Understanding the characteristics of Spikevax Bivalent vaccine

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

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

Presentation

Spikevax bivalent Original / Omicron 0.10 mg/mL dispersion for injection is presented in multi-dose vials in a ready to administer form. Both 2.5ml (5 x 0.5mL dose) and 5mL (10 x 0.5mL dose) vials are available. We refer to it as Spikevax Bivalent in our web articles and SOPs.

Spikevax Bivalent is normally thawed by the NHS’s Specialist Pharmaceutical Logistics (SPL) providers before onward supply to the NHS at 2-8°C. The SPLs supply whole 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 Bivalent 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.

Initial Supply

The initial supply of Spikevax Bivalent Original / Omicron will have different carton and vial labels to the licensed product, and will carry the description “0 (Zero) / O (Omicron)” on the carton artwork and “0/O” on the vial label. The product, although packaged differently initially, is the Spikevax Bivalent product.

Spikevax bivalent initial 2.5mL label

Spikevax bivalent initial 5mL label

Spikevax bivalent subsequent 2.5mL label

Supply with the licensed carton and vial artwork will be introduced from Q4 2022 onwards. For further information, including label artwork, see the Direct Healthcare Professional Communication issued by Moderna.

Consumables and Patient Information Leaflets

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

Shelf life and storage

  • Spikevax Bivalent may be stored for up to 30 days between 2 and 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 between 2°C and 8°C and 24 hours between 8°C and 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 Vials

Transit of unpunctured vials between 2 and 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 Vials

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 Bivalent is presented as a ‘ready to use’ formulation

Each dose is 0.5mL. Be aware, this is different to the booster course dose volume for Spikevax Original vaccine.

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

Risk management

Spikevax 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

Spikevax 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.

Initial stock supplied into the UK  will be labelled as Spikevax “(0 (Zero) / O (Omicron)” and do not have any marketing authorisation number on the carton. The MHRA have reviewed and approved the data for these products as “Batch Specific Variations” and therefore they are approved to be used as licensed vaccines. For further information see the Direct Healthcare Professional Communication issued by Moderna.

Useful resources

Refer to the following recommended resources for further information.

Summary of Product Characteristics

Spikevax bivalent Original / Omicron 0.1 mg/mL dispersion for injection

Cold chain management

Maintaining the COVID-19 vaccines cold chain