Moderna has announced that the primary efficacy analysis data of its COVID-19 vaccine candidate mRNA-1273 indicated 100 per cent vaccine efficacy in preventing severe SARS-CoV-2 infection based on the phase III COVE study.
The randomised, 1:1 placebo-controlled trial analysed mRNA-1273 at 100µg dose level in adult participants. Prevention of symptomatic COVID-19 disease formed the primary endpoint of the study while prevention of severe COVID-19 and infection by SARS-CoV-2 were the key secondary endpoints.
The primary analysis data derived from 196 cases, showed 185 instances of COVID-19 in the placebo group as compared to 11 in the mRNA-1273 group, showing vaccine efficacy of 94.1%. Meanwhile, the analysis of secondary endpoint found 30 severe cases, all in the placebo group and none in the treatment group showing a 100% efficacy in preventing severe infection.
Moderna will submit an application to the US Food and Drug Administration (FDA) for an emergency use authorisation (EUA) and plans to seek conditional marketing authorisation (CMA) from the European Medicines Agency (EMA). The National Institutes of Health (NIH)-appointed Data Safety Monitoring Board (DSMB) is monitoring the study, while safety data continues to accrue.
The study was conducted in partnership with the NIH unit NIAID and the Biomedical Advanced Research and Development Authority (BARDA), enrolling over 30,000 participants in the US.
Moderna CEO Stéphane Bancel said: “This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease.”Separately, Moderna signed a deal with the UK government to supply an additional two million doses of mRNA-1273 from March 2021. The UK has already secured seven million doses of the jab from the US firm – enough for vaccinating around 3.5 million people in the UK.