Revenues in the fourth quarter dropped year-on-year, going against the upwards trend seen in 2010, but costs also fell. Novavax continues to invest though and over the next 12 months will develop a detailed plan for its rapid response vaccine manufacturing facility.
The plant will produce a “finished vaccine within 12 weeks and at least 50m doses within six months of an influenza pandemic declaration”, said Rahul Singhvi, president and CEO of Novavax.
Producing 50m doses in six months is “a huge challenge”, Singhvi told a conference call with investors, but the technology has the potential to hit the target. Looking at the production process and data so far achieving 50m doses is “within the realm of reasonableness”, said Singhvi.
Novavax has improved yield and quality by moving to 1000L fermentation tanks and making changes in downstream processing. Having changed the manufacturing process Novavax can now better control bioprocesses.
BARDA contract
Development of the plant plan is funded by a $97m (€69m) Biomedical Advanced Research and Development Authority (BARDA) contract. The BARDA contract covers development of a firm plan, with architectural drawings, but a separate deal will be needed to fund construction.
Before reaching this point there will “be a lot of back and forth with BARDA on the eventual design and location” of the plant, said Singhvi. At this stage Singhvi is unable to say where the plant would be built.
Novavax will also use money from the BARDA contract for Phase II and III trials of its seasonal vaccine candidate and further development of its pandemic adjuvant product.