The Biomedical Advanced Research and Development Authority (BARDA) has committed up to $483 million to Moderna toward accelerating development of the company’s mRNA vaccine candidate mRNA-1273 targeting SARS-CoV-2.
mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein. The vaccine candidate is among leading “Front Runner” COVID-19 drugs and vaccines in development highlighted by GEN in an updated A-List of more than 160 candidates published April 13.
mRNA-1273 is under study in a Phase I open-label, dose-ranging trial 1273 (NCT04283461) being conducted by the NIH. The trial began March 16 as a study of 45 healthy adult volunteers ages 18-55 years in three dose cohorts (25 µg, 100 µg and 250 µg). The NIH recently amended the Phase I protocol to include an additional six cohorts for which enrollment is ongoing: three of older adults (ages 51–70) and three of elderly adults (ages 71 and up).
If safety data from the Phase I trial proves positive, Moderna said, it intends to begin a Phase II study of mRNA-1273 under its own IND application in the second quarter. Based on positive data from the two studies and talks with regulators, a Phase III study could begin as soon as the fall, according to Moderna.
BARDA funding is intended to support late-stage clinical development programs and the scale-up of mRNA-1273 manufacturing this year. Moderna said that it plans to hire up to 150 new staffers this year, and expand its manufacturing capacity from two shifts per day, five days per week, to three shifts daily, seven days a week.
The new staffers will include engineers to manage process scale-up, and clinical and regulatory staff to support clinical development.
“Time is of the essence to provide a vaccine against this pandemic virus,” Moderna CEO Stéphane Bancel said in a statement. “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.”
Moderna selected its vaccine candidate in collaboration with the NIH’s selected by Moderna in collaboration with investigators from the Dale and Betty Bumpers Vaccine Research Center (VRC) at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID)—a collaboration that began as an effort to develop a vaccine against MERS-CoV.
The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIH-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.
BARDA Director Rick Bright, PhD, added: “Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action. BARDA’s goal is to have vaccine available as quickly as possible and preparing now for advanced stage clinical trials and production scale-up while the Phase I is underway could shave months off development of COVID-19 vaccines.”