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
Storage requirements for each COVID-19 Vaccine
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 It must be further diluted with preservative free sodium chloride 0.9% before being withdrawn into syringes for administration.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.
Advising individuals with allergies on their suitability for COVID-19 Vaccine Pfizer-BioNTech
Process flow for vaccination session
A diagram giving an overview of the process during a vaccination session is attached below.
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.
Receiving and storing the COVID-19 Vaccine Pfizer-BioNTech at PCN designated sites
Preparing the COVID-19 Vaccine Pfizer-BioNTech at PCN designated sites
Stocktaking and reconciliation of COVID-19 Vaccine Pfizer-BioNTech at PCN designated sites
Disposing of damaged, unused or expired COVID-19 Vaccine Pfizer-BioNTech at PCN designated sites
Dealing with spillages and breakages of COVID-19 Vaccine Pfizer-BioNTech at PCN Designated Sites
Transporting COVID-19 Vaccine Pfizer-BioNTech from Designated Sites to end user location
Preparing COVID-19 Vaccine Pfizer-BioNTech Syringes for Administration at end user locations
Change history
- Amended in line with introduction of licensed Comirnaty product. Link to allergy page mended.
- Storage conditions amended to 31 days in the fridge
- Published