Authorisation and marketing authorisation
Changes in August 2021
Pfizer-BioNTech Vaccine was originally authorised for use under Regulation 174 of the Human Medicines Regulations. The vaccine will be available as Comirnaty brand in August 2021 since this has now received a conditional Marketing Authorisation (CMA).
The SPC for the Comirnaty branded product has key differences to the Conditions of Authorisation from the Regulation 174 product. The appropriate manufacturer’s conditions must be followed depending on which product is currently in use. Furthermore, there are changes to the packaging and supplementary labelling of the Comirnaty branded product, which impact on its safe operational use.
Please note that initial supplies of Comirnaty will bear the EU marketing authorisation number (EU/1/20/1528/001) rather than the PLGB number (PLGB 53632/0002). This is expected and has been authorised by the MHRA. Later stocks of Comirnaty are expected to be labelled with a PLGB number.
SPS approach for SOPs
During the introduction of the new product, both the Comirnaty and Regulation 174 product will be in use at the same time. To reduce the risk of products being used or stored outside of the manufacturer’s conditions, our standard operating procedures clearly state when different requirements apply to Comirnaty and Regulation 174 stock.
Changes affecting Comirnaty and R174 stock
Changes from previous manufacturer’s recommendations affecting both Comirnaty and Regulation 174 stock.
The MHRA has agreed that room temperature storage of undiluted vials is now allowed up to 30°C for 2 hours
Maximum allowed transport time of thawed undiluted vials remains at 12 hours at 2-8C. However, the restriction to two separate 6 hour journeys has been removed; there is no maximum number of journeys the undiluted vial can make in 12 hours.
We recommend that robust local systems are required to monitor and control the total time in transport to ensure the 12 hour maximum is not exceeded, and to guarantee and communicate that the cold chain has been maintained whenever transported.
Differences between Comirnaty and R174 stock
Differences between manufacturer’s recommendations exist between Comirnaty and regulation 174 stock.
The frozen storage temperature range is specified as between -90°C to -60°C for Comirnaty and as between -80°C to -60°C for Regulation 174 stock.
For Comirnaty, room temperature storage of both undiluted and diluted vials is allowed at temperatures up to 30°C within the time periods defined in the SPC. For Regulation 174 stock, room temperature storage of the undiluted vial is allowed up to 30°C and for the diluted vial up to 25°C as defined in the R174 Information for Health care Professionals.
Transport after dilution
For Comirnaty only, chemical and physical stability during transportation after dilution has been demonstrated for 6 hours at 2°C to 30°C.
However, the Comirnaty COVID-19 vaccine contains no preservative and the method of dilution cannot preclude the risk of microbial contamination, therefore the SPS advises that transport of diluted vials should not be routine and should be at 2-8°C. For further information see our institutional readiness guidance or SOP for transport to end user PCN locations.
Differences with Comirnaty product packaging
Differences between product packaging exist between Comirnaty and Regulation 174 stock. The following affect Comirnaty.
Labelling vial expiry time
The Comirnaty vial label has a space to record the expiry date and time not the date and time of dilution. This difference must be effectively communicated to all staff involved in preparation of the vaccine to prevent errors in recording and reading the information on the vial label. See SOP for preparation in Trusts, SOP for preparation for PCN end-user locations, and SOP for preparation for PCN designated sites for further details.
Pfizer is no longer providing separate thaw labels. A space is now available on the secondary packaging (outer carton) to add the 31-day expiry date with an indelible permanent marker (e.g. a Sharpie). The 31 day post thaw expiry is now rounded to the full day. See SOP for unpacking frozen vaccine and transferring to fridges and SOP for moving from an ULT freezer to thaw in a fridge in Trusts for details.
When individual vials are thawed, a locally prepared thaw label is required to track the vial’s thawed expiry. See SOP for thawing small numbers of vials for details.
Handling multiple vaccines
Familiarise yourself with our general advice on this issue
- updated with a note about use of EU MA number on the first supplies and published by TR