The federal government is pledging up to $483 million to accelerate the development of Moderna’s experimental COVID-19 vaccine, an infusion of money that the Cambridge biotech says would allow it to manufacture the yet-to-be approved product around the clock, seven days a week.
Moderna’s chief executive, Stephane Bancel, said Thursday that the money from the government’s Biomedical Advanced Research and Development Authority, or BARDA, will enable the company 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."
That timeline seems more optimistic than those Moderna previously gave for the experimental vaccine. The company said on March 23 that it might seek federal emergency approval of it for some people ― including health care workers ― in the fall, but said the vaccine wouldn’t be commercially available for at least 12 to 18 months. Other vaccine developers gave a similar timeline for their experimental products, all of which would need federal regulatory approval.
There is no approved vaccine for COVID-19, but the World Health Organization lists more than 40 vaccine candidates around the globe, as scientists and biotech firms race to find a way to stop the virus that has killed about 140,000 people worldwide. Several of the efforts underway have been launched by firms with a presence in Massachusetts or partnerships with laboratories in Massachusetts.
“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate," Bancel said. “Time is of the essence to provide a vaccine against this pandemic virus.” BARDA is part of the US Department of Health and Human Services.
Alan Carr, an analyst at Needham & Co., said that the real significance of the announcement is that the federal funding will enable Moderna to continue other drug development projects “without draining resources to fund the COVID-19 effort.”
The National Institutes of Health has completed enrollment for an early-stage clinical trial of Moderna’s experimental vaccine, which was the first potential vaccine to go to trial. It relies on custom-built messenger RNA to produce an immune response. Forty-five healthy volunteers between the age of 18 and 55 began getting doses on March 16 in Seattle. The NIH recently broadened the first phase of the trial to include three groups of participants ages 51 to 70, and three groups of those 71 and older. Enrollment in those studies is ongoing.
If the vaccine proves safe and appears to work, Moderna plans to begin a mid-stage trial in the second quarter of this year, and then, if all goes well with that testing, the company would start a late-stage trial in the fall — the last step before seeking approval from the Food and Drug Administration, which would be expected to act quickly on any vaccine proven to work.
“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” said Rick Bright, director of the research and development authority. “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 1 is underway could shave months off development of COVID-19 vaccines.”
Moderna isn’t the first drug maker to receive such federal funding in its effort to make a COVID-19 vaccine. BARDA and health care giant Johnson & Johnson last month announced that it was investing more than $1 billion in a potential vaccine developed partly by a laboratory at Beth Israel Deaconess Medical Center in Boston.
Nonetheless, it’s a big boost for Moderna, which delivered its vaccine candidate in late February to the Maryland-based National Institute of Allergy and Infectious Diseases, part of NIH. It had taken high-flying Moderna a mere 42 days to produce the shipment after receiving the genetic sequence of the virus that causes COVID-19.
Moderna says it expects to hire up to 150 new employees in the United States so the company can expand manufacturing from two shifts a day, five days a week, to three shifts a day, seven days a week. Moderna has a $130 million plant in Norwood.
Jonathan Saltzman can be reached at firstname.lastname@example.org