FDAnews
www.fdanews.com/articles/198506-novavax-says-it-will-meet-us-needs-for-covid-19-vaccine-but-is-aiming-higher

Novavax Says It Will Meet U.S. Needs for COVID-19 Vaccine, but Is Aiming Higher

August 12, 2020

Novavax plans to have enough COVID-19 vaccine manufacturing capacity to meet U.S. demand at a minimum, but the Maryland-based vaccine developer is also looking to be able to supply billions of doses next year, the company’s CEO said.

Speaking at an Aug. 10 investor call, Novavax CEO Stanley Erck said the company expects to be able to fulfill domestic needs at the very least — a goal that could require the production of 500 million to 600 million doses annually. The company has also set its sights on delivering billions of doses per year and is taking steps to achieve the massive capacity required to do so.

“We expect to have well over a couple billion units of capacity on an annual basis soon,” Erck said.

Novavax’s U.S. capacity is centered in two Fujifilm facilities it has contracted with to manufacture its vaccine candidate, Erck said. Outside the U.S., Praha Vaccines, a Czech Republic firm the company acquired in May for $167 million, is preparing to finish a three-year remodeling process at its facility and will likely start engineering runs in the next several weeks. The plant, which Erck said should begin large-scale production at the beginning of 2021, is expected to offer a yearly capacity of more than 1 billion doses.

Erck noted that the company intends to announce more details about its supply strategy in the next few weeks.

Novavax has received more than $2 billion in funding for its vaccine candidate, NVX-CoV2373, including a $1.6 billion contract from HHS’ Biomedical Advanced Research and Development Authority that extends to a phase 3 trial of 30,000 participants.

The company recently announced positive results from a phase 1 trial, and it is slated to begin a phase 2 trial this month (DID, Aug. 5). — James Miessler