AP: 2nd COVID-19 Vaccine Trial Paused Over Unexplained Illness
A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot. The company said in a statement Monday evening that illnesses, accidents and other so-called adverse events “are an expected part of any clinical study, especially large studies,” but that its physicians and a safety monitoring panel would try to determine what might have caused the illness. The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S. (10/13)

Stat: Johnson & Johnson Covid-19 Vaccine Study Paused Due To Illness
The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant. A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. (Herper, 10/12)

USA Today: Johnson & Johnson COVID-19 Vaccine Trial Paused By Unexplained Illness
It is not known if the unidentified illness is related to the vaccine, but clinical protocols require a pause while it is investigated. Johnson & Johnson's JNJ-78436735 vaccine is one of four large-scale, final-stage COVID-19 vaccine trials underway in the U.S. Another trial, run by AstraZeneca, was halted Sept. 8 after a second participant was diagnosed with a neurological condition. Johnson & Johnson said Monday it has paused further dosing in its trial while the participant's illness is reviewed and evaluated by an independent Data Safety Monitoring Board as well as the company's clinical and safety physicians. (Weise and Weintraub, 10/12)

In other development news —

The New York Times: Covid-19 Vaccines Are Chance At Salvation, Financial And Beyond, For Drug Makers
Now, with pharmaceutical companies racing to find vaccines to end the coronavirus pandemic, the industry is hoping to redeem itself in the public’s mind. The primary goal, of course, is to rescue the world from the grips of a vicious virus. But a big fringe benefit is to get public credit — and to use an improved image to fend off government efforts to more heavily regulate the industry. (Drucker, Gelles and Thomas, 10/13)

New York Post: Pfizer COVID-19 Vaccine Study To Include Kids As Young As 12
Pfizer plans to test its experimental coronavirus vaccine in kids as young as 12 in an effort to make its late-stage clinical trial more diverse. The US Food and Drug Administration cleared Pfizer this month to include adolescents ages 12 to 15 in its Phase 3 study of the COVID-19 vaccine it’s developing with German firm BioNTech, the company said on its website Monday. (Manskar, 10/13)

CNN: Experimental Covid Vaccine: Thousands Are Signing Up To Be Deliberately Exposed To The Virus
As most of us obsess with avoiding Covid-19 at all costs, a rapidly growing group of people around the world say they are prepared to deliberately take on the virus. Tens of thousands of people have signed up to a campaign by a group called 1 Day Sooner to take an experimental vaccine candidate and then face coronavirus in a controlled setting. (Krever, Black and Moisescu, 10/12)

Vaccine skepticism presents challenges —

Stat: Letter Urging Covid-19 Vaccine Trial Participation Sparks Backlash
The episode illustrates the challenges historically Black colleges and universities face as they seek to leverage their legacies of trust within African American communities to bolster lagging Black enrollment in Covid-19 vaccine clinical trials. Their recruitment efforts will need to overcome the deep-seated suspicions many Black Americans hold toward medical researchers, pharmaceutical companies, and the government that stem from long-standing racial injustices perpetrated by those institutions. Now, as the four HBCU medical colleges prepare to host Covid-19 vaccine trials on their campuses, there’s hope their efforts will have more success. (St. Fleur, 10/12)

Popular Science: A Taskforce Of Black Doctors Is Independently Evaluating COVID-19 Vaccine Candidates
As the COVID-19 pandemic shows no signs of waning in the US, researchers are working to develop a vaccine at historic speed. President Donald Trump has pushed for a vaccine to become available by Election Day, now less than a month away, causing many Americans to worry that a vaccine will be approved too hastily. Responding to these concerns, a taskforce of Black doctors has formed to independently vet COVID-19 vaccine candidates. The taskforce is organized by the National Medical Association, which was founded in 1895 to represent Black healthcare professionals at a time when organizations such as the American Medical Association restricted membership to white people. (Baggaley, 10/12)

Axios: Gallup: Americans' Willingness Get A Coronavirus Vaccine Has Dropped To 50% In September
According to the latest Gallup poll, Americans' willingness get a coronavirus vaccine has dropped to 50% in late September, a dramatic 11-point fall from the previous month. Why it matters: This steep drop is further evidence that the vaccine has been politicized. Republicans are now more willing to be vaccinated, while Democrats and independents have become increasingly uncomfortable. (Arias, 10/12)

USA Today: COVID-19 Reinfection: Nevada Man Is First Confirmed American Case
An otherwise healthy 25-year-old Nevada man is the first American confirmed to have caught COVID-19 twice, with the second infection worse than the first. He has recovered, but his case raises questions about how long people are protected after being infected with the coronavirus that causes the disease, and potentially how protective a vaccine might be. "It's a yellow caution light," said Dr. William Schaffner, an infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee, who was not involved in the research. (Weintraub, 10/12)

The Hill: Scientists Confirm Nevada 25-Year-Old Got Coronavirus Twice, Second Case Was More Severe 
According to the case study, his second infection was more severe than the first, with symptoms including fever, cough and dizziness. The researchers sequenced the RNA from both virus samples and found they were two different strains, making it a true reinfection. (Seipel, 10/12)

NPR: Scientists Confirm Nevada Man Was Infected Twice With Coronavirus
It is the first confirmed case of so-called reinfection with the virus in the U.S. and the fifth confirmed reinfection case worldwide. ... The two infections in the Nevada patient occurred about six weeks apart, according to a case study published Monday in the medical journal The Lancet. The patient originally tested positive for the virus in April and had symptoms including a cough and nausea. He recovered and tested negative for the virus in May.(Hersher, 10/12 )

CNBC: Dr. Fauci Says U.S. Faces 'A Whole Lot Of Trouble' As Coronavirus Cases Rise Heading Into Winter
The United States is “facing a whole lot of trouble” as coronavirus cases continue to surge across the country heading into the cold winter months, Dr. Anthony Fauci, the nation’s top infectious disease expert, told CNBC on Monday. The U.S. reported more than 44,600 new cases on Sunday and the seven-day average rose to over 49,200 new cases per day, up more than 14% compared with a week ago, according to a CNBC analysis of data compiled by Johns Hopkins University. Average daily cases were up by more than 5% in 36 states and the District of Columbia, CNBC’s analysis shows. (Feuer, 10/12)

CNN: US Coronavirus: Amid Rising Covid-19 Cases And Hospitalizations, Local Leaders And Public Health Experts Worry Of A Coming Surge 
With 33 states reporting a rise in new Covid-19 cases and a nationwide uptick in hospitalizations, local officials worry this could be the beginning of the coming surge experts have warned about. In Colorado, Denver Mayor Michael Hancock said Covid-19 cases are rising at a "concerning rate," while the city's seven-day average daily case rates are as "high right now as they were at the height of the pandemic back in May." (Maxouris, 10/13)

The Hill: Former CDC Director: 20,000 More COVID-19 Deaths Possible By End Of Month 
Former Centers for Disease Control and Prevention (CDC) Director Tom Frieden predicted October will see another 20,000 additional COVID-19 deaths based on the rising number of cases in dozens of states. Frieden, who served under former President Obama, spoke at CNN’s "Coronavirus: Facts and Fears" town hall on Sunday night and warned that he thinks that as many as 20,000 more people will die due to complications from the coronavirus by the end of the month. (Coleman, 10/12)

In global developments —

The Washington Post: Second Wave Of Covid-19 In Europe Leads To New Restrictions But No National Lockdowns 
England has seen new coronavirus cases quadruple in the past three weeks and now has more covid-19 patients hospitalized than before the government imposed a lockdown in March, health authorities said Monday, laying the groundwork for a fresh package of restrictions. But, like much of Europe, Britain is now pursuing targeted local restrictions — such as closing pubs in Liverpool, England — while doing everything it can to avoid another national lockdown and closure of schools. (Adam, 10/12)

AP: UN Warns Against Pursuing Herd Immunity To Stop Coronavirus
The head of the World Health Organization warned against the idea that herd immunity might be a realistic strategy to stop the pandemic, dismissing such proposals as “simply unethical.” At a media briefing on Monday, WHO Director-General Tedros Adhanom Ghebreyesus said health officials typically aim to achieve herd immunity by vaccination. Tedros noted that to obtain herd immunity from a highly infectious disease such as measles, for example, about 95% of the population must be immunized. (10/12)

Politico: White House Physician Says Trump Has Tested Negative For Covid, Is No Longer Infectious 
President Donald Trump has tested negative for Covid-19 on consecutive days and is not infectious to others, his physician said on Monday. Antigen tests from Abbott were used, along with laboratory data that included viral load, to determine that the president would not be able to spread the coronavirus to others, Sean Conley said in a memo to White House press secretary Kayleigh McEnany. (Kim, 10/12)

The Washington Post: Trump Returns To Campaign Trail After Bout With Covid-19 As Biden Seeks To Make Handling Of Pandemic An Issue 
Though Trump has declared himself now “immune” to the virus — which has killed more than 214,000 Americans and infiltrated the White House — he and his team have not clarified for the public the last time he tested negative before his covid-19 diagnosis was announced Oct. 2. This has raised questions about whom Trump may have infected before isolating himself at the White House and then at Walter Reed National Military Medical Center. On Monday afternoon, however, Trump’s doctor, Sean P. Conley, said in a memo released by the White House that the president had tested negative for the virus “on consecutive days,” using the Abbott rapid testing machine, and was no longer contagious. (Parker, Dawsey, Sullivan and Olorunnipa, 10/12)

The Hill: Trump Tests Negative For COVID-19 On Consecutive Days, Doctor Says 
Antigen tests are commonly used in the White House, though they are less sensitive than molecular tests, such as the PCR test. For example, the Food and Drug Administration notes on its website that antigen tests are "more likely to miss an active coronavirus infection compared to molecular tests." The president was said to have tested positive for COVID-19 on Oct. 1 with an antigen test and then received a PCR test to confirm the result. (Samuels, 10/12)

AP: Defiant Trump Defends Virus Record In 1st Post-COVID Rally
Defiant as ever about the coronavirus, President Donald Trump on Monday turned his first campaign rally since contracting COVID-19 into a full-throated defense of his handling of the pandemic that has killed 215,000 Americans, joking that he was healthy enough to plunge into the crowd and give voters “a big fat kiss.” There was no social distancing and mask-wearing was spotty among the thousands who came to see Trump’s return to Florida. He held forth for an hour, trying to get his struggling campaign back on track with just weeks left before Election Day. (Colvin and Lemire, 10/13)

USA Today: 'I Just Feel So Powerful.' Trump Hits The Campaign Trail In Florida For First Rally Since COVID-19 Diagnosis
While claiming himself cured of COVID, Trump also asserted he is "immune" from the virus moving forward, though some medical professionals said there is no guarantee of that. "Now they say I'm immune. I just feel so powerful," Trump said. "I'll kiss everyone in that audience. I'll kiss the guys and the beautiful women and the... I'll just give you a big, fat kiss." (Jackson, 10/12)

Trump's plans to rally in virus hot spots raises concerns —

Stat: Trump Prepares To Campaign In Iowa, Where Covid-19 Is 'Out Of Control'
President Trump’s mad dash to campaign with in-person rallies and other events this week will take him to Iowa, a state that even the president’s own Covid-19 task force has warned is seeing an uptick in preventable deaths due to the coronavirus. He’ll visit Pennsylvania and North Carolina, too, both of which have also seen cases spike in the last week. Monday night, he held an event in Florida. (Florko, 10/13)

The Hill: News Outlets Decline To Send Staff To Travel With Trump Over Lack Of Coronavirus Precautions 
Several major media organizations have declined to allow reporters to travel with President Trump aboard Air Force One to campaign events in recent days due to concerns about a lack of COVID-19 protocols observed by White House staff. The New York Times reported Monday that The Wall Street Journal and The Washington Post had joined the Times in declining to send reporters with the president in recent days, forcing the White House Correspondents' Association to seek other journalists for White House press pool duties during those times. (Bowden, 10/12)

The New York Times: Fauci Cautions Trump Against Holding Large Rallies, Warning It Is ‘Asking For Trouble.’
Hours before President Trump was set to return to the campaign trail in Florida on Monday, the nation’s top infectious disease expert, Dr. Anthony S. Fauci, warned that holding large rallies was “asking for trouble” with cases of the coronavirus surging in many states. (Vigdor and Kaplan, 10/13)

PBS NewsHour: How Risky Is Voting In Person? Here’s How To Navigate Your Options During The Pandemic
The COVID-19 pandemic has made many Americans ask a question they’ve likely never pondered before: Is casting a ballot in person a risk to your physical health?With the November election three weeks away and daily COVID-19 case counts rising in virtually every state, voters have been hearing a confounding barrage of mixed messages regarding the safest — and most reliable — way to cast a ballot during a pandemic. (Isaacs-Thomas, 10/12)

NPR: Georgia Voters Wait In Hours-Long Lines At Polls For Early Balloting 
Early voting opened Monday in Georgia for the 2020 general election — but the first day was marred by technical issues and lines that in some locations stretched more than five hours long, particularly in the Atlanta metro area. Voters arriving in the morning at Atlanta's State Farm Arena, the home of the NBA's Hawks — and the state's largest early voting site, with 300 voting machines — encountered technical issues, which election officials blamed on problems with the electronic poll pads. (Tsioulcas, 10/12)

Politico: California Officials Tell State GOP To Stop Collecting Ballots With Unofficial Drop Boxes
California officials on Monday sent the state Republican Party a cease-and-desist notice to remove unofficial ballot drop boxes, while Gov. Gavin Newsom slammed the party as "willing to lie, cheat, and threaten our democracy all for the sake of gaining power." The controversy comes as the two major parties feud nationally over how the November election is being conducted during the pandemic. (Bermel, 10/12)

AP: Thousands Of N.C. Voters Wait Weeks For Absentee Ballots
Weeks from the election, three of North Carolina’s most populous counties are often taking two weeks or more to send absentee ballots out to voters who request them, an Associated Press analysis shows. Understaffing, outdated technology and voter registration groups are straining a system that has struggled to handle an unprecedented surge of requests as many seek to avoid the risks of in-person voting during the coronavirus pandemic. (Anderson and Fassett, 10/12)

In other presidential election news —

The Daily Beast: Dr. Fauci: The Trump Campaign Is ‘In Effect, Harassing Me’
The nation’s top infectious disease expert Dr. Anthony Fauci demanded that the Trump campaign refrain from using him in future campaign ads, saying Monday that it would be “outrageous” and “terrible” if he was featured in another commercial and it could “come back to backfire” on Team Trump. Asked by The Daily Beast if his comments were a thinly-veiled threat to leave his post if he ended up in a new campaign spot, Fauci replied: “Not a chance.” "Not in my wildest freakin’ dreams,” he said, “did I ever think about quitting." (Banco and Baragona, 10/12)

AP: Trump, Biden Try To Line Up By Fauci As They Court Voters
President Donald Trump and Democrat Joe Biden are both looking to harness the credibility of America’s best-known infectious disease expert, Dr. Anthony Fauci, as they make their case to American voters. Trump is quoting him out of context, the doctor says. Biden, for his part, is eagerly promising to seek Fauci’s advice if elected. Overall, it’s an uncomfortable season for Fauci, who’s been studiously apolitical over a five-decade career in public health. The doctor is calling out the Trump campaign for taking one of his quotes and popping it into a campaign ad to suggest Fauci is in the president’s corner. (Madhani, 10/13)

And from state races —

Houston Chronicle: Prescription Drug Costs Take Center Stage In Texas Races For Congress 
The cost of prescription drugs has taken center stage in congressional races all over Texas. In battles from Austin to San Antonio to Houston, candidates are insisting they are committed to tackling the high price of prescription drugs while they claim their opponents can’t be trusted on the issue. (Wallace, 10/12)

Deseret News: Health Care, Racism Divide Ben McAdams, Burgess Owens In Only Debate
In their only debate before the November election, Democratic Rep. Ben McAdams and Republican Burgess Owens sparred over some of Owens’ more controversial statements during the campaign, as well as issues including health care and whether there is systemic racism in the United States. (Riley Roche, 10/12)

The Hill: Democrats Warn Of ObamaCare Threat From Barrett, Trump 
Democrats on Monday painted Judge Amy Coney Barrett, President Trump’s high court nominee, as an existential threat to the Affordable Care Act (ACA), allowing them to go on offense in the fight over the Supreme Court and the fast-approaching election. Democrats view health care as a politically potent issue that resonates with voters and galvanizes their base with only 22 days left to go until Nov. 3, when they are hoping to win back both the White House and the Senate majority. (Kruzel and Carney, 10/12)

The Washington Post: Barrett Promises To Be Apolitical As Democrats Warn Of Threat To Health Care
Supreme Court nominee Amy Coney Barrett presented herself to the nation Monday as a humble and apolitical judge, opening a pandemic-altered Senate confirmation hearing that Democrats tried to make as much about health care, covid-19 and President Trump as about Barrett’s qualifications. It was the start of what will be an acrimonious four days, as Republicans embark just weeks before Election Day on a historic move to lock in a long-sought 6-to-3 conservative majority on the Supreme Court and perhaps boost Trump’s and their own reelection prospects. (Barnes, Min Kim and Hawkins, 10/12)

The New York Times: Two Parties Offer Dueling Views Of Barrett As Confirmation Fight Begins
Republicans and Democrats offered sharply divergent arguments on Monday in a Supreme Court confirmation fight whose outcome is likely to steer the court to the right for years, vying to define Judge Amy Coney Barrett and frame the political stakes of President Trump’s rush to install her before he faces voters. In a marathon day of opening statements, Democrats assailed Judge Barrett as a conservative ideologue who would overturn the Affordable Care Act and abortion rights, and whose nomination amounted to an illegitimate power grab by a president in the last days before the election. (Fandos, 10/12)

AP: Barrett To Face Senators On Health Care, Legal Precedent
Supreme Court nominee Amy Coney Barrett will face senators’ questions over her approach to health care, legal precedent and even the presidential election during a second day of confirmation hearings on track to lock in a conservative court majority for years to come. The mood is likely to shift to a more confrontational tone as Barrett, an appellate court judge with very little trial court experience, is grilled in 30-minute segments Tuesday by Democrats gravely opposed to President Donald Trump’s nominee, yet virtually powerless to stop her rise. Republicans are rushing her to confirmation before Election Day. (Sherman, Mascaro and Jalonick, 10/13)

AP: Health Care Law On Line At Court, But Is It Likely To Fall?
To hear Democrats tell it, a Supreme Court with President Donald Trump’s nominee Amy Coney Barrett could quickly get rid of the law that gives more than 20 million Americans health insurance coverage. But that’s not the inevitable outcome of a challenge the court will hear Nov. 10, just one week after the election. Yes, the Trump administration is asking the high court to throw out the Obama-era healthcare law, and if she is confirmed quickly Barrett could be on the Supreme Court when the court hears the case. (Gresko and Sherman, 10/13)

Also —

The Washington Post: Sen. Lee, Recently Infected With Coronavirus, Speaks Without A Mask At Barrett Hearing
On Sept. 29, Sens. Ted Cruz (R-Tex.) and Mike Lee (R-Utah) attended a party together to watch the first presidential debate. Two days later, feeling sick, Lee took a test for the novel coronavirus, receiving a positive diagnosis, the first of three GOP senators to announce in a 24-hour span that they contracted the virus. Less than 11 full days later, Lee participated in Monday’s Supreme Court confirmation hearing for Judge Amy Coney Barrett, delivering an opening statement in person — with no mask — and periodically whispering to his GOP colleagues. (Kane, 10/12)

NPR: Joni Ernst Focuses On Amy Coney Barrett's Gender In Hearing
Iowa Republican Sen. Joni Ernst zeroed in on the issue of gender at Monday's confirmation hearing for Amy Coney Barrett. She used her opening statement to link herself to Barrett "as a fellow mom, a fellow Midwesterner" and accused Democrats of launching attacks on the judge's religious beliefs — even though Republicans were the only ones bringing up the issue at the hearing. Ernst pointed out Monday that this was her first chance on the Judiciary Committee to be involved in a confirmation hearing for a Supreme Court nominee. She was one of two female GOP senators added to the panel in 2019 after a contentious confirmation process for Brett Kavanaugh in 2018 highlighted the then-all male lineup on the Republican side of the committee. (Walsh, 10/12 )

Dallas Morning News: Dems Use Supreme Court Hearing To Slam Cornyn Over Obamacare Repeal, Election-Year Confirmation
Democrats on Monday sought to turn the opening day of a contentious, four-day confirmation hearing for Amy Coney Barrett, President Donald Trump’s Supreme Court nominee, into a fight over the sweeping health care law known as the Affordable Care Act. Texas Sen. John Cornyn, a Republican facing a tough reelection challenge, ended up right in the thick of it – thanks to, of all people, a Democratic senator from Rhode Island. (Benning, 10/12)

The New York Times: Showtime In A Potential Petri Dish 
There is, traditionally, a predictable rhythm to the start of a “much-awaited hearing” on Capitol Hill. There are protesters and counterprotesters, enhanced police and news media presences, insufferable opening statements and an overall sense that something more momentous than usual might be going on. The start of the Senate Judiciary Committee’s hearings for Judge Amy Coney Barrett on Monday had all of that. But like everything else in Washington these days, this was an entirely different kind of pinstripe rodeo. Start with the hazmat suits. (Leibovich, 10/12)

Bangor Daily News: COVID-19 Swab Maker Will Open 2nd New Factory In Pittsfield
The Piscataquis County, Maine, company that’s one of the world’s two largest makers of COVID-19 testing swabs said Monday that it’s opening a second Pittsfield factory with $51.2 million in federal pandemic relief funds. Puritan Medical Products, which is based in Guilford, first expanded into Pittsfield this past summer, when it received a $75.5 million federal contract to boost production of the swabs that have been in short supply throughout the pandemic. (Eichacker, 10/12)

The Hill: Abbott Gets Emergency Authorization For New COVID Antibody Test 
Medical device maker Abbott Labs on Monday said it received emergency authorization for a new COVID-19 blood test that can detect more recent infections. The AdviseDx is a lab-based test that can detect the IgM (Immunoglobulin M) antibody. The IgM antibody is most useful for determining a recent infection, as they become undetectable weeks to months following infection. (Weixel, 10/12)

Reuters: Roche Plans To Sell COVID-19 Antigen Lab Tests By End-2020 
Roche plans to start selling a higher-volume COVID-19 antigen test for laboratories by the end of the year as the Swiss drugmaker expands diagnostics for the pandemic. “These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser,” the group said in a statement. (10/13)

In other pharmaceutical and biotech news —

Stat: How Software Infuses Racism Into U.S. Health Care 
The railroad tracks cut through Weyling White’s boyhood backyard like an invisible fence. He would play there on sweltering afternoons, stacking rocks along the rails under the watch of his grandfather, who established a firm rule: Weyling wasn’t to cross the right of way into the white part of town. The other side had nicer homes and parks, all the medical offices, and the town’s only hospital. As a consequence, White said, his family mostly got by without regular care, relying on home remedies and the healing hands of the Baptist church. (Ross, 10/13)

Stat: Five Takeaways From Investigation Of Bias In Use Of Health Software 
By crunching data on patients, software developers promise to help U.S. hospitals and insurers accomplish a crucial task: identifying those most in need of stepped-up care to manage their chronic illnesses. But a STAT investigation found that these software systems are infusing racism into health care by systematically overlooking obstacles faced by people of color. (Ross, 10/13)

Stat: Selling Stock At A Clip, Top Moderna Doctor Gets $1 Million Richer Each Week
Every Tuesday, Moderna’s top doctor gets about $1 million richer. As the world awaits results from Moderna’s pivotal Covid-19 vaccine study, Chief Medical Officer Tal Zaks has been selling his existing stock like clockwork every week through pre-scheduled trades — earning him more than $50 million since the dawn of the pandemic, according to disclosures made to the Securities and Exchange Commission. (Garde and Feuerstein, 10/13)

Stat: How Would Doctors Navigate Demand For A New, Narrow Alzheimer’s Drug?
For Kristin Davie, it’s a tempting possibility. Her 70-year-old mother has late-stage Alzheimer’s, which likely means she would not get a chance to take an experimental drug for the devastating disease being reviewed next month by a regulatory panel. That’s because the clinical trial data for the medicine, called aducanumab, pertains only to patients in the early stages of the disease. But if regulators approve the experimental Biogen (BIIB) therapy next month, Davie might still pursue the drug for her mother. (Silverman, 10/13)

FierceHealthcare: Mayo Clinic, Startup Launch 'Health Passport' App With Initial Focus On COVID-19
Mayo Clinic has teamed up with a health technology company to launch a new digital service focused on reducing the high cost of testing and care for COVID-19, sexually transmitted diseases and other common medical conditions. Mayo Clinic is partnering with Los Angeles-based Safe Health Group on the venture to improve access to efficient, affordable treatment for common medical conditions, the health system announced in conjunction with the start of the HLTH 2020 virtual conference Monday. The venture will focus on testing for STDs and common ailments but will initially target COVID-19 through symptom tracking and testing by linking consumers, clinicians and test distribution into one digital solution, called HealthCheck. (Landi, 10/12)

PBS NewsHour: How Federal Rules For Reporting COVID-19 Data Could Threaten Hospital Funding
The Trump administration says requirements for how hospitals report COVID-19 data are critical to keeping them prepared for potential surges this winter, but health experts warn the rules can also be overly burdensome, and that new consequences for failing to comply could lead to critical losses in funding that may put communities at risk. (Santhanam, 10/12)

Georgia Health News: Honoring Generosity, New Pediatric Hospital To Be Named For Blank 
Thanks to a $200 million donation, the new hospital being built by Children’s Healthcare of Atlanta will be named the Arthur M. Blank Hospital. The naming gift for the $1.5 billion Brookhaven project came from the Arthur M. Blank Family Foundation. Blank, a co-founder of Home Depot, is the owner of the Atlanta Falcons. (Miller, 10/12)

Bloomberg: Ray Dalio Donates $50 Million To Fight Health-Care Injustice
Bridgewater Associates founder Ray Dalio is giving $50 million to New York-Presbyterian Hospital to fund a center dedicated to health equity and justice, at a time when the Covid pandemic has underlined the stark racial disparities in the U.S. The Dalio Center for Health Justice, a research and advocacy organization, will focus on reducing differences in access to quality health care that overwhelmingly affect communities of color, New York-Presbyterian and Dalio Philanthropies said in a statement. (Pendleton, 10/13)

KHN: Black Doctors Work To Make Coronavirus Testing More Equitable
When the coronavirus arrived in Philadelphia in March, Dr. Ala Stanford hunkered down at home with her husband and kids. A pediatric surgeon with a private practice, she has staff privileges at a few suburban Philadelphia hospitals. For weeks, most of her usual procedures and patient visits were canceled. So she found herself, like a lot of people, spending the days in her pajamas, glued to the TV. And then, at the beginning of April, she started seeing media reports indicating that Black people were contracting the coronavirus and dying from COVID-19 at greater rates than other demographic groups. (Feldman, 10/13)

KHN: ‘No Mercy’ Chapter 3: Patchwork Of Urgent Care Frays After A Rural Hospital Closes
Emergency care gets complicated after a hospital closes. On a cold February evening, when Robert Findley fell and hit his head on a patch of ice, his wife, Linda, called 911. The delays that came next exposed the frayed patchwork that sometimes stands in for rural health care. After Mercy Hospital Fort Scott shut down, many locals had big opinions about what kind of health care the town needed. (Tribble, 10/12)

USA Today: 'Like We're Going Into Quarantine': Americans Plan To Stockpile Food This Fall Over Fears Of COVID-19 Surge, Election Unrest
Slightly more than half of Americans in a recent poll from Sports and Leisure Research Group say they already have or plan to stockpile food and other essentials. The chief reason: fears of a resurgent pandemic, which could lead to disruptions such as new restrictions on businesses. On Oct. 2, the number of COVID-19 cases in the USA was its highest in almost two months. (Picchi, 10/12)

North Carolina Health News: Mental Health Patients Wait Weeks For Help 
Bridget Narsh said she was unhappy that her son, Mason, spent 26 days this summer in a “windowless room” at UNC Hospital’s Emergency Department in Chapel Hill. Mason is a 15-year-old with autism, ADHD, anxiety and PTSD. The changes and disruptions generated by the coronavirus pandemic have been difficult for him and the whole family, she said. He’s had angry outbursts, ran away from his parents in public and at home, and refused to take his medications. (Knopf, 10/13)

New Orleans Times-Picayune: Heavy Drinking Is Killing Women In Record Numbers, And Experts Fear A Coronavirus-Related Spike 
With an average of 1,591 alcohol-related deaths from 2011 to 2015, Louisiana is tied for 10th among U.S. states on a per-capita basis when it comes to people succumbing to the disease, according to a recent analysis of death certificates by the Centers for Disease Control and Prevention. (Woodruff, 10/11)

KHN: New Moms Behind Bars Get Help From Someone Who’s Been There 
Nine years ago, Nina Porter gave birth in a hospital bed with one of her ankles chained to the frame. Corrections officers stood watch as Porter held her daughter, Gianna, to her chest for the first time. Back at a nursery inside Indiana Women’s Prison, Gianna slept in a crib in her mother’s cell, about 2 feet from her pillow. The prison program allowed Porter to keep her baby with her — including when she went out into the yard — until her discharge nearly a year later. She didn’t recall ever bonding so closely with her previous 11 kids. She finally felt her life moving in a positive direction. (Bruce, 10/13)

In school news —

USA Today: COVID-19 Disrupting College Spring Reopenings, Calendars
Scores of universities and colleges have upended spring schedules as the coronavirus infection rate in the U.S. shows no sign of slowing. After a rocky start to the fall, uncertainty over the next few months of the pandemic has pushed universities from coast-to-coast to overhaul in-person learning, spring break, and graduation. Colleges and universities in California, Mississippi, Nevada, Texas, North Carolina, Indiana, Vermont, Kansas, Pennsylvania and Washington state have already announced changes and more are almost certain to follow. (Aspegren, 10/12)

CNN: The 2020-21 School Report So Far: No One Knows What Is Going On 
A 6-year-old afraid to go outside. A mom scared to send her children back to school, then thrilled at how they've thrived. A teacher worried she'll be ordered back to the classroom and become some kind of test subject. These are some of the stressed stories of the pandemic-hit school year so far -- but it's impossible to know how widespread the experiences are because there is no national tracking of what happens when children and staff return to schools. (Grayer, 10/12)

Detroit Free Press: Michigan Supreme Court Strikes Down Gov. Whitmer's Emergency Orders, Effective Immediately
Emergency orders Gov. Gretchen Whitmer has issued under the Emergency Powers of Governor Act are struck down, effective immediately, the Michigan Supreme Court said Monday in a 4-3 order that added an exclamation mark to an Oct. 2 ruling. But new emergency orders that the Whitmer administration has issued through the state health department director — which replicate mask requirements, restrictions on gathering sizes and restaurant capacity, among other features — are not affected by the court's ruling. (Egan, 10/12)

Milwaukee Journal Sentinel: Judge Denies GOP Effort To End Tony Evers' Mask Mandate
A Wisconsin judge on Monday blocked an effort by Republicans to end Democratic Gov. Tony Evers' statewide mask mandate at a time when coronavirus cases are surging and hospitalizations reached a record.  The conservative group that brought the lawsuit promised to immediately appeal, and Republicans who control the Legislature took an initial step Monday to eliminate a separate COVID-19 order from Evers that limits business occupancy. (Becky and Marley, 10/12)

In other news from the Midwest —

The Hill: Michigan Senator Shares Story Of Wife's Life-Saving Abortion
Sen. Gary Peters (D-Mich.) in an interview with Elle magazine disclosed his wife's abortion for the first time, which she underwent after doctors warned she was at risk of losing her uterus or possibly dying. While Heidi Peters was four months pregnant with the couple’s second child in the 1980s, her water broke and her doctor recommended she go home and wait to miscarry. The next day, however, a heartbeat was still detectable. (Budryk, 10/12)

Indianapolis Star: Indianapolis Crime: City Sees Most Violent Year Ever With Months Left
A total of 154 criminal homicide cases were investigated by IMPD in 2019. Until last year, annual criminal homicide numbers had grown annually since 2011, reaching record highs from 2015 to 2018. The criminal homicide total does not include killings made in self-defense, police action shootings or accidental homicides. Homicides in other parts of Marion County, such as in Lawrence or Cumberland, are also not included. There have been 187 total homicides in Indianapolis this year. (Mack, 10/12)

In news from the South and East —

Houston Chronicle: Texans Delaying Or Skipping Health Care Visits During Pandemic, Study Finds 
More than a third of Texans have put off health care decisions and are now without health insurance during the COVID-19 pandemic, according to figures from the Episcopal Health Foundation, a Houston-based health advocacy organization. (Wu, 10/13)

New Orleans Times-Picayune: True Toll Of Coronavirus: Deaths Are Up By 27% In Louisiana. That's Even Higher Than U.S. Average. 
The coronavirus pandemic in Louisiana has marked some of the deadliest months on record for the state. From March 1 to August 1, about 24,000 people died, a 27% increase compared to the same five-month span in at least the last six years, according to a new study analyzing deaths during the pandemic. (Woodruff, 10/12)

USA Today: Nashville 'Worship Protest' Under Investigation After Drawing Largely Unmasked Crowd Of Thousands
Christian worship leader Sean Feucht hosted a "worship protest" that is now under investigation by health officials after it drew thousands of people who appeared to be largely without masks in Nashville, Tennessee, on Sunday night. Feucht, who is based in California and has amassed hundreds of thousands of followers across social media, posted a video of the gathering, saying the event faced resistance and had three venue changes before landing at the courthouse grounds. (Wegner, 10/12)

The Washington Post: Goucher Poll: Half Of Maryland Residents Would Not Take Coronavirus Vaccine
Half of Maryland residents would not take a federally approved coronavirus vaccine today even if it were offered free, a new poll found. The Goucher Poll released Tuesday also found widespread concern in Maryland about contracting the coronavirus. About 7 in 10 people say they are either “somewhat” or “very concerned” about themselves or a loved one getting sick. (Cox, 10/13)

The New York Times: In Emptier Subways, Violent Crime Is Rising 
When the pandemic hit New York and subway ridership plunged, misdemeanor and felony crimes dropped to record lows: Between January and the end of September, the number of reported crimes in the system fell roughly 40 percent compared with the same period last year. But even as overall crime has declined, violent crime and episodes of vandalism are rising, a trend that is stoking fear among passengers and posing another challenge for a transit system crippled by a virus outbreak that has deprived it of riders and money. So far this year, the number of reported homicides, rapes, burglaries and robberies in the subway are higher than during the same period last year, according to Police Department statistics. (Goldbaum, 10/12)

Reuters: Mainland China Reports First Local COVID-19 Infections In Nearly Two Months
Mainland China reported its first locally transmitted COVID-19 infections in nearly two months, as Qingdao launched a city-wide testing drive after discovering new cases linked to a hospital designated to treat imported infections. The National Health Commission said in a statement that a total of 13 COVID-19 infections were reported in mainland China on Oct. 12, down from 21 a day earlier. (10/12)

CIDRAP: Chinese Study Shows Possible COVID-19 Transmission Via Sewage
A COVID-19 outbreak investigation in a densely populated community in China provides evidence for possible transmission via sewage, highlighting the importance of sewage management for pandemic control. Prior studies have identified SARS-CoV-2—the virus that causes COVID-19—in patient fecal matter, but sewage transmission has not yet been demonstrated. Today's study in Clinical Infectious Diseases examined an April outbreak in a 2,888-resident community of Guangzhou City in southern China to identify the source of infection and mode of transmission in order to recommend prevention and control measures. (10/12)

In other global news —

AP: Danes Start Culling 2.5 Million Minks After Virus Hits Farms
Danish veterinarians and farmers have begun culling at least 2.5 million minks in northern Denmark, authorities said Monday, after coronavirus has been reported in at least 63 farms. ... Denmark is among the largest mink exporters in the world and produces an estimate 17 million furs per year. ... Scientists are still digging into how the minks got infected and if they can spread it to people. Some may have gotten the virus from infected workers. Dutch authorities say some farm workers later caught the virus back from the minks. (Olsen, 10/12)

AP: Cuba Relaxes Coronavirus Restrictions 7 Months Into Pandemic
Cuba relaxed coronavirus restrictions Monday in hopes of boosting its economy, allowing shops and government offices to reopen and welcoming locals and tourists at airports across the island except in Havana. Face masks and social distancing remain mandatory, although authorities will no longer isolate those who have been in contact with suspected cases as the island returns to a semblance of normality. (Rodriguez, 10/13)

Also —

Reuters: Mexico Says Two Women May Have Had Non-Consensual Surgery In U.S. Detention Center 
Mexico’s Foreign Ministry said it has identified two Mexican migrant women who may have had surgery performed on them without their consent while detained at a U.S. immigration center in the state of Georgia. While being held at the Irwin center in Georgia, one Mexican woman was reportedly subject to gynecological surgery without her approval and without receiving post-operative care, the ministry said in a weekend statement. The ministry said its findings were based on actions taken by consular staff and interviews Mexican officials conducted at the center. (10/12)

Bloomberg: FDA Is Right To Hold Covid-19 Vaccines To High Safety Standards 
The FDA’s rules will indeed make it hard for a vaccine to be approved before Nov. 3 — but they’re no political ploy. They’re essential to assure the country that any shot the FDA approves quickly will be safe and effective. It’s disgraceful that, to do its job, the agency was forced to make an end run around the president. That’s hardly the FDA’s fault. Faced with a boss who often belittles them and refuses their advice without understanding it, what are the experts to do? (10/12)

The Houston Chronicle: FDA Shows President Trump Backbone On COVID Vaccine
The Food and Drug Administration guidance requiring two months of safety testing for the COVID-19 Emergency Use Authorization was just issued. This is important. Two months is not arbitrary. The vast majority of side effects occur within that period; at least one patient in COVID-19 testing developed a spinal cord condition (related to “transverse myelitis”) within less than two months. In transverse myelitis, 2/3 of people are left with some weakness, loss of bowel or bladder control or paralysis lasting up to several years. Importantly, this side effect has not been proven to be due to the vaccination, but the two-month waiting period is absolutely key to finding out how many people do develop serious problems. (Arthur Garson, Jr., 10/12)

Stat: The Placebo Response: A Hidden Risk To Covid-19 Trials
The response to the Covid-19 pandemic by drug and vaccine developers has been swift. BioCentury lists more than 400 unique compounds — small molecules, antibodies, and vaccines — that are currently in clinical development for Covid-19. Yet the success of this work is at risk due to an invisible threat: the placebo response. It could contribute to clinical trial failures and delay the delivery of medications and vaccines to mitigate this global public health disaster. (Erica Smith and Dominique Demolle, 10/13)

The New York Times: With Russia's Coronavirus Vaccine, Putin Jumps Ahead Of Trump
Before regulators held their ground earlier this month, there were good reasons to be concerned about President Trump’s push for a coronavirus vaccine. But he had already missed becoming the first world leader to get one approved. Vladimir Putin of Russia had already done it. And in stark contrast to Mr. Trump’s “America First” approach, Mr. Putin is using his under-tested vaccine as part of a global full-court press to win friends and enhance his country’s soft power. (Judyth Twigg, 10/13)

The Washington Post: We’re Public Health Experts. We Need To Do A Better Job Of Talking To Conservatives.
A toxic “infodemic” rages alongside the coronavirus pandemic. And while false ideas about the nature and spread of covid-19 have come from many places — most prominently President Trump and his allies in the conservative media — we in the public health community bear some responsibility, too. We have failed to nurture and preserve our own standing as a trusted resource for much of America. We must do better. (Lindsey J. Leininger and Harold Pollack, 10/12)

The Wall Street Journal: Why Trump Doesn’t Need To Wear A Mask
President Trump should have worn a mask before he got the coronavirus. You should wear a mask now, whether you’ve had it or not. But he no longer needs to. What about the millions of other Americans who have already recovered from the virus? They are likely to have better immunity than a vaccine will confer, and we’ll all stop wearing masks once the population is properly vaccinated. It might seem logical to spare from the mask requirement those who’ve already recovered. We don’t because of two problems: identification and verification. Neither applies to the president. (Michael Segal, 10/12)

CNN: Trump Mocks Virus As He Launches Potential Superspreader Sprint To Win Reelection 
Donald Trump on Monday launched a three-week quest to save his presidency, behaving as though the pandemic that has killed 215,000 Americans was already a memory in front of a packed-in crowd -- even amid chilling new warnings about the resurgent virus. In his first rally since his own bout with Covid-19, Trump painted a deeply dishonest picture of the nation's battle with the disease, mocked former Vice President Joe Biden over social distancing and vowed victory on November 3 as he began a frantic push to Election Day, marked by multiple rallies a day that could act as superspreader events. (Stephen Collinson, 10/13)

The Wall Street Journal: Dr. Fauci Protests Too Much
Dr. Fauci nonetheless took umbrage at his appearance in the Trump ad. “In my nearly five decades of public service, I have never publicly endorsed any political candidate,” he told CNN. “The comments attributed to me without my permission in the GOP campaign ad were taken out of context from a broad statement I made months ago about the efforts of federal public health officials.” Campaigns aren’t required to get permission to use his public statements. A Democratic Super Pac has run ads using such Fauci statements as the testing “system is not really geared to what we need right now” and “You don’t make the timeline. The virus makes the timeline” spliced side-by-side with cheerier statements by Mr. Trump. (10/12)

The Washington Post: America’s Children Are Suffering. Why Are They Still An Afterthought This Election?
American children are out of school, out of food and increasingly getting chucked off their health insurance. Yet somehow, they seem to be an afterthought in this election. Even before the coronavirus pandemic struck, the number of children without health coverage had been rising. Between 2016 and 2019, the number of uninsured kids rose by 726,000, according to recently released Census Bureau data. The tally has probably risen further this year, too, given job losses during the pandemic (and, with them, employer-provided health insurance). A new report from Georgetown University’s Center for Children and Families estimates that an additional 300,000 children have become uninsured in 2020. (Catherine Rampell, 10/12)

The Colorado Sun: I’m A CU Boulder Resident Adviser. Administrators Have Grossly Mishandled COVID-19. 
As a University of Colorado Boulder Resident Adviser during this pandemic, I’m in a constant state of fear and disgust. RAs are required to live and work in an unsafe environment, one that constantly threatens their health and safety. As an RA, I’ve dealt with multiple cases where residents, whom I live only a few doors from, have tested positive for COVID-19. Not only was I uninformed of these positive cases, but those infected students were not moved to quarantine for days. (Vayle Lafehr, 10/11)

The Washington Post: Trump Again Puts Politics Over Health — But You Shouldn’t. Wear A Mask On Mass Transit.
Enclose spaces, crowds, poor ventilation — these are the ingredients of coronavirus transmission. To block it, one of the most effective tools is to wear a face mask that prevents inhaling the virus particles or broadcasting them to others. Anyone who has ever ridden buses or trains will understand why it is a good idea to wear a face mask these days. So it is once again astounding that the White House has ordered the Centers for Disease Control and Prevention to shut up on a key matter of public health. (10/12)