News from Bioethics.com

Pfizer Won’t Apply for Covid-19 Vaccine Authorization Before Mid-November, CEO Confirms

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(STAT News) – Pfizer confirmed Friday it expects to seek emergency authorization of its experimental vaccine against Covid-19, if it is effective, in the third week of November. An analysis of the efficacy of the vaccine could be available sooner, the company said in an open letter from its CEO, Albert Bourla, but required safety data will take longer. 

Virus at ‘Turning Point’ in Europe, Hitting At-Risk Groups

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(ABC News) – Doctors are warning that Europe is at a turning point as the coronavirus surges back across the continent, including among vulnerable people, and governments try to impose restrictions without locking whole economies down. With newly confirmed cases reaching records, the Czech Republic has shut schools and is building a field hospital, Poland has limited restaurant hours and closed gyms and schools, and France is planning a 9 p.m. curfew in Paris and other big cities. In Britain, authorities are closing pubs and bars in areas in the country’s north, while putting limits on socializing in London and other parts of the country.

WHO Study Finds Remdesivir Didn’t Help COVID-19 Patients

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(Associated Press) – A large study led by the World Health Organization suggests that the antiviral drug remdesivir did not help hospitalized COVID-19 patients, in contrast to an earlier study that made the medicine a standard of care in the United States and many other countries. The results announced Friday do not negate the previous ones, and the WHO study was not as rigorous as the earlier one led by the U.S. National Institutes of Health. But they add to concerns about how much value the pricey drug gives because none of the studies have found it can improve survival.

Why Most US Home Health Aides ‘Can’t Afford Not to Work’–Even Without PPE

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(The Guardian) – During the pandemic, home health aides have buttressed the US healthcare system by keeping the most vulnerable patients – seniors, the disabled, the infirm – out of hospitals. Yet even as they have put themselves at risk, this workforce of 2.3 million – of whom nine in 10 are women, nearly two-thirds are minorities and almost one-third foreign-born – has largely been overlooked. Home health providers scavenged for their own face masks and other protective equipment, blended disinfectant and fabricated sanitizing wipes amid widespread shortages. They have often done it all on poverty wages, without overtime pay, hazard pay, sick leave and health insurance. And they have gotten sick and died – leaving little to their survivors.

Eli Lilly to Continue Other COVID-19 Antibody Drug Trials After Pausing One on Safety Concerns

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(Medscape) – Eli Lilly & Co on Wednesday said that other trials of its experimental COVID-19 antibody drug bamlanivimab will continue apace after it paused one ongoing trial of the drug, citing safety concerns. The paused trial, which Lilly calls ACTIV-3, focused on hospitalized patients. Lilly said it differed from its other trials in some key respects, including the fact that the patients had more serious illness and were being treated with other drugs, including Gilead Sciences Inc’s remdesivir.

Covid-19 Is Helping Wealthy Countries Talk About Death

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(The Economist) – A new survey by Hospice uk, a charity, found that this year 40% of British who lost a family member to covid-19 wrote down their end-of-life wishes, and a third planned their own funerals. (Overall, less than a fifth of Britons have done either.) More people are opting to die at home: since early June the percentage has been 30-40 points above the five-year average in England and Wales. Reminders of the epidemic—not just news reports but masks and hand-sanitiser bottles—raise the subliminal awareness of death which psychologists term “mortality salience”. “We are surrounded by death whether we like it or not, and it is healthier for us to accept it,” says Tracey Bleakley, head of Hospice uk.

 

Long COVID ‘May Be Four Syndromes’

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(Medscape) – The condition commonly called ‘long COVID’ may not be one syndrome but possibly up to four different syndromes, according to a new review. The finding comes from a dynamic themed review of available scientific evidence published by the National Institute for Health Research (NIHR). The paper, Living with COVID19 draws on the latest expert consensus and published evidence, as well as the experience of patients.

Self-Medication Increases Pandemic Deaths in Peru

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(The Economist) – Luis espinoza has been battling covid-19 in Peru since March. A doctor specialising in tropical medicine and infectious diseases, he was sent by the health ministry to Iquitos, in the northern jungle, when the pandemic began, then moved to Sullana, a sweltering northern city. Both cities have high numbers of deaths from covid-19. Many, says Dr Espinoza, were avoidable. “Patients who should not be dying are dying because of complications caused by self-medicating,” he says. That may help explain why Peru has had more deaths from the disease as a share of its population than all but one other country.

Months into Pandemic, Iran Sees Worst Wave of Virus Deaths

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(Associated Press) – Iran’s capital has run out of intensive care beds as the country confronts a new surge of infections that is filling hospitals and cemeteries alike. The single-day death toll hit a record high three times this week.

Did Lockdowns Lower Premature Births? A New Study Adds Evidence

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(New York Times) – Studies in Ireland and Denmark this summer showed that preterm births decreased in the spring during lockdowns to stop the spread of the virus in those countries. Anecdotally, doctors around the world reported similar drops. They speculated that reduced stress on mothers, cleaner air or better hygiene might have contributed. A large study from the Netherlands, published on Tuesday in The Lancet Public Health, has yielded even stronger evidence of an association between the lockdowns and a smaller number of early births.

Early Approval of a COVID-19 Vaccine Could Stymie the Hunt for Better Ones

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(Science) – Success in the push to find a COVID-19 vaccine at record-breaking speed could hand the world a new problem. The first vaccine to cross the finish line might be only marginally effective, yet it could become the enemy of the good—or even the great—candidates in the wings by disrupting ongoing studies.

AI Is About to Face a Major Test: Can It Differentiate Covid-19 from Flu?

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(STAT News) – With Covid-19 cases surging in parts of the U.S. at the start of flu season, developers of artificial intelligence tools are about to face their biggest test of the pandemic: Can they help doctors differentiate between the two respiratory illnesses, and accurately predict which patients will become severely ill? Numerous AI models are promising to do exactly that by sifting data on symptoms and analyzing chest X-rays and CT scans.

Chinese Firm Gives Experimental Covid Vaccines to Students

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(The Wall Street Journal) – China is expanding distribution of its coronavirus vaccines outside of clinical trials, with a state-owned company offering them to students going abroad amid a campaign by officials to boost public confidence in homegrown inoculations.

Russia Approves 2nd Virus Vaccine After Early Trials

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(ABC News) – Russian authorities have given regulatory approval to a second coronavirus vaccine after early-stage studies, two months after a similar move prompted widespread criticism from scientists both at home and abroad.

Central Europe, Spared in the Spring, Suffers as Virus Surges

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(New York Times) – Much of Central Europe locked down quickly in the spring, before the coronavirus took root, and largely avoided widespread infection during the first wave of the pandemic. But now — from the Polish port city of Gdansk on the Baltic to the ancient fortress town of Kotor on the Adriatic in Montenegro — the virus is sweeping across the region. Hospitals beds are filling up in Poland; doctors in Hungary are issuing dire warnings about a lack of medical workers; the authorities in Romania are struggling to track new cases; and health care workers are falling ill in Bulgaria. The Czech Republic has the highest coronavirus transmission rates in Europe.

3 Covid-19 Trials Have Been Paused for Safety. That’s a Good Thing.

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(New York Times) – Clinical trials experts said these delays were comforting, in a way: They show that the researchers were following proper safety procedures. But for now, details about the nature of the volunteers’ illnesses are scant. And although pauses of vaccine trials are not unusual, some experts said that pausing treatment trials — like that of Eli Lilly’s antibody drug — is rarer, and perhaps more worrisome.

Eli Lilly’s Antibody Trial Is Paused Over Potential Safety Concern

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(New York Times) – A government-sponsored clinical trial that is testing an antibody treatment for Covid-19 developed by the drugmaker Eli Lilly has been paused because of a “potential safety concern,” according to emails that government officials sent on Tuesday to researchers at testing sites. The company confirmed the pause. The news comes just a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer, and a month after AstraZeneca’s vaccine trial was halted over concerns about two participants who had fallen ill after getting the company’s vaccine.

Johnson & Johnson Covid-19 Vaccine Study Paused Due to Unexplained Illness in Participant

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(STAT News) – 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. The document was obtained by STAT.

Scientists Confirm Nevada Man Was Infected Twice with Coronavirus

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(NPR) – A 25-year-old was infected twice with the coronavirus earlier this year, scientists in Nevada have confirmed. 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 cases underscore the importance of social distancing and wearing masks even if you were previously infected with the virus, and they raise questions about how the human immune system reacts to the virus.

From a Small Town in North Carolina to Big-City Hospitals, How Software Infuses Racism into U.S. Health Care

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(STAT News) – A STAT investigation found that a common method of using analytics software to target medical services to patients who need them most is infusing racial bias into decision-making about who should receive stepped-up care. While a study published last year documented bias in the use of an algorithm in one health system, STAT found the problems arise from multiple algorithms used in hospitals across the country. The bias is not intentional, but it reinforces deeply rooted inequities in the American health care system, effectively walling off low-income Black and Hispanic patients from services that less sick white patients routinely receive.

First, a Vaccine Approval. Then Chaos and Confusion.

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(New York Times) – The first vaccines may provide only moderate protection, low enough to make it prudent to keep wearing a mask. By next spring or summer, there may be several of these so-so vaccines, without a clear sense of how to choose from among them. Because of this array of options, makers of a superior vaccine in early stages of development may struggle to finish clinical testing. And some vaccines may be abruptly withdrawn from the market because they turn out not to be safe.

Remdesivir Effective, Well-Tolerated in Final Trial Report

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(Medscape) – A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection. In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial.

Hacking’s Next Targets

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(The Wall Street Journal) – Implanted medical devices, such as insulin pumps, pacemakers and cochlear implants, have been hacked repeatedly, but so far only by researchers, ethical hackers and fictional characters in television shows. The risk of criminals targeting these devices is expected to increase as more of them come equipped with GPS trackers, Bluetooth and internet connectivity. The devices also pose a “potential unwitting insider threat to national security,” according to research from Virginia Tech’s Hume Center for National Security and Technology. 

Lessons for the Next Pandemic–Act Very, Very Quickly

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(The Wall Street Journal) – Here’s how the next outbreak of a dangerous new virus should unfold: Several people in a city develop a fever and cough, and a few land in the hospital. Machine-learning algorithms quickly detect anomalies in their lung scans. Scientists notice a pattern of strange infections in routinely collected blood samples. Whatever has sickened people is spreading, the samples suggest.

Schools Aren’t Super-Spreaders

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(The Atlantic) – Fear and bad press slowed down or canceled school reopenings elsewhere. Many large urban school districts chose not to open for in-person instruction, even in places with relatively low positivity rates. Chicago, L.A., Houston—all remote, at least so far. It’s now October. We are starting to get an evidence-based picture of how school reopenings and remote learning are going (those photos of hallways don’t count), and the evidence is pointing in one direction. Schools do not, in fact, appear to be a major spreader of COVID-19.

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