News from Bioethics.com

AstraZeneca Denies Vaccine Trial Subject Had Nerve Ailment

1 month 6 days

(Bloomberg) – AstraZeneca Plc, the drugmaker working with the University of Oxford on a Covid-19 vaccine, contradicted a report that a volunteer in U.K. tests of the shot developed a rare nerve disease that might have signaled severe safety problems. AstraZeneca was responding Thursday to a CNN report citing documents indicating that the diagnosis of the participant was confirmed as transverse myelitis. The diagnosis was “based on preliminary findings,” and is inaccurate, the Cambridge, England-based drugmaker said in an emailed statement.

Iran Appears to Be in Grip of ‘Third Wave’ of Coronavirus Outbreak

1 month 6 days

(The Guardian) – Iran appears to be in the grip of a “third wave” of the coronavirus outbreak, with the number of new infections above 3,000 a day – as high as at any point since the virus first hit in February. Iran was one of the first countries to be struck by the virus outside China. Its officials brought the disease under a form of control by early May, but then experienced an increase at the start of June that drifted down to fewer than 1,600 new cases a day in late August.

Drug Shows Promise in 1st Largely Minority COVID-19 Study

1 month 6 days

(ABC News) – A drug company said Friday that a medicine it sells to tamp down inflammation has helped prevent the need for breathing machines in hospitalized COVID-19 patients in the first large study that primarily enrolled Hispanics and Blacks. Switzerland-based Roche reported the results for tocilizumab, sold now as Actemra and RoActemra for treating rheumatoid arthritis and some other diseases.

AP Exclusive: More Migrant Women Say They Didn’t OK Surgery

1 month 6 days

(Associated Press) – An Associated Press review of medical records for four women and interviews with lawyers revealed growing allegations that Amin performed surgeries and other procedures on detained immigrants that they never sought or didn’t fully understand. Although some procedures could be justified based on problems documented in the records, the women’s lack of consent or knowledge raises severe legal and ethical issues, lawyers and medical experts said.

Nursing Homes Given Federal Go-Ahead to Allow More Visitors

1 month 6 days

(NPR) – The Centers for Medicare and Medicaid Services, which regulate nursing facilities, are lifting the ban on visitors, effective immediately. CMS imposed the restriction in March in an effort to control outbreaks of the coronavirus. Advocates for nursing home residents and family organizations have been clamoring for a repeal, noting the many residents who have suffered anxiety or depression, as well as physical or mental decline since the ban was imposed. The issue was also raised in the report of the Coronavirus Commission for Safety and Quality in Nursing Homes, which became public on Wednesday. 

Coronavirus May Increase Premature Births, Study Suggests

1 month 1 week

(New York Times) – Pregnant women who are infected with the coronavirus and hospitalized are at risk for developing serious complications, and may face an elevated risk for delivering their babies prematurely, according to new studies from the Centers for Disease Control and Prevention. They may also be at greater risk of losing the pregnancy or having a stillbirth.

Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial

1 month 1 week

(The New York Times) – The biotech company Moderna released a 135-page document on Thursday that spells out the details of how it is conducting the late-stage trial of its coronavirus vaccine, and how safety and efficacy will be determined. The document suggests that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Subsequent analyses, scheduled for March and May, are more likely to provide an answer.

An ‘Uncoordinated’ Immune Response May Explain Why COVID-19 Strikes Some Hard, Particularly the Elderly

1 month 1 week

(Science) – Even a world-class orchestra will produce a cacophony if its strings, woodwinds, brass, and percussion sections don’t play in harmony. Similarly, the sophisticated human immune system can fail to beat back a pathogen if its many players don’t hit the right notes at the right times. A new study now finds that people who suffer the most from COVID-19 have an immune response that’s out of sync.

Clinician Deaths from COVID-19: ‘A Crisis on a Staggering Scale’

1 month 1 week

(Medscape) – More than 7000 healthcare workers worldwide have died of COVID-19, according to a new analysis released this month by Amnesty International. The group called it “a crisis on a staggering scale.” Mexico has had the most healthcare workers affected (1320 deaths), followed by the United States (1077), the United Kingdom (649), and Brazil (634).

U.S. Plans to Ship First Covid-19 Vaccine 24 Hours After Authorization

1 month 1 week

(The Wall Street Journal) – The U.S. government plans to begin shipping the first Covid-19 vaccine within 24 hours after regulators authorize its use, federal health officials said. Shipments of the first vaccine cleared for use would start soon after the U.S. Food and Drug Administration issued the OK, according to plans that federal health officials released Wednesday. Vaccine makers have already begun manufacturing doses so they will be ready for shipment should the shots prove to work safely in testing and regulators authorize their use.

 

Safety Driver Charged in 2018 Incident Where Self-Driving Uber Car Killed a Woman

1 month 1 week

(The Guardian) – Prosecutors in Arizona charged the safety driver behind the wheel of a self-driving Uber test car that struck and killed a woman in 2018 with negligent homicide. Court records show that Rafaela Vasquez, 46, on Tuesday pleaded not guilty in the death of Elaine Herzberg. Vasquez is the only person facing criminal consequences in the first death of a pedestrian involving a self-driving vehicle, after prosecutors last year said Uber was not criminally liable in the crash.

To Find a Vaccine for COVID-19, Will We Have to Deliberately Infect People?

1 month 1 week

(National Geographic) – Josh Morrison isn’t a doctor or scientist, but as a well-intentioned activist he’s provoked a fierce debate over how to develop a coronavirus vaccine. To speed up testing, he wants to be deliberately infected with the coronavirus. And he’s drawn considerable attention to his cause by starting a nonprofit that already has recruited more than 37,000 volunteers to get infected too—all in the name of science.

Lilly’s Covid-19 Antibody Helps Some Patients Rid Their Systems of Virus Sooner in Early Analysis

1 month 1 week

(STAT News) – A drug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data. The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus. 

World Health Organization Announces Distribution Plan for COVID-19 Vaccine

1 month 1 week

(ABC News) – As the possibility of a widely available COVID-19 vaccine steadily approaches, initial limitations in supply have left experts worldwide asking: Who gets the vaccine first? The World Health Organization and its appointed Strategic Advisory Group of Experts on Immunization, or SAGE, have released a worldwide vaccine distribution plan — it pushes back on so-called vaccine nationalism, the idea that each country should prioritize its own citizens.

Pfizer COVID-19 Vaccine Trial Reaches Initial Goal of 30,000 Volunteers

1 month 1 week

(WFAA) – Pfizer announced on Wednesday that it has reached its initial goal of 30,000 participants for the phase 3 trial of its coronavirus vaccine.  Over the weekend, the drugmaker submitted an “amended protocol” to the U.S. Food and Drug Administration to expand the enrollment for its trial to about 44,000 participants. The company said in a statement that this would help increase the diversity of the trials.

AstraZeneca COVID-19 Vaccine Trial in US on Hold Until at Least Midweek: Sources

1 month 1 week

(Medscape) – AstraZeneca’s COVID-19 vaccine trial remains on hold in the United States pending a U.S. investigation into a serious side effect in Britain even as other trials of the vaccine resume, sources familiar with the details told Reuters. AstraZeneca on Saturday said it had restarted its trial in Britain after regulators completed their review of a serious side effect in one trial participant there.

How COVID-19 Can Damage the Brain

1 month 1 week

(Nature) – In the early months of the COVID-19 pandemic, doctors struggled to keep patients breathing, and focused mainly on treating damage to the lungs and circulatory system. But even then, evidence for neurological effects was accumulating. Some people hospitalized with COVID-19 were experiencing delirium: they were confused, disorientated and agitated. In April, a group in Japan published the first report of someone with COVID-19 who had swelling and inflammation in brain tissues. Another report described a patient with deterioration of myelin, a fatty coating that protects neurons and is irreversibly damaged in neurodegenerative diseases such as multiple sclerosis.

Ethical or Exploitive–Should Prisoners Participate in COVID-19 Vaccine Trials?

1 month 1 week

(Science) – As 38 clinical trials seek tens of thousands of volunteers to receive doses of experimental vaccines, researchers are discussing how to find and recruit participants effectively and ethically. Some people who are especially vulnerable to COVID-19 have not been well represented in studies—or represented at all. Prisoners, for instance, have borne a heavy burden of COVID-19, with more than 125,000 U.S. prisoners infected, and more than 1000 dead. But prisoners have also been excluded from the trials out of concern that they might be coerced into participating or exploited if they do.

How Did I Catch the Coronavirus?

1 month 1 week

(The New Yorker) – For the majority of the nearly five million COVID-19 cases across the United States, the point of infection is unknown. “We don’t know how their exposure occurred or what kind of environment they were in when it happened,” Crystal Watson, an expert on contact tracing at the Johns Hopkins Center for Health Security, told me. When an outbreak is under control, this would not be the case. Test-and-trace teams would track the percentage of cases that can be linked to another person—or, more specifically, the percentage of cases that were already on the health agency’s radar, as potentially exposed contacts.

Scientists Relieved as Coronavirus Vaccine Trial Restarts–But Question Lack of Transparency

1 month 1 week

(Nature) – The UK trial of a leading coronavirus vaccine, which was abruptly halted last week because of safety concerns, restarted on Saturday, after the university conducting the trial said an independent committee found that it was safe to do so.  The University of Oxford and pharmaceutical company AstraZeneca paused enrolment in global trials of the vaccine candidate they are developing on 6 September, after a person participating in the UK trial experienced an adverse reaction.

Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

1 month 1 week

(New York Times) – It’s standard for drug companies to withhold details of clinical trials until after they are completed, tenaciously guarding their intellectual property and competitive edge. But these are extraordinary times, and now there is a growing outcry among independent scientists and public health experts who are pushing the companies to be far more open with the public in the midst of a pandemic that has already killed more than 193,000 people in the United States.

Kids at Day Care Spread COVID-19 to Parents and Teachers, CDC Says

1 month 1 week

(NBC News) – Very young children can catch COVID-19 and spread the virus to adults, even if they never show symptoms, according to a study published Friday by the Centers for Disease Control and Prevention. The findings have implications as day care centers and schools reopen across the country — and as a growing number of children are being diagnosed with the coronavirus.

China Has Quietly Vaccinated More than 100,000 People for Covid-19 Before Completing Safety Trials

1 month 1 week

(Vox) – Individuals received one of two Sinopharm vaccines in development in an emergency use program launched by the Chinese government in late July, which also authorized a third vaccine, CoronaVac, developed by the privately owned drugmaker Sinovac Biotech. Under Chinese vaccine law, such authorization is allowed within a certain scope and time frame during a health emergency. China’s top vaccine official mentioned front-line medical workers and customs officials when he first announced the program, implying these high-risk groups had been prioritized to receive the still-experimental vaccines.

One Sperm Donor. 36 Children. A Mess of Lawsuits.

1 month 1 week

(The Atlantic) – To the mothers, he was just Donor 9623. They did not know his name, but from his glowing sperm-donor profile, they knew he had an IQ of 160, spoke four languages, was pursuing a doctorate in neuroscience engineering, and looked like Tom Cruise. But Donor 9623 wasn’t who he said he was. He wasn’t in graduate school. He had never even finished college. The lies began to unravel in 2014, when the sperm bank accidentally revealed his name—Chris Aggeles—and his email address in a message to a group of mothers. By then, the sperm he’d produced over 14 years had been sent to multiple states and three countries, resulting in at least 36 children.

Dozens of Hospitals Poised to Defy FDA on Plasma Therapy for COVID-19 Patients

1 month 1 week

(Los Angeles Times) – Dozens of major hospitals across the U.S. are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID-19 patients to treat the disease in favor of dedicating their resources to a gold-standard clinical trial that could help settle the science for good. As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice.

Pages