Coronavirus (COVID-19) vaccine - Comirnaty® (mRNA Vaccine, Pfizer/BioNTech): national protocol

1. About the National Protocol

This protocol is for the supply and administration of Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) to individuals in accordance with the national COVID-19 vaccination programme. This protocol only allows administration during or in anticipation of COVID-19 pandemic where the disease represents a serious risk or potentially serious risk to human health.

This protocol is for the supply and administration of Comirnaty® (COVID-19 mRNA Vaccine, Pfizer/BioNTech) by appropriately trained persons in accordance with regulation 247A of the Human Medicines Regulation 2012, as inserted by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020

The Scottish Government has developed this protocol which has been approved by the Scottish Ministers to facilitate the delivery of the national COVID-19 vaccination programme by Health Boards in Scotland and any organisation a Health Board makes arrangements with to deliver such services on its behalf, referred to as "the provider". Please note that in the context of this protocol, "the provider" means:

(a) a Health Board,

(b) a Health Board working with Armed Forces staff where Armed Forces staff are working in Health Board settings, or

(c) an organisation delivering services on behalf of a Health Board.

This protocol may be followed wholly from patient assessment through to post-vaccination by a single person. Alternatively, obtaining consent and patient assessment may be undertaken by a registered healthcare professional with the process of administration undertaken by a non-registered professional or a non-registered Armed Forces staff member under clinical supervision.

This issue of consent for children and young people under the age of 16 is complex. In Scotland, the legal age of capacity is 16. However, children under the age of 16 can consent to medical treatment if they understand what is being proposed. Providers should ensure that capacity is assessed in line with current established practice, seeking advice from their legal advisers on consent as required.

Where multiple person models are used the provider must ensure that all elements of the protocol are complied with in the provision of vaccination to each patient.

The provider is responsible for ensuring that persons are trained and competent to safely deliver the activity they are authorised to provide under this protocol. As a minimum, competence requirements stipulated in the protocol under 'Characteristics of staff' must be adhered to.

The provider must identify a clinical supervisor who has overall responsibility for provision of vaccinations under the protocol at all times. This includes overall responsibility for the activities of any Armed Forces staff working under the protocol.

The clinical supervisor must be a registered healthcare professional trained and competent in all aspects of the protocol and provide clinical supervision for the overall provision of clinical care provided under the protocol.

The clinical supervisor must be identifiable to service users. Whenever the protocol is used, the name of the clinical supervisor taking responsibility and all of the people working under different activity stages of the protocol must be recorded for the session using the schedule in Annex C or maintaining an equivalent electronic record. The clinical supervisor has ultimate responsibility for safe care being provided under the terms of the protocol. Persons working under the protocol may be supported by additional registered healthcare professionals, but the clinical supervisor retains responsibility.

Persons working to the protocol must understand who the clinical supervisor for their practice is at any time and can only work under their authority. The clinical supervisor may withdraw this authority for all persons or individual persons at any time and has authority to stop and start service provision under the protocol as necessary. All members of staff have 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.

Individual practitioners must be designated by name to work to this protocol. Individuals working in accordance with this protocol must ensure they meet the staff characteristics for the activity they are undertaking, make a declaration of competence and be authorised in writing by the provider. This can be done by completing Annex B of this protocol or maintaining an equivalent electronic record.

It is a Health Board's responsibility to adhere to this protocol. Where the Health Board is not the provider, it is the Health Board's responsibility to ensure that the provider adheres to this protocol. The final authorised copy of this protocol should be kept, by Health Boards for 8 years after the protocol expires. Providers adopting authorised versions of this protocol should also retain copies, along with the details of those authorised to work under it, for 8 years after the protocol expires.

Providers must check that they are using the current version of this protocol. Amendments may become necessary prior to the published expiry date. Current versions of protocols authorised by the Scottish Ministers in accordance with regulation 247A of the Human Medicines Regulations 2012 can be found on the Scottish Government website: TBC

Any concerns regarding the content of this protocol should be addressed to: VaccinationsDelivery@gov.scot