Observational studies of COVID vaccine efficacy are riddled with bias/ Not counting cases 14 days after dose 2 is a problem

Link:https://www.drvinayprasad.com/p/observational-studies-of-covid-vaccine

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In the experiment, he says, what if we compare the control arm of the Pfizer study against an imaginary vaccine arm. And for the thought experiment assume the vaccine is useless. As the table above shows, both groups have identical numbers of covid cases— just what you would expect from a useless vaccine. A straight forward analysis shows no benefit (second to last row)

But in the ‘fictional vaccine observational study’ cases are excluded for 36 days. When this is done the useless vaccine, looks like it reduces infections by 48%!!

Doshi makes a very good point in his paper that the solution is to subtract the 36 day infection rate from the observational control arm. Sadly most investigations don’t do that.

This is one of several biases Doshi discusses, and it plagues the vaccine literature.

Author(s): Vinay Prasad

Publication Date: 14 May 2024

Publication Site: Vinay Prasad’s Observations and Thoughts, substack

Reports of COVID-19 Vaccine Adverse Events in Predominantly Republican vs Democratic States

Link: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2816958?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=032924

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Importance  Antivaccine sentiment is increasingly associated with conservative political positions. Republican-inclined states exhibit lower COVID-19 vaccination rates, but the association between political inclination and reported vaccine adverse events (AEs) is unexplored.

Objective  To assess whether there is an association between state political inclination and the reporting rates of COVID-19 vaccine AEs.

Design, Setting, and Participants  This cross-sectional study used the AE reports after COVID-19 vaccination from the Vaccine Adverse Event Reporting System (VAERS) database from 2020 to 2022, with reports after influenza vaccines from 2019 to 2022 used as a reference. These reports were examined against state-level percentage of Republican votes in the 2020 US presidential election.

Exposure  State-level percentage of Republican votes in the 2020 US presidential election.

Main Outcomes and Measures  Rates of any AE among COVID-19 vaccine recipients, rates of any severe AE among vaccine recipients, and the proportion of AEs reported as severe.

Results  A total of 620 456 AE reports (mean [SD] age of vaccine recipients, 51.8 [17.6] years; 435 797 reports from women [70.2%]; a vaccine recipient could potentially file more than 1 report, so reports are not necessarily from unique individuals) for COVID-19 vaccination were identified from the VAERS database. Significant associations between state political inclination and state AE reporting were observed for all 3 outcomes: a 10% increase in Republican voting was associated with increased odds of AE reports (odds ratio [OR], 1.05; 95% CI, 1.05-1.05; P < .001), severe AE reports (OR, 1.25; 95% CI, 1.24-1.26; P < .001), and the proportion of AEs reported as severe (OR, 1.21; 95% CI, 1.20-1.22; P < .001). These associations were seen across all age strata in stratified analyses and were more pronounced among older subpopulations.

Conclusions and Relevance  This cross-sectional study found that the more states were inclined to vote Republican, the more likely their vaccine recipients or their clinicians reported COVID-19 vaccine AEs. These results suggest that either the perception of vaccine AEs or the motivation to report them was associated with political inclination.

Author(s):David A. Asch, MD, MBA1,2; Chongliang Luo, PhD3; Yong Chen, PhD2,4,5Author(s):

Publication Date: 29 Mar 2024

Publication Site: JAMA Network Open

Unhelpful, inflammatory Jama Network Open paper suggests that people in Red states dream up vaccine injuries

Link:https://www.drvinayprasad.com/p/unhelpful-inflammatory-jama-network?utm_source=post-email-title&publication_id=231792&post_id=143191018&utm_campaign=email-post-title&isFreemail=true&r=9bg2k&triedRedirect=true&utm_medium=email

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Now let’s turn to the paper. Here is what the authors find (weak correlation btw voting and vaccine injuries) , and here are the issues.

  1. These data are ecological. It doesn’t prove that republicans themselves are more likely to report vaccine injuries. It would not be difficult to pair voting records with vaccine records at an individual patient level if the authors wished to do it right— another example of research laziness.
  2. What if republicans actually DO have more vaccine injuries? The authors try to correct for the fact by adjusting for influenza adverse events.

Let me explain why this is a poor choice. The factors that predict whether someone has an adverse event to influenza vaccine may not be the same as those that predict adverse events from covid shots. It could be that there are actually more covid vaccine injuries in one group than another— even though both had equal rates of influenza injuries.

Another way to think of it is, there can be two groups of people and you can balance them by the rate with which they get headaches from drinking wine, but one group can be more likely to get headaches from reading without glasses because more people in that group wear glasses. In other words, states with more republicans might be states with specific co-morbidities that predict COVID vaccine adverse side effects but not influenza vaccine side effects. We already know that COVID vaccine injuries do affect different groups (young men, for e.g.).

Author(s): Vinay Prasad

Publication Date: 2 Apr 2024

Publication Site: Vinay Prasad’s Thoughts and Observations at substack

Mounting research shows that COVID-19 leaves its mark on the brain, including with significant drops in IQ scores

Link:https://theconversation.com/mounting-research-shows-that-covid-19-leaves-its-mark-on-the-brain-including-with-significant-drops-in-iq-scores-224216

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From the very early days of the pandemic, brain fog emerged as a significant health condition that many experience after COVID-19.

Brain fog is a colloquial term that describes a state of mental sluggishness or lack of clarity and haziness that makes it difficult to concentrate, remember things and think clearly.

Fast-forward four years and there is now abundant evidence that being infected with SARS-CoV-2 – the virus that causes COVID-19 – can affect brain health in many ways.

In addition to brain fog, COVID-19 can lead to an array of problems, including headaches, seizure disorders, strokes, sleep problems, and tingling and paralysis of the nerves, as well as several mental health disorders.

Author(s): Ziyad Al-Aly

Publication Date: 28 Feb 2024

Publication Site: The Conversation

Adele vs. Taylor Swift, Covid, and Entertainment Industry Pandemic Insurance

Link: https://www.nakedcapitalism.com/2024/02/adele-vs-taylor-swift-covid-and-entertainment-industry-pandemic-insurance.html

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Making those timelines — 2020, 2021, 2022, 2023, 2024 — really brought home to me how long this pandemic has been going on; I lost track in the daily grind (though the daily grind is also my form of coping). And it’s a bit discouraging to see the most solidarity our society seems capable of fizzle out after 2020, followed by a struggle to return to business as usual, a struggle that failed by 2024, in that a once-essential part of touring — contact with the fans — has now gone missing.

We can, of course, moralize about what how these artists have gone about their business:

To be fair, though, when CDC Director Mandy Cohen is swanning about with no mask, modeling how to infect everybody she breathes on, what’s a poor celebrity to do? Restoring social norms that support non-pharmaceutical interventions will probably take a whole-of-society approach (which could happen when those Tiktokers start doing their research).

Here, however, are two small steps artists like Adele and Taylor Swift could do to improve the Covid pandemic situation.

First, big acts could really help out smaller acts by supporting organizations like this one: [Clean Air Club]

Second, sell N95s at your concerts and on your websites as branded merch. K-Pop powerhouse Twice already does this (though KN94s, not N95s):

And if, by some happy chance, some intern from either organization reads this post, please champion these ideas!

Oh, and champion clean air, too. Who could be against that? Miasma delenda est!

Author(s): Lambert Strether

Publication Date: 28 Feb 2024

Publication Site: naked capitalism

Few Nursing Facility Residents and Staff Have Received the Latest COVID-19 Vaccine

Link: https://www.kff.org/medicaid/issue-brief/few-nursing-facility-residents-and-staff-have-received-the-latest-covid-19-vaccine/

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Uptake of the current COVID-19 vaccine is higher in non-profit facilities than in for-profit or government facilities (Figure 2). The percentage of nursing facility residents who received the updated vaccine is 46% in non-profit facilities compared with 35% in for-profit facilities and 43% in government facilities. Uptake of the fall 2022 vaccine was also highest in non-profit facilities and lowest in for-profit facilities. Rates of vaccine uptake for nursing facility staff were low in all types of facilities with minimal variation across facility types (data not shown).

Author(s): Priya Chidambaram and Alice Burns

Publication Date: 13 Feb 2024

Publication Site: KFF, Medicaid

Lessons Learned During the Pandemic Can Help Improve Care in Nursing Homes

Link: https://oig.hhs.gov/documents/evaluation/9808/OEI-02-20-00492.pdf

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OIG recommends that the Centers for Medicare & Medicaid Services (CMS):

1. Implement and expand upon its policies and programs to strengthen the nursing home workforce.

2. Reassess nurse aide training and certification requirements.

3. Update the nursing home requirements for infection control to incorporate lessons learned from the pandemic.

4. Provide effective guidance and assistance to nursing homes on how to comply with updated infection control requirements.

5. Facilitate sharing of strategies and information to help nursing homes overcome challenges and improve care.

CMS did not explicitly state its concurrence or nonconcurrence for the five recommendations.

Author: Christi A. Grimm

Publication Date: February 2024

Publication Site: Office of the Inspector General, HHS

Cognitive impairment after long COVID-19: current evidence and perspectives

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10423939/

Published online 2023 Jul 31. doi: 10.3389/fneur.2023.1239182

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COVID-19, caused by the SARS-CoV-2 virus, is a respiratory infectious disease. While most patients recover after treatment, there is growing evidence that COVID-19 may result in cognitive impairment. Recent studies reveal that some individuals experience cognitive deficits, such as diminished memory and attention, as well as sleep disturbances, suggesting that COVID-19 could have long-term effects on cognitive function. Research indicates that COVID-19 may contribute to cognitive decline by damaging crucial brain regions, including the hippocampus and anterior cingulate cortex. Additionally, studies have identified active neuroinflammation, mitochondrial dysfunction, and microglial activation in COVID-19 patients, implying that these factors may be potential mechanisms leading to cognitive impairment. Given these findings, the possibility of cognitive impairment following COVID-19 treatment warrants careful consideration. Large-scale follow-up studies are needed to investigate the impact of COVID-19 on cognitive function and offer evidence to support clinical treatment and rehabilitation practices. In-depth neuropathological and biological studies can elucidate precise mechanisms and provide a theoretical basis for prevention, treatment, and intervention research. Considering the risks of the long-term effects of COVID-19 and the possibility of reinfection, it is imperative to integrate basic and clinical research data to optimize the preservation of patients’ cognitive function and quality of life. This integration will also offer valuable insights for responding to similar public health events in the future. This perspective article synthesizes clinical and basic evidence of cognitive impairment following COVID-19, discussing potential mechanisms and outlining future research directions.

Author(s):Zhitao Li,# 1 , 2 , † Zhen Zhang,# 3 , † Zhuoya Zhang,# 4 , † Zhiyong Wang, 3 , * and Hao Li

Publication Date: 2023 Jul 31

Publication Site: Frontiers in Neurology

COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020

Link: https://oig.hhs.gov/oei/reports/OEI-02-20-00490.pdf

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The overall mortality rate in nursing homes rose 32 percent in 2020. The pandemic had far-reaching implications for all nursing home beneficiaries, beyond those who had or likely had COVID-19. Among all Medicare beneficiaries in nursing homes, 22.5 percent died in 2020, which is an increase of one-third from 2019 when 17.0 percent of Medicare beneficiaries in nursing homes died. This 32-percent increase amounts to 169,291 more deaths in 2020 than if the mortality rate had remained the same as in 2019. Each month of 2020 had a higher mortality rate than the corresponding month a year earlier.

Almost 1,000 more beneficiaries died per day in April 2020 than in the previous year. In April 2020 alone, a total of 81,484 Medicare beneficiaries in nursing homes died. This is almost 30,000 more deaths—an average of about 1,000 per day—compared to the previous year. This increase in number occurred even though the nursing home population was smaller in April 2020. Overall, Medicare beneficiaries in nursing homes were almost twice as likely to die in April 2020 than in April 2019. In April 2020, 6.3 percent of all Medicare beneficiaries in nursing homes died, whereas 3.5 percent died in April 2019.

The mortality rates also rose at the end of 2020. In November, 5.1 percent of all Medicare beneficiaries in nursing homes died, and in December that increased to 6.2 percent. Again, these rates are markedly higher than the previous year. In November 2019, 3.6 percent of all Medicare beneficiaries in nursing homes died, and, in December 2019, 3.8 percent did.

Author(s): Jenell Clarke-Whyte and team

Publication Date: June 2021

Publication Site: Office of Inspector General, HHS

CDC Downplayed News of Vax Myocarditis

Link: https://checkyourwork.kelleykga.com/p/cdc-downplayed-news-of-vax-myocarditis

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With the recent discovery that the CDC drafted — but never sent — a Health Alert in May 2021 about myocarditis after mRNA vaccination, I put together this timeline about vaccine myocarditis news and updates from government officials. I include a combination of documents from CDC and FDA, as well as what was covered in the mainstream media.

I think this timeline shows a pattern in which CDC & FDA failed to adequately investigate and inform the public about the risks of myocarditis early in the vaccine rollout. However, there was public acknowledgement by the CDC, as early as May 20, 2021, about a potential pattern of myocarditis after the 2nd dose of mRNA vaccines, particularly in young men.

On June 1, 2021, the CDC confirmed that they had identified a higher than expected signal of myocarditis for young men after mRNA vaccination, but that they still recommended Covid vaccination for everyone in this age group. Despite a lot more analysis and discussion of myocarditis after that, and a changing landscape with widespread natural immunity, the CDC & FDA position has changed very little since that time.

Author(s): Kelley in Georgia

Publication Date: 19 Jan 2024

Publication Site: Check your Work on substack

German death figures 2023 – almost back to normal, still a disturbing overall picture

Link: https://ulflorr.substack.com/p/german-death-figures-2023-almost

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Destatis yesterday published deaths figures for the whole of 2023. In order to obtain a reliable assessment of the situation, I calculated the weekly time series of life expectancy, applied an ARIMA forecast from the reference epoch 2016-2020 and compared it with the actual values. In this way, results are now available for all 4 pandemic years to date (Fig. 1)

Author(s): Ulf Lorre

Publication Date: 10 Jan 2024

Publication Site: Demographic Data Analysis

Pulse oximeters’ inaccuracies in darker-skinned people require urgent action, AGs tell FDA

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Link:https://www.statnews.com/2023/11/07/pulse-oximeters-attorneys-general-urge-fda-action/

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More than two dozen attorneys general are urging Food and Drug Administration officials to take urgent action to address disparities in how well pulse oximeters, the fingertip devices used to monitor a person’s oxygen levels, work on people with darker skin.

In a Nov. 1 letter, the AGs noted that it had been a year since the FDA convened a public meeting of experts, who called for clearer labeling and more rigorous testing of the devices, and that no action had been taken.

“We, the undersigned Attorneys General, write to encourage the FDA to act with urgency to address the inaccuracy of pulse oximetry when used on people with darker toned skin,” said the letter, written by California Attorney General Rob Bonta and signed by 24 other attorneys general.

Pulse oximeters’ overestimation of oxygen levels in patients with darker skin has, in a slew of recent research studies, been linked to poorer outcomes for many patients because of delayed diagnosis, delayed hospital admissions, and delayed access to treatment, including for severe Covid-19 infections. Higher amounts of pigments called melanin in darker skin interfere with the ability of light-based sensors in pulse oximeters to detect oxygen levels in blood.

….

The delay has frustrated health care workers who use pulse oximeters and have studied them and followed the progress toward creating new devices that work better. “I just get mad that these things are not on the market,” Theodore J. Iwashyna, an ICU physician at Johns Hopkins, told STAT. “Just last week in my ICU, I had a patient whose pulse oximeter was reading 100% at the same time that his arterial blood gas showed that his oxygen levels were dangerously low. I need these things to work, and work in all my patients.”

Author(s):Usha Lee McFarling

Publication Date: 7 Nov 2023

Publication Site: STAT News