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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Abstract:

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

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

Staffing shortages, poor infection control plague nursing homes

Link: https://www.upi.com/Health_News/2024/03/01/nursing-home-staffing-shortage/8751709302182/

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Although the pandemic has ended, staffing shortages and employee burnout still plague U.S. nursing homes, a new government report finds.

But the problems didn’t end there: The report, issued Thursday by the Inspector General’s Office at the U.S. Department of Health and Human Services, showed that infection-control procedures were still sorely lacking at many facilities.

Not only that, COVID-19 booster vaccination rates remain far lower than they should be, with only 38% of residents and 15% of staff up-to-date on their shots, according to a recent KFF report.

Author(s): Robin Foster

Publication Date: 1 Mae 2024

Publication Site: UPI

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

Excess Death Rates for Republican and Democratic Registered Voters in Florida and Ohio During the COVID-19 Pandemic

Link: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2807617

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Key Points

Question  Was political party affiliation a risk factor associated with excess mortality during the COVID-19 pandemic in Florida and Ohio?

Findings  In this cohort study evaluating 538 159 deaths in individuals aged 25 years and older in Florida and Ohio between March 2020 and December 2021, excess mortality was significantly higher for Republican voters than Democratic voters after COVID-19 vaccines were available to all adults, but not before. These differences were concentrated in counties with lower vaccination rates, and primarily noted in voters residing in Ohio.

Meaning  The differences in excess mortality by political party affiliation after COVID-19 vaccines were available to all adults suggest that differences in vaccination attitudes and reported uptake between Republican and Democratic voters may have been a factor in the severity and trajectory of the pandemic in the US.

Abstract

Importance  There is evidence that Republican-leaning counties have had higher COVID-19 death rates than Democratic-leaning counties and similar evidence of an association between political party affiliation and attitudes regarding COVID-19 vaccination; further data on these rates may be useful.

Objective  To assess political party affiliation and mortality rates for individuals during the initial 22 months of the COVID-19 pandemic.

Design, Setting, and Participants  A cross-sectional comparison of excess mortality between registered Republican and Democratic voters between March 2020 and December 2021 adjusted for age and state of voter registration was conducted. Voter and mortality data from Florida and Ohio in 2017 linked to mortality records for January 1, 2018, to December 31, 2021, were used in data analysis.

Exposures  Political party affiliation.

Main Outcomes and Measures  Excess weekly deaths during the COVID-19 pandemic adjusted for age, county, party affiliation, and seasonality.

Results  Between January 1, 2018, and December 31, 2021, there were 538 159 individuals in Ohio and Florida who died at age 25 years or older in the study sample. The median age at death was 78 years (IQR, 71-89 years). Overall, the excess death rate for Republican voters was 2.8 percentage points, or 15%, higher than the excess death rate for Democratic voters (95% prediction interval [PI], 1.6-3.7 percentage points). After May 1, 2021, when vaccines were available to all adults, the excess death rate gap between Republican and Democratic voters widened from −0.9 percentage point (95% PI, −2.5 to 0.3 percentage points) to 7.7 percentage points (95% PI, 6.0-9.3 percentage points) in the adjusted analysis; the excess death rate among Republican voters was 43% higher than the excess death rate among Democratic voters. The gap in excess death rates between Republican and Democratic voters was larger in counties with lower vaccination rates and was primarily noted in voters residing in Ohio.

Conclusions and Relevance  In this cross-sectional study, an association was observed between political party affiliation and excess deaths in Ohio and Florida after COVID-19 vaccines were available to all adults. These findings suggest that differences in vaccination attitudes and reported uptake between Republican and Democratic voters may have been factors in the severity and trajectory of the pandemic in the US.

Author(s): Jacob Wallace, PhD1; Paul Goldsmith-Pinkham, PhD2; Jason L. Schwartz, PhD1

Publication Date: 24 July 2023

Publication Site: JAMA Internal Medicine

Public Health Agencies Try to Restore Trust as They Fight Misinformation

Link: https://khn.org/news/article/public-health-agencies-try-to-restore-trust-as-they-fight-misinformation/

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Across the country, health officials have been trying to combat misinformation and restore trust within their communities these past few years, a period when many people haven’t put full faith in their state and local health departments. Agencies are using Twitter, for example, to appeal to niche audiences, such as NFL fans in Kansas City and Star Wars enthusiasts in Alabama. They’re collaborating with influencers and celebrities such as Stephen Colbert and Akbar Gbajabiamila to extend their reach.

Some of these efforts have paid off. By now, more than 80% of U.S. residents have received at least one shot of a covid vaccine.

But data suggests that the skepticism and misinformation surrounding covid vaccines now threatens other public health priorities. Flu vaccine coverage among children in mid-December was about the same as December 2021, but it was 3.7 percentage points lower compared with late 2020, according to the Centers for Disease Control and Prevention. The decrease in flu vaccination coverage among pregnant women was even more dramatic over the last two years: 18 percentage points lower.

Other common childhood vaccination rates are down, too, compared with pre-pandemic levels. Nationally, 35% of all American parents oppose requiring children to be vaccinated for measles, mumps, and rubella before entering school, up from 23% in 2019, according to a KFF survey released Dec. 16. Suspicion swirling around once-trusted vaccines, as well as fatigue from so many shots, is likely to blame.

Author(s): Laurie Sausser

Publication Date: 3 Jan 2023

Publication Site: Kaiser Health News

Under Government Pressure, Twitter Suppressed Truthful Speech About COVID-19

Link: https://reason.com/2023/01/02/under-government-pressure-twitter-suppressed-truthful-speech-about-covid-19/?utm_medium=email

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Twitter’s ban on “COVID-19 misinformation,” which Elon Musk rescinded after taking over the platform in late October, mirrored the Biden administration’s broad definition of that category in two important respects: It disfavored perspectives that dissented from official advice, and it encompassed not just demonstrably false statements but also speech that was deemed “misleading” even when it was arguably or verifiably true. In a recent Free Press article, science writer David Zweig shows what that meant in practice, citing several striking examples of government-encouraged speech suppression gleaned from the internal communications that Musk has been disclosing to handpicked journalists.

Twitter’s moderation of pandemic-related content was intertwined with government policy from the beginning. Even before Joe Biden was elected president and his administration began publicly and privately demanding that social media companies suppress speech it viewed as a threat to public health, the company’s guidelines deferred to the positions taken by government agencies such as the Centers for Disease Control and Prevention (CDC). And those rules explicitly covered “misleading information” as well as “demonstrably false” statements.

….

That July, Twitter sought to clarify “our rules against potentially misleading information about COVID-19″ (emphasis added). “For a Tweet to qualify as a misleading claim,” the company said, “it must be an assertion of fact (not an opinion), expressed definitively, and intended to influence others’ behavior.” Possible topics included “the origin, nature, and characteristics of the virus”; “preventative measures, treatments/cures, and other precautions”; “the prevalence of viral spread, or the current state of the crisis”; and “official health advisories, restrictions, regulations, and public-service announcements.”

That was a very wide net, potentially encompassing anyone who questioned the CDC’s ever-shifting guidance or criticized government policies, such as lockdowns and mask mandates, aimed at reducing virus transmission. While the intent requirement ostensibly allowed dissent as long as it was not aimed at influencing behavior, that limitation did not mean much in practice, since moderators were apt to infer the requisite intent when they encountered tweets that implicitly or explicitly deviated from the recommendations of “public health authorities and governments.”

….

Another example that Zweig cites: Last August, @KelleyKga, a self-described “public health fact checker,” responded to another Twitter user’s claim that “COVID has been the leading cause of death from disease in children” since December 2021. “What an excellent example of cherry picking!” @KelleyKga wrote. “If you narrow it down to only the specific months you specify, which include the largest Covid wave (seen across the world), AND you ignore all non-disease deaths, AND you ignore cancer, heart disease, SIDS, then COVID is ‘leading.'”

Author(s): Jacob Sullum

Publication Date: 2 Jan 2023

Publication Site: Reason

Why Do Vaccinated People Represent Most COVID-19 Deaths Right Now?

Link: https://www.kff.org/policy-watch/why-do-vaccinated-people-represent-most-covid-19-deaths-right-now/

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The waning protection from vaccines is why CDC recommends recent booster shots, and why it’s especially important for people at higher risk to stay up-to-date on boosters. Per current recommendations, most adults should have received at least 2-3 booster doses by now (including the new bivalent booster), in addition to their primary series. However, only 14% of adults overall and 31% of older adults (65 years and older) have received the latest bivalent boosters. The CDC data show that about 95% of adults who died from COVID-19 in 2022 in these jurisdictions were over age 50, and about 8 in 10 were age 65 or older, underscoring the need for older adults to stay up-to-date on recommended booster shots.

The fall in the share of deaths that are among unvaccinated people could also be explained by changes in the unvaccinated population. By this far into the pandemic, it is estimated that many unvaccinated people have had COVID-19 at least once and while hundreds of thousands of unvaccinated people have needlessly died from COVID, those who survived may have gained some immune protection against the virus that can help protect them against severe outcomes when they have subsequent infections. However, this protection from a past infection can also diminish over time, which is why it is still recommended that unvaccinated people with prior COVID-19 infections get vaccinated and stay up-to-date on boosters.

Author(s): Cynthia Cox Follow @cynthiaccox on Twitter , Krutika Amin Follow @KrutikaAmin on Twitter , Jennifer Kates Follow @jenkatesdc on Twitter , and Josh Michaud Follow @joshmich on Twitter

Publication Date: 30 Nov 2022

Publication Site: KFF

State Surgeon General Dr. Joseph A. Ladapo Issues New mRNA COVID-19 Vaccine Guidance

Link: https://content.govdelivery.com/accounts/FLDOH/bulletins/3312697

Guidance: https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-doc.pdf?utm_medium=email&utm_source=govdelivery

Analysis: https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-analysis.pdf?utm_medium=email&utm_source=govdelivery

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Today, State Surgeon General Dr. Joseph A. Ladapo has announced new guidance regarding mRNA vaccines. The Florida Department of Health (Department) conducted an analysis through a self-controlled case series, which is a technique originally developed to evaluate vaccine safety.

This analysis found that there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group. Non-mRNA vaccines were not found to have these increased risks.

As such, the State Surgeon General recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines. Those with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when making this decision.

Author(s): Joseph A. Ladapo

Publication Date: 7 Oct 2022

Publication Site: Florida Dept of Health

KFF COVID-19 Vaccine Monitor: September 2022

Link: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-september-2022/

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Overall adult vaccination rates have been relatively steady over the past year. The latest COVID-19 Vaccine Monitor finds that nearly eight in ten adults (77%) say they have gotten at least one dose of a COVID-19 vaccine, including about half who say they are fully vaccinated and also received at least one booster dose (47%), about a quarter who have been fully vaccinated but have not gotten a booster (26%), and a small share who are partially vaccinated (3%). Twenty-three percent remain unvaccinated, the vast majority of whom say they will “definitely not” get the COVID-19 vaccine (88% of unvaccinated, or 21% of all adults). For the latest breakdown of self-reported vaccination rates by demographic group, see the Vaccine Monitor Dashboard.

In late August, the Food and Drug Administration authorized the use of new, updated COVID-19 vaccine boosters that target both the new omicron variants and the original strain of the virus. The bivalent boosters (one by Moderna and one by Pfizer) are now authorized for use by those ages 12 and older who have gotten an initial series of a COVID-19 vaccine, including those who have already received one or more boosters.

Awareness of the new boosters is modest, with about half of adults saying they have heard “a lot” (17%) or “some” (33%) about updated booster, 31% saying they have heard “a little,” and one in five saying they have heard “nothing at all” about the new booster doses.

Older adults and Democrats are somewhat more likely than their counterparts to say they have heard at least “some” about the new boosters, but fewer than a quarter across these groups report hearing “a lot” about the new shots.

Author(s): Grace Sparks Follow @gracesparks on Twitter , Lunna Lopes , Liz Hamel Follow @lizhamel on Twitter , Alex Montero , Marley Presiado , and Mollyann Brodie Follow @Mollybrodie on Twitter

Publication Date: 30 Sept 2022

Publication Site: Kaiser Family Foundation