Great Britain Authorizes US-Produced COVID-19 Vaccine

Massachusettes-based Moderna announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) had approved its mRNA-based COVID-19 Vaccine Moderna for use under Regulation 174. The temporary authorization permits the supply of COVID-19 Vaccine Moderna in Great Britain and is based upon the UK Commission on Human Medicines' advice.

The decision from the MHRA is based on a rolling submission of data that was announced on October 27, 2020. The MHRA based its authorization on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30, 2020.

Stéphane Bancel, CEO of Moderna, stated in a press release issued on January 8, 2021, “I want to thank the MHRA and the Commission on Human Medicines’ reviewers for their tireless efforts.

The UK government has also exercised its option to purchase an additional 10 million doses of the COVID-19 Vaccine Moderna, bringing its confirmed order commitment to 17 million doses. The first deliveries of the COVID-19 Vaccine Moderna to the UK from Moderna’s dedicated non-U.S. supply chain are expected to commence in early 2021.

The UK is the fifth jurisdiction to authorize COVID-19 Vaccine Moderna, following the USA on December 18, 2020, Canada on December 23, 2020, Israel on January 4, 2021, and the European Union on January 6, 2021. Additional authorizations are currently under review in several countries, including Singapore and Switzerland.