On Wednesday, Moderna CEO Stephane Bancel told the Financial Times that the company won’t seek an emergency use authorization for its coronavirus vaccine before November 25.
Stephane Banceltold the newspaper: “November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA (Food and Drug Administration) – assuming that the safety data is good, i.e. a vaccine is deemed to be safe.”
The news is a set back to President Donald Trump’s hopes of having an injection ready before the election to give his campaign a much-needed boost.
Trump, whose approval has taken a hit over his handling of the Covid-19 crisis, has frequently hinted a vaccine could be ready before the November 3 vote.
This has raised concern among experts that his administration may attempt to interfere with the regulatory process for political reasons.
Another vaccine developer Pfizer, whose CEO Albert Bourla has taken the position that his company may have a clear answer about whether their shot works by October.
Speaking to the Washington Post on Tuesday, Bourla denied he was attempting to curry favor with the president by making his October claim.
He said: “For me, the election day is an artificial day. The end of October is an artificial day. This is how we operate. If we can bring it earlier, we will.”