Novavax, Inc. (NVAX) has announced another milestone event in the development of its coronavirus vaccine, codenamed NVX-CoV2373.
What Happened: The Gaithersburg, Maryland-based company said Monday it has enrolled the first volunteers in the Phase 2 portion of its ongoing Phase 1/2 trial to evaluate the immunogenicity and safety of the vaccine candidate.
About 50% of the Phase 2 trial population will comprise older adults ages 60-84, the company said.
The Phase 1 trial, for which interim results were released in early August, had enrolled healthy adults ages 18-59.
"We expect this Phase 2 portion of the trial to expand on the encouraging Phase 1 safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults," Gregory Glenn, Novavax's R&D president, said in a statement.
Why It's Important: Older adults are particularly vulnerable to COVID-19, and therefore data from the Phase 2 trial will be critical in assessing efficacy and safety.
The Novavax trial will assess two doses — 5mcg and 25mcg — each with 50 mcg of Matrix-M adjuvant, which enhances the immune response.
Apart from immunogenicity and safety, the trial will also assess secondary objectives, including efficacy, the company said.
Novavax aims to enroll about 1,500 participants in the U.S. and Australia.
Last week, the company initiated a Phase 2b efficacy study in South Africa.
What's Next: Novavax said it expects to release interim results from the "closely watched" trial in the fourth quarter.
At last check, Novavax shares were tumbling 12.48% to $120.44.
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