How is vaccine safety monitored after it’s been approved or authorized?

The FDA and CDC continue to closely monitor vaccine safety after the public begins using the vaccine. Both agencies have both longstanding and new safety systems in place for heightened monitoring of all COVID-19 vaccines. Learn more about the vaccine safety monitoring systems: 

CDC’s V-SAFE is a new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. Vaccine recipients can opt-in to receive text messages and web surveys from CDC on how to report health problems following COVID-19 vaccination. The system will also provide telephone follow-up to anyone who reports medically significant adverse events. The report will be submitted to the Vaccine Adverse Event Reporting System (VAERS) while keeping patient identity confidential. 

Vaccine Adverse Event Reporting System (VAERS) - VAERS is an early-warning system that collects and analyzes reports of any problems that happen after vaccination. Anyone can submit a report, including parents, patients, and health care professionals.

Vaccine Safety Datalink (VSD) - VSD is a collaboration between CDC and several health care organizations to monitor vaccine safety. The system analyzes healthcare information for over 24 million people to conduct studies about rare and serious adverse events after immunization.  Post-licensure Rapid Immunization Safety Monitoring (PRISM) - PRISM is the FDA’s immunization safety monitoring program. PRISM actively monitors the safety of medical products using electronic health information from over 190 million people. 

Clinical Immunization Safety Assessment Project (CISA) - CISA is a collaboration between CDC and seven medical research centers to answer complex safety questions. CISA conducts clinical research studies to further understand vaccine safety and recommend prevention strategies for adverse events following immunization. Vaccine recommendations may change if safety monitoring reveals new information about vaccine risks, such as a new serious side effect. The CDC, with the help of the Colorado Department of Public Health and Environment, will send safety alerts to health care providers. If necessary, a vaccine may be removed from the market.


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