There is no question that vaccines provide substantial benefits to support and protect public health. To ensure their continued success, it is critical to continually assess vaccine safety. The Vaccines National Strategic Plan 2021–2025 (Vaccine Plan) supports efforts to innovate around vaccine safety systems in the second goal of the Vaccine Plan.
The agenda outlines the efforts of federal agencies on vaccine safety and the ongoing and planned associated scientific activities and interagency coordination that contribute to the safety system.
Below in three charts are the vaccine safety activities of our federal partners, including:
- Pre-licensure Vaccine Safety Activities
- Routine Vaccine Safety Monitoring and Research Systems
- Post-licensure Vaccine Safety Activities
Pre-licensure Vaccine Safety Activities
The evaluation of vaccine safety is an important component of vaccine research and development. Below is a summary of the scientific activities at this stage of vaccine development:
|Leading Institution||Vaccine Safety Activity||Scientific Agenda|
Identification and development of
Develop and provide resources to facilitate basic and applied research including the ability to assess vaccines for safety and immunogenicity
|NIH||Design of novel vaccine strategies||
Support research to explore novel vaccine technologies and strategies to improve the immunization profile
|NIH||Investigate the variability in human immune responses||Support research to understand the range of variability in the human population that impacts responses to vaccines and potential associations with AEFIs|
|NIH||Improving vaccine immunomodulators, administration, and formulations||Discover and develop novel adjuvants, alternative routes of administration, and formulations|
Develop pre-clinical models, and vaccine efficacy and safety screening methodology
|FDA||Study of pathogenicity||Study molecular mechanisms of pathogenicity and determine biomarkers of virulence that might improve the safety profile|
Routine Vaccine Safety Monitoring and Research Systems
The federal agencies and departments that oversee and coordinate vaccine safety evaluation continuously monitor and conduct research on the safety of marketed vaccines being administered to the public. Below is a summary of the routine federal vaccine safety systems:
|Leading Institution||Safety System||Objectives|
|CDC and FDA||Vaccine Adverse Event Reporting System (VAERS)||
Receives reports of possible adverse events from a variety of sources, including parents, providers, manufacturers, pharmacists, and the military, and rapidly detects “signals”: possible adverse events for follow up.
|CDC||Vaccine Safety Datalink (VSD)||
Rapidly tests, and confirms or rejects VAERS-generated signals. It links databases, including vaccination and medical records and allows for near real-time surveillance.
|CDC||Clinical Immunization Safety Assessment (CISA)||
Addresses vaccine safety issues, conducts high quality clinical research, and assesses complex clinical AEFIs
|FDA||Post-Licensure Rapid Immunization Safety Monitoring Program (PRISM)||
Monitors the safety of vaccines post licensure using a national large, linked electronic healthcare database and a variety of observational study designs, including near-real time surveillance
|DOD||Defense Health Agency-Immunization Healthcare Branch (DHA-IHB)||
Researches adverse events using electronic health records and can contact individuals when consultation for follow-up or care is needed. Can follow up on VAERS signal detections.
|DOD||Armed Forces Health Surveillance Center (AFHSC)||
Supports post-marketing database studies
|VA||Adverse Drug Event Reporting System (ADERS)||
Reports, tracks and monitors adverse events caused by medications and vaccines across the entire VA health care system using a passive surveillance system comparable and linked to VAERS.
|VA||Center for Medication Safety (VAMedSAFE)||
Obtains data from VA ADERS and VA Integrated Databases to track the safety of vaccines administered in the VA healthcare system.
Post-licensure Vaccine Safety Activities
Continued vaccine safety research is essential to advance knowledge of vaccine safety and inform clinical and public health practice. To that end, following vaccine licensure, all the federal partners collaborate to conduct comprehensive product-specific safety research. Below are some of the current vaccine safety research activities:
|Leading Institution||Vaccine Safety Research Topic||Research Plan|
|CDC and FDA||Vaccine recipient’s individual risk factors||(1) improve safety monitoring and assessment by defining which sub-populations should be monitored, (2) identify individuals at increased risk for AEFIs, (3) improve the clinical approaches to treating AEFIs, (4) develop advanced vaccines with a decreased likelihood of AEFI occurrence, and (5) enhance risk communication about the safety of vaccines, particularly with regard to groups identified at higher risk for AEFIs.|
|FDA||General vaccine safety studies||Research potential safety concerns of newly licensed products such as autoimmune diseases or anaphylaxis|
|FDA||Concomitant and multiple dose vaccine administration||Study potential AEFIs that may arise after administering concomitant vaccine doses and multiple dose vaccines given at recommended intervals|
|FDA||Study of vulnerable populations||Vaccine safety research on special populations such as pregnant women|
|FDA||Safety evaluation methodology testing||Improve sensitivity and eliminate analytic bias when studying vaccine administration outcomes|
|CDC||Prevention of AEFI||Assessment of vaccine products, dosing and administration to identify factors that could be modified to avoid AEFIs|
|CDC||Assessing safety of new vaccines||CDC monitors new vaccines after their introduction using spontaneous reporting systems, and conducts population-based surveillance using electronic health data|
|CDC||Assessing vaccine safety in understudied populations||Special populations, such as pregnant women, immune deficient patients, and special ethnicities, have been historically excluded from vaccine clinical trials. CDC evaluates vaccine safety among these populations as well|
|CDC||Continued research on statistical methods and study design||Because of the complexity of studying populations receiving vaccines, sophisticated statistical methods and study designs are being developed and refined for both active and passive surveillance. Continuing to refine near real-time surveillance techniques (e.g., rapid cycle analysis, RCA)|
|CDC||Communications Research||Research on knowledge, attitudes, beliefs, and behaviors related to vaccine safety and AEFI reporting, and continuously improving strategies for communicating risks|
|DOD and VA||Pandemic Vaccination Safety||Utilizes near real-time analysis to identify possible safety signals|
|DOD||Detecting AEFIs in special populations||Pregnancy registries are mined to assess maternal and fetal/infant outcomes after vaccination|
|VA||Seasonal flu active safety surveillance||Identify possible adverse outcomes in the VA healthcare system such as GBS, anaphylaxis, Bell’s palsy, encephalitis, meningitis, idiopathic thrombocytopenia, optic neuritis, seizures and convulsions|
|VA||End of season analysis||Yearly assessment of influenza vaccine associated AEFIs in the VA healthcare system|