The Centers for Disease Control and Prevention (CDC) says a preliminary COVID-19 vaccine “safety signal” has been identified and is investigating whether the bivalent Pfizer-BioNTech vaccine creates an increased risk of ischemic stroke in people 65 and older.
In the Friday statement, the CDC said the preliminary signal has not been identified with the Bivalent Moderna COVID-19 vaccine.
“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to request further investigation into whether there was a safety concern for ischemic stroke in humans aged 65 and older who received Pfizer-BioNTech COVID-1[ads1]9 vaccine, Bivalent,” the CDC said.
“Rapid-response investigation of the signal in VSD raised a question about people 65 years and older who have received Pfizer-BioNTech COVID-19 vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days after vaccination compared with days. 22-44 after vaccination.”
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In the statement, the CDC pointed out that a large study of updated bivalent vaccines from Pfizer-BioNTech “using the Centers for Medicare and Medicaid Services database showed no increased risk of ischemic stroke.”
The agency also said that the Vaccine Adverse Event Reporting System (VAERS) administered by the CDC and FDA has not seen an increase in reporting of ischemic strokes after the updated (bivalent) vaccine.
In a statement to Fox News Digital, a Pfizer spokesperson said, “Pfizer and BioNTech have been made aware of limited reports of ischemic stroke that have been observed in the CDC Vaccine Safety DataLink (VSD) database in individuals 65 and older following vaccination with the Omicron The BA.4/BA.5 adapted bivalent covid-19 vaccine from Pfizer and BioNTech.”
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“Neither Pfizer and BioNTech nor CDC or the US Food and Drug Administration (FDA) have observed similar findings across a number of other surveillance systems in the US and globally, and there is no evidence to conclude that ischemic stroke is associated with the companies’ use ‘ COVID-19 vaccines, the spokesperson continued.
“Compared to published rates of ischemic stroke in this elderly population, the companies to date have observed a lower number of reported ischemic strokes following vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine. CDC continues to recommend vaccination with the Pfizer- BioNTech Omicron BA.4/BA.5 customized bivalent covid-19 vaccine for all approved ages and indications.”
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The CDC does not recommend a change in vaccine practice.
Fox News medical contributor Dr. Marc Siegel said this is not “evidence” of a link between the vaccine and stroke.
“This is not evidence. This is that they see there may be a link here and they want to investigate it, and they are trying to be transparent,” he said.