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
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 CDCannounced 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 databaseturned up no signal for an increased risk with either Pfizer or Moderna's bivalent vaccines, both of which were first authorizedin 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.
"Oftenthese safety systems detect signals that could be due to factors other than the vaccine itself," the agencies stated. (REALLY?, “often”—where is the proof of this statement?)
"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.
MY QUESTION TO THE CDC & FDA IS:
Are you going to actually PERFORM “formal epidemiologic studies” SINCE, IN YOUR OWN WORDS:
"ALL signals REQUIREfurther INVESTIGATION AND CONFIRMATION FROM formal epidemiologic studies.”
OR
are you going tochoose to do nothing but “share this information with the public” AND choose not to do the “REQUIRED further investigation AND confirmation FROM formal epidemiologic studies” because:
you “noted that confounding factors may have contributed to the signal identified.”
"Oftenthese safety systems detect signals that could be due to factors other than the vaccine itself," the agencies stated.
REALLY? DON’T YOU JUST LOVE THE TOTALLY UNSUPPORTED GENERALIZATION OF “often” these safety systems detect signals that could be due to factors other than the vaccine itself—where is the OBJECTIVE proof of this statement?
I THINK THE CDC & FDA WILL choose to do nothing but “share this information with the public” at the already-scheduled January 26 meeting of FDA's Vaccines and Related Biological Products Advisory Committee BECAUSE, as the FDA & CDC SUBJECTIVELY stated:
"Oftenthese safety systems detect signals that could be due to factors other than the vaccine itself,"
Yeah, & the signals could OBJECTIVELY be due to the vaccine UNLESS:
formal epidemiologic studies ARE DONE & CONFIRM that factors other than the vaccine are the cause of early safety signal of stroke risk that was detected in older adults who received Pfizer-BioNTech's bivalent COVID-19 vaccine.
The most efficient, effective, objective & safe decision for the FDA & CDC would be to just go with the World Council on Health Pharmacovigilance Report’s findings & just halt the Covid vaccination program, BUT, I HIGHLY DOUBT THAT WILL EVER HAPPEN.
