United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna
CAMBRIDGE, Mass.: Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (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 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,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I want to thank the MHRA and the Commission on Human Medicines’ reviewers for their tireless efforts. The authorization 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.”
The United Kingdom 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 early in 2021.
The UK is the fifth jurisdiction to authorize 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 authorizations are currently under review in a number of countries including Singapore and Switzerland.
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.
