Novavax Inc. (NVAX) - Get Report said Monday that a late-stage, U.S.-based trial for its developing coronavirus vaccine could start in the coming weeks following delays linked to ramping-up its manufacturing.
Novavax, which currently has around 15,000 people enrolled in a phase 3 trial in the United Kingdom testing the the effectiveness and immunogenicity of its NVX-CoV2373 coronavirus vaccine candidate, said it has around 100 trial sites selected in the U.S. and will use "vaccine material produced at commercial scale" for the trials. The group is working closely with the U.S. Food & Drug Administration to complete trial-initiation gating activities, the company said, relating to production at the FUJIFILM Diosynth Biotechnologies in North Carolina.
Novavax has expected to start its U.S. trials in October, before delaying the start to November, after receiving so-called 'fast-track' designation by the FDA on November 9.
"Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said CEO Stanley Erck. “We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide."
Novavax shares were marked 2..3% higher in early trading Monday to change hands at $128.56 each, a move that still leaves the biotech stock with a six-month gain of nearly 140%.
Interim data from its U.K. trial, where more than 25% of those enrolled are over the age of 65, should be available in the first quarter of next year, Novavax said.
Earlier Monday, Moderna Inc. (MRNA) - Get Report said it will ask the U.S. Food & Drug Administration for emergency approval of its coronavirus vaccine later today, adding that late-stage trial data showed a 100% effectiveness rate against severe forms of the respiratory virus.