CDC identifies possible ‘safety concern’ for certain people receiving COVID vaccines

The Facilities for Illness Management and Prevention (CDC) says {that a} preliminary COVID-19 vaccine “security sign” has been recognized and is investigating whether or not the Bivalent Pfizer-BioNTech vaccine creates an elevated threat of ischemic stroke in folks 65 and older.

Within the Friday assertion, the CDC mentioned that the preliminary sign hasn’t been recognized with the Bivalent Moderna COVID-19 vaccine.

“Following the provision and use of the up to date (bivalent) COVID-19 vaccines, CDC’s Vaccine Security Datalink (VSD), a close to real-time surveillance system, met the statistical standards to immediate extra investigation into whether or not there was a security concern for ischemic stroke in folks ages 65 and older who obtained the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” the CDC mentioned. 

“Fast-response investigation of the sign within the VSD raised a query of whether or not folks 65 and older who’ve obtained the Pfizer-BioNTech COVID-19 Vaccine, Bivalent had been extra more likely to have an ischemic stroke within the 21 days following vaccination in contrast with days 22-44 following vaccination.”

In line with the CDC, an ischemic stroke “happens when blood clots or different particles block the blood vessels to the mind.”

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Within the assertion, the CDC identified that a big research of up to date bivalent vaccines from Pfizer-BioNTech “utilizing the Facilities for Medicare and Medicaid Providers database revealed no elevated threat of ischemic stroke.”

The company additionally mentioned that the Vaccine Adversarial Occasion Reporting System (VAERS) managed by CDC and FDA has not seen a rise in reporting of ischemic strokes following the up to date (bivalent) vaccine.

In a press release to Fox Information Digital, a spokesperson for Pfizer mentioned, “Pfizer and BioNTech have been made conscious of restricted stories of ischemic stroke which have been noticed within the CDC Vaccine Security DataLink (VSD) database in folks 65 and older following vaccination with the Omicron BA.4/BA.5-adapted bivalent COVID-19 Vaccine by Pfizer and BioNTech.”

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Liesl Eibschutz, a medical pupil from Dartmouth College, masses a syringe with Pfizer COVID-19 vaccine earlier than giving it to folks on the primary day that individuals ages 16 and up can obtain the vaccine at Kedren Well being in Los Angeles on April 15, 2021.
( Allen J. Schaben / Los Angeles Instances by way of Getty Photographs)

“Neither Pfizer and BioNTech nor the CDC or the U.S. Meals and Drug Administration (FDA) have noticed related findings throughout quite a few different monitoring techniques within the U.S. and globally and there’s no proof to conclude that ischemic stroke is related to the usage of the businesses’ COVID-19 vaccines,” the spokesperson continued. 

“In comparison with printed incidence charges of ischemic stroke on this older inhabitants, the businesses to this point have noticed a decrease variety of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine. The CDC continues to suggest vaccination with the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for all approved ages and indications.”

This August 2022 photograph exhibits vials of Pfizer’s up to date COVID-19 vaccine throughout manufacturing in Kalamazoo, Michigan. 
(Pfizer by way of AP)

The CDC is not recommending a change in vaccine follow.

Fox Information medical contributor Dr. Marc Siegel mentioned that this is not “proof” of a hyperlink between the vaccine and strokes.

“This isn’t proof. That is that they see there could also be a hyperlink right here, they usually need to examine it, they usually’re attempting to be clear,” he mentioned.