�������ýҕ�l

About 2.8 million people signed up for Affordable Care Act health plans during an unprecedented, six-month special enrollment period that President Biden ordered to help Americans find insurance coverage during the coronavirus pandemic, according to figures his administration released Wednesday. The additional enrollees push the reliance on ACA health plans to 12.2 million, the highest level since the insurance marketplaces created under the law first offered health plans in 2014. (Goldstein, 9/15)

Nearly 3 million consumers took advantage of a special six-month period to sign up for subsidized health insurance coverage made more affordable by the COVID-19 relief law, President Joe Biden said Wednesday. He called that number encouraging and urged Congress to keep the trend going by extending the more generous financial assistance, currently available only through the end of next year. “That’s 2.8 million families who will have more security, more breathing room, and more money in their pocket if an illness or accident hits home,” Biden said in a statement. “Altogether, 12.2 million Americans are actively enrolled in coverage under the Affordable Care Act — an all-time high.” That’s an increase of about 20% since the end of last year. (Superville, 9/15)

Nearly half of the customers on HealthCare.gov that selected a new plan had a monthly premium of $10 or less, a sharp drop compared to the 25% during the same period in 2020, HHS’ report said. The American Rescue Plan Act boosted income-based subsidies sold on the exchanges but only through the 2022 coverage year. Democrats are hoping to extend the subsidies as part of a $3.5 trillion infrastructure package being considered this month. (King, 9/15)

Almost 90% of people expected to have gained Medicaid coverage during the COVID-19 pandemic could get dropped from the program once the public health emergency ends, a new report finds. Federal law has prohibited states from kicking beneficiaries off of their Medicaid programs during the public health emergency. That, coupled with COVID-related job losses, has caused membership to remain higher than usual. However, 15 million new members risk losing coverage once the federal government ends its emergency declaration, researchers at the Urban Institute said in a report released Wednesday. (Bannow, 9/15)

A new report by the Urban Institute, funded by Robert Wood Johnson Foundation, anticipates that 15 million people could be out of Medicaid coverage when the pandemic public health emergency ends. Medicaid enrollment initially swelled as a result of early pandemic joblessness and continuous coverage requirement of the Families First Coronavirus Response Act, according to the Sept. 15 report. With the public health emergency in place through the end of 2021, researchers estimated that Medicaid enrollment could grow to 17 million new members since the start of the pandemic. That would bring the total number of Medicaid beneficiaries under the age of 65 to 76.3 million. (Moran, 9/15)

Gov. Henry McMaster and the South Carolina Department of Health and Human Services Tuesday denounced a Biden administration move to prevent the state from inputting work requirements for certain people on Medicaid. In 2019, South Carolina got approval from the Trump administration to implement work or community service requirements for Medicaid recipients. South Carolina’s plan to implement the work requirements had been delayed until January 2022 because of the ongoing pandemic. But the federal Department of Health and Human Services reversed those requirements in August. (Bustos, 9/15)

Federal regulators have barred three Medicare health plans operated by UnitedHealth Group Inc. and another owned by Anthem Inc. from enrolling new members next year because they didn’t spend the minimum amount required on medical benefits. Private Medicare health plans are required to spend a certain threshold of their premium revenue on medical claims. The Centers for Medicare and Medicaid Services determined that the plans didn’t hit the required 85% level for three years in a row, prompting the sanctions, according to letters dated Sept. 2 and posted on the CMS website. (Tozzi, 9/15)

House Speaker Nancy Pelosi’s aggressive drug pricing package failed a key committee vote on Wednesday, prompting questions about whether the measure can survive a full House vote. Reps. Scott Peters (Calif.), Kurt Schrader (Ore.), and Kathleen Rice (N.Y.), all Democrats, followed through on their threats to vote against the provision in the House Energy and Commerce Committee’s markup. Republicans unanimously opposed the measure, too, leading to a tie vote that means the provision failed to advance to a full House vote. (Cohrs, 9/15)

While another key House panel endorsed the drug pricing plan later on Wednesday, leadership may not yet have the votes to pass it as part of a larger bill. The public standoff underscores the significant hurdles ahead in securing the near-unanimous support Democrats will need to advance the social spending package. Speaker Nancy Pelosi and her leadership team had spent days working to convince the holdouts, according to people familiar with the push. And Energy and Commerce Chair Frank Pallone (D-N.J.) made multiple public appeals to the centrists to support the drug pricing language during the markup, saying it was essential to negotiating a final agreement with the Senate. (Miranda Ollstein and Ferris, 9/15)

The three moderates said they worried the measure would harm innovation from drug companies and pushed a scaled-back rival measure. The pharmaceutical industry has also attacked Democratic leaders' measure, known as H.R. 3, as harming innovation. The three lawmakers had long signaled their concerns with the drug pricing measure, but actually voting it down in the House Energy and Commerce Committee is an escalation. (Sullivan, 9/15)

Five House Democrats, including the three who voted no on Wednesday, have signed onto rival drug-pricing legislation they officially unveiled this week. Ahead of the vote, Mr. Peters said any pricing provision needs to both lower out-of-pocket costs while also supporting further incentives for private investment and innovation. Democratic leaders will need to find a consensus, given their narrow margins in both chambers. On legislation opposed by all Republicans, Democrats can afford no more than three defections in the House and none in the Senate. (Peterson and Bykowicz, 9/15)

House Democrats writing the health provisions of their big social spending bill aimed high: new coverage for poor Americans without insurance; extra subsidies for people who buy their own coverage; and new dental, hearing and vision benefits for older Americans through Medicare. To pay for those, they also aimed high when it came to lowering drug prices. A measure that would link the prices of certain prescription drugs to those paid overseas was devised to save the government enough money to offset the costs of those other priorities. The House approach, estimates suggest, could save the government around $500 billion over a decade, with that money coming out of the pockets of the pharmaceutical industry. But it’s risky to bet against the drug companies. (Sanger-Katz, 9/15)

Millions of Americans who smoke could soon see an increase in their prices, as Democrats target tobacco and nicotine to help finance their $3.5 trillion economic package. The new proposal put forward in the House this week would raise or impose taxes on a wide array of products: It would hike existing federal levies on cigarettes and cigars while introducing new taxes on vaping. Democrats say the changes could help them raise $100 billion in revenue over the next 10 years. (Romm, 9/15)

A key congressional committee failed to pass Democrats' signature drug pricing bill yesterday, but that doesn't mean the party's push to lower drug prices is anywhere near over. Hundreds of billions of dollars are on the line — and Democrats need that money to pay for the rest of their giant legislative agenda. (Owens, 9/16)

As lawmakers in Washington grapple with legislation to alter the upward trajectory of prescription drug prices, a key talking point is likely to be found in a recent report from the Congressional Budget Office. Released late last month with little fanfare, the analysis concluded that limiting prices — as envisioned in a controversial House bill known as H.R. 3 — would lead to 59 fewer new drugs over the next three decades. (Silverman, 9/16)

With the sound of one final gavel, House Democrats on Wednesday completed the mammoth task of translating President Biden’s economic vision into a $3.5 trillion tax-and-spending proposal — marking a major milestone in a fight that’s still far from finished. Assembling the House package proved to be an enormous undertaking, as Democrats raced over the past week to produce roughly 2,600 pages of legislative text spanning the party’s vast policy ambitions. The measure seeks to shepherd major changes to federal health care, education, immigration, climate and tax laws, introducing a sprawling set of federal programs that Democratic leaders have described as historic in their size and scope. (Romm, 9/15)

The House Ways and Means Committee on Wednesday approved a major portion of Democrats’ $3.5 trillion social spending package, including provisions that would raise taxes on high-income individuals and corporations in order to offset the cost of new spending. The committee advanced the legislation in a near party-line vote of 24-19. Rep. Stephanie Murphy (D-Fla.) joined Republicans in voting against the measure. It now heads to the House Budget Committee, which will combine the various pieces of the spending package approved by House panels. (Jagoda and Folley, 9/15)

Vice President Kamala Harris pressed lawmakers on Wednesday to back legislation that she said would expand access to child care and raise the wages of day-care workers, even as her party’s massive spending initiative is facing resistance from key Democrats. The push from Harris, who joined Treasury Secretary Janet L. Yellen in releasing a Treasury report that made the case for the proposal, came the same day that President Biden is reported to have met with a pair of centrist Democrats who have indicated they do not support the overall costs of the party’s $3.5-trillion spending plan. (Logan, 9/15)

A federal judge on Wednesday scheduled a hearing for Oct. 1 to consider temporarily blocking Texas’ near-total abortion ban, following an emergency request from the Biden administration. The Justice Department requested the temporary restraining order late Tuesday as part of its lawsuit in the U.S. District Court for the Western District of Texas aiming to overturn the law. (Oxner, 9/15)

Women driving hundreds of miles alone for an abortion, clinics overwhelmed with out-of-state patients, providers facing "relentless harassment" from "emboldened vigilante activities," those are some of the impacts detailed by the federal government in new court documents since the most restrictive abortion law went into effect in Texas earlier this month. Nearly a week after announcing a lawsuit against the state, the U.S. Department of Justice filed for an immediate injunction Tuesday to halt the enforcement of the law, known as SB8, which bars physicians from providing abortions once they detect a so-called fetal heartbeat -- technically the flutter of electrical activity within the cells in an embryo. That can be seen on an ultrasound as early as six weeks into a pregnancy -- before many women even know they're pregnant. (Deliso, 9/15)

One Texas woman traveled nearly 1,000 miles to Colorado for an abortion. Others are driving four hours to New Mexico. And in Houston, clinics that typically perform more than 100 abortions in a week are down to a few a day. Two weeks after the nation’s strictest abortion law took effect in Texas, new court filings showed the deepening and swift impact of the state’s near-total ban on abortion. A federal judge on Wednesday set an Oct. 1 hearing over the Biden administration’s efforts to block the law known as Senate Bill 8. One network of clinics in Texas, which performed more than 9,000 abortions in 2020, said it has so far turned away more than 100 patients. (Weber, 9/15)

Each morning, Brenna McCaffrey, a Ph.D. student at City University of New York, checks her TikTok inbox, where people send messages about videos she makes about self-managed abortions. In the past two months, she says, 60% of the dozens of messages have been from people in Texas asking for more resources about how to manage a medication abortion at home. In her most recent video, McCaffrey, who studies medical anthropology, explains an illustrated graphic that details the process of properly taking the abortion-inducing medications. Other videos have specifically discussed where Texas women can find the pills, which are widely available online and in pharmacies across the border in Mexico. (O'Hanlon, 9/15)

The City Council in Portland, Oregon, has scrapped a plan to boycott Texas businesses because of a new law that prohibits most abortions there, deciding Wednesday to instead set aside $200,000 to fund reproductive care. The liberal Pacific Northwest city made headlines earlier this month when Mayor Ted Wheeler announced plans to ban city business with the Lone Star State. However the proposal was abandoned due to concerns that it could be “punitive to Texans who, are in fact, the most affected” by the abortion law. (Cline, 9/15)

Montana lawmakers are studying Medicaid coverage of abortion after a session of passing several bills to restrict access to the service. A proposal to create a politically appointed panel to decide who gets Medicaid coverage for abortions was met with bipartisan pushback last session. Republican lawmakers compromised and changed the proposal to a study of the issue over the next two years instead. (Ragar, 9/15)

South Dakota has enlisted one of former President Donald Trump’s lead attorneys to help in its attempt to lift a decade-old injunction that nullified part of a state law requiring women to consult with a crisis pregnancy center before having an abortion, the governor and attorney general said Wednesday. Jay Sekulow, who was one of President Donald Trump’s lead attorneys during his impeachment trial last year, will offer the services of his firm, the American Center for Law and Justice, for free, the governor’s and attorney general’s offices said. The nonprofit Christian legal advocacy group is based in Washington, D.C. (9/15)

When the U.S. Supreme Court this month declined to block a restrictive Texas law banning abortion after about six weeks into a pregnancy, abortion rights campaigners across Europe watched with dismay. Anti-abortion campaigners, however, were taking notes. Abortion is available on demand to more than 95 percent of girls and women of reproductive age in Europe, according to the Center for Reproductive Rights — from Greece to the United Kingdom, which allows abortions up to 24 weeks and beyond in rare cases. France moved last week to offer free contraception to girls and women under 25, in a sign of the continent’s generally liberal approach. (Smith, 9/16)

Wading into an issue splitting the U.S. Catholic Church, Pope Francis on Wednesday said the decision about granting Communion to politicians who support abortion rights should be made from a pastoral point of view, not a political one. Francis did not take a direct stance on the raging debate over whether President Biden should be denied the sacred rite because of an abortion stance that goes against church doctrine. But the pope advised that bishops should be “pastors, and not go condemning.” “God’s style is closeness, compassion and tenderness,” Francis said. (Harlan and Boorstein, 9/15)

Pfizer and BioNTech plan to file for Food and Drug Administration (FDA) emergency authorization in November for their COVID-19 vaccine for children younger than 5, Pfizer Chief Financial Officer Frank D'Amelio said this week. Pfizer has previously said the company expects to file in early October for emergency use authorization in children ages 5 to 11. (Weixel, 9/15)

Pfizer expects to release clinical trial data on how well its Covid-19 vaccine works in 6-month to 5-year-old children as early as the end of October, CEO Albert Bourla said Tuesday. Covid vaccine data for kids between ages 5 and 11 will come much sooner, he said, potentially ready to be submitted to the Food and Drug Administration by the end of this month. (Lovelace Jr., 9/14)

Pfizer is planning to submit data to the Food and Drug Administration by the end of this month with hopes for a green light to start vaccinating kids 5 to 11 years old before Halloween. Health officers across the Bay Area are starting to prepare how distribution will work once the vaccine is authorized for emergency use. ... Susan Rojas works with San Francisco's COVID-19 taskforce. Her staff is already preparing to expand the Mission's 24th Street pop-up site to be able to vaccinate up to 500 children per day once Pfizer's vaccine is authorized. "We have a lot of families coming in trying to figure out if they can put their names on a waitlist," she said. (Sierra, 9/15)

Food and Drug Administration scientists have expressed skepticism about the need for additional doses of Pfizer’s Covid-19 vaccine for all people who have received it. The assessment by the agency’s staff, included in documents released Wednesday, sets up a high-stakes debate over who will need an additional booster dose — and when they will need it — at the meeting of experts being convened by the Food and Drug Administration on Friday. (Herper and Branswell, 9/15)

The debate over COVID-19 booster shots for all Americans remains intense with less than a week to go before the target rollout date desired by the White House and days before government advisers plan to vote on the issue. Experts are eagerly parsing the data on booster shots after internal feuding at the Food and Drug Administration spilled into the public this week, with two top vaccine regulators arguing in a review of global data in The Lancet that there is not enough evidence to recommend them. (Kopp, 9/15)

An outside panel of scientific advisers will review the FDA report on Friday, along with a companion analysis from Pfizer and other information, as part of a discussion over who needs booster shots and when. ... The booster campaign hinges on FDA clearance of the additional shots and input by the panel meeting on Friday, plus a separate committee of outside experts that advises the Centers for Disease Control and Prevention. The CDC recommends who gets priority for the vaccines and when. (Hopkins and Schwartz, 9/15)

It's not clear if or when boosters doses of Covid-19 vaccines will be OK'd for fully vaccinated people in the United States, but state and local health departments across the United States are moving ahead with plans for a potential rollout next week. (Howard, 9/16)

Pfizer Inc. said that data from the U.S. and Israel suggest that the efficacy of its Covid-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants. The company detailed the data in a presentation it will deliver to a meeting of outside advisers to the Food and Drug Administration on Friday. The panel is expected to make recommendations for whether more Americans should receive booster shots. (Langreth, 9/15)

Moderna on Wednesday released more data on so-called breakthrough cases it says supports the push for wide use of Covid-19 vaccine booster shots. The U.S. drugmaker shared a new analysis from its phase three study that showed the incidence of breakthrough Covid cases, which occur in fully vaccinated people, was less frequent in a group of trial participants who were more recently inoculated, suggesting immunity for earlier groups had started to wane. (Lovelace Jr., 9/15)

Delawareans fully vaccinated with the Moderna vaccine have been the least likely to become infected with COVID-19, according to data analysis by the state, and less than 1% of people immunized with any vaccine later contracted a confirmed case of the virus. The new data from Delaware add to a growing body of early research showing that the shots offer strong protection, even as the highly transmissible delta variant circulates. (McCarthy and McDaniel, 9/15)

A third dose of the Pfizer Inc.-BioNTech SE Covid vaccine can dramatically reduce rates of Covid-related illness in people 60 and older, according to data from a short-term study in Israel. Starting 12 days after the extra dose, confirmed infection rates were 11 times lower in the booster group compared with a group that got the standard two doses, the analysis released Wednesday by the New England Journal of Medicine found. Rates of severe illness were almost 20 times lower in the booster group. (Langreth, 9/15)

KHN: How Fauci And The NIH Got Ahead Of The FDA And CDC In Backing Boosters 

In January — long before the first jabs of covid-19 vaccine were even available to most Americans — scientists working under Dr. Anthony Fauci at the National Institute of Allergy and Infectious Diseases were already thinking about potential booster shots. A month later, they organized an international group of epidemiologists, virologists and biostatisticians to track and sequence covid variants. They called the elite group SAVE, or SARS-Cov-2 Variant Testing Pipeline. And by the end of March, the scientists at NIAID were experimenting with monkeys and reviewing early data from humans showing that booster shots provided a rapid increase in protective antibodies — even against dangerous variants. (Tribble and Allen, 9/16)

The number of people getting a first dose of Covid-19 vaccine is declining again in the U.S. after a fleeting uptick in August. The drop is being led by the South and Central regions of the U.S. It’s a reversal of what just a month ago seemed like a hopeful trend for public health officials, when those places — hit hard by a wave of delta variant-driven cases — briefly led the nation in the number of people starting vaccinations. (Armstrong, 9/15)

Seated in an ornate, columned hearing room before a panel of state legislators, the 7-year-old girl spoke with conviction. “I love God with my whole heart,” she said. “He made our immune systems perfect.” Therefore she — and other children from families with such religious beliefs — should be exempt from requirements to get vaccinated against measles and other infectious diseases, the girl argued. A crowd of supporters erupted in applause. And within days, lawmakers tabled their effort to tighten the state’s school vaccination rules, leaving intact the option of obtaining a religious exemption. A scene from a red state, perhaps? Somewhere in the Great Plains or the Deep South? Try New Jersey, which has voted for Democrats in the last eight presidential elections. (Avril, 9/16)

Southwest Airlines will give vaccinated workers two days of bonus pay that will arrive in paychecks just before Christmas, moving to reward workers even as the White House pushes its own mandates for all large businesses. Dallas-based Southwest also told workers in a memo Wednesday that only vaccinated workers would be allowed to take time off for contracting COVID-19 without having to use their own sick or vacation time. “There are a lot of opinions swirling right now around COVID-19 vaccines, and we respect that every employee has individual thoughts on the topic,” the memo said. “That said, Southwest supports vaccines as our best line of defense against COVID to protect our employees and the customers you are serving each and every day, as well as maintain a reliable operation.” (Arnold, 9/15)

More than nine months after coronavirus vaccines were made available, inequities in Florida’s distribution process are still affecting some populations. Though a majority of people who haven’t been vaccinated are white, vaccination rates among Black Floridians are still far behind their white and Hispanic counterparts. The state reports 49% of white people in Florida are vaccinated, compared with 31% of Black people. (Colombini and Sheridan, 9/15)

Ron DeSantis isn't anti-vaccine. But he has started standing shoulder-to-shoulder those who are. The Florida governor’s clear and unadulterated public messaging about the need for vaccines has become more diluted in recent months, culminating with a press conference he held this week to bash President Joe Biden’s new vaccine mandate plan — and threaten to fine cities and counties that impose their own mandates. (Caputo and Fineout, 9/15)

For four-plus years of Donald Trump’s ramblings on Twitter, the GOP conveniently didn’t see that tweet. When Trump claimed a stolen election, his fellow Republicans instead offered a watered-down case for merely questioning the election results — even as the Jan. 6 Capitol rioters internalized Trump’s starker version. And now, with coronavirus vaccine misinformation proliferating in their midst and severely hampering efforts to stomp out the virus, they have repeatedly shrugged off the need to do anything about it. ... At an event Monday, Florida Gov. Ron DeSantis (R) appeared with a man who promoted a conspiracy theory common among anti-vaxxers. “The vaccine changes your RNA,” claimed the man, an employee of a utility company. “So for me, that’s a problem.” DeSantis stood right next to him, staring at him as he said this. But when pressed on why he, as an advocate for vaccination, didn’t weigh in, DeSantis claimed he didn’t hear the man’s statement. (Blake, 9/15)

The CDC moved too slowly at several points in the coronavirus pandemic, ultimately hindering the U.S. response, former FDA Commissioner Scott Gottlieb writes in a new book, Uncontrolled Spread. The book argues that American intelligence agencies should have a much bigger role in pandemic preparedness, even if that's sometimes at the expense of public health agencies like the CDC. (Reed, 9/16)

Clinical trials for coronavirus vaccines should include examination of any possible effects on women's menstrual cycles -- if only because so many women are worried about possible problems, a British expert argued Wednesday. But there's also evidence the immune response prompted by both vaccines and viral infections can temporarily affect menstrual cycles, so studying these effects is important, Dr. Victoria Male, a reproductive specialist at Imperial College London, wrote in the BMJ. "Vaccine hesitancy among young women is largely driven by false claims that Covid-19 vaccines could harm their chances of future pregnancy," Male wrote. (Fox, 9/15)

U.S. Customs and Border Protection (CBP) officers in Pittsburgh have seized two shipments of phony COVID-19 vaccination cards shipped from China. CBP seized the first of the two international parcels on August 24. CBP officers determined that the parcel of 20 cards had a "low-quality appearance." CBP said the cards were being shipped to someone in Beaver County, Pa. That individual, whose identity was not released, is not from the Centers for Disease Control and Prevention (CDC) or a certified medical entity, CBP said. (Betz, 9/15)

As someone who’s been working in the recruiting and talent acquisition industry for two decades, Dustin Mazanowski knows how important it is for job candidates to have “key words” on their profiles and resumes that quickly distinguish them from the pack. That’s why he has “#vaccinated” in his LinkedIn profile. ... Job seekers say volunteering their COVID-19 vaccination status could be a way to give them a competitive edge. (Keshner, 9/16)

The Biden administration is considering requiring vaccinations against COVID-19 and contact tracing of international visitors after the U.S. revamps current broad restrictions that bar many foreigners from traveling to the U.S., a top White House adviser said Wednesday. Jeffrey Zients, the White House coronavirus response coordinator, said that because of the recent increase in COVID-19 cases, current travel restrictions will remain in place until the administration rolls out a “new system” for regulating international travel. (9/15)

The man who ran former President Barack Obama's Department of Transportation thinks President Joe Biden is going too soft on airlines and airline travelers as part of the government's efforts to get the pandemic under control. Former Transportation Secretary Ray LaHood says the White House should push airlines to put a vaccine mandate on airline travelers in place. If the airlines refuse, LaHood said, the White House should do it itself. What’s more, he contends it wouldn’t be a heavy lift operationally. (Korecki, Pawlyk and Fuchs, 9/15)

People applying to immigrate to the U.S. will have to show they've been vaccinated against COVID-19 as part of a required medical exam, the U.S. Citizenship and Immigration Services says. The new policy takes effect on Oct. 1. The requirement includes an exception for children who are too young to receive the vaccine as well as for people with medical conditions that rule them out for the shot. It also outlines a waiver process for people who refuse to be vaccinated due to religious and other reasons. The COVID-19 shot joins a list of well-established vaccines required by the U.S., from hepatitis A to polio and varicella (chickenpox), according to a policy update issued by USCIS. (Chappell, 9/15)

President Biden met Wednesday with executives from companies including Walt Disney Co. , Microsoft Corp. and Walgreens Boots Alliance Inc. to advance his Covid-19 vaccination requirements for the private sector. The White House meeting comes after a plan Mr. Biden announced last week designed to bring the coronavirus pandemic under control, which includes vaccine requirements affecting roughly 100 million workers. (Siddiqui, 9/15)

The White House offered Wednesday to connect Nicki Minaj with one of the Biden administration’s doctors to address her questions about the COVID-19 vaccine, after the Trinidadian-born rapper’s erroneous tweet alleging the vaccine causes impotence went viral. The White House said that they’ve offered such calls with others concerned about the vaccine, part of an aggressive public relations campaign to beat back rampant disinformation about the vaccine’s safety and effectiveness. Minaj tweeted Wednesday that “the White House has invited me” and “yes, I’m going,” but a White House official said the rapper was simply offered a call. (Jaffe, 9/16)

Dr. Anthony Fauci, the nation's top infectious disease expert, has debunked a viral tweet from rapper Nicki Minaj that suggested the COVID-19 vaccine could cause reproductive issues. Minaj, who has over 22 million Twitter followers, sparked controversy Monday for a series of tweets she posted about the COVID-19 vaccine ahead of the Met Gala. "They want you to get vaccinated for the Met," the 38-year-old wrote. "if I get vaccinated it won't for the Met. It'll be once I feel I've done enough research. I'm working on that now. In the meantime my loves, be safe. Wear the mask with 2 strings that grips your head & face. Not that loose one" (Jones, 9/15)

Federal District Judge Lee Yeakel said Wednesday morning he intends to fast-track a lawsuit filed on behalf of 14 Texas schoolchildren with disabilities who allege that Gov. Greg Abbott’s ban on mask mandates breaks federal law by discriminating against them because they are particularly vulnerable to COVID-19. In Wednesday’s hearing, Yeakel denied a request for a temporary restraining order that would have barred Texas from enforcing Abbott’s order until Oct. 6, when the case is scheduled for trial. (McKinley, 9/15)

A federal judge declined Wednesday to block a ban imposed by Republican Gov. Ron DeSantis to prevent mandating masks for Florida school students amid the ongoing coronavirus outbreak. Judge K. Michael Moore in Miami denied a request by parents of disabled children for a preliminary injunction against an executive order that DeSantis issued in July that served as the basis for the Florida Department of Health issuing a rule that required school districts to allow parents to opt out of any student mask mandates. (9/16)

Arkansas’ largest school district has ended its mask mandate as the state reported 28 new COVID-19 deaths. The Springdale School Board on Tuesday voted to end its requirement Wednesday for K-7 students to wear masks indoors and on buses. Springdale was among more than 100 districts that imposed mask requirements after a judge blocked the state’s ban on government mask mandates. The requirements have covered more than half of the state’s public-school students. (9/15)

The school boards for two of the Bay Area’s biggest public school districts — Oakland and West Contra Costa Unified — plan to vote next week on whether to require mandatory COVID-19 vaccinations for all staff and eligible students 12 and older. These districts would become the first in Northern California to require vaccinations if mandates are approved. Los Angeles and Culver City school districts have recently mandated shots against COVID-19 for staff and students. (Swan, 9/15)

COVID-19 vaccination rates among Hispanic people and Latinos continue to lag behind all other ethnicities in Denver — and the division appears to be widening. Over the past few weeks, city health officials have ramped up vaccine outreach at K–12 public schools to target students and their families. The city launched an in-school immunization program offering free vaccines to eligible students and their relatives. (Alvarez, 9/15)

As wildfires rage across Western states, flattening rural towns and forcing thousands of people to evacuate, coronavirus cases and pandemic-related supply chain problems have made it harder to deploy firefighting resources to where they’re needed, fire officials say. More firefighters appear to be falling ill with COVID-19 and quarantining this year than last year, the officials say, because of the highly contagious delta variant and mixed adherence to COVID-19 safety measures such as masking, vaccinations and social distancing. “Last year, I actually was incredibly, pleasantly surprised by how little COVID it seemed like we had,” said Melissa Baumann, president of the National Federation of Federal Employees’ Forest Service Council. Her union represents U.S. Forest Service employees, including wildland firefighters who work for the agency. (Quinton, 9/15)

More than a year and a half into the COVID-19 pandemic, most Americans believe the coronavirus remains a major threat to public health and the U.S. economy, according to a Pew Research Center report released Wednesday. Despite widespread vaccination efforts, 54% of U.S. adults say the worst of the outbreak is still to come. The report, based on a survey of 10,348 U.S. adults conducted Aug. 23-29, 2021, found 73% of those ages 18 and older say they’ve received at least one dose of a vaccine for COVID-19. (Bacon, Santucci and Hauck, 9/15)

Nevada’s hospital association urged residents Wednesday to stay out of emergency rooms except in true emergencies, especially in northern Nevada where a resurgence in COVID-19 cases continues at a rate twice as high as the Las Vegas area. “Many hospital emergency departments in northern Nevada are at capacity with patients,” said Pat Kelly, president and CEO of the Nevada Hospital Association. (Sonner, 9/16)

A Utah Republican lawmaker made an inaccurate claim that the shortage of ICU beds in Utah hospitals was not because of the COVID-19 pandemic but partly because of bad business decisions. Rep. Paul Ray, R-Clearfield made the comment during a hearing on what lawmakers could do to thwart President Joe Biden’s vaccine mandate for businesses. Ray was riffing on whether people should be required to be vaccinated. “It’s a person’s choice. If you choose not to get vaccinated, you get sick and you die. That’s on you. That’s your call,” Ray said. Unprompted, Ray shifted to the reports that ICU beds in Utah were beyond capacity because unvaccinated people were being hospitalized due to the runaway spread of the delta variant. (Schott, 9/15)

Beaumont Health announced Wednesday that all of its 10 emergency departments are nearly full, and officials are urging patients to consider all options for treatment and evaluation, such as urgent care and their primary care physician, when appropriate. The health system, like others in Michigan and nationwide, is experiencing more patients overall and staffing shortages and has temporarily closed about 180 beds (just over 5% of its total beds) because of a lack of staffing. (Hall, 9/15)

The state’s health care system continues to operate in crisis mode as hospital intensive care units still overflow with gravely ill patients, even though COVID-19 admissions have declined since hitting a pandemic peak in early September. The high demand for critical care has pushed hospitals to try to limit ambulance traffic to their severely crowded emergency departments. The result: frequent scenes of ambulances piling up outside ERs, as EMS workers keep caring for patients on stretchers and listening to radio calls they can’t quickly respond to. (Teegardin and Berard, 9/15)

Oklahoma County jail inmate Leo Alexander Destea died at a hospital Tuesday night. Destea tested postive for COVID-19 in early August and was quarantined at the jail. He was hospitalized Aug. 30 after developing trouble breathing. He died Tuesday night. The jail announced the death Wednesday morning in a news release. The state medical examiner’s office will make a final determination as to the cause of death, the jail's communications director said. (Clay, 9/15)

A infant has died with COVID-19 in Orange County, one of 56 deaths related to the virus reported iby the county since Sept. 9. “The age range for the deaths was 0 to 95. That means someone younger than 1. And we will not give any details about that individual at all. Because it’s just one single case. And it could be easily identified,” says Dr. Raul Pino, the county's Department of Health medical director. Pino says he believes the baby is the youngest person to die with COVID in the county. (Prieur, 9/15)

Cloth or surgical facial masks reduced SARS-CoV-2 RNA 77% in exhaled coarse aerosol particles and 48% in exhaled fine aerosol particles, offering "modest" source control, according to a Clinical Infectious Diseases study yesterday. The study also found that the Alpha (B117) COVID-19 variant contained 43-fold more fine-aerosol viral RNA compared with earlier virus strains. The study used breath samples collected using a Gesundheit II machine, which was developed by senior study author Donald Milton, MD, PhD, of the University of Maryland. The machine measures viral shedding in exhaled breaths during talking and other vocalizations. "Source control" refers to covering the mouth and nose to reduce expelled pathogens and thus the likelihood of disease transmission. (9/15)

The National Institute of Health is launching a nationwide series of studies with as many as 40,000 people to research the long-term effects of COVID-19. COVID symptoms that last more than four weeks, usually referred to as long COVID, have become an emerging public health concern as researchers do not know the cause. (Fernandez, 9/15)

KHN: When Covid Deaths Are Dismissed Or Stigmatized, Grief Is Mixed With Shame And Anger

Months after Kyle Dixon died, his old house in Lanse, Pennsylvania, is full of reminders of a life cut short. His tent and hiking boots sit on the porch where he last put them. The grass he used to mow has grown tall in his absence. And on the kitchen counter, there are still bottles of the over-the-counter cough medicine he took to try to ease his symptoms at home as covid-19 began to destroy his lungs. (Sholtis, 9/16)

Before she died in April 2020, one of the last academic articles Lorna Breen co-authored focused on the “alarming prevalence” of burnout among emergency-department clinicians, and what was to be done about it. But if Breen, an emergency-department physician at NewYork-Presbyterian Allen Hospital, was ever experiencing burnout herself, she didn’t show it, her family says. She had no history of mental illness, no bouts of anxiety or depression, and that was what made what happened to Breen feel so implausible after the pandemic hit, said her sister, Jennifer Feist. Weeks into the pandemic, Breen fell ill with covid-19. After she recovered, she promptly returned to work at the hospital. Twenty-four days later, she died by suicide in Charlottesville, where her family lives and where she is from — feeling overwhelmed by the onslaught of dying covid-19 patients. (Flynn, 9/15)

A worker was killed Wednesday when an MRI machine fell to the ground outside University of Utah Hospital, officials said in a news conference. Workers were moving the medical imaging machine from the fourth floor to the first floor of the hospital around 11 a.m. when it fell near a loading dock on the west side of the building, just north of the School of Medicine. The hospital stated in a news release that the worker killed was not a hospital employee and had been part of a team contracted to move the device. The worker fell alongside the machine. He was taken to the hospital’s emergency department, where he died. Another contracted worker suffered a minor injury. (Miller, 9/15)

As the opioid crisis spiraled in 2015, Dr. Adrian Dexter Talbot allegedly signed off on prescriptions to 81 different patients in a single day — most of them for pain medication with a "high potential for abuse. "Most general practitioners like Talbot are only able to see about 20 patients a day, according to a 2018 survey of American physicians by the Physicians Foundation. A federal grand jury in New Orleans recently indicted Talbot, 55, on seven counts of illegal dispensation of controlled substances "not for a legitimate medical purpose." The indictment claims he illegally prescribed over a million doses of oxycodone, morphine and other opioids and defrauded health care benefit programs of $5.1 million from February 2015 to July 2018. (Pierce, 9/15)

After nine years of regular vaginal and breast examinations with her gynecologist, Morgan Hellquist slowly came to a distressing realization. The doctor whom she had trusted with countless examinations was, she suspected, her biological father. The first inkling came during an appointment this April, Hellquist alleges in a lawsuit filed this weekend. Hellquist had never known her biological father, having been conceived via artificial insemination and born in September 1985. But she knew one thing, according to the lawsuit: The doctor, Morris Wortman, facilitated the artificial impregnation of her mother, though she and her family believed it had involved the sperm of a medical student. (Mark, 9/15)

A former Theranos Inc. lab worker testified Wednesday that she raised alarms about the blood-testing startup’s practices with colleagues, managers and even a top executive and a board member but was rebuffed at every turn. ... Over two days of testimony, Ms. Cheung testified that Theranos’s highly publicized proprietary technology often didn’t work, and that the company cut corners to give the impression that its product was ready for wide-scale use by patients. (Randazzo, 9/15)

Aetna will update its coverage rules for infertility treatment just two days after a woman sued the insurer over its policy that forced LGBTQ individuals to pay tens of thousands of dollars out of pocket for procedures that it offered to heterosexual people with no cost-sharing. The insurer, which is owned by CVS Health, acknowledged it improperly denied coverage to Emma Goidel, a 31-year-old covered under an Aetna plan for Columbia University students who filed the proposed class-action against the company Monday. (Tepper, 9/15)

DirectTrust is creating a body to establish standards that healthcare organizations and human services providers can use when exchanging data on social determinants of health, the trade organization announced Wednesday. Healthcare providers are increasingly focused on addressing the ways social determinants of health such as food, transportation and financial insecurity can affect patients' health. While screening for social determinants has become more common among healthcare providers, they've run into roadblocks when setting up programs to actually refer patients to needed services. That's partly because many human services providers don't use software programs that easily exchange referrals and other data with healthcare organizations. (Kim Cohen, 9/15)

A company is launching out of Stanford University on Wednesday to tackle one of the most enduring challenges of digitized medicine: How do you apply data from past patients to inform the care of new ones? The company, named Atropos Health, is seeking to commercialize a consultation service designed to use mountains of existing data to quickly answer a wide range of pressing questions, such as which drug is most effective for certain kinds of cancer patients, or when antibiotics can be safely discontinued in the treatment of a particular infection. (Ross, 9/15)

A catalyzing new review found virtually no research into ethics, security, and data rights of digital health measures — a worrying trifecta of blind spots for a field and an industry that will need the public’s trust to make a difference in health outcomes. The promise of digital health measures like movement and heart rate have gained prominence during the pandemic, as doctor’s appointments shifted online and clinical trials were forced to go remote. Research into these measures is being steered both by academia and industry, including the tech titans whose wearable devices can drive the bulk of data collection. (Palmer, 9/15)

Banner Health named Amy Perry president and chief operating officer on Wednesday, with the former Atlantic Health System executive preparing to assume the new role November 1. Perry currently serves as head of Morristown, New Jersey-based Atlantic Health's hospital division and executive vice president of care delivery, where she oversees operations across the company's more than 400 sites of care. Those include medical centers, home health, hospice, adult day care services, along with the organization's information technology and innovation efforts. She will succeed Banner Health COO Becky Kuhn, whose previously-announced retirement will be effective November 3. Phoenix, Arizona-based Banner Health is an integrated delivery system that provides care in six states and officials say it is one of the largest, secular not-for-profit health systems in the nation. In 2020, Banner Health generated $10.4 billion in revenue. (Tepper, 9/15)

When the pandemic hit, the little health center on Vinalhaven, an island 15 miles off the coast of Maine, was prepared in ways many larger facilities were not. The Islands Community Medical Services had long been using telehealth to provide primary and behavioral care to its 1,500-strong year-round community, relying on grants to cover costs. As the public health emergency lifted many restrictions on virtual care, the clinic ramped up its offerings. “We were able to pivot pretty quickly,” said former operations director Christina R. Quinlan, describing a scramble to add specialized medical and social care. (Sellers, 9/15)

“You should assume when you get a medical bill, that it might contain some type of an error. That would be a safe assumption,” says Marshall Allen, author of the new book “Never Pay the First Bill: And Other Ways to Fight the Health Care System and Win.” In fact, he says, “When I talk to experts who review medical bills, they say that most of them contain some type of error.” (Pitt, 9/15)

The Food and Drug Administration has reversed an internal decision and will now review an experimental treatment for amyotrophic lateral sclerosis — a victory for ALS patients and advocates who have been pressuring regulators to act with more urgency against the fatal, neurodegenerative disease. Amylyx Pharmaceuticals, a Cambridge, Mass.-based drug maker, said Wednesday that it will submit an application for its ALS treatment, called AMX0035, “in the coming months.” (Feuerstein, 9/15)

A combination treatment that pairs Amgen’s KRAS-blocking drug Lumakras with another of its targeted cancer medicines showed improved tumor response rates in patients with advanced colon cancer, the company said Thursday. Amgen secured U.S. approval of Lumakras in May to treat patients with lung cancer caused by a genetic mutation to the KRAS protein. But the pill’s benefit in other types of solid tumors where KRAS also plays a role has proven to be more modest, necessitating a search for combination treatments that might boost efficacy. (Feuerstein, 9/16)

A few months ago, a federal court judge dismissed all claims against more than a dozen generic manufacturers over allegations that their versions of the Zantac heartburn pill may contain a carcinogen. Now, those companies are seeking to recover potentially significant costs from approximately 1,000 people who filed the lawsuits alleging they were harmed by the pills. (Silverman, 9/15)

Hospitals participating in a federal drug discount program marked up cancer medicines four times for privately insured patients, and often charged cash-paying consumers the same as commercial insurers, a practice that does not “fit the mission” of serving low-income populations, a new analysis found. Specifically, the median price charged for cancer treatments to commercial insurers or cash-paying patients was 3.8 times what was paid by 123 hospitals participating in the so-called 340B program. Moreover, the hospitals did not reduce prices charged to insurers or patients when their own purchase prices decline, according to the analysis by Moto Bioadvisors, a consulting firm. (Silverman, 9/15)

Hong Kong-based Prenetics Group Ltd. is going public on the Nasdaq Stock Market via a special-purpose acquisition company, in a deal that values the medical diagnostic startup at $1.25 billion. Prenetics, whose revenue has surged during the coronavirus pandemic, will merge with Artisan Acquisition Corp. , a blank-check company founded by Adrian Cheng, grandson of the late Hong Kong real estate and jewelry magnate Cheng Yu-tung. The younger Mr. Cheng invested in Prenetics last year and held a 0.8% stake in the startup before the latest deal. (Yang, 9/16)

The gene-editing tool CRISPR is moving toward the market, promising better tests, disease cures — and maybe even a woolly mammoth. CRISPR is already a historic scientific achievement, but we're just now entering the moment when it will begin to impact patients and possibly the planet. (Walsh, 9/15)

The number of states with high obesity rates nearly doubled over two years as Americans grappled with pandemic stress, the Centers for Disease Control and Prevention reported Wednesday. A total of 16 states had obesity rates of 35% or more in 2020, up from nine states in 2018. Just two decades ago, no state had an adult obesity rate above 25%. Experts say the CDC figures, based on self-reported data of height and weight, represent an alarming trend because obesity is linked to type 2 diabetes, heart disease, stroke and many types of cancer. It also increases health spending by $149 billion a year and raises the risk of COVID-19 hospitalization and death, according to the Trust for America's Health, which released a report analyzing the CDC figures. (Alltucker, 9/15)

Maternal mortality in the U.S. has worsened over the past three decades due in large part to mounting disparities in access to quality perinatal care among women of color, according to a report the U.S. Commission on Civil Rights issued Wednesday. The maternal mortality rate rose from 6.6 deaths for every 100,000 live births in 1987 to 20.1 deaths by 2019, for a total of 754 that year, according to the report. The U.S. maternal death rate ranks among the highest of any high-income nation. (Ross Johnson, 9/15)

Black children consistently have more medical complications during appendectomies than their white peers, including higher rates of “perforated” or burst appendixes. That not only leads to extended hospital stays for the children, but it’s costing the U.S. health care system millions. (Cueto, 9/16)

Nearly 10% of children in the U.S. lived with someone who was mentally ill or severely depressed, data released Thursday from the National Center for Health Statistics show. The datapoint from 2019 was part of a larger effort to understand the number of children with different racial and ethnic backgrounds who are exposed to violence, parental incarceration or have lived with someone with mental health, alcohol or drug problems. (Fernandez, 9/16)

Food banks in New Mexico with high rates of childhood poverty and hunger are watching with apprehension as the federal government boosts standard food stamp benefits in October and extends generous emergency allotments temporarily. President Joe Biden’s administration has approved a permanent 25% increase in food aid over pre-pandemic levels, available to all 42 million SNAP beneficiaries across the country. The increase on Oct. 1 coincides with the expiration of a smaller, 15% boost in food-aid benefits that was ordered as a pandemic protection measure. (Lee, 9/15)

The Boy Scouts of America’s latest effort to reach an agreement with tens of thousands of alleged victims of sexual abuse is facing opposition from a court-appointed group representing victims in the Scouts’ bankruptcy proceedings as well as other victims’ attorneys. On Tuesday, the Boy Scouts proposed a new settlement — the fifth so far — that includes new money from the Church of Jesus Christ of Latter-day Saints, and more money from insurers. In total, it would give over $1 billion to about 82,500 individuals who allege they were victims of sexual abuse during their time in the Boy Scouts. (Asbury, 9/15)

Andrea Urton, who grew up homeless in Los Angeles, has seen how little corporate interests  tend to care about helping the impoverished. So it was with some surprise when she received a phone call from an Apple representative. “I have never had an Apple or a Google or a Facebook reach out to me personally and say, ‘We really want to work on developing this property that we own and we don’t just want to kick people off,’” said Urton, the CEO of HomeFirst, an organization that provides services to homeless people in Santa Clara County, the Silicon Valley home to numerous tech companies, including Apple. (Farivar, 9/15)

KHN: No Papers, No Care: Disabled Migrants Seek Help Through Lawsuit, Activism

Desperation led José Luis Hernández to ride atop a speeding train through northern Mexico with hopes of reaching the United States 13 years ago. But he didn’t make it. Slipping off a step above a train coupling, he slid under the steel wheels. In the aftermath, he lost his right arm and leg, and all but one finger on his left hand. He had left his home village in Honduras for the U.S. “to help my family, because there were no jobs, no opportunities,” he said. Instead, he ended up undergoing a series of surgeries in Mexico before heading home “to the same miserable conditions in my country, but worse off.” (de Marco, 9/16)

Star Olympic gymnast Simone Biles denounced the FBI for turning “a blind eye” to the sexual abuse she and other young athletes suffered at the hands of former USA Gymnastics doctor Larry Nassar in emotionally powerful testimony before a Senate panel Wednesday. “It truly feels like the FBI turned a blind eye to us and went out of its way to protect” the USA Gymnastics organization and the U.S. Olympic and Paralympic Committee, said Biles, who testified before the Senate Judiciary Committee alongside three other women who were abused by Nassar. (Strohm and House, 9/15)

California Governor Gavin Newsom, a Democrat, warned Wednesday that his party needs to "lean in" on COVID-19 prevention, despite hardline opposition. Speaking with CBS News chief Washington correspondent Major Garrett less than 24 hours after he overwhelmingly survived a recall challenge, Newsom said he views the victory as a sign that his constituents approve of his handling of the pandemic. "So, what I'm saying here is, be affirmative," Newsom said he would tell national Democrats. "Don't be timid. Lean in. Because at the end of the day, it's not just about formal authority of setting the tone and tenor on masks — on vaccines and masks. But it's the moral authority that we have: that we're on the right side of history and we're doing the right thing to save people's lives." (9/15)

Republican lawmakers in more than half of U.S. states have weakened state or local officials' authority to implement policies to protect the public against the coronavirus and other infectious diseases, AP and Kaiser Health News report. Since the coronavirus pandemic began, lawmakers in all 50 states have introduced bills to curb state and local officials' public health authority, a KHN review found. (Gonzalez, 9/15)

As Hurricane Nicholas barreled toward the Gulf Coast Monday, multiple Houston health care institutions announced they would be close COVID-19 testing and vaccine sites Tuesday as a precaution. The storm produced high winds, downed power lines and trees and flooding in some areas of Southeast Texas. However, by midday Tuesday, Houston Health Department and Harris County Public Health announced regular testing and vaccine appointments would resume Wednesday. (Garcia, 9/15)

Now that the Utah Supreme Court has ruled that transgender Utahns can list their gender identity on state records, state lawmakers need to decide how they want to move forward. Legislators essentially have three options, according to Rep. Merrill Nelson, R-Grantsville. The easiest approach, he said, would be for lawmakers to do nothing, and let the Supreme Court’s May ruling stand. Another option, he said, is to revisit state law and clearly define what sex means, particularly when it comes to birth certificates. That “fixed definition” would carry over to other government documents, such as driver licenses, according to Nelson. (Jacobs, 9/15)

The U.S. subsidiary of Formosa Plastics has been fined millions of dollars for endangering the health of the public as well as workers at its Texas petrochemical plant. The plastics company, with headquarters in Taiwan, has agreed to pay $2.85 million in civil penalties to resolve alleged violations of the Clean Air Act at its petrochemical manufacturing plant in Point Comfort, near Victoria. (de Luna, 9/15)

State and local governments have shed more than 400,000 jobs since the beginning of 2020, and those jobs have been far slower to return than the private sector positions that have rebounded after the initial shock of the coronavirus pandemic and its economic lockdowns. And there are signs that the exodus of government employees has not reached its nadir: Private sector employment has risen 3.4 percent since December, while state and local governments jobs, exclusive of education positions, are down 0.6 percent, according to an analysis by The Pew Charitable Trust’s State Fiscal Health Initiative. (Wilson, 9/15)

The World Health Organization (WHO) has reported 4 million weekly COVID-19 cases, reflecting the first marked decline in more than two months. In recent weeks, there were about 4.4 million cases. All regions worldwide reported declines in new infections compared to the prior week, according to the WHO’s latest COVID-19 weekly epidemiological update, released Sept. 14. Nevertheless, the U.S., U.K., India, Iran and Turkey contributed the highest numbers of new reported cases. New reported deaths worldwide also declined over the prior week, at 62,000 fatalities, though Africa reported a 7% increase in weekly deaths. (Rivas, 9/15)

European Commission President Ursula von der Leyen said Wednesday that the bloc would donate an additional 200 million coronavirus vaccine doses to Africa and low-income nations, AP reports. The new donation, slated to be delivered by the middle of next year, comes as confirmed cases of the coronavirus have reached 225 million globally. (Reyes, 9/15)

China has fully vaccinated more than 1 billion people against Covid-19 -- over 70% of its total population -- powering ahead of the U.S. and Europe despite having no immediate plans to ease some of the strictest pandemic measures in the world. A total of 2.16 billion doses have been given in China as of Sept. 15, Mi Feng, a spokesperson at the National Health Commission, told reporters in Beijing on Thursday, fully inoculating more than 1.01 billion people. (9/16)

Storing donor lungs at a slightly warmer temperature — 10 degrees Celsius instead of 4 degrees — can make the organs viable for six times as long as traditional preservation methods for transplants, a new study found. For decades, cold organ storage has relied on a simple ice cooler and a gold standard of 4 degrees. The new paper, published in Science Translational Medicine, may eventually change that practice and help erase some of the limitations that make it difficult for patients to receive successful and timely organ transplants, senior author Marcelo Cypel, surgical director of the transplant program at University Health Network in Toronto, told STAT. (Cueto, 9/15)

Johnson & Johnson's two-dose vaccine regimen against Ebola is safe and produces a strong immune response in people 1 year old and older, according to two studies published this week in The Lancet Infectious Diseases. The studies detailed the results of phase 2 randomized, controlled trials in Sierra Leone, which is one of the three countries that was hit hard during the massive 2014-16 West African Ebola outbreak. (McLernon, 9/15)

Extremely premature infants are at a high risk for brain damage. Researchers have now found possible targets for the early treatment of such damage outside the brain: Bacteria in the gut of premature infants may play a key role. The research team found that the overgrowth of the gastrointestinal tract with the bacterium Klebsiella is associated with an increased presence of certain immune cells and the development of neurological damage in premature babies. (University of Vienna, 9/3)

A University at Buffalo-led research team has shown that a protein named for the mythical land of youth in Irish folklore is effective at reversing aging in skeletal muscle cells. Published Sept. 3 in Science Advances, the study centers on the protein NANOG, which is derived from Tír na nÓg, a place in Irish lore renowned for everlasting youth, beauty and health. (University at Buffalo, 9/14)

A study today in JAMA Network Open that found quadruple the risk of COVID-19 in California farmworkers reveals risk factors for current or previous SARS-CoV-2 infection in the group, including outdoor work exposures, crowded living conditions, and high body mass index (BMI). (Van Beusekom, 9/15)

A COVID-19 outbreak in a French nursing home—where 95% of residents but only a third of healthcare workers were fully vaccinated— infected nearly a quarter of residents and 12% of staff, finds a study today in JAMA Network Open. Nursing home residents may be particularly vulnerable to COVID-19 infections and complications owing to impaired immune function tied to advanced age, congregate living, exposure to rotating unvaccinated healthcare personnel, weaker antibody response to vaccination, and underlying medical conditions such as malnutrition, diabetes, and cancer, the study authors noted. (Van Beusekom, 9/13)

If jails "decarcerated," or released, 80% of their inmates—an amount the researchers say is often proportionate to people detained for nonviolent crimes—daily COVID-19 case growth rates in the community would drop 2%, according to a modeling study yesterday in JAMA Network Open. The researchers say if such a strategy had been implemented nationally at the beginning of the pandemic, millions of cases could have been prevented. The researchers looked at 165 US counties, which encompassed 51% of all counties, 72% of the US population, and 60% of the US jail population. The average prison population was 283.4 people, and the average county density was 315.2 people per square mile. (9/3)

Remdesivir treatment did not significantly affect mortality, clinical outcomes, or time to improvement in patients hospitalized with severe COVID-19, according to a study published in The Lancet Infectious Diseases yesterday. The data included results from the DisCoVeRy trial, which the researchers say is the fifth large, randomized, controlled trial to include remdesivir thus far. The cohort was recruited from 48 sites in Europe, with 39 sites in France. Exclusion criteria included elevated liver enzymes, severe chronic kidney disease, and pregnancy. (9/15)

America is suffering from a serious case of vaccinopia: an inability to look beyond shots in arms when considering how to manage the pandemic. This was made clear by President Biden’s new Covid-19 plan, which emphasizes vaccine mandates while providing insufficient support for rapid tests, which we believe to be the most promising — and most underused — tool in the armamentarium against the coronavirus. (Daniel P. Oran and Eric J. Topol, 9/16)

One in four American adults have yet to receive even one dose of the coronavirus vaccine. To explain the risk they pose to themselves and others, we propose an analogy: The choice to remain unvaccinated is equivalent to driving while intoxicated. Some might balk at this comparison, but here are the similarities. Both causes of severe bodily harm are largely preventable — covid-19 through vaccination, and drunken driving by not driving after drinking alcohol. Both are individual decisions with societal consequences. (Leana S. Wen and Sam Wang, 9/15)

Tens of millions of children are awaiting the approval of a vaccine to protect them from COVID-19. Their impatient parents should know that they don't just have to sit around and wait. Consider, for example, what happened during the AIDS epidemic, when the advocacy group ACT UP, but a scant year old at the time, figured out where the holdup in dealing with the AIDS crisis was: a featureless building in Maryland, home of the Food and Drug Administration. ACT UP’s realization was as relevant three decades ago as it is now. (Linda Hirshman, 9/14)

Through a recent article he wrote in the Independent, we learned about Steve Shorney, who lived with depression for most of his life despite years of psychotherapy, medication, yoga and many other attempts at holistic treatments. With his decision to enroll in a psilocybin clinical trial at Imperial College London, his life “radically changed.” Psilocybin was different from every other treatment or experience he had. As he recalled in the Independent article, “I had seen an alternative reality, another way of being, and knew beyond anything I’d known before that day that life is extraordinary. And in that moment I felt happier, more alive, and more Me than I imagined was possible.” (Danielle Schlosser and Thomas R. Insel, 9/14)

For a few months, the pandemic afforded a glimpse into an alternate reality: a health care system where doctors like us could evaluate patients via telemedicine from all over the country who sought our opinions as experts in our fields. Patients found that they did not have to board a plane or book rooms in a hotel overnight just to find out if they were good fits for a clinical trial in another state. Others could check-in on video and have their prescriptions updated rather than wait weeks for an appointment without medications. Well, the jig is up. (Trisha Pasricha and Pankaj Jay Pasricha, 9/15)

One of the fundamental principles on which the U.S. economy is based is that the expectation of a positive return drives one’s willingness to invest time and money. Individuals investing in a portfolio of stocks hope that some stocks’ gains will offset others’ losses. Yet Congress threatens to dismantle this framework, extinguishing an ecosystem that employs millions of people and serves as a global leader in creating new medicines for deadly diseases. (Peter Kolchinsky and Daphne Zohar, 9/15)

Struggles with mental ill-health are the world’s leading cause of disability. Beset by the coronavirus pandemic, underresourced mental health systems have strained to keep up. But access to care is limited by three major obstacles: a dearth of professional care providers, embedded stigma surrounding mental health problems and a distrust of institutions. (Brandon Staglin and Helen Herrman, 9/14)

The acceleration of investment in digital health and adoption of health-related apps triggered by the pandemic, which aimed to expand access at a time when access was difficult and health care needs were growing, may be harming the particularly important subset known as digital therapeutics (DTx). Health apps constitute a broad category, focusing on everything from health and well-being to treatment of disease. They may be unvalidated or based on limited evidence, essentially a caveat emptor situation. Digital therapeutics, in contrast, deliver medical interventions using evidence-based, clinically evaluated software, with a focus on treating, managing, and preventing diseases and disorders such as asthma and musculoskeletal pain. (Tom Denwood and Scott Kollins, 9/16)