Protection of Messenger RNA Vaccines Against Hospitalized Coronavirus Disease 2019 in Adults Over the First Year Following Authorization in the United States.

BACKGROUND

Coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines were authorized in the United States in December 2020. Although vaccine effectiveness (VE) against mild infection declines markedly after several months, limited understanding exists on the long-term durability of protection against COVID-19-associated hospitalization.

METHODS

Case-control analysis of adults (≥18 years) hospitalized at 21 hospitals in 18 states 11 March-15 December 2021, including COVID-19 case patients and reverse transcriptase-polymerase chain reaction-negative controls. We included adults who were unvaccinated or vaccinated with 2 doses of a mRNA vaccine before the date of illness onset. VE over time was assessed using logistic regression comparing odds of vaccination in cases versus controls, adjusting for confounders. Models included dichotomous time (<180 vs ≥180 days since dose 2) and continuous time modeled using restricted cubic splines.

RESULTS

A total of 10 078 patients were included, 4906 cases (23% vaccinated) and 5172 controls (62% vaccinated). Median age was 60 years (interquartile range, 46-70), 56% were non-Hispanic White, and 81% had ≥1 medical condition. Among immunocompetent adults, VE <180 days was 90% (95% confidence interval [CI], 88-91) versus 82% (95% CI, 79-85) at ≥180 days (P < .001). VE declined for Pfizer-BioNTech (88% to 79%, P < .001) and Moderna (93% to 87%, P < .001) products, for younger adults (18-64 years) (91% to 87%, P = .005), and for adults ≥65 years of age (87% to 78%, P < .001). In models using restricted cubic splines, similar changes were observed.

CONCLUSIONS

In a period largely predating Omicron variant circulation, effectiveness of 2 mRNA doses against COVID-19-associated hospitalization was largely sustained through 9 months.

Informations de copyright

Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2022.

Déclaration de conflit d'intérêts

Potential conflicts of interest. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. W. H. S. reports grant funding from the Centers for Disease Control and Prevention (CDC) for this work, grants and consultant fees from Merck (for research on the surveillance of pneumococcal infections) and Gilead Sciences (for research on the surveillance of hepatitis C virus infections) outside this work. M. G. reports grant support from CDC (Ambulatory US Flu/COVID VE Network and Adult Inpatient Flu/COVID VE Network, HAIVEN), CDC-Abt Associates (Flu Vax Immunogenitiy RCT and RECVOERPROTECT COVID/Flu VE studies), CDC-Westat (VISION COVID Study), and Janssen (Johnson & Johnson) (RSV Severity App Birth Cohort Study). A. A. G. reports grant support from CDC, National Institute of Health (NIH), Department of Defense (DoD), AbbVie, and Faron Pharmaceuticals. J. D. C. reports grants from the CDC, NIH (K23HL153584), and Department of Defense. N. M. reports grants from the CDC (funded two other multicenter COVID-related projects separate from this work through payments to my institution). T. M. reports a grant from CDC and fees from the Society of Hospital Medicine for a talk about managing patients with congestive heart failure. K. G. reports grants from the CDC and the received grant funding for participation in executive committee of COVID-19 therapeutics from the NIH (ACTIV-4HT NECTAR Trial). D. C. F. reports grant support from CDC, consultant fees from Cytovale, and membership on a Medpace Data Safety Monitoring Board (DSMB). D. N. H. reports contracts from CDC, National Heart, Lung, and Blood Institute (NHLBI; funding for participation in the ACTIV4d - Host Tissue Trial), and Incyte Corporation (funding to enroll in RUCOVID-DEVENT) and membership on the SAFE EVICT Trial of VIT C in COVID-19 as DSMB chair. M. C. E. reports talks on nutrition in COVID pneumonia at the American Society of Parenteral and Enteral Nutrition (ASPEN) conference sponsored by Abbott Labs. M. N. G. reports grant support from CDC, NHLBI, NIH, and Agency for Healthcare Research and Quality (AHRQ), travel support for American Thoracic Society board meeting, and membership on the Regeneron DSMB for monoclonal antibodies in COVID-19. N. J. reports grants from CDC, NIH/NHLBI/NINDS, and University of Washington Royalty Research Fund, and payment for expert testimony from the Washington Department of Health. I. D. P. reports grants from CDC, NIH, Intermountain Research & Medical Foundation, and Janssen Pharmaceuticals, and institutional fees from Asahi Kasei Pharma and from Regeneron Pharmaceuticals. S. M. B. reports grants from CDC, NIH (for trials and other research activities related to COVID), and DoD (to study COVID); fees from Hamilton ventilators for chairing a DSMB; and personal fees from New York University for service on a DSMB. E. T. M. reports a grant from Merck outside the submitted work. A. M. reports grant support from CDC, NIH, NIAID, and membership on a DSMB for the Food and Drug Administration (FDA). A. K. reports grants from CDC, Gilead Sciences, Ely Lily, United Therapeutics, BOA-Medical, and 4D Medical and membership on the Guidelines Committee for Chest. C. L. H. reports grants from CDC, NIH, and the American Lung Association. A. D. reports a grant from the CDC and consulting fees from ALung Technologies (Steering Committee). J. W. reports grants from the CDC and NIH (ARREST Pneumonia Trial UH3HL141722, ACTIV3a and 3b trials, and ACTIV4a trial), and membership on the American Board of Internal Medicine Critical Care Medicine exam committee. S. Y. C. reports grants from CDC and Regeneron (for 6R88-COV-2040 trial) and consulting fees from PureTech Health (for COVID study) and Kiniska (for possible ARDS study). J. H. K. reports grant support from CDC and NIH (1K23 AI137321-01A1). A. S. L. reports grants from the CDC, NIH, and Burroughs Wellcome Fund, consultant fees for antiviral drugs from Sanofi and fees from Roche for membership on a baloxavir trial steering committee. N. H. reports grants from CDC, NIH, Sanofi, and Quidel and honoraria for speaking at a continuing medical education event at American Academy of Pediatrics. C. G. G. reports consultant fees from Pfizer, Merck, and Sanofi and grants from Syneos Health, CDC, NIH, FDA, AHRQ, and Sanofi. T. R. reports grants from CDC and Abbvie Inc, consultant fees from Cytovale, Inc. and Cumberland Pharmaceuticals Inc., membership on a Sanofi, Inc. DSMB, a voluntary role as the Immediate Past President of ASPEN and stock in Cumberland Pharmaceuticals, Inc. I. J. reports grants/contracts from the CDC, NIH, Quidel, and Sanofi. C. J. L. reports grants/contracts from CDC, NIH, DoD, bioMerieux, Endpoint Health, Entegrion, Inc., and AbbVie; a patent issued to Cincinnati Children’s Hospital Medical Center for risk stratification in sepsis and septic shock, membership on a Study Principal Investigators DSMB for clinical trials unrelated to the current work, Executive Committee; Immediate Past President, Member, Board of Directors, Association for Clinical and Translational Science, and stock options in Bioscape Digita unrelated to the current work. W. B. S. reports a grant from the CDC and NIH (5K12HL133117-05). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.