1. Pink Sheet

Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax

 
• By Sarah Karlin-Smith

US vaccine surveillance systems were triggered, but so far further investigation clears the bivalent COVID vaccine of any new safety concern. CDC and FDA’s attempt to control the narrative appears to have backfired, however, making what looks to be a non-issue more controversial than it needed to be due to limited public communication.

Vaccine fake news
• Source: Shutterstock

Pfizer Inc./BioNTech SE’s bivalent COVID-19 vaccine is under continued investigation over a preliminary safety signal related to strokes in people ages 65, though thus far the signal identified in the Vaccine Safety Datalink has not been confirmed in other monitoring systems, leading regulators to conclude that it is very unlikely the signal represents a true clinical risk.

That news, made public on 13 January, should largely have represented a win for US public health agencies – demonstrating that systems put in place to rapidly warn of potential harms worked by quickly identifying a

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