The American biotech firm Moderna will not seek an emergency use authorization for its coronavirus vaccine before November 25, its CEO told the Financial Times on Wednesday.
The news deals a blow to President Donald Trump’s hopes of having an injection ready before the election to give his campaign a much-needed boost.
Stephane Bancel told the newspaper: “November 25 is the time when we will have enough safety data to be able to put it in a US file that we would send to the FDA (Food and Drug Administration), assuming the safety data is good, in other words, a vaccine is considered safe. “
Trump, whose approval has been affected by his handling of the Covid-19 crisis, has frequently hinted that a vaccine could be ready before the Nov. 3 vote.
This has raised concerns among experts that his administration may attempt to interfere with the regulatory process for political reasons.
The Republican repeated his claim Tuesday night, during a debate with his Democratic rival, former Vice President Joe Biden.
“We may have the answer before November 1,” he said.
Moderna’s vaccine is one of 11 experimental vaccines in the final testing phase.
Another is being developed by Pfizer, whose chief executive, Albert Bourla, has taken the position that his company may have a clear answer on whether its shot works by October.
Most experts are skeptical of the claim, believing that ongoing trials will not have enough statistical data to demonstrate the drug’s safety and efficacy at that time.
Speaking to the Washington Post on Tuesday, Bourla denied that he was trying to win the president’s favor by making his October claim.
“For me, Election Day is an artificial day. The end of October is an artificial day. This is how we operate. If we can bring it forward, we will,” he said.
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