The U.S. Centers for Disease Control and Prevention (CDC) has launched an investigation into Pfizer’s updated “boosters” after the government’s safety monitoring system detected a potential link between the pharmaceutical giant’s bivalent shots and strokes.
The CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, detected a spike in strokes in people over 65 years old who have received the vaccine booster shots.
Bivalent COVID vaccines were authorized by the FDA last August.
They were pushed through due to claims they would provide greater protection against the virus as it progressed into different strains, such as the Omicron variant.
According to the FDA, the updated boosters include a component of the original COVID strain along with a component from Omicron.
The CDC said in a statement that its VSD system detected data that “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 concerning VSD signal has caused the agency to question whether those 65 and older who received Pfizer’s bivalent COVID vaccine were at an increased risk of having an ischemic stroke up to three weeks after their vaccination compared to 22-44 days after the shot.
Moderna’s bivalent Covid vaccine was not identified for the same risk by its monitoring system, the CDC said.
Former National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci tried to downplay the CDC’s investigation into the detection.
Fauci told Fox News host Neil Cavuto that the detection “most likely is not going to be a relevant signal because several of the other surveillance and monitoring mechanisms that are put in place have not come up and found this signal.”
Fauci added that it is good that the CDC is letting the public know about what its surveillance system has detected.
However, the agency is “not changing any of the recommendations of getting people vaccinated with the bivalent booster,” he insisted.
The CDC added that there “may be other confounding factors contributing” to the VSD’s signaling of the Pfizer vaccine.
The federal agency emphasized that other studies conducted on Pfizer and Moderna bivalent vaccines did not validate the signal.
Furthermore, the agency said it is not responding to any increases in reports in the U.S. or other countries of ischemic strokes following the updated vaccine.
“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,” the CDC said.
Despite launching the new investigation, the government agency has not issued any changes to its vaccination recommendations.
The CDC continues to urge “everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination,” including those “eligible to receive an updated (bivalent) vaccine.”