The U.S. government will fund development of an experimental coronavirus vaccine from Moderna through to approval by the Food and Drug Administration, pledging as much as $483 million to speed clinical testing and prepare for large-scale production should the vaccine prove safe and effective.
The award, announced Thursday evening by Moderna, will allow the biotech to hire up to 150 additional manufacturing workers, engineers and clinical staff. As of February, Moderna employed about 830 people.
The cash is also a vote of confidence from the Biomedical Advanced Research and Development Authority, the federal agency which is partnering with the Cambridge, Massachusetts-based biotech on vaccine development. Awards from the agency are typically smaller or are tied to supply orders for national stockpiles.
"The grant's going to be a big accelerator to the development of mRNA-1273," said Moderna CEO Stéphane Bancel on a Friday conference call, referring to the company's current name for the vaccine.
Moderna specializes in a new and, as of yet, unproven type of vaccine technology, which helped it design and ready a prototype for initial human testing in just over two months — an exceptionally fast turnaround that reflects the urgency at which companies and regulators are moving to address the global pandemic.
Moderna was the first biotech to begin clinical testing of a vaccine against SARS-CoV-2, as the coronavirus is called, but other groups, including China's CanSino Biologics, have now followed. Larger drugmakers like Sanofi, GlaxoSmithKline and Johnson & Johnson are rapidly moving through preclinical studies with an aim to begin human trials this year, too.
A Phase 1 study of mRNA-1273, led by the National Institutes of Health, began on March 16 and has already met its target of enrolling 45 healthy volunteers, Moderna also said Thursday evening. Six new groups of older and elderly adults will be added to the study, while Moderna simultaneously prepares to start a Phase 2 trial within the next two months, pending positive safety data.
If all goes well, Moderna thinks it can start a Phase 3 study by this fall, which would be an unheard-of pace of development for a vaccine.
"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," said Rick Bright, BARDA's director, in a statement provided by Moderna.
U.S. officials, including National Institute of Allergy and Infectious Diseases director Anthony Fauci, have repeatedly laid out a 12- to 18-month timeline for the fastest a vaccine against SARS-CoV-2 could be developed.
In an interview with CBS Evening News on Wednesday, Fauci used similar language as Bright to suggest a vaccine might be ready sooner than expected, although he cautioned against over-promising.
Emma Walmsley, the CEO of GlaxoSmithKline, said recently she believes more than one vaccine will be needed to curb the spread of SARS-CoV-2, a view other experts share.
Vaccines are typically the product of many years of careful design and testing. Because vaccines are given to healthy people, experimental ones are typically studied in lengthy trials that enroll thousands of patients. Manufacturing can also be an expensive and challenging proposition, particularly for the attenuated or protein-based vaccines that are widely used for diseases like measles, influenza or pneumonia.
Moderna uses messenger RNA, the genetic instructions used by cells, to instruct the body to make proteins which can prime the immune system to recognize and attack invading pathogens. In the case of SARS-CoV-2, Moderna's vaccine encodes for a "spike" protein that the coronavirus uses to infiltrate healthy cells. Other companies, including Germany's BioNTech, CureVac and the Lexington, Massachusetts-based Translate Bio, are also developing mRNA vaccines.
No mRNA vaccine is approved for any kind of infectious disease and Moderna, as a biotech with no approved products, has little experience manufacturing at the kind of scale which would be needed if its vaccine succeeds.
Moderna aims to be capable of supplying millions of doses per month of its vaccine this year and, with further funding, tens of millions per month next year. Production will happen alongside clinical testing, a bet on the vaccine's potential that would be particularly risky for Moderna if not for the financial backstop BARDA is providing.
"We aren't waiting for the typical de-risking from Phase 1, Phase 2, Phase 3," said Bancel on the Friday conference call. The CEO said Moderna would also partner with a contract research organization to help support its development, but didn't specify further.
No details were given about the structure of the BARDA award, which if paid in full would equate to about 5% of Moderna's current market value. The grant does not, however, include money for federal stockpiling of the vaccine, which could represent another opportunity for the biotech.