Pubmed article- The mRNA-LNP vaccines - the good, the bad and the ugly?

[dhupverg]

Abstract

"The mRNA-LNP vaccine has received much attention during the COVID-19 pandemic since it served as the basis of the most widely used SARS-CoV-2 vaccines in Western countries. Based on early clinical trial data, these vaccines were deemed safe and effective for all demographics. However, the latest data raise serious concerns about the safety and effectiveness of these vaccines. Here, we review some of the safety and efficacy concerns identified to date. We also discuss the potential mechanism of observed adverse events related to the use of these vaccines and whether they can be mitigated by alterations of this vaccine mechanism approach."

 

https://pubmed.ncbi.nlm.nih.gov/38390323/#full-view-affiliation-1

 

Igyarto and Qin from the Department of Microbiology and Immunology, Thomas Jefferson University, Philadelphia, PA, United States, published a pointed review on the topic in Frontiers in Immunology.

 

 

 

[TallGuyJohninBKK]

Worth noting that at least several of the footnoted citations this article bases its claims on have been roundly dismissed as bogus anti-vax propaganda...

 

Such as:

 

48. Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, et al. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine (2022) 40:5798–805. doi: 10.1016/j.vaccine.2022.08.036

 

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"But experts have been highly critical of the Vaccine paper, and an abundance of other data contradict it. Experts and fact-checkers, including FactCheck.org, have said it has numerous problems.

 

One of the authors of the paper, Dr. Joseph Fraiman, an emergency medicine physician in Louisiana, joined a panel of contrarian experts gathered by Florida Gov. Ron DeSantis in December to falsely suggest the shots were too risky. As we’ve written, the paper was also cited in a report that falsely claims COVID-19 vaccines caused 310,000 excess deaths in 2021 and 2022. "

 

https://www.factcheck.org/2023/05/scicheck-covid-19-vaccine-benefits-outweigh-small-risks-contrary-to-flawed-claim-from-u-k-cardiologist/

 

AND

 

Peer review fail: Vaccine publishes antivax propaganda disguised as “reanalyses” of Pfizer and Moderna COVID-19 vaccine clinical trial data

 

In order portray COVID-19 vaccines as dangerous, Peter Doshi has now managed to get poorly designed and performed “reanalyses” of the clinical trial data used by the FDA to grant emergency use approval of the Pfizer and Moderna vaccines published in two reputable journals, The BMJ and Vaccine? What happened?

 

https://sciencebasedmedicine.org/peer-review-fail-vaccine-publishes-antivax-propaganda/

 

AND

 

Fact Check: Moderna, Pfizer Vaccines Do NOT Show Increased Risk Of Serious Adverse Events Of Special Interest In Randomized Trials

 

https://leadstories.com/hoax-alert/2022/07/fact-check-moderna-pfizer-vaccines-do-not-show-increased-risk-of-serious-adverse-events-of-special-interest-in-randomized-trials.html

 

[TallGuyJohninBKK]

And likewise with the following cited pre-print study that has been widely discredited:

 

3. McKernan K, Helbert Y, Kane LT, McLaughlin S. Sequencing of bivalent Moderna and Pfizer mRNA vaccines reveals nanogram to microgram quantities of expression vector dsDNA per dose. OSFpreprint (2023). doi: 10.31219/osf.io/b9t7m

 

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COVID-19 Vaccines Have Not Been Shown to Alter DNA, Cause Cancer

October 26, 2023

 

"Small amounts of DNA from the manufacturing process may remain in the mRNA COVID-19 vaccines. Purification and quality control steps ensure any leftover DNA is present within regulatory limits. There isn’t reason to think that this residual DNA would alter a person’s DNA or cause cancer, contrary to claims made online."

...

"We reached out to Kevin McKernan, an author on both preprints, to better understand his views. Rather than replying to our email, he posted a screenshot of it on X, formerly known as Twitter, and included responses there. McKernan, who has an undergraduate degree in biology, is the founder of Medicinal Genomics, a company that markets test kits and genomics-related services to the cannabis, hemp and mushroom industries."

...

Experts say there isn’t reason to think that any small pieces of leftover DNA, including SV40 DNA, in the vaccines would be harmful. 

“It is very unlikely that any residual DNA would integrate into a person’s genome and if it did it would be even much less likely to cause cancer,” Barry Milavetz, a molecular biologist who studies SV40 at the University of North Dakota, told us in an email.

 

https://www.factcheck.org/2023/10/scicheck-covid-19-vaccines-have-not-been-shown-to-alter-dna-cause-cancer/

 

AND

Return of the revenge of “vaccines permanently alter your DNA”

In a new twist on the “vaccines permanently alter your DNA” trope that antivaxxers love, a microbiologist named Kevin McKernan is falsely claiming that contaminating plasmid DNA from COVID-19 vaccines can get into the nucleus during cell division and “permanently alter your DNA” to horrible effect.

 

"Last week, I discovered a new antivax scientist named Kevin McKernan, whose message had been recently amplified by long time quack tycoon Joe Mercola. At the time, his false claim was that SV40 promoter sequences in plasmid DNA contaminating the Pfizer and Moderna mRNA-based COVID-19 vaccines were somehow putting people at risk for cancer. In my deconstruction, I pointed out that this claim was an even more ridiculous variation on an old antivax claim that oral polio vaccines from the late 1950s to 1963 that had been discovered to be contaminated with SV40 virus were responsible for a wave of cancer. They weren’t, but this antivax claim keeps coming back from the grave (going back a decade, at least), ready to party. This time is no different, except that the claim is even more ridiculous than the movie from which I adapted that tagline to describe it."

 

https://www.respectfulinsolence.com/2023/06/06/return-of-the-revenge-of-vaccines-permanently-alter-your-dna/

 

https://sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/

 

https://mediabiasfactcheck.com/science-based-medicine/

 

[TallGuyJohninBKK]

If the authors of the OP cited study are using these kind of garbage, discredited anti-vax "studies" as the basis for their findings, one has to wonder just how credible their own work and conclusions may be...

 

Must confess -- never before heard of the author of the OP cited study -- Botond Z. Igyártó.

 

 

[TallGuyJohninBKK]

And another one...similar to the junk above. I'm now clearly sensing a BAD "junk science" pattern here, with the latest example being the OP study's cited "research letter" below -- not a peer reviewed study -- posted by a trio of Danish researchers that also seems to have been discredited.

 

15. Schmeling M, Manniche V, Hansen PR. Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine. Eur J Clin Invest (2023) 53:e13998. doi: 10.1111/eci.13998

 

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Findings above reviewed by the prestigious Paul-Ehrlich-Institut in Germany, which is the German government's vaccine safety monitor

 

Statement from the Paul-Ehrlich-Institut: No batch-specific increases of reports of suspected vaccine side effects after COVID-19 vaccinations with Comirnaty

 

As of 18 August 2023

 

"The Paul-Ehrlich-Institut cannot confirm any batch-specific increases of reports of suspected vaccine side effects after COVID-19 vaccinations with the mRNA vaccine Comirnaty (BioNTech/Pfizer) [emphasis added] based on the analysis of the data from the prospective observational study with the SafeVac 2.0 app. A disproportionate increase of the number of adverse events reported in relation to certain Comirnaty batches used in Germany, as stated by the authors of a published research letter with data from Denmark (Schmeling et al. [1]), is not discernible in the evaluation of the SafeVac 2.0 data for the entirety of app-reported adverse events nor specifically for serious adverse events.

...

United Kingdom

In June 2022, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) published its evaluation of its spontaneous reporting scheme (Yellow Card) and the resulting response to the question of a link between suspected adverse event reports and certain batches of COVID-19 vaccine as part of a Freedom of Information Act request. These evaluations did not reveal any safety concerns related to individual batches. [emphasis added]

...

Notes to the publication by Schmeling et al. [1]

There are methodological deficiencies that severely limit the significance of the results in the published evaluation by Schmeling et al. [1]. [emphasis added]

 

https://www.pei.de/EN/newsroom/positions/covid-19-vaccines/statement-covid-19-vaccines-no-batch-specific-increases-suspected-side-effects.html

 

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And regarding one of the other co-authors of the OP cited Schmeling research letter -- Vibeke Manniche -- and again dismissing their general findings:

 

Analysis of adverse event variation between Pfizer COVID-19 vaccine batches doesn’t indicate safety problems

 

"Manniche also previously spread COVID-19 misinformation that was debunked by Danish fact-checking group TjekDet. In March 2020, Manniche called COVID-19 pandemic measures hysterical and falsely claimed that COVID-19 wasn’t actually spreading, writing on several occasions that there was no coronavirus epidemic on the way. In February 2021, she baselessly asserted that the Danish population had already achieved herd immunity.

 

Neither Campbell nor Manniche’s claims are sufficiently supported by the published research letter, as we will explain below.

 

https://healthfeedback.org/claimreview/analysis-adverse-event-variation-pfizer-covid-19-vaccine-batches-doesnt-indicate-safety-problems-contrary-john-campbell/