Novavax aims for billions of COVID-19 vaccine doses in 2021—more than enough to supply U.S.

Some of the world’s largest biopharma companies are working to deliver safe and effective COVID-19 vaccines, but at the same time, a much smaller biotech has laid out its own big ambitions in the field.

Novavax will have billions of doses of COVID-19 vaccine capacity next year and could single-handedly meet U.S. demand, executives say. On a conference call Monday, chief medical officer Filip Dubovsky said the Gaithersburg, MD-based biotech expects to be able to make "well over a couple billion units" each year, starting in 2021.

That would easily outpace U.S. demand, which Dubovsky estimated will come in at 500 million to 600 million doses annually.

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To aid with the scale-up, Novavax in May purchased Praha Vaccines and its vaccine factory in the Czech Republic. That plant will have an annual capacity of 1 billion doses, CEO Stanley Erck told analysts Monday. And last month, the company also enlisted Fujifilm to produce supplies at sites in North Carolina and Texas. The partners have started making clinical doses for late-stage testing.

Aside from those deals, Novavax has brought on AGC Biologics and PolyPeptide to help produce its Matrix-M adjuvant.  

The company has wrapped up phase 1/2 testing and expects to start a phase 2 trial in the U.S. and Australia this month. Frontrunners in the race, including AstraZeneca and the Pfizer-BioNTech team, have already started phase 3 testing.

To help fund the work, the company picked up $1.6 billion in federal funding as part of a commitment to deliver 100 million doses as early as late 2020. Before that, the biotech nabbed $388 million from the Coalition for Epidemic Preparedness Innovations and $60 million from the U.S. Department of Defense for its COVID-19 vaccine program.

The biotech, which has been around for decades but hasn’t developed a marketed vaccine, isn’t alone with its COVID-19 ambitions. Global pharma giants are also involved in the hunt, with Pfizer, AstraZeneca and Johnson & Johnson among the frontrunners. Behind those companies, Merck and a partnership between Sanofi and GlaxoSmithKline are advancing promising shots. Moderna, a biotech without any marketed products, is also in phase 3.

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With all the expertise between those companies, it'll be a tough task for Novavax to wrestle a significant portion of the COVID-19 vaccine market. Still, its program has attracted significant attention, and J.P. Morgan analysts recently said the company's early data look “best-in-class.”