AstraZeneca, Moderna Hit Speed Bumps In Vaccine Race; Pfizer Watched Closely

Reuters: Exclusive: FDA Widens U.S. Safety Inquiry Into AstraZeneca Coronavirus Vaccine - Sources 
The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters. AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis. The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said. (Taylor and Levine, 9/30)

MarketWatch: Moderna CEO Tells FT That Coronavirus Vaccine Won't Be Ready By Election Day
CEO Stéphane Bancel told the [Financial Times] in an interview that Moderna — a front-runner in the COVID-19 vaccine race — will not seek emergency-use authorization from the U.S. Food and Drug Administration until Nov. 25 at the earliest and does not expect to have secured approval for distribution of the vaccine to the general public until spring 2021. “I think a late [first quarter], early [second quarter] approval is a reasonable timeline, based on what we know from our vaccine,” Bancel told the FT. (Murphy, 9/30)

The New York Times: All Eyes Are On Pfizer As Trump Pushes For Vaccine By October
In media appearances and talks with investors, Pfizer’s chief executive nearly always mentions a word that is so politically perilous, most of his competitors shy away from it: October. “Right now, our model — our best case — predicts that we will have an answer by the end of October,” the chief executive, Dr. Albert Bourla, told the “Today” show earlier this month. In other interviews, he has said he expected a “conclusive readout” by then, with an application for emergency authorization that could be filed “immediately.”Dr. Bourla’s statements have put his company squarely in the sights of President Trump, who has made no secret of his desire for positive vaccine news to boost his chances on Election Day, Nov. 3. “We’re going to have a vaccine very soon. Maybe even before a very special date,” Mr. Trump said recently. (Thomas, 9/30)

Stat: Eager For A Covid Vaccine, Trump Now Trusts Drug Makers He Once Vilified
Amid the chaos and rancor of the first presidential debate, President Trump gave a dramatic and troubling look into his ideas about the vaccine approval process. He also left the clear impression that he trusts pharma companies more than government scientists. In fact, he called out three biopharma companies by name — Pfizer, Johnson & Johnson, and Moderna. (Herper, 9/30)

More on vaccine clinical trials —

The Hill: Fauci Calls For Racial And Ethnic Diversity In Coronavirus Vaccine Trials 
National Institute of Allergy and Infectious Diseases Director Anthony Fauci on Wednesday said coronavirus vaccine trials need to be conducted on a diverse population to make sure any potential vaccines are safe and effective for everyone. "We need to get a diverse representation of the population in the clinical trials," Fauci told a panel of Congressional Hispanic Caucus (CHC) members. (Bernal, 9/30)

North Carolina Health News: Getting Diverse Subjects For COVID Vaccine Trials A Challenge 
Last week, Noshima Darden-Tabb logged onto Facebook for an informal research study. “I was just doing my own little mini-research. I’d been out talking to people all day, and I was seeing a trend,” the 53-year-old said. “So I asked a handful of people online: Would they participate in a vaccine research study for COVID-19? “I only had one person that said yes,” Darden-Tabb said. (Critchfield, 10/1)

And more on vaccine safety —

USA Today: Experts: Politics Will Have A Hard Time Getting In The Way Of A Safe, Effective COVID-19 Vaccine
Despite the public's legitimate concerns about political rhetoric, politics is not having an impact on the development of a COVID-19 vaccine, several public health experts testified to Congress Wednesday. Both government and independent researchers provide strong oversight of the vaccine development process, said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University and a former Food and Drug Administration commissioner. (Weise and Weintraub, 9/30)

Politico: Cuomo Says State Will Have Final Say In Vaccine Approval, Administration
Health care experts, scientists and state officials will vet all federally authorized Covid-19 vaccines to ensure they are safe — and not used as political tools — before being administered and will supervise distribution throughout New York, Gov. Andrew Cuomo said Thursday. The governor, who has repeatedly criticized the Trump administration’s handling of the coronavirus pandemic, said he’s formed an independent Clinical Advisory Task Force to review every Covid-19 vaccine authorized by the federal government and counsel the state on their safety and effectiveness in fighting the virus. (Young, 10/1)