UK authorises Moderna's coronavirus vaccine

Moderna's mRNA-1273 on Friday became the third COVID-19 vaccine in the UK to receive regulatory approval for supply by the Medicines and Healthcare products Regulatory Agency (MHRA), a decision that comes just days after it was granted a conditional marketing authorisation in the EU. The UK government also secured an additional 10 million doses for a total of 17 million doses of the vaccine, with supply beginning in early 2021, once Moderna expands its production capability.

Health Secretary Matt Hancock called it "another weapon in our arsenal to tame this awful disease," adding it will "boost our vaccination programme even further once doses become available from the spring." So far, the two other coronavirus vaccines authorised in the UK are Pfizer and BioNTech's BNT162b2, another vaccine based on mRNA technology, and AstraZeneca and the University of Oxford's AZD1222, which uses a replication-deficient chimpanzee viral vector and contains the genetic material of the SARS-CoV-2 virus spike protein.

The UK's latest temporary authorisation is based on a rolling review that included data from the Phase III COVE study. An interim analysis conducted on 196 cases from the ongoing trial showed an efficacy rate of 94.1% for Moderna's vaccine at reducing the number of symptomatic COVID-19 cases among people who had no sign of previous infection.

Authorisation of the two-dose vaccine, which can be stored at -20°C for up to six months, is for use in people 18 years and over, with the UK noting it is recommended that the second dose be administered 28 days after the first. The regulator did not specify whether a controversial move by the UK to allow a gap of up to 12 weeks between doses, in a bid to vaccinate more people, would apply to mRNA-1273 as it does with AZD1222 or BNT162b2. Moderna's vaccine has already been authorised for emergency use in the US, Canada and Israel. The company indicated that additional authorisations are currently under review in other countries as well, including Singapore and Switzerland.

Meanwhile, the next Phase III readout of an investigational COVID-19 vaccine could be for Johnson & Johnson's single-dose candidate Ad26.COV2.S. The company recently said it intends to unveil interim results from the ENSEMBLE trial by the end of this month. The MHRA has initiated a rolling review of the adenoviral vector vaccine, with the UK having put in an initial order of 30 million doses and has the option of securing 22 million more.

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