Pfizer’s Bivalent COVID Booster Potentially Linked to Strokes, CDC Launches Investigation

The Centers for Disease Control and Prevention (CDC) announced Friday it has launched an investigation into Pfizer’s bivalent COVID booster after identifying a preliminary “safety signal” for ischemic strokes in people 65 and older.

This is the same COVID booster authorized by the FDA and CDC last August based on a “safety study” of only eight mice.

“CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” the CDC said in a statement. 

VSD showed people who received the bivalent booster were more likely to have an ischemic stroke in the 21 days following vaccination than days 22-42 following vaccination. This preliminary signal has not been identified with the Moderna bivalent booster shot, the agency added.

According to the agency, an ischemic stroke “occurs when blood clots or other particles block the blood vessels to the brain.”

The CDC, in its statement, said there might be other confounding factors contributing to the VSD safety signal, and other studies did not validate the signal, nor has it been identified in other countries following the rollout of updated boosters.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public,” the CDC said.

In an interview with Fox News host Neil Cavuto, Dr. Anthony Fauci said the finding “most likely is not going to be a relevant signal because several of the other surveillance and monitoring mechanisms that are put in place have not come up and found this signal.”

The CDC said its Vaccine Adverse Event Reporting System (VAERS) has not seen an increase in reporting of ischemic strokes following the bivalent vaccine. Yet, the most recent VAERS data show there have been 45,093 reports of blood-clotting disorders and 2,272 reports of ischemic strokes attributed to COVID-19 vaccines, including bivalent boosters.

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 people 65 and older following vaccination with the Omicron BA.4/BA.5-adapted bivalent COVID-19 Vaccine by Pfizer and BioNTech.”

“Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration 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 spokesperson added. 

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

In other words, Pfizer denies there’s a problem with its vaccine and holds the belief people who receive their bivalent booster have a lower incidence of ischemic strokes — a claim undoubtedly based on the false assertion COVID vaccines prevent severe COVID-19.