USA – Moderna’s COVID-19 vaccine enters pivotal phase 3 trial

Moderna’s COVID-19 vaccine candidate has entered a late-stage phase 3 clinical trial, reinforcing its position at the forefront of the race for an effective vaccine targeting the novel coronavirus.

Moderna and the US National Institutes of Health (NIH) are collaborating on the late-stage COVE trial, which will evaluate the vaccine in 30,000 study participants. The trial will investigate two shots of the candidate, mRNA-1273, at a dosage of 100 µg.

The primary endpoint is the prevention of symptomatic COVID-19 disease, with key secondary endpoints including the prevention of severe COVID-19 disease and prevention of infection with SARS-CoV-2, which causes COVID-19, regardless of symptoms.

With its collaborators, Moderna has chosen nearly 100 clinical research sites cross the US with representative demography. The company is also working closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study.

If the vaccine can prove effective in this study, Moderna plans to be able to deliver around 500 million doses per year and up to one billon doses thereafter, beginning in 2021…