The study is being carried out along with the NIH unit NIAID and the US BARDA. Credit: Ewa Urban from Pixabay.

Moderna has announced that the Phase III COVE study of mRNA-1273, its vaccine candidate against Covid-19, met the statistical criteria pre-specified in the study protocol, with a vaccine efficacy of 94.5%.

The independent, UK National Institute of Health (NIH)-appointed Data Safety Monitoring Board (DSMB) confirmed the efficacy data.

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mRNA-1273 is a vaccine against Covid-19 encoding for a prefusion stabilised form of the Spike (S) protein.

The study is being carried out along with the NIH unit National Institute of Allergy and Infectious Diseases (NIAID) and the US Biomedical Advanced Research and Development Authority (BARDA).

The randomised, 1:1, placebo-controlled trial enrolled over 30,000 adult participants in the US. They were administered a 100µg dose of mRNA-1273 or placebo.

Its primary endpoint is the prevention of symptomatic Covid-19 disease, while key secondary endpoints include the prevention of severe disease and infection.

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This first interim analysis was based on 95 cases, of which 90 cases were observed in the placebo group versus five in mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5%.

A secondary endpoint analysed 11 severe cases of Covid-19 in this first interim analysis. Data showed that all cases occurred in the placebo group.

As per the preliminary analysis, the vaccine has consistent safety and efficacy profile across all evaluated subgroups.

Moderna CEO Stéphane Bancel said: “This positive interim analysis from our Phase III study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.”

Moderna plans to apply for emergency use authorisation (EUA) with the US Food and Drug Administration (FDA) soon.

Last month, Moderna completed the enrolment of participants for the Phase III COVE study of mRNA-1273.