Big News: CDC, FDA Flag Early Signal of Stroke Risk

This is huge news, because the VSD database that produced the red flag for ischemic strokes (which comprise 80% of all strokes and are due to blood clots) has been analyzed by CDC in a manner that prevented it from showing red flags in the past.

No red flag for myocarditis, heart attacks, sudden deaths, Bell’s palsy, etc. In other words, they are using a bum algorithm or method that is designed to miss adverse event signals. Eventually CDC stumbled on a myocarditis signal in this database, but missed all the other obvious diagnoses. So if they are using the same crude technique and found strokes, that means there were a great deal of strokes, many more than would have been expected as the baseline rate.

Furthermore, the VSD is considered an active surveillance database of high reliability, which includes the medical records of 12 million Americans.

This announcement probably means that not only are the bivalent vaccines worthless, but they are also considerably more harmful than the earlier, monovalent vaccines, which is something I warned about on September 6 when they were rushed out. There was something very spooky about the CDC and FDA hiding of safety data on them, back then. Here is the story from totally pro-narrative MedPage Today:

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/102644

One surveillance system detects potential link in seniors, yet multiple others show none

by Ian Ingram, Managing Editor, MedPage Today January 13, 2023

An early signal of stroke risk was detected in older adults who received Pfizer-BioNTech’s bivalent COVID-19 vaccine, the FDA and CDC announced in a joint statement late on Friday, yet the agencies found no link in further analyses and are not recommending a change in COVID-19 vaccination practice.

According to the agencies, incidence of ischemic stroke in CDC’s Vaccine Safety Datalink (VSD) among individuals 65 and up in the 21 days following vaccination with Pfizer’s bivalent booster “met the statistical criteria to prompt additional investigation” when compared with the 22-44 days thereafter.

However, subsequent analyses of the Vaccine Adverse Event Reporting System, the Centers for Medicare & Medicaid Services database, and a preliminary study of the Veterans Affairs database turned up no signal for an increased risk with either Pfizer or Moderna’s bivalent vaccines, both of which were first authorized in late August.

Furthermore, Pfizer-BioNTech’s global safety database detected no signal for ischemic stroke with their updated vaccine, nor have surveillance systems from other nations.

“Often these safety systems detect signals that could be due to factors other than the vaccine itself,” the agencies stated. “All signals require further investigation and confirmation from formal epidemiologic studies. When one system detects a signal, the other safety monitoring systems are checked to validate whether the signal represents an actual concern with the vaccine or if it can be determined to be of no clinical relevance.”

The CDC and FDA noted that confounding factors may have contributed to the signal identified.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” they noted.

These and other data from vaccine safety systems will be presented at an already-scheduled January 26 meeting of FDA’s Vaccines and Related Biological Products Advisory Committee, according to the statement.

Source

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