Tuesday, June 25, 2024


Long COVID Clarity—Three-Year Study of VA Population in America

Those who were hospitalized with acute SARS-CoV-2 have a significantly higher risk for ongoing death and long COVID symptoms

Researchers affiliated with the VA St. Louis Health Care System as well as well-known physician-scientist Eric Topol at Scripps Research Institute using national health care databases designed a cohort of 135,161 US veterans who survived the first 30 days of COVID-19 and a control of 5,206,835 users of the VA healthcare system with no evidence of SARS-CoV-2 infection.

To ensure 3-year follow-up, these cohorts were enrolled between March and December 2020, an era that pre-dated the availability of COVID-19 vaccines and antivirals and when the ancestral SARS-CoV-2 virus predominated. These cohorts were followed longitudinally for 3 years to estimate the risks of death and incident of long COVID symptoms throughout the 3-year follow-up and cumulatively at 3 years in mutually exclusive groups according to care setting of the acute phase of the disease (in non-hospitalized and hospitalized).

The net summary of this important study, albeit one with limitations.

Those who were hospitalized with acute SARS-CoV-2 have a significantly higher risk for ongoing death and long COVID symptoms. While the vast majority of SARS-CoV-2 infections were mild to moderate and the authors here minimize the risk of death and significant long COVID symptoms in the non-hospitalized COVID-19 infection population, they acknowledge the vast population meaning there are many people struggling with issues, while deemed mild to moderate under long COVID symptom category, nonetheless see overall decline in quality of life. The authors acknowledge the need for more research and eventually therapeutic options.

An important point TrialSite emphasizes is that the vast majority of acute SARS-CoV-2 infections were mild to moderate meaning no hospitalization. While this study highlights the greater risks of persons in the VA system who were hospitalized, a great toll on individuals and society now impacts persons who could be considered a mild long COVID. Meaning they had a mild to moderate COVID-19 and continue to face long COVID symptoms, ones that adversely impact quality of life. Even the authors herein acknowledge this vast cohort.

They declare “Consequently, much of the burden of PASC in populations is attributed to mild infection. According to an analysis by the Global Burden of Disease (GBD) collaborators, about 90% of people with PASC had mild COVID-19, suggesting that, although preventing severe disease is important, strategies to reduce the risk of post-acute and long-term health loss in people with mild COVID-19 are also needed.”

Findings

There were 114,864 participants (13,810 (12.0%) females and 101,054 (88.0%) males) in the non-hospitalized COVID-19 group and 20,297 participants in the hospitalized COVID-19 group (1,177 (5.8%) females and 19,120 (94.2%) males), plus 5,206,835 participants in the control group with no infection (503,509 (9.7%) females and 4,703,326 (90.3%) males).

The researchers ensured these patients all had follow up totaling 344,592, 60,891 and 15,620,505 person-years of follow-up in the non-hospitalized COVID-19, hospitalized COVID-19 and control groups, respectively. In total this all equaled 16,025,988 person-years of follow-up. The researchers investigated the demographic, health characteristics and standardized mean differences of the non-hospitalized COVID-19, hospitalized COVID-19 and control groups before and after inverse probability weighting for baseline covariates.

Examining the risks and burdens of death and a set of pre-specified PASC as well as sequelae aggregated by organ system and aggregated as an overall outcome of PASC by care setting during the acute phase of SARS-CoV-2 infection (non-hospitalized (n = 114,864) and hospitalized (n = 20,297) groups) in the first, second and third year after SARS-CoV-2 infection.

Among non-hospitalized study subjects, there was no longer an increased risk of death post the first year of infection, and the risk of long COVID declined over the three year duration, however still contributed 9.6 (95% confidence interval (CI): 0.4–18.7) disability-adjusted life years (DALYs) per 1,000 persons in the third year.

Among hospitalized individuals, risk of death declined but remained significantly elevated in the third year post infection (incidence rate ratio: 1.29 (95% CI: 1.19–1.40)). Risk of incident PASC declined over the 3 years, but substantial residual risk remained in the third year, leading to 90.0 (95% CI: 55.2–124.8) DALYs per 1,000 persons.

With risks diminishing over time, a death mortality continues in addition to overall loss of good health by year three in that cohort that was hospitalized.

Breakdown

Is it the finding that the risk after 3 years among non-hospitalized persons goes down, and in fact the risk of mortality goes away?

Yes. The risk of death goes away after the first year of infection, plus the risk of long COVID symptoms also declines substantially by year 3.

What about hospitalized persons with COVID-19?

Their risk declines as well but remains significantly “elevated” on into the third year post infection (29% increased risk and excess burden of death of 8.16 per 1,000 persons).

So, does this mean that persons that were hospitalized have higher chances of long COVID incidence as well?

Yes. While the risks for post-acute sequelae went down over the years, nonetheless a material “residual risk remained in the third year, leading to 252.8 sequelae per 1,000 persons and 90.0 DALYs per 1,000 persons.”

How can the risks be summarized?

The totality of the study finds overall lower risks of symptoms over 3 years of follow-up, however, continued amplified risks of major adverse outcomes among hospitalized individuals.

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Supreme Court Turns Away COVID-19 Vaccine Appeals

This case was about compulsory vaccination but it failed on the purely legal ground that the petitioners "lacked standing"

U.S. Supreme Court justices on June 24 rejected appeals brought over COVID-19 vaccines by Children’s Health Defense (CHD), a nonprofit founded by Robert F. Kennedy Jr., an independent candidate running for president.

The nation’s top court rejected an appeal seeking to overturn lower court rulings that found that CHD and its members lacked standing to sue the Food and Drug Administration (FDA) over its emergency authorizations of COVID-19 vaccines for minors.

The justices also rebuffed another CHD appeal in a case that challenged the COVID-19 vaccine mandate imposed on students at Rutgers University, a public college in New Jersey.

The Supreme Court did not comment on either denial. It included them in a lengthy list dealing with dozens of cases.
“Disappointing that the courts are closed to FDA fraud harming millions of Americans,” Robert Barnes, an attorney representing CHD in the FDA case, told The Epoch Times in an email.

He called for Congress to pass reforms.

Julio Gomez, an attorney representing CHD in the Rutgers case, told The Epoch Times in an email that the Supreme Court’s denials marked a sad day because clarity is needed on vaccines and the Supreme Court’s 1905 decision in Jacobson v. Massachusetts, which upheld a city’s law requiring vaccination against smallpox.

Mr. Gomez pointed to a recent federal appeals court ruling that determined that Jacobson did not apply to a case filed against a vaccine mandate in California because plaintiffs had produced evidence that the COVID-19 vaccines do not prevent the spread of COVID-19.
Lawyers for Rutgers and the government did not return requests for comment.

In the FDA case, CHD and parents in Texas and Florida argued that the regulatory agency cleared COVID-19 vaccines under emergency authorization despite COVID-19 posing less risk than influenza to children and without adequate clinical testing. The FDA also wrongly promoted the vaccines, the plaintiffs alleged.

U.S. District Judge Alan Albright tossed out the lawsuit in 2023, finding that CHD and the parents did not meet the requirements for standing, or the ability to sue over the actions, under Article III of the U.S. Constitution.

While the parents said their children were at risk of being vaccinated by other people, they did not show that they faced imminent harm because of the FDA issuing emergency authorization for COVID-19 vaccines, the judge said. Imminent harm is one requirement for standing.

The judge also said CHD had not shown that its resources were drained in responding to the FDA’s conduct and that it was airing a “generalized grievance,” which is not allowed under Supreme Court precedent.

A panel of the U.S. Court of Appeals for the Fifth Circuit in January upheld the ruling.

“Plaintiffs contend that the injury-in-fact element is satisfied because a third party might vaccinate their children over their objections, and that such vaccine could allegedly injure them and their children,” the panel stated. “Be that as it may, we agree with the district court that Plaintiffs fail to demonstrate an injury in fact because the alleged injury is neither concrete nor imminent.”

Mr. Barnes had urged the Supreme Court to look at the case.

“Can no one sue the FDA? Is that what Article III means?” he wrote in a filing

Government lawyers waived their right to file a brief to the court.

In the case against Rutgers, CHD and some of its members said the vaccine mandate was unconstitutional in part because the Constitution’s due process clause enables people to refuse medical treatment.

U.S. District Judge Zahid Quraishi ruled against the plaintiffs in 2022, finding that Rutgers mandated vaccination as part of a legitimate goal of protecting the school community from COVID-19 and that the students either brought claims that had become moot because they were granted religious exemptions to the mandate or failed to state a claim.

A panel of the U.S. Court of Appeals for the Third Circuit upheld the decision in February.

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