Washington, United States:
U.S. biotech company Moderna will not apply for emergency use authorization for its coronavirus vaccine until Nov. 25, its CEO told the Financial Times on Wednesday.
The news is a blow to President Donald Trump’s hopes of having an injection ready before the election to give his campaign a much-needed boost.
Stéphane Bancel told the newspaper: “November 25 is when we will have enough safety data to be able to put in an EUA file that we would send to the Food and Drug Administration (FDA) – assuming the safety data is good, ie a vaccine is considered safe. “
Trump, whose approval negatively impacted his handling of the Covid-19 crisis, has often hinted that a vaccine could be ready before the November 3 vote.
This has raised concerns among experts that his administration may attempt to interfere with the regulatory process for political reasons.
The Republican reiterated his claim Tuesday night, during a debate with his Democratic rival, former Vice President Joe Biden.
“It is possible that we will have the answer before November 1,” he said.
Moderna’s vaccine is one of 11 experimental vaccines in the final stages of testing.
Another is in development by Pfizer, whose CEO Albert Bourla felt his company might have a clear answer as to whether their photo works by October.
Most experts are skeptical of the claim, believing that ongoing trials will not have sufficient statistical data to prove the drug’s safety and effectiveness at that time.
Speaking to the Washington Post on Tuesday, Bourla denied attempting to curry favor with the president by making his October request.
“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 earlier, we will,” he said.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)