By Mike Murphy
Moderna Inc.’s potential coronavirus vaccine will not be ready by the U.S. presidential election, the biotech company’s chief executive told the Financial Times on Wednesday.
CEO Stéphane Bancel told the FT in an interview that Moderna /zigman2/quotes/205619834/composite MRNA -1.42% — a front-runner in the COVID-19 vaccine race — will not seek emergency-use authorization from the U.S. Food and Drug Administration until Nov. 25 at the earliest and does not expect to have secured approval for distribution of the vaccine to the general public until spring 2021.
“I think a late [first quarter], early [second quarter] approval is a reasonable timeline, based on what we know from our vaccine,” Bancel told the FT.
President Donald Trump has pressed for a vaccine by Election Day, worrying some experts who fear a rushed and inadequate testing process.
FDA Commissioner Stephen Hahn has promised that the approval process will be based on science, not politics. “FDA will not permit any pressure from anyone to change that,” Hahn said recently . “I will put the interest of the American people above anything else.”
Despite Trump’s assertions that a vaccine could be ready in weeks , Centers for Disease Control and Prevention Director Robert Redfield told Congress earlier this month that widespread vaccinations are not expected until well into next year .
Cambridge, Mass.–based Moderna has one of seven coronavius vaccine candidates being tested in the U.S., and one of four to have advanced to late-stage trials.
MarketWatch video: This is how much it costs to develop a vaccine
In August, Moderna said the U.S. government had agreed to buy 100 million doses of its vaccine candidate, with an option to buy 400 million more doses, for $2.48 billion in total.
Moderna shares are up more than 261% in 2020, compared with the benchmark S&P 500’s /zigman2/quotes/210599714/realtime SPX -0.05% 4% year-to-date gain. Moderna shares were lower by 1% in premarket trades on Thursday.