Boulder’s CordenPharma begins shipping lipids for Moderna vaccine

BOULDER and CAMBRIDGE, Massachusetts — Moderna Inc. (Nasdaq: MRNA), one of the three leading biotechnology companies pioneering vaccines for the COVID-19 disease, said Monday that it would request emergency use authorization from the Food and Drug Administration to distribute its vaccine.

A piece of the vaccine production is already occurring in Boulder by CordenPharma Boulder Inc. “We shipped product on Friday,” said CordenPharma Boulder President Brian McCudden.

“It’s the most important thing we’ve been working on for months to get the quality, and it looks like the work will pay off,” McCudden told BizWest.

Corden produces a lipid that is necessary for the vaccine to work. It has been scaling up in order to produce the quantities necessary so that Moderna can manufacture millions of doses. McCudden said the Boulder facility will produce quantities of lipids sufficient to create 100 million to 200 million doses of the vaccine per month, which will be used in all of Moderna’s markets worldwide but especially in the U.S. and Europe.

The lipids, like the vaccine that will ultimately result, are shipped at minus 20 degrees Celsius or minus 4 Fahrenheit, McCudden said.

Moderna’s Phase 3 study conducted on 196 cases confirms an efficacy of 94.1%, according to information the company released Monday. The study enrolled 30,000 participants in the U.S. The vaccine uses messenger RNA therapeutics to create a new generation of medicines for patients. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board. 

The Moderna vaccine will be a two-dose regimen. Efficacy in the study was consistent across age, race and ethnicity and gender demographics, the company said. Requests for emergency authorization are being submitted to the FDA and to the European Medicines Agency. Similar requests have already been underway with other world health agencies for use authorization. Shipping of the vaccine can begin shortly after approvals are granted.

The company expects to produce 20 million doses available in the United States by the end of 2020, and it will manufacture 500 million to 1 billion doses globally in 2021. 

BizWest reported in June that CordenPharma extended its manufacturing agreement with Moderna. Corden will use facilities in Boulder, Switzerland and Germany to produce the lipids for the vaccine.

© 2020 BizWest Media LLC

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