COVID- 19 Vaccine Dangers, Side Effects, Controversy - Closed thread, please see scientific library

[sharon sanders]

Also - it is well known that batches of drugs can be bad. I do not have the links readily available but I have seen many, many FDA recalls over the years for batches. Same with the European health officials. Unfortunately - this is common.

[sharon sanders]

Thank you for posting the article but we can not post articles in their entirely due to US copyright law. Already US gov admin (allegedly) tried to control the internet via manipulation of the copyright laws by suing bloggers, etc. Please - snips only from published works. What would be easier is that the Epoch Times let people freely read at least 1/2 of their articles without requiring people's email.

[GardenSpider]

[QUOTE=GardenSpider;n972881]Study Shows 4.2 Percent of Pfizer COVID Vaccine Batches Made up Most Adverse Events, Raising Serious Concerns

https://www.theepochtimes.com/only-4...ender_A_health

In Denmark, 4.2 percent of Pfizer COVID-19 vaccine batches accounted for 71 percent of suspected adverse events (SAEs), according to Danish researchers in a recent study published in the European Journal of Clinical Investigation on March 30.

The study has raised serious concerns about the inconsistencies in the quality of different vaccine batches and the implications for vaccine recipients.

snip

Questionable Vaccine Quality

One study found that vaccine vials are not of equal quality across batches. Researchers suggested the individual vaccine vial should be considered when investigating serious adverse reactions such as anaphylaxis since it might be caused by a defective vial.

Researcher Craig Paardekooper, on his website HowBadIsMyBatch.com believes that batches are in fact different, and provides evidence showing that the number and severity of adverse events vary across different batch numbers.

This problem was not found only in Pfizer’s COVID-19 vaccines.

In 2021, after 39 vials were found to contain foreign materials, three lots of the Moderna vaccine totaling more than 1.6 million doses were recalled in Japan.

In April 2022, Moderna recalled 764,900 doses of its COVID-19 vaccine in Europe after contaminants were discovered in a vial.

Many factors contribute to variations in vaccine quality, including vaccine manufacturing, storage, transportation, and clinical handling.

In the United States, the Food and Drug Administration has issued guidance for COVID-19 vaccine development and licensing. But according to McCullough, there are no inspections of the final filled and finished vials required under Emergency Use Authorization.

“The lack of inspections has led to a safety disaster. Some unfortunate patients are getting too much mRNA, contaminants, or both, and thus are exposed to damaging and in some cases, lethal injections,” said McCullough.

Study Limitations
The authors of the Danish study acknowledged there are certain limitations to their study.

snip

The Epoch Times has contacted Pfizer for comment.

Update: This article has been update with additional information provided by Max Schmeling on April 14.

Marina Zhang contributed to this report.

[sharon sanders]

Study Shows 4.2 Percent of Pfizer COVID Vaccine Batches Made up Most Adverse Events, Raising Serious Concerns

https://www.theepochtimes.com/only-4...ender_A_health

In Denmark, 4.2 percent of Pfizer COVID-19 vaccine batches accounted for 71 percent of suspected adverse events (SAEs), according to Danish researchers in a recent study published in the European Journal of Clinical Investigation on March 30.

The study has raised serious concerns about the inconsistencies in the quality of different vaccine batches and the implications for vaccine recipients.

The Study
Danish researchers studied the rates of SAEs between different batches of the Pfizer-BioNTech vaccine, BNT162b2, which was administered in Denmark from December 27, 2020–January 11, 2022.

There were approximately 7.8 million doses administered to 3.7 million people from 52 different Pfizer vaccine batches during that time period.

SAEs of 43,496 were reported by 13,635 individuals, which was an average of 3.19 events per person.

“Unexpectedly, rates of SAEs per 1000 doses varied considerably between vaccine batches,” the researchers wrote in the publication.

--more

Here is the free and open access to the paper. No email registration required:



RESEARCH LETTER
Open Access

Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine

Max Schmeling, Vibeke Manniche, Peter Riis Hansen
First published: 30 March 2023

https://doi.org/10.1111/eci.13998

[Correction added on 13 April 2023, after first online publication: The corresponding author’s affiliation was updated in this version]
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To the Editor,

Vaccination has been widely implemented for mitigation of coronavirus disease-2019 (Covid-19), and by 11 November 2022, 701 million doses of the BNT162b2 mRNA vaccine (Pfizer-BioNTech) had been administered and linked with 971,021 reports of suspected adverse effects (SAEs) in the European Union/European Economic Area (EU/EEA).¹ Vaccine vials with individual doses are supplied in batches with stringent quality control to ensure batch and dose uniformity.² Clinical data on individual vaccine batch levels have not been reported and batch-dependent variation in the clinical efficacy and safety of authorized vaccines would appear to be highly unlikely. However, not least in view of the emergency use market authorization and rapid implementation of large-scale vaccination programs, the possibility of batch-dependent variation appears worthy of investigation. We therefore examined rates of SAEs between different BNT162b2 vaccine batches administered in Denmark (population 5.8 million) from 27 December 2020 to 11 January 2022.

Data on all SAE cases with corresponding vaccine batch labels reported to the Danish Medical Agency (DKMA) and classified by the DKMA according to SAE seriousness, and numbers of BNT162b2 doses in individual vaccine batches registered by the Danish Serum Institute, respectively, are publicly available and were retrieved upon request. The DKMA-managed spontaneous SAE reporting system accepts reports of SAEs from any source, for example healthcare providers, patients and other members of the public. SAEs are assigned Medical Dictionary for Regulatory Activities (MedDRA) terms that do not necessarily correspond to verified medical diagnoses, and more than 1 SAE may be assigned to a report. SAE seriousness was classified as non-serious, serious (hospitalization or prolongation of existing hospitalization, life-threatening illness, permanent disability or congenital malformation) or SAE-related death respectively. The study relied exclusively on the secondary use of these anonymized data and was thus exempt from research ethics board review. SAEs were counted on a batch level by linking individual SAEs to the batch label(s) of BNT162b dose(s) that the subject had received. The total number of SAEs associated with each batch was divided by the number of doses in the batch to obtain the rate of SAEs per 1000 doses. Since the observed relationship between the numbers of SAEs and BNT162b2 vaccine doses was highly heterogeneous, conventional regression statistics were not considered to be applicable. Therefore, heterogeneity in the relationship between the numbers of SAEs and doses per vaccine batch was assessed by log-transformation followed by non-hierarchical cluster analysis and general linear model (GLM) test for differences in SAE rates between batches. Reporting of the study conforms to broad EQUATOR guidelines.³

A total of 7,835,280 doses were administered to 3,748,215 persons with the use of 52 different BNT162b2 vaccine batches (2340–814,320 doses per batch) and 43,496 SAEs were registered in 13,635 persons, equaling 3.19 ± 0.03 (mean ± SEM) SAEs per person. In each person, individual SAEs were associated with vaccine doses from 1.531 ± 0.004 batches resulting in a total of 66,587 SAEs distributed between the 52 batches. Batch labels were incompletely registered or missing for 7.11% of SAEs, leaving 61,847 batch-identifiable SAEs for further analysis of which 14,509 (23.5%) were classified as severe SAEs and 579 (0.9%) were SAE-related deaths. Unexpectedly, rates of SAEs per 1000 doses varied considerably between vaccine batches with 2.32 (0.09–3.59) (median [interquartile range]) SAEs per 1000 doses, and significant heterogeneity (p < .0001) was observed in the relationship between numbers of SAEs per 1000 doses and numbers of doses in the individual batches. Three predominant trendlines were discerned, with noticeable lower SAE rates in larger vaccine batches and additional batch-dependent heterogeneity in the distribution of SAE seriousness between the batches representing the three trendlines (Figure 1). Compared to the rates of all SAEs, serious SAEs and SAE-related deaths per 1.000 doses were much less frequent and numbers of these SAEs per 1000 doses displayed considerably greater variability between batches, with lesser separation between the three trendlines (not shown).

The observed variation in SAE rates and seriousness between BTN162b2 vaccine batches in this nationwide study was contrary to the expected homogenous rate and distribution of SAEs between batches. In Denmark and other EU/EEA countries, vaccine quality is monitored according to Official Control Authority Batch Release (OCABR) guidelines and to our knowledge, potential differences in BNT162b2 vaccine batch clinical safety or effectiveness have not been reported previously, for example in pre-authorization trials and subsequent population-based studies.^{4, 5} Such effects may be easier to detect in small countries like Denmark where BNT162b2 vaccines during the study period were generally provided in several smaller batches. Also, regulatory monitoring and scientific interest in COVID-19 vaccine safety have primarily focused on serious adverse events, for example myocarditis.⁶ In any case, identification of such effects evidently requires that observed adverse events are linked with the respective individual batch labels and sizes (dose numbers). Previously, variation in the production (culture growth) of the Bacille Calmette-Guérin vaccine has been shown to influence important immunological effects of this vaccine,⁷ and two cases of myocarditis have been reported in two young males after receiving mRNA-1273 COVID-19 vaccine (Moderna) from the same vaccine batch on the same day.⁸ Indeed, variations (batch-to-batch, vial-to-vial and even dose-to-dose) in vaccines may occur as a result of variabilities and practice breaches in, for example vaccine manufacturing, storage, transportation, clinical handling and control aspects, and in 2021, three lots of the mRNA1273 vaccine totalling more than 1.6 million doses were recalled in Japan after 39 vials of the vaccine were found to contain foreign materials.⁹ Leaked and contested data have also suggested that some early commercial batches of the BNT162b2 vaccine contained lower than expected levels of intact mRNA.¹⁰
FIGURE 1
Open in figure viewerPowerPoint
Numbers of suspected adverse events (SAEs) after BNT612b2 mRNA vaccination in Denmark (27 December 2020–11 January 2022) according to the number of doses per vaccine batch. Each dot represents a single vaccine batch. Trendlines are linear regression lines. Blue: R² = 0.78, β = 0.0898 (95% confidence interval [CI] 0.0514–0.1281), green: R² = 0.89, β = 0.0025 (95% CI 0.0021–0.0029), yellow: R² = 0.68, β = 0.000087 (95% CI 0.000056–0.000118). Vaccine batches representing the blue, green and yellow trendlines comprised 4.22%, 63.69% and 32.09% of all vaccine doses, respectively, with 70.78%, 27.49% and 47.15% (blue trendline), 28.84%, 71.50% and 51.99% (green trendline), and 0.38%, 1.01%, and 0.86% (yellow trendline) of all SAEs, serious SAEs, and SAE-related deaths, respectively.
The present preliminary findings must be interpreted in the light of several limitations. The DKMA-managed spontaneous SAE reporting system in Denmark is a passive surveillance system akin to the Vaccine Adverse Event Reporting System (VAERS) in the US, and reports from these systems are subject to reporting biases, with potential for both under- and over-reporting, as well as incomplete data and variable quality of the reported information.^{11, 12} Owing to these inherent limitations, signals detected by these systems must be considered to be hypothesis-generating and generally cannot be used to establish causality.^11-14 In addition, in the present study, the SAE case history of prior COVID-19 was unknown, and specific SAE types (MedDRA system organ class etc.), demographics of SAE cases, relationships of SAEs with consecutive vaccine doses in individuals cases, temporal trends in the observed batch-dependency of SAEs, and batch-dependent effects on vaccine effectiveness, respectively, were not examined. Notably, to our knowledge, the Danish Serum Institute has not issued recalls of BNT162b2 vaccine batches. In conclusion, the results suggest the existence of a batch-dependent safety signal for the BNT162b2 vaccine, and more studies are warranted to explore this preliminary observation and its consequences.

https://onlinelibrary.wiley.com/doi/10.1111/eci.13998

[sharon sanders]

I believe this is a paper presented at 33rd European Congress of Clinical Microbiology & Infectious Diseases, which going on now in Copenhagen. The fact it is stored on a google product is irrelevant. https://www.eccmid.org/

[sharon sanders]

I am not going to give Epoch Times my email so that I can read their article.

[sharon sanders]

Do you have a Pfizer documents link that does not cost $?

[sharon sanders]

The links above require a payment or book purchase to read the Pfizer documents. I am not paying. Let's say you are correct and Pfizer lied - that still does not prove the vaccines are ineffective for the majority of the population. And Pfizer is not the only COVID-19 manufacturer....

Look at the trends:
2020...largest year for COVID-19 deaths when no vaccines or N95 masks were available.
2021-2023 COVID-19 deaths down as a percentage of the infections when vaccines became available and as more N95 masks were produced.
2020-2022 - excess deaths up...in a pandemic where a virus that damages the body's circulatory system becomes increasingly widespread and people become repeatedly infected by different strains.

Since most people have not taken the 5th dose, and even that was 6 months ago, how are the excess deaths applied now? Still vaccine related even after most people dropped off the booster regime by the end of 2021? We are in mid-year 2023 now.

I am not saying the vaccines are safe. I am trying to apply some logic to the situation.

[sharon sanders]

There is no link on this post.

[sharon sanders]

No. You do not understand the physics of N95 masks. It is not a strainer only affecting particles that are larger. They are electrostatic attracting all size particles where they stick to the fibers. Here is a video on this phenomena:

https://www.youtube.com/watch?v=eAdanPfQdCA

[GardenSpider]

This is confusing since, by Pfizer's own admission, the vaccine neither prevented illness nor transmission. And of course the number of severe CoVid-19 vaccine injures and deaths rigorously counted and verified, far exceed the number of "lives saved." So how can it have been worth it?

In fact the Pfizer Documents show that the more a person is vaccinated, the more likely they are to get CoVid-19. Indeed this is confounding given how vigorously the media continue to propagate information that is contradicted by their own source material in the Pfizer documents. The question remains, why do they continue to push a narrative that is not true, by their own admission?

The data points you show from Google --- documented as being government controlled and compromised, complied with government officials and Big Pharma to silence opposition and ensure maximum uptake of the jab at all costs, to ostensibly avert vaccine hesitancy.

So I think it's important to focus our attention on what's actually in the internal Pfizer Documents, that is, the documents they wanted hidden from the public for 75 years, for the truth. Read what they say-- in their own words. I think it will shake all readers to their very foundation.

[GardenSpider]

Study Shows 4.2 Percent of Pfizer COVID Vaccine Batches Made up Most Adverse Events, Raising Serious Concerns

https://www.theepochtimes.com/only-4-2-percent-of-pfizer-covid-vaccine-batches-accounted-for-71-percent-of-adverse-events-danish-study_5193114.html?ea_med=desktop_health&tmp=1&ea_src=ai_recommender_A_health

In Denmark, 4.2 percent of Pfizer COVID-19 vaccine batches accounted for 71 percent of suspected adverse events (SAEs), according to Danish researchers in a recent study published in the European Journal of Clinical Investigation on March 30.

The study has raised serious concerns about the inconsistencies in the quality of different vaccine batches and the implications for vaccine recipients.

The Study
Danish researchers studied the rates of SAEs between different batches of the Pfizer-BioNTech vaccine, BNT162b2, which was administered in Denmark from December 27, 2020–January 11, 2022.

There were approximately 7.8 million doses administered to 3.7 million people from 52 different Pfizer vaccine batches during that time period.

SAEs of 43,496 were reported by 13,635 individuals, which was an average of 3.19 events per person.

“Unexpectedly, rates of SAEs per 1000 doses varied considerably between vaccine batches,” the researchers wrote in the publication.

--more

[tetano]

Estimated number of deaths directly averted as a result of COVID-
19 vaccination


COVID-19 vaccinations have directly saved at least 1,004,927 lives between weeks 50/2020
and 12/2023, with the majority (95%) in those aged 60 years and older. Among this age
group, the first booster saved the most lives, accounting for 64% of lives saved. Overall,
across all age groups and countries or areas, vaccination were estimated to have saved the
largest number of lives during the Omicron wave: at least 568,064 deaths were averted
representing a 57% reduction in the number of deaths from what could have been expected.

https://drive.google.com/file/d/18Q58-zOcz2Z_BZX4YwJ19oekSqwAkk24/view

[GardenSpider]

Sharon, I encourage you to read the Pfizer Documents: the internal documents that Pfizer wanted to keep hidden from the public for 75 years.. It will change everything for those who read it. They are public thanks to a FOIA request and a judge who ordered the release. Now we know what Pfizer knew and when they knew it. We know they lied. And this lie continues to be perpetuated through, yes, the media. But read it for yourself. It's shocking. And eye opening.

[sharon sanders]

I disagree. I know of only one person who decided not to get any boosters due to negative personal experience. They reported a sore arm and temporary flu-like symptoms after the 2nd shot of the initial two shot protocol. The remainder of the people I know who have not taken boosters cite various general concerns about the vaccines safety to due information widely available in various media.

Imho all of this discussion is moot because even the people who took the 5th booster last fall are probably at the end of any lingering vaccine protection. So I guess we move forward into unknown territory or maybe back to 2020 when no vaccines or N95 masks were available.