COVID Vaccine Trials Show Counting Window Issues

"Counting windows" refers to how long you wait for an effect to emerge. For example: If you took two years to die from the effects of a vaccination but your counting window is only one year you may fail to pick up that death as caused by vaccination

Written by Raphael Lataster, PhD

The Journal of Evaluation in Clinical Practice’s hugely important unofficial series of articles on exaggerated COVID-19 vaccine effectiveness and safety claims, involving BMJ editor Peter Doshi and myself, has now concluded. The initial Fung, Jones, and Doshi paper outlines statistical biases, such as the case counting window bias, that likely lead to the COVID vaccines’ effectiveness being exaggerated in observational studies.

The subsequent paper by Lataster (that’s me) then explained the situation is worse, as the case counting window bias is often accompanied by a definitional bias, and noted that this could exaggerate vaccine safety as well.

Doshi and Fung then returned with a further paper indicating that numerous cases in the vaccinated were overlooked in the clinical trials, likely leading to exaggerated effectiveness estimates.

The fourth and final article in this ‘series’, again by myself, notes that this also appears to apply to safety estimates in the clinical trials, whilst also confirming my earlier concerns about safety estimates in observational studies, and noting that the myocarditis issue alone could mean that the jabs are not worth the risk in the young and healthy.

Safety estimates appeared to be exaggerated in a recent observational study championing the use of the jabs in the omicron era, which OTN readers will already know all about.

I again state that Doshi’s team may have understated things. While they expect that effectiveness was exaggerated in the clinical trials, I note that “numerous issues with the clinical trials and FDA briefing documents had gone unmentioned.

For example, there are a significant number of trial participants lost to follow-up, and Pfizer also acknowledged ‘3410 total cases of suspected but unconfirmed COVID-19 in the overall study population’ in the FDA briefing document on their vaccine trial, split almost evenly between the treatment and placebo groups, which would have drastically brought down treatment efficacy estimates.”

Counting windows for adverse effects in the clinical trials were incredibly short, going against long-established norms, especially with the treatment and placebo groups quickly merged, and reliant on unsolicited reporting, as well as the opinions of researchers paid by BioNTech and Pfizer (like cardiovascular deaths being written off as unrelated to the jab when we now know the jab does cause cardiovascular deaths).

I note the concerning “large number of trial participants lost to follow-up” and that “deceased trial participants will not be contacting the researchers to describe their issues”. Wrap your head around that one. You’re in the vaccinated group. You die, thanks to the jab. As a result, you don’t report this to Pfizer. Your death is not included in the data, as with the potentially many other jab-caused deaths. With relatively few adverse reports the jab is declared safe. It’s a bit like how we can’t refer to many of the adverse event reports as they’re perpetually unverified.

Couldn’t avoid again referring to the Fraiman et al. and Benn et al. articles indicating that, with the data as unreliable as it is, the trials indicated an excess of deaths and “serious adverse events of special interest” in the vaccinated groups, relative to the unvaccinated groups.

I note that increasing research on myocarditis alone appears to indicate that the risks of the jabs outweigh the benefits in the young and healthy, the topic of my BMJ rapid response.

I reveal that Pfizer acknowledges myocarditis risks and limitations of their study. And that Pfizer is currently running a trial, again plagued by counting window issues, to “determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted”.

Would this information have been handy before you got jabbed, and before the jabs were universally declared “safe and effective”, and before people were fired for not submitting?
I conclude that there is more than enough here to “nullify the claim that the benefits of the vaccines still outweigh the risks in all populations”. Source.

Just remember that the claims about these COVID-19 vaccines being safe and effective were, at best, based on these clinical trials and observational studies.

https://principia-scientific.com/covid-vaccine-trials-show-counting-window-issues/

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Overwhelming Percentage of VA Patients Eligible, Not Given COVID-19 Antivirals

In the latest Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) titled “Underuse of Antiviral Drugs to Prevent Progression to Severe COVID-19—Veterans Health Administration (VA), March—September 2022,”

Boston-based rheumatologist Paul Monach, M.D, Ph.D., and colleagues from VA Boston Healthcare System/VA Boston Center for Healthcare Organization & Implementation Research, Harvard Medical School and Dana-Farber Cancer Institute report based on their observational study of electronic medical records that 80% of 110 immunosuppressed patients in the VA system with non-severe COVID-19 at risk for progression were not offered any antiviral drugs.

For nearly 50% of the participant cohort, the only rationale offered for the lack of access to antiviral drugs was that the SARS-CoV-2 symptoms were mild. Other reasons for withholding antivirals to COVID-19-infected at-risk persons include symptom duration of less than 5 days (22.7%), lack of symptoms (22.7%), and drug interaction concerns (5.7%). 20% of the study participants declined any antivirals.

The antivirals for COVID-19 include both nirmatrelvir/ritonavir (Paxlovid) as well as remdesivir (Veklury)–both approved by the Food and Drug Administration (FDA). Merck’s molnupiravir (Lagevrio) is authorized for emergency use.

Background

As the weight of the evidence suggests, FDA-approved or emergency-authorized antivirals can reduce risk of hospitalization and death and are recommended for patients with mild-to-moderate COVID-19 facing a higher risk of disease progression due to age or medical conditions. The study team was concerned that other research revealed that eligible at-risk patients were not being prescribed antivirals nearly enough.

The authors of this CDC-backed study report that the basis for this investigation concerned the fact that the VA reported the use of outpatient antiviral medications among 24% of all documented SARS-CoV-2 infections in 2022, remaining at that level through early 2023.

The authors expressed concern that many of the patients met the criteria for access to these drugs. Interestingly, similar overall rates of use (maximum = 34%) were observed in a large cohort from healthcare systems participating in the National Patient-Centered Clinical Research Network (PCORnet).

Purpose of this Study

The study authors tapped into a sample of VA patients with COVID-19, reviewing their records to better understand the barriers to antiviral use. What were the reasons for the non-treatment of these patients with mild-to-moderate disease at the time of initial evaluation and testing?

All of the patient cohort were deemed fully vaccinated and were associated with one of three relatively common conditions linked to severe immunocompromise, thus placing them in the at-risk category for COVID-19, vaccinated or not. These included 1) solid organ transplantation 2) chronic lymphocytic leukemia (CLL) or plasma cell malignancies.

Findings

This observational study identified 110 COVID-19 mild-to-moderate VA system patients during the period March to September 2022 with either solid organ transplantation, CLL, or plasma cell malignancies. They had previously received a COVID-19 vaccine but did not receive antiviral treatment after receiving positive SARS-CoV-2 test results, again during a mild-to-moderate or asymptomatic infection.

While 20% of the total study group were offered antivirals but declined, 80% of the study population were not offered treatment

The authors cannot be certain why so many patients who fit into an at-risk category are not administered antivirals for COVID-19. To further investigate this quandary, with a deeper probe into electronic medical record text, the authors propose “algorithms to determine these reasons.” As these algorithms would need to be textual in nature, they would be bias-prone, according to the authors.

The authors also point out that VA EMR data also underestimates antiviral use yet the percentage of eligible patients who are not offered an antiviral remains considerable.

https://www.trialsitenews.com/a/overwhelming-percentage-of-va-patients-eligible-not-given-covid-19-antivirals-3f11aca2

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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