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Promising coronavirus vaccine news has dominated news coverage lately, but one company just announced the second delay of a Phase 3 trial that was scheduled to start in the U.S. this month. Novavax Inc. announced on Monday that its trial would instead likely begin in December.
“Novavax expects its pivotal Phase 3 clinical trial in the United States and Mexico to begin in the coming weeks,” a press release posted Monday said. “More than 100 trial sites have been selected with some alternate sites in place, should they be needed.”
The company said that the preliminary data on NVX-CoV2373 in older adults that is needed to proceed with a Phase 3 trial has already been reviewed by the FDA, and that it is working with the agency to complete work related to commercial-scale production.
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The first delay, which came in October, was also related to manufacturing, Reuters reported.
Elsewhere in the world, Novavax has moved forward with ongoing testing, including in the U.K. where the company enrolled 15,000 participants, 25% of which are over the age of 65 for Phase 3 clinical trial. In South Africa, the company said its fully enrolled participants in a Phase 2b trial to evaluate the safety and provide an early indication of the efficacy of its vaccine.
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Unlike Pfizer and Moderna, who both use the mRNA technology to develop their vaccines, Novavax instead opted for a protein-based candidate engineered from the genetic sequence of SARS-CoV-2.
“NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies,” according to a company statement.
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Novavax announced the delay on the same day that Moderna said it was prepared to file for emergency use authorization with the FDA.
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