The legal mechanisms available for giving COVID-19 vaccines and their application

Tracy Rogers, Director, Medicines Use & Safety, Medicines Use and Safety TeamPublished Last updated See all updates

A summary of the different legal mechanisms available, a priority order for the options, and advice on their application to different professional groups.

Introduction

All injectable medicines are Prescription Only Medicines (POM). Therefore they must be prescribed prior to administration or administered under an alternative legal mechanism.
Below we summarise the available mechanisms, signpost to available resources that describe them, and give common points of clarification concerning their use for COVID-19 vaccination.
This page should be read in conjunction with NHS England’s Summary of the legal mechanisms for administering the COVID-19 vaccine(s).

Option 1: National Protocol

This is the primary mechanism for the majority of deployment models. It can be used by a single registered healthcare professional undertaking all stages of the vaccination process, or by up to four persons undertaking different stages, as detailed in the national protocol. It has been introduced specifically to support the vaccination programme and is a new legal mechanism following amendment of the Human Medicines Regulations.

Hence, the protocol allows a wider range of suitably trained and competent persons to deliver the vaccination programme. The operational stages of activity that can be undertaken by registered and non-registered persons, are detailed in:

Common national protocol clarifications

Local authorisation

The National Protocols do not require local authorisation.

Option 2: National Patient Group Direction (PGD)

This mechanism fits the deployment method where a single registered healthcare professional undertakes the entire process. The registered HCP must be listed in the Patient Group Directions: Who can use them guidance from gov.uk.

Under a PGD all stages must be undertaken by the same registered healthcare professional; if any part of the process is undertaken by another person, then the National Protocol should be used and not the PGD.

The PGD is an option where a specified registered healthcare professional is working without the clinical supervision of a doctor, nurse or pharmacist which is a requirement of the National Protocol.

For the national COVID-19 vaccine PGD, refer to NHS England’s:

You can find more background information about PGDs in our guide An introduction to PGDs: definitions and examples of use

Common PGD clarifications

Delegation

Delegation of responsibilities to another healthcare professional is not permissible. All aspects of use covered by the PGD including clinical assessment, preparation (drawing up), administration, and record keeping must be undertaken only by the same registered healthcare professional working under this direction. See our guide Delegation of supply or administration of medicines using a Patient Group Direction

Exception to delegation for Pfizer-BioNTech vaccines

The dilution stage only for Pfizer-BioNTech vaccines can be undertaken by another suitably trained person, under the supervision of a doctor, nurse or pharmacist (Regulation 3A).

Local authorisation

The national PGDs do not require local authorisation.

Doctors, dentists, and PGDs

Doctors and dentists cannot work under a PGD. See our guide Doctors, dentists, and use of PGDs

Option 3: Patient Specific Directions (PSDs)

Where an individual falls outside the inclusion criteria stated in the National Protocol or PGD, they need to be clinically assessed on an individual basis to receive vaccine by a prescriber. If this results in a decision to vaccinate, a PSD should be used.
For background on PSDs, refer to our guide Questions about Patient Specific Directions (PSD)
With specific reference to COVID-19 vaccination, NHS England has produced a PSD proforma in appendix B of NHS England’s Legal mechanisms for administration of the COVID-19 Vaccine(s).

Common PSD vaccination clarifications

Doctors and independent prescribers can write a PSD for a COVID-19 vaccine with a UK marketing authorisation if clinically competent. Dentists should see our specific advice.

Use for health and social care staff

A PSD is a suitable mechanism to vaccinate health and social care staff. See also Questions about Patient Specific Directions (PSD)

Use at mass vaccination sites and in Primary Care Network (PCN) designated sites

A PSD is a suitable mechanism to vaccinate eligible individuals at mass vaccination sites and in PCN Designated Sites. See also Questions about Patient Specific Directions (PSD)

Use of a PSD including when the prescriber is working remotely

A PSD is a suitable mechanism for use by prescribers, including those working remotely, across PCN sites. However, the prescriber must:

  • accept their duty of care and professional and legal accountability—they should ensure that the person to whom they delegate has the qualifications, experience, knowledge and skills to provide the care or treatment involved.
  • the practitioner issuing the PSD remains responsible for the care delivered under it and should be contactable should issues arise.
  • be mindful that the delivery model may require Regulation 3A The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 to be met (i.e. where the vaccine is not prepared and administered by the same person acting under the PSD).

Retaining records following vaccine administration

The individual’s clinical record is maintained for 8 years for an adult and up to the 26th birthday if given to a child under the age of 18, as per general retention of clinical records.

If a paper PSD is completed, this needs to be included in the individual’s electronic clinical record as this is the legal authorisation for administration.  Records Management Code of Practice 2021 has further advice on scanning documents into clinical records.

Other mechanisms: Written Instructions

Common written instruction clarifications

Vaccinating health and social care staff using a written instruction

A written instruction is not the correct mechanism for the provision of COVID-19 vaccination to health and social care staff.
This is because all COVID-19 vaccination is part of the nationally commissioned vaccination programme and is not being provided as an Occupational Health Service (OHS). Therefore the mechanism for health and social care staff vaccination will be via the national protocol, national PGD or PSD.

Change history

  1. Links to PGD and NP for Comirnaty® Original/Omicron BA.1 (15/15 micrograms)/dose COVID-19 mRNA vaccine added to relevant sections
  1. Details added for the retention of records
  1. Links updated and references to products no longer available removed.
  1. Reference to Regulation 174 product removed.
  1. The current content is still accurate.
  1. Minor update regarding prescribing of licensed product by independent prescribers.
  1. References to COVID-19 Vaccine Moderna updated to Spikevax® (formerly COVID-19 Vaccine Moderna)
  1. Minor editorial changes to National Protocol, Patient Specific Directions and Written Instruction sections.
  1. National PGD for Comirnaty vaccine - link added
  1. National protocol for Comirnaty vaccine - link added
  1. Link to advice on non-registered healthcare professionals added.
  1. COVID-19 Vaccine Moderna National PGD link added
  1. Link to national protocol for COVID-19 Vaccine Moderna added to 'Option 1: National Protocol'
  1. Update to Common PGD clarifications - delegation section to reflected updated national Pfizer-BioNTech PGD content.
  1. Minor editorial and styling changes.
  2. Page title changed from "Using appropriate legal mechanisms for the administration of COVID-19 vaccines" to "The legal mechanisms available for giving COVID-19 vaccines and their application"
  3. Advice on application to individual professional groups added
  4. Additional explanation in PGD paragraph about use in absence of clinical supervisor.
  1. Published