Impfungen - unnötig oder unbedingt notwendig?
28.04.2019 um 16:14geeky schrieb:Genau. Er hat weder was mit Impfungen zu tun noch mit der wissenschaftlichen Methode.Du betitelst andere am liebsten als dumm, bist aber nicht Mal annähernd in der Lage Analogien und komplexe Sachverhalte zu verbinden. Deswegen erkläre ich es dir nochmal.
Die Pharmaindustrie verschleiert Nebenwirkungen um Studien besser aussehen zu lassen und die Behörden ruhig zu stellen. Und jetzt zeige ich dir den Zusammenhang zwischen dem was ich gepostet habe und was das mit Impfstoffsicherheit zu tun hat. Das funktioniert am besten am Beispiel von Hexavac:
Der Fette Teil ist der wichtige für dich.
https://childrenshealthdefense.org/news/infant-deaths-following-vaccination-the-numbers-dont-lie-or-do-they/
GlaxoSmithKline neglected to report to regulatory authorities that there was a statistically significant increased risk of sudden infant death in the four days after administration of its hexavalent vaccine…
A 2017 commentary by India-based physicians Jacob Puliyel and C. Sathyamala in the Indian Journal of Medical Ethics describes a shocking dereliction of duty on the part of regulators who were presented with vaccine data carefully tailored to obscure serious risks. Tackling concerns about infant deaths that have occurred following hexavalent vaccination in several European countries, the authors of the commentary show that GlaxoSmithKline (GSK) neglected to report to regulatory authorities that there was a statistically significant increased risk of sudden infant death in the four days after administration of its hexavalent vaccine—and the regulatory agency in question (the EMA) ignored the omission and accepted GSK’s apparently whitewashed data at face value.
Problematic hexavalent vaccines and problematic analyses
Among world regions, European countries have taken the lead in incorporating hexavalent vaccines into their childhood vaccine schedules. Hexavalent vaccines are potent six-in-one combination shots covering diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type B. In 2000, the European Union (EU) approved two hexavalent vaccines—GSK’s Infanrix hexa and Sanofi Pasteur’s Hexavac—but suspended Hexavac five years later after a detailed analysis suggested that children who received the vaccine in their second year of life had an elevated risk of sudden death. The analysis by Drs. Puliyel and Sathyamala suggests that Infanrix hexa may be just as problematic as the discredited Hexavac vaccine.
In Europe, vaccine manufacturers routinely provide the EMA with pharmacovigilance documents called periodic safety update reports (PSURs). The PSURs are intended to be critical medical analyses that evaluate “new or changing safety data,” and the EMA relies on them to make or uphold its vaccine-related policies. In its PSURs for Infanrix hexa, GSK typically compares “expected” and “observed” deaths following hexavalent vaccination. If the observed deaths were to significantly exceed the expected deaths, GSK would be forced to report “an increased risk of sudden infant death following vaccination with Infanrix hexa.”
According to Drs. Puliyel and Sathyamala, GSK’s analyses have been marred by statistical maneuvers and flawed assumptions that enable the company to mask probable risks. For example, GSK’s calculation of expected deaths relies on assumptions that overestimate expected deaths, while the company gleans its figures for observed deaths through passive surveillance reports that are not actively solicited or investigated and are notorious for underestimating the true magnitude of adverse events. In the U.S., the Food and Drug Administration (FDA) estimates that passive surveillance captures about one percent of vaccine-related adverse events. A study in Africa that compared passive with active surveillance found that passive surveillance “failed to identify half of all AEFIs [adverse events following immunization] that were identified through active surveillance, including all of the serious AEFIs.”
Reviewing and reanalyzing GSK’s sudden death data from five PSURs (numbers 15-19), Drs. Puliyel and Sathyamala start with the earliest PSUR (number 15) and note a “clustering” of sudden deaths among infants (under age one) in the first three days following vaccination—with 72% of the deaths (42/58) taking place in that time frame and nearly all (93% or 54/58) occurring within 10 days of vaccination. The authors state:
“The fact that the rate of death decreases rapidly with the passage of time following immunization suggests that the deaths could be related to vaccination.”
Turning to the 19th PSUR (which should include all cumulative deaths reported in prior PSURs), Puliyel and Sathyamala note that the numbers in number 19 are not “consistent” with the numbers in the 16th PSUR; specifically, “the cumulative deaths reported are lower in the PSUR 19 than in the PSUR 16.” After correcting the data by restoring the missing deaths, the two authors find that “the number of observed deaths is significantly higher than expected for the first four days after vaccination” [emphasis added]. They suggest that GSK owes consumers and regulators an explanation as to why it did not report this statistically significant increased risk of infant death. They also caution:
“If one glosses over the deaths after vaccination, one can prevent/delay the evaluation of the vaccine’s safety profile and this has the potential to result in more, unnecessary deaths, which is difficult to justify ethically.”
Clinical evidence on hexavalent vaccines
Italian researchers have published clinical reports that suggest a relationship between Infanrix hexa and sudden infant death. In one case report, a three-month-old female infant died within 24 hours of vaccination with Infanrix hexa due to a likely anaphylactic reaction. The authors of the study suggest that anaphylaxis may be underreported as a vaccine-related outcome, given the difficulty of pinpointing which specific vaccine components were involved and the possibility that several ingredients (i.e., vaccine antigens, animal proteins, antibiotics) could be responsible.
Another analysis looked at 13 SIDS deaths that occurred one to seven days after administration of either Hexavac or Infanrix hexa (2000-2010) and likewise speculated that “vaccine components could have a direct role in sparking off a lethal outcome in vulnerable babies.” Elaborating on possible mechanisms, the authors stated: