News from Bioethics.com

The Ethics of Pausing a Vaccine Trial in the Midst of a Pandemic: a Conversation with Ruth Faden

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(STAT News) – The revelation that AstraZeneca paused its clinical trials for a Covid-19 vaccine has focused attention on the company and the clinical trial process. The hold occurred after a participant in the trial developed symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis. To better understand the ethics of vaccine trials in the time of coronavirus, I talked with Ruth Faden, a Johns Hopkins bioethicist with a special interest in vaccine development. Here’s a lightly edited version of our conversation.

Risk Score Predicts COVID-19 Mortality, Outperforms Others

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(Medscape) – The scoring system classifies patients as having low, intermediate, high, or very high likelihood of death on the basis of a total score from 0 to 21, with higher numbers reflecting greater risk. People in the low-risk group could potentially be managed in the community, the researchers note. Those in the intermediate group might be monitored on a hospital ward, whereas patients with a high risk for death could be triaged to prompt, aggressive treatment. High-risk patients might receive steroid treatment and be transferred to critical care, for example.

Claims of 99% Accuracy for UK Covid Antibody Test ‘Cannot Be Trusted’

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(The Guardian) – Claims that a rapid Covid-19 antibody test the government hopes to roll out this year is more than 99% accurate cannot be trusted, says a leading expert, calling for the full trial data to be made public. Jon Deeks, a professor of biostatistics and head of the test evaluation research group at the University of Birmingham, says the data published by Abingdon Health about the performance of its fingerprick antibody test were inadequate. The government hopes to roll out the test to millions of people.

Why AstraZeneca Pausing Its COVID-19 Vaccine Trial May Be Good News

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(ABC News) – The promising vaccine candidate created by researchers at Oxford had been marching through rounds of clinical trials before word of the voluntary pause came down Tuesday night. Trial participants in the U.S had started injections just last week. Specialists ABC News spoke with said they welcomed the pause.

Wildfires Kill Seven and Displace Thousands in Oregon, California and Washington

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(The Guardian) – Wildfires searing through the American west have killed at least seven people, leveled entire neighborhoods and displaced tens of thousands, forcing stretched firefighting crews to make tough decisions about where to deploy.

Kids’ Smartwatches Are a Security Nightmare Despite Years of Warnings

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(Wired) – Connecting every possible device in our lives to the internet has always represented a security risk. But that risk is far more pronounced when it involves a smartwatch strapped to your child’s wrist. Now, even after years of warnings about the security failings of many of those devices, one group of researchers has shown that several remain appallingly easy for hackers to abuse.

Oregon Fires: Evacuated Prisoners Sleep on Floor in Packed Covid-19 Hotspot

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(The Guardian) – Unprecedented wildfires and rushed evacuations in Oregon have wreaked havoc on the state’s incarcerated population, with thousands now packed into a single overcrowded prison that was already a major Covid-19 hotspot. A destructive and rapidly spreading fire in Marion county prompted the state to evacuate three prisons on Tuesday, transferring 1,450 people to the Oregon state penitentiary (OSP) in Salem. Evacuees are sleeping on the floor and on emergency beds throughout OSP, including in indoor recreational areas, program rooms and other facilities not typically used for housing.

The Controversial Company Using DNA to Sketch the Faces of Criminals

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(Nature) – It was April 2019 when it all started to fall apart for Parabon Nanolabs. At the time, it was the most famous forensic-genetics company on the planet. From its headquarters in Reston, Virginia, Parabon was helping police to crack cold-crime cases almost weekly, such as the murder of a Canadian couple in 1987 and the case of a young woman who was sexually assaulted and killed in the 1960s. The company had made its name by comparing suspects’ DNA to profiles on genealogy databases and piecing together family trees to track down alleged offenders.

Why COVID-19 Is More Deadly in People with Obesity–Even If They’re Young

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(Science) – Since the pandemic began, dozens of studies have reported that many of the sickest COVID-19 patients have been people with obesity. In recent weeks, that link has come into sharper focus as large new population studies have cemented the association and demonstrated that even people who are merely overweight are at higher risk. For example, in the first metaanalysis of its kind, published on 26 August in Obesity Reviews, an international team of researchers pooled data from scores of peer-reviewed papers capturing 399,000 patients. They found that people with obesity who contracted SARS-CoV-2 were 113% more likely than people of healthy weight to land in the hospital, 74% more likely to be admitted to an ICU, and 48% more likely to die.

Covid-19 Vaccine Trial Participant Had Serious Neurological Symptoms, but Could Be Discharged Today, AstraZeneca CEO Says

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(STAT News) – The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning. The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said.

AstraZeneca Covid-19 Vaccine Study Put on Hold Due to Suspected Adverse Reaction in Participant in the U.K.

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(STAT News) – A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” In a follow-up statement, AstraZeneca said it initiated the study hold.

A New Theory Asks: Could a Mask Be a Crude ‘Vaccine’?

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(New York Times) – Masked exposures are no substitute for a bona fide vaccine. But data from animals infected with the coronavirus, as well as insights gleaned from other diseases, suggest that masks, by cutting down on the number of viruses that encounter a person’s airway, might reduce the wearer’s chances of getting sick. And if a small number of pathogens still slip through, the researchers argue, these might prompt the body to produce immune cells that can remember the virus and stick around to fight it off again.

The Coronavirus Is Mutating–Does It Matter?

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(Nature) – Compared with HIV, SARS-CoV-2 is changing much more slowly as it spreads. But one mutation stood out to Korber. It was in the gene encoding the spike protein, which helps virus particles to penetrate cells. Korber saw the mutation appearing again and again in samples from people with COVID-19. At the 614th amino-acid position of the spike protein, the amino acid aspartate (D, in biochemical shorthand) was regularly being replaced by glycine (G) because of a copying fault that altered a single nucleotide in the virus’s 29,903-letter RNA code. Virologists were calling it the D614G mutation

It’s Not Easy to Get a Coronavirus Test for a Child

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(New York Times) – As child care centers and schools reopen, parents are encountering another coronavirus testing bottleneck: Few sites will test children. Even in large cities with dozens of test sites, parents are driving long distances and calling multiple centers to track down one accepting children. The age policies at testing sites reflect a range of concerns, including differences in health insurance, medical privacy rules, holes in test approval, and fears of squirmy or shrieking children.

New York Will Test the Dead More Often for Coronavirus and Flu

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(New York Times) – Cough, fever, chills — with fall fast on the way, symptoms alone won’t be useful in distinguishing Covid-19 from similar-looking cases of the flu. That means routinely testing for both viruses will be crucial — even, perhaps, after some patients have already died. That will at least be true in New York, where officials recently announced a ramp-up in post-mortem testing for the coronavirus as well as the flu. Deaths linked to respiratory illnesses that weren’t confirmed before a person died are to be followed up with tests for both viruses within 48 hours, according to the new regulation.

The Most American COVID-19 Failure Yet

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(The Atlantic) – Openshaw is so suspicious of contact tracing that when restaurants she dines at ask her for a phone number so they can call her if someone else at the restaurant tests positive for COVID-19, she sometimes gives them a fake number, she told me later. Her fears are ill-founded. Contact tracers recommend that infected people self-isolate, but they have no power to enforce isolation. Most countries with coronavirus outbreaks have started contact tracing, and of them, only China is Communist. But Openshaw’s outraged reaction to the concept helps explain a major problem bedeviling the American pandemic response: Contact tracing does not work as well here as it has in other rich countries.

Human Embryo Gene Editing Gets a Road Map–Not a Green Light

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(Wired) – In 2012 these dreams (or nightmares, depending on where you stand) started to get real. With the emergence of Crispr, genetic manipulations were suddenly much easier to make and the tools to make them quick and cheap to obtain. The National Academy of Sciences arranged summits and reports in an attempt to set some boundaries. In 2017 the academy concluded that using Crispr for human genetic enhancement was a hard no. But they stopped short of a full moratorium. What about gene editing to address serious, incurable diseases? Well, that could maybe one day be fine, provided it was proven safe and effective. But that 2017 report didn’t spell out exactly how one might prove those things. And a year later, into that gray area walked a Chinese researcher named He Jiankui, with claims to have edited the DNA of twin baby girls to make them immune to HIV/AIDS.

Russians Publish Early Coronavirus Vaccine Results

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(New York Times) – On Friday, a team of Russian scientists published the first report on their Covid-19 vaccine, which had been roundly criticized because of President Vladimir Putin’s decision last month to approve it before clinical trials had proved it safe and effective. In a small group of volunteers, the scientists found that the vaccine produced a modest level of antibodies against the coronavirus, while causing only mild side effects. The research has not yet shown, however, whether people who are vaccinated are less likely to become infected than those who are not.

Expert Panel Lays Out Guidelines for Germline Editing, While Warning Against Pursuit of ‘CRISPR Babies’

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(STAT News) – Nearly two years after the birth of the first “CRISPR babies” stunned the world, an international group of experts on Thursday warned such human experimentation — in which the DNA of embryos is edited before starting pregnancies — should not be conducted because of unresolved scientific and ethical issues. But the group’s eagerly awaited report detailed the steps that scientists should go through before attempting to create gene-edited babies should countries ever greenlight the procedure.

Uighur Muslim Teacher Tells of Forced Sterilisation in Xinjiang

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(The Guardian) – A teacher coerced into giving classes in Xinjiang internment camps has described her forced sterilisation at the age of 50, under a government campaign to suppress birth rates of women from Muslim minorities. Qelbinur Sidik said the crackdown swept up not just women likely to fall pregnant, but those well beyond normal childbearing ages. Messages she got from local authorities said women aged 19 to 59 were expected to have intrauterine devices (IUDs) fitted or undergo sterilisation.

Saliva COVID-19 Test as Good as, Perhaps Beats, Nasal Swab: Study

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(Medscape) – A COVID-19 saliva test protocol developed by researchers at Yale University appeared to perform at least as well as nasal swabs in a study of hospital patients, a finding that may help encourage more frequent use of self-collected samples. In a letter published August 28 in the New England Journal of Medicine, Anne L. Wyllie, PhD, of the Yale School of Public Health, New Haven, Connecticut, and her coauthors reported on testing done on 70 patients. 

As Covid-19 Depletes Blood Supplies, Scientists Test an Alternative

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(Wall Street Journal) – At a lab in Kyoto, Japan, scientists are running a pioneering clinical trial to treat this singular patient with a long-sought goal: artificial blood. Led by Dr. Koji Eto and a team at Kyoto University’s Center for IPS Cell Research and Application, the study aims to assess the safety and efficacy of platelets engineered in a lab out of a special type of stem cell. If successful, the research could pave the way for larger clinical trials and, ultimately, the broad use of lab-made blood.

Opioids Leading Cause of Drug Overdose Deaths in First Half of 2019

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(UPI) – More than 80% of all drug overdose deaths reported across the country in the first half of 2019 involved opioids, according to figures released Thursday by the U.S. Centers for Disease Control and Prevention. All of the 10 most common drugs or drug combinations found in overdose-related deaths during the first six months of last year included at least one opioid, the agency said. 

Experts See a Chance for a Covid-19 Vaccine Approval This Fall–If It’s Done Right

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(STAT News) – There is growing concern that the Food and Drug Administration, under political pressure, could approve a Covid-19 vaccine before it has robust safety and efficacy data. The consequences of such a decision could be significant, particularly if the vaccine is ultimately shown to be less effective than early data suggest. But an approval before the completion of large, Phase 3 trials does not have to be problematic. Experts aren’t ruling out the possibility that a vaccine could be cleared this fall if it is very effective.

‘CRISPR Babies’ Are Still Too Risky, Says Influential Panel

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(Nature) – Editing genes in human embryos could one day prevent some serious genetic disorders from being passed down — but for now the technique is too risky to be used in embryos destined for implantation, according to a high-profile international commission. And even when the technology is mature, it would initially apply only in a narrow set of circumstances, the panel says.

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