PhRMA Aims To Clarify Use Of AERS Signals Through Data Mining Studies
While all sources of reports to FDA's Adverse Event Reporting System make significant contributions to signal detection, foreign sources appear to be one of the strongest contributors, preliminary results from a PhRMA-sponsored study of the database suggest
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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