News from Bioethics.com

Vaccine Chaos Is Looming

3 weeks 5 days

(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

3 weeks 5 days

(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

4 weeks 1 day

(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

4 weeks 1 day

(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

4 weeks 1 day

(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

4 weeks 1 day

(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?

4 weeks 1 day

(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

4 weeks 1 day

(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

1 month 12 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

1 month 12 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

1 month 13 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 month 1 day

(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 month 1 day

(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 month 1 day

(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.

‘I Just Want the Suffering to Be Over.’ Brazilians Flock to COVID-19 Vaccine Trials

1 month 1 day

(Science) – More than 6 months after the first COVID-19 case was confirmed in Brazil, the pandemic is still raging, now with about 30,000 new cases and 740 deaths daily. (The total death toll, 136,000, is second only to the United States’s.) Those grim statistics—along with a good medical infrastructure, vaccination expertise, a well-established regulatory system, and experience running clinical trials—have made Brazil an ideal place to put experimental COVID-19 vaccines to the test. At least four vaccine candidates, produced by Western and Chinese firms, are in trials here or soon will be. Negotiations are ongoing to test Russia’s Sputnik V vaccine as well.

64 High-Income Nations Join Effort to Expand Global Access to Covid-19 Vaccines, But U.S. and China Do Not

1 month 1 day

(STAT News) – ountries representing about 64% of the world population have signed up to expand global access to Covid-19 vaccines by funding a purchasing pool organized by the World Health Organization and other nonprofit groups, leaders of the effort announced Monday. Not among the countries: the United States, which had previously said it is not taking part in the so-called COVAX Facility, or Russia nor China, both of which have already issued emergency use licenses for Covid-19 vaccines.

Most N95 Masks Imported from China Fail to Meet US Standards

1 month 1 day

(Medscape) – ECRI quality assurance researchers rigorously tested nearly 200 N95-style masks, reflecting 15 different manufacturer models purchased by some of the largest health systems in the United States. They found that for 60% to 70% of the imported masks that had not been certified by the US National Institute for Occupational Safety and Health (NIOSH), filtration performance was “significantly inferior” to NIOSH-certified N95s. These masks did not filter 95% of aerosol particulates, contrary to what their name suggests.

AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints

1 month 2 days

(New York Times) – AstraZeneca revealed details of its large coronavirus vaccine trials on Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.Polls are finding Americans increasingly wary of accepting a coronavirus vaccine. And scientists inside and outside the government are worried that regulators, pressured by the president for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine.

The Core Lesson of the COVID-19 Heart Debate

1 month 2 days

(The Atlantic) – Autopsies have found traces of the coronavirus’s genetic material in the heart, and actual viral particles within the heart’s muscle cells. Experiments have found that SARS-CoV-2 can destroy lab-grown versions of those cells. Several studies have now shown that roughly 10 to 30 percent of hospitalized COVID-19 patients had high levels of troponin—a protein released into the blood when the heart’s muscle cells are damaged. Such patients are more likely to die than others with no signs of heart injury. This is worrying for people with severe symptoms, but more recently, a few studies suggested that COVID-19 can cause heart inflammation, or myocarditis, even in people who showed mild symptoms, or had recovered. These results were controversial but concerning.

WHO Unveils Global Plan to Fairly Distribute COVID-19 Vaccine, But Challenges Await

1 month 2 days

(Science) – The World Health Organization (WHO) announced today that countries representing close to two-thirds of the world’s population have joined its plan to buy and fairly distribute COVID-19 vaccines around the globe. It also unveiled the mechanism through which it plans to allocate the vaccine as it becomes available, aiming “to end the acute phase of the pandemic by the end of 2021.”

Rural Hospitals Teeter on Financial Cliff as COVID Medicare Loans Come Due

1 month 2 days

(Kaiser Health News) – More than 65% of the nation’s small, rural hospitals — many of which were operating at a deficit before the pandemic — jumped at the Medicare loans when the pandemic hit because they were the first funds available, said Maggie Elehwany, former vice president of government affairs for the National Rural Health Association. CMS halted new loan applications to the program at the end of April.

When AI in Healthcare Goes Wrong, Who Is Responsible?

1 month 2 days

(Quartz) – Artificial intelligence can be used to diagnose cancer, predict suicide, and assist in surgery. In all these cases, studies suggest AI outperforms human doctors in set tasks. But when something does go wrong, who is responsible? There’s no easy answer, says Patrick Lin, director of Ethics and Emerging Sciences Group at California Polytechnic State University. At any point in the process of implementing AI in healthcare, from design to data and delivery, errors are possible.

Russia Is Slow to Administer Virus Vaccine Despite Kremlin’s Approval

1 month 3 days

(The New York Times) – More than a month after becoming the first country to approve a coronavirus vaccine, Russia has yet to administer it to a large population outside a clinical trial, health officials and outside experts say. The approval, which came with much fanfare, occurred before Russia had tested the vaccine in late-stage trials for possible side effects and for its disease-fighting ability. It was seen as a political gesture by President Vladimir V. Putin to assert victory in the global race for a vaccine.

Migrant Detention Centers Have a Long History of Medical Neglect and Abuse

1 month 3 days

(The Washington Post) – The recent allegation that a doctor has performed hysterectomies on immigrant women at the Irwin County Detention Center in Georgia has sparked calls for investigation. The disturbing allegation is only the latest case of systemic medical neglect and mistreatment in immigration detention settings. The spread of the novel coronavirus has been particularly devastating for people in migrant detention centers. The difficulty of social distancing within these centers has led to outbreaks at facilities throughout the country — including most recently at an ICE detention center in Adelanto, Calif., where six people have been hospitalized.

Europe Coronavirus Cases Surge as Countries Prepare Drastic Measures Against Second Wave

1 month 6 days

(Newsweek) – Coronavirus cases in Europe have climbed past five million, with over 300,000 new infections reported last week alone across the region. Between September 7 and September 13, Europe reported 323,536 new COVID-19 cases, according to the latest report Thursday from the WHO.

Pages