January 14, 2023 – A vaccine database has identified a possible link between Pfizer/BioNTech’s bivalent COVID-19 vaccine and ischemic strokes in people over 65 who received the shot, the CDC and FDA said in a joint press release.
The press release didn't recommend that individuals change their vaccination habits since the database findings were unlikely to pose a “real clinical risk.” The CDC said everyone, including people over 65, should keep their COVID vaccinations up up to now, including the bivalent booster shot.
The press release he said Data link on vaccine safety (VSD), “a near real-time surveillance system,” has raised safety concerns in regards to the Pfizer/BioNTech booster vaccine.
“A rapid examination of the signal in the VSD raised the question of whether people aged 65 years and older who received the Pfizer-BioNTech bivalent COVID-19 vaccine were more likely to experience ischemic stroke in the 21 days following vaccination compared with days 22 to 44 following vaccination,” the press release said.
Ischemic strokes are congestion of blood within the brain, often brought on by blood clots.
“Although the totality of the data currently suggests that it is very unlikely that the signal in the VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have done in the past when one of our safety monitoring systems detects a signal,” the press release said.
Pfizer/BioNTech, the Veterans Administration, the CDC and FDA-operated Vaccine Adverse Event Reporting System (VAERS), or other agencies that monitor vaccine reactions haven't identified an increased risk of stroke related to Pfizer's bivalent vaccine, the press release said. No safety concerns related to stroke have been identified with the bivalent vaccine Modera.
CNN, Citing a CDC official, the CDC reported that about 550,000 seniors who received Pfizer's bivalent booster shots were monitored by the VSD and 130 of them suffered a stroke inside three weeks of vaccination. None of those 130 people died, CNN reported. The official spoke on condition of anonymity because he was not authorized to share the information.
The issue will likely be discussed on the January meeting of the FDA's Vaccines and Related Biological Products Advisory Committee.
In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings in numerous other surveillance systems in the United States and around the world, and there is no evidence that ischemic strokes are associated with the use of the companies' COVID-19 vaccines.”
Bivalent boosters contain two vaccine strains – one to guard against the unique COVID-19 virus and one other that targets omicron subvariants.