After racing from discovery to first-in-human studies in just 63 days, the US Biomedical Advanced Research and Development Authority (BARDA) has backed Moderna’s mRNA vaccine by agreeing to commit up to $483m (€446m) in funds. The investment could potentially push the vaccine through to Phase III trials and enable the scale up manufacture.
In a joint release, the two organizations suggested that Phase III studies could begin by this coming fall and that capacity of production will be expanded to ‘enable a potential pandemic response’ during this year.
In order for the company to move the vaccine so rapidly from early-stage to potentially delivering it to the public, Moderna will hire 150 additional team members in the US this year.
A number of these new employees will focus on manufacturing of the vaccine, with Moderna noting that they will work on managing the scale-up by enabling staff to rotate around performing three shifts per day, seven days per week.
Stéphane Bancel, Moderna’s CEO, explained what the aim for the funding is: “By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.”
The Phase I that began in March was confirmed as having completed enrollment, with 45 adults volunteering to the trial between the ages of 18 to 55 years old. In addition, six additional cohorts will be added with older adults in two different age groups, 56-70 years of age and 71 years and above.
Should safety of the mRNA vaccine be proven in this trial, a Phase II trial is expected in the second quarter and a Phase III trial subsequently following later this year.