by Michael Ehrman
(Reuters) – An updated Pfizer/BioNTech COVID-19 booster shot from a U.S. Centers for Disease Control and Prevention (CDC) database shows a link to stroke risk in older adults, but the signal is weaker than the agency says. It marked the beginning of January, health officials said on Thursday.
US Food and Drug Administration officials said two other safety monitoring databases found no link between the shot and stroke.
The new information was presented at a meeting of outside experts who advise the FDA on vaccine policy.
Earlier this month, US health officials reported in the Vaccine Safety Datalink (VSD) database that they found an association with ischemic stroke in people over 65 who took the new booster. At the time, it was very unlikely to represent a real clinical risk, he said.
Dr. Nicole Klein of the health care company Kaiser Permanente, which maintains VSD data for the CDC, said the rate of strokes in the database has decreased in recent weeks, but the trend is still statistically significant, meaning it’s unlikely to be a coincidence.
Most of the confirmed cases received the flu vaccine at the same time, which could be a factor, she said.
FDA scientist Richard Forshey said the agency plans to study whether there is an increased risk of stroke from receiving the two shots at the same time.
Both agencies still recommend that seniors receive booster shots, now targeted for micron variants and the original coronavirus.
Dr. Walid Gelad, a professor of medicine at the University of Pittsburgh, said the issue needs further investigation.
“Sometimes symptoms are not clear,” Gelad said in an email. “Given the known benefits (of getting the reinforcement) in this age group, it makes sense to look into it more, and it doesn’t make sense to change the practice.”
(Reporting by Michael Ehrman; Editing by Bill Berkert)