HHS Injects $483 Million Into Moderna’s COVID-19 Vaccine Candidate

HHS has granted Moderna up to $483 million to support its promising mRNA-1273 vaccine candidate for COVID-19.

The Cambridge, Mass.-based drugmaker launched the first U.S. clinical trial for a coronavirus vaccine in March. Initial enrollment included 45 healthy adults aged 18 to 55 in three dose cohorts (25, 100 and 250 micrograms), but the trial has since been expanded to include an additional six cohorts.

Moderna said it plans to begin a phase 2 trial in the second quarter if the safety data supports it, and said a phase 3 study could start as soon as the fall.

The new funding from HHS’ Biomedical Advanced Research and Development Authority (BARDA) will help pay for late-stage clinical development and the expansion of manufacturing to produce millions of vaccine doses.

“Time is of the essence to provide a vaccine against this pandemic virus,” said Moderna CEO Stéphane Bancel. “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 World Health Organization reported last week that there are 70 novel coronavirus vaccines currently in development globally, with two other vaccines in trials besides Moderna’s. In the U.S., Inovio Pharmaceuticals has entered human trials for INO-4800, a DNA-based vaccine. But Chinese firm CanSino Biologics appears to be in the lead, with its candidate adenovirus vector vaccine, Ad5-nCoV, first in line for a phase 2 trial (DID, April 15). — James Miessler