Novavax starts enrolling people for phase two of COVID-19 vaccine trial
Novavax said on Monday it has begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.
In the new phase, the age range has been expanded, with adults between 60 and 84 years accounting for nearly 50% of the trial’s population.
Early-stage data from a small clinical trial of the vaccine has shown it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December.
About Novavax vaccine candidate NVX-CoV2373
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 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 data 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 August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).