Novavax Announces Publication of Phase 1 Data for COVID-19 Vaccine Candidate in The New England Journal of Medicine
“The rapid publication of Phase 1 results from our trial in a prestigious peer-reviewed journal reflects both the importance of the data and the urgent need for an effective vaccine to slow the COVID-19 pandemic,” said
The Phase 1 portion of the Phase 1/2 clinical trial was randomized, observer-blinded, and placebo-controlled.
NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August.
The trial was supported by funding from the
Phase 1 Results Summary
- NVX-CoV2373 was well-tolerated and reactogenicity events were generally mild
- There were no severe (Grade 3) unsolicited adverse events (AEs); the vast majority of AEs were mild and deemed not related to vaccination. No serious AEs were reported. Safety follow-up continues.
- All subjects in the 5 µg group developed anti-spike IgG antibodies after a single dose of vaccine, many of which included neutralizing antibody responses to wild-type virus
- 100 percent of participants developed wild-type virus neutralizing antibody responses after Dose 2
- Both 5 µg and 25 adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300
- Anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease
- Matrix-M adjuvant was dose-sparing, with the lower 5 µg dose of NVX‑CoV2373 performing comparably with the of 25 µg dose
- Cellular immune responses measured in a subset of participants demonstrated induction of antigen-specific polyfunctional CD4+ T cell responses with a strong Th1 phenotype bias
- NVX-CoV2373 has a favorable product profile; it is stable and will allow handling in a liquid formulation that can be stored at 2°C to 8°C, allowing for successful cold chain management with existing infrastructure
Further details may be found in Novavax’
NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax Forward-Looking Statements
Statements herein relating to the future of