Researchers Point to Statistically Significant Autoimmune & Auto-Inflammatory Adverse Event Incidence Post COVID-19 Vax

Mostly small effects but not all

Biomedical researchers from prominent academic research centers in both South Korea and the United States conducted a study identifying 3620 autoimmune-related adverse events among 223.2 million US residents using Vaccine Adverse Events Reporting System and the COVID-19 Data Tracker.

Seong-Jan Kim an expert in nuclear medicine from Pusan National University Yangsan Hospital and Sung Ryul Shim, an epidemiological researcher at Konyang University and Yale University-based pharmaco-epidemiologist and mental health investigator Taeho Greg Rhee declare their recent investigation published in the journal Clinical Immunology is the first to quantify the cumulative incidence of autoimmune and auto-inflammatory adverse events after COVID-19 vaccination. This includes an accounting of autoimmune and auto-inflammatory adverse events across six major classes of medical conditions and stratified by age, sex, as well as COVID-19 vaccine manufacturer.

The study involves an accounting of the investigators’ initiative to estimate the cumulative incidence (CIR) of autoimmune and autoinflammatory adverse reactions per 100,000 people fully vaccinated against COVID-19 in the United States.

Study Method

Following STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) reporting guidelines, the authors point out that as publicly available de-identified data was used for the study, it was exempted by the Institutional Review Boards at Konyang University and Yale School of Medicine.

Finding

Tapping into both the U.S. VAERS as well as the CDC Data Tracker databases, the study authors for this investigation report 3620 autoimmune and autoinflammatory adverse events (AEs) across 223,270,498 fully vaccinated individuals in the United States.

A study duration starting upon first administration of the COVID-19 vaccines based on Food and Drug Administration (FDA) emergency use authorization (December 2020) to September 2022, the reports of AEs by Pfizer-BioNTech, Moderna, and Janssen groups

Measuring statistical significance at p<0.05, the following adverse event classes were identified:

Cardiovascular and/or pulmonary events (Pfizer-BioNTech 0.109; Moderna 0.180 and Janssen 0.170); Hematologic events (Pfizr-BioNTech 0.195; Modern 0.283 and Janssen 0.217);

Musculoskeletal events (Pfizer-BioNTech 0.554; Moderna 0.738 and Janssen 9.422) and Other events (Pfizer-BioNTech 0.198; Moderna 0.259 and Janssen 0.211).

https://www.trialsitenews.com/a/researchers-point-to-statistically-significant-autoimmune-auto-inflammatory-adverse-event-incidence-post-covid-19-vax-8da1bf67

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City University of New York & Pfizer Study: COVID-19 Infected, Vaxxed Americans Mostly Reject Pfizer & Merck Antivirals

TrialSite was at the forefront of reporting the boom in use of ivermectin and other off-label regimen such as hydroxychloroquine and even fluvoxamine during the earlier stages of the COVID-19 pandemic. Most physicians in North America initially learned of the use of ivermectin in research or in COVID-19 care scenarios in low-and middle-income countries as TrialSite chronicled this activity early on in the pandemic.

TrialSite also chronicled the substantial public investment the National Institutes of Health (NIH) made in novel branded pharmaceutical antiviral development during the pandemic, including those developed by Pfizer (Paxlovid) and Merck (molnupiravir). The market was targeted in the several billions per annum given SARS-CoV-2 was to persist—the biomedical research establishments worldwide made the faulty assumption at first that sterilizing vaccines would eradicate viral transmission, leading to herd immunity. When it became clear that this was not the case—that the vaccines would not do a good job of stopping viral transmission and that SARS-CoV-2 would continue to mutate, the antiviral market was considered a winner by pharmaceutical analysts. See “Feds Now See the Need for Funding Antivirals: TrialSite Will Track the Spend, Carefully.”

During the pandemic, what was especially disturbing to both industry and the Food and Drug Administration (FDA) was a report by TrialSite on an obscure study revealing ivermectin use in America surged from about 3,000 prescriptions per week pre-pandemic to nearly 90,000 prescriptions per week during the height of the pandemic. This kind of data raised the risk of off label generic competition.

An aggressive series of public health programs were unleashed, some terming it propaganda including the FDA’s frontal attack on ivermectin. Ultimately, the FDA lost in a lawsuit by frontline doctors arguing the agency overstepped its mandate. Regardless, Pfizer’s Paxlovid and Merck’s molnupiravir were to be key antiviral medications in the transition from the COVID-19 pandemic to endemic status.

But much like how the market in America has rejected the COVID-19 vaccines at this point, so too are these antivirals routinely for the most part, avoided despite the greenlight from the FDA. In fact, according to a recent study published in Open Forum Infectious Diseases, despite any surges in the number of COVID-19 cases, Americans tended to avoid these products.

In this prospective cohort study involving persons infected with COVID-19 between December 2021 and October 2022, the authors representing the CHASING COVID Cohort Study Team describe the uptake of Paxlovid (nirmatrelvir/ritonavir) and Molnupiravir (MOV) among a cohort of highly vaccinated adults across America.

Representing the authors is corresponding authors Yanhan Shen, MS, an epidemiologist and biostatistician at City University of New York (CUNY), Institute for Implementation Science in Population Health. Other authors are affiliated with CUNY and Pfizer.

Findings

While overall and not surprisingly, uptake did increase during the study period given surges in underlying COVID-19, overall demand was depressed among the cohort under investigation. This was especially true among African Americans/Blacks and low income Americans.

For example, of those infected, in the study sample of 1,594 only 13.6% (95% confidence interval [CI], 11.9% to 15.2%) opted for Pfizer’s Paxlovid. The situation for Merck was far bleaker—out of 1,398 participants only 1.4% of infected individuals opted for MOV (95% CI, 0.8% to 2.1%).

Undoubtedly, due to a confluence of factors including company marketing and government promotion, Paxlovid use grew substantially during the study period. By December 2021 and March 2022, 1.9% of the total subgroup consumed the drug once infected. That percentage surged to 25.3% between August and October 2022. But the data supports the financial data TrialSite reports on Pfizer’s grim COVID-19 vaccine and antiviral sales numbers. See TrialSite “Pfizer Bloodbath? Collapse of COVID-19 Revenues.”

Given that during the entire study period a majority of participants could access antivirals (Paxlovid 85%; MOV 84%), the study team did find that individuals aged 65 and up opted to use the antivirals more than others. For example, among the elderly cohort Paxlovid use was higher at 30.2% (95% CI, 22.2% to 38.2).

Not surprisingly, participants with comorbidities had higher uptake rates as well.

Interestingly, although COVID-19 at least according to some studies impacted African Americans more than Whites and other racial groups, non-Hispanic Black participants opted to mostly stay away from the COVID-19 antivirals (7.2%[95% CI: 2.4%-12.0%]). Also, low-income groups avoided the products relative to other higher income groups (10.6%%[95% CI:7.3%-13.8%]).

What about persons with long COVID versus those without the condition? This cohort was found to take the Paxlovid more frequently (22.0% vs. 7.9%; P=0.001).

Of 216 persons prescribed Paxlovid, 137 (63%[95% CI: 57%-70%]) reported the antiviral as helpful in reducing symptoms.

https://www.trialsitenews.com/a/cuny-pfizer-study-covid-19-infected-vaxxed-americans-mostly-reject-pfizer-merck-antivirals-8a4cf5ec

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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)

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