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Stroke Risk With Bivalent COVID Vaccine
Kotalpa - 01/17/23 21:37

Stroke Risk With Bivalent COVID Vaccin

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.

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二泉映月 - 01/18/23 07:12

几亿人次用疫苗,出现1百多个某种副作用,不算严重。

Ares - 01/18/23 10:48

影响人数非常的多,以至于FAA悄悄修改了飞行员体检要求。

In the October 2022 version of the FAA Guide for Aviation Medical Examiners, the FAA quietly widened the EKG parameters beyond the normal range (from a PR max of .2 to unlimited). And they didn’t widen the range by a little. They widened it by a lot. It was done after the vaccine rollout.
This is extraordinary. They did it hoping nobody would notice. It worked for a while. Nobody caught it.
But you can’t hide these things for long.
This is a tacit admission from the US government that the COVID vaccine has damaged the hearts of our pilots. Not just a few pilots. A lot of pilots and a lot of damage.
The cardiac harm of course is not limited to pilots.