Califf: FDA Vaccine Safety Oversight Would Be Enhanced By Federal Public Health Data Authority
US FDA continues to push for new federal funding and authorities to improve vaccine safety surveillance.
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US FDA Investigating Concomitant Flu, COVID Vaccine Link To Stroke Safety Signal
No stroke risk has been identified, but FDA and CDC officials want to investigate whether concomitant administration of influenza and COVID-19 vaccines are related to the issue.
Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax
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.
Artificial Intelligence Is Future Of Postmarketing Surveillance, US FDA’s Marks Says
CBER director’s vision for a national safety surveillance system includes use of AI and natural language processing to enable near-real time signal detection from adverse event reports.