Understanding the characteristics of Comirnaty 30 Concentrate for adults and adolescents vaccine

Ian Allen, Pharmacy Quality Assurance Regional Specialist (NW), North West Pharmaceutical Quality AssurancePublished Last updated See all updates

An overview of the Comirnaty 30 Concentrate for adults and adolescents vaccine and signposts to other useful resources

Presentation

Comirnaty COVID-19 mRNA Vaccine 30micrograms/0.3ml dose concentrate for dispersion for injection multidose vials is presented in multi-dose vials for dilution with 1.8mL 0.9% sodium chloride solution for injection. We refer to it as Comirnaty 30 Concentrate in our web articles and SOPs. The vials contain 6 doses of 0.3mL.

Comirnaty 30 Concentrate is normally thawed by the NHS’s Specialist Pharmaceutical Logistics (SPL) providers before onward supply to the NHS at 2-8°C. The SPLs either:

  • attach a thaw label to the original “pizza box” carton of 195 vials
  • repackage a smaller number of vials into a labelled plain carton

The thaw label applied by SPLs bears the new shelf life between 2 and 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 30 Concentrate frozen at -90°C to -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.

Consumables and Patient Information Leaflets

Patient Information Leaflets, and syringes and needles for dilution and administration are provided with the vaccines.

Shelf life and storage

  • Comirnaty 30 Concentrate may be stored for up to 31 days between 2 and 8°C following thawing.
  • Within the 31 days, it may be stored for up to 2 hours at room temperature (between 8°C and 30°C) following removal from the refrigerator.
  • Once diluted the vaccine vial may be stored for up to 6 hours at room temperature (up to 30°C). This must be within the allowed use period of 31 days between 2°C and 8°C and 6 hours between 8°C and 30°C. However, from a microbiological point of view, unless the method of dilution 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

Undiluted vaccine

Transit of the undiluted product at 2-8°C can occur for a maximum of 48 hours. This may be broken into multiple separate journeys totalling no more than 48 hours.

It is assumed that 6 hours of transport time will already have been used during delivery to the NHS, which means that another 6 hours remain for transport once received by the NHS. The NHS logistics providers will inform the NHS if their journey has been longer than 6 hours.

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

Diluted vaccine

The diluted product may be moved during the 6 hours at room temperature. However, the vaccines contain no preservative and the method of dilution cannot preclude the risk of microbial contamination, so SPS advises that transport of diluted vials should not be routine.

The decision to move diluted Comirnaty 30 concentrate 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 diluted.

Preparation

After dilution with 1.8mL 0.9% sodium chloride solution for injection, each vial contains 6 doses. Diluted vaccine should be used as soon as practically possible, and within 6 hours.

Detailed advice about preparation, including a model standard operational procedure and work instruction can be found on our Comirnaty 30 Concentrate preparation page.

Risk management

It is possible that Comirnaty 30 concentrate 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 30 concentrate 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 30 micrograms/dose concentrate for dispersion for injection 12+ years COVID-19 mRNA Vaccine (nucleoside modified)

Manufacturers Supporting Information

www.comirnatyeducation.co.uk

Cold chain management

Maintaining the COVID-19 vaccines cold chain

Change history

  1. Hyperlink to Good governance when handling multiple Covid-19 vaccines updated
  1. Published