In addition to our SOPs, further points of clarification related to preparation and administration are as follows.
Diluent supplied with vaccine
PHE Operating Model for storage and UK distribution of vaccine advises that the correct number of packs of diluent will be delivered with each pack of vaccine. Note that the MHRA Information for Healthcare Professionals highlights that the diluent is not provided in the vaccine carton.
Incorrect diluent used – action to take
MHRA Information for Healthcare Professionals advises that sodium chloride 0.9% solution for injection (preservative-free) is the only diluent that can be used to dilute the Pfizer-BioNTech COVID-19 vaccine. If you have used another diluent, the vial should be discarded. PHE guidance for healthcare practitioners provides information on when and how to report errors relating to preparation or administration.
Withdrawing a sixth dose
On 24th December 2020 the MHRA Information for Healthcare Professionals was updated to reflect the potential for 6 doses being extracted from the diluted vial.
This now states that the vial volume was optimised to reliably obtain 5 doses regardless of syringe type used as most syringe and needle combinations require withdrawal of excess volume in order to ensure the full 0.3 mL dose of vaccine can be administered. After correct dilution of the product and when low dead-volume syringes and/or needles are used, the amount remaining in the vial after 5 doses have been extracted may be sufficient for an additional (sixth) dose. The Patient Group Direction (PGD) was updated on the 5th January 2021 and the National Protocol was updated on the 10th January 2021 to allow for the sixth dose to be administered from a vial under this mechanism if a full 0.3ml dose can be extracted.
Care should be taken to ensure a full 0.3 mL is administered to the individual and that all doses from a single prepared vial are administered within 6 hours of the time of dilution. Any unused vaccine should be discarded 6 hours after dilution.
Observation following administration
Immediately post vaccination
Public Health England’s Immunisation Against Infections Disease (the Green book) states that recipients of the Pfizer-BioNTech COVID-19 vaccine should be kept for observation and monitored for a minimum of 15 minutes in all delivery settings.
Monitoring for adverse effects
Supervision should always be readily available in case of an anaphylactic event following the administration of any vaccine.
Public Health England’s Immunisation Against Infections Disease (the Green book) states that the British Society for Allergy and Clinical Immunology (BSACI) advises that individuals with a local urticarial (itchy) skin reaction (without systemic symptoms) to the first dose of any COVID-19 vaccine should receive the second dose of vaccine with prolonged observation (30 minutes) in a setting with full resuscitation facilities (e.g. a hospital).
Information related to batch numbers removed. Information now on the generic all vaccine administration and preparation page
Page title changed from "Administering the Pfizer-BioNTech COVID-19 Vaccine"
Information on diluents added
Detail added on checking batch numbers
Observation following administration added
Page summary and purpose changed to reflect additions