News from Bioethics.com

Years of Research Laid Groundwork for Speedy COVID-19 Shots

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(Associated Press) – How could scientists race out COVID-19 vaccines so fast without cutting corners? A head start helped — over a decade of behind-the-scenes research that had new vaccine technology poised for a challenge just as the coronavirus erupted. “The speed is a reflection of years of work that went before,” Dr. Anthony Fauci, the top U.S. infectious disease expert, told The Associated Press. “That’s what the public has to understand.” Creating vaccines and having results from rigorous studies less than a year after the world discovered a never-before-seen disease is incredible, cutting years off normal development. But the two U.S. frontrunners are made in a way that promises speedier development may become the norm — especially if they prove to work long-term as well as early testing suggests.

The Elderly vs. Essential Workers: Who Should Get the Coronavirus Vaccine First?

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(New York Times) – With the coronavirus pandemic surging and initial vaccine supplies limited, the United States faces a hard choice: Should the country’s immunization program focus in the early months on the elderly and people with serious medical conditions, who are dying of the virus at the highest rates, or on essential workers, an expansive category encompassing Americans who have borne the greatest risk of infection?

WHO Looks at Giving Covid-19 to Health People to Speed Up Vaccine Trials

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(The Guardian) – The World Health Organization is holding discussions on Monday about the feasibility of trials in which healthy young volunteers are deliberately infected with coronavirus to hasten vaccine development – amid questions over whether they should go ahead given the promising data from the frontrunner vaccine candidates. Some scientists have reservations about exposing volunteers to a virus for which there is no cure, although there are treatments that can help patients. However, proponents argue that the risks of Covid-19 to the young and healthy are minimal, and the benefits to society are high.

PPE Shortage Crisis Continues at Most Hospitals, Survey Shows

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(Medscape) – A majority of hospitals and healthcare facilities surveyed report operating according to “crisis standards of care” as they struggle to provide sufficient personal protective equipment (PPE). For example, in a national survey, 73% of 1083 infection prevention experts said respirator shortages related to care for patients with COVID-19 drove their facility to move beyond conventional standards of care. Furthermore, 69% of facilities are using crisis standards of care (CSC) to provide masks, and 76% are apportioning face shields or eye protection.

Millions of Hungry Americans Turn to Food Banks for 1st Time

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(Associated Press) – Now, in the pandemic of 2020, with illness, job loss and business closures, millions more Americans are worried about empty refrigerators and barren cupboards. Food banks are doling out meals at a rapid pace and an Associated Press data analysis found a sharp rise in the amount of food distributed compared with last year. Meanwhile, some folks are skipping meals so their children can eat and others are depending on cheap food that lacks nutrition.

COVID-19 Fuels Surge in Overdose-Related Cardiac Arrests

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(Medscape) – There has been a sharp increase in overdose-related cardiac arrests in the US during the COVID-19 pandemic, a new analysis shows. Overall rates in 2020 were elevated above the baseline from 2018 and 2019 by about 50%, the data show. “Our results suggest that overdoses may be strongly on the rise in 2020, and efforts to combat the COVID-19 pandemic have not been effective at reducing overdoses,” Joseph Friedman, MPH, MD/PhD student, Medical Scientist Training Program, University of California, Los Angeles, told Medscape Medical News.

Facebook Bans False Claims About COVID-19 Vaccines

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(Medscape) – Facebook Inc on Thursday said it would remove false claims about COVID-19 vaccines that have been debunked by public health experts, following a similar announcement by Alphabet Inc’s YouTube in October. The move expands Facebook’s current rules against falsehoods and conspiracy theories about the pandemic. The social media company says it takes down coronavirus misinformation that poses a risk of “imminent” harm, while labeling and reducing distribution of other false claims that fail to reach that threshold.

Abortion Clinics Are Rapidly Closing. Many Won’t Come Back

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(TIME) – Most independent abortion clinics across the country are in a similar boat. Keeping clinic doors open during COVID-19 has required spending much more money—on on cleaning and personal protective equipment, and on hiring more staff to facilitate social distancing rules that also reduced the number of patients who could be seen. At at the same time, 11 states temporarily suspended abortion services this spring, amid the growing pandemic. While all of those orders were blocked by courts or expired, the temporary closures and legal battles were financially devastating for independent abortion clinics. Meanwhile, as layoffs have spiked and businesses have gone under, patients have been less able to pay for their care, putting clinics even more in the red.

How Nanotechnology Helps mRNA Covid-19 Vaccines Work

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(STAT News) – While the first two Covid-19 vaccines relying on messenger RNA technology speed toward regulatory approval in the U.S., it’s worth remembering the vehicle that gets them where they need to go in the body. Lipid nanoparticles are the fatty molecular envelopes that help strands of mRNA — the genetic messenger for making DNA code into proteins — evade the body’s biological gatekeepers and reach their target cell without being degraded. They are enabling some of the most advanced technologies being used in vaccines and drugs. 

AMA Statement on COVID-19 Vaccine Allocation Recommendations

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(AMA) – The American Medical Association (AMA) commends the Advisory Committee on Immunization Practices (ACIP) for their efforts to ensure equitable allocation of COVID-19 vaccines as soon as they become available. We strongly support ACIP’s evidence-based interim recommendation adopted today for phase 1a of the COVID-19 vaccine allocation process, which align with AMA’s public health policy and Code of Medical Ethics. By first vaccinating our frontline health care personnel and residents of long-term care facilities against COVID-19, we will help ensure patients continue to receive vital care during the pandemic and safeguard those who are most at risk for severe illness and death associated with COVID-19.

As Hospitals Cope with a COVID-19 Surge, Cyber Threats Loom

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(ABC News) – The Vermont hospital had fallen prey to a cyberattack, becoming one of the most recent and visible examples of a wave of digital assaults taking U.S. health care providers hostage as COVID-19 cases surge nationwide. The same day as UVM’s attack, the FBI and two federal agencies warned cybercriminals were ramping up efforts to steal data and disrupt services across the health care sector. By targeting providers with attacks that scramble and lock up data until victims pay a ransom, hackers can demand thousands or millions of dollars and wreak havoc until they’re paid.

China’s ‘Vaccine Diplomacy’ Begins as Shots to Be Rolled Out in Turkey, Latin America

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(Newsweek) – A Chinese coronavirus vaccine is set to be rolled out in Turkey later this month, with some Latin American country also in line to receive COVID-19 shots developed in the East Asian nation over the coming months. On Wednesday, Turkish health minister Fahrettin Koca said his country had ordered 50 million doses of the CoronaVac vaccine produced by China’s Sinovac Biotech pharmaceutical company, with the first shipment set to arrive on December 11, according to a statement. Turkish labs will assess the safety of the vaccine and initial results from Phase III clinical trials, with an emergency use authorization possible soon, he said.

Study: Black Americans in NYC Up to 40% Less Likely to Suffer Severe COVID-19

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(UPI) – Black people in New York City are up to 40% less likely to experience serious illness from COVID-19 and have a 30% lower risk for death than White people, according to an analysis published Friday by JAMA Network Open. This is despite the fact that they are 30% more likely to test positive for the virus, the data showed. In addition, while hospitalization rates were similar for Black, Hispanic and White people in the city, Asian Americans and those of mixed racial background had up to a 60% higher risk for needing hospital care, the researchers said.

EU Police Agency Europol Warns of Fake Coronavirus Vaccine

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(ABC News) – European Union police agency Europol issued a warning Friday highlighting the risk of organized crime scams linked to COVID-19 vaccines, including the possibility criminals will try to sell dangerous counterfeit vaccines or to hijack shipments of genuine shots. In an “early warning notification,” Europol said that crime gangs already have reacted to opportunities presented by the coronavirus pandemic.

World Athletics Accused Over ‘Abusive Sex Testing’ of Athletes from Global South

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(The Guardian) – World Athletics, the sport’s global governing body, targets women from countries in the global south for “abusive sex testing” based on arbitrary definitions of femininity and racial stereotypes, according to Human Rights Watch (HRW). A report by the rights group, published on Friday, claims female runners are being pushed out of competitive events, which some rely on for their livelihoods. Athletes struggle with emotional trauma and feel discriminated against and humiliated by the testing, said HRW.

As Hospitals Fill Up, Some COVID-19 Patients Are Sent Home

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(Medscape) – Overall weekly hospitalizations are at their highest point in the pandemic for much of the nation. And healthcare facilities are becoming overwhelmed — to the point where some patients who may benefit from inpatient care are being sent home from the emergency department (ED), researchers and clinicians say. “There is something funny happening with COVID hospitalizations,” Ashish K. Jha, MD, MPH, a professor of Health Services, Policy, and Practice and dean of the School of Public Health at Brown University, Providence, Rhode Island, tweeted earlier this week. “Proportion of COVID [patients] getting hospitalized [is] falling. A lot.”

Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain Obstacles

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(The Wall Street Journal) – Pfizer Inc. expects to ship half of the Covid-19 vaccines it originally planned for this year because of supply-chain problems, but still expects to roll out more than a billion doses in 2021. “Scaling up the raw material supply chain took longer than expected,” a company spokeswoman said. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”

‘Malicious and Misconceived.’ Indian Vaccine Producer Hits Back at Complaint from Trial Volunteer

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(Science) – An Indian man is suing one of the world’s largest vaccine manufacturers after falling seriously ill during a trial of a COVID-19 vaccine developed by the University of Oxford and AstraZeneca. The patient developed a neurological condition after being vaccinated last month and is seeking 50 million rupees ($680,000) in damages from the Serum Institute of India (SII), which produces the vaccine in India. But SII has hit back hard: In a 29 November statement, it called the allegations “malicious and misconceived” and said it may seek damages of up to 1 billion rupees in a countersuit that claims reputational damage. The volunteer was “specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent,” the company said.

‘There Absolutely Will Be a Black Market’: How the Rich and Privileged Can Skip the Line for Covid-19 Vaccines

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(STAT News) – Athletes, politicians, and other wealthy or well-connected people have managed to get special treatment throughout the pandemic, including preferential access to testing and unapproved therapies. Early access to coronavirus vaccines is likely to be no different, medical experts and ethicists told STAT. It could happen in any number of ways, they said: fudging the definition of “essential workers” or “high-risk” conditions, lobbying by influential industries, physicians caving to pressure to keep their patients happy, and even through outright bribery or theft.

CDC Advisory Panel’s Lone Dissenter on Why Long-Term Care Residents Shouldn’t Receive Covid-19 Vaccine First

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(STAT News) – When a Centers for Disease Control and Prevention advisory committee voted Tuesday to recommend residents of long-term care facilities should be at the front of the line — with health care providers — for Covid-19 vaccines, the lone dissenting voice came from a researcher who studies vaccines in older adults. Helen Keipp Talbot — who is known by her middle name — raised serious concerns during the meeting of the Advisory Committee on Immunization Practices about using the vaccines in the frail elderly, noting there are no data yet to suggest the vaccines work in this population. All the U.S.-based Phase 3 trials of Covid vaccines have to include people 65 and older. But none has specifically tested the vaccines in people who are in long-term care. One can’t assume findings in people over age 65 who are healthy enough to be accepted for a clinical trial are indicative of everyone in that demographic, she said.

Pfizer Says Placebo Patients Will Eventually Get Its Covid-19 Vaccine. The Question of When Is Complicated

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(STAT News) – Should patients who volunteer to be in Covid-19 vaccine studies, but who are assigned to get placebo, be offered the vaccine? As companies and regulators raced to start clinical trials in the summer, that question was left open. But for Pfizer and partner BioNTech, the answer now is not if but when. In a memo to researchers conducting the clinical trial, a copy of which was obtained by STAT, Pfizer said that it is working to find a way to eventually give the vaccine to volunteers who were assigned to receive placebo. But that would not occur until the Food and Drug Administration has granted an emergency use authorization or another kind of regulatory approval.

‘Nobody Sees Us’: Testing-Lab Workers Strain Under Demand

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(New York Times) – Nearly a year into a pandemic that has claimed more than 272,000 American lives, some 192 million tests for the coronavirus have been processed nationwide. Millions more will be needed to detect and contain the virus in the months ahead. Behind these staggering figures are thousands of scientists who have been working nonstop to identify the coronavirus in the people it infects. Across the nation, testing teams are grappling with burnout, repetitive-stress injuries and an overwhelming sense of doom. As supply chains sputter and laboratories rush to keep pace with diagnostic demand, experts warn that the most severe shortage stymieing America’s capacity to test is not one that can be solved by a wider production line or a more efficient machine. It is a dearth of human power: the dwindling ranks in a field that much of the public does not know even exists.

Rationale for Baricitinib’s Use in COVID-19 Patients Demonstrated

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(Medscape) – It should not be surprising that the RA drug baricitinib (Olumiant), a Janus kinase (JAK) 1/2 inhibitor, might be beneficial in controlling the cytokine storm of hyperinflammation that can follow severe SARS-CoV-2 infections and lead to lung damage and acute respiratory distress syndrome – the leading cause of death from the virus. But to demonstrate within a matter of months, at least preliminarily, that baricitinib reduces mortality and morbidity in hospitalized patients with COVID-19 pneumonia required a widely cross-disciplinary international team of researchers from 10 countries working at breakneck speed, said Justin Stebbing, PhD, the principal investigator of a new baricitinib study published Nov. 13 in Science Advances.

The Duelling Realities of the Coronavirus in Russia

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(The New Yorker) – Internal documents obtained by Mediazona, an independent news outlet, show that, by November 22nd, nearly seventy-five thousand people had died in COVID wards. Estimates of excess deaths point to even greater numbers. Mediazona journalists have compiled a database of both national and regional death figures and concluded that Russia has lost a hundred and twenty thousand more people this year than it lost, on average, during the same period in the previous five years. If this trend keeps up, it could land Russia among the top five countries with the fastest-growing mortality rates. Even according to official data, the number of people getting sick and dying is on an unrelenting upward curve, setting daily records for at least a week.

Moderna Plans to Begin Testing Its Coronavirus Vaccine in Children

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(New York Times) – The drugmaker Moderna said on Wednesday that it would soon begin testing its coronavirus vaccine in children ages 12 through 17. The study, listed Wednesday on the website clinicaltrials.gov, is to include 3,000 children, with half receiving two shots of vaccine four weeks apart, and half getting placebo shots of salt water.

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