The European Medicines Agency threw cold water on Commission President Ursula von der Leyen's suggestion that a coronavirus vaccine could be "on the market" by the fall.
"We would estimate that it will take six months or more before candidate vaccines are tested in larger clinical studies, and 12-18 months before a vaccine against COVID-19 is ready for approval," an EMA spokesperson said Wednesday in a statement to POLITICO.
On Tuesday, von der Leyen posted a video noting her talks with CureVac, a German biotech working on a coronavirus vaccination. With the help of EU financial backing, she said, she hoped the jab could be "on the market, perhaps before autumn."
Pressed on why her timeline seemed much more optimistic than that of public health experts, von der Leyen said at a Tuesday evening press conference that her sense of timing came from CureVac. Amid a crisis, she said, "we are able to speed up any of the [regulatory] processes that are slow normally."
The EMA confirmed that it is already working to move coronavirus treatments and vaccines to patients "as rapidly as possible" by actively reaching out to developers and providing regulatory advice.
CureVac officials have not publicly said their experimental vaccine could be on the market by the fall.
"Ensuring a rapid response to COVID-19 is our number one priority," the EMA statement said. A team has been set up within the Amsterdam-based agency to "work on this and the regulatory tools available to accelerate approval."
CureVac officials have not publicly said their experimental vaccine could be on the market by the fall. However, Dietmar Hopp, the majority shareholder, has implied in various interviews that the vaccine could be ready by then.
He said in an interview with Bild published Wednesday that if regulators give the go-ahead, CureVac could deliver the vaccine in the fall.
According to CureVac's experts, the company is hopeful that results of the Phase 1 trial - a small-scale study to determine basic safety - will be ready at that point. Vaccines and medicines normally need to go through two more steps of larger-scale studies before winning approval.
CureVac spokesman Thorsten Schüller said Wednesday he was unable to comment on Hopp's statements.
The company has every intention of conducting all three phases of clinical trials as required by authorities, Schüller added. Any decision to change the process would have to be made by regulators, he noted, "not by us."
Yet he didn't directly respond to a question about whether the company would be comfortable administering the vaccine to the public based just on early stage trials, if regulators allowed it.
The EU announced financial help for CureVac on Monday amid German accusations - rejected by the company and the U.S. - that U.S. President Donald Trump tried to get exclusive access to its eventual immunization. Trump, incidentally, has also come under fire for repeatedly suggesting a vaccine is just months away.
"It's a European company," von der Leyen said of CureVac Tuesday. "We wanted to keep it in Europe."
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