The Centers for Disease Control and Prevention (CDC) says that data collected on the Pfizer-BioNTech COVID-19 vaccine merits an investigation into potential stroke risks for people aged 65 and older.
"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," reads a Friday statement.
"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," the release continues.
The bivalent vaccine includes "a component of the original virus strain to provide broad protection against COVID-19 and a component of the omicron variant to provide better protection against COVID-19 caused by the omicron variant," according to the FDA.
The agency notably did not see the same "preliminary signal" that prompted the investigation in the Moderna vaccine.
The agency added that it's "very unlikely that the signal in VSD represents a true clinical risk," and doesn't recommend any changes to vaccine protocols at this time.
According to Rep. Cathy McMorris Rodgers (R-WA), who chairs the House Commmerce Committee, has called on the CDC to "rapidly investigate" the matter.
"The lack of transparency over the past three years has broken Americans’ trust in our public health agencies," said McMorris in a Friday statement. "CDC and FDA have systems in place to monitor vaccine safety that have identified this preliminary signal."
"Now these agencies must rapidly investigate, in an open and transparent manner, whether or not the vaccine may have contributed to the reported strokes."