Publications

Search our bibliography using the filters on the right-hand side.

Displaying 1 through 50 of 56 publications.

Mayer SE, Kawai A, Fuller CC, Agan AA, Rao S, Koram N, Calingaert B, Marshall J, Connolly JG, Moyneur E, Jamal-allial A, Brown J, Burk J, Chomistek A, Daniels K, Dea K, DeFor TA, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB, Kendrick K, Layton JB, Ma Q, Mai X, Mack M, Pawloski PA, Reynolds JS, Selvan M, Sharma V, Vetter J, McMahill-Walraven CN, Platt R, Gilsenan A. Interim utilization results from a post-approval safety study of Pfizer-BioNTech monovalent COVID-19 vaccine in the United States. Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.

Layton JB, Richey M, Lindaas A, Muthuri S, Lloyd PC, Gruber JF, Bui C, McKillop M, Kowarski L, Lyu H, Cheng A, Wan Z, Clarke TC, Kawai AT, Beers J, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Events on day zero of follow-up: considerations for cohort studies of adverse events after COVID-19 diagnosis. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.

Kawai A, Fuller CC, Koram N, Agan A, Brown J, Burk J, Cai B, Daniels K, Fearrington J, Franklin JM, Hague C, Jamal-allial A, Johannes CB, Kempner M, Layton JB, Ma Q, Mai X, Mayer SE, Pawloski PA, Reynolds JS, Seals RM, Selvan M, Smith S, McMahill-Walraven CN, Gilsenan A, Platt R. Monitoring results from a postapproval safety study of Pfizer-BioNTech COVID-19 vaccine in the United States: vaccine utilization and incidence rates of myocarditis/pericarditis. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):182. doi: 10.1002/pds.5687

Mayer SE, Fuller CC, Haynes K, Alam S, Brown JS, Daniels K, Hawrusik R, Horgan C, Jamal-allial A, Johannes CB, Kawai AT, Layton JB, Mai X, Marshall J, McMahill-Walraven CN, Reynolds JS, Seals R, Selvan M, Stemkowski S, Wang FT, Yost E, Gilsenan A, Platt R. Use of Janssen Ad26.COV2.S COVID-19 Vaccine (JCOVDEN) and mRNA COVID-19 vaccines in four large US national insurers. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):186. doi: 10.1002/pds.5687

Ogilvie RP, Layton JB, Wong HL, Jiao Y, Parambi RJ, Deng J, Miller M, Song J, Lloyd PC, Weatherby L, Peetluk LS, Bell EJ, Yang G, Amend KL, Kawai A, Lo AC, Matuska K, Wernecke M, Gruber JF, Clarke TC, Forshee RA, Anderson SA, Anthony MS, Chillarige Y, Seeger JD, Shoaibi A. Effectiveness of BNT162b2 COVID-19 vaccine in US children aged 5-17 years. Presented at the 39th ICPE Annual Conference; August 26, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):78. doi: 10.1002/pds.5687

Layton JB, Peetluk LS, Wong H, Jiao Y, Ogilvie RP, Miller M, Glazier-Essalmi A, Parambi RJ, Song J, Garcia de Albeniz Martinez X, Lloyd PC, Lo A, Kawai A, Weatherby L, Bell EJ, Yang G, Amend KL, Gruber JF, Clarke TC, Forshee RA, Anderson SA, Wernecke M, Matuska K, Chillarige Y, Anthony M, Seeger JD, Shoaibi A. Effectiveness of monovalent COVID-19 booster/additional vaccine doses in the United States. Presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):608. doi: 10.1002/pds.5687

Margulis AV, Calingaert B, Kawai AT, Rivero-Ferrer E, Anthony MS. Distribution of gestational age at birth by maternal and infant characteristics in U.S. birth certificate data: informing gestational age assumptions when clinical estimates are not available. Pharmacoepidemiol Drug Saf. 2023 Sep;32(9):1012-20. doi: 10.1002/pds.5633

Gilsenan A, Kawai A. Considerations for planning safety surveillance studies of COVID-19 vaccine. Presented at the North American Chapter of the International Society of Pharmacovigilance (NASoP); November 8, 2022.

Kawai AT, Fuller CC, de Luise C, Layton JB, Johannes CB, Brown J, Platt R, Gilsenan AW. Adapting to the dynamic landscape of the COVID-19 pandemic: proposed study design approaches for a postauthorization safety study for Pfizer-BioNTech COVID-19 vaccine in the United States. Presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark.

Margulis AV, Calingaert B, Kawai AT, Rivero-Ferrer E, Anthony MS. Distribution of gestational age by maternal and infant characteristics in US birth certificate data: toward informing gestational age assumptions when clinical estimates are not available. Poster presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

Fuller CC, Kawai AT, Haynes K, Coughlin K, Reynolds JS, Hawrusik R, Horgan C, Calingaert B, Johannes CB, Bradley Layton J, Peterson A, Praet N, Willame C, Yost E, Brannan C, McMahill-Walraven CNN, Guzman M, Jamal-allial A, Nair V, Seals RM, Wang FT, Selvan M, Ma Q, Platt R, Gilsenan AW, Brown J. Capacity for identifying Janssen Ad26.COV2.S COVID-19 vaccination in four US health insurance and state Immunization Information System databases: preparation for a post authorization safety study. Presented at the 2022 ICPE Conference; August 2022. Copenhagen, Denmark.

Margulis AV, Kawai AT, Anthony MS, Rivero-Ferrer E. Perinatal pharmacoepidemiology: how often are key methodological elements reported in publications? Pharmacoepidemiol Drug Saf. 2022 Jan;31(1):61-71. doi: 10.1002/pds.5353

Hellwig K, Magyari M, McDonald T, Gembert K, Wergeland S, Leinonen MK, Aydemir A, Sabido M, Kawai A, Arana A. A multi-country cohort database study to assess pregnancy and infant outcomes in women exposed to cladribine tablets: CLEAR study. Poster presented at the 2021 Digital 37th Conference of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); October 13, 2021.

Kawai K, Kawai AT. Racial/ethnic and socioeconomic disparities in adult vaccination coverage. Am J Prev Med. 2021 Oct;61(4):465-73. doi: 10.1016/j.amepre.2021.03.023

Margulis AV, Kawai AT, Anthony M, Rivero-Ferrer E. Pregnancy pharmacoepidemiology: how often are key methodological data elements reported in publications? Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.

Baker MA, Jankosky C, Yih WK, Gruber S, Li L, Cocoros NM, Lipowicz H, Coronel-Moreno C, DeLuccia S, Lin ND, McMahill-Walraven CN, Menschik D, Selvan MS, Selvam N, Chen Tilney R, Zichittella L, Lee GM, Kawai AT. The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines. Vaccine. 2020 Feb 24;38(9):2166-71. doi: 10.1016/j.vaccine.2020.01.046

Kawai AT, Martinez D, Saltus CW, Vassilev ZP, Soriano-Gabarro M, Kaye JA. Incidence of skeletal-related events in patients with castration-resistant prostate cancer: an observational retrospective cohort study in the US. Prostate Cancer. 2019 Jul 9. doi: 10.1155/2019/5971615

Kawai AT, Martin D, Henrickson SE, Goff A, Reidy M, Santiago D, Selvan N, McMahill-Walraven C, Lee GM. Validation of febrile seizures identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program. Vaccine. 2019 Jul 9;37(30):4172-6. doi: 10.1016/j.vaccine.2019.05.042.

Kawai AT, Martinez D, Saltus CW, Vassilev Z, Soriano-Gabarro M, Kaye JA. Incidence of skeletal-related events in men with castration-resistant prostate cancer. Poster presented at the Palliative and Supportive Care in Oncology Symposium; November 17, 2018. San Diego, CA. [abstract] J Clin Oncol. 2018 Nov 28; 36(34_suppl):188. doi: 10.1200/JCO.2018.36.34_suppl.188

Groom HC, Irving SA, Koppolu P, Smith N, Vazquez-Benitez G, Kharbanda EO, Daley MF, Donahue JG, Getahun D, Jackson LA, Tse Kawai A, Klein NP, McCarthy NL, Nordin JD, Sukumaran L, Naleway AL. Uptake and safety of Hepatitis B vaccination during pregnancy: a vaccine safety datalink study. Vaccine. 2018 Oct 1;36(41):6111-6. doi: 10.1016/j.vaccine.2018.08.074

Rhee C, Wang R, Jentzsch MS, Hsu H, Kawai AT, Jin R, Horan K, Broadwell C, Lee GM. Impact of the 2012 Medicaid health care-acquired conditions policy on catheter-associated urinary tract infection and vascular catheter-associated infection billing rates. Open Forum Infect Dis. 2018 Sep 4;5(9). doi: 10.1093/ofid/ofy204

Kawai AT, Reidy M, Zichittella L, Stockdale C, Longley E, Walraven C, Liu C, Shoaibi A, Feibelmann S, Lee G. Developing the infrastructure to assess pregnancy outcomes following vaccination: influenza vaccines and spontaneous abortion as a use case. Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):395. doi: 10.1002/pds.4629

Calderwood MS, Kawai AT, Jin R, Lee GM. Centers for medicare and medicaid services hospital-acquired conditions policy for central line-associated bloodstream infection (CLABSI) and cather-associated urinary tract infection (CAUTI) shows minimal impact on hospital reimbursement. Infect Control Hosp Epidemiol. 2018 Aug;39(8):897-901. doi: 10.1017/ice.2018.137

Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Sheth SS, Zhu J, Naleway AL, Klein NP, Hechter R, Daley MF, Donahue JG, Jackson ML, Kawai AT, Sukumaran L, Nordin JD. Risk of spontaneous abortion after inadvertent human papillomavirus vaccination in pregnancy. Obstet Gynecol. 2018 Jul;132(1):35-44. doi: 10.1097/AOG.0000000000002694

Hsu HE, Kawai AT, Wang R, Jentzsch MS, Rhee C, Horan K, Jin R, Goldmann D, Lee GM. The impact of the Medicaid healthcare-associated condition program on mediastinitis following coronary artery bypass graft. Infect Control Hosp Epidemiol. 2018 Jun;39(6):694-700. doi: 10.1017/ice.2018.69

Sukumaran L, McCarthy NL, Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Jackson L, Klein NP, Naleway AL, McClure DL, Hechter RC, Kawai AT, Glanz JM, Weintraub ES. Infant hospitalizations and mortality after maternal vaccination. Pediatrics. 2018 Mar;141(3):e20173310. doi: 10.1542/peds.2017-3310

Rouse CE, Eckert LO, Babarinsa I, Fay E, Gupta M, Harrison MS, Kawai AT, Kharbanda EO, Kucuku M, Meller L, Mallett Moore T, Subelj M, Kochhar S, Tavares-Da-Silva F, GAIA Abortion Work Group, Brighton Collaboration Abortion Working Group. Spontaneous abortion and ectopic pregnancy: case definition & guidelines for data collection, analysis, and presentation of maternal immunization safety data - Commentary. Vaccine. 2017 Dec 4;35(48 Pt A):6563-74. doi: 10.1016/j.vaccine.2017.01.047

Kawai K, Kawai AT, Wollan P, Yawn BP. Adverse impacts of chronic pain on health-related quality of life, work productivity, depression and anxiety in a community-based study. Fam Pract. 2017 Nov 16;34(6):656-61. doi: 10.1093/fampra/cmx034

Baker M, Jankosky C, Yih K, Gruber S, Li L, Cocoros N, Lipowicz H, Coronel-Moreno C, Feibelmann S, Lin N, McMahill-Walraven C, Menschik D, Selvan M, Selvam N, Tilney RC, Zichittella L, Lee G, Kawai AT. The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines. Poster presented at the 2017 Infectious Disease Week Conference; October 6, 2017. San Diego, CA. [abstract] Open Forum Infect Dis. 2017 Oct; 4(Suppl 1):S464-5. doi: 10.1093/ofid/ofx163.1187

Kawai AT, Anderson S, Andrade SE, Zichittella L, Stockdale C. Developing capabilities to monitor the safety of vaccine use during pregnancy in Sentinel's Prism Program. Presented at the 4th International Neonatal & Maternal Immunization Symposium; September 2017. Brussels, Belgium.

Panucci G, Chada K, Izurieta H, Shoaibi A, Said M, Forshee R, Obidi J, Petrone A, Cocoros N, Woodworth T, Kawai AT. Trends of tetanus, diphtheria, and acellular pertussis (Tdap) vaccination during pregnancy in the Sentinel System. Poster presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26((Suppl. 2)):414.

Kawai AT, Andrade SE, Rosofsky R, Zichittella L, Haffenreffer K, Walraven C, Hayes K, Selvan M, Loughlin AM, Shoaibi A, Anderson S, Lee G. Developing a mother-infant cohort in Sentinel's Prism Program as a resource to monitor the safety of vaccine use during pregnancy. Presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):21.

DaSilva T, Gonik B, Mcmillan M, Keech C, Dellicour S, Bhange S, Tila M, Harper DM, Woods C, Kawai AT, Kochhar S, Munoz FM, Brighton Collaboration Stillbirth Working Group. Stillbirth: case definition and guidelines for data collection, analysis, and presentation of maternal immunization safety data. Vaccine. 2016 Dec 1;34(49):6057-68. doi: 10.1016/j.vaccine.2016.03.044

DeSilva M, Munoz FM, Mcmillan M, Kawai AT, Marshall H, Macartney KK, Joshi J, Oneko M, Rose AE, Dolk H, Trotta F, Spiegel H, Tomczyk S, Shrestha A, Kochhar S, Kharbanda EO, Brighton Collaboration Congenital Anomalies Working Group. Congenital anomalies: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2016 Dec 1;34(49):6015-26. doi: 10.1016/j.vaccine.2016.03.047

Li R, Stewart B, McNeil MM, Duffy J, Nelson J, Kawai AT, Baxter R, Belongia EA, Weintraub E. Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons. Pharmacoepidemiol Drug Saf. 2016 Aug;25(8):928-34. doi: 10.1002/pds.3996

Cocoros N, Hennessy S, Fuller C, Kawai AT, Filion K. Public health surveillance using distributed data networks: lessons from FDA's Sentinel initiative and the Canadian network for observational drug effect studies. Presented at the 2016 Epidemiology Congress of the Americas; June 2016. Miami, FL.

Yih WK, Kulldorff M, Sandhu SK, Zichittella L, Maro JC, Cole DV, Jin R, Kawai AT, Baker MA, Liu C, McMahill-Walraven CN, Selvan MS, Platt R, Nguyen MD, Lee GM. Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System. Pharmacoepidemiol Drug Saf. 2016 May;25(5):481-92. doi: 10.1002/pds.3908

Kawai AT, Calderwood MS, Jin R, Soumerai SB, Vaz LE, Lee GM. Impact of the CMS healthcare-acquired conditions policy on billing rates of two targeted conditions. Poster presented at the 2016 Society for Healthcare Epidemiology of America Conference; April 2016. Atlanta, GA.

Calderwood MS, Vaz LE, Tse Kawai A, Jin R, Rett MD, Grant PS, Lee GM. Impact of hospital operating margin on central line-associated bloodstream infections following Medicare's hospital-acquired conditions payment policy. Infect Control Hosp Epidemiol. 2016 Jan;37(1):100-3. doi: 10.1017/ice.2015.250

Li L, Kulldorff M, Russek-Cohen E, Kawai AT, Hua W. Quantifying the impact of time-varying baseline risk adjustment in the self-controlled risk interval design. Pharmacoepidemiol Drug Saf. 2015 Dec;24(12):1304-12. doi: 10.1002/pds.3885

Kawai AT, Martin D, Kulldorff M, Li L, Cole DV, McMahill-Walraven CN, Selvam N, Selvan MS, Lee GM. Febrile seizures after 2010-2011 trivalent inactivated influenza vaccine. Pediatrics. 2015 Oct;136(4):e848-855. doi: 10.1542/peds.2015-0635

Kawai AT, Calderwood MS, Jin R, Soumerai SB, Vaz LE, Goldmann D, Lee GM. Impact of the Centers for Medicare and Medicaid Services hospital-acquired conditions policy on billing rates for 2 targeted healthcare-associated infections. Infect Control Hosp Epidemiol. 2015 Aug;36(8):871-7. doi: 10.1017/ice.2015.86

Vaz LE, Kleinman KP, Kawai AT, Jin R, Kassler WJ, Grant PS, Rett MD, Goldmann DA, Calderwood MS, Soumerai SB, Lee GM. Impact of Medicare's Hospital-Acquired Condition policy on infections in safety net and non-safety net hospitals. Infect Control Hosp Epidemiol. 2015 Jun;36(6):649-55. doi: 10.1017/ice.2015.38.

Baker MA, Lieu TA, Li L, Hua W, Qiang Y, Kawai AT, Fireman BH, Martin DB, Nguyen MD. A vaccine study design selection framework for the postlicensure rapid immunization safety monitoring program. Am J Epidemiol. 2015 Apr 15;181(8):608-18. doi: 10.1093/aje/kwu322

Kawai AT, Jin R, Soumerai S, Vaz LE, Rett M, Lee G. Impact of nonpayment for preventable infections on billing rates for central line associated bloodstream infections and catheter-associated urinary tract infections. Presented at the 2014 Infectious Disease Week Conference; October 10, 2014. Philadelphia, PA. [abstract] Open Forum Infect Dis. 2014 Dec; 1(Suppl_1):S44. doi: 10.1093/ofid/ofu051.118

Kawai AT, Martin D, McMahill-Walraven C, Selvam N, Selvan M, Lee G, Mini-Sentinel PRISM Team. Validation of febrile seizures identified in the Mini-Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system. Poster presented at the 2014 Infectious Diseases Society of America; October 10, 2014. Philadelphia, PA.

Patrick SW, Kawai AT, Kleinman K, Jin R, Vaz L, Gay C, Kassler W, Goldmann D, Lee GM. Health care-associated infections among critically ill children in the US, 2007-2012. Pediatrics. 2014 Oct;134(4):705-12. doi: 10.1542/peds.2014-0613

Kawai AT. Assessment of febrile seizures after trivalent influenza vaccines during the 2010-2011 influenza season in PRISM. Presented at the Brookings Institution Roundtable on Active Medical Product Surveillance; July 21, 2014.

Kawai AT. Febrile seizures after TIV: PRISM System, 2010-2011 influenza season. Presented at the 2014 Advisory Committee on Immunization Practices (ACIP); June 2014. Atlanta, GA.

Kawai AT, Li L, Kulldorff M, Vellozzi C, Weintraub E, Baxter R, Belongia EA, Daley MF, Jacobsen SJ, Naleway A, Nordin JD, Lee GM. Absence of associations between influenza vaccines and increased risks of seizures, Guillain-Barré syndrome, encephalitis, or anaphylaxis in the 2012-2013 season. Pharmacoepidemiol Drug Saf. 2014 May;23(5):548-53. doi: 10.1002/pds.3575