Corresponding Author: Nicola P. Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612 (nicola.klein@kp.org).
Accepted for Publication: August 18, 2021.
Published Online: September 3, 2021. doi:10.1001/jama.2021.15072
Author Contributions: Dr Klein had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Klein, Lewis, Goddard, Fireman, Zerbo, Naleway, Nelson, Shimabukuro, DeStefano, Weintraub.
Acquisition, analysis, or interpretation of data: Lewis, Goddard, Fireman, Zerbo, Hanson, Donahue, Kharbanda, Naleway, Nelson, Xu, Yih, Glanz, Williams, Hambidge, Lewin, Shimabukuro, DeStefano, Weintraub.
Drafting of the manuscript: Klein, Lewis, Goddard, Fireman, Weintraub.
Critical revision of the manuscript for important intellectual content: Lewis, Goddard, Fireman, Zerbo, Hanson, Donahue, Kharbanda, Naleway, Nelson, Xu, Yih, Glanz, Williams, Hambidge, Lewin, Shimabukuro, DeStefano, Weintraub.
Statistical analysis: Lewis, Fireman, Nelson, Xu, Glanz, Lewin, Weintraub.
Obtained funding: Klein, Goddard, Zerbo, Hanson, Donahue, Weintraub.
Administrative, technical, or material support: Goddard, Hanson, Donahue, Yih, Hambidge, Shimabukuro, Weintraub.
Supervision: Klein, Hambidge, Shimabukuro, DeStefano, Weintraub.
Case review and adjudication, vaccine capture in the health record: Lewin.
Conflict of Interest Disclosures: Dr Klein reported receiving grants from the Centers for Disease Control and Prevention (CDC) during the conduct of the study, and grants from Pfizer, Merck, GSK, Sanofi Pasteur, and Protein Science (now SP) outside the submitted work. Ms Hanson reported receiving grants from CDC during the conduct of the study. Dr Donahue reported receiving grants from CDC during the conduct of the study and from Janssen Vaccines & Prevention for a study unrelated to COVID-19 vaccines. Dr Kharbanda reported receiving other from CDC (contract 200-2012-53526) during the conduct of the study. Dr Naleway reported receiving grants from CDC during the conduct of the study and grants from Pfizer outside the submitted work. Dr Nelson reported receiving grants from Moderna outside the submitted work. Dr Yih reported receiving grants from Pfizer outside the submitted work. Dr Williams reported receiving grants from CDC Vaccine Safety Datalink COVID-19 Infrastructure Funding during the conduct of the study. Dr Lewin reported receiving grants from CDC Vaccine Safety Datalink during the conduct of the study. No other disclosures were reported.
Funding/Support: This study was supported by grant funding from the CDC, contract 200-2012-53581/0001.
Role of the Funder/Sponsor: The study sponsor, CDC, participated as a coinvestigator and contributed to protocol development, conduct of the study, interpretation of the data, review and revision of the manuscript, approval of the manuscript through official CDC scientific clearance processes, and the decision to submit the manuscript for publication. CDC authors must receive approval through the CDC scientific clearance process to submit an article for publication. Final decision to submit rested with the first author. The study sponsor did not have the right to direct the submission to a particular journal.
Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the CDC. Mention of a product or company name is for identification purposes only and does not constitute endorsement by CDC.
Additional Contributions: We thank Ed Belongia, MD (Marshfield Clinic Research Institute) for providing clinical expertise for this manuscript. We thank Rachael Burganowski, MS (Kaiser Permanente Washington Health Research Institute), Bradley Crane, MS (Center for Health Research, Kaiser Permanente Northwest), Sungching Glenn, MS (Research and Evaluation, Kaiser Permanente Southern California), Tat’Yana Kenigsberg, MPH (Immunization Safety Office, Centers for Disease Control and Prevention), Erica Scotty, MS (Marshfield Clinic Research Institute), Gabriela Vazquez Benitez, PhD (HealthPartners Institute), Arnold Yee, BS (Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California), and Jingyi Zhu, PhD (HealthPartners Institute), for their contributions to data collection and preparation. We thank Nandini Bakshi, MD (The Permanente Medical Group), Tom Boyce, MD (Marshfield Clinic Research Institute), Jennifer Covey, BS (Kaiser Permanente Washington Health Research Institute), Jonathan Duffy, MD (Immunization Safety Office, Centers for Disease Control and Prevention), Stacy Harsh, BSN, RN (Center for Health Research, Kaiser Permanente Northwest), Linda Heeren, BS (Marshfield Clinic Research Institute), Juraj Kavecansky, MD (Kaiser Permanente Northern California, Antioch Medical Center), Mike M. McNeil, MD (Immunization Safety Office, Centers for Disease Control and Prevention), Tanya Myers, PhD (Immunization Safety Office, Centers for Disease Control and Prevention), Matthew E. Oster, MD, MPH (Centers for Disease Control and Prevention, COVID-19 Response), Ashok Pai, MD (Kaiser Permanente Northern California, Oakland Medical Center), and Pat Ross, BA (Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California), for their contributions to medical record review and adjudication. We thank Laurie Aukes, RN (Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California), Cheryl Carlson, MPH (Research and Evaluation, Kaiser Permanente Southern California), Stephanie Irving, MHS (Center for Health Research, Kaiser Permanente Northwest), Mara Kalter, MA (Center for Health Research, Kaiser Permanente Northwest), Tia Kauffman, MPH (Center for Health Research, Kaiser Permanente Northwest), Erika Kiniry, MPH (Kaiser Permanente Washington Health Research Institute), Leslie Kuckler, MPH (HealthPartners Institute), Denison Ryan, MPH (Research and Evaluation, Kaiser Permanente Southern California), and Lina Sy, MPH (Research and Evaluation, Kaiser Permanente Southern California), for their contributions to overall project management. All non-CDC personnel received financial compensation through CDC Vaccine Safety Datalink grant funding for their work on this project. CDC personnel were not compensated for their role in the study.
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