The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for a variation in licence for Pfizer-BioNTech’s 30 micrograms dose of Comirnaty XBB.1.5, a Covid-19 vaccine targeting the Omicron variant.
The decision follows the vaccine’s fulfilment of the UK regulator’s safety, quality and effectiveness standards.
The latest approval for the single-dose vials allows for the vaccine’s thawing and re-labelling by an authorised manufacturer outside of the UK’s National Health Service (NHS), adhering to good manufacturing practice standards.
The NHS previously managed the thawing and distribution of the Comirnaty Omicron XBB.1.5 vaccine centrally.
The vaccine requires ultra-low temperature storage at -80°C before it is thawed for usage.
MHRA noted that the formulation of the Comirnaty vaccine, approved in September 2023, remains unchanged.
The new authorisation by the MHRA is applicable only in Great Britain.
The UK regulator also approved Novavax’s Nuvaxovid, an adapted vaccine targeting the Omicron XBB 1.5 subvariant.
This vaccine is authorised for individuals aged 12 and above.
The authorisation for Nuvaxovid in Great Britain was granted through the European Commission (EC) decision reliance route.
This process involves a review of the marketing authorisation application by the MHR, referencing the decision by the European Medicines Agency Committee for Medicinal Products for Human Use then reaching an independent conclusion on the vaccine’s quality, safety and effectiveness.
The new development comes after the MHRA introduced the International Recognition Procedure (IRP), a new pathway for medicine approvals.
Effective from 1 January 2024, the IRP streamlines the approval process by incorporating assessments from trusted regulatory partners worldwide.
The IRP is a post-Brexit initiative aimed at ensuring UK patients have timely access to life-saving medicines.