The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a change to the licence of the Comirnaty Omicron XBB.1.5 30 micrograms/dose (single-dose vials) after it was found to meet the UK regulator's standards of safety, quality and effectiveness.
This approval enables the thawing and re-labelling of the vaccine by a manufacturer outside of the NHS, that has been authorised by the MHRA and confirmed to meet the globally recognised Good Manufacturing Practice standards.
The Comirnaty COVID-19 vaccine needs to be stored at ultra-low temperatures of -80 ºC and then thawed before use. Until now, the thawing and distribution of the Comirnaty Omicron XBB.1.5 30 micrograms/dose vaccine has been centrally managed by the NHS.
The formulation of the vaccine is otherwise the same as that approved by the MHRA in September 2023.
This new authorisation granted by the MHRA is valid in Great Britain only.
