Coronavirus (COVID-19) mRNA vaccine BNT162b2 Pfizer/BioNTech: national protocol

Protocol guidance for the COVID-19 mRNA Vaccine BNT162b2 Pfizer/BioNTech.

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2. Approval and Clinical Authorisation

This protocol is not legally valid, in accordance with regulation 247A of Human Medicines Regulation 2012, as inserted by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020, until approved by the Scottish Ministers.

On 2 February 2021 the Scottish Ministers, approved this protocol in accordance with regulation 247A of Human Medicines Regulation 2012. Approval of clinical information in Annex A is via the Scottish Government Chief Medical Officer, Chief Pharmaceutical Officer and Chief Nursing Officer for the delivery of the national COVID-19 vaccination programme, with defined limitations to authorisation that may be updated from time to time as may be required.

Authorised for use by the following organisations and/or services

All Health Boards in Scotland, and organisations Health Boards make arrangements with to deliver services on their behalf.

Limitations to authorisation

This authorisation applies to the supply and administration of the vaccine(s) only under the conditions set out in the authorisation for supply or license set out by the Medicines and Healthcare products Regulatory Agency

Clinical authorisation





Gregor Smith

18 September 2021


Anne Armstrong

18 September 2021


Alison Strath

18 September 2021

It is Health Boards' responsibility to ensure they and any organisations they make arrangements with to deliver services on their behalf operate the specified vaccination services in accordance with the protocol. Any provider administering COVID-19 mRNA Vaccine BNT162b2 Pfizer/BioNTech vaccine under protocol must work strictly within the terms of this protocol.

The national COVID-19 vaccination programme may also be provided under patient group direction, under written instruction for supply and administration in the course of an occupational health scheme, or on a patient specific basis, by or on the directions of an appropriate prescriber. Supply and administration in these instances are not related to this protocol.



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