TOPIC: Perspectives on Post-market Safety Surveillance of Vaccines
TOPIC DESCRIPTION: Pharmacovigilance and safety surveillance of vaccines spans the broad continuum of pre- and post-market settings and includes passive and active surveillance approaches. There is considerable effort focused on vaccine safety. FDA uses many sources of information in its ongoing assessments of vaccine safety including information submitted by the sponsor during the premarket phases, the Vaccine Adverse Event Reporting System (VAERS) (passive surveillance), the BEST (Biologics Effectiveness and Safety) system and Medicare databases (both active surveillance) as well as peer-reviewed literature, required periodic safety update reports, information from other US government agencies, international partners and other sources. FDA vaccine clinical and statistical experts review clinical study safety data submitted by the manufacturer in its considerations of licensure. FDA post-market safety staff also review Pharmacovigilance Plans (PVPs) submitted by the manufacturer as part of their Biologic License Application during the premarket review process and assess and recommend post-market studies to address potential or identified risks. For vaccines that are licensed there is ongoing review of safety by expert FDA physicians and epidemiological experts as part of its ongoing "safety throughout the lifecycle approach" which includes updates to evaluate and ensure a favorable vaccine benefit-risk profile as new safety information becomes available. Surveillance contributes to vaccine safety throughout the product lifecycle process that employs data infrastructure sources, analytics and methods that generate real-world evidence for updating product benefit-risk assessment profiles. This information supports risk management decisions and activities by regulators and healthcare providers aimed at improving product safety and the health of the American public. As a former FDA Office Director Dr. Anderson will share an overview and insights derived a long career at FDA and from recent vaccine surveillance experience during the pandemic and lessons learned for the new post-pandemic era of vaccine safety monitoring.
SPEAKER: Dr. Steven Anderson
SPEAKER BIOGRAPHY: Steve Anderson, Ph.D., M.P.P., is currently an Independent Consultant for SA Pharma Consulting LLC with expertise in pre- and post-market studies, epidemiology, real-world evidence, benefit-risk assessment and analytics. Part of his consulting work includes supporting the Gates Foundation (GF) in international pharmacovigilance capacity building. He has been involved in development of the African Union Smart, Safety, Surveillance (AU-3S) program since 2018. He also served as a member of the WHO Global Advisory Committee on Vaccine Safety (2020-2024) and was involved in COVID-19 Vaccine Safety and Maternal Immunization Safety Work Groups. He is also supporting some academic and private sector post-market drug safety and effectiveness evaluations and systems development. Prior to his work as a consultant, Dr. Anderson was the Director of the Office of Biostatistics and Pharmacovigilance (OBPV) at the FDA until January of 2025 after almost 25 years of service at the FDA. He led FDA post-market vaccine safety surveillance efforts for COVID-19 vaccines during the pandemic and provided leadership for all CBER statistical, epidemiological and surveillance programs as OBPV Director. He has led numerous important surveillance and epidemiological studies and quantitative benefit-risk assessments of vaccines, blood and advanced therapeutic products using systems such as VAERS, the FDA Sentinel and CMS data. In 2017, Dr. Anderson led the launch of the FDA Biologics Effectiveness and Safety (BEST) system, CBER's premier post-market risk identification and analysis system that engages new data sources, tools, new innovative technologies such as artificial intelligence, and experts to further enhance biologic product effectiveness and safety surveillance. Dr. Anderson earned a Master's Degree in Public Policy (MPP) at Georgetown University and his PhD in Biology from the University of Cincinnati where he worked in the areas of biochemistry, drug resistance and ion pumps, pathogenicity and genomics of unique tropical disease pathogens. He has published a number of articles in biologic product safety, surveillance, risk assessment, epidemiology, infectious diseases, and genomics.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied towards re-certification /continuing education from the following organizations:
| 1.5 pts |
RAC recertification from RAPS |
| 1.5 CEUs |
CCRP recertification from SOCRA |
| 1.5 CEUs |
CIP recertification from PRIM&R |