UK begins rolling review of Moderna's mRNA vaccine against COVID-19
US biotech Moderna (Nasdaq: MRNA) today revealed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has started the rolling review process of mRNA-1273, the company’s vaccine candidate against COVID-19.
This announcement follows positive results from a pre-clinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase I study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.
Earlier this month, the European Medicines Agency confirmed that mRNA-1273 is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure. However, at the end of the UK’s Brexit transition period on December 31, if there is no Brexit deal, the MHRA becomes responsible for reviewing requests for marketing approval of medicines intended for use in Britain.
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