New data from a CDC (Centers for Disease Control and Prevention) database in the United States shows a possible risk of stroke (cerebrovascular accident) for older adults who received Pfizer’s updated Covid19 vaccine /BioNTech. However, the signal is weaker than the agency signaled in early January, health authorities said on Thursday (26).
Officials at the FDA the drugregulatory agency similar to Anvisa in Brazil said they found no link between the vaccines and stroke in two other safety monitoring databases.
The new data were presented at a meeting of outside experts who advise the FDA on vaccination policy.
Earlier this month, US health officials said they had discovered the possible link to ischemic strokes in people over 65 who received the new booster shots in their Vaccine Safety Datalink (VSD) database.
They said at the time that it was very unlikely to pose any real clinical risk.
Nicola Klein of the Kaiser Permanente healthcare company, which maintains the VSD data for the CDC, said the stroke rate in the database has been declining in recent weeks, but the signal is still statistically significant, meaning it’s probably not a fluke.
Most confirmed cases also received flu shots at the same time, which could be a factor, he said.
FDA scientist Richard Forshee said the agency plans to investigate whether there is an increased risk of stroke from giving the two injections at the same time.
Both agencies continue to recommend that older adults receive booster shots, now tailored for Omicron subvariants as well as the original coronavirus.
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