Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing.

Johannes C FischerAlbrecht G SchmidtEdwin BoelkeVerena KeitelTorsten FeldtBjörn JensenNoemi F FreiseDieter HäussingerE Marion SchneiderDerik HermsenDetlef Kindgen-MillesWolfram Trudo KnoefelJan HaussmannBalint TamaskovicsChristian PlettenbergKathrin ScheckenbachStefanie CorradiniJutta RoxVera BalzKitti MaasLivia SchmidtOlaf GrebeAnja EhrhardtPeter Arne GerberMatthias PeiperBettina Alexandra BuhrenArtur LichtenbergAmir RezazadehWilfried BudachChristiane Matuschek

Published in: European journal of medical research (2021)

Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.

Keyphrases

sars cov
transcription factor
randomized controlled trial
electronic health record
respiratory syndrome coronavirus
big data
adverse drug
drug induced