Maryland-based vaccine developer, Novavax, has received $1.6 billion from the federal government to complete late-stage clinical development; set up large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, its COVID-19 vaccine candidate, as early as late 2020.
This is the largest vaccine deal to date with the Trump administration as part of their Operation Warp Speed, which is focused on making a COVID-19 vaccine and treatments available as quickly as possible.
Novavax has not brought any of their developed vaccines to market. According to information on their website, they have developed several vaccines for infectious diseases, however they are all in various stages of development or clinical trials. These include vaccines for the seasonal flu and RSV. Other vaccines created by Novavax are not actively being developed or studied at this time, including ones for Ebola, MERS, and SARS.
According to a statement from Novavax, the agreement with the federal government includes the company demonstrating being able to rapidly get manufacturing and large-scale production of the vaccine going once approved. Novavax hopes to conduct their late-stage clinical study with 30,000 subjects in fall 2020.
An early-stage clinical study took place in Australia in May on 130 participants. Study results are expected at the end of July.
“Today’s $1.6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people,” said U.S. Health and Human Services Secretary Alex Azar.
Regeneron Pharmaceuticals has also received $450 million through Operation Warp Speed on Tuesday, to make and supply its COVID-19 vaccine candidate, REGN-COV2. Their vaccine is currently in phase 2 and phase 3 clinical studies for the treatment and prevention of COVID-19.
Regeneron has several vaccines on the market currently, including Dupixent, used to treat allergic diseases such as eczema, asthma and nasal polyps which result in chronic sinusitis, and Praluent, used to treat high cholesterol.