by Fabio Giuseppe Carlo Carisio
In the lates weeks the British Medical Journal blamed the Food and Drug Administration because had concealed the result of a big study of active pharmacovigilance, so not only based on individual and free reports to database (EudraVigilance managed by EMA in European Union and VAERS by CDC in US), instead focused also on a follow-up some vaccinees.
The statistical research named “Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older” was finally released by FDA and published on December, 1, 2022 by specialistic Journal of Vaccine and Elsevier by Science Direct.
The first signatory is Hui-Lee Wong, Associate Director for Innovation and Development Office of Biostatistics and Epidemiology, Center for Biologics Evaluation of US Food and Drug Administration, Silver Spring, MD, USA. The study is focused on data covering 30,712,101 elderly persons.
Below we report the Abstract in which FDA confirmed the alarms launched by many other studies since two years and more about the risk of 4 serious adverse reactions sometimes lethal: pulmonary embolism, acute myocardial infarction, disseminated intravascular coagulation, and immune thrombocytopenia.
These are the same side effects denounced by Gospa News in many scientific articles based on clinical researches or literary study.
The huge disturbing issue is on the pulmonary embolism because the danger of this autoimmune damage with mRNA sera was highlighted by two Chinese university on October, 2020 when the scientists asked to stop the advanced trial clinic on human guineas pig and to restart the research from the beginning on mice.
Instead this study was ignored by scientific community and FDA, CDC, EMA and in Italy AIFA went on with emergency use authorization under press ion of the will of Western governments, the US, EU, German and Italian ones above all, which was lobbied by Bill Gates, Pfizer and GSK (Pfizer partner) as we demonstrated in many investigations of WuhanGates cycle.
How many people was killed by these choices?
However, there are still very important limitations in this FDA study. First of all, the study reports statistics concerning only the mRNA vaccine produced by the pharmaceutical company Pfizer in New York and not the similar one from Moderna in Cambridge.
This may have been determined by the precise desire not to point the finger at Moderna’s biotechnology which was financed directly by Gates and by the US government through three instruments: Operation Warp Speed (which Pfizer renounced), grants from the military agency DARPA of the Pentagon and those of Anthony Fauci’s NIAID.
As we well know, thanks to this money, Cambridge’s Big Pharma managed to patent the active principle of its anti-Covid vaccine in March 2019, or nine months before the Covid-19 pandemic.
Another somewhat suspicious issue is that the FDA, after having approved bivalent boosters even for 6-month-old babies, continues to arbitrarily believe that the risk of these very serious side effects is lower than that deriving from a symptomatic infection with Covid-19 although by now any doctor on earth is aware that it can be easily treated with anti-inflammatories, antivirals and antibiotics if administered at the first symptoms (and not after 72 as supported by the criminal protocol of the Ministry of Health in Italy).
The third element that makes this research of little use in understanding the real seriousness of the adverse reactions of Pfizer-Biontech’s Comirnaty gene serum derives from the fact that it is limited to the over 65s while the more serious side effects and unexplained sudden illnesses are even more common among the under 4os and even more so among the under 20s.
That’s why, although the FDA study confirms what has already been claimed by thousands of serious doctors and scientists for two years now. it still proves to be too much in favor of Big Pharma which has been influencing the choices of Western governments for years.
Below is the summary and a commentary article by The Epoch Time science journalist Zachary Stieber.
Monitoring safety outcomes following COVID-19 vaccination is critical for understanding vaccine safety especially when used in key populations such as elderly persons age 65 years and older who can benefit greatly from vaccination. We present new findings from a nationally representative early warning system that may expand the safety knowledge base to further public trust and inform decision making on vaccine safety by government agencies, healthcare providers, interested stakeholders, and the public.
We evaluated 14 outcomes of interest following COVID-19 vaccination using the US Centers for Medicare & Medicaid Services (CMS) data covering 30,712,101 elderly persons. The CMS data from December 11, 2020 through Jan 15, 2022 included 17,411,342 COVID-19 vaccinees who received a total of 34,639,937 doses. We conducted weekly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination.
Four outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism (PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91), and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the mRNA-1273 or Ad26 COV2.S vaccines.
This early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.
Pfizer’s COVID-19 Vaccine Linked to Blood Clotting: FDA
by Zachary Stieber – originally published by The Epoch Time – All links to Gospa News articles have been added aftermath
Pfizer’s COVID-19 vaccine has been linked to blood clotting in older individuals, according to the U.S. Food and Drug Administration (FDA).
FDA researchers, crunching data from a database of elderly persons in the United States, found that pulmonary embolism—blood clotting in the lungs—met the initial threshold for a statistical signal and continued meeting the criteria after a more in-depth evaluation.
Three other outcomes of interest—a lack of oxygen to the heart, a blood platelet disorder called immune thrombocytopenia, and another type of clotting called intravascular coagulation—initially raised red flags, researchers said. More in-depth evaluations, such as comparisons with populations who received influenza vaccines, showed those three as no longer meeting the statistical threshold for a signal.
Researchers looked at data covering 17.4 million elderly Americans who received a total of 34.6 million vaccine doses between Dec. 10, 2020, and Jan. 16, 2022.
The study was published by the journal Vaccine on Dec. 1.
The FDA said it was not taking any action on the results because they do not prove the vaccines cause any of the four outcomes, and because the findings “are still under investigation and require more robust study.”
Pfizer did not respond to a request for comment.