Preparing and administering the COVID-19 Vaccine Pfizer-BioNTech

Tim Meadows, Medicines Information Pharmacist, Midlands and East Medicines Advice Service (East site)Published Last updated See all updates

Preparing vaccine using our SOPs, plus additional advice on diluent use, post-vaccination observation and driving advice

Guidance on handling and Standard Operating Procedures (SOPs)

Our guidance and standard operating procedures specific to handling and preparation cover many points and can be found below.

Additional clarifications

In addition to our SOPs, further points of clarification related to preparation and administration are as follows.

Using diluents

Diluent supplied with vaccine

UK Health Security Agency (UKHSA – formerly known as 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 and the Summary of Product Characteristics 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. UK Health Security Agency (UKHSA – formerly known as PHE) guidance for healthcare practitioners provides information on when and how to report errors relating to preparation or administration.

Observation following administration

Monitoring for adverse effects

The Summary of Product Characteristics for the Pfizer-BioNTech COVID-19 vaccine states that events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

Immediately post vaccination

No observation period is necessary in individuals aged 12 years and over who have no history of a severe allergic reaction. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place.

UK Health Security Agency (UKHSA – formerly known as PHE) Immunisation Against Infectious Disease (the Green Book) recommends a 15-minute observation period post-vaccination for those individuals who had non-allergic reactions such as vasovagal episodes, non-urticarial skin reaction or non-specific symptoms following previous vaccine doses.

Advising individuals with allergies on their suitability for COVID-19 Vaccine Pfizer-BioNTech provides guidance on the monitoring requirements for those with a history of allergic reactions.

Driving advice

UK Health Security Agency (UKHSA – formerly known as PHE) Immunisation Against Infectious Disease (the Green Book) states that as fainting can occur following vaccination, all those vaccinated with any of the COVID-19 vaccines should not drive for 15 minutes after vaccination.

Administering to patients with a previous allergy status

Advising individuals with allergies on their suitability for COVID-19 Vaccine Pfizer-BioNTech

Advice on whether people with a previous allergic reaction can have the COVID-19 Vaccine Pfizer-BioNTech (Comirnaty).

Change history

  1. Information on observation recommendations updated in-line with current recommendations. References to Omicron variant removed.
  1. All information resources checked and information up to date.
  1. Information on observation recommendations for individuals that experienced non-allergic reactions to a previous dose added. Advice for individuals driving after vaccination added.
  1. Updated to reflect suspension of the 15 minute observation period following administration to those without a history of allergy.
  1. Statement from British Society for Allergy and Clinical Immunology (BSACI) removed as link available to 'administering to patients with a previous allergy status' page with associated tool.
  1. Information related to withdrawing a sixth dose removed as this is now standard practice
  1. Section on administering to patients with a previous allergy status added with link
  1. Information related to batch numbers removed. Information now on the generic all vaccine administration and preparation page
  1. Observation following administration added
  2. Page summary and purpose changed to reflect additions
  3. Detail added on checking batch numbers
  4. Information on diluents added
  5. Page title changed from "Administering the Pfizer-BioNTech COVID-19 Vaccine"
  1. Published