Maryland-based biotech Novavax has launched a Phase 1/2 clinical trial of its COVID-19 vaccine candidate, marking a significant milestone in the global race for coronavirus prevention. The company joins a select group of developers with vaccines in clinical development, as tracked by the World Health Organization.
The vaccine candidate, NVX-CoV2373, leverages Novavax's innovative nanoparticle technology to deliver a stable, prefusion protein. The formulation incorporates the company's proprietary Matrix-M adjuvant, designed to enhance immune responses and boost the production of neutralizing antibodies.
Trial Design and Timeline
The Phase 1 portion comprises a randomized, observer-blinded, placebo-controlled study enrolling approximately 130 healthy participants aged 18 to 59 years. The trial, conducted across two Australian sites, will evaluate two dose levels (5 and 25 micrograms) both with and without the Matrix-M adjuvant.
Initial immunogenicity and safety data from the Phase 1 segment are expected in July 2020. The subsequent Phase 2 portion will expand to multiple countries, including the United States, to assess immunity, safety, and COVID-19 disease reduction across a broader age demographic.
Manufacturing and Distribution Plans
With substantial financial backing from the Coalition for Epidemic Preparedness Innovations (CEPI), including a recent $384 million investment, Novavax has outlined ambitious production targets. The company projects manufacturing capacity of 100 million vaccine doses by year-end 2020, scaling up to exceed one billion doses throughout 2021.
Global Access Commitment
Novavax and CEPI have emphasized their shared commitment to ensuring global equitable access to the vaccine. Distribution will be coordinated through global mechanisms currently under discussion as part of the Access to COVID-19 Tools Accelerator, an international initiative launched by the World Health Organization.
Competitive Landscape
The vaccine development landscape continues to evolve rapidly, with the WHO reporting ten candidates in clinical trials and over a hundred in preclinical development. Currently, CanSino Biological and the Beijing Institute of Technology lead the field with their Phase 2 candidate, while Moderna's mRNA-based vaccine, developed in collaboration with the US National Institute of Allergy and Infectious Diseases, has received clearance for Phase 2 studies.
