News from Bioethics.com

Pharmacies Close Doors Over Shortages in Crisis-Hit Lebanon

1 day 22 hours

(Associated Press) – Pharmacies across Lebanon shuttered their doors on Friday to protest severe shortages of medicines as motorists lined up for hours outside gas stations since the crack of dawn. The two-day strike called by pharmacists over lack of supplies, including infant milk, as well as gasoline shortages were the latest signs of Lebanon’s economic and financial meltdown, which appears to be spinning out of control while the country’s leaders seem unable, or unwilling, to rein in the crises. (Read Full Article)

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China’s Children May Be Next in Line for COVID-19 Vaccines

1 day 22 hours

(Associated Press) – If China is to meet its tentative goal of vaccinating 80% of its population against the coronavirus by the end of the year, tens of millions of children may have to start rolling up their sleeves. Regulators took the first step last week by approving the use of the country’s Sinovac vaccine for children aged 3 to 17, and on Friday announced the same for the Sinopharm vaccine. No date has been set for the shots to start. (Read Full Article)

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CDC Plans “Emergency Meeting” on Rare Heart Inflammation Following COVID-19 Vaccines

1 day 23 hours

(CBS News) – The Centers for Disease Control and Prevention announced Thursday that it will convene an “emergency meeting” of its advisers on June 18th to discuss rare but higher-than-expected reports of heart inflammation following doses of the mRNA-based Pfizer and Moderna COVID-19 vaccines. So far, the CDC has identified 226 reports that might meet the agency’s “working case definition” of myocarditis and pericarditis following the shots, the agency disclosed Thursday. The vast majority have recovered, but 41 had ongoing symptoms, 15 are still hospitalized, and 3 are in the intensive care unit. The reports represent just a tiny fraction of the nearly 130 million Americans who have been fully vaccinated with either Pfizer or Moderna’s doses. (Read Full Article)

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CVST Risk Still Higher with COVID-19 Than With AZ, J&J Vaccine

1 day 23 hours

(Medscape) – Another study has suggested that rates of cerebral venous sinus thrombosis (CVST) are much higher among patients with COVID-19 than among persons after they have been vaccinated with either the AstraZeneca or the Johnson & Johnson vaccine. For the study, a group led by Behnood Bikdeli, MD, Brigham and Women’s Hospital, Boston, Massachusetts, estimated on the basis of publicly reported data the rate of CVST associated with the two vaccines in comparison with the rate among patients hospitalized with COVID-19 and in comparison with the estimated incidence rates among the US population before the pandemic. (Read Full Article)

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Delta Variant and COVID-19 Vaccines: What to Know

1 day 23 hours

(Medscape) – As the highly transmissible Delta coronavirus variant continues to devastate India and spread to other nations, health experts are reiterating the importance of getting the COVID-19 vaccine – both doses of the shot, that is. A preprint study conducted in the United Kingdom that was cited by the Biden administration finds that one dose of the Pfizer vaccine provided about 33% protection against the Delta variant, which is officially designated B.1.617.2. (Read Full Article)

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Lab Risks Face Scrutiny Amid COVID Origins Controversy

1 day 23 hours

(Axios) – The controversy over the origin of the COVID-19 virus is renewing focus on how the risks and benefits of pathogen-altering experiments are weighed and managed. Why it matters: Better governance of biorisks would limit the threat of a human-made pandemic — and could help identify the origin of future outbreaks more quickly and with a lot less controversy. (Read Full Article)

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Biogen Says FDA Didn’t Push for Trial Before Alzheimer’s Approval

1 day 23 hours

(Axios) – Two Biogen executives said in an interview the company’s newly approved Alzheimer’s drug is priced fairly, and that it didn’t conduct another clinical trial before approval because the FDA didn’t push them to do so. Why it matters: The scientific consensus is the drug, Aduhelm, has not been proven to work. But Biogen and the FDA are content with “hopefully” validating the $56,000 drug’s efficacy at some unknown point in the future. (Read Full Article)

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The Ruthless Hackers Behind Ransomware Attacks on U.S. Hospitals: ‘They Do Not Care’

1 day 23 hours

(Wall Street Journal) – A ransomware attack on a national hospital chain nearly brought Las Vegas hospitals to their knees. Another attack in Oregon abruptly shut down alerts tied to patient monitors tracking vital signs. In New York, one county’s only trauma center briefly closed to ambulances, with the nearest alternative 90 miles away. Multiple attacks were carried out in recent months against U.S. hospitals, suspending some surgeries, delaying medical care and costing hospitals millions of dollars. The Wall Street Journal tracked the most disruptive attacks to one group: a notorious gang of Eastern European cybercriminals once called the “Business Club,” with ties to Russian government security services, according to threat analysts and former law-enforcement officials who closely follow Eastern European cybercrime operations. (Read Full Article)

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Covid-19 Deaths This Year Have Already Eclipsed 2020’s Toll

1 day 23 hours

(Wall Street Journal) – More people have died from Covid-19 already this year than in all of 2020, according to official counts, highlighting how the global pandemic is far from over even as vaccines beat back the virus in wealthy nations. It took less than six months for the globe to record more than 1.88 million Covid-19 deaths this year, according to a Wall Street Journal analysis of data collected by Johns Hopkins University. The university’s count for 2021 edged just ahead of the 2020 death toll on Thursday. (Read Full Article)

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The IVF Case That Broke Birthright Citizenship

2 days 16 hours

(The Atlantic) – Ethan and Aiden Dvash-Banks are twin brothers—born just four minutes apart on the same September day in the same hospital room in Ontario, Canada. But shortly after their birth in 2016, the U.S. State Department decided that the two boys were very different in the eyes of American law: Aiden was a U.S. citizen but Ethan, the brother with whom he’d shared a womb, was not. The reasoning, as it were, came down to how the boys had been conceived, via technology that a half-century-old immigration law could have in no way anticipated. The boys’ fathers, Andrew and Elad Dvash-Banks, used eggs from an anonymous donor, a gestational surrogate, and their own sperm. Aiden was genetically related to Andrew and Ethan to Elad, but each considered himself a father, in equal measure, to both boys.  (Read Full Article)

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A Pivotal Mosquito Experiment Could Not Have Gone Better

2 days 16 hours

(The Atlantic) – Dengue fever is caused by a virus that infects an estimated 390 million people every year, and kills about 25,000; the World Health Organization has described it as one of the top 10 threats to global health. It spreads through the bites of mosquitoes, particularly the species Aedes aegypti. Utarini and her colleagues have spent the past decade turning these insects from highways of dengue into cul-de-sacs. They’ve loaded the mosquitoes with a bacterium called Wolbachia, which prevents them from being infected by dengue viruses. Wolbachia spreads very quickly: If a small number of carrier mosquitoes are released into a neighborhood, almost all of the local insects should be dengue-free within a few months. It’s as if Utarini’s team vaccinated a few individuals against a disease, and soon after the whole population had herd immunity. (Read Full Article)

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FDA Accuses Company of Distributing Unapproved Covid Test and Using Falsified Data

2 days 16 hours

(STAT News) – The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test, accusing the company that makes the tests of distributing them without regulatory approval and using falsified data that inflates their performance. The agency announced a “Class 1 recall” — its most serious type, indicating that use of the tests may cause serious injuries or death — and fired off a warning letter to Innova Medical Group of Pasadena, Calif., saying an FDA investigation revealed serious problems in the company’s data, but also in its making unapproved rapid tests available to consumers in the United States. (Read Full Article)

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Third Member of FDA Expert Committee Resigns Over Controversial Alzheimer’s Therapy Decision

2 days 16 hours

(STAT News) – A third member of a Food and Drug Administration expert panel has resigned over the agency’s contentious approval of an Alzheimer’s therapy this week, a sign of a growing backlash over the decision. In a letter to acting FDA Commissioner Janet Woodcock on Thursday, Aaron Kesselheim, who had served on the FDA’s advisory committee for nervous system therapies since 2015, wrote that the approval of Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.” (Read Full Article)

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U.S. Health Officials Report Higher-Than-Expected Heart Inflammation Cases Following Covid-19 Vaccination

2 days 16 hours

(STAT News) – Federal health officials said Thursday they’re seeing rare but higher-than-expected cases of a heart issue called myocarditis among adolescents and young adults who received their second shot of one of the mRNA Covid-19 vaccines. The data are preliminary and limited, and experts are still trying to determine if there is indeed a link or if there is no connection at all. (Read Full Article)

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The C.D.C. Urges Parents to Get Childhood Vaccinations Up To Date Following a Steep Decline Last Year.

2 days 17 hours

(New York Times) – Pediatricians are urging U.S. parents to get their children caught up on routine vaccinations, following a decline in the number of inoculations for diseases like measles as the pandemic forced restrictions, including shelter-at-home orders, last year. New data from 10 jurisdictions that closely monitor immunizations confirm that the number of administered vaccine doses plunged between March and May of last year, especially among older children, the Centers for Disease Control and Prevention reported on Thursday. (Read Full Article)

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Scottish Study Estimates Risk of Bleeding and Clotting Disorders After AstraZeneca Vaccine

2 days 17 hours

(Medscape) – A nationwide analysis of over 2.5 million Scottish adults who received a first dose of the Oxford/AstraZeneca or Pfizer/BioNTech vaccine between December 2020 and April 2021 has confirmed a small increased risk of immune thrombocytopenic purpura (ITP) and other bleeding and vascular events associated with the Oxford/AstraZeneca vaccine. However, the research, published in Nature Medicine, suggests the risks are comparable with those seen with other vaccines, including vaccines against hepatitis B, measles, mumps and rubella, and influenza. (Read Full Article)

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Covid-19 Delta Variant First Found in India Is Quickly Spreading Across Globe

3 days 17 hours

(Wall Street Journal) – The highly transmissible Covid-19 variant that first emerged in India is rapidly spreading around the world, health authorities say, intensifying the race to increase global vaccinations. The B.1.617.2 variant, now dubbed the Delta variant, is in at least 60 countries, including the U.S. and the U.K., and British scientists recently estimated that it might be 40% to 50% more transmissible than the B.1.1.7 variant, or Alpha, which in turn is more transmissible than the original virus and quickly spread across the globe. (Read Full Article)

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AstraZeneca Vaccine Carries Slightly Higher Risk of Bleeding Disorders, Study Shows

3 days 17 hours

(New York Times) – People receiving the Covid vaccine made by Oxford-AstraZeneca had a slightly increased risk of a bleeding disorder, and possibly other rare blood problems, researchers reported on Wednesday. The findings, from a study of 2.53 million adults in Scotland who received their first doses of either the AstraZeneca vaccine or the one made by Pfizer-BioNTech, were published in the journal Nature Medicine. About 1.7 million of the shots were the AstraZeneca vaccine. The study found no increased risk of the blood disorders with the Pfizer-BioNTech vaccine. (Read Full Article)

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US Deaths from Heart Disease and Diabetes Climbed Amid COVID

3 days 17 hours

(Associated Press) – The U.S. saw remarkable increases in the death rates for heart disease, diabetes and some other common killers in 2020, and experts believe a big reason may be that many people with dangerous symptoms made the lethal mistake of staying away from the hospital for fear of catching the coronavirus.  (Read Full Article)

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AP Source: US to Buy 500M Pfizer Vaccines to Share Globally

3 days 17 hours

(Associated Press) – The U.S. will buy 500 million more doses of the Pfizer COVID-19 vaccine to share through the global COVAX alliance for donation to 92 lower income countries and the African Union over the next year, a person familiar with the matter said Wednesday. (Read Full Article)

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Member of FDA’s Expert Panel Resigns Over Controversial Alzheimer’s Therapy Approval

3 days 17 hours

(STAT News) – Following the Food and Drug Administration’s polarizing authorization of the Alzheimer’s therapy Aduhelm on Monday, a member of an agency advisory committee that recommended against the drug’s approval has resigned. Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA’s expert panel for nervous system therapies, told STAT in an email that he had quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.” (Read Full Article)

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Mixing COVID-19 Vaccines Appears to Boost Immune Responses

3 days 17 hours

(Science) – Faced with short supplies of COVID-19 vaccines and unforeseen side effects, some countries have adopted an unproven strategy: switching shots midstream. Most authorized vaccines require two doses administered weeks or months apart, but Canada and several European countries are now recommending a different vaccine for the second dose in some patients. Early data suggest the approach, born of necessity, may actually be beneficial. (Read Full Article)

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Brazil Gives Russian COVID-19 Vaccine a Chance, Approving the Import of Limited Doses

3 days 17 hours

(Science) – Despite safety concerns, the Brazilian Health Regulatory Agency (Anvisa) reversed itself last week and voted to allow a trickle of Sputnik V, the Russian-made COVID-19 vaccine, into the country. Only 928,000 doses will be imported—just a fraction of the total requested by a group of state governors—and the agency imposed stringent measures to reduce supposed health risks and monitor the vaccine’s safety and efficacy. (Read Full Article)

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U.S. Report Found It Plausible Covid-19 Leaked from Wuhan Lab

4 days 14 hours

(Wall Street Journal) – A report on the origins of Covid-19 by a U.S. government national laboratory concluded that the hypothesis claiming the virus leaked from a Chinese lab in Wuhan is plausible and deserves further investigation, according to people familiar with the classified document. The study was prepared in May 2020 by the Lawrence Livermore National Laboratory in California and was drawn on by the State Department when it conducted an inquiry into the pandemic’s origins during the final months of the Trump administration. (Read Full Article)

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The Complex Ethical Morass of COVID-19 Human Challenge Trials

4 days 14 hours

(MedPage Today) – Two institutions in England have launched COVID-19 human challenge trials, which will deliberately infect participants with the SARS-CoV-2 virus. Despite the approval of these trials by European regulators, debates have continued over whether the ethical justification is sufficient. The studies, conducted at Imperial College London and the University of Oxford, are in their initial stages and have recruited participants ages 18 to 30 who have no risk factors for severe COVID-19 illness. (Read Full Article)

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