Vaccine maker Novavax said Monday it had won fast-track designation for its experimental coronavirus vaccine from the US Food and Drug Administration – something that could help speed regulatory approval or emergency use authorization.
"Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November," the company said in a statement.
The Maryland-based company has been awarded $1.6 billion from the federal government’s Operation Warp Speed to help it run clinical trials of the vaccine.
Like several other experimental coronavirus vaccines, Novavax’s would require two doses. It hopes deliver 100 million doses by the end of this year.
Novavax's vaccine is made by growing synthetic versions of the coronavirus spike protein in armyworm moth cells. The vaccine combines these particles with the company’s adjuvant -- a plant-based compound that helps boost the immune response to the vaccine.