By Ciara Linnane, MarketWatch
The number of confirmed cases of the coronavirus that causes COVID-19 worldwide rose above 26.4 million on Friday, with the U.S. accounting for about a quarter of that total, as a key member of the government’s vaccine program said the chances of a vaccine being ready by late October are “very, very low.”
Moncef Slaoui, a venture-capital investor and former GlaxoSmithKline PLC /zigman2/quotes/209463850/composite GSK +0.38% executive who heads up the government’s Operation Warp Speed program, told NPR he cannot imagine trials producing data by the end of October.
“There is a very, very low chance that the trials that are running as we speak could read before the end of October, and therefore, there could be — if all other conditions required for an [EUA] are met — an approval,” he said. “I think it’s extremely unlikely but not impossible.”
Slaoui’s comments come amid growing concerns that the Trump administration may try to rush out a vaccine just in time for the November presidential election. Those concerns were fueled by the news that the Trump-appointed head of the Centers for Disease Control and Prevention has directed governors to do what is needed to have vaccine distribution centers ready in their states by Nov. 1.
Dr. Howard Koh, a former assistant secretary of health and current professor of public health leadership at the Harvard T.H. Chan School of Public Health, said that, while speed is needed in developing a vaccine during a pandemic, “we also need attention to safety. And the public needs to hear more about the attention to safety.”
In an interview with MarketWatch, Koh added his voice to a chorus of criticism of the recent emergency-use authorization granted by the U.S. Food and Drug Administration for convalescent plasma as a treatment for hospitalized COVID-19 patients, which experts say was granted without sufficient data to prove it’s effective.
FDA commissioner Stephen Hahn, also a Trump nominee, announced the EUA at a press conference with President Donald Trump on the eve of the Republican National Convention. Hahn was later forced to admit he misspoke at that briefing in describing the survival rate that plasma had produced in a study.
“It was fairly clear to me and many of my scientific colleagues that the data on [convalescent plasma’s] effectiveness was not strong enough to proceed with an EUA,” said Koh. “There have been no definitive outcomes from randomized, placebo-controlled trials. The Mayo Clinic data that was held up as justifying authorization were analyses where everybody got convalescent plasma and there was no control arm.”
Koh also called for a national approach to managing the pandemic, which he said “has been absent” and “allowed this pandemic to persist for way too long,” and for a national face-mask mandate.
Americans are heading into the Labor Day weekend after adding more than 44,000 new COVID-19 cases on Thursday. The U.S. now has 6.2 million confirmed cases of COVID-19, and 187,152 people have died, according to data aggregated by Johns Hopkins University.
State and local officials are cautioning residents against large gatherings that would expose them to the virus and are urging them to continue to follow public safety instructions.
New York City Mayor Bill de Blasio reminded New Yorkers that if they travel to a destination on the state’s travel-advisory list, they will be obliged to quarantine for 14 days on return.
Louisiana Gov. John Bel Edwards, who is working on the clean up after Hurricane Laura hammered the state in late August, issued his own warning at a Thursday press conference.
”We know the last surge in COVID-19 cases started with Memorial Day, and now we’re about to have Labor Day. We don’t want a repeat. If you celebrate, do so in way that is safe and use mitigation measures,” he said.
Dr. Anthony Fauci, head of the National Institute for Allergies and Infectious Diseases, said seven states — North Dakota, South Dakota, Arkansas, Iowa, Missouri, Illinois and Indiana — are at the highest risk for a surge in new cases this holiday weekend.
“We don’t want to see a surge under any circumstances, but particularly as we go out the other side of Labor Day and enter into the fall,” Fauci said in an interview with Bloomberg. “We want to go into that with a running start in the right direction. We don’t want to go into that with another surge that we have to turn around again.”
In other news:
• Brazil marked a grim milestone on Friday of more than 4 million COVID-19 cases, the Johns Hopkins data show. President Jair Bolsonaro has been widely criticized for his handling of the crisis, which he has consistently played down, even after testing positive himself. At least 124,614 Brazilians have died, second only to the U.S. There was a glimmer of hope in a statement from the Brazilian health ministry which said infections were slowing in recent days.
• Silvio Berlusconi, the former Italian prime minister who announced Thursday that he had tested positive, has been admitted to hospital, according to the party he led, Forza Italia. The 83-year-old was reported to be in isolation in his home in Arcore, near Milan. He is not in intensive care, according to news agency AGI, but rather in a room he often occupies at San Raffaele hospital, suggesting his condition is not serious.