Posted on 01/11/2023 4:14:29 PM PST by NoLibZone
Background 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.
Methods 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.
Findings
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.
Interpretation
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.
I’m so sorry.
My husband has had every booster, I wish he would stop.
The language is tortured.
What a tragic, sad story, Engedi. I’m so sorry for your loss. Best wishes to you for getting through this sad, sad time.
Prayers up for you and your family.
If the CDC told me that the sun was out at noon here in sunny New Mexico, I would go outside to check for myself.
A good test report starts with the results, and the confidence in the results. A casual reader can then quickly learn the findings and read further if they are interested in evaluating the how confident they are in the quality and believability of the authors.
The best way of hiding the results is to start out with the minutiae of the details, and then bury the findings among these minutiae. This report certainly does this. It’s also interesting that the html version of the document further hides the findings, compared with the pdf version.
I simply have no confidence in the authors of this report, based on these facts.
BTW, I am a working professional engineer, and have authored hundreds of test reports, and edited thousands more.
Thank you for your kind words.
Thank you for your kind words.
Thank you. I do believe he would be alive today had he not got the two shots that day.
Thank you. I do believe he would be alive today had he not got the two shots that day.
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