Authorisation for use

The MHRA’s conditions of authorisation and the information for healthcare professionals and recipients outlines the framework through which the vaccine can be used.

Storing vaccine appropriately

Effective process control is essential to ensure that vaccines are stored correctly and new expiry dates and times are allocated.

Storage prior to dilution

COVID-19 Vaccine Pfizer-BioNTech may be stored for up to 31 days between 2ºC and 8ºC, followed by an additional 2 hours at room temperature.

Storage subsequent to dilution

After dilution the vaccine should be used as soon as practically possible and within 6 hours.

Further detail on storage

Handling and preparing vaccine

Dilution

The COVID-19 Vaccine Pfizer BioNTech is a multi-dose vial containing a concentrate. It must be further diluted with preservative free sodium chloride 0.9% before being withdrawn into syringes for administration. Robust systems are required to prevent inadvertent administration of the concentrate vaccine, and to ensure vials of concentrate are effectively segregated from diluted vials. Only one vial of vaccine should be in use at any one time.

Full process

Pfizer has produced a training video which shows the correct handling and preparation of the COVID-19 Vaccine Pfizer-BioNTech.

Each step of the process described changes the vaccine characteristics that will require a change in the shelf life. This requires diligent process control to ensure the vaccine is safe and effective at the point of use.

Extracting additional doses

The vials are multi dose containers for dilution and contain 6 doses in each vial.

After dilution, vials of COVID-19 Vaccine Pfizer-BioNTech contain 6 doses of 0.3 mL of vaccine. The regulatory Information for Healthcare Professionals states that in order to extract 6 doses from a single vial, low dead-volume syringes and needles should be used. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.

When extracting additional doses, also remember (irrespective of the type of syringe and needle used) that:

• Each dose must contain 0.3 mL of vaccine
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
• You should not pool excess vaccine from multiple vials

If it is not possible to withdraw a 6th dose, the category “no 6th dose available” should be recorded as a free text comment on the Foundry stock control system.

Administration

Administration requires diligent process control to ensure the vaccine is safe and effective at the point of use.

Use in relation to prior allergy

Administration requires diligent process control to ensure the vaccine is safe and effective at the point of use.

Process flow for vaccination session

A diagram giving an overview of the process during a vaccination session is attached below.

• Overview_of_the_Pfizer-BioNTech_COVID-19_Vaccine_pathway_during_a_vaccination_session_v1 · PDF · 218 KB

SOPs, work instructions and checklists to adapt

Relevant Standard Operating Procedures, work instructions and checklists are available below. These may be adapted by Superintendent Pharmacists for use in Community Pharmacy settings.

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