Presentation

VidPrevtyn Beta solution and emulsion for emulsion for injection is presented in two multidose vials (antigen vial and adjuvant vial) that must be mixed before use. We refer to it as VidPrevtyn Beta in our web articles and Standard Operating Procedures (SOPs). After mixing, the vaccine vial contains 10 doses of 0.5 mL.

VidPrevtyn Beta is stored and supplied between 2°C to 8°C in packs containing 10 antigen vials and 10 adjuvant vials (100 doses per pack).

Further information about the supply of VidPrevtyn Beta may be found on our Ordering, receipt & storage of COVID-19 Vaccines page.

Carton / Vial Presentation

Cartons

           

The outer carton (co-pack) contains one carton of 10 antigen vials and one carton of 10 adjuvant vials.

The batch number on the outer carton (co-pack) should always be used when making records relating to the vaccine. This allows both the antigen carton/vials and adjuvant carton/vials, which have independent batch numbers, to be traced.

 

Vial artwork

Antigen vial label 2.5mL (10 doses after mixing)                            Adjuvant vial label 2.5mL

                                                

Consumables and Patient Information Leaflets

Patient Information Leaflets are provided with the vaccines. Combined needle/syringes for dilution or administration will need to be ordered separately.

Shelf life and storage

VidPrevtyn Beta has a manufacturer’s shelf life of 1 year stored between 2°C to 8°C.

After mixing, the SmPC says that the product should be returned to storage at 2°C to 8°C and protected from light between every dose and used within 6 hours.

However, returning the mixed vial to these conditions between every dose may be impractical. A MHRA review of quality data has shown that the mixed antigen/adjuvant VidPrevtyn Beta is stable at room temperature up to 27°C for several hours. Therefore,

• During the in use period, when doses are being withdrawn from the vial and administered, the vial may remain at room temperature (up to 25°C according to SPC) and exposed to room light. This may include the time it takes to move short distances between patients e.g. in a care home, or the time between patients in a clinic.
• If within the work session there is no immediate need to withdraw further doses, the vial should be returned to storage between 2-8°C in a container which protects the vial from light and maintains segregation from the un-mixed vials. The vial must be discarded 6 hours after mixing.

This is consistent with the guidance in the Green Book.

From a microbiological point of view, unless the method of puncture precludes the risk of microbial contamination, the product should be used as soon as practically possible.

There is no additional data available regarding temperature excursions, and the Sanofi Medical Information Department (uk-medicalinformation@sanofi.com) should be contacted in the event of an excursion. Sanofi state that “each incidence of a temperature excursion is handled on a case by case basis, depending on the maximum temperature reached and the time that the vaccine was stored out of range. As a result, these details are required in every case before Sanofi can provide any further advice.”

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

Unmixed vaccine

The manufacturer does not specify any restriction on transport of the vaccine prior to mixing.

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

Mixed vaccine

The manufacturer does not specify any restriction on transport of the vaccine after to mixing. However, the vaccines contain no preservative and the method of puncture cannot preclude the risk of microbial contamination, so SPS advises that transport of mixed vials should not be routine.

The decision to move mixed VidPrevtyn Beta 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 mixed 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

VidPrevtyn Beta is presented as two multidose vials (antigen vial and adjuvant vial) that must be mixed before use. After mixing, the vaccine vial contains 10 doses of 0.5 mL.

The amount of adjuvant provided in the adjuvant vial may vary between 2.85 mL and 3.25 mL. Nonetheless, the complete volume of adjuvant should always be transferred into the antigen vial. The overfill is required by health authorities to guarantee that 10 doses of 0.5 mL vaccine can be delivered.

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

Risk management

It is possible that VidPrevtyn Beta 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

VidPrevtyn Beta has a Marketing Authorisation (PLGB) in the UK.

Allergy, excipients and dietary advice

VidPrevtyn is contraindicated in those with a hypersensitivity to the active substance, any excipient (ingredient) in the vaccine or to octylphenol ethoxylate (a trace residual). However, vaccination may be possible on the advice of an expert (e.g. allergy specialist). See the Summary of Product Characteristics (SPC) for full details of the active substance, trace residuals and excipients included in the vaccine.

VidPrevtyn contains polysorbate 20 and polysorbate 80; rarely people with allergy to polyethylene glycol (PEG) may also be allergic to polysorbate 80. See the Green Book Chapter 14a: COVID-19 for details on how to manage individuals with a history of allergy.

The SPC for VidPrevtyn does not indicate presence of egg, gluten, nut, soy or latex. It does however, list squalene (a naturally-occurring oil found in humans, plants and animals) as an adjuvant. The vaccine is also produced by recombinant DNA technology from a baculovirus expression system in an insect line that is derived from Sf9 cells of the fall armyworm. Therefore, this vaccination may not be suitable for people with certain dietary or religious preferences. Further information has been requested from the manufacturer (particularly around the source of squalene used as an adjuvant), in the interim contact the manufacturer directly if you require further detail.

Useful resources

Refer to the following recommended resources for further information.

Summary of Product Characteristics

VidPrevtyn Beta solution and emulsion for emulsion for injection

Manufacturer’s Supporting Information

Awaiting link from manufacturer

Cold chain management

• Maintaining the COVID-19 vaccines cold chain

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