Vaccine effectiveness of primary series and booster doses against covid-19 associated hospital admissions in the United States: living test negative…
October 11, 2022
Contributors: KA, JPR, and DS contributed equally to this work as lead author. WHS and MWT contributed equally to this work as senior author. Guarantors of this work include WHS (protocol and data integrity), KA (statistical analysis), ASL (viral sequencing laboratory methods), JDChappell (reverse transcription polymerase chain reaction laboratory methods), and NJT (antibody measurement methods). WHS was responsible for the decision to submit the manuscript, KA, JPR, DS, MWT, and WHS drafted the initial manuscript (without outside assistance). KA, JPR, DS, MG, AAG, TM, SG, BH, KT, JDCasey, NM, AZ, NIS, KWG, DCF, MH, DNH, HA, MP, AEF, MCE, MG, AM, NJJ, VS, JSS, IDP, SMB, ETM, AM, ASL, AK, CLH, LWB, CtL, AD, JGW, AJG, NQ, SYC, CM, CR, HB, JHK, JDChappell, NH, CGG, TR, WBS, AB, CJL, KH, SNL, NJT, SP, MLM, MMP, MWT, and WHS conceptualized the study methods. KA, MWT, CJL, KH, and YZ were responsible for statistical analysis and data management. WHS acquired funding. KA, JPR, DS, MG, AAG, TM, SG, DH, HKT, JDCasey, NM, AZ, NIS, KWG, DCF, MH, DNH, HA, MP, AEF, MCE, MG, AM, NJJ, VS, JSS, IDP, SMB, ETM, AM, ASL, AK, CLH, LWB, CtL, AD, JGW, AJG, NQ, SYC, CM, CR, HB, JHK, JDChappell, NH, CG, TR, WBS, AB, CJL, KH, SNL, NJT, SP, MLM, MMP, MWT, and WHS critically reviewed the manuscript for important intellectual content. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: Funding for this work was provided to all participating sites by the US Centers for Disease Control and Prevention. SMB reports grants from the National Institutes of Health (NIH) and Department of Defense (DoD), participation as the Data Safety Monitoring Board (DSMB) chair for Hamilton Ventilators, and participation as a member of the DSMB for New York University covid-19 clinical trials. JDCasey reports funding from NIH and DoD. SYC reports consulting fees from La Jolla Pharmaceuticals, PureTech Health, and Kiniska Pharmaceuticals, payments or honorariums from La Jolla Pharmaceuticals, and participation on a DSMB for an investigator initiated study conducted at UCLA. JDChappell reports grants and other support from NIH. AD reports consulting fees from ALung technologies. MCE reports payments or honorariums from Abbott Laboratory for sponsored talks. DCF reports consulting fees from Cytovale and participation on a DSMB for Medpace. AEF reports grants from NIH. MG reports grants from CDC, CDC-Abt Associates, CDC-Westat, and Janssen, and a leadership role as co-chair of the Infectious Disease and Immunization Committee of the Texas Pediatric Society, Texas Chapter of American Academy of Pediatrics. KWG reports funding from NIH/National Heart, Lung, and Blood Institute (NHLBI) for the ACTIV-4HT NECTAR trial. AAG reports grants from NIH, DoD, AbbVie, and Faron Pharmaceuticals. MG reports grants from NIH/NHLBI and Agency for Healthcare Research and Quality (AHRQ), consulting fees from Endpoint, a leadership role on the American Thoracic Society (ATS) executive committee and board as well as support from ATS for meeting travel expenses, and participation on a DSMB for Regeneron. CG reports grants from NIH, CDC, Food and Drug Administration, AHRQ, Sanofi, and Syneos Health and consulting fees from Pfizer, Merck, and Sanofi. DNH reports grants from NIH/NHLBI for the ACTIV-4HT NECTAR trial and Incyte and participation as a DSMB chair for the SAFE EVICT Trial of vitamin C in COVID-19. NH reports grants from NIH, Quidel, and Sanofi and honorariums for speaking at the American Academy of Pediatrics (AAP) conference. CLH reports grants from NIH and American Lung Association (ALA) and participation as a DSMB member for iSPY COVID and Team (ANZICS). NJJ reports grants from NIH/NHLBI/NINDS and the University of Washington Royalty Research Fund and payment for expert testimony for the Washington Department of Health. AK reports grants from United Therapeutics, Gilead Sciences, and 4D Medical and a leadership role on the guidelines committee for Chest. JHK reports grants from NIH/NIAID. ASL reports grants from CDC, NIH/NIAID, and Burroughs Wellcome Fund and consulting fees from Sanofi and Roche. CJL reports grants from NIH, DoD, CDC, bioMerieux, Entegrion, Endpoint Health, and AbbVie, patents for risk stratification in sepsis and septic shock, participation on DSMBs for clinical trials unrelated to the current work, a leadership role on the executive committee for the Board of Directors of the Association for Clinical and Translational Science, and stock options in Bioscape Digita. ETM reports grants from Merck, CDC, and NIH and payment/honorariums from the Michigan Infectious Disease Society. TM reports payment/honorariums from the Society of Hospital Medicine. AM reports grants from CDC and NIAID/NIH and participation on a DSMB for the FDA. IDP reports grants from NIH, Janssen, Regeneron, and Asahi Kasei Pharma. TR reports grants from AbbVie, consulting fees from Cumberland Pharmaceuticals, and Cytovale, membership on a DSMB for Sanofi, a leadership role as immediate past president of the American Society of Parenteral and Enteral Nutrition, and stock options in Cumberland Pharmaceuticals. WHS reports receiving the primary funding for this project from the CDC, and research funding from Merck and Gilead Sciences. WBS reports grants from the NIH/NHLBI.
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Vaccine effectiveness of primary series and booster doses against covid-19 associated hospital admissions in the United States: living test negative...