Guidance

National protocol for Spikevax® bivalent Original/Omicron COVID-19 vaccine

This protocol is for the administration of Spikevax® bivalent Original/Omicron COVID-19 vaccine to individuals in accordance with the national COVID-19 vaccination programme.

• From: UK Health Security Agency
• Published: 24 August 2022

This publication was withdrawn on 6 April 2023

This protocol has been superseded by the COVID-19 adult and children 5 to 17 years national protocols.

Applies to England

Documents

[Withdrawn] National protocol for Spikevax® bivalent Original/Omicron COVID-19 vaccine

Ref: UKHSA gateway number GOV-13080

MS Word Document, 216 KB

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Details

This protocol is for the administration of Spikevax® bivalent Original/Omicron COVID-19 vaccine by appropriately trained persons.

National protocol Spikevax® bivalent Original/Omicron COVID-19 vaccine version 01.01 is valid from 24 August 2022 to 25 August 2023.

The Direct Healthcare Professional Communication (DHPC) informs that the initial supply of Spikevax® bivalent Original/Omicron COVID-19 vaccine will have a different tradename (in particular the word ‘Bivalent’ is not included), and different carton and vial labels to the licensed product. The product will consist of:

• 16 batches of vials containing 2.5 ml (5 doses) entering the supply chain from mid/end August
• 1 batch of vial containing 5 ml (10 doses) entering the supply chain from end of August
• both 2.5 ml and 5 ml vials may be circulating in the supply chain at the same time, but these batches will only differ in fill volume/number of doses per vial

To ensure continuity in supply, the Medicines and Healthcare products Regulatory Agency (MHRA) has agreed for these batches to be supplied to market via a Batch Specific Variation and therefore they are approved to be used as a licensed product. The leaflet supplied with the batches is approved, therefore this Spikevax® bivalent Patient Information Leaflet (PIL) should be provided to vaccine recipients.

Published 24 August 2022