Presentation
Comirnaty JN.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) bretovameran is presented in a single dose vial. We refer to it as Comirnaty 10 (JN.1) ready to use in our web articles and SOPs. The vials contain one dose of 0.3mL.
Comirnaty 10 (JN.1) ready to use is thawed by the NHS’s Specialist Pharmaceutical Logistics (SPL) providers before onward supply to the NHS at 2 to 8°C. The SPLs attach a thaw label to the original carton of multidose vials.
The thaw label applied by SPLs bears the new shelf life at 2 to 8°C. The vials inside the cartons are not labelled with the post thaw expiry date so it is essential that the vials remain within their carton until the point of removal from the fridge for immediate use.
Further information may be found on our Ordering, receipt & storage of COVID-19 Vaccines page.
Carton / Vial Artwork
Carton artwork
Vial artwork
Consumables and Patient Information Leaflets
Patient Information Leaflets, and syringes and needles for administration are provided with the vaccines.
Shelf life and storage
- Comirnaty 10 (JN.1) ready to use may be stored for up to 10 weeks at 2 to 8°C following thawing.
- Within the 10 weeks, it may be stored for up to 12 hours at room temperature (between 8°C and 30°C) following removal from the refrigerator before use.
- The manufacturer’s summary of product characteristics contains additional information on the handling of temperature excursions.
Transport and movement
Unpunctured vaccine vials stored at 2 to 8°C may be transported throughout their 10-week post-thaw shelf life.
Further information can be found in our Transport of COVID-19 vaccines article.
Preparation
Comirnaty 10 (JN.1) ready to use is presented as a ‘ready to use’ formulation
Detailed advice about preparation, including a model standard operational procedure can be found on our Comirnaty 10 (JN.1) ready to use preparation page.
Risk management
It is possible that Comirnaty 10 (JN.1) ready to use will be handled in the same location as other vaccines. Following the guidance on Handling multiple COVID-19 Vaccines will reduce the risk of errors.
Licensed status
Comirnaty 10 (JN.1) ready to use has a Marketing Authorisation (PLGB) in the UK.
Some of the vaccine vials being supplied to the UK have been labelled for the European market and so bear an EU marketing authorisation number rather than the PLGB number, and have one or more EU Patient Information Leaflets (PILs) in the carton. These vials are still considered licensed in the UK, but the EU PILs should not be given to patients. GB PILs are provided with the vaccines.
Allergy, excipients and dietary advice
Comirnaty 10 (JN.1) ready to use is contraindicated in those with a hypersensitivity to the active substance or to any excipient (ingredient) in the vaccine, although revaccination may be possible on the advice of an expert (e.g. allergy specialist). See the Summary of Product Characteristics (SPC) for full details of the active substance and excipients included in the vaccine.
Allergy to any excipient is possible, but polyethylene glycol (PEG) is of particular importance. See the Green Book Chapter 14a: COVID-19 for details on how to manage individuals with a history of allergy.
Comirnaty 10 (JN.1) ready to use is free from gluten, nut, soy, latex and animal products such as egg. However, as with most pharmaceutical products the manufacturer cannot guarantee that minute amounts of substances (listed previously) are not contained in raw materials from their suppliers, or that the product has not come into contact with latex during the manufacturing process.
Useful resources
Refer to the following recommended resources for further information.
Summary of Product Characteristics
Comirnaty JN.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
Manufacturer’s Supporting Information
Update history
- Published