Zdaj bo začel bluzit o Doning Krugerju, čeprav se ne zaveda, da je na napačnem koncu krivulje.
Covid-19 Cepiva
- Ustvarjalec teme AndY1
- Začetni datum
Si trd kot pohorski tonalit.
Če nimaš kontrolne skupine, potem ne modeš izračunati RRR (relative risk reduction), posledični niti ARR ni NNT
(Absolute risk reduction/ number needed to treat)
https://rumble.com/vobcg5-relative-vs-absolute-risk-reduction.html
Če nimaš kontrolne skupine, potem ne modeš izračunati RRR (relative risk reduction), posledični niti ARR ni NNT
(Absolute risk reduction/ number needed to treat)
https://rumble.com/vobcg5-relative-vs-absolute-risk-reduction.html
Kontrolna skupina je bila, relevantni podatki so bili izračunani. Točne številke so bile že večkrat prilimane., poglej si FDA/EMA dokumente.
Še enkrat, v čem je problem "unblindinga".
Covid-19 vaccines and treatments: we must have raw data, now
Covid-19 vaccines and treatments: we must have raw data, now
Data should be fully and immediately available for public scrutiny In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk...
Data should be fully and immediately available for public scrutiny
In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.
Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023
We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny.
Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information.23 This month, however, a judge rejected the FDA’s offer and ordered the data be released at a rate of 55 000 pages a month. The data are to be made available on the requesting organisation’s website (https://phmpt.org/).
Big pharma is the least trusted industry.30 At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars.31 One pleaded guilty to fraud.31 Other companies have no pre-covid track record. Now the covid pandemic has minted many new pharma billionaires, and vaccine manufacturers have reported tens of billions in revenue.32
Bo dovolj?
AndY1 si pa zabaven (pa vidi se da pomanjkanje vsebinskega razumevanja kompenziraš s intenzivnim kopiranjem tuje literature)
Na jasno vprašanje, kaj je problem "unblindinga" odgovoriš s vsebinsko povsem nepovezano tematiko, zabavni del zgodbe pa je pa so pri "unblindingu" dejansko bili razkriti podatki in to prehitro, kar je zelo zmotilo tebi podobne, ti pa prilimaš tekst, kako se tebi podobni pritožujejo o tem da je pri cepivih potrebno razkriti vse.
Na jasno vprašanje, kaj je problem "unblindinga" odgovoriš s vsebinsko povsem nepovezano tematiko, zabavni del zgodbe pa je pa so pri "unblindingu" dejansko bili razkriti podatki in to prehitro, kar je zelo zmotilo tebi podobne, ti pa prilimaš tekst, kako se tebi podobni pritožujejo o tem da je pri cepivih potrebno razkriti vse.
Dejstvo je, da vse okoli Pfizerjevega Covid cepiva, smrdi. Vse.
South Africa, for example, has set up a hub to begin developing mRNA vaccines where scientists, with the backing of the W.H.O., are trying to reverse-engineer the Moderna vaccine from scratch, because the U.S. drugmaker won’t share its technology.
Včasih so Kitajci delal, da so en avto kupil, ga razstavil in naredili kopijo... Sam tist ni bilo v redu a?
Did Pfizer Bribe Its Way Out of Criminal Charges in Nigeria?
WikiLeaks cables shed new light into one of Big Pharma's darkest hours
www.theatlantic.com
Hvala za tole. Si si že spricnu Moderno? Ce ne, imas se priloznost.
COVID-19: Moderna Gets Its Miracle
COVID-19 erased the regulatory and trial-related hurdles that Moderna could never surmount before. Yet, how did Moderna know that COVID-19 would create those conditions months before anyone else, and why did they later claim that their vaccine being tested in NIH trials was different than their commercial candidate?
COVID-19: Moderna Gets Its Miracle
COVID-19 erased the regulatory and trial-related hurdles that Moderna could never surmount before. Yet, how did Moderna know that COVID-19 would create those conditions months before anyone else, and why did they later claim that their vaccine being tested in NIH trials was different than their...
unlimitedhangout.com
Moderna Gets to Bypass Its Long-Standing Issues with R & D
Controversially, in order to begin its human trial on March 16, regulatory agencies had to allow Moderna to bypass major aspects of traditional animal trials, which many experts and commentators noted was highly unusual but was now deemed necessary due to the urgency of the crisis. Instead of developing the vaccine in distinct sequential stages, as is the custom, Moderna “decided to do all of the steps [relating to animal trials] simultaneously.” In other words, confirming that the candidate is working before manufacturing an animal-grade vaccine, conducting animal trials, analyzing the animal-trial data, manufacturing a vaccine for use in human trials, and beginning human trials were all conducted simultaneously by Moderna. Thus, the design of human trials for the Moderna vaccine candidate was not informed by animal-trial data.
This should have been a major red flag, given Moderna’s persistent difficulties in getting its products past animal trials. As noted in Part I, up until the COVID-19 crisis, most of Moderna’s experiments and products had only been tested in animals, with only a handful able to make it to human trials. In the case of the Crigler-Najjar therapy that it was forced to indefinitely delay, toxicity concerns related to the mRNA delivery system being used had emerged in the animal trials, which Moderna was now greenlighted to largely skip. Given that Moderna had subsequently been forced to abandon all multidose products because of poor results in animal trials, being allowed to skip this formerly insurmountable obstacle was likely seen as a boon to some at the company. It is also astounding that, given Moderna’s history with problematic animal trials, more scrutiny was not devoted to the regulatory decision to allow Moderna to essentially skip such trials.
Animal studies conducted on Moderna’s COVID-19 vaccine did identify problems that should have informed human trials, but this did not happen because of the regulatory decision. For example, animal reproductive toxicity studies on the Moderna COVID-19 vaccine that are cited by the European Medicines Agency found that there was reduced fertility in rats that received the vaccine (e. g., overall pregnancy index of 84.1% in vaccinated rats versus 93.2% in the unvaccinated) as well as an increased proportion of aberrant bone development in their fetuses. That study has been criticized for failing to report on the accumulation of vaccine in the placenta as well as failing to investigate the effect of vaccine doses administered during key pregnancy milestones, such as embryonic organogenesis. In addition, the number of animals tested is unstated, making the statistical power of the study unknown. At the very least, the 9 percent drop in the fertility index among vaccinated rats should have prompted expanded animal trials to investigate concerns of reproductive toxicity before testing in humans.
Yet, Moderna declined to further investigate reproductive toxicity in animal trials and entirely excluded reproductive toxicity studies from its simultaneous human trials, as pregnant women were excluded from participation in the clinical trials of its vaccine. Despite this, pregnant women were labeled a priority group for receiving the vaccine after Emergency Use Authorization (EUA) was granted for the Moderna and Pfizer/BioNTech vaccines. Per the New England Journal of Medicine, this meant that “pregnant women and their clinicians were left to weigh the documented risks of Covid-19 infection against the unknown safety risks of vaccination in deciding whether to receive the vaccine.”
Moderna only began recruiting for an “observational pregnancy outcome study” of its COVID-19 vaccine in humans in mid-July 2021, and that study is projected to conclude in early 2024.
Sem jokica. Pfizer sicer. Boš še kaj nalimal?Hvala za tole. Si si že spricnu Moderno? Ce ne, imas se priloznost.
COVID-19: Moderna Gets Its Miracle
COVID-19 erased the regulatory and trial-related hurdles that Moderna could never surmount before. Yet, how did Moderna know that COVID-19 would create those conditions months before anyone else, and why did they later claim that their vaccine being tested in NIH trials was different than their commercial candidate?
COVID-19: Moderna Gets Its Miracle
COVID-19 erased the regulatory and trial-related hurdles that Moderna could never surmount before. Yet, how did Moderna know that COVID-19 would create those conditions months before anyone else, and why did they later claim that their vaccine being tested in NIH trials was different than their...
Moderna Gets to Bypass Its Long-Standing Issues with R & D
Controversially, in order to begin its human trial on March 16, regulatory agencies had to allow Moderna to bypass major aspects of traditional animal trials, which many experts and commentators noted was highly unusual but was now deemed necessary due to the urgency of the crisis. Instead of developing the vaccine in distinct sequential stages, as is the custom, Moderna “decided to do all of the steps [relating to animal trials] simultaneously.” In other words, confirming that the candidate is working before manufacturing an animal-grade vaccine, conducting animal trials, analyzing the animal-trial data, manufacturing a vaccine for use in human trials, and beginning human trials were all conducted simultaneously by Moderna. Thus, the design of human trials for the Moderna vaccine candidate was not informed by animal-trial data.
This should have been a major red flag, given Moderna’s persistent difficulties in getting its products past animal trials. As noted in Part I, up until the COVID-19 crisis, most of Moderna’s experiments and products had only been tested in animals, with only a handful able to make it to human trials. In the case of the Crigler-Najjar therapy that it was forced to indefinitely delay, toxicity concerns related to the mRNA delivery system being used had emerged in the animal trials, which Moderna was now greenlighted to largely skip. Given that Moderna had subsequently been forced to abandon all multidose products because of poor results in animal trials, being allowed to skip this formerly insurmountable obstacle was likely seen as a boon to some at the company. It is also astounding that, given Moderna’s history with problematic animal trials, more scrutiny was not devoted to the regulatory decision to allow Moderna to essentially skip such trials.
Animal studies conducted on Moderna’s COVID-19 vaccine did identify problems that should have informed human trials, but this did not happen because of the regulatory decision. For example, animal reproductive toxicity studies on the Moderna COVID-19 vaccine that are cited by the European Medicines Agency found that there was reduced fertility in rats that received the vaccine (e. g., overall pregnancy index of 84.1% in vaccinated rats versus 93.2% in the unvaccinated) as well as an increased proportion of aberrant bone development in their fetuses. That study has been criticized for failing to report on the accumulation of vaccine in the placenta as well as failing to investigate the effect of vaccine doses administered during key pregnancy milestones, such as embryonic organogenesis. In addition, the number of animals tested is unstated, making the statistical power of the study unknown. At the very least, the 9 percent drop in the fertility index among vaccinated rats should have prompted expanded animal trials to investigate concerns of reproductive toxicity before testing in humans.
Neskončno limanje kretenizmov ter bedarij ni koristno.
Za bonus pa dostikrat niti ne razumeš, kaj prilimaš
