UK MHRA announces Approval for Moderna COVID-19 Vaccine

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced approval (Jan 10) for Moderna’s RNA vaccine against COVID-19 for use under Regulation 174. The temporary authorisation permits the supply of COVID-19 Vaccine Moderna in Great Britain and is based upon the advice of the UK Commission on Human Medicines. “We appreciate the confidence shown by the UK MHRA in COVID-19 Vaccine Moderna with this decision, which marks an important step forward in the global fight against COVID-19,” Stéphane Bancel said. “I want to thank the MHRA and the Commission on Human Medicines’ reviewers for their tireless efforts. The authorisation of a product developed by Moderna is a significant milestone on the Company’s 10-year journey and I would like to thank all our colleagues that have helped us get to this point.”

Following recommendation of the European Medicines Agency The European Commission also granted a conditional marketing authorisation (Jan 6, 2021) for COVID-19 Vaccine Moderna. Deliveries of COVID-19 vaccine to EU and EEA Member States began on January 11. All shipments of the COVID-19 Vaccine Moderna are being conducted by Kuehne+Nagel, a world-leading logistics company and will originate from its centralised pharma hub in Europe.

The UK is the fifth jurisdiction to authorise COVID-19 Vaccine Moderna, following the United States on December 18, 2020, Canada on December 23, 2020, Israel on January 4, 2021 and the European Union on January 6, 2021. Additional authorisations are currently under review in a number of countries including Singapore and Switzerland.