News from Bioethics.com

A Boy, His Brain, and a Decades-Long Medical Controversy

2 weeks 5 days

(Wired) – The chiropractor arranged for a doctor he worked with to write a prescription for azithromycin, an antibiotic used to treat strep. Rita had her doubts. She’d told other doctors about the skin irritation; why hadn’t any of them diagnosed Timothy with PANDAS? But the risks to her son were low, and she figured they might as well try. Two days later, the boy was starting to become himself again. The bad men had disappeared. He wanted to go out for pizza and read his favorite sci-fi books. For the first time in almost five months, Rita and John recognized their son. The relief was immense, but it was tinged with uncertainty: If this disease was “made-up,” why was Timothy getting better? Would the improvement in his condition last? And the biggest question, the one that would dog the family well into Timothy’s adolescence: When doctors disagree on the cause of an illness, where does that leave the patient?

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Pfizer and BioNTech to Begin Testing Covid-19 Vaccine in Children

2 weeks 5 days

(STAT News) – Pfizer and BioNTech said Thursday they are beginning a study aimed at showing their Covid-19 vaccine can be used in children as young as 6 months. The study follows the launch of a separate and ongoing trial in children ages 12 to 15, which was fully enrolled in January. That study could lead to results by the end of the first half of the year, depending on the data, and then to an emergency use authorization. That will depend on the Food and Drug Administration and the Centers for Disease Control and Prevention. The vaccine already has an EUA for people 16 and older.

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UN-Backed Vaccine Delivery Program Warns of Supply Delays

2 weeks 5 days

(Associated Press) – The U.N.-backed program to ship COVID-19 vaccines worldwide has announced supply delays involving a key Indian manufacturer, a major setback for the ambitious rollout aimed at helping low- and middle-income countries vaccinate their populations and fight the pandemic. Gavi, the Vaccine Alliance, and its partners said Thursday that the Serum Institute of India, a pivotal vaccine maker behind the COVAX program, will face increasing domestic demands as coronavirus infections surge.

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India Cuts Back on Vaccine Exports as Infections Surge at Home

2 weeks 5 days

(New York Times) – With its own battle against the coronavirus taking a sharp turn for the worse, India has severely curtailed exports of Covid-19 vaccines, triggering setbacks for vaccination drives in many other countries. The government of India is now holding back nearly all of the 2.4 million doses that the Serum Institute of India, the private company that is one of the world’s largest producers of the AstraZeneca vaccine, makes each day. India is desperate for all the doses it can get. Infections are soaring, topping 50,000 per day, more than double the number less than two weeks ago.

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Dramatic Drop in COVID-19 Cases Seen Among Vaccinated Healthcare Workers

2 weeks 5 days

(Medscape) – Data from healthcare workers at medical centers in the United States and Israel are confirming the effectiveness of both the Pfizer and Moderna vaccines against COVID-19. The reports all appear as letters in The New England Journal of Medicine. Pooled employee data from the University of California, San Diego and the University of California Los Angeles health systems shows that during a system of aggressive testing, conducted during a surge of COVID-19 cases in the general population, the rate of new infections among the staff dropped dramatically, beginning the second week after the first dose was given.

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AstraZeneca Releases Updated Covid-19 Vaccine Data Showing 76% Efficacy

2 weeks 5 days

(Wall Street Journal) – AstraZeneca AZN +1.61% PLC released more pivotal-trial data for its Covid-19 vaccine, saying the shot was 76% effective at preventing Covid-19 with symptoms in a fuller analysis of study results than the company had earlier provided. AstraZeneca said its latest figure on the vaccine’s efficacy was based on an analysis of 190 cases of symptomatic Covid-19 in the trial, 49 more cases than the company had analyzed earlier.

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Facebook Finds Chinese Hacking Operation Targeting Uyghurs

2 weeks 6 days

(Associated Press) – Hackers in China used fake Facebook accounts and impostor websites to try to break into the computers and smartphones of Uyghur Muslims, the social network said Wednesday. The company said the sophisticated, covert operation targeted Uyghur activists, journalists and dissidents from China’s Xinjiang region, as well as individuals living in Turkey, Kazakhstan, the U.S., Syria, Australia, Canada and other nations.

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Brighter Outlook for US as Vaccinations Rise and Deaths Fall

2 weeks 6 days

(Associated Press) – More than three months into the U.S. vaccination drive, many of the numbers paint an increasingly encouraging picture, with 70% of Americans 65 and older receiving at least one dose of the vaccine and COVID-19 deaths dipping below 1,000 a day on average for the first time since November. Also, dozens of states have thrown open vaccinations to all adults or are planning to do so in a matter of weeks. And the White House said 27 million doses of both the one-shot and two-shot vaccines will be distributed next week, more than three times the number when President Joe Biden took office two months ago.

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Variants of SARS-CoV-2 Variants Emerge in Brazil

2 weeks 6 days

(Medscape) – The unchecked spread of the more contagious SARS-CoV-2 variants in Brazil appears to have created even more dangerous versions of the virus that causes COVID-19. The changes are documented by a team of researchers from FIOCRUZ, a large public health research lab run by Brazil’s Ministry of Health. The findings were recently posted in a preprint on Virological[dot]org, ahead of peer review. The study describes 11 SARS-CoV-2 sequences from five different Brazilian states. Each had telltale changes to the receptor binding domain, making it one of the known variants of concern or variants of interest. Each one also had additional changes to another important region on the virus: the N-terminal domain.

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Vaccinated People Can Get Covid, But It’s Most Likely Very Rare

2 weeks 6 days

(New York Times) – The doctor, who requested anonymity to protect his privacy, is among the few reported cases of people who have been infected after being partly or even fully vaccinated. Nearly 83 million Americans have received at least one dose of a Covid vaccine, and it’s unclear just how many of them will have a “breakthrough” infection, though two new reports suggest the number is very small.

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AstraZeneca Covid-19 Vaccine Dispute Shines Spotlight on Data Monitoring Boards

2 weeks 6 days

(Wall Street Journal) – The dispute over AstraZeneca’s Covid-19 vaccine trial has exposed the crucial role played by independent expert panels in behind-the-scenes oversight of clinical pharmaceutical trials. The panels, called data and safety monitoring boards, are typically composed of medical experts and scientists such as biostaticians, clinicians and epidemiologists. They are tasked with safeguarding the safety of study volunteers and the scientific integrity of the studies, said Joseph Ross, professor of medicine and of public health at Yale University School of Medicine.

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Quick to Contain Covid-19, Asia Trails West in Vaccinations

2 weeks 6 days

(Wall Street Journal) – Vaccine rollouts around the world have upended the narrative of the pandemic’s first year, as the Asian countries that succeeded in containing Covid-19 have now fallen behind much of the West in the race toward herd immunity. Most Asian countries have administered doses to less than 3% of their populations, while mainland China and Hong Kong have vaccinated around 5%, according to Our World in Data, a project based at Oxford University. Meanwhile, the U.S. has administered at least one dose to around 25% of the population, and the U.K. reached 41% this week.

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A Rapid COVID-19 Vaccine Rollout Backfired in Some US States

3 weeks 9 hours

(Medscape) – Despite the clamor to speed up the U.S. vaccination drive against COVID-19 and get the country back to normal, the first three months of the rollout suggest faster is not necessarily better. A surprising new analysis found that states such as South Carolina and Florida that raced ahead of others to offer the vaccine to ever-larger groups of people have vaccinated smaller shares of their population than those that moved more slowly and methodically, such as Hawaii and Connecticut. The explanation, as experts see it, is that the rapid expansion of eligibility caused a surge in demand too big for some states to handle and led to serious disarray.

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AstraZeneca COVID Vaccine 79% Efficacious in Phase 3 Interim Results

3 weeks 9 hours

(Medscape) – AstraZeneca today announced interim results of their phase 3 US study, which indicate 79% overall efficacy of their vaccine against symptomatic COVID-19, 80% in people aged 65 years and older, and 100% efficacy against severe or critical disease and hospitalization. The vaccine’s efficacy was consistent with regard to ethnicity and age, according to the company.

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Vaccine Fight Between EU and U.K. Threatens to Escalate

3 weeks 9 hours

(Wall Street Journal) – A fight between the European Union and the U.K. over vaccine supplies is demonstrating how securing national access to doses can generate conflict among U.S. allies and underlining the vulnerability of successful Covid-19 vaccine rollouts to the breakdown of international supply chains. Tensions have been rising for months between the EU, where governments have stumbled in their vaccine campaigns, and the U.K., which left the bloc last year. The U.K. has delivered at least one shot of Covid-19 vaccine to more than 40% of its population in one of the world’s speediest inoculation rollouts.

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U.S. Health Officials Raise Concerns Over AstraZeneca Vaccine Data

3 weeks 9 hours

(Wall Street Journal) – In an early-morning statement, the National Institute of Allergy and Infectious Diseases said it had been informed by the independent data-monitoring board working with AstraZeneca on the U.S. trials that the drug company might have used out-of-data information in its public disclosure of the vaccine’s effectiveness. The day before, AstraZeneca released interim data from a large-scale U.S. trial that it said found its Covid-19 vaccine to be 79% effective in preventing symptomatic disease.

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Europe’s Vaccine Ethics Call: Do No Harm and Let More Die?

3 weeks 1 day

(New York Times) – European health agencies this week faced, with millions of lives in the balance, a staggeringly high-stakes incarnation of what ethicists call the trolley problem. Imagine standing at a railway switch. If you do nothing, a trolley barreling down the track will hit three people in its path. If you pull the lever, the trolley will divert to an alternate track with one person. Which option is morally preferable: deliberately killing one person or passively allowing three to die? In Europe’s version, German regulators identified seven cases of a rare cerebral blood clot, three of them fatal, out of 1.6 million who had received the AstraZeneca vaccine. Regulators had no proof they were linked, only a statistical anomaly.

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Some Nations Could Wait Years for Covid Shots. That’s Bad for Everyone.

3 weeks 1 day

(New York Times) – The nurse lay in bed this month, coughing, wheezing and dizzy with fever. It was three months after rich countries began vaccinating health workers, but Kenyans like the nurse, Stella Githaiga, had been left behind: Employed in the country’s largest public hospital, she caught the coronavirus on an outreach trip to remote communities in February, she believes, sidelining her even as Kenya struggles with a vicious third surge of infections.

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EU, China Impose Tit-for-Tat Sanctions Over Xinjiang Abuses

3 weeks 1 day

(Reuters) – The European Union imposed sanctions on Monday on four Chinese officials, including a top security director, for human rights abuses in Xinjiang, to which Beijing responded with its own sanctions on Europeans. Unlike the United States, the EU has sought to avoid confrontation with Beijing, but a decision to impose the first significant sanctions since an EU arms embargo in 1989 following the Tiananmen Square pro-democracy crackdown indicates a change in posture.

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Covid-19 Vaccine Manufacturing in U.S. Races Ahead

3 weeks 1 day

(Wall Street Journal) – Covid-19 vaccine manufacturers are ramping up production, churning out far more doses a week than earlier in the year, progress that is accelerating mass vaccination campaigns in the U.S. After a slow start, Pfizer Inc., its partner BioNTech SE and Moderna Inc. have raised output by gaining experience, scaling up production lines and taking other steps like making certain raw materials on their own. Pfizer figured out how to stretch scarce supplies of special filters needed for the vaccine production process by recycling them. Moderna shortened the time it needed to inspect and package newly manufactured vials of its vaccine.

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AstraZeneca: US Data Shows Vaccine Effective for All Adults

3 weeks 1 day

(Associated Press) – AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S. In the study of 30,000 people, the vaccine was 79% effective at preventing symptomatic cases of COVID-19 — including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots — a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.

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Spain Adopts Euthanasia Law Despite Conservative Opposition

3 weeks 4 days

(ABC News) – Lawmakers voted Thursday to make Spain the sixth country in the world, and the fourth in Europe, to allow physician-assisted suicide and euthanasia for long-suffering patients with incurable diseases and for people with unbearable permanent conditions.

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A Woman Lost Her Pregnancy But Was Jailed for Abortion. She Later Died.

3 weeks 4 days

(NBC News) – El Salvador has a total ban on abortion — one of the world’s most restrictive — and sentences can run up to 50 years in prison. It is estimated that between 2000 and 2019, 181 women suffered obstetric emergencies but were criminalized for alleged abortions or charged with aggravated homicides. The Inter-American Court began an investigation of the case in 2012 after Manuela’s relatives could not get justice from El Salvador’s courts, the groups say.

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Scientist Behind Coronavirus Shot Says Next Target Is Cancer

3 weeks 4 days

(ABC News) – The scientist who won the race to deliver the first widely used coronavirus vaccine says people can rest assured the shots are safe, and the technology behind it will soon be used to fight another global scourge — cancer. Ozlem Tureci, who co-founded the German company BioNTech with her husband, was working on a way to harness the body’s immune system to tackle tumors when they learned last year of an unknown virus infecting people in China.

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Doctor Who Gave Expiring COVID Doses Still in Legal Limbo

3 weeks 4 days

(Medscape) – The Texas Medical Board has dropped its investigation of Hasan Gokal, MD, after finding insufficient evidence that he violated the Medical Practice Act when he gave vaccine doses to people outside the vaccination event he was leading, as the doses were about to expire. However, Harris County District Attorney Kim Ogg and prosecutor Kim Smith continue to pursue a criminal indictment from a grand jury against Gokal.

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