An updated version of the COVID-19 vaccine from US drugmaker Pfizer Inc and German partner BioNTech may be linked to a type of stroke in the elderly, according to preliminary data analyzed by US health authorities. . Reuters.

The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said Friday that the CDC’s vaccine database has identified a possible safety issue because people over age 65 are more likely to have an ischemic stroke within 21 day after administration of the Pfizer/BioNTech bivalent vaccine compared to 22-44 days.

An ischemic stroke, also known as cerebral ischemia, is caused by a blockage in the arteries that carry blood to the brain.

The FDA and CDC said other large studies, the CDC’s Adverse Reaction Reporting System, other countries’ databases and the Pfizer-BioNTech database did not see this safety issue, adding that more research is needed.

“Although the body of evidence currently suggests that the VSD (Vaccine Safety Datalink) signal represents a true clinical risk is highly unlikely, we believe it is important to make this information public,” the health authorities said.

Pfizer and BioNTech said in a statement that they had been alerted to reports of ischemic strokes in people aged 65 and over after vaccination with the updated version of the vaccine.

“Neither Pfizer and BioNTech, nor the CDC or FDA have seen similar results in numerous other surveillance systems in the US and around the world, and there is no evidence that ischemic stroke is associated with the use of COVID-19 vaccines,” the companies said . added (News.ro)