National protocol for inactivated influenza vaccine (IIV) - Version v7.0 - Effective 1 September 2025

Aug 31, 2026

National protocol defining how inactivated influenza vaccine (IIV) is administered within the national influenza immunisation programme. It sets requirements for authorisation of appropriately trained and competent persons, including declaration of competence and written authorisation records. The protocol specifies the presence and responsibilities of a clinical supervisor, indemnity, staffing models where multiple persons undertake stages, and reporting of concerns. Service providers must retain copies for 25 years and use current protocol versions and referenced documents.

LanguageEnglish

CategoryGeneral

FormatDOCX

Pages22

Reading Time8 min

AccessFree to download

Scope and governance

Authorisation, competence and training

Clinical supervisor responsibilities

Indemnity and staffing model compliance

Records retention and version control

Legal validity and approval

Administration requirements

Manufacturer instructions

UKHSA Publications gateway number: GOV-18486 National protocol for inactivated influenza vaccine (IIV) Reference no: Inactivated influenza vaccine protocol Version no: v7.0 Valid from: 1 September 2025 Expiry date: 1 April 2026 This protocol is for the administration of inactivated influenza vaccine to individuals in accordance with the national influenza immunisation programme. This protocol is for the administration of inactivated influenza vaccine by appropriately trained persons in accordance with HYPERLINK "https://www.legislation.gov.uk/uksi/2020/1125/regulation/14/made" regulation 247A of the HYPERLINK "https://www.legislation.gov.uk/uksi/2012/1916/contents" Human Medicines Regulations 2012 (HMR 2012), inserted by HYPERLINK "https://www.legislation.gov.uk/uksi/2020/1125/contents/made" The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020. The UK Health Security Agency (UKHSA) has developed this protocol for authorisation by or on behalf of the Secretary of State for Health and Social Care, to facilitate the delivery of the national influenza immunisation programme commissioned by NHS England. This protocol may be followed wholly from assessment through to post-vaccination by an appropriately registered healthcare professional (see HYPERLINK \l "_Characteristics_of_staff" Characteristics of staff). Alternatively, multiple persons may undertake stages in the vaccination pathway in accordance with this protocol. Where multiple person models are used, the service provider or contractor must ensure that all elements of the protocol are complied with, in the provision of vaccination to each individual. The provider or contractor is responsible for ensuring that persons are trained and competent to safely deliver the activity they are employed to provide under this protocol. As a minimum, competence requirements stipulated in the protocol under HYPERLINK \l "_Characteristics_of_staff" Characteristics of staff must be adhered to. The provider or contractor and registered healthcare professionals are responsible for ensuring that they have adequate and appropriate indemnity cover. Persons must be authorised by name to work under this protocol. They must ensure they meet the staff characteristics for the activity they are undertaking, make a declaration of competence and be authorised in writing. This can be done by completing HYPERLINK \l "PractitionerAuthorisationSheet" section 4 of this protocol or maintaining an equivalent electronic record. A clinical supervisor, who must be a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol, must be present and take overall responsibility for provision of vaccination under the protocol at all times and be identifiable to service users. Any time the protocol is used, the name of the clinical supervisor taking responsibility and all the people working under different stages of the protocol must be recorded for the session. The clinical supervisor has ultimate responsibility for safe care being provided under the terms of the protocol. Staff working under the protocol may be supported by additional registered healthcare professionals, but the clinical supervisor retains overall responsibility. Staff working to the protocol must understand who the clinical supervisor for their practice at any time is and can only proceed with their authority. The clinical supervisor may withdraw this authority for all members of staff or individual members of staff at any time and has authority to stop and start service provision under the protocol as necessary. Every member of staff has a responsibility to, and should, report immediately to the clinical supervisor any concerns they have about working under the protocol in general or about a specific individual, process, issue or event. Operation under this protocol is the responsibility of service providers or contractors. Provider organisations or contractors using

FAQs

Who is allowed to administer the inactivated influenza vaccine under this protocol?

Inactivated influenza vaccine administration must be carried out by appropriately trained and competent persons in accordance with the protocol. Staff must be authorised by name, meet staff characteristics, declare competence, and be authorised in writing.

What is the role of the clinical supervisor?

A clinical supervisor (registered doctor, nurse, or pharmacist) must be present at all times and take overall responsibility for vaccination provision under the protocol. The clinical supervisor records responsibility for sessions, has ultimate responsibility for safe care, and can stop or start service provision.

How long must provider organisations retain copies of the protocol?

Provider organisations or contractors using the protocol should retain copies, including details of those authorised to work under it, for 25 years after the protocol expires.

Aug 31, 2026

Upload by วิน