BioPharma, Policy

Moderna gets up to $483M from BARDA for rapid Covid-19 vaccine development

The funding will support the development of the vaccine, mRNA-1273, through to its potential licensing by the Food and Drug Administration. The company said a Phase II study is expected to start in the second quarter.

One of the lead companies involved in developing a vaccine to prevent Covid-19 just got a big boost from the federal government.

In an early evening announcement, Cambridge, Massachusetts-based Moderna said the Biomedical Advanced Research and Development Authority – part of the Department of Health and Human Services – had provided the biotechnology company an award of up to $483 million. The funding, the company said, would support the development of the vaccine, mRNA-1273, through its potential licensing by the Food and Drug Administration.

Shares of Moderna were up more than 9% in after-hours trading on the Nasdaq following the announcement.

A messenger RNA-based vaccine, mRNA-1273 is currently in a Phase I clinical trial under the National Institute of Allergy and Infectious Diseases. It is expected to enter a Phase II clinical trial in the second quarter sponsored by Moderna, as long as Phase I data prove the vaccine safe, the company said. Depending on how data from that study turn out, a Phase III trial could start as early as this fall. The funding from BARDA will support the late-stage programs and scaling up of manufacturing of the vaccine. The company plans to hire up to 150 new staff to support its efforts in developing the vaccine.

“Time is of the essence to provide a vaccine against this pandemic virus,” Moderna CEO Stephane Bancel said in a statement. “By investing now in ou rmanufacturing 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.”

Moderna is one of several companies developing vaccines for Covid-19, and among U.S. companies is the furthest along in development. Another company, Tianjin, China-based CanSino Biologics, said in a regulatory filing last week that it planned to move its own vaccine candidate into Phase II testing. The ClinicalTrials.gov page for the Phase II study – sponsored by a biotechnology research institute under the Chinese People’s Liberation Army’s Academy of Military Medical Sciences – states that the study is recruiting participants, but only in China. CanSino’s vaccine is based on recombinant adenovirus vector technology.

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