Federal health officials said Friday COVID-19 injections prepared by Pfizer Inc and its European partner BioNTech may increase the risk of stroke in older adults, according to a preliminary investigation by the the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
In a statement released Friday, federal health officials said the potential risk was flagged by a system that analyzes public health data.
The FDA posted the following statement:
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 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. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.
As part of its disclosure, the FDA downplayed the threat.
“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, as we have in the past, when one of our safety monitoring systems detects a signal,” the FDA said.
As such, the FDA and CDC are still recommending the injections.