CDC identifies possible ‘safety issue’ for some people receiving COVID vaccines

The Centers for Disease Control and Prevention (CDC) reports that a preliminary “safety signal” from the COVID-19 vaccine has been identified and is studying whether the bivalent Pfizer-BioNTech vaccine creates an increased risk of ischemic stroke in people aged 65 years and older.

In Friday’s statement, the CDC said the preliminary signal has not been identified with the Bivalent Moderna COVID-19 vaccine.

“Following the availability and use of updated (bivalent) COVID-19 vaccines, the CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, has met the statistical criteria to prompt an investigation. further to determine if there was a safety concern for ischemic stroke in people aged 65 and older who received the Pfizer-BioNTech COVID-19 vaccine, bivalent,” the CDC said.

“The signal rapid response investigation in the VSD raised the question of whether people 65 years of age and older who received the Pfizer-BioNTech COVID-19 vaccine, bivalent were more likely to have ischemic stroke within 21 days post-vaccination versus days 22-44 post-vaccination.”

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A syringe is prepared with the Pfizer COVID-19 vaccine at a vaccination clinic at the Keystone First Wellness Center in Chester, Pennsylvania on December 15, 2021.

A syringe is prepared with the Pfizer COVID-19 vaccine at a vaccination clinic at the Keystone First Wellness Center in Chester, Pennsylvania on December 15, 2021.
(AP Photo/Matt Rourke, File)

In the statement, the CDC pointed out that a large study of Pfizer-BioNTech’s updated bivalent vaccines “using the Centers for Medicare and Medicaid Services database found no increased risk of ischemic stroke.”

The agency also said the Vaccine Adverse Event Reporting System (VAERS) operated by the CDC and FDA has not seen an increase in the number of ischemic stroke cases following the update to the vaccine (bivalent).

In a statement to Fox News Digital, a Pfizer spokesperson said, “Pfizer and BioNTech have become aware of limited reports of ischemic strokes that have been observed in the CDC Vaccine Safety DataLink (VSD) database in people 65 years and older after vaccination with the bivalent COVID-19 vaccine adapted Omicron BA.4/BA.5 by Pfizer and BioNTech.

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Dartmouth University medical student Liesl Eibschutz loads a syringe with the Pfizer COVID-19 vaccine before giving it to people on the first day that people aged 16 and older can receive the vaccine at Kedren Health in Los Angeles on April 15, 2021.

Dartmouth University medical student Liesl Eibschutz loads a syringe with the Pfizer COVID-19 vaccine before giving it to people on the first day that people aged 16 and older can receive the vaccine at Kedren Health in Los Angeles on April 15, 2021.
(Allen J. Schaben/Los Angeles Times via Getty Images)

“Neither Pfizer and BioNTech, nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar results in many other surveillance systems in the U.S. and around the world and there is no no evidence to conclude that ischemic stroke is associated with business use. ‘ COVID-19 vaccines,” the spokesperson continued.

“Compared to the published incidence rates of ischemic strokes in this older population, the companies have observed a lower number of ischemic strokes reported to date following vaccination with the adapted bivalent Omicron BA.4/BA.5 vaccine. The CDC continues to recommend vaccination with the Pfizer-BioNTech Omicron BA.4/BA.5 tailored bivalent COVID-19 vaccine for all ages and all licensed indications.

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This August 2022 photo shows vials of Pfizer's updated COVID-19 vaccine during production in Kalamazoo, Michigan.

This August 2022 photo shows vials of Pfizer’s updated COVID-19 vaccine during production in Kalamazoo, Michigan.
(Pfizer via AP)

The CDC does not recommend a change in vaccine practice.

Fox News medical contributor Dr. Marc Siegel said that was not “proof” of a link between the vaccine and strokes.

“It’s not evidence. It’s that they see there may be a connection here, and they want to investigate it, and they’re trying to be transparent,” he said.

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