A man is inoculated with the Pfizer-BioNTech COVID-19 vaccine at La Colaborativa in Chelsea, Mass., on Feb. 16, 2021. (Joseph Prezioso/AFP via Getty Images)
The Epoch Times
“As to your question on stroke, EMA can confirm that to date no such signal has been identified in the EU,” a spokesperson for the European Medicines Agency (EMA) told The Epoch Times via email on Jan. 20.
Salman Zarka, an Israeli health official, told reporters in a recent briefing that authorities had not detected a stroke signal for Pfizer’s bivalent booster, Israeli media reported.
“We did not find such a finding even after we went back and rechecked all our data after the announcement,” Zarka was quoted as saying. Israel’s Ministry of Health did not respond to a request for comment.
U.S. authorities announced this month that ischemic stroke met the threshold for a safety signal in a surveillance system that helps monitor vaccines among the elderly. The signal arose for Pfizer’s updated vaccine, which is a bivalent booster that was authorized by U.S. regulators in the fall of 2022.
U.S. authorities also detected signals for ischemic stroke and other types of stroke for the original Pfizer and Moderna vaccines among all adults in a different surveillance system, the Vaccine Adverse Event Reporting System (VAERS), according to records obtained by The Epoch Times.
The U.S. Centers for Disease Control and Prevention (CDC) said that other systems did not show an increased risk of ischemic stroke following vaccination with the Pfizer or Moderna bivalents, but did not release the results for outside researchers to verify.
The agency has also not said whether any of the stroke signals showed up for the original vaccines outside of the Vaccine Adverse Event Reporting System. The agency has not responded to requests for comment and Freedom of Information Act requests are pending.
Safety signals indicate a vaccine may cause certain side effects but additional evidence is needed to establish causality.
In a post-marketing evaluation (pdf) that was released by U.S. authorities after a lawsuit was filed, Pfizer reported 41 cases of ischaemic stroke following Pfizer vaccination through Feb. 28, 2021, as well as more than 200 other events that were “indicative” of the type of stroke. Ischaemic stroke is a different spelling of ischemic stroke.
The clinical trial (pdf) that led to the authorization of Pfizer’s vaccine recorded one case of ischaemic stroke in the vaccinated arm and one case in the placebo arm. There were more nervous system disorders logged in the vaccinated group than in the placebo group. A reanalysis of the initial trials for the Pfizer and Moderna vaccines found that the vaccinated were at higher risk of serious adverse events.
Pfizer and its partner BioNTech said in a joint statement that the companies were made aware of “limited reports of ischemic stroke” observed in the CDC’s Vaccine Safety DataLink system, the system that monitors vaccines among the elderly, following vaccination with their new shot.
“Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines,” the companies added.
Neither company responded to requests for comment.
Officials with the CDC and U.S. Food and Drug Administration plan to brief members of the latter’s vaccine advisory panel in a Jan. 28 meeting on safety monitoring. Authorities have not revised the clearance for the original or bivalent vaccines despite a growing awareness of side effects and possible side effects, and the CDC keeps recommending virtually all Americans not only receive a primary series, but at least one booster.
The bivalent boosters were authorized on Aug. 31, 2022, for many Americans without clinical data, and the CDC soon issued its recommendations. The authorization and recommendations were later broadened to include people as young as 6 months of age. Neither Pfizer nor Moderna has released clinical data for the new boosters as of Jan. 20.
Lia Onely contributed to this report.