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UK secures 5m doses of Moderna's vaccine after it shows 94.5% interim efficacy

Published on 17/11/20 at 12:42pm

US firm Moderna has swooped in with Phase 3 interim data for its own messenger RNA (mRNA) vaccine candidate, mRNA-1273, boasting even higher efficacy than its rival from Pfizer and BioNTech. 

The COVE study was conducted in partnership with the US National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority (BARDA) and has enrolled over 30,000 participants in the US. Interim analysis of the data carried out by an independent Data Safety Monitoring Board was based on 95 cases of COVID-19 confirmed in the patient population. Of these total cases, 90 were identified in the placebo group, whereas only five were found in the vaccine group, placing the vaccine’s efficacy at an estimated 94.5%.  

Among the 95 cases were 15 participants over the age of 65, while 12 patients were Hispanic or LatinX, four were Black or African American, and three were Asian American.

There were 11 identified cases of severe adverse events among these 95 cases, but none of these occurred in the vaccine group and were all associated with patients receiving placebo.

No significant safety concerns were reported, and Moderna said that the vaccine was “broadly” equally safe and effective in all tested sub-populations. The majority of adverse events, occurring in 2% of participants overall, were mild or moderate, with patients reporting brief spells of headache, fatigue, joint pain and pain at the injection site.

Based on these data, Moderna now plans to file for Emergency Use Authorisation from the FDA and other regulators around the world, but not until 151 cases of COVID-19 are confirmed in the study population. Originally, this had not been expected until early next year, but, due to the current surge in cases across the US, the company believes that this threshold will be passed by late November.

Secretary of State for Business, Energy and Industrial Strategy Alok Sharma tweeted later the same day to confirm that the UK Government had sealed a deal to access the vaccine:

“Delighted to confirm that today we concluded negotiations with Moderna & secured access to 5 million doses of its promising coronavirus vaccine, with the option to procure more. This is on top of the 350 million doses we’ve already secured from a range of other developers.”

The deal secures enough doses to inoculate 2.5 million people, with delivery commencing as early as spring next year. So far, the government has secured 355 million vaccine doses with seven different developers. The Medicines and Healthcare products Regulatory Agency (MHRA) has now launched a rolling review into Moderna’s candidate.   

Matt Fellows

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