Last month, Moderna became the first company to test a COVID-19 vaccine in humans, and, now, the Biomedical Advanced Research and Development Authority (BARDA) is stepping up to pay its way to approval. The agency is committing up to $483 million to bankroll late-stage clinical trials and scale up manufacturing for the vaccine.
The National Institutes of Health (NIH) is testing three dose levels of Moderna’s candidate, mRNA-1273, in a healthy volunteers. Since it kicked off one month ago, the phase 1 study has finished enrolling 45 adults aged 18 to 55. The NIH is recruiting two more patient groups—adults aged 51 to 70 and those 71 and older—to see how the mRNA vaccine fares in older people.
If all goes well, Moderna aims to start a phase 2 study of the vaccine in the second quarter, with a phase 3 study that could begin “as soon as fall, 2020,” the company said in a statement Thursday. The company plans to scale up manufacturing of the vaccine this year by hiring up to 150 new workers in the U.S. including manufacturing staff, engineers, and clinical and regulatory personnel.
“Time is of the essence to provide a vaccine against this pandemic virus," Moderna CEO Stéphane Bancel said in the 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.”
The BARDA award comes weeks after Bancel told Goldman Sachs that the vaccine could become available to “some people,” such as healthcare workers, as early as this fall under an emergency use provision.
“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” BARDA Director Rick Bright, Ph.D., said in the statement. “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.”
Several of Moderna’s peers are also working on mRNA vaccines, including CureVac and BioNTech, both of which have told regulatory agencies that they would need to “abbreviate” the vaccine approval process to speed up development. One big unknown is how long it would take to make this type of vaccine, shortened pathway or not. There are no mRNA vaccines on the market, so there is no road map.