Gregory M. Glenn, M.D., President of Research and Development, Novavax, said: “The FDA’s decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine.
“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the US and globally.”
Fast track status
The FDA’s Fast track process is designed to facilitate the development - and expedite the review - of drugs to treat serious conditions and fill an unmet medical need. Essentially, its role is to get important new drugs to patients earlier.
Fast track designation may include the benefits of:
- More frequent meetings with FDA to discuss the development plan and ensure collection of appropriate data needed to support drug approval
- More frequent written communication from FDA about such issues such as the design of the proposed clinical trials
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- Eligibility for Rolling Review, which means that a company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. (BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA)
Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373, is engineered from the genetic sequence of SARS‑CoV‑2. It uses Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein, and contains Novavax’s saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
The vaccine started Phase 3 trials in the UK last month. Novavax expects this trial to be fully enrolled by the end of this month, reaching 10,000 individuals aged 18-84.
The vaccine can be stored at 2°C to 8°C: allowing distribution in standard vaccine channels.
As part of the vaccine’s Phase 1/2 clinical trial, the Phase 1 element showed that NVX‑CoV2373 was ‘generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.’
Novavax’s supply agreements for its COVID-19 vaccine candidate include 100 million doses for the US and 60 million doses for the UK. In July it was awarded $1.6bn from the US’ Operation Warp Speed.
It has set its sights on producing up to two billion doses a year.
