Novavax, Inc. NVAX shares were moving to the downside Monday following an update from the company on its coronavirus vaccine program.
What Happened: Gaithersburg, Maryland-based Novavax said it has commenced the PREVENT-19 Phase 3 study of its coronavirus vaccine candidate NVX-CoV2373 in the U.S. and Mexico.
The vaccine candidate showed immune response and a favorable safety profile in Phase 1/2 studies.
The start of the Phase 3 trial represents a delay from the end-of-November timeline provided by the company in its third-quarter report Nov. 9.
In an update Nov. 30, the company had said it expected the late-stage study in the U.S. and Mexico to start in the coming weeks.
Novavax said it expects to enroll up to 30,000 volunteers ages 18 and older across about 115 sites in the two countries.
About two-thirds of the enrollees will receive an active vaccine, Novavax said. Two intramuscular injections of the vaccine given 21 days apart are envisaged.
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Why It's Important: Moderna Inc MRNA and Pfizer Inc. PFE-BioNTech SE – ADR BNTX have rolled out their vaccine candidates for emergency use following regulatory authorization.
AstraZeneca plc AZN is on the cusp of receiving conditional U.K. regulatory approval for the coronavirus vaccine candidate it is co-developing with the Oxford University.
Given the delay in the start of the late-stage study for Novavax's vaccine candidate, a potential launch is unlikely before the second quarter of 2021.
Novavax has a logistical advantage, as its investigational vaccine is stable at 2°C to 8°C and can be shipped in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels.
What's Next: Novavax's vaccine candidate is being evaluated in a large pivotal Phase 3 clinical study in the U.K., a Phase 2b safety and efficacy study in South Africa and an ongoing Phase 1/2 trial in the U.S. and Australia.
The company said it expects data from these trials as soon as early the first quarter of 2021, adding that the timing depends on regional transmission rates.
NVAX Price Action: At last check, Novavax shares were down 5.92% to $121.68.
Related Link: The Week Ahead In Biotech (Dec. 27-Jan. 2): Data Releases, Regulatory Filings To Move Stocks
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