Comirnaty Omicron Gets Updated License

UK MHRA approves change to the license of Comirnaty Omicron XBB.1.5 30 micrograms/dose

The UK 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.

Specifications

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.

UK MHRA Approval

Approval has been granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Novavax Covid-19 vaccine that targets the Omicron XBB 1.5 subvariant, after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.

This vaccine has been approved for use in individuals from 12 years of age.

Mechanism

The vaccine causes the immune system (the body’s natural defences) to produce antibodies and specialised white blood cells that work against the virus, to give protection against Covid-19. None of the ingredients in this vaccine can cause Covid-19.   

Authorisations

This new authorisation granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA considers the application together with due consideration of the EC decision, before making an independent decision on the quality, safety, and effectiveness of the vaccine.

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