News from Bioethics.com

Healthcare Workers Have 7-Fold Increased Risk of Severe COVID-19

1 month 5 days

(Medscape) – Healthcare workers have more than a seven-fold increased risk of severe COVID-19 compared to non-essential workers, with the risk rising almost nine-fold in medical support staff, finds research from the first UK-wide lockdown. The study, published in Occupational & Environmental Medicine, linked baseline UK Biobank data (2006-10) for England to SARS-CoV-2 test results from Public Health England (16 March to 26 July 2020).

The Vaccine Is Not Coming Soon Enough for Nursing Homes

1 month 5 days

(The Atlantic) – A new COVID-19 spike in America’s long-term-care facilities emerged in the West and Northeast last week, with both regions reporting their highest numbers of new cases in the past six months. The Midwest and South saw a small downturn in new cases, which is promising, yet the week still saw the nation’s highest number of newly reported cases—51,574—in long-term-care facilities since we started collecting these data in May.

Fighting COVID-19 in the Amazon, with Herbs and the Internet

1 month 5 days

(The New Yorker) – During the peak of the outbreak, when the morgues of Ecuador’s largest city, Guayaquil, were overflowing—and while indigenous communities attempted to quarantine—the oil, mining, and forestry industries continued to work in the rain forest. In May, Ecuador’s coalition of indigenous governments, CONFENIAE, launched an online dashboard to track cases of the disease in indigenous communities and identify outbreaks so that medical brigades, PCR tests, and emergency kits could be directed to the places that needed them. As of November, the dashboard had logged more than three thousand cases in ten indigenous nations. Carlos Mazabanda, Amazon Watch’s field coördinator for Ecuador, who worked on creating the dashboard, said, “In the absence of a response from the government, indigenous peoples were forced to take matters into their own hands.”

What We Know About Pfizer’s COVID-19 Vaccine

1 month 5 days

(The New Yorker) – An all-day hearing of the Food and Drug Administration’s vaccine advisory committee closed, on Thursday evening, with a vote to recommend an Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine for people sixteen and older. The proceedings involved a great deal of data and technical talk, but might be quickly summarized this way: there are things we still do not know about the vaccine, but nothing that we do know looks bad.

UAE Says Sinopharm Vaccine Has 86% Efficacy Against COVID-19

1 month 5 days

(Medscape) – An experimental coronavirus vaccine developed by China National Pharmaceutical Group (Sinopharm) has 86% efficacy, the health ministry of the United Arab Emirates said on Wednesday, citing an interim analysis of late-stage clinical trials. While the positive data comes soon after last month’s upbeat results from Western rivals, such as Pfizer Inc, Moderna, AstraZeneca Plc and from Russia, neither the UAE nor Sinopharm have released detailed data from the pivotal study.

COVID-19 Vaccine Trial Ethics Once We Have Efficacious Vaccines

1 month 6 days

(Science) – The unprecedented effort to identify one or more safe and effective vaccines for COVID-19 includes more than 180 candidates in development (1), with at least 12 in phase 3 trials (2). The testing of so many vaccine candidates, in a pandemic of a disease for which there are to date limited treatment options, raises a critical challenge: What should researchers do if a vaccine candidate is judged to be safe and efficacious? Guidance from the U.S. Food and Drug Administration (FDA) states that in the event that a COVID-19 vaccine candidate is judged to be “safe and effective,” discussion may be necessary “to address ethical arguments to break the blind and offer vaccine to placebo recipients” (3). We consider here two questions raised by this guidance: First, if a vaccine candidate is found to be safe and efficacious in a placebo-controlled trial, should the researchers continue that trial as designed? Second, should researchers continue to test other vaccine candidates using placebo-controlled trials? These two questions are especially timely given recent announcements by Pfizer and Moderna that their vaccine candidates have been found to be efficacious in preventing symptomatic COVID-19 (4, 5).

F.D.A. Advisory Panel Gives Green Light to Pfizer Vaccine

1 month 6 days

(New York Times) – Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week. The F.D.A.’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. Although the F.D.A. does not have to follow the advice of its advisory panel, it usually does.

Covid-19 Surge Could Lead to Another Drop in Patient Visits, Doctors Fear–And More Missed Pediatric Cancers

1 month 6 days

(STAT News) – Nothing prepares a parent for a child’s cancer diagnosis. Even more unthinkable is wondering if the cancer could have been caught sooner. When the coronavirus pandemic exploded in March, people in many states were urged to stay home — and they did. Primary care offices closed, gradually converting to telehealth if they could. In-person office visits for both children and adults fell off a cliff, dropping by as much as 60% in April by some estimates, while what-if questions about possible harms soared. 

DOD Unveils Its Coronavirus Vaccine Distribution Plan

1 month 6 days

(NPR) – The Department of Defense aims to administer just under 44,000 doses of Pfizer’s coronavirus vaccine within 24 to 48 hours of authorization for emergency use. U.S. Food and Drug Administration officials have said they will make a decision soon after they hear from an advisory committee which meets Thursday. The vaccine will be distributed through 16 DOD installations, 13 in the U.S and three overseas. The facilities selected are in California, Florida, Indiana, Maryland, New York, North Carolina, Texas, Virginia and Washington, director of the Defense Health Agency Army Lt. Gen. Ronald Place said in a news conference Wednesday.

Drive-By Burials and FaceTime Farewells: Grief in the Covid Era Will Weigh on the American Psyche for Years to Come

1 month 6 days

(STAT News) – The rituals of grief and mourning are as old as time: the swift Jewish burial and seven days of sitting shiva to honor the dead; the Muslim washing and three-sheeted shrouding of a body; the solemn Mass of Christian Burial with Holy Communion and the promise of an afterlife. All these — and other rites of faith and community across the globe — have been brutally curtailed by the Covid-19 pandemic, with effects on the mental and physical health of those left behind that have yet to be grasped.

Johnson & Johnson Cuts Size of Covid-19 Vaccine Study Due to Prevalence of Disease in U.S.

1 month 6 days

(STAT News) – Johnson & Johnson is cutting the size of its pivotal U.S. Covid-19 vaccine trial — the only major study testing a single dose of a Covid vaccine — from 60,000 volunteers to 40,000 volunteers. The change is being made possible by the fact that Covid-19 is so pervasive across the country, according to a person familiar with the matter. The more virus there is in the U.S., the more likely it is that participants will be exposed to it, meaning researchers will be able to reach conclusions based on a smaller trial.

Analysis–World Watches as First-Mover Britain Probes Adverse Reactions to Pfizer Vaccine

1 month 6 days

(Reuters) – Britain hailed “V-Day” when it became the first country to roll out the Pfizer-BioNTech COVID-19 vaccine. Yet, as first mover, it has also become the first to report cases of adverse reactions, allowing other nations to watch and learn. Officials from around the world are keen for British authorities to give them as much information as possible about the two reported cases of anaphylaxis among thousands of people inoculated since mass-vaccination began on Tuesday.

The Vaccine Is Not Coming Soon Enough for Nursing Homes

1 month 1 week

(The Atlantic) – A new COVID-19 spike in long-term-care facilities emerged in the West and Northeast last week, with both regions reporting their highest numbers of new cases in the past six months. The Midwest and South saw a small downturn in new cases, which is promising, yet the week still saw the nation’s highest number of newly reported cases—51,574—in long-term-care facilities since we started collecting these data in May. Nationally, deaths increased by 27 percent from the previous week. More than a third of long-term-care-facility deaths were reported in the Midwest; Michigan, Illinois, and Minnesota each reported more than 200 deaths. In the South, Texas reported the highest number of new deaths, 360.

UK to Refine Allergy Warning on Pfizer Vaccine Sparked by Two Adverse Reactions

1 month 1 week

(Reuters) – Britain’s medicine regulator warned people with significant allergies not to get Pfizer-BioNTech’s COVID-19 vaccine after two people suffered adverse reactions, but was set to give more detailed guidance on Wednesday based on reviews of those cases.

Nine Out of 10 in Poor Nations to Miss Out on Inoculations as West Buys Up Covid Vaccines

1 month 1 week

(The Guardian) – Nine out of 10 people in 70 low-income countries are unlikely to be vaccinated against Covid-19 next year because the majority of the most promising vaccines coming on-stream have been bought up by the west, campaigners have said. As the first people get vaccinated in the UK, the People’s Vaccine Alliance is warning that the deals done by rich countries’ governments will leave the poor at the mercy of the rampaging virus. Rich countries with 14% of the world’s population have secured 53% of the most promising vaccines.

Canada Approves First COVID-19 Vaccine, Expects Inoculations Next Week

1 month 1 week

(Reuters) – Canada on Wednesday approved its first COVID-19 vaccine and said initial shots will be delivered and administered across the country starting next week, while every Canadian will be able to be inoculated as early as the end of September. Canada is the third country after Britain and Bahrain to give the green light to Pfizer Inc’s vaccine, developed with Germany’s BioNTech SE.

What the Chaos in Hospitals Is Doing to Doctors

1 month 1 week

(The Atlantic) – The original “God Committee” had seven members: a surgeon, a minister, a banker, a labor leader, a housewife, a government worker, and a lawyer. They convened in the summer of 1961 in Seattle because a professor of medicine at the University of Washington had invented a new method of dialysis that could indefinitely filter the blood of people whose kidneys were failing. His device, hailed as the first artificial human organ, resided in an unobtrusive annex of Seattle’s Swedish Hospital, and it seemed like a true medical miracle. Suddenly people with less than a month to live could be restored to health, provided they could be dialyzed regularly. But at the time, roughly 100,000 Americans were dying of end-stage kidney disease. There were hundreds, possibly thousands, of viable candidates. The program could take only 10. Who should get the lifesaving care?

Oxford COVID Vaccine Paper Highlights Lingering Unknowns About Results

1 month 1 week

(Nature) – The first formally published results from a large clinical trial of a COVID-19 vaccine — which scientists hope could be among the cheapest and easiest to distribute around the world — suggest that the vaccine is safe and effective. But the data also highlight a number of lingering unknowns, including questions about the most effective dosing regimen and how well it works in older adults.

Detailed Data on AstraZeneca-Oxford Covid-19 Vaccine Show It Has Moderate Efficacy

1 month 1 week

(STAT News) – The Covid-19 vaccine being developed by the University of Oxford and AstraZeneca appears to have moderate efficacy in preventing symptomatic illness, and may significantly reduce hospitalization from the disease, data from four clinical trials of the vaccine reveal. The highly anticipated publication of the data, released Tuesday in The Lancet, also point to some signals that deserve further exploration — the possibility of protection after a single dose and the suggestion that at least one dosing regimen may have led to a decrease the number of asymptomatic infections.

FDA Scientists Endorse ‘Highly Effective’ Pfizer/BioNTech Covid-19 Vaccine Ahead of Key Panel

1 month 1 week

(STAT News) – Scientists at the Food and Drug Administration endorsed the efficacy and safety of the Covid-19 vaccine from Pfizer and BioNTech in detailed documents released Tuesday, setting the stage for an emergency authorization as early as this week. The documents are a prelude to a Thursday meeting of outside experts, which is likely the final step before the FDA grants an emergency use authorization, or EUA. The FDA reviewers state that the two-dose vaccine was “highly effective” in preventing symptomatic Covid-19, and that the data “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.” The data also suggest that the two-dose vaccine may begin preventing some Covid-19 cases after the first dose.

Covid-19 Vaccine: First Person Receives Pfizer Jab in UK

1 month 1 week

(BBC) – A UK grandmother has become the first person in the world to be given the Pfizer Covid-19 jab as part of a mass vaccination programme. Margaret Keenan, who turns 91 next week, said the injection she received at 06:31 GMT was the “best early birthday present”. It was the first of 800,000 doses of the Pfizer/BioNTech vaccine that will be dispensed in the coming weeks. Up to four million more are expected by the end of the month. 

UK Trial to Mix and Match Covid Vaccines to Try to Improve Potency

1 month 1 week

(The Guardian) – A trial is likely to go ahead in January to find out whether mixing and matching Covid vaccines gives better protection than two doses of the same one, the head of the British government’s taskforce has said. The trial will begin if the University of Oxford/AstraZeneca vaccine is approved in the coming weeks, as is hoped. The treatment can only be administered with licensed vaccines.

The Life and COVID Death of a Revered Siberian Doctor

1 month 1 week

(The New Yorker) – Shikankov, who was sixty-three years old, with deep-set eyes and a trademark bushy dark mustache, was a respected and well-known local cardiologist, who was equally revered for his modesty and quiet professionalism—it wouldn’t be like him to make a fuss and start asking for special treatment. After doctors refused to admit him to the overcrowded hospital, he called a taxi and went home. Another three days passed, and Shikankov felt worse. He managed to call for an ambulance—which felt like a small victory in and of itself, but, when it brought him to Medical-Sanitary Unit Number Two, as the hospital is known, the answer was the same: no room, we’re all full, orders are to take only those whose lungs are in worse shape.

COVID-19 Vaccine Has Potential Side Effects, Nurse Volunteer Says

1 month 1 week

(Medscape) – Nurse researcher Kristen Choi, PhD, RN, experienced first-hand a “worst-case scenario” of potential side effects after receiving an experimental COVID-19 vaccine in a phase 3 trial. She says clinicians should be prepared to reassure patients if reports of similar experiences spread when vaccine rollouts begin. “This was the highest fever I can ever remember having, and it scared me,” said Choi, with the School of Nursing at the University of California, Los Angeles. Choi volunteered to participate in Pfizer’s COVID-19 vaccine trial in August. When she came back for the second dose in September she began to experience distressing symptoms.

CDC Urges Universal Mask Wearing for First Time

1 month 1 week

(Medscape) – As the United States faces a worsening surge of SARS-CoV-2 infections, hospitalizations, and deaths, the Centers for Disease Control and Prevention (CDC) has, for the first time during the almost year-long pandemic, urged Americans to wear face masks universally. The recommendation — published on December 4 in Morbidity and Mortality Weekly Report — was highlighted as the first of 10 key strategies to mitigate the spread of the virus and to restore the American economy and community life.

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