Agencies: Report of link between Pfizer booster and strokes ‘unlikely’ to represent true risk

The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration issued a joint statement Friday saying, “It is very unlikely” that the COVID-19 booster shots made by Pfizer-BioNTech increase the risk of stroke in those over age 65, despite information from a vaccine monitoring system.

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The Vaccine Safety Datalink system flagged Pfizer-BioNTech’s updated COVID-19 bivalent shot, saying it had seen an increase in the risk of a type of stroke in older adults.

The monitoring system showed an uptick in the risk of an ischemic stroke in some older than 65 during the first 21 days after receiving the Pfizer bivalent shot, compared with days 22-44.

An ischemic stroke is caused by a blockage in arteries that carry blood to the brain.

Of the 550,000 people aged 65 and older who had received the Pfizer-BioNTech bivalent booster, 130 had ischemic strokes within 21 days of receiving the shot, the monitoring system showed.

The signal was specific to the Pfizer-BioNTech vaccine. The increased risk of stroke in those over age 65 did not appear in data on Moderna’s bivalent COVID-19 booster, nor in the original COVID-19 vaccines.

The CDC and the FDA said they found no other link to stroke in other studies of booster vaccines. The agencies noted that neither the Vaccine Adverse Event Reporting System, the Centers for Medicare & Medicaid Services database, nor a preliminary study of the Veterans Affairs database turned up any signal of increased risk with either the Pfizer or Moderna’s bivalent vaccines.

The agencies are not recommending a change in COVID-19 vaccination practice.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public,” the health authorities noted in the statement.

The joint statement did note that the report needs to be investigated further.

The bivalent boosters, aimed at the original virus and the omicron variant, were authorized for use in late August.

In a statement to Fox News Digital, a spokesperson for Pfizer 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 (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 spokesperson continued.

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