BARDA prepares for COVID-19 vaccine clinical trials with Janssen, Moderna

The Biomedical Advanced Research and Development Authority (BARDA) is speeding up timelines for clinical trials of COVID-19 vaccine candidates produced by Janssen Research & Development and Moderna.

“Vaccines are essential to saving lives,” BARDA Director Rick Bright said. “Delivering a safe and effective vaccine for a rapidly spreading disease like COVID-19 requires accelerated action with parallel development streams. The rapid progress we are making with industry partners clearly demonstrates a commitment to protecting people at home and abroad.”

Janssen — a subsidiary of Johnson & Johnson — is in the early stages of such work and looks to soon have both non-clinical studies and a Phase 1 clinical trial undertaken. That clinical trial, set to begin no later than this fall, will focus on healthy adult volunteers and the vaccine’s ability to induce an immune response. Work on the vaccine began in February, through a platform initially meant for an Ebola vaccine, and now BARDA and Janssen hope to have it on the market for emergency use by early 2021. As part of this effort, BARDA will accelerate advanced clinical trials, regulatory support, and large-scale manufacturing that could produce as many as 300 million doses of vaccine each year.

Meanwhile, Moderna is preparing for Phase 2 and 3 clinical trials of its vaccine, which is being jointly developed alongside the National Institute of Allergy and Infectious Diseases (NIAID). Hundreds, perhaps even thousands, of people would need to be enrolled in these trials to guarantee its efficacy and safety. BARDA intends to lend its expertise and funding for manufacturing, to produce thousands of doses for the studies’ use.

BARDA’s support will also come into play with the U.S. Food and Drug Administration (FDA), to which all must apply for licensure. BARDA will work to streamline development and regulatory processes to get the vaccines out there as soon as possible, as there are currently no FDA-approved vaccines or treatments for COVID-19. What potentials there are have been operating under an emergency use authorization (EUA) from the administration instead.

Unlike the ordinarily drawn-out process of trials, BARDA’s support in this matter will also allow the companies to shave off downtime, effectively hopping from one clinical trial to the next immediately. All involved hope this will shave months off the traditional timeline.

Moderna and Janssen are far from the only ones racing for a cure, though. Just last week, BARDA awarded contracts to New York University for specimen acquisition meant to aid the development of medical countermeasures, and to Cue Inc., Luminex, and Vela Diagnostics USA, Inc. as they work on new diagnostic tests.