Understanding the characteristics of Comirnaty 10 Concentrate (for children 5-11 years) vaccine

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

An overview of the Comirnaty 10 Concentrate for Children 5 to 11 years vaccine and signposts to other useful resources

Presentation

Comirnaty Children 5-11 years COVID-19 mRNA Vaccine 10micrograms/0.2ml dose concentrate for dispersion for injection (Comirnaty 10 Concentrate) is presented in multi-dose vials for dilution with 1.3mL 0.9% sodium chloride solution for injection. We refer to it as Comirnaty 10 Concentrate in our web articles and SOPs.

Comirnaty 10 Concentrate is normally thawed by the NHS’s Specialist Pharmaceutical Logistics (SPL) providers before supply to the NHS. The SPLs supply thawed cartons each containing 10 multidose vials.

The thaw label applied by SPLs bears the new shelf life at 2-8°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 10 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 10 Concentrate may be stored for up to 10 weeks at 2-8°C following thawing.
  • Within the 10 weeks, it may be stored for up to 24 hours at room temperature (between 8ºC and 30°C) following removal from the refrigerator.
  • Once diluted 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 – 8°C and 24 hours at 8°C – 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

Undiluted vaccine vials stored at 2-8°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.

Diluted vaccine

The diluted product may be transported for up to 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 10 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 1.3mL 0.9% sodium chloride solution for injection, each vial contains 10 doses.  Diluted vaccine should be used as soon as practically possible, and within 12 hours.

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

Risk management

Comirnaty 10 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 10 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 10 micrograms/dose concentrate for dispersion for injection Children 5 to 11 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 the Good Governance when handling multiple vaccines updated
  1. Published