Postapproval Vaccine Safety Surveillance for COVID-19 Vaccines in the US
Grace M. Lee, José R. Romero, Beth P. Bell
Abstract
This Viewpoint reviews systems in place to monitor postlicensure vaccine safety, and recommends harmonizing end points and protocols across vaccine trials and surveillance systems to enable timely identification and reliable evaluation of potential adverse events.
Topics & Concepts
MedicineCoronavirus disease 2019 (COVID-19)Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Vaccine safety2019-20 coronavirus outbreakIdentification (biology)Intensive care medicineVirologyAdverse effectMedical emergencyImmunologyImmunizationOutbreakPathologyInfectious disease (medical specialty)PharmacologyDiseaseAntigenBiologyBotanyPharmacovigilance and Adverse Drug ReactionsPharmaceutical studies and practicesVaccine Coverage and Hesitancy