Understanding the characteristics of Spikevax Original vaccine

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

An overview of the Spikevax Original vaccine and signposts to other useful resources

Presentation

Spikevax COVID-19 mRNA (nucleoside modified vaccine 0.1mg/0.5mL dose dispersion for injection (Spikevax Original) is presented in multi-dose vials in a ready to administer form. We refer to it as Spikevax Original in our web articles and SOPs.

Each vial 5mL vial contains 10 x 0.5mL primary course doses or 20 x 0.25mL booster doses

Spikevax Original 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 Spikevax Original frozen at -25°C to -15°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 are provided with the vaccines.

Shelf life and storage 

  • Spikevax Original may be stored for up to 30 days at 2-8°C following thawing.
  • Within the 30 days, it may be stored for up to 24 hours at room temperature (between 8°C and 25°C) following removal from the refrigerator.
  • Once punctured, the vaccine vial may be stored for up to 6 hours at room temperature up to 25°C, (within the allowed use period of 30 days at 2°C – 8°C and 24 hours at 8°C – 25°C). 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

Transit of unpunctured vials at 2-8°C can occur for a maximum of 12 hours. This may be broken into multiple separate journeys totalling no more than 12 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.

Punctured vaccine

The decision to move punctured vials 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

Spikevax Original is presented as a ‘ready to use’ formulation

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

Risk management

It is possible that Spikevax Original 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

Spikevax Original 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

Spikevax COVID-19 mRNA Vaccine (nucleoside modified)

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