Vaccine safety datalink rapid cycle analysis

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.

Read the Vaccine Safety Scientific Agenda

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

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:

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. https://vaers.hhs.gov/about.html
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. https://www.cdc.gov/vaccinesafety/Activities/vsd.html
CDC	Clinical Immunization Safety Assessment (CISA)	Addresses vaccine safety issues, conducts high quality clinical research, and assesses complex clinical AEFIs http://www.cdc.gov/vaccinesafety/Activities/cisa...
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 http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability...
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. https://health.mil/vaccines
DOD	Armed Forces Health Surveillance Center (AFHSC)	Supports post-marketing database studies https://health.mil/afhsb
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. http://www.pbm.va.gov/PBM/vacenterformedicationsafety...
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. http://www.pbm.va.gov/vacenterformedicationsafety...

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

Monitoring vaccine safety using the vaccine safety Datalink: Assessing capacity to integrate data from Immunization Information systems.

Groom HC, Crane B, Naleway AL, Weintraub E, Daley MF, Wain K, Beth Kurilo M, Burganowski R, DeSilva MB, Donahue JG, Glenn SC, Goddard K, Jackson ML, Kharbanda EO, Lewis N, Lou Y, Lugg M, Scotty E, Sy LS, Williams JTB, Irving SA. Groom HC, et al. Vaccine. 2022 Jan 31;40(5):752-756. doi: 10.1016/j.vaccine.2021.12.048. Epub 2021 Dec 31. Vaccine. 2022. PMID: 34980508 Free PMC article.

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Vaccine safety datalink rapid cycle analysis

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