The U.S. Centers for Disease Control and Prevention (CDC) on Friday announced the agency has been prompted to conduct an “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 called the move an expression of the agency’s commitment to “Transparency and vaccine safety.”
“U.S. government agencies use multiple, complementary safety monitoring systems to help detect possible safety signals for vaccines and other medical countermeasures as early as possible and to facilitate further investigation, as appropriate,” the announcement read.
The CDC’s Vaccine Safety Datalink (VSD) system found a potential safety concern for ischemic stroke in people ages 65 and older who received the Pfizer vaccine, leading to further investigation.
“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,” the announcement reads.
The VSD raised a question of whether people 65 and older who received the vaccine were more likely to have an ischemic stroke in the 21 days following vaccination compared to days 22-44, the release states.
While the CDC and the Food and Drug Administration (FDA) have become aware of this potential safety concern regarding the Pfizer-BioNTech shot in older people, the health agency maintains it is likely not a real risk and promised to continue to study the issue and will share updates with the public.
“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 CDC’s message says. “CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems.”
The CDC emphasized it made “no change is recommended in COVID-19 vaccination practice.”
