A NEAR real-time surveillance system has picked up a 'preliminary' safety signal indicating that Pfizer and BioNTech's Omicron-adapted COVID-19 booster vaccine is potentially linked to stroke in people 65 and older, the FDA and US Centers for Disease Control and Prevention (CDC) reported last week.
However, the agencies are not recommending changes to vaccination practice for now as the overall data suggests it is 'very unlikely' the signal represents a true clinical risk.
They noted that this preliminary signal, flagged by the Vaccine Safety Datalink (VSD), has not been identified with Moderna's bivalent shot.
The VSD is a collaboration between CDC and about a dozen healthcare organisations with electronic health records on 12m people.
Out of around 550,000 people aged 65-plus who received the Pfizer/BioNTech bivalent booster vaccine, 130 people had strokes (no deaths) in the first three weeks after being vaccinated.
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