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
This protocol provides information on JYNNEOS, a vaccine indicated for the prevention of smallpox and mpox 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 mpox 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 mpox 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).
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:
Medical practitioners operating under this protocol must:
All prescriver and vaccine administrators must ensure that consent has been obtained from the patient.
The Vaccine may be administered by registered nurses only at the direction and under the authority of a medical practitioner.
All designated vaccine locations 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 all vaccination settings are required to keep under this Protocol.
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 mpox 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).
JYNNEOS must only be administered by subcutaneous injection in the deltoid.
For PrEP, a complete vaccination course with JYNNEOS requires two doses, which must be given at least 28 days apart.
If a vaccine course was commenced using the intradermal route for the first dose, it can be completed by subcutaneous injection for the second dose.
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 mpox if they are exposed to an infected person. People at high risk of mpox infection who have received a smallpox vaccine dose more than ten years prior are recommended to receive a booster dose.
For PEP, a single dose is recommended for protection against contracting mpox 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 mpox.
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).
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 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 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).
The Vaccine can only be moved from one provider to another in accordance with the conditions set out in the "Licence to supply by wholesale poisons and restricted substances – Licence No LHD 005" dated 20 December 2022 (as amended from time to time) (Licence). The Licence requires the licensee to comply with the directions regarding the Vaccine as set out in this protocol (as amended from time to time at the direction of the Chief Health Officer).
If there is a cold chain breach, contact the public health unit (PHU) on 1300 066 055. Where the event is specifically related to mpox 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.
Vaccine administration must be recorded into the eMR and / or other specific vaccination record for loading the information up to the Australian Immunisation Register (AIR). Patients without a Medicare Card can be registered via the Individual Health Identifier (IHI) process. If Vaccine administration is not recorded on AIR, clinics must be able to provide a record of Vaccine use.
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 upon request.
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.
As a result of receiving additional vaccine supplies, NSW now has sufficient vaccine to vaccinate the following persons at greatest risk of mpox:
The following groups will also be prioritised for vaccination:
This is applicable as at the date of this Protocol, however is subject to revision.
Vaccination (including for PEP) can occur at any of the following locations:
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 mpox in NSW protocol at Appendix F)
Providers should maintain familiarity with the Australian Technical Advisory Group on Immunisation clinical guidance for monkeypox vaccination
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.
Below is the protocol for administration of the JYNNEOS smallpox/mpox vaccine for people 18 years of age and over, in authorised settings.
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.
see section 4.1
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).
0.5 mL suspension administered subcutaneously for patients 18 years and older.
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.
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).
No interaction studies with other vaccines or medicinal products have been performed.
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.
If expert advice is needed, the medical officer can contact the NSW Immunisation Specialist Service (NSWISS) on 1800 679 477.
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.
