US biotech firm Moderna won’t 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 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.”
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.
The Republican repeated his claim on Tuesday night, during a debate with his Democratic rival, former vice president Joe Biden.
“It’s a possibility that we’ll have the answer before November 1,” he said.
Moderna’s vaccine is one of 11 experimental vaccines in final stage trials.
Another is being developed by Pfizer, whose CEO Albert Bourla has taken the position that his company may have a clear answer about whether their shot works by October.
Most experts are skeptical of the claim, believing that the ongoing trials will not have sufficient statistical data to prove the drug’s safety and effectiveness by that time.
Speaking to the Washington Post on Tuesday, Bourla denied he was attempting to curry favor with the president by making his October claim.
“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,” he said.
© 2020 AFP
Spain becomes first EU nation with one million virus cases
Spain has become the first European Union nation to surpass a million coronavirus infections, official data showed Wednesday, as the government mulls fresh restrictions on public life to curb the spread of the disease.
The country recorded 16,973 confirmed cases of Covid-19 over the past 24 hours, the health ministry announced Wednesday, taking the total to 1,005,295 since its first case was diagnosed on January 31 on the remote island of La Gomera in the Canary Islands.
Of this number, 34,366 people have died, after 156 more deaths were recorded in the previous 24 hours.
Spain, which is home to around 47 million people, is only the sixth country in the world to cross this grim milestone after the United States, India, Brazil, Russia and Argentina, according to an AFP tally based on official figures.
‘Vote these monsters out’: Trump officials weigh deep funding cuts to COVID-19 relief, newborn screenings in Democratic-led cities
Documents obtained by Politico reveal that the Trump White House is weighing millions of dollars in federal funding cuts to Covid-19 relief, newborn screenings, and other crucial healthcare programs in Democrat-led cities, a move critics decried as politically motivated "retribution" that could have a devastating impact on poor and sick Americans amid the ongoing pandemic.
Politico reported late Tuesday that the Department of Health and Human Services (HHS) has "identified federal grants covering... nearly 200 health programs that could be in line for cuts as part of a sweeping government-wide directive the administration is advancing during the final weeks of the presidential campaign and amid an intensifying pandemic Trump has downplayed."
Paul McCartney to release new lockdown album
British pop legend Paul McCartney revealed Wednesday he will release the third in a trilogy of self-titled solo albums this year, after resurrecting unfinished music during the coronavirus lockdown.
The former Beatle's latest record "McCartney III", which will be unveiled on December 11, follows months of work at his home studio in Sussex in southern England on previously started and new songs.
It has all been written, produced and performed by McCartney, who said he hadn't been planning to release an album in 2020 until the pandemic forced him to stay at home for months.
"I had some stuff I'd worked on over the years but sometimes time would run out and it would be left half-finished so I started thinking about what I had," McCartney said, in comments published by Britain's Press Association news agency.