UK MHRA Approves Comirnaty Omicron XBB.1.5 License Update

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a change of license for Comirnaty Omicron XBB.1.5 30 micrograms/dose (single dose vial) after it was found to meet safety, quality and management tandards of the United Kingdom. effectiveness

This approval allows vaccines to be diluted and re-labelled by non-NHS manufacturers approved by the MHRA and guaranteed to meet internationally recognized standards of good manufacturing practice. Komirnati The COVID-19 vaccine must be stored in extreme cold at -80°C and thawed before use. Until now, the NHS managed the manufacture and distribution of the 30 microgram/dose Comirnaty Omicron XBB.1.5 vaccine.

The vaccine formulation is the same as that approved by the MHRA in September 2023. This new approval granted by the MHRA is only available in the UK. Omicron's modified Novavax COVID-19 vaccine targeting XBB type 1.5 has been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) after meeting the United Kingdom's regulatory product safety, quality and compliance standards. This vaccine is approved for anyone 12 years of age or older.

This vaccine helps your immune system (the body's natural defenses) produce antibodies and special white blood cells that fight the virus and protect against COVID-19. None of the ingredients in this vaccine will cause COVID-19.

This new approval granted by the MHRA is only valid in the UK and has been given through the European Commission's (EC's) decision-making process. This is the case when the marketing authorization application prepared by the company is subject to the decision of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). In such cases, the MHRA will consider the application, considering the EC's decision, before deciding on the vaccine's quality, safety and efficacy.