Gaithersburg, Md.-based Novavax’s commercial-scale manufacturing is expected to produce 100 million doses of the investigational vaccine that would become available for use in clinical trials or, should the FDA grant emergency use authorization (EUA) or approval, the government would be able to distribute the doses as part of a COVID-19 vaccine campaign, according to a news release.
By scaling manufacturing while clinical trials are underway, Novavax could shave a large chunk of time off the traditional vaccine development timeline, which would aid the government’s effort to reach the target of 300 million doses of a safe and effective vaccine by 2021.
The project includes a fill-finish manufacturing process in the U.S., so vaccine doses are packaged and ready to ship immediately if trials bring success and the FDA grants EUA or a license to the vaccine. If the doses are used as part of a COVID-19 vaccination campaign, the vaccine would come at no cost to Americans, although healthcare professionals could charge insurers for the cost of administering the doses.
Novavax already agreed to a $70 million deal with DoD last month and will build on its original plan to manufacture the vaccine (NVX-CoV2373) and deliver 10 million doses that could be used in Phase 2/3 clinical trials or under EUA. NVX-CoV2373 uses a prefusion protein antigen to stimulate the body’s immune response against the virus.
“Operation Warp Speed is creating a portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said in the release. “Depending on success in clinical trials, today’s $1.6 billion investment supports our latest vaccine candidate, being developed by Novavax, all the way through clinical trials and manufacturing 100 million doses for the American people.”