CAMBRIDGE, Mass.—Moderna has reported that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved its mRNA vaccine against COVID-19, known as COVID-19 Vaccine Moderna, for use under Regulation 174. The temporary authorization allows the supply of COVID-19 Vaccine Moderna in Great Britain, and is based upon the advice of the UK Commission on Human Medicines.
The decision from the MHRA is based on a rolling submission of data that was announced on October 27, 2020. The MHRA based its decision on the totality of scientific evidence shared by Moderna, including a recent data analysis from the company’s Phase 3 clinical study.
“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,” stated Stéphane Bancel, CEO 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 UK government has also exercised its option to purchase an additional 10 million doses of the COVID-19 Vaccine Moderna, bringing its confirmed order to 17 million doses. The first deliveries of the COVID-19 Vaccine Moderna to the UK from Moderna’s dedicated non-US supply chain are expected to begin in early 2021.
The UK is the fifth jurisdiction to authorize COVID-19 Vaccine Moderna, following the US on December 18, 2020; Canada on December 23; Israel on January 4, 2021; and the European Union on January 6. Additional authorizations are currently under review in a number of countries, including Singapore and Switzerland.
Moderna also announced on January 11 the expansion of its vaccines pipeline, adding three new development programs based on the clinical success of its infectious disease vaccine portfolio to date. The development programs include mRNA vaccine candidates against seasonal flu, HIV, and the Nipah virus. Moderna also announced an expansion of its respiratory syncytial virus (RSV) vaccine program into older adults.
“The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna,” Bancel noted in a press release. “Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more ambitious development programs within our prophylactic vaccines modality. Beyond vaccines, we are extending our mRNA development work to a total of 24 programs across five therapeutic areas.”