News from Bioethics.com

China’s Sinovac Delays Covid-19 Vaccine Trial Results

3 weeks 2 days

(The Wall Street Journal) – hinese firm Sinovac Biotech Ltd. has delayed the announcement of results from late-stage trials of its Covid-19 vaccine to January as it consolidates data from Brazil with test results from Indonesia and Turkey. Brazil, which is the first country to complete Phase 3 trials of CoronaVac, had been expected to announce the vaccine’s efficacy rate on Wednesday. However, Brazil’s Butantan Institute, the research center backed by São Paulo’s state government that has been testing CoronaVac, said Sinovac asked for 15 more days to analyze the data together with results from other trials of the vaccine, which is also being tested in Indonesia and Turkey.

Why Some Countries Suspended, Replaced, or Relaunched Their Covid Apps

3 weeks 2 days

(MIT Technology Review) – This spring, while the US government was spinning its wheels on an official covid-19 response, countries around the world were rolling out national contact tracing apps. Beginning with Singapore in mid-March, more than 40 countries have launched digital exposure notification systems, to varying degrees of success. Our Covid Tracing Tracker logs each country’s app and the technologies used, noting privacy considerations and giving each one a transparency rating. We regularly update the tracker to document changes—for example, after finding that several countries rolled back privacy measures. Among the other changes: countries whose apps have been suspended, relaunched, or replaced.

Argentina First in Latin America to Approve Russian Vaccine

3 weeks 2 days

(Medical Xpress) – Argentina’s health ministry said Wednesday it has given the controversial Russian Sputnik V coronavirus vaccine “emergency” authorization, making the country the first in Latin America to do so. The first shipment of the 25 million doses of the vaccine bought by the Argentine government is due to arrive on Thursday.

Trial of High-Dose Blood Thinners in I.C.U. Coronavirus Patients Is Halted

3 weeks 2 days

(New York Times) – A major trial of high-dose blood thinners in critically ill hospitalized Covid-19 patients is being temporarily halted because there appears to be no benefit to the treatment and there may be some harm, the trial’s leaders announced Tuesday. The independent monitoring board that called for the trial to be paused did not announce what possible harms it had found. High doses of anticoagulants are known to cause uncontrollable bleeding — in places including the inside of the skull, which can be very dangerous.

‘Every Day Is an Emergency’: The Pandemic Is Worsening Psychiatric Bed Shortages Nationwide

3 weeks 2 days

(STAT News) – The Covid-19 pandemic has dramatically cut the availability of inpatient psychiatric beds, with facilities across the country forced to reduce their capacity to meet social distancing requirements, stem outbreaks of the virus, or repurpose psychiatric beds to care for the surge of Covid-19 patients. The crisis — combined with years of mental health care budget cuts, rising demand for mental health care, and an existing shortage of both psychiatric beds and providers — appears to have put health care systems on a wartime footing.

‘There’s No Back to Normal’: For People with Terminal Illnesses, Time Lost to Covid-19 Can’t Be Made Up

3 weeks 2 days

(STAT News) – It’s become standard for some to cast 2020 as a throw-away year, something the door should hit on its way out. Plans were disrupted, celebrations postponed, everything — dating, vacations, just a dinner out — hit by flying wrenches. Some things, of course, aren’t recoverable. But many people have embraced trudging through until they can pick up where life left off, when a semblance of their former normal is restored. But losing a year is not the same for everyone. For people with life-limiting illnesses, time is less of a nebulous concept than a pressing constraint; there are fewer chances for do-overs. When you’re told that you have a cap on your life, patients say, a switch flips that you need to make the most of the time you have left.

‘Each Day Is Critical’: South Korea’s 11th Hour Battle with Covid

3 weeks 2 days

(New York Times) – In several provinces across South Korea, there are no I.C.U. beds available to treat the rapidly rising number of Covid-19 patients. As of Monday, the government confirmed that there were only 42 beds available nationwide. In the Seoul metropolitan area, home to half of the country’s population and the majority of its recent infections, there were just six. The latest explosion of coronavirus cases in South Korea has put the country on edge in a way that it has not been since the beginning of the pandemic. If cases can’t be brought under control and the strain on hospitals continues to deteriorate, the government may for the first time impose Level 3 restrictions, the highest level of social-distancing rules ?short of a lockdown in South Korea.

Makers of Successful COVID-19 Vaccines Wrestle with Options for Placebo Recipients

3 weeks 2 days

(Science) – Now that regulators around the world have begun to issue emergency use authorizations (EUAs) for COVID-19 vaccines—the United States authorized a candidate vaccine from the biotech Moderna on Friday—a theoretical debate that has simmered for months has become a pressing reality: Should ongoing vaccine efficacy studies inform their tens of thousands of volunteers whether they were injected with a placebo or the vaccine, and also offer an already authorized vaccine to those who got the placebo?

COVID Makes 2020 the Deadliest Year in U.S. History

3 weeks 2 days

(Medscape) – The number of deaths in the United States is expected to top 3.2 million by the end of December, making 2020 the deadliest year in the nation’s history, the Associated Press reported. The coronavirus is driving the trend. Almost 320,000 people have died so far from coronavirus-related reasons, according to Johns Hopkins University. The daily death rate has been rising lately, with 1,696 people dying on Monday, according to the Covid Tracking Project. Official death statistics will not be available for months. But if the projections hold true and 3.2 million people die in the United States in 2020, that would be 400,000 more than in 2019 ? a 15% increase, AP said.

COVID-19 Mortality Rates Declined, but Vary by Hospital

3 weeks 2 days

(Medscape) – Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show. “[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.

CDC Updates COVID-19 Vaccine Priority Recommendations

3 weeks 3 days

(UPI) – The U.S. Centers for Disease Control and Prevention on Tuesday further detailed its recommendations for distribution of COVID-19 vaccines, reaffirming that healthcare workers and older adults should receive priority.

California Records Half a Million Covid Cases in Two Weeks

3 weeks 3 days

(The Guardian) – California has recorded a half-million coronavirus cases in the past two weeks, overwhelming emergency rooms across the state. The state could be facing a once-unthinkable scenario of nearly 100,000 hospitalizations within a month, the governor Gavin Newsom said Monday. Newsom, himself quarantined for the second time in two months, said a state projection model shows previously unfathomable hospitalization numbers. He is likely to extend his stay-at-home order for much of the state next week.

Feds Sue Walmart Over Role in Opioid Crisis

3 weeks 3 days

(Associated Press) – The Justice Department is suing Walmart, alleging the company unlawfully dispensed controlled substances through its pharmacies, helping to fuel the opioid crisis in America. The civil complaint being filed Tuesday points to the role Walmart’s pharmacies may have played in the crisis by filling opioid prescriptions and by unlawfully distributing controlled substances to the pharmacies during the height of the opioid crisis. Walmart operates more than 5,000 pharmacies in its stores around the country.

Will Pregnant Women Receive the Covid-19 Vaccine? It Depends

3 weeks 3 days

(BBC) -As the long-awaited coronavirus vaccine begins to roll out, it’s already clear that not everyone will have access. For pregnant and breastfeeding women, this access will depend on where they live. Clinical trials for the Pfizer-BioNTech vaccine did not include either pregnant or lactating women, and the company has said available data is so far “insufficient” to determine any risks to pregnancy posed by the vaccine. In the UK, this absence of data has led regulators to exclude pregnant and breastfeeding women from vaccination programmes. In the US, the decision has been left up to these women themselves. 

This Is the Stanford Vaccine Algorithm That Left Out Frontline Doctors

3 weeks 3 days

(MIT Technology Review) – When resident physicians at Stanford Medical Center—many of whom work on the front lines of the covid-19 pandemic—found out that only seven out of over 1,300 of them had been prioritized for the first 5,000 doses of the covid vaccine, they were shocked. Then, when they saw who else had made the list, including administrators and doctors seeing patients remotely from home, they were angry. During a planned photo op to celebrate the first vaccinations taking place on Friday, December 18, at least 100 residents showed up to protest. Hospital leadership apologized for not prioritizing them, and blamed the errors on “a very complex algorithm.” 

Chinese and Russian Vaccines Remain Unproven–But Desperate Countries Plan to Use Them Anyway

3 weeks 4 days

(Washington Post) – In the race to vaccinate the world, China and Russia appear headed to becoming international players, as countries buy up doses and push ahead with approvals even before the release of crucial trial data. Although both countries’ coronavirus vaccine efforts were initially viewed with skepticism, a growing list of nations remains eager to work with Beijing and Moscow to slow the virus’s deadly spread. Much of this has to do with scarcity. Rich countries have snapped up most of the early doses of the promising vaccines by U.S.-based Moderna and Pfizer, which is working with Germany’s BioNTech. A multilateral effort to equitably distribute doses is moving slowly. For some, China and Russia are the only immediate option.

Will You Have to Carry a Vaccine Passport on Your Phone?

3 weeks 4 days

(MIT Technology Review) – You may have heard about using “vaccine certification” or “immunity passports,” analog or digital tools to prove you’re vaccinated. Some experts champion them as a way to get back to normal life, while others warn about privacy risks and the potential for discrimination and abuse.  These debates are mostly speculative, but underlying issues of privacy, verification, and ethical use aren’t unique to the vaccine. Governments and businesses already use covid-related records every day to make decisions about who can do what. Here’s what we know.

Moderna’s Vaccine Rolls Out in the U.S.

3 weeks 4 days

(The Verge) – A week after planes and trucks carried the first Covid-19 vaccine across the United States, inching a weary public toward hope, the second was shipped to sites around the country. The Moderna vaccine, like Pfizer’s, requires two shots, spaced weeks apart. The Food and Drug Administration authorized its emergency use on Friday.

California Hospitals Discuss Rationing Care as Virus Surges

3 weeks 4 days

(Associated Press) – California’s overwhelmed hospitals are setting up makeshift extra beds for coronavirus patients, and a handful of facilities in hard-hit Los Angeles County are drawing up emergency plans in case they have to limit how many people receive life-saving care. The number of people hospitalized across California with confirmed COVID-19 infections is more than double the state’s previous peak, reached in July, and a state model forecasts the total could hit 75,000 patients by mid-January. 

One in Every Five Prisoners in US Has Tested Positive for Covid-19

4 weeks 8 hours

(The Guardian) – One in every five state and federal prisoners in the United States has tested positive for the coronavirus, a rate more than four times as high as the general population. In some states, more than half of prisoners have been infected, according to data collected by the Associated Press and the Marshall Project.

Dying Inside: As More Women Fill America’s Jails, Medical Tragedies Mount

4 weeks 9 hours

(Reuters) – The female population in U.S. jails has risen as the male population has declined. Many women enter jails suffering mental health crises and addictions, and sometimes pregnant. Yet local lockups are ill-equipped to handle this growing population pool.

ER Doctor Says He Walks Into a ‘War Zone’ Every Day

4 weeks 9 hours

(NPR) – Emergency room physician Cleavon Gilman compares working in a hospital amid the pandemic to war. “You can actually die at your job now, and that’s never really been an issue before,” he says. He has the experience to make the comparison: Gilman served as a combat medic in the Iraq War. “Health care providers are walking into a war zone every day where we can be killed by this virus, and even serve as a Trojan horse to bring it home to our family and to kill our loved ones,” Gilman tells Rachel Martin on Morning Edition. “The amount of emotional strain our health care providers are under right now is just unimaginable.”

COVID-19 Ranks as Leading Cause of Death in US

4 weeks 9 hours

(Medscape) – COVID-19 became a leading cause of death in the U.S. in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday. Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying due to the coronavirus.

COVID-19 Vaccines: Safe for Immunocompromised Patients?

4 weeks 9 hours

(Medscape) – “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.” That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

Moderna COVID-19 Vaccine Wins Decisive Recommendation from FDA Panel

4 weeks 9 hours

(Medscape) – Federal advisers on Thursday overwhelmingly recommended an emergency clearance for Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continued testing of this medicine. The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

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