Covid-19 Living Data

Study registration: *
Publication Self WH, MMWR, 2021
Dates: 2021-03-11 to 2021-08-15
Funding: Mixed (Wesley H. Self reports grants and consultant fees from Merck and consultant fees from Aerpio Pharmaceuticals. Adit A. Ginde reports grant support from AbbVie and Faron Pharmaceuticals. Jonathan D. Casey reports a grant (N23HL153584) from the National Institutes of Health (NIH). D. Clark Files reports consultant fees from Cytovale and membership on a Medpace Data Safety Monitoring Board (DSMB). David N. Hager reports salary support from Incyte Corporation, EMPACT Precision Medicine, and the Marcus Foundation. Michelle N. Gong reports grant support from NIH and the Agency for Healthcare Research and Quality (AHRQ) and fees for participating on a DSMB for Regeneron and for participating on a scientific advisory panel for Philips Healthcare. Daniel J. Henning reports consulting fees from Cytovale and Opticyte. Ithan D. Peltan reports grants from NIH and Janssen Pharmaceuticals, institutional fees from Asahi Kasei Pharma and from Regeneron. Samuel M. Brown reports fees from Hamilton for chairing a DSMB, and institutional fees from Faron, Sedana, and Janssen; grants from Sedana, Janssen, NIH, and the Department of Defense (DoD); book royalties from OxfordUniversity and Brigham Young University; and personal fees from New York University for service on a DSMB. Emily T. Martin reports personal fees from Pfizer for unrelated work and a grant from Merck for unrelated work. Akram Khan reports grants from United Therapeutics, Johnson & Johnson, 4D Medical, Lung LLC, and Reata Pharmaceuticals. Arnold S. Monto reports consulting fees from Sanofi-Pasteur and Seqirus. Steven Y. Chang was a speaker for La Jolla Pharmaceuticals and a Consultant for PureTech Health. Jennie H. Kwon reports grant support from NIH. Matthew C. Exline reports talks on nutrition in COVID pneumonia at APEN conference sponsored by Abbott Labs. Natasha Halasa reports grants from Sanofi and Quidel. James D. Chappell reports a grant from the National Center for Advancing Translational Sciences, NIH. Adam S. Lauring reports consultant fees from Sanofi and fees from Roche for membership on a trial steering committee. Carlos G. Grijalva reports consultant fees from Pfizer, Merck, and Sanofi-Pasteur and grants from Campbell Alliance/Syneos Health, NIH, the Food and Drug Administration, AHRQ, and Sanofi. Todd W. Rice reports personal fees from Cumberland Pharmaceuticals, Inc., as the Director of Medical Affairs, consultant fees from Avisa Pharma, LLC; and DSMB membership fees from Sanofi. Christopher J. Lindsell reports grants from NIH, DoD, and the Marcus Foundation; organizational contract fees from bioMerieux, Endpoint LLC, and Entegrion, Inc.; and a patent issued to Cincinnati Children’s Hospital Medical Center for risk stratification in sepsis and septic shock. No other potential conflicts of interest were disclosed)
Conflict of interest: Yes (Wesley H. Self reports grants and consultant fees from Merck and consultant fees from Aerpio Pharmaceuticals. No other potential conflicts of interest were disclosed)

Methods
Methods	Study design:Test-negative Description of participants: Adults hospitalized with COVID-19 like illness without Immunocompromising conditions living in United States, Inclusion criteria: adults aged ≥18 years without an immunocompromising condition hospitalized at 21 U.S. hospitals across 18 states during March 11–August 15, 2021, unvaccinated or vaccinated with Moderna vaccine, Pfizer-BioNTech or Janssen vaccine. Exclusion criteria: Patients were excluded if: had immunocompromising conditions if they received a COVID-19 vaccine other than Moderna, Pfizer-BioNTech, or Janssen received ≥1 vaccine dose but did not meet criteria for full vaccination or received doses of two different COVID-19 vaccine products Follow-up duration (months): 5
Vaccines:	2 doses of BNT162b2 2 doses of mRNA-1273 1 dose of Ad26.COV2.S
Variant description :
Variant description :	Variant name: Delta Evidence: Indirect evidence (prevalence of variant in the population: *)
Documents available	Protocol NR Statistical plan NR Data-sharing stated: NR Data accessibility: NR
General comment	Concerns about uncontrolled confounding (comorbidities were unbalanced between vaccination groups); in addition, there are uncertainties over the possibility of selection bias in a test-negative design and in relation to the missing data.