News from Bioethics.com

COVID-19 Cases Rising Among US Children as Schools Reopen

23 hours 43 min

(Associated Press) – After preying heavily on the elderly in the spring, the coronavirus is increasingly infecting American children and teens in a trend authorities say appears driven by school reopenings and the resumption of sports, playdates and other activities. Children of all ages now make up 10% of all U.S cases, up from 2% in April, the American Academy of Pediatrics reported Tuesday.

WHO to Probe ‘Sexual Exploitation’ by Aid Workers in DR Congo

23 hours 48 min

(BBC) – The World Health Organization (WHO) has pledged to investigate allegations that aid workers tackling the Ebola outbreak in the Democratic Republic of Congo sexually abused and exploited women. WHO and other aid agency staff were accused by 50 women in a joint investigation by two news agencies. Local women were allegedly plied with drinks, “ambushed” in hospitals, forced to have sex, and two became pregnant.

Regeneraon’s Covid-19 Antibody May Help Non-Hospitalized Patients Recover Faster, Early Data Show

23 hours 49 min

(STAT News) – New data from the biotechnology firm Regeneron seem likely to add to the excitement about drugs called monoclonal antibodies as treatments for Covid-19, but experts caution more data will be needed to know how potentially beneficial the medicines are. A high dose of the company’s antibody cocktail, REGN-COV2, led levels of the virus to decrease more quickly in infected, non-hospitalized patients, potentially indicating the treatment may help them get better, Regeneron reported Tuesday via press release. Full results will be published at a later date.

WHO, Partners Roll Out Faster COVID Tests for Poorer Nations

1 day 1 sec

(Associated Press) – The World Health Organization announced Monday that it and leading partners have agreed to a plan to roll out 120 million rapid-diagnostic tests for the coronavirus to help lower- and middle-income countries make up ground in a testing gap with richer countries — even if it’s not fully funded yet.

Worldwide Death Toll from Coronavirus Eclipses 1 Million

1 day 1 min

(Associated Press) – The worldwide death toll from the coronavirus has eclipsed 1 million, nine months into a crisis that has devastated the global economy, tested world leaders’ resolve, pitted science against politics and forced multitudes to change the way they live, learn and work.

A Ransomware Attack Has Struck a Major US Hospital Chain

1 day 22 hours

(Wired) – Universal Health Services, a hospital and health care network with more than 400 facilities across the United States, Puerto Rico, and United Kingdom, suffered a ransomware attack early Sunday morning that has taken down its digital networks at locations around the US. As the situation has spiraled, some patients have reportedly been rerouted to other emergency rooms and facilities and had appointments and test results delayed as a result of the attack. 

The UK Could Be the First Country to Intentionally Give People Coronavirus to Test Vaccines

1 day 22 hours

(Gizmodo) – The UK is considering a controversial approach to testing potential vaccines for the coronavirus that causes covid-19: intentionally exposing volunteers to the virus, in a strategy known as challenge trials. Last week, the Financial Times reported that the UK government will allow human challenge vaccine trials to begin by January 2021. In these trials, volunteers would be given an experimental vaccine and then later exposed to the coronavirus in a controlled setting.

New Document Reveals Scope and Structure of Operation Warp Speed and Underscores Vast Military Involvement

1 day 22 hours

(STAT News) – Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January — and the military is intimately involved, according to Paul Mango, HHS’ deputy chief of staff for policy. It has already helped prop up more than two dozen vaccine manufacturing facilities — flying in equipment and raw materials from all over the world. It has also set up significant cybersecurity and physical security operations to ensure an eventual vaccine is guarded very closely from “state actors who don’t want us to be successful in this,” he said, adding that many of the Warp Speed discussions take place in protected rooms used to discuss classified information.

Covid-19 Tests That Give Results in Minutes to Be Rolled Out Across World

1 day 22 hours

(The Guardian) – Tests for Covid-19 that show on-the-spot results in 15 to 30 minutes are about to be rolled out across the world, potentially saving many thousands of lives and slowing the pandemic in both poor and rich countries. In a triumph for a global initiative to get vital drugs and vaccines to fight the virus, 120m rapid antigen tests from two companies will be supplied to low- and middle-income countries for $5 (£3.90) each or even less.

Novavax Researcher Says No Chance of a ‘Shortcut’ in Vaccine Safety

1 day 22 hours

(NPR) – Novavax, a vaccine maker in Maryland, is becoming the 10th coronavirus vaccine candidate to enter the final phase of testing, called phase 3. The trial is taking place in the U.K., where researchers plan to enroll up to 10,000 adults of various ages in the next four to six weeks. Half the participants will get a placebo and half will get the company’s vaccine. At least a quarter of participants will be over the age of 65, the company says, and it will also “prioritize groups that are most affected by COVID-19, including racial and ethnic minorities.”

‘There Is a Fear That This Will Eradicate Dwarfism’: The Controversy Over a New Growth Drug

1 day 22 hours

(The Guardian) – The treatment is in its “early days”, but she believes that it is potentially life-changing. It is also a treatment that is the subject of division within the dwarfism community, with many believing that achondroplasia, along with other forms of dwarfism, is not something to be “fixed”. Earlier this month, the results of the phase-three study of vosoritide, the drug Samuel takes, were published in the medical journal the Lancet (the previous phase established that it was safe). Covering several countries, with 119 children taking part, it found that those taking the drug for a year grew faster than those on a placebo.

Vaccine Chaos Is Looming

1 day 22 hours

(The Atlantic) – On the day that a COVID-19 vaccine is approved, a vast logistics operation will need to awaken. Millions of doses must travel hundreds of miles from manufacturers to hospitals, doctor’s offices, and pharmacies, which in turn must store, track, and eventually get the vaccines to people all across the country. The Centers for Disease Control and Prevention, along with state and local health departments, coordinates this process. These agencies distributed flu vaccines during the 2009 H1N1 pandemic this way, and they manage childhood vaccines every day. But the COVID-19 vaccine will be a whole new challenge.  

Pfizer Urged to Wait for November to Seek Vaccine Authorization

1 day 22 hours

(Bloomberg) – Pfizer Inc. should wait until at least late November before seeking FDA authorization of its Covid-19 vaccine to meet rigorous safety standards, more than 60 leading researchers and bioethicists said. The letter, obtained by Bloomberg Law and verified by six signatories, was sent Friday following reports that Pfizer’s clinical trial will yield conclusive results in October. That would likely put the company ahead of Moderna Inc. and AstraZeneca PLC and other promising vaccine candidates. But the researchers said Pfizer’s clinical trial needs to monitor participants for at least two months after they received the second dose.

Among People of Color Asked to Join Covid-19 Vaccine Trials, Worries About Inequalities Run Deep

5 days 4 hours

(STAT News) – That the communities hardest hit by Covid-19 have also been woefully underrepresented in clinical trials is no coincidence, and in racing to find 30,000 participants who could represent an even broader population, pharma companies have found themselves face to face with health care’s deepest fault lines. Being Black, Latinx, Native American, or Pacific Islander, for instance, means you are more likely to go without health insurance than if you’re white, and that makes a difference. If you want people to sign up as test subjects for experimental vaccines, it helps if they feel comfortable going to a hospital — and are able to take sick leave.

Why the Pandemic Could Change the Way We Record Deaths

5 days 4 hours

(NPR) – According to World Health Organization data, each year, two-thirds of global deaths are not registered with local authorities. That’s a total of 38 million annual deaths that aren’t part of any permanent record. Not only are the numbers not part of any global death tally, but the cause of death is also not recorded — leaving policymakers without critical information about population trends and health. Now, that vast undercount of deaths might be changing — thanks to the virus. It’s pushed the science of death-counting into the international spotlight, highlighting the importance of strong and developed death registries.

COVID-Vaccine Results Are on the Way–And Scientists’ Concerns Are Growing

5 days 4 hours

(Nature) – Several ongoing coronavirus-vaccine trials could announce game-changing results next month. But as anticipation grows, concerns are growing about whether the vaccines will clear safety trials, what they will achieve if they do and the risk that the approval process will be influenced by politics, or at least seem to be.

France and Spain Scramble to Deal with Sharp Rise in Covid Infections

5 days 4 hours

(The Guardian) – The number of new Covid-19 cases in France has jumped to a record high, while in Spain, the western European country hardest hit by the virus, the Madrid authorities have rejected the central government’s call for a lockdown across the capital. Santé Publique France, the French public health authority, recorded 16,096 new infections in the previous 24 hours on Thursday evening.

Why Is It So Hard to Study Covid-Related Smell Loss?

5 days 4 hours

(Wired) – Traditionally, researchers would bring their subjects into the lab and measure their powers of smell using scientifically-validated tools like an olfactometer, a device that delivers precise amounts of scents to the subject’s nose, or a scratch and sniff booklet called the University of Pennsylvania Smell Identification Test (UPSIT) that requires subjects to smell a scent and correctly identify it from among four choices. But thanks to the pandemic, many labs are closed and patients cannot come in for screenings. Even if they could bring people in, the tests Hayes would normally use can’t easily be adapted for Covid-19 research.

China Aims to Make 1 Billion COVID-19 Vaccine Doses a Year

5 days 5 hours

(Associated Press) – A Chinese health official said Friday that the country’s annual production capacity for coronavirus vaccines will top 1 billion doses next year, following an aggressive government support program for construction of new factories. Capacity is expected to reach 610 million doses by the end of this year, Zheng Zhongwei from the National Health Commission said.

Bioethicists Condemn DIY COVID-19 Vaccine Efforts

5 days 22 hours

(ABC News) – Across the country, a small handful of scientists are brewing up their own homemade and unproven COVID-19 vaccines and giving them to friends, family and themselves. These scientists hail from disparate groups. Some are shadowy and anonymous, while others are highly organized and Ivy-league affiliated. “It’s actually simpler than most recipes in home cookbooks,” said Preston Estep, chief scientist and co-founder of a DIY effort backed by a Harvard geneticist. 

As Pandemic Deaths Add Up, Racial Disparities Persist–And in Some Cases Worsen

5 days 22 hours

(NPR) – Data gathered early in the pandemic showed that communities of color are disproportionately affected by COVID-19 across the United States. But incomplete data left a muddy picture of these disparities. Today, as the U.S. has surpassed 200,000 COVID-19 deaths, and reached nearly 7 million confirmed cases, racial data is more complete, and the trend is crystal clear: People of color get sick and die of COVID-19 at rates higher than whites and higher than their share of the population. 

Report: FDA to Release Tougher COVID Vaccine Rules

5 days 23 hours

(Medscape) – As soon as this week, the FDA is expected to issue tougher guidelines for an emergency use authorization of a coronavirus vaccine, according to The Washington Post. The new standards will likely make approval more difficult, and a vaccine won’t likely be cleared before Election Day, the newspaper reported.

Why Tens of Thousands of People Are Key to Testing a COVID-19 Vaccine

1 week 5 min

(NPR) – More than 100,000 people are taking part in studies to see if one or more COVID-19 vaccine candidates actually work. Janssen Pharmaceutical Cos. of Johnson & Johnson today starts wide-scale testing for its vaccine. It will involve as many as 60,000 volunteers worldwide. AstraZeneca, Pfizer and Moderna already have vaccine candidates in large studies in the United States. Novavax should start its study later this fall. The reason the trials are so large has to do with the complications of getting an accurate analysis of whether the vaccine works — and how the scientists and public health officials define “works.”

Battle Rages Inside Hospitals Over How COVID Strikes and Kills

1 week 8 min

(Kaiser Health News) – Front-line health care workers are locked in a heated dispute with many infection control specialists and hospital administrators over how the novel coronavirus is spread ? and therefore, what level of protective gear is appropriate. At issue is the degree to which the virus is airborne ? capable of spreading through tiny aerosol particles lingering in the air ? or primarily transmitted through large, faster-falling droplets from, say, a sneeze or cough. This wonky, seemingly semantic debate has a real-world impact on what sort of protective measures health care companies need to take to protect their patients and workers.

Colleges’ Opening Fueled 3,000 COVID Cases a Day, Researchers Say

1 week 10 min

(Kaiser Health News) – Reopening colleges drove a coronavirus surge of about 3,000 new cases a day in the United States, according to a draft study released Tuesday. The study, done jointly by researchers at the University of North Carolina-Greensboro, Indiana University, the University of Washington and Davidson College, tracked cellphone data and matched it to reopening schedules at 1,400 schools, along with county infection rates.

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