- The leading coronavirus vaccine candidate just got up to $483 million in additional funding from the US government.
- The cash will pay for future trials to see if the vaccine works in humans, as well as for simultaneously ramping up production of the vaccine.
- “This allows us to go full speed and very aggressively,” CEO Stephane Bancel told Business Insider in a Thursday video interview, saying the vaccine program will now go “as fast as humanly possible.”
- The upstart biotech Moderna developed the vaccine candidate in record time using its technology platform called messenger RNA. The new technology has yet to produce an approved vaccine, but has shown promise in its potential to quickly respond to new viruses.
- The first human trial has been running since mid-March. Early safety results are expected later in spring, Bancel has said, which would instruct future clinical trials.
- Bancel has said the vaccine could be ready for emergency use this fall, if needed by US regulators.
- Visit Business Insider’s homepage for more stories.
A leading potential coronavirus vaccine just got a big funding boost from the US government.
The upstart biotech Moderna will receive up to $483 million to pay for clinical testing and mass production of its experimental vaccine. The agency funding this work is the US Biomedical Advanced Research and Development Authority (BARDA).
“This allows us to go full speed and very aggressively,” CEO Stephane Bancel told Business Insider in a Thursday video interview, saying the vaccine program will now go “as fast as humanly possible.”
This includes hiring up to 150 more employees, who will expedite the vaccine by working in a range of clinical, regulatory, scientific, and manufacturing roles, Bancel said.
Moderna has led the early stages of the race to develop a coronavirus vaccine. It was first to start human testing in mid-March and announced Thursday that its study has completed enrolling 45 healthy adults.
The study is designed to focus on the vaccine’s safety in humans, as well as if it can provoke an immune response. While the trial has enrolled 45 healthy adults between the ages of 18 and 55 years old, researchers are now expanding the study to also include the elderly, Moderna said. The trial is now recruiting older volunteers, aged 51 and older, in Washington state and Georgia.
Bancel said this expansion will help determine if the elderly may need a different dose strength of the vaccine.
Never miss out on healthcare news. Subscribe to Dispensed, Business Insider’s weekly newsletter on pharma, biotech, and healthcare.
Moderna expects initial safety data from the study later this spring. If positive, the biotech plans to start another mid-stage trial in the second quarter of 2020. A late-stage study could begin as soon as this fall, Moderna said.
The BARDA funding will pay for additional clinical trials and for boosting Moderna’s manufacturing capabilities.
Normally, the plant operates with two shifts per day for five days a week. Moderna is scaling the process and hiring up to start running every day with three daily shifts.
“We want to go 24/7 and get every dose out of this site that we can,” Bancel said. “Every dose, every day, will help.”
This should support a supply of millions of doses per month in 2020. Moderna could produce tens of millions per month in 2021 with further investment.
BARDA boosts its role in coronavirus vaccine work
In the sprint to halt the pandemic by developing a vaccine, BARDA has now thrown roughly $1 billion behind two leading efforts — Moderna’s and Johnson & Johnson’s — in the past few weeks.
BARDA Director Rick Bright said in a Thursday statement the goal is to have a vaccine available as soon as possible, and this funding can “shave months off development” timelines.
The agency was formed in 2006 as part of the US Department of Health and Human Services. It focuses on biodefense preparedness.
More to come on international manufacturing, Bancel hints
While Moderna is hiring up in the US and fully building out all unused space in its Massachusetts plant, there is a plan in the early stages for a global strategy.
Bancel said it is essential to think globally in addressing a pandemic. While the CEO could not share any specifics, he said it would make sense to use a contract manufacturing organization (CMO) to help boost global production.
“The work we are doing with CMOs, when we are able to talk about, we will show we have a global strategy of supply,” Bancel said.
Another alternative would be building an additional plant from the ground up, but Bancel said that “would just take too long.”
“Time is not our friend here,” he said. “So, the goal is to be able to maximize this and … go with a pretty large CMO so we could have a lot more capacity online pretty quickly.”
“As soon as we have more on those plans,” Bancel added, “we will share those publicly.”