Authorities in Europe and Israel say they haven’t identified a safety signal for stroke related to Pfizer’s updated COVID-19 vaccine.
“As to your question on stroke, EMA [European Medicines Agency] can confirm that to date no such signal has been identified in the EU,” a spokesperson for the European Medicines Agency told The Epoch Times via email on Jan. 20.
Salman Zarka, an Israeli health official, told reporters in a recent briefing that authorities hadn’t 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 didn’t respond by press time to a request by The Epoch Times 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, according to records
obtained by The Epoch Times.
The U.S. Centers for Disease Control and Prevention (CDC) stated that other systems didn’t show an increased risk of ischemic stroke following vaccination with the Pfizer or Moderna bivalents, but didn’t release the results for outside researchers to verify.
The agency also hasn’t stated whether any of the stroke signals showed up for the original vaccines outside of the Vaccine Adverse Event Reporting System. The agency didn’t respond by press time to requests by The Epoch Times for comment, and Freedom of Information Act requests are pending.
Safety Evaluation
Safety signals indicate that 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 ischemic stroke following Pfizer vaccination through Feb. 28, 2021, as well as more than 200 other events that were “indicative” of the type of stroke.
The clinical trial (
pdf) that led to the authorization of Pfizer’s vaccine recorded one case of ischemic 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 variation of the vaccine.
“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 stated.
Representatives for each company didn’t respond by press time to requests by The Epoch Times for comment.
Bivalent Authorization
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 haven’t 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 that virtually all Americans receive not only 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.
