CDC announces potential 'safety concern' related to Pfizer COVID-19 vaccine and strokes

The Centers for Disease Control and Prevention announced a "signal" related to whether there is a problem with ischemic stroke in individuals ages 65 and above who have had the updated Pfizer-BioNTech COVID-19 jab.

"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," a press release states.

"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 agency added. "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 press release states. "CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems."

The press release listed various other considerations which did not indicate an elevated ischemic stroke risk related to the vaccine.

"A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke," the press release stated. "A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine."

"The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine," the press release added. "Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine."

The CDC is still advising that individuals ages 6 months and above should keep up to date on their COVID-19 vaccinations.

"Pfizer and BioNTech have been made aware of limited reports of ischemic stroke that have been observed in the CDC Vaccine Safety DataLink (VSD) database in people 65 and older following vaccination with the Omicron BA.4/BA.5-adapted bivalent COVID-19 Vaccine by Pfizer and BioNTech," a Pfizer spokesperson noted in a statement to Fox News Digital.

"Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines," the Pfizer spokesperson added, according to the outlet. "Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine. The CDC continues to recommend vaccination with the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for all authorized ages and indications."

CDC Director Rochelle Walensky tested positive for COVID-19 in October 2022, after having already received an updated bivalent COVID-19 shot in September. She then took Paxlovid, tested negative, but then tested positive again.

"COVID-19 vaccines may not prevent every infection, but they do provide us important protection against severe illness, hospitalization, and death from COVID-19. My updated #COVID19 vaccine helped ensure my immune system was equipped to protect me against severe illness," Walensky said in a November tweet on the @CDCDirector Twitter account.

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