All Myocarditis, Pericarditis Cases With COVID-19 Vaccines Now Must Be Reported To VAERS
The change to three vaccine emergency use authorizations was made quietly, most recently for the Novavax vaccine.
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FDA Real-Time Surveillance Not Practical For All Drugs, CDER’s Safety Surveillance Chief Says
Gerald Dal Pan indicated in an interview that the agency's safety systems as now constituted are generating the data needed and that so-called real-time surveillance, which is in place for COVID-19 vaccines and therapeutics, is not practical for all approved products.
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.