The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety
James Baggs,Julianne Gee,Edwin Lewis,Gabrielle Fowler,Patti Benson,Tracy A. Lieu,Allison L. Naleway,Nicola P. Klein,Roger Baxter,Edward A. Belongia,Jason M. Glanz,Simon J. Hambidge,Steven J. Jacobsen,Lisa A. Jackson,Jim Nordin,Eric Weintraub +15 more
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TLDR
With its recent enhancements, the VSD provides scientific expertise, continues to develop innovative approaches for vaccine-safety research, and may serve as a model for other patient safety collaborative research projects.Abstract:
The Vaccine Safety Datalink (VSD) project is a collaborative project between the Centers for Disease Control and Prevention and 8 managed care organizations (MCOs) in the United States. Established in 1990 to conduct postmarketing evaluations of vaccine safety, the project has created an infrastructure that allows for high-quality research and surveillance. The 8 participating MCOs comprise a large population of 8.8 million members annually (3% of the US population), which enables researchers to conduct studies that assess adverse events after immunization. Each MCO prepares computerized data files by using a standardized data dictionary containing demographic and medical information on its members, such as age and gender, health plan enrollment, vaccinations, hospitalizations, outpatient clinic visits, emergency department visits, urgent care visits, and mortality data, as well as additional birth information (eg, birth weight) when available. Other information sources, such as medical chart review, member surveys, and pharmacy, laboratory, and radiology data, are often used in VSD studies to validate outcomes and vaccination data. Since 2000, the VSD has undergone significant changes including an increase in the number of participating MCOs and enrolled population, changes in data-collection procedures, the creation of near real-time data files, and the development of near real-time postmarketing surveillance for newly licensed vaccines or changes in vaccine recommendations. Recognized as an important resource in vaccine safety, the VSD is working toward increasing transparency through data-sharing and external input. With its recent enhancements, the VSD provides scientific expertise, continues to develop innovative approaches for vaccine-safety research, and may serve as a model for other patient safety collaborative research projects.read more
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Launching PCORnet, a national patient-centered clinical research network
Rachael L. Fleurence,Lesley H. Curtis,Robert M. Califf,Richard Platt,Joe V. Selby,Jeffrey S. Brown +5 more
TL;DR: The Patient-Centered Outcomes Research Institute has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research.
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Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).
TL;DR: Fundamental vaccine safety concepts are described, an overview of VAERS is provided for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and how CDC and FDA analyze VAERS data are explained.
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Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices - United States, June 2021.
Julia W. Gargano,Megan J. Wallace,Stephen C. Hadler,Gayle E Langley,John R. Su,Matthew E. Oster,Karen R. Broder,Julianne Gee,Eric Weintraub,Tom T. Shimabukuro,Heather M. Scobie,Danielle Moulia,Lauri E. Markowitz,Melinda Wharton,Veronica V. McNally,Jose R. Romero,H. Keipp Talbot,Grace M. Lee,Matthew F. Daley,Sara E. Oliver +19 more
TL;DR: In 2019, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID19 (mRNA-1273) vaccine, and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively as mentioned in this paper.
Journal ArticleDOI
Surveillance for Adverse Events After COVID-19 mRNA Vaccination.
Nicola P. Klein,Ned Lewis,Kristin Goddard,Bruce Fireman,Ousseny Zerbo,Kayla E. Hanson,James G. Donahue,Elyse O. Kharbanda,Allison L. Naleway,Jennifer C. Nelson,Stan Xu,W. Katherine Yih,Jason M. Glanz,Jason M. Glanz,Joshua T B Williams,Simon J. Hambidge,Bruno Lewin,Tom T. Shimabukuro,Frank DeStefano,Eric Weintraub +19 more
TL;DR: In this article, the authors present an interim analysis of safety surveillance data from Vaccine Safety Datalink for COVID-19 vaccination, with a risk interval of 21 days for individuals after either vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 2 or 3.
Journal ArticleDOI
Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures
Nicola P. Klein,Bruce Fireman,W. Katherine Yih,Edwin Lewis,Martin Kulldorff,Paula Ray,Roger Baxter,Simon J. Hambidge,James D. Nordin,Allison L. Naleway,Edward A. Belongia,Tracy A. Lieu,James Baggs,Eric Weintraub +13 more
TL;DR: Providers who recommend MMRV should communicate to parents that it increases the risk of fever and seizure over that already associated with measles-containing vaccines.
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Vaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United States
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