Category: Covid-19

The antiviral drug remdesivir cut death rates 17% to 25% in adults hospitalized for COVID-19 who didn't require supplemental oxygen at admission, suggests a large USstudy published yesterday in Open Forum Infectious Diseases.

The study, led by researchers from remdesivir (Veklury) developer Gilead Sciences, used a multicenter US hospital billing database to compare rates of in-hospital death among 58,188 patients on room air who received at least one dose of remdesivir within the first 2 days of hospital admission and 17,574 matched patients not given the drug. The drug is most effective when given early in infection, when viral replication is most active.

The study period, December 2020 to April 2022, spanned the predominance of the pre-Delta (eg, Alpha, Beta), Delta, and Omicron SARS-CoV-2 variants of concern (VOC).

The study authors noted that previous trials have shown remdesivir to be safe and effective in reducing death rates in hospitalized COVID-19 patients, regardless of the need for supplemental oxygen, and in cutting hospitalization and death rates in nonhospitalized patients at risk for severe illness.

"Nonetheless, much of the evidence relating to remdesivir effectiveness, including real-world studies, is based on data from the early phase of the COVID-19 pandemic," they wrote. "Since then, there has been an emergence of VOC, improvements in standards of care through the approval and authorization of different therapeutics, and widespread initial and follow-up vaccination."

In total, 5.4% of remdesivir-treated and 7.3% of non-remdesivir patients died within 14 days, and 8.0% and 9.8%, respectively, died by 28 days. Remdesivir therapy was tied to a statistically significant reduction in inpatient death relative to remdesivir nonreceipt (14-day adjusted hazard ratio [aHR], 0.75; 28-day aHR, 0.83), translating to a 25% and 17% reduction in risk of death for the two time spans, respectively.

These findings highlight a potential survival benefit when clinicians initiated remdesivir upon admission across the dominant variant eras of the evolving pandemic.

During each VOC period, remdesivir therapy was linked to a significant decline in in-hospital death relative to remdesivir nonreceipt for both 14-day (pre-Delta aHR, 0.73; Delta aHR, 0.80; Omicron aHR, 0.73) and 28-day risk of death (aHRs, 0.83, 0.87, and 0.76, respectively).

"These findings highlight a potential survival benefit when clinicians initiated remdesivir upon admission across the dominant variant eras of the evolving pandemic," the researchers concluded. "Conducting a randomized controlled trial appropriately powered for mortality is impractical in this patient population."

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Remdesivir tied to 25% lower risk of in-hospital death in adults with COVID and no added oxygen - University of Minnesota Twin Cities

Rates of early death and poor health caused by HIV/AIDS and diarrhea have been cut in half since 2010, and the rate of disease burden caused by injuries has dropped by a quarter in the same time period, after accounting for differences in age and population size across countries, based on a new study published in The Lancet. The study measures the burden of disease in years lost to early death and poor health. The findings indicate that total rates of global disease burden dropped by 14.2% between 2010 and 2019. However, the researchers found that the COVID-19 pandemic interrupted these downward trends: rates of disease burden increased overall since 2019 by 4.1% in 2020 and by 7.2% in 2021. This is the first study to measure premature death and disability due to the COVID-19 pandemic globally and compare it to other diseases and injuries.

The study reveals how healthy life expectancy, which is the number of years a person can expect to live in good health, rose from 61.3 years in 2010 to 62.2 years in 2021. Pinpointing the factors driving these trends, the researchers point to rapid improvements within the three different categories of disease burden: communicable, maternal, neonatal, and nutritional diseases; non-communicable diseases; and injuries. Among communicable, maternal, neonatal, and nutritional diseases, the burden of disease declined for neonatal disorders (diseases and injuries that appear uniquely in the first month of life), lower respiratory infections, diarrhea, malaria, tuberculosis, and HIV/AIDS between 2010 and 2021, ranging from reductions of 17.1% for neonatal disorders to 47.8% for HIV/AIDS. In the category of non-communicable diseases, disease burden from stroke dropped by 16.9%, while disease burden from ischemic heart disease fell by 12.0% during this period.

For injuries, the years of healthy life lost due to road injuries was slashed by nearly a quarter (22.9%), while disease burden from falls was reduced by 6.9%. Progress in reducing disease burden varied by countries' Socio-demographic Index a measure of income, fertility, and education underscoring inequities. For example, the burden of disease due to stroke dropped by 9.6% from 2010 to 2021 in countries with the lowest Socio-demographic Index, but it declined faster by 24.9% among countries with higher Socio-demographic Index.

Our study illuminates both the world's successes and failures. It demonstrates how the world made huge strides in expanding treatment for HIV/AIDS and combatting vaccine-preventable diseases and deaths among children under 5. At the same time, it shows how COVID-19 exacerbated inequities, causing the greatest disease burden in countries with the fewest resources, where health systems were strained and vaccines were difficult to secure. Governments should prioritize equitable pandemic preparedness planning and work to preserve the momentum that we've seen in improving children's health."

Dr. Alize Ferrari, Affiliate Associate Professor at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Honorary Associate Professor at the School of Public Health at the University of Queensland, and co-first author of the study

The research presents updated estimates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021. The GBD 2021 study analyzes incidence, prevalence, years lived with disability (years lived in less-than-ideal health), and disability-adjusted life years (lost years of healthy life) at global, regional, national, and subnational levels. It presents estimates of health and health loss in age-adjusted rates and total rates per 100,000 people. The study provides globally comparable measures of healthy life expectancy and is the first study to fully evaluate burden of disease amid the first two years of the COVID-19 pandemic. COVID-19 was the single leading cause of disease burden worldwide in 2021, accounting for 7.4% of total disease burden globally.

The study also examined how the COVID-19 pandemic affected males and females differently. The researchers found that males were more likely than females to die of COVID-19; the age-standardized disease burden rate for COVID-19 among males was nearly twice that of females. However, the secondary effects of the COVID-19 pandemic, including long COVID and mental disorders, hit females hardest. For example, females were twice as likely as males to develop long COVID. Depression, which increased sharply during the pandemic, was most likely to affect females between ages 15 and 65. Looking at differences between age groups, COVID-19 caused the most disease burden in older adults. For COVID-19, adults 70 years and older had more than double the levels of disease burden compared to adults between the ages of 50 and 69.

The study highlights not only the diseases and injuries that cut life short and cause poor health, and how the burden of disease from different causes has changed over time, but also examines how these patterns differ across countries and regions. "In essence," the authors write, the study "provides a comprehensive toolkit to inform and enhance decision-making processes across various levels of governance and practice."

GBD 2021 shines a light on the different causes of disease burden, showing which ones have improved and which are stagnating or worsening. It also tallies the number of years that people are living healthy lives. Healthy life expectancy rose significantly in 59 countries and territories between 2010 and 2021, with the greatest improvements in countries ranking lowest on the Socio-demographic Index, jumping from 52.2 years in 2010 to 54.4 years in 2021. In contrast, healthy life expectancy showed minimal change among countries in the highest levels of the Socio-demographic Index, decreasing slightly from 68.9 years in 2010 to 68.5 years in 2021. The findings on healthy life expectancy demonstrate that even though people are living longer lives all over the world, they aren't spending all those years in good health. The researchers found that the main causes of poor health were low back pain, depressive disorders, and headache disorders.

"With low back pain, the leading cause of poor health globally, we see that the existing treatments aren't working well to address it," said Dr. Damian Santomauro, Affiliate Assistant Professor of Health Metrics Sciences at IHME; Stream Lead at Queensland Centre for Mental Health Research; Adjunct Fellow at the School of Public Health at the University of Queensland; and co-first author of the study. "We need better tools to manage this major cause of global disease burden."

"In contrast, for depressive disorders, we know what can work: therapy, medication, or both in combination for an adequate period of time. However, most people in the world have little or no access to treatment, unfortunately," he said. "Considering how depression increased dramatically during the COVID-19 pandemic, it's urgent to ensure that everyone with this disorder can get treatment."

Another way to understand what is making people ill is by looking at which diseases are growing fastest. GBD 2021 reveals that diabetes experienced the most rapid growth among the different causes of poor health, what the researchers call years lived with disability. Age-adjusted years lived with disability due to diabetes rose by 25.9% between 2010 and 2021. Poor health from diabetes increased in every country and territory that the researchers studied.

"Diabetes is a major contributor to stroke and ischemic heart disease, which are among the top three causes of disease burden worldwide," said Dr. Theo Vos, Professor Emeritus at IHME and one of the study's senior authors. "Without intervention, more than 1.3 billion people in the world will be living with diabetes by 2050. To counter the threat of diabetes, we must ensure that people in all countries can access preventive care and treatment, including to anti-obesity medications, which can lower a person's risk of developing diabetes."

Source:

Journal reference:

GBD 2021 Diseases and Injuries Collaborators.,(2024) Global incidence, prevalence, years lived with disability (YLDs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries in 204 countries and territories and 811 subnational locations, 19902021: a systematic analysis for the Global Burden of Disease Study 2021. The Lancet. doi.org/10.1016/S0140-6736(24)00757-8.

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Global disease burden study highlights COVID-19 impact and health inequities - News-Medical.Net

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This transcript has been lightly edited for clarity

The GBD study uses the disability-adjusted life year, or the DALY, as its main metric to measure disease burden or health loss, essentially. And to estimate the DALYs for a particular cause, or disease or injury, we take both the morbidity, or the disability, associated with that disease, combined with the mortality the years lost to premature mortality associated with that disease as well. HALE is essentially the opposite of the DALY. We leverage what we know about the morbidity and the mortality within a given population to estimate the years spent in good health as opposed to poor health.

Theres a lot to digest from GBD 2021 in terms of trends in disease burden globally. There are a few things Id like to highlight here. First off, between 1990 and 2019, weve seen rather encouraging and consistent improvements in disease burden, largely due to reductions in vaccine-preventable deaths and reductions in under-5 mortality rates.

What this has meant in 2021 is weve seen a shift in the drivers of disease burden globally, from communicable diseases now to non-communicable diseases coming to the fore. So, stroke, ischemic heart disease, COPD, diabetes, for example. So what that means is although populations are now living longer, theyre not necessarily living in good health. And we need to pay attention to those non-communicable diseases, as well as continuing gains made to communicable diseases, such as HIV/AIDS, as we move forward.

The second trend Id like to highlight from GBD 2021 is that it provided us with an opportunity to look at the impacts of the COVID-19 pandemic. GBD 2021 estimated burden for both 2020 and 2021, and there we saw COVID-19 emerge as a leading cause of disease burden for those years.

What we saw for the first time in 30 years, in 2020 and 2021, was an increase in age-standardized DALY rates at the global level due to the COVID-19 pandemic.

We saw, as I said before, COVID-19 emerge as the fourth-leading cause of disease burden in 2020 and the leading cause of disease burden in 2021, largely due to deaths from COVID-19 in those years. Over and above that, GBD 2021 also looked at burden from the long-term, secondary consequences of COVID-19. We saw additional burden from long COVID, as well as additional burden from the mental health consequences of the COVID-19 pandemic, so added burden from depressive and anxiety disorders as a result of the pandemic.

Different diseases and injuries will come with different trends when it comes to both sex and age. But we were talking about COVID-19 just before. And what was interesting there was that, although males and females were impacted largely in the same way when it came to COVID-19 infections, we saw a larger burden from COVID in men compared to women, and that was because men were more likely to die from COVID-19 compared to women. However, when we when it came to the long-term consequences of COVID-19, we saw the opposite effect: women were more likely to be impacted by long COVID. They were also more likely to be impacted by the mental health consequences of the COVID-19 pandemic, compared to men.

Overall, weve seen improvements and continue to see increases in HALE between 2010 and 2021, say.

And that is in spite of a decrease in HALE of about 1.4 years during the two COVID years, so during 2020 and 2021. These HALE results serve as a new baseline for years to come as we continue to recover from the COVID-19 pandemic, as the sociodemographic circumstances of different countries change, hopefully for the better. As life expectancy improves, we expect to continue to see this increasing trend in HALE, so GBD 2021 serves as an important baseline for that.

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Q&A: Populations are now living longer, but not necessarily in better health - Institute for Health Metrics and Evaluation |

Editors Note:Sarah Gilmore, a Neag School doctoral candidate in the Department of Educational Psychology, prepared the followingrapid research brief(unabridged version)with theCenter for Education Policy Analysis, Research, and Evaluation(CEPARE). Below is an executive summary.

Since the beginning of the COVID-19 pandemic in 2019, and the school closures that swept the United States from early 2020 through 2021, grave concerns have been raised about the effects on K-12 education. Now that the dust has begun to settle, recent analyses by policy research centers and organizations like the National Bureau of Economic Research (NBER) have begun to quantify the effects on student achievement, and to consider the future implications of widespread learning loss. Data from the National Assessment of Educational Progress (NAEP) has shown that from 2019-2022, the average public school student in grades 3-8 lost around half a year of progress in math, and a quarter of a years progress in reading (Harvard University Center for Education Policy Research, 2023), and a recent report states that from 2019 to 2022, public schools in the United States lost 40% of the past 20 years progress in increasing math and reading achievement (Kane et al., 2022). If not recovered, this decline is estimated to result in a loss of almost $20,000 in lifetime earnings per student, or $900 billion dollars for all K-12 public school students enrolled in during the 2019-2022 academic year (Kane et al., 2022).

While it is clear that these economic losses will most negatively impact students already disadvantaged by income and racial disparities (Office for Civil Rights, n.d.), recent analyses are beginning to reveal a landscape in which the impact of COVID-19 on student outcomes does not appear to be the product of individual or household factors like race or income. Instead, it appears that levels of learning loss are most variable between districts as opposed to within them, suggesting that, in addition to community-level factors like local COVID-19 death rates and poverty status, the cause of achievement loss was likely due to district level differences (such as school resources, the quality of remote instruction, or the level of disruption in district classrooms), (Fahle et al., 2023).

In light of evidence that COVID-19 impacts are likely to be more localized than previously understood, we can look to the experiences and outcomes of individual school districts to explore how district-level factors have influenced student achievement. One small, largely blue-collar, urban public school district in southern New England District A may provide an example of what Shulman (Shulman, 1999) would call the possible: a district that, despite these community factors, has shown significant resilience in the face of COVID.

The findings from this case study not only suggest answers to these questions, but have implications beyond District A: If sustained student achievement growth during COVID-19 is possible, what can we learn from this case that might go beyond supporting recovery from the next event of great social adversity, but resilience in the face of it?

This research aims to understand the factors that contributed to unexpected student achievement growth in District A a small blue-collar urban public school district in Connecticut despite prevailing community challenges and the broader negative impact of the COVID-19 pandemic on K-12 education. By studying District As reforms and practices prior to and during COVID-19, this study seeks to understand the factors that enabled this growth and its resilience through COVID-19, and identify the implications of this case for broader educational policy and practice.

If sustained student achievement growth during COVID-19 is possible, what can we learn from this case that might go beyond supporting recovery from the next event of great social adversity, but resilience in the face of it? — Sarah Gilmore

This report uses explanatory case study methodology and inductive analysis to identify key points and recurring themes in district-level documentation and semi-structured interviews with key stakeholders.

From 2016 2020, a newly-established leadership team led District A through an era of comprehensive reform to address declining student achievement, resulting in several district-wide initiatives to increase equity and instructional rigor. These initiatives were successful in increasing student achievement results, a positive trend that continued despite the challenges of COVID-19. Analysis of district data, documentation, and interviews suggests that four factors enabled District A to achieve these outcomes, and demonstrate resilience to, rather than recovery from, the pandemic:

The findings of this case study suggest that policy makers and district leaders who aim to develop effective, sustainable, and resilient reforms for student achievement growth and educational recovery may not achieve these goals through specific initiatives alone. Instead, these findings suggest that successful reform may be achieved by establishing a context-driven vision and framework for continuous improvement, in which initiatives and the ways in which they are implemented act as expressions of clearly articulated and internally consistent principles.

CEPARE produces high-quality research, evaluation, and policy analysis that informs leaders and policymakers on a range of pressing issues, with a particular focus on enhancing social justice and equity across p-20 educational settings in Connecticut and beyond. CEPARE produced this Rapid Research Brief as part of the SETER Alliance, which aims to strengthen and support learning opportunities in Connecticuts Alliance districts. Learn more about CEPARE cepare.uconn.edu. Access the PDF VERSION (including all references and appendices).

Sarah Gilmore is a doctoral student in Educational Psychology in the Learning Sciences program at the University of Connecticut, and an awardee of the NSF-funded TRANScend fellowship in Educational Neuroscience. She is also pursuing a Graduate Certificate in Cognitive Science and holds an MA Ed in Leadership and Management.

Prior to beginning her doctorate, Gilmore was a primary teacher for 15 years in international schools, going on to specialize in transdisciplinary technology integration and teacher coaching. She is a passionate supporter of classroom teachers and teaching, and holds feminist, humanist, and democratic perspectives. She has a broad base of research experience that has included qualitative, quantitative, and mixed methods, as well as lab-based research on science learning, including EEG, eye- tracking, and behavioral measures. Her research interests are in using technology to develop scalable, equitable, and evidence-informed pathways for teacher learning, and understanding how teachers identities, beliefs, and lived experiences inform theways in which they learn and teach. She is currently developing a statewide mixed methods study to describe current literacy teaching practices and identify connections between teaching practices and individual and contextual factors.

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A Case of the Possible: Creating the Conditions for K-12 Student Achievement Growth in the Face of COVID-19 ... - University of Connecticut

Even with the lessons learned from the recent COVID-19 pandemic, the US Department of Health and Human Services (HHS) failed to respond effectively or coordinate a national response to the 2022 mpox outbreak, with state leaders citing a lack of communication and uneven access to tests and vaccines, according to a new report from the US Government Accountability Office (GAO).

Moreover, HHS still lacks a "coordinated, department-wide after-action program to identify and resolve recurring emergency response challenges," the report read.

The authors of the report warned that the failures seen in handling mpox, rarely deadly and only transmitted among a small proportion of the population, are a warning sign the HHS needs to continue to refine its approach to pandemic response.

They also warn that unlike COVID-19, the federal government had medical countermeasures in place to immediately begin fighting mpox, including an effective vaccine. But it still took a critical 3 months of confusion surrounding distribution and delivery before the HHS ordered the right number of doses of the Jynneos vaccine, and it wasn't until August of 2022 that a White House response team was created to get the first shots in arms.

To complete the report, the GAO interviewed officials from the Department of Homeland Security, HHS, and 14 selected jurisdictions (six states, the District of Columbia, and seven localities). The jurisdictions saw a high number of mpox cases and included Los Angeles,San Francisco, Georgia, and New York City.

In a podcast on the GAO report, GAO's Mary Denigan-Macauley, who led work for the new report, says many of the problems in the mpox response were due to a deflated and exhausted public health workforce across the country.

"We were short of workforce to be able to control Mpox. If you remember correctly, this came at right during COVID at the heels of COVID and the workforce was absolutely exhausted," Denigan-Macauley said.

We were short of workforce to be able to control Mpox.

She also emphasized poor communication between HHS officials and state leaders. In the report, the GAO writes, "HHS did not effectively communicate to the public the significantly increased risk of mpox for certain individuals during the initial stages of the outbreak, according to some jurisdictional officials we interviewed."

"Some officials said CDC's risk communication at the beginning of the mpox outbreak did not clearly identify the individuals who were most at-risk for mpox (men who have sex with men) and the most common mode of transmission (sexual contact)."

Denigan-Macauley said the HHS needs to listen to outside stakeholders as well as invest in public health infrastructure before something more deadly and widely transmissible than mpox is seen in the United States.

"What happens if a bad guy were to introduce something for which we have no medical countermeasures and they introduce it in simultaneous and multiple places around the United States? It will be overwhelming. So we are looking for HHS to step up its game because it is a matter of saving lives," Denigan-Macauley said.

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GAO report: HHS mpox failures shows persistent emergency response gaps - University of Minnesota Twin Cities

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by Germans Trias i Pujol Research Institute

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A study led by the Centre for Epidemiological Studies on STIs and AIDS of Catalonia (CEEISCAT)a group from the Germans Trias i Pujol Research Institute (IGTP), the Fundaci Lluita contra les Infeccions (FLI), and Odense University Hospital (OUH)has revealed that people living with HIV who have experienced an episode of COVID-19 face a significant increase in the risk of cardiovascular diseases in the year following infection.

The project, conducted within the framework of the PISCIS Cohort of individuals living with HIV in Catalonia and the Balearic Islands, examined over 18,000 people with HIV, 4,000 of whom had been diagnosed with COVID-19 between 2020 and 2022.

Of all the individuals studied, 832 had suffered a cardiovascular illness, and it was noted that those who had contracted COVID-19 were at a 30% increased risk of developing cardiovascular diseases a year after the coronavirus infection, particularly within the first six months.

According to the researcher who has led the study, the physician Raquel Martn-Iguacel, "The most common cardiovascular diseases we have observed in this group have been blood clots in the lungs or legs, as well as heart failure and various heart diseases."

Martn-Iguacel, an associate physician in the Department of Infectious Diseases at Odense University Hospital (Denmark) and a researcher at CEEISCAT, says, "The importance of COVID-19 vaccination in people with HIV as a key preventive measure."

The study has identified several factors associated with an increased risk of cardiovascular diseases among people living with HIV, including age, being a heterosexual man or woman, the presence of previous cardiovascular disease, and other conditions such as chronic kidney or liver disease.

Martn-Iguacel concludes, "It is vital to urge patients who have had COVID-19 to be aware of this increased risk and to manage other cardiovascular risk factors, such as smoking, diabetes, hypertension, or high cholesterol."

Likewise, the study serves as a warning to physicians taking care of individuals with HIV, who will need to consider this increased cardiovascular risk during the first year post-COVID. There are various therapeutic strategies under study to mitigate this risk that must be closely monitored.

The research is published in the journal Clinical Microbiology and Infection.

More information: Raquel Martn-Iguacel et al, Major cardiovascular events after COVID-19 in people with HIV, Clinical Microbiology and Infection (2024). DOI: 10.1016/j.cmi.2024.02.006

Provided by Germans Trias i Pujol Research Institute

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COVID-19 found to increase the risk of severe cardiovascular problems in people with HIV - Medical Xpress

A review of death certificates in Oregon failed to turn up evidence of a greater risk of sudden cardiac death among individuals ages 16 to 30 who had recently received a COVID-19 vaccine, researchers report.

Of three deaths possibly related to cardiac causes in this age group that occurred within 100 days of getting vaccinated, two were attributed to preexisting chronic conditions. For the third, the cause was undetermined, and a potential link to the vaccine could not be confirmed or excluded.

These data do not support an association between receipt of mRNA COVID-19 vaccine and sudden cardiac death among previously healthy young persons, Juventila Liko, MD, and Paul Cieslak, MD (both from the Oregon Health Authority, Portland), conclude in a paper published recently in Morbidity and Mortality Weekly Report.

COVID-19 vaccination is recommended for all persons aged 6 months to prevent COVID-19 and complications, including death, they add.

In the months after COVID-19 vaccines started rolling out in late 2020, reports of myocarditis following receipt of the mRNA-based shots emerged around the world. A greater risk of myocarditis with these vaccines, particularly in younger males, was confirmed in subsequent studies, which highlighted the rarity and relatively benign course of the complication.

Still, Liko and Cieslak say, this risk raised concerns about the possibility of vaccine-related cardiac deaths. They note that reports about sudden deaths among previously healthy young athletes, with some purported to be tied to COVID-19 vaccination, started to spread in the media. Generally, though, there has been no strong evidence to support such a link, which has been deemed misinformation.

As of July 17, 2023, there were no fatal cases of myocarditis reported out of Oregon to the federal Vaccine Adverse Event Reporting System (VAERS) but, Liko and Cieslak point out, that systemwhich relies on passive reportinglikely underestimates adverse events associated with vaccination.

To explore the issue, they searched death certificates for Oregon residents ages 16 to 30 who died between June 2021 and December 2022 and then matched any deaths with records from the states ALERT Immunization Information System, which collected data on COVID-19 vaccination during the pandemic. Of note, between May 2021 and December 2022, nearly 980,000 doses of COVID-19 vaccine were administered in this age group in Oregon.

I dont think anybody should be scared about getting the vaccine and were not seeing any evidence that it leads to serious sequalae due to myocarditis.Thomas Maddox

Of 1,292 identified deaths, COVID-19 was listed as the cause for 30 (2.3%) and a noncardiac diagnosis was listed for 89.9%. For the 101 remaining deaths (7.8%), the researchers could not exclude a cardiac cause. Of these, 88 had matching records in the immunization databasethree of the individuals had received an mRNA-based vaccine within 100 days of death.

Two of the deaths were attributed to chronic underlying conditions:

The third individual who died had received the COVID-19 vaccine 45 days earlier. The recorded cause of death was undetermined natural cause, and follow-up with the medical examiner could not confirm or exclude the possibility that the death was due to a vaccine-related adverse event.

None of the death certificates examined as part of the study listed vaccination as the cause of death.

To put the potential cardiac risk of COVID-19 vaccination into perspective, the investigators note that a study using electronic health records from 30 US healthcare systems demonstrated that the risk for cardiac complications was significantly higher after COVID-19 itself than after receipt of an mRNA-based vaccine among individuals 5 years and older. In addition, during the first 2 years of COVID-19 vaccine availability in the United States, vaccination prevented an estimated 18.5 million hospitalizations and 3.2 million deaths, according to an analysis by the Commonwealth Fund.

Liko and Cieslak acknowledge that the study cant exclude the possibility that vaccine-associated deaths occurred more than 100 days after vaccination and that the small size of the study population makes it less likely to see a rare vaccine-related side effect among younger people.

Despite the limitations, though, Thomas Maddox, MD (Washington University School of Medicine, St. Louis, MO), said it is comforting to see that the rare cases of myocarditis that we know can sometimes occur with COVID-19 vaccination dont appear to translate into anything super concerning like cardiac-related death. Regarding the analysis, he added that by and large, its consistent with the rest of the evidence that we have to date that COVID vaccine-related myocarditis appears to be very rare and pretty self-limited.

To TCTMD, Maddox said the decision to get vaccinated against COVID-19 has to take into account ones own assessment of the relative risks and benefits.

Theres multiple reasons to consider getting the vaccine, but at the end of the day, its a nuanced decision and you kind of have to work with your doc, and in this case your kid, to say what are the pros and cons, and then make a decision that makes sense for you, he said.

His general message regarding the cardiac safety of COVID-19 vaccination is that its overwhelmingly safe. I do not have concerns for any person of any age or sex in getting the vaccine and Im really glad that we have it available to us. And I do think its important to think not only about protecting yourself, but protecting the community where you are.

Overall, I think its a very good decision to get the vaccine, Maddox said. If somebody is really healthy and isnt in a place where they might spread it to others and they feel like they would want to hold off on the vaccine for now, I dont think its an unreasonable decision as long as its being made in consultation with your doc. But by and large, I dont think anybody should be scared about getting the vaccine and were not seeing any evidence that it leads to serious sequalae due to myocarditis, and this report certainly doesnt contradict that.

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Data Fail to Support Link Between COVID-19 Vaccines and SCD in Young People - TCTMD

The governments continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task Forces (CFETF) report released on April 9, 2024. The CFETF, which represents a concerted effort across numerous federal agencies to investigate pandemic-related fraud, has, according to its 2024 report, succeeded in prosecuting over 3,500 defendants in criminal enforcement matters, in bringing civil enforcement actions resulting in more than 400 civil settlements and judgments, and in securing more than $1.4 billion in seizures and forfeitures. The report itself is a showcase of the CFETFs COVID-19 fraud enforcement efforts to date.

Despite the CFETFs apparent success, however, the report begins with a plea from the CFETF for legislation that would increase its total funding and simultaneously extend the statutes of limitations for all COVID-19 fraud related offenses. On the same date of the reports release, Senators introduced a sweeping billion-dollar legislation package to fuel the governments pandemic fraud fighting efforts and raise the statute of limitations on pandemic unemployment insurance fraud and the White House released a fact sheet detailing the Biden Administrations proposals related to investigation of pandemic fraud. Chief among the Presidents proposals is the enactment of several bills, some of which would meet the CFETFs requests.

The 2024 COVID-19 Fraud Enforcement Task Force Report

Although the CFETFs request for assistance is, on its face, general in nature, reading through the report it appears that the CFETF may be concerned with its ability to operate within budgetary and statutory constraints to investigate the newly opened 1,200 civil fraud matters related to multiple pandemic-related programs. According to the report, over half of these matters are qui tam cases. The Department of Justice (DOJ) Civil Fraud Section observed a steady increase in pandemic fraud actions filed under the False Claims Act year-over-year from 2020 through 2023. Combined with the growing number of investigative leads developed through data analytics, the Civil Fraud Section anticipates that civil pandemic fraud enforcement will continue to require substantial resources for years to come. We have noted previously how the wave of civil pandemic fraud enforcement that we expected has not yet publicly materialized, and the report offers a glimpse as to why.

One potential reason for the slower resolution of pandemic-related civil enforcement actions may be the underlying complexity of the schemes that the DOJ has chosen to pursue beyond the many criminal cases prosecuted to date involving receipt of pandemic fraud funds to which the recipient is not entitled (but subsequently spends on various luxury items). For example, the CFETFs report includes examples of particularly nuanced theories of pandemic-related fraud. In one instance, the DOJ Tax Division, along with the U.S. Attorneys Office for the District of New Jersey,charged a defendantwith preparing more than a thousand false tax returns seeking tens of millions of dollars in refunds based on the Employee Retention Credit and the COVID-related Sick and Family Leave Credit. The report notes how the Tax Division has implemented a nationwide training program and assigned trial attorneys to COVID-19 fraud strike forces to assist with the development and prosecution of such fraud cases.

Another example of the escalating complexity of COVID-19 fraud prosecutions can be seen in DOJs investigations related to the submission of false claims to Medicare for medically unnecessary respiratory pathogen panels (RPPs) paired with COVID testing. Although prior prosecutions have focused on pursuing criminal convictions for allegedly medically unnecessary RPP testing performed in conjunction with COVID testing, a recent criminal plea and civil settlement against a Georgia laboratory owner demonstrates how the prosecution of these matters may be evolving. According to the settlement, independent contractor sales representatives forged physician signatures on requisition forms, added sham diagnosis codes that distorted the medical condition of the seniors for whom providers had ordered COVID testing, and fraudulently added RPP testing to COVID testing orders in exchange for volume-based commissions payments from co-defendants. Defendants knowingly submitted or caused the submission of false or fraudulent claims to Medicare, Medicaid, the Health Resources and Services Administration, TRICARE, and the Railroad Retirement Medicare Program for medically unnecessary RPPs tainted by volume-based commissions prohibited by the Anti-Kickback Statute.

The difficulty faced by investigators is that as the complexity of the alleged fraud schemes grow, so too do the time and resources needed to investigate those schemes. Despite the governments apparent success in prosecuting COVID-19 fraud, given their plea for additional funding and extended statutes of limitations, the government appears concerned that it may be unable to successfully prosecute pandemic fraud schemes without more time and money.

Proposed COVID-19 Fraud Legislation

Fortunately for pandemic-fraud investigators, the White House, along with a bipartisan group of legislators, have put forth several proposals that, if enacted, would further support the investigators efforts.

On April 9, 2024, Senators Gary Peters (D-MI), Dick Durbin (D-IL), and Ron Wyden (D-OR) introduced a comprehensive anti-fraud proposal, largely modeled on the Biden Administrations anti-fraud proposal included in the White House FY 2025 Budget. The bill, whose text has yet to be released by the Senators as of this writing, would, among other things:

Another piece of legislation introduced in the Senate includes the bipartisan proposal put forth by Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) that would, among other things, raise the statute of limitations for pandemic unemployment insurance (UI) fraud from 5 years to 10 years. The Wyden-Crapo proposal is similar to the COVID19 EIDL Fraud Statute of Limitations Act of 2022 and the PPP and Bank Fraud Enforcement Harmonization Act of 2022, that extended the statute of limitations for the prosecution of Economic Injury Disaster Loan and Paycheck Protection Programfraud, respectively, to ten years.

Conclusion

It is unclear which, if any, of the above legislation will be enacted into law. But given the plea of the CFETF in its report, there is a possibility that without additional resources investigators may need to pull back on the number of fraud cases they can investigate and eventually resolve. If the proposals put forth are enacted, and the CFETFs requests are met, then we could expect to see the number of COVID-19 fraud prosecutions not only continue, but potentially skyrocket. Given the estimates of over $300 billion in fraud on pandemic relief programs thus far and the over $1.4 billion in fraudulently obtained CARES Act funds recouped by the CFETF, the $300 million proposal appears to be a worthwhile investment.

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DOJ Releases COVID-19 Fraud Enforcement Task Force Report Touting Its Successes and Urging Lawmakers to ... - JD Supra

A University of Maryland researcher who helped influence guidelines on masking and other measures nationwide to limit the spread of COVID-19 joined fellow experts on Thursday in publishing a new report designed to standardize how the medical and scientific fields communicate about transmission of respiratory viruses.

Released by the World Health Organization, the report aims to combat the misinformation that spread rapidly during the pandemic and sometimes cost people their healthor lives.

The report corrects a number of misconceptions and misunderstandings that were major problems earlier in the COVID-19 pandemic, said Dr. Donald Milton, a School of Public Health environmental health professor and leading authority on respiratory virus transmission. It is important to have clear terminology and a shared understanding as a basis for developing effective policy to prevent infection and control pandemics.

Milton was instrumental in convincing health authorities to take precautions against viruses that remain suspended in the air for minutes or longer, even though conventional wisdom at the beginning of the pandemic was oriented toward avoiding germs on surfaces and in virus-containing particles directly sprayed by sneezes or coughs.

The new report proposes airborne transmission/inhalation as the standardized term for infectious respiratory particles emitted into the air and breathed in. This term applies regardless of whether particles capable of infecting others travel short or long distances from the infected person.

When infectious respiratory particles follow a direct spray trajectory over a short distance through the air to the mouth, nose or eyes of another individual, the report proposes using the term direct deposition. Because aerosol and droplet were widely misunderstood by some practitioners and officials, these terms were avoided in the new report.

The report states clearly that the risk of airborne/inhalation transmission is greatest close to an infected person, Milton said.

He noted that a great deal of work is still needed to reach scientific consensus on the relative importance of each mode of transmission for specific infectious agents.

They require very different controls to protect health care workers and other high-risk people, Milton said. How this report is translated into infection prevention and control policy will be criticalthat work lies ahead. Acknowledging that airborne/inhalation and direct deposition transmission are very different, as described in the body of the report, could be a first step toward new and more effective policies.

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UMD Infectious Disease Expert Co-authors Global Health Report to - Maryland Today

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A new study based on German data shows that SARS-CoV-2 caused a 21% excess of acute respiratory infections (ARIs) during the winter of 2022-23. The study was published this week in the International Journal of Infectious Diseases and suggests COVID-19 will add a significant burden during cold and flu seasons.

The study was based on answers to an online survey about ARIs during the past 7 months sent to 70,000 registered participants in a digital health study in March 2023. At that point, 3 years after the pandemic began, many people in Germany and elsewhere no longer regularly tested for COVID-19, or testing at home and did not report official results.

A total of 37,708 participants reported 54,813 ARIs, including 9,358 SARS-CoV-2 infections confirmed with either at-home or clinical tests. Twenty-eight percent10,638 peoplereported no infections.

There were 45,455 ARIs without a positive SARS-CoV-2 test, the authors said. For 11,699 of those, no SARS-CoV-2 test was available, while the others had a negative test. The proportion of positive tests among all conducted tests was 21%.

The highest incidence for all ARIs was observed in December 2022, with 26 infections per 100 people. Adults aged 30 to 39 years had the highest cumulative incidence, with 208 infections per 100 people across the 7 months.

"Decision makers need to be aware of this burden to adapt and create new policies with the goal of reducing infection incidences, for example by establishing new strategies on vaccinations." the authors wrote.

Decision makers need to be aware of this burden to adapt and create new policies with the goal of reducing infection incidences

"While the risk of severe SARS-CoV-2 infections is reduced due to the achieved immunity in the population, we will likely face a higher burden of ARI than before the pandemic, even if no new SARS-CoV-2 variants will appear," the authors concluded. "This additional burden of ARI has to be considered particularly with respect to the implications for the work force."

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COVID-19 caused 21% excess of respiratory infections last winter, analysis finds - University of Minnesota Twin Cities