U.S. FDA, CDC see early signal of possible Pfizer bivalent COVID shot link to stroke

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U.S. FDA, CDC see early signal of possible Pfizer bivalent COVID shot link to stroke
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A safety monitoring system flagged that U.S. drugmaker Pfizer and German partner BioNTech's updated COVID shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/File Photoand German partner BioNTech's updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities.

The FDA and CDC said that other large studies, the CDC's Vaccine Adverse Event Reporting System, other countries' databases and Pfizer-BioNTech's databases had not flagged this safety issue, adding that it requires more investigation.

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