Novavax Strikes Coronavirus Vaccine Manufacturing Deal, Pushes Back Release Of Phase 1 Data

Novavax, Inc. NVAX, which issued an update on its coronavirus vaccine program earlier this week, announced late Thursday a manufacturing agreement with a CDMO, while also flagging a slightly delay in the Phase 1 readout.

Novavax' Deal With Fujifilm: Novavax, which is working on an investigational vaccine (codenamed NVX-CoV2373) against the SARS-CoV2, said it struck a manufacturing deal with Fujifim Diosynth Biotechnologies for manufacturing bulk drug substance for the vaccine candidate.

The companies said Fujifilm's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

The agreement draws upon the $1.6 billion funding award Novavax was granted under the federal's government's Operation Warp Speed project.

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The companies said the batches produced at Fujifilm's site in North Carolina will be used in a future pivotal Phase 3 clinical trial of up to 30,000 subjects, which will determine the safety and efficacy of NVX-CoV2373. The trial is set to start in the fall.

"We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate," said Stanley Erck, CEO of Novavax.

Novavax Flags Delay: Novavax said it plans to announce Phase 1 data, consisting of immunogenicity and safety results, in the first week of August. The company had earlier given a July timeframe for the release.

The Phase 1 trial is part of the Phase 1/2 trial the company initiated in 130 healthy participants, ages 18 to 59 years, in Australia in May.

Novavax said it now expects the Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction to begin shortly thereafter.

In pre-market trading, Novavax shares were down 3.28% to $135.01, having gained over 3,400% in the year-to-date period.