FDA sees preliminary safety signal for older users of Pfizer bivalent vaccine

The Centers for Disease Control and Prevention, or CDC, and the Food and Drug Administration, or FDA, announced that following the availability and use of the updated, bivalent COVID-19 vaccines, CDC’s Vaccine Safety Datalink, or 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 (PFE) and BioNTech (BNTX) 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. This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal," the agencies stated. "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. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. No change in vaccination practice is recommended," the agencies added. Reference Link