FDA Approved: No Brand name: Novavax COVID-19 Vaccine Generic name: SARS-CoV-2 vaccine Previous Name: NVX-CoV2373 Company: Novavax, Inc. Treatment for:Prevention of COVID-19
The Novavax COVID-19 Vaccine (NVX-CoV2373) is an investigational SARS-CoV-2 vaccine in development for the prevention of COVID-19.
The Novavax COVID-19 Vaccine (NVX‑CoV2373) is engineered from the genetic sequence of SARS‑CoV‑2, and uses recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It contains Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
The Phase 1/2 randomized, observer-blinded, placebo-controlled trial of NVX‑CoV2373 commenced in May 2020 and included 131 healthy volunteers aged 18-59 years at two Australian sites (Melbourne and Brisbane). The study evaluated two doses (administered 21 days apart) of NVX‑CoV2373 across two dose levels (5 µg and 25 µg), with and without the Matrix‑M™ adjuvant. Novavax reported Phase 1 data in early August 2020, and announced the vaccine was generally well-tolerated and elicited robust antibody responses.
The most commonly reported local reactions (80%) were pain and tenderness, and the most common systemic reactions (>60%) were headache, fatigue and myalgia. Most reactions were mild or moderate, but reactogenicity was greater following the second dose.
The Phase 2 clinical trial commenced August 2020 expanding 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’s population. The trial assessed two doses (5 and 25 µg), each with 50 µg of Matrix‑M. The study targeted enrollment of up to 1,500 healthy volunteers, with approximately 50 percent of participants ≥60 years of age, at up to 40 sites across the U.S. and Australia.
The UK Phase 3 pivotal clinical trial commenced September 2020 to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects aged 18 to 84 years. Half the participants received two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, and half of the trial participants received placebo (saline). An additional Phase 3 pivotal clinical trial conducted in the United States and Mexico commenced December 2020 and included 30,000 participants with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age, and those living with co-morbidities.