Mpox state-wide protocol for the supply and administration of the JYNNEOS vaccine.
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
2.1 Electronic consent via VAM3.3 Movement of vaccine3.4 VAM downtime4.1 Vaccine eligibility4.3 Additional designated clinics6. Additional sites for ID vaccination7.1 Administration of adrenaline by nurses in the event of an adverse event.
Monkeypox renamed to mpox 3.4. Removal of the vaccination administration management system (VAM) and record keeping requirements updated 4.3. Updated designated Vaccine sites
2.2. Update of prescriber setting requirements to Requirements for vaccine administration
4.2. Additional groups for vaccination updated
4.3. Updated designated Vaccine sites
Age recommendations changed in line with Australian Immunisation Handbook and ATAGI guidance.
Expansion of the eligibility criteria to include people who attend SOPVs and gender diverse and transgender people.
Enrolled nurses allowed to administer the Vaccine under supervision of a medical practitioner.
Pharmacist immunisers allowed to order and administer the Vaccine for PPV to non-pregnant eligible individuals aged 16 years and over.
JYNNEOS is now listed in the Australian Immunisation Handbook. Information that duplicates the handbook has been removed and the protocol should be used in conjunction with the AIH.
4.2. Vaccination sites no longer require individual CHO approval if they fall into authorised provider settings.
This protocol provides information on JYNNEOS, a vaccine indicated for the prevention of smallpox and mpox disease.
JYNNEOS has been made available in Australia under the Therapeutic Goods (Medicines – MVA-BN) (Emergency) Exemption) 2023 (as amended from time to time), which is an instrument made under section 18A of the Therapeutic Goods Act 1989 (Cth). The requirements set out in this protocol are directions of the CHO for the purposes of the Therapeutic Goods (Medicines – MVA-BN) (Emergency) Exemption) 2023 (as amended from time to time).
This protocol is subject to revision and may be updated in the future.
The following training requirements must be met by health practitioners prior to administration of the JYNNEOS vaccine:
The Vaccine can be supplied and administered by treating authorised prescribers. Registered and enrolled nurses, who are not authorised nurse/midwife immunisers, may administer at the direction and under the authority of a medical practitioner or under a medication standing order allowing the administration of the Vaccine.
Health practitioners operating under this Protocol must:
Information on JYNNEOS Vaccine is available in the Australian Immunisation Handbook Mpox (previously known as monkeypox) chapter.
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 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 to authorised vaccination sites within NSW in accordance with this protocol.
For distribution, the Vaccine will be transported either frozen or at +2°C to +8°C to authorised vaccination site or the hospital pharmacy.
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 B) 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 beyond 24 weeks at +2ºC to +8ºC after thawing from -50°C. Only an LHD or speciality network may move the Vaccine from one authorised vaccination setting to another and only in accordance with section 3.2. Recods must be maintained of any Vaccine redistribution.
Cold chain breaches should be reported to the public health unit (PHU) who must send the details of the breach to MOH-VaccReports@health.nsw.gov.au for further advice.
To reduce wastage, LHDs or speciality networks may move unexpired, unused Vaccine to authorised vaccination sites within LHDs and speciality networks subject to:
Unusable Vaccine and Vaccine waste products must be disposed of in designated clinical waste bins for destruction and records kept of Vaccine disposal.
Vaccine administration should be recorded in an appropriate medication record system and the Australian Immunisation Register (AIR) (unless a patient opts out of the Vaccine being recorded on AIR). Patients without a Medicare Card should be registered via the Individual Health Identifier (IHI) process. If Vaccine administration is not recorded on AIR, authorised vaccination providers must be able to provide a record of Vaccine use.
Processes must be in place in authorised vaccination sites 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 all vaccination sites are required to keep under this Protocol.
Suspected adverse events following immunisation (AEFI) must 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. Further information about AEFI can be found at Adverse events following immunisation (AEFI).
The CHO will keep records relating to the quantity, location, storage, transportation, supply, use and disposal of the Vaccine. Providers must keep a record of Vaccine received, used and disposed and these are required to be provided to the CHO upon request.
Primary preventative vaccination (PPV) against mpox is only available for:
sexually active transgender and gender diverse people, if at risk of exposure
sex workers, particularly those whose clients are at risk of mpox exposure
people who are attending sex on premises venues (SOPVs)
Post-exposure preventative vaccination (PEPV) is available for people categorised by Public Health Unit or medical practitioner as a high or medium risk mpox contact as per the NSW Health Control Guidelines for mpox a within the past 14 days. Risk assessment for people exposed to mpox (contacts) who are being assessed for PEPV is stratified by high, medium or low risk.
Eligible people under the age of 16 for both PPV and PEPV must only have vaccination administered after a risk assessment by a medical practitioner and vaccine administration should occur by an LHD or speciality network with paediatric services.
The Vaccine may only be administered to patients in an authorised vaccination setting or site. All authorised vaccination settings and sites must comply with this protocol. Authorised vaccination settings or sites must have or establish a system to order from the NSW State Vaccine Centre.
The following authorised vaccination settings may order and administer the Vaccine in compliance with this protocol:
Individual vaccination sites can be approved by the Director of Communicable Disease Branch, Executive Director of Health Protection NSW or the CHO provided that the approver is satisfied that:
These sites may include non-s100 GP practices, community pharmacies or additional sites as deemed suitable vaccination settings. Community pharmacies may only supply PPV against mpox via subcutaneous injection to non-pregnant eligible individuals aged 16 years and over as per the NSW Pharmacist Vaccination Standards. Authorised vaccination sites approved under a previous version of this protocol remain approved unless revoked by the CHO.
All public hospitals should have pathways in place to offer PEPV after-hours if required. These pathways must be developed in advance and are the responsibility of the public health unit in consultation with the LHD or speciality network Director of Clinical Governance.
For additional guidance on the provision of PEPV refer to the Post exposure preventative vaccination (PEPV) for mpox in NSW protocol (Appendix C).
Providers should remain up to date on any new advice from the Australian Technical Advisory Group on Immunisation (ATAGI), Australian Immunisation Handbook or Therapeutic Goods Administration (TGA) regarding JYNNEOS vaccine.
In NSW, JYNNEOS must be administered by subcutaneous injection. The preferred site is over the deltoid. In times of vaccination shortage, dose sparing administration by intradermal injection may be permitted if authorised by the CHO.
Treating authorised practitioners must ensure that consent has been obtained from the patient prior to Vaccine administration. A medical practitioner may direct a registered or enrolled 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.
The following steps must be followed when preparing for Vaccine administration:
