The biotechnology company Moderna said Thursday that it expects to begin a crucial phase three trial of its potential coronavirus vaccine as soon as early summer.
The company also said the Food and Drug Administration has completed its review to allow the potential vaccine to proceed to a phase two trial beginning “shortly.”
Shares of the company surged in premarket trading on the news.
The company said it is already preparing for manufacturing of the vaccine, a crucial step to start early given that manufacturing millions of doses is a logistical challenge.
The company said it is “accelerating manufacturing scale-up” to get “in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective.”
The Trump administration is pushing to speed up the development of vaccines with its “Operation Warp Speed,” seeking to have millions of doses ready by January, a very ambitious timeline that would be far faster than any vaccine has been developed before.
Moderna said its vaccine could be ready by 2021 but did not specify when in the year.
Anthony Fauci, the top government infectious disease expert, said last week having millions of doses by January is “doable if things fall in the right place.”
Other potential vaccines, like those from Johnson & Johnson, Pfizer and a team at Oxford University, are also being worked on as researchers scramble to make a vaccine ready.