Wednesday, September 16, 2020

Monitoring Safety of Vaccines

Post-Marketing Safety of Vaccines Approved
by the U.S. Food and Drug Administration

  

Dr. Narayan Nair, Director for Division of Epidemiology in the Office of Biostatistics and Epidemiology within the FDA Center for Biologics Evaluation and Research, will highlight how the FDA monitors the safety of vaccines, including potential vaccines for prevention of COVID-19. He will also describe how the Vaccine Adverse Event Reporting System (VAERS) is utilized, along with its strengths and limitations.

The clinical significance of emerging post marketing vaccine-related safety issues have not been systematically previously studied. Dr. Daniel Shepshelovich, researcher at the Tel Aviv Sourasky Medical Center, will report on a study which aimed to describe the prevalence and characteristics of post-approval safety related vaccine label changes as well as the distribution of data sources triggering these modifications.

 

Speakers

 

	Monitoring Safety of Vaccines
	Narayan Nair, MD, Director, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
	Post-Marketing Safety of Vaccines Approved by the U.S. Food and Drug Administration
	Daniel Shepshelovich, MD, Medicine T, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

 

 

Series Partners

American Academy of Clinical Toxicology (AACT) | American Academy of Emergency Medicine (AAEM) | American Academy of Emergency Nurse Practitioners (AAENP) | American Association of Poison Control Centers (AAPCC) | American College of Medical Toxicology (ACMT) | Asia Pacific Association of Medical Toxicologists (APAMT) | Emergency Nurses Association (ENA) | European Association of Poison Centers and Clinical Toxicologists (EAPCCT) | Middle East & North Africa Clinical Toxicology Association (MENATOX)