New data from a US Centers for Disease Control and Prevention (CDC) database shows a possible link to stroke risk for older adults who received an updated Pfizer/BioNTech COVID-19 booster shot, but the signal is weaker than what the agency said earlier in January, health officials said Thursday.
U.S. Food and Drug Administration officials said they had found no link between the shots and strokes in two other safety-check databases.
The new data was presented at a meeting of outside experts who advise the FDA on vaccine policy.
Earlier this month, US health officials said they had discovered the possible link to ischemic strokes in people over age 65 who received the newer booster shots in the Vaccine Safety Datalink (VSD) database. They said at the time that it was very unlikely to represent any real clinical risk.
Dr. Nicola Klein of health care company Kaiser Permanente, which tracks VSD data for the CDC, said the number of strokes seen in the database had decreased in recent weeks, but the signal was still statistically significant, meaning it’s probably not a coincidence .
Most of the confirmed cases had also received a flu vaccine at the same time, which could be a factor, she said.
FDA scientist Richard Forshee said the agency plans to investigate whether there is an increased risk of stroke if the two injections are given at the same time.
Both agencies still recommend that older adults get the booster shots, now tailored for both Omicron variants and the original coronavirus.
Dr. Walid Gellad, a professor of medicine at the University of Pittsburgh, said the matter requires further investigation.
“Sometimes signals aren’t clear,” Gellad said in an email. “It makes sense to look at it more, and there’s no point in changing the practice given the known benefits (of getting the booster) in this age group.”
(Except for the headline, this story has not been edited by DailyExpertNews staff and is being published from a syndicated feed.)
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