The UK regulatory agency MHRA authorised the vaccine based on a rolling review of data, including data from the Phase 3 COVE study
Moderna has received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval for its mRNA-based Covid-19 vaccine, for individuals people aged 18 years and older.
The temporary authorisation of Covid-19 Vaccine Moderna is based on the recommendation of the UK Commission on Human Medicines, and facilitate its supply in Great Britain.
MHRA authorisation is based on the totality of scientific evidence, including a data analysis from the Phase 3 clinical study released on 30 November 2020.
Moderna chief executive officer Stéphane Bancel said: “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. 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.”
The UK government has exercised its option to purchase an additional 10 million doses of its Covid-19 vaccine, making the total confirmed order reach 17 million doses.
The US-based biotech firm said that the initial delivery of its Covid-19 vaccine to the UK is expected to begin in early 2021, from its dedicated non-US supply chain.
The UK marks the fifth dominion to authorise Covid-19 Vaccine Moderna, after the US, Canada, Israel and the European Union, with Singapore, Switzerland and other countries reviewing the vaccine for additional authorisations.
The Covid-19 Vaccine Moderna is an mRNA vaccine that targets Covid-19 encoding for a prefusion stabilized form of the Spike (S) protein.