Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Richard, Forshee"'
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 4, Pp 286-290 (2021)
Abstract As part of the US Food and Drug Administration (FDA)’s Prescription Drug User Fee Act (PDUFA) VI commitments, the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are conducting a model
Externí odkaz:
https://doaj.org/article/5f1a7d7dc0cd4e0ca2b90c5d2f271522
Autor:
Keran, Moll, Bradley, Lufkin, Kathryn R, Fingar, Cindy, Ke Zhou, Ellen, Tworkoski, Chianti, Shi, Shayan, Hobbi, Mao, Hu, Minya, Sheng, Jillian, McCarty, Shanlai, Shangguan, Timothy, Burrell, Yoganand, Chillarige, Jeff, Beers, Patrick, Saunders-Hastings, Stella, Muthuri, Kathryn, Edwards, Steven, Black, Jeff, Kelman, Christian, Reich, Kandace L, Amend, Djeneba Audrey, Djibo, Daniel, Beachler, Rachel P, Ogilvie, Alex, Secora, Cheryl N, McMahill-Walraven, John D, Seeger, Patricia, Lloyd, Deborah, Thompson, Rositsa, Dimova, Thomas, MaCurdy, Joyce, Obidi, Steve, Anderson, Richard, Forshee, Hui-Lee, Wong, Azadeh, Shoaibi
Publikováno v:
Vaccine. 41:333-353
The U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are compar
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f8aef7bb5020f78a013080315d163c66
https://doi.org/10.1016/j.vaccine.2022.11.003
https://doi.org/10.1016/j.vaccine.2022.11.003
Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years
Autor:
Patricia C. Lloyd, Mao Hu, Hui-Lee Wong, Azadeh Shoaibi, Cindy Ke Zhou, An-Chi Lo, Kandace Amend, Daniel C. Beachler, Cheryl N. McMahill-Walraven, Elizabeth R. Smith, John Seeger, Alex Secora, Djeneba Audrey Djibo, Joyce Obidi, Yuhui Feng, Jennifer Song, Christian Reich, Charalynn Harris, Sandia Akhtar, Robin Clifford, Nandini Selvam, Jennifer L. Pigoga, Yixin Jiao, Yoganand Chillarige, Thomas MaCurdy, Richard Forshee, Steven A. Anderson
Publikováno v:
Vaccine. 40:6481-6488
Active monitoring of safety outcomes following COVID-19 vaccination is critical to understand vaccine safety and can provide early detection of rare outcomes not identified in pre-licensure trials. We present findings from an early warning rapid surv
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::83f45f224befa1e313aefa58c7c9a7ec
https://doi.org/10.1016/j.vaccine.2022.09.060
https://doi.org/10.1016/j.vaccine.2022.09.060
Autor:
Gayathri Sridhar, Fang Tian, Richard Forshee, Martin Kulldorff, Nandini Selvam, Andrea Sutherland, Wilson Bryan, Samuel Barone, Lei Xu, Hector S. Izurieta
Publikováno v:
Human Vaccines & Immunotherapeutics, Vol 13, Iss 7, Pp 1705-1713 (2017)
To assess the relationship between human papillomavirus (HPV) vaccination and occurrence of optic neuritis (ON) and to evaluate a claims-based algorithm for identification of ON. Females of 9–26 year olds in the HealthCore's Integrated Research Dat
Externí odkaz:
https://doaj.org/article/6e2f6e89e3374da6be36bc561ec73277
Autor:
Mao Hu, Hui Lee Wong, Yuhui Feng, Patricia C. Lloyd, Elizabeth R. Smith, Kandace L. Amend, Annemarie Kline, Daniel C. Beachler, Joann F. Gruber, Mahasweta Mitra, John D. Seeger, Charlalynn Harris, Alex Secora, Joyce Obidi, Jing Wang, Jennifer Song, Cheryl N. McMahill-Walraven, Christian Reich, Rowan McEvoy, Rose Do, Yoganand Chillarige, Robin Clifford, Danielle D. Cooper, Azadeh Shoaibi, Richard Forshee, Steven A. Anderson
Publikováno v:
JAMA Pediatrics.
ImportanceActive monitoring of health outcomes after COVID-19 vaccination offers early detection of rare outcomes that may not be identified in prelicensure trials.ObjectiveTo conduct near–real-time monitoring of health outcomes following BNT162b2
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::47c7500b602b68fab78767c74766d3be
https://doi.org/10.1001/jamapediatrics.2023.1440
https://doi.org/10.1001/jamapediatrics.2023.1440
Autor:
Zhao-Hua Zhou, Margaret M. Cortese, Jia-Long Fang, Robert Wood, Donna S. Hummell, Kimberly A. Risma, Allison E. Norton, Mark KuKuruga, Susan Kirshner, Ronald L. Rabin, Cyrus Agarabi, Mary A. Staat, Natasha Halasa, Russell E. Ware, Anna Stahl, Maureen McMahon, Peter Browning, Panagiotis Maniatis, Shanna Bolcen, Kathryn M. Edwards, John R. Su, Sai Dharmarajan, Richard Forshee, Karen R. Broder, Steven Anderson, Steven Kozlowski
BackgroundThe mechanism for anaphylaxis following mRNA COVID-19 vaccination has been widely debated; understanding this serious adverse event is important for future vaccines of similar design. A mechanism proposed is type I hypersensitivity (i.e., I
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7ff339813a34daee1822c1fe92408594
https://doi.org/10.1101/2023.04.11.23288372
https://doi.org/10.1101/2023.04.11.23288372
Autor:
Brian Custer, Barbee Whitaker, Lance Pollack, Renata Buccheri, Roberta Bruhn, Lauren Crowder, Susan L. Stramer, Rita Reik, Suchitra Pandey, Mars Stone, Clara Di Germanio, Kate Buchacz, Anne Eder, Yun Lu, Richard Forshee, Steven Anderson, Peter Marks
ImportanceBlood donor selection policies should be evidence-based. Individual risk assessment allows potential donors to be evaluated based on their own behaviors.ObjectiveThe Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) stud
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e07513c8e6c53717bd31c01b03965e11
https://doi.org/10.1101/2023.04.08.23288320
https://doi.org/10.1101/2023.04.08.23288320
Autor:
Mao Hu, Hui Lee Wong, Yuhui Feng, Patricia C. Lloyd, Elizabeth R. Smith, Kandace L. Amend, Annemarie Kline, Daniel C. Beachler, Joann F. Gruber, Mahasweta Mitra, John D. Seeger, Charlalynn Harris, Alex Secora, Joyce Obidi, Jing Wang, Jennifer Song, Cheryl N. McMahill-Walraven, Christian Reich, Rowan McEvoy, Rose Do, Yoganand Chillarige, Robin Clifford, Danielle D Cooper, Azadeh Shoaibi, Richard Forshee, Steven A. Anderson
ImportanceActive monitoring of health outcomes following COVID-19 vaccination offers early detection of rare outcomes that may not be identified in pre-licensure trials.ObjectiveTo conduct near-real time monitoring of health outcomes following BNT162
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::66234f2d329803a45b6a6553863e73ea
https://doi.org/10.1101/2022.10.28.22281532
https://doi.org/10.1101/2022.10.28.22281532
Autor:
Artur, Belov, Yin, Huang, Carlos H, Villa, Barbee I, Whitaker, Richard, Forshee, Steven A, Anderson, Anne, Eder, Nicole, Verdun, Michael J, Joyner, Scott R, Wright, Rickey E, Carter, Deborah T, Hung, Mary, Homer, Corey, Hoffman, Michael, Lauer, Peter, Marks
Publikováno v:
American journal of hematology. 97(6)
The efficacy of COVID-19 convalescent plasma (CCP) as a treatment for hospitalized patients with COVID-19 remains somewhat controversial; however, many studies have not evaluated CCP documented to have high neutralizing antibody titer by a highly acc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f2da571f44811ea1f0e9112ee77ac50e
https://pubmed.ncbi.nlm.nih.gov/35303377
https://pubmed.ncbi.nlm.nih.gov/35303377
Autor:
Hui-Lee Wong, Mao Hu, Cindy Ke Zhou, Patricia C Lloyd, Kandace L Amend, Daniel C Beachler, Alex Secora, Cheryl N McMahill-Walraven, Yun Lu, Yue Wu, Rachel P Ogilvie, Christian Reich, Djeneba Audrey Djibo, Zhiruo Wan, John D Seeger, Sandia Akhtar, Yixin Jiao, Yoganand Chillarige, Rose Do, John Hornberger, Joyce Obidi, Richard Forshee, Azadeh Shoaibi, Steven A Anderson
Publikováno v:
Lancet (London, England). 399(10342)
Several passive surveillance systems reported increased risks of myocarditis or pericarditis, or both, after COVID-19 mRNA vaccination, especially in young men. We used active surveillance from large health-care databases to quantify and enable the d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::df87fb3a3f124624bee9fbb7af2c8c13
https://pubmed.ncbi.nlm.nih.gov/35691306
https://pubmed.ncbi.nlm.nih.gov/35691306