record-keeping and disclosure

Vaccine administration must be recorded into the eMR and / or other specific vaccination record for loading the information up to the Australian Immunisation Register, unless the patient specifically requests that this does not occur. Patients without a Medicare Card can be registered via the Individual Health Identifier (IHI) process.

Suspected adverse events following immunisation (AEFI) can be reported by contacting the local PHU on 1300 066 055 or by reporting it directly to the TGA. It is advised to report all uncommon, serious or unexpected AEFI. The form can be found in Appendix G. More information about AEFI.

The CHO will keep records relating to the quantity, location, storage, transportation, supply, use and disposal of the vaccine. Providers will keep a record of vaccine received and used and disposed and these will be provided to the CHO through periodic assessments of compliance as outlined in 2.2.

All clinics if administering vaccination for both pre-exposure and post-exposure prophylaxis are required to provide NSW Health with data on vaccine administration, vaccine wastage and vaccine availability. These data can be provided through the vaccination administration management (VAM) platform or another NSW Health approved source.

The Monkeypox VAM is a booking and tracking platform developed by NSW Health and eHealth NSW, with technology partner ServiceNow. This platform is intended to support clinic staff in delivering monkeypox vaccinations by providing a single platform with automated workflows and capacity management. Clinics will need to complete a sitrep, available through the VAM workflow on the number of vaccine doses administered by route and account for any vaccine wastage on a daily basis. This data will be accessible to NSW Health via the same portal. Local health district mass vaccination clinics (sites managing high throughput with planned >200 doses/day) may report using an agreed template with the Ministry of Health, this will need to be provided on a weekly basis via an email to NSW Health.

3.5. Disposal

Unusable vaccine and vaccine waste products will be disposed of in designated clinical waste bins for destruction. The CHO will direct unused vaccine to another designated vaccination provider of increased need.

4.Vaccination priority groups and vaccination sites

4.1. Identification of patients for vaccination

A questionnaire has been developed to record expression of interest of patients, collect personal details and determine eligibility of JYNNEOS vaccination. Once patients have been approved by NSW Health for vaccination, patients will then be contacted regarding booking an allocated time slot for vaccine administration.

Previously vaccine was prioritised to gay or bisexual men and other men (including trans) who have sex with men (GBMSM), who are sexually active and at greatest risk of acquiring monkeypox, these included:

  • sexually active GBMSM who are immunocompromised or those living with HIV with a CD4 count <200 cells/ uL
  • sexually active GBMSM who are particularly vulnerable should monkeypox become locally endemic (sex worker, transgender, homeless, Aboriginal, significant drug use)
  • sexually active GBMSM who report attendance at sex-on-premises venues (SOPV) and private sex parties in NSW, interstate or abroad.

People who fall into the above categories remain eligible, however the eligibility criteria to receive the monkeypox vaccine has been expanded in NSW to include all gay and bisexual men (cis and trans) with multiple or casual sexual partners and anyone who has sex with these men, including women (cis and trans) and non-binary people.

4.2. Additional groups for vaccination

The following groups will also be prioritised for vaccination:

  • PEP for close contacts of known monkeypox cases (ideally within 4 days of last exposure but up to 14 days since last exposure)
  • laboratory workers that are performing monkeypox virus culture where the virus is amplified
  • Westmead Hospital Biocontainment Unit health care workers who may be involved in the care of hospitalised patients

This is applicable as at the date of this Protocol, however is subject to revision.

4.3. Designated locations for vaccination

Vaccination (including for PEP) can occur at any of the following locations:

  • S100 prescriber sites: Taylor Square Private Clinic, East Sydney Doctors, Holdsworth House Medical Practice.
  • Publicly funded sexual health centres: The Albion Centre, St Vincent’s Immunology B Ambulatory Care (IBAC), Sydney Sexual Health Centre, Short Street Centre Sexual Health Clinic, Western Sydney Sexual Health Centre, Lismore Sexual Health Service, Clinic 145 - Tweed Valley Sexual Health Service, Clinic 33 - Coffs Harbour, Clinic 33 - Port Macquarie, Clinic 229 - Grafton, Clinic 33 - Kempsey, Clinic 16 Royal North Shore, RPA Sexual Health Clinic, Nepean Sexual Health Clinic, Pacific Clinic Newcastle Sexual Health Service, Illawarra Shoalhaven Sexual Health Clinics - Port Kembla and Nowra, Liverpool Sexual Health Clinic, Holden Street Sexual Health Clinic, Albury Sexual Health Service – Clinic 72, Griffith Community Health Centre – Sexual Health, Wagga Wagga Sexual Health - Brookong Centre, Queanbeyan Sexual Health Service, Eurobodalla Sexual Health Service, Bega Shire Sexual Health Service, Griffith Sexual Health Service, Broken Hill Community Health Centre, Dubbo Sexual Health Centre and other publicly funded sexual health centres as designated by the CHO.
  • Monkeypox vaccination clinics: Gosford Monkeypox Vaccination Clinic, Port Kembla NSW Health Monkeypox Vaccination Clinic, St Leonards NSW Health Monkeypox Vaccination Centre, St Vincents NSW Health Monkeypox Vaccination Centre, RPA NSW Health Monkeypox Vaccination Centre, Liverpool NSW Health Monkeypox Vaccination Centre, Blacktown NSW Health Monkeypox Vaccination Centre, Nepean NSW Health Monkeypox Vaccination Centre, Crown Street NSW Health Monkeypox Vaccination Centre, Wallsend NSW Health Monkeypox Vaccination Centre, Tamworth NSW Health Monkeypox Vaccination Clinic, Tweed Valley NSW Health Monkeypox Vaccination Clinic, Lismore NSW Health Monkeypox Vaccination Clinic, Broken Hill NSW Health Monkeypox Vaccination Centre, Albury NSW Health Monkeypox Vaccination Clinic, Wagga Wagga NSW Health Monkeypox Vaccination Clinic, Queanbeyan NSW Health Monkeypox Vaccination Clinic, Eurobodalla NSW Health Monkeypox Vaccination Clinic, Bega NSW Health Monkeypox Vaccination Clinic, Dubbo NSW Health Monkeypox Vaccination Clinic, Griffith NSW Health Monkeypox Vaccination Clinic, Orange NSW Health Monkeypox Vaccination Clinic and Far West (Mobile Clinic) NSW Health Monkeypox Vaccination Clinic.
  • The Kirketon Road Centre in SESLHD.
  • A designated NSW Health vaccination clinic sanctioned by a Local Health District.

Vaccination for PEP can also occur at any Public Hospital. The public health unit of the LHD is responsible for determining how PEP can be delivered safely in the Public Hospital, in consultation with the LHD Director of Clinical Governance, and the relevant facility general manager. These pathways must be developed in advance and may include the direction of the person to an Emergency Department. This includes identification of separate patient waiting areas, streamlined administration to reduce risk of transmission and follow up pathways. For additional guidance on the provision of PEP refer to the Post exposure prophylaxis (PEP for monkeypox in NSW protocol at Appendix F)

Providers should maintain familiarity with the Australian Technical Advisory Group on Immunisation clinical guidance for monkeypox vaccination

4.4. Intradermal Pre-Exposure Prophylaxis Program

Prior to offering PrEP via the intradermal route, clinics must ensure any staff administering vaccine are competent in intradermal administration technique and that there are staff competent in drawing up from a multi-dose vial, in addition to the other training requirements outlined in section 1.3. The clinic must be sanctioned by the Local Health District.

During the Intradermal PrEP Program clinics may only administer PrEP via the intradermal route unless the patient has severe immunosuppression or a history of keloid scarring (see ATAGI advice for full details). Eligible patients with these conditions are recommended to receive PrEP via the subcutaneous route.

If a clinic does not have practitioners trained in the intradermal route – including administration and preparation of the vaccine, the clinic may continue to offer PrEP via the subcutaneous route to eligible persons if vaccine supply is available. However, in this circumstance, the clinic must report that PrEP is being provided via subcutaneous route via the VAM TRAINING REQUIREMENTS FOR VACCINATORS.

Training requirements are outlined in 1.3.

Registered nurses and doctors administering vaccine are also encouraged to complete the Training for healthcare practitioners – Vaccination against monkeypox using the Jynneos Vaccine module.

Persons providing vaccine via the intradermal route must be trained to understand the differences between this route and the subcutaneous routes and special precautions, mode of administration and, if preparing the vaccine for administration, appropriate technique in managing the drawing up and preparation of the vaccine from the vial.

5. Adrenaline (Epinephrine) for anaphylaxis

Anaphylaxis must be managed as per the Anaphylaxis after vaccination guidance, found in supporting documents below.

In addition, advice in the Australian Immunisation Handbook must be followed.

6. Protocol for administration of the JYNNEOS vaccine

Below is the protocol for administration of the JYNNEOS smallpox/monkeypox vaccine for people 18 years of age and over, in authorised settings.

Title Protocol for JYNNEOS vaccine
Drug(s) JYNNEOS smallpox vaccine
Presentation1

If the vaccine is received frozen, it must be allowed to thaw at room temperature before administration. Once thawed, it should not be frozen again.

Store vials at +2 to +8 oC. (Refrigerate. Do not freeze. Discard after 24 weeks if defrosted from -50°C or 12 hours if thawed from -20°C)

One vial provides one dose subcutaneously of 0.5 mL or up to five doses intradermally of 0.1 mL. Once thawed, JYNNEOS is a milky, light yellow to pale white coloured suspension. It should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Always maintain cold chain storage and protect from light.

Indication2

see section 4.1

Contraindications1

Hypersensitivity to the active substance or to any of the excipients (tromentalmol, sodium chloride, water for injections) or trace residues (chicken protein, benzonase, gentamicin and ciprofloxacin).

Precautions1
  • Persons who experienced a severe allergic reaction following a previous dose of JYNNEOS or following exposure to any component of JYNNEOS may be at increased risk for severe allergic reactions after JYNNEOS. The risk for a severe allergic reaction should be weighed against the risk for disease due to monkeypox
  • Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS. They should receive vaccine subcutaneously.
  • Vaccination with JYNNEOS may not protect all recipients
  • Persons should be screened for symptoms of monkeypox to ensure that they do not already have clinical illness
  • JYNNEOS may be given concomitantly with other vaccines. Whether JYNNEOS is associated with a risk of myocarditis is uncertain. For PrEP purposes only, spacing JYNNEOS and an mRNA COVID-19 vaccine apart by several weeks may be considered for people with increased risk of myocarditis and/or pericarditis following an mRNA COVID-19 vaccine, (for example, young adult males).
  • Persons with a history of keloid scarring have a risk of increased scarring if the intradermal route is used. Use the subcutaneous route instead
  • Bleeding disorders or anticoagulation are not a contraindication.
  • Pregnancy and breastfeeding are not contraindications
Dose1

0.5 mL suspension administered subcutaneously for patients 18 years and older.

0.1mL suspension administered intradermally for patients 18 years and older.

Dose frequency1

Post-exposure prophylaxis: a single dose

Pre-exposure prophylaxis: Two doses - a second dose should be administered at least 4 weeks after a first dose.

Administration1

Swirl the vial gently before use for at least 30 seconds.

Subcutaneous injection:

Withdraw a dose of 0.5 mL into a sterile syringe for injection.

Administer JYNNEOS by subcutaneous injection, preferably into the upper arm (in the region of the deltoid muscle).

Intradermal injection:

The use of an insulin syringe is only acceptable if a fit-for-purpose syringe is unavailable. If an insulin syringe is being used, the risks associated with the use of an insulin syringe, including risk of under/overdosing, must be highlighted to the staff involved and checks put into place to mitigate the risks. These checks should be clearly documented in a locally approved standard operating procedure.

Wipe the top of the vial with an alcohol swab

Withdraw a dose of 0.1 mL into a sterile syringe for injection (where available use a low dead space syringe).

Administer JYNNEOS by intradermal injection, on the volar aspect of the forearm) or the skin over the region where the deltoid muscle inserts into the humerus. This is just above the midpoint of the upper arm.

If an intradermal dose is administered incorrectly, administer a repeat dose as soon as possible, namely a 0.5 mL dose subcutaneously, withdrawn from a new vaccine vial (to ensure a full 0.5mL dose is given).

Drug interactions1

No interaction studies with other vaccines or medicinal products have been performed.

Adverse effects1

JYNNEOS has a good safety profile. The main adverse events seen in clinical trials include local injection site irritation (increased frequency in people with atopic dermatitis), myalgia, fatigue, fever, chills, nausea and headache.

For further information on adverse effects, please refer to the product information.

Documentation3
  • Explain risks and possible adverse effects, provide patient information sheet on the JYNNEOS vaccine and obtain informed consent.
  • Advise patient they may be contacted by SMS or email in the following week to check for side effects, as part of vaccine safety surveillance.
  • Record vaccination on the Australian Immunisation Register (AIR), and advise patient their vaccination record can be accessed through the Express Plus Medicare mobile app, MyGov, or My Health Record.
  • Report adverse events to the TGA using AEFI form (see appendix).
  • Clinics administering vaccination on any given day must complete the MPX clinic daily reporting webform
  1. The drug information provided in this protocol is to act as a guide only. For comprehensive information, refer to the latest manufacturer’s product information. If any contraindications, precautions or other concerns in relation to suitability for treatment are identified, refer to a medical practitioner.
  2. Emergency approval granted based on overseas known efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing assessment.
  3. Informed consent must be obtained by a medical practitioner.

If expert advice is needed, the medical officer can contact the NSW Immunisation Specialist Service (NSWISS) on 1800 679 477.

7. Procedure for vaccine administration

7.1. Procedure for preparing for vaccine administration

This Protocol allows for administration of the vaccine where the patient does not have a relevant precaution or contraindication to treatment. Where a relevant precaution or contraindication exists, treatment (JYNNEOS® vaccination) can only proceed under the direct authority of a medical practitioner.

The following steps must be followed when preparing for vaccine administration.

All assessments and details relating to the administration of the vaccine must be documented.

Procedure

  • Practice according to this Protocol for JYNNEOS® administration and its supporting documents (see Appendices)
  • Arrange the supply of the vaccine from the designated supply point. The immuniser must ensure an anaphylaxis kit is available. This includes adrenaline (epinephrine),1mL syringes, 23g needles and cotton swabs. They must also be familiar with the adrenaline (epinephrine) treatment protocol, found in the online version of The Australian Immunisation Handbook
  • Provide the patient with the relevant patient information sheet: Refer to Appendix D.
  • Determine whether the patient meets the criteria for the Protocol by:
    • reviewing the patient-completed screening tool in the consent form, and performing a focussed medical history related to any “Yes” answer. Identify any language or communication barriers that may prevent informed consent, before proceeding. Refer the patient for further assessment by a medical practitioner should any health concerns or questions be identified. This assessment should be documented.
    • providing information in relation to the benefits and risks of the JYNNEOS vaccine. Explain the rationale and purpose of the vaccine to the patient/ /guardian. Ensure if there are any questions/concerns, the patient / guardian has had the opportunity to discuss benefits and risks with a medical practitioner using the latest available benefits and risks information and advice from the Australian Technical Advisory Group on Immunisation (ATAGI).
    • documenting all assessments and details relating to the administration of the vaccine.
  • Explain the expected adverse effects of the vaccine and the use of simple over the counter medication in the 24-48 hours following vaccination if required. Provide post-vaccination care advice as per the latest ATAGI advice, including the period during which symptoms should be carefully monitored, symptoms to look out for, and when to seek medical attention. In particular, provide advice to immediately seek medical review for any new or unexpected or severe symptoms.
  • Provide written post-vaccination advice.
  • For each person, document the following details:
    • Name
    • Address
    • Date of birth
    • Sex
    • Phone number
    • whether the person has any relevant conditions, including precautions or contraindications, established above
    • that they have received the relevant information sheet and appropriate post-immunisation advice
    • the date and time the vaccine was administered, batch number, serial number, site of vaccine injection, route of injection and name of vaccination service provider and supervising medical practitioner (if provider is a RN).
  • Following vaccination, observe the patient for 15 minutes, and check the patient has no signs or symptoms requiring clinical review prior to discharge.
  • Record the administration of each vaccine

8. Appendices – Relevant links

[1] Precautions must be applied in vaccinating people with the following conditions leading to immunocompromise. While there is limited information, it is recommended that JYNNEOS vaccine should be administered via subcutaneous injection and the second dose given at 28 days among people who fulfil the following criteria for immunocompromise. These recommendations are informed by expert opinion and are subject to updates by ATAGI.

  • Primary immunodeficiency or acquired immunodeficiency: HIV/AIDS with CD4<200, or uncontrolled viraemia
  • Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders, post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months), primary immunodeficiency,
  • Receipt in the last 3 months any of:
    • Chemotherapy or whole-body radiotherapy
    • High-dose corticosteroids (≥ 20 mg of prednisone per day, or equivalent) for at least 14 days in 1 month, or pulse corticosteroid therapy
    • Biological agents and other treatments that deplete or inhibit B- or T-cell function (anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin)
    • Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate (more than 0.4 mg/kg/week), leflunomide, azathioprine (at least 3 mg/kg/day), 6-mercaptopurine (at least 1.5 mg/kg/day), alkylating agents (eg, cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus).

There are no data yet on the immune response to the JYNNEOS vaccine immunosuppressed individuals. JYNNEOS vaccine is considered safe to use in people with weakened immune system.

Current as at: Thursday 27 October 2022
Contact page owner: Health Protection NSW