Sunday, November 7, 2021

Novavax taps Baxter for commercial production as COVID-19 vaccine nears finish line

With a phase 3 data readout on its COVID-19 vaccine looming, Novavax has already started stockpiling doses ahead of an authorization. Now, thanks to a fresh manufacturing tie-up, the company’s ex-U.S. supplies just got a little more secure.

Novavax tapped Baxter BioPharma Solutions to handle commercial-scale vaccine manufacturing at its facility in Halle, Germany. Once production work kicks off, Baxter will be on deck to crank out supplies for the European and U.K. markets, the companies said.

The Bloomington, Indiana-based CMO will tackle fill-finish work on Novavax’s recombinant nanoparticle adjuvanted vaccine, a Novavax spokeswoman said via email. The company’s candidate, NVX-CoC2373, is still in phase 3, though it’s eyeing a phase 3 data readout sometime during the first quarter.

Back in August, Novavax was already setting lofty production goals. On a conference call, Chief Medical Officer Filip Dubovsky, M.D., said the company expected to be able to make “well over a couple billion units” each year, beginning in 2021. That’s more than enough for the Gaithersburg, Maryland-based biotech to single-handedly meet U.S. demand, which Dubovsky pegged at around 500 million to 600 million doses annually.

RELATED: Novavax inks $1.6B Warp Speed deal to fund COVID vaccine’s phase 3 testing, manufacturing

As of January, Novavax has built out a worldwide manufacturing network with production firepower to churn out 2 billion vaccine doses per year, CEO Stan Erck said Monday at the annual J.P. Morgan healthcare conference. The company plans to deliver 110 million doses to the U.S. in the second quarter of the year, he added.

Novavax in May bought Praha Vaccines and its vaccine plant in the Czech Republic, which boasts annual capacity of 1 billion doses, Erck told investors in August. It also brought Fujifilm into the fold to produce clinical supplies and signed AGC Biologics and PolyPeptide to help produce its Matrix-M adjuvant.

RELATED: Novavax scores $384M deal, CEPI’s largest ever, to fund coronavirus vaccine work

In September, the company added two more manufacturing partners, tapping vaccine powerhouse the Serum Institute of India and generics player Endo.

Meanwhile, the company in November revealed two new real estate transactions meant to bolster its manufacturing and commercial presence in its home state of Maryland. The first, a 15-year lease for some 122,000 square feet of space, will house offices, manufacturing and R&D activities and is expected to come online early this year. At the same time, a Novavax affiliate snapped up 9.7 acres on Firstfield Road in Gaithersburg for future development.

Novavax may not have been the first to the finish line in the vaccine race, but plenty of countries are still hoping the biotech’s shot can help see their immunization efforts through. The U.K. has secured 60 million doses, while the U.S. is set to receive a little over 100 million doses initially. Plus, Novavax isn’t stopping there. The company late last week locked in a purchase agreement with Australia for 51 million doses.

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