6 August 2020
Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID‑19 vaccine with and without Matrix‑M™ adjuvant in healthy adults 18-59 years of age.
NVX‑CoV2373, the Company’s recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The Phase 1 trial was conducted by Australia’s largest Phase 1 specialist, Nucleus Network, at both its Melbourne and Brisbane clinics, supported by 360biolabs. Novavax’s Australian engagement is also supported by BioIntelect.
The data have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org.
Overall, the vaccine was well-tolerated and reactogenicity events were generally mild. Following Dose 1, tenderness and pain were the most frequent local symptoms and systemic events were individually less frequent with headache or fatigue being reported most commonly. As expected, following Dose 2, greater reactogenicity was reported, although the majority of symptoms were reported as ≤ Grade 1. The average duration of events
was < 2 days. Unsolicited adverse events were collected through 28 days after Dose 2. There were no severe (Grade 3) unsolicited adverse events, and the vast majority of adverse events were mild and deemed not related to vaccination. No serious adverse events (SAEs) were reported and safety follow-up continues.