Understanding the characteristics of Comirnaty Bivalent vaccine

Ian Allen, Pharmacy Quality Assurance Regional Specialist (NW), North West Pharmaceutical Quality AssurancePublished

An overview of the Comirnaty Bivalent vaccine and signposts to other useful resources

Presentation

Comirnaty Original/Omicron BA.1 COVID-19 mRNA Vaccine 15micrograms/15micrograms/0.3ml dose dispersion for injection is presented in multi-dose vials. We refer to it as Comirnaty Bivalent in our web articles and SOPs. The vials contain 6 doses of 0.3mL.

Comirnaty Bivalent is normally 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 10 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.

Some hospitals and vaccination centres may receive Comirnaty Bivalent frozen at ultra low temperature (-90°C and -60°C), and will need to thaw the vaccine locally. Further information may be found on our Ordering, receipt & storage of COVID-19 Vaccines page.

Carton / Vial Artwork

The supply of Comirnaty Bivalent Original / Omicron BA. 1 in the UK will have different carton and vial labels to the licensed product, and will carry the description “tozinameran / riltozinameran” on the carton artwork and vial label. See images below:

Initial supply carton artwork

Initial supply 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 Bivalent 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 24 hours at room temperature (between 8°C and 30°C) following removal from the refrigerator.
  • Once punctured the vaccine vial may be stored for up to 12 hours at room temperature (up to 30°C). This must be within the allowed use period of 10 weeks at 2°C to 8°C and 24 hours at 8°C to 30° However, from a microbiological point of view, unless the method of puncture precludes the risk of microbial contamination, the product should be used immediately.

Shelf life extensions

From time to time, variations to the marketing authorisation may mean that some batches may have shelf lives beyond the labelled manufacturer’s expiry date. If there are any applicable shelf life extensions, they will be listed on our vaccine expiry extension page.

Transport and movement

Unpunctured vaccine

Unpunctured vaccine vials stored at 2to 8°C may be transported throughout their 10 week post-thaw shelf life.

Further information can be found on our Transport of COVID-19 vaccines article and our Mutual Aid guidance.

Punctured vaccine

The punctured vaccine may be transported for up to 6 hours at room temperature. However, the vaccines contain no preservative and the method of puncture cannot preclude the risk of microbial contamination, so SPS advises that transport of punctured vials should not be routine.

The decision to move punctured Comirnaty Bivalent between locations within the same legal entity must include an assessment of the risk of microbial contamination and proliferation versus risk of wastage and loss of opportunities to administer vaccines at alternative locations.

Any decision to move punctured vials must be made locally under the direction of the Chief Pharmacist or site lead pharmacist, taking the specific circumstances into account, and using appropriate risk control measures such as temperature control, infection prevention and control, and a means to identify that the vial has been punctured.

Preparation

Comirnaty Bivalent is presented as a ‘ready to use’ formulation

Detailed advice about preparation, including a model standard operational procedure can be found on our Comirnaty Bivalent preparation page .

Risk management

It is possible that Comirnaty Bivalent 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 Bivalent has a Conditional 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.

Useful resources

Refer to the following recommended resources for further information.

Summary of Product Characteristics

Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection

Cold chain management

Maintaining the COVID-19 vaccines cold chain