Assessing the risk and costs of COVID-19 in immunocompromised populations in a large United States commercial insurance health plan: the EPOCH-US Study

References

• World Health Organization Emergency Response Team. COVID-19 Weekly Epidemiological Update: World Health Organization; 2023 [updated 22 February 2023; cited 2023 1 March]; 131:[Available from: https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19–-22-february-2023.
   Google Scholar
• Centers for Disease Control and Prevention. COVID Data Tracker. Daily Update for the United States Atlanta, Georgia: Centers for Disease Control and Prevention; 2023 updated 2 March 2023; cited 2023 3 March]. Available from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
   Google Scholar
• Clark A, Jit M, Warren-Gash C, et al. Global, regional, and national estimates of the population at increased risk of severe COVID-19 due to underlying health conditions in 2020: a modelling study. Lancet Glob Health. 2020; 8(8):e1003–e1017. doi: 10.1016/S2214-109X(20)30264-3.
   PubMed Web of Science ®Google Scholar
• Ryan C, Minc A, Caceres J, et al. Predicting severe outcomes in Covid-19 related illness using only patient demographics, comorbidities and symptoms. Am J Emerg Med. 2021; 45:378–384. doi: 10.1016/j.ajem.2020.09.017.
   PubMed Web of Science ®Google Scholar
• Velayos FS, Dusendang JR, Schmittdiel JA. Prior immunosuppressive therapy and severe illness among patients diagnosed with SARS-CoV-2: a community-based study. J Gen Intern Med. 2021; 36(12):3794–3801. doi: 10.1007/s11606-021-07152-2.
   PubMed Web of Science ®Google Scholar
• SeyedAlinaghi S, Karimi A, Barzegary A, et al. COVID-19 mortality in patients with immunodeficiency and its predictors: a systematic review. Eur J Med Res. 2022; 27(1):195. doi: 10.1186/s40001-022-00824-7.
   PubMed Web of Science ®Google Scholar
• Choi JH, Choi SH, Yun KW. Risk factors for severe COVID-19 in children: a systematic review and meta-analysis. J Korean Med Sci. 2022; 37(5):e35. doi: 10.3346/jkms.2022.37.e35.
   PubMed Web of Science ®Google Scholar
• Abbasi J. Researchers tie severe immunosuppression to chronic COVID-19 and virus variants. JAMA. 2021; 325(20):2033–2035. doi: 10.1001/jama.2021.7212.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. People with certain medical condtions [updated February 10. 2023; April 25, 2023]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html.
   Google Scholar
• Singson JRC, Kirley PD, Pham H, et al. Factors associated with severe outcomes among immunocompromised adults hospitalized for COVID-19 - COVID-NET, 10 states, march 2020-February 2022. MMWR Morb Mortal Wkly Rep. 2022; 71(27):878–884. doi: 10.15585/mmwr.mm7127a3.
   PubMed Web of Science ®Google Scholar
• Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19. [Internet]. New York; 2020. Available from: businesswire.com/news/home/20201211005640/en/.
   Google Scholar
• Di Fusco M, Moran MM, Cane A, et al. Evaluation of COVID-19 vaccine breakthrough infections among immunocompromised patients fully vaccinated with BNT162b2. J Med Econ. 2021; 24(1):1248–1260. doi: 10.1080/13696998.2021.2002063.
   PubMed Web of Science ®Google Scholar
• Galmiche S, Luong Nguyen LB, Tartour E, et al. Immunological and clinical efficacy of COVID-19 vaccines in immunocompromised populations: a systematic review. Clin Microbiol Infect. 2022; Feb28(2):163–177. doi: 10.1016/j.cmi.2021.09.036.
   PubMed Web of Science ®Google Scholar
• Speich B, Chammartin F, Abela IA, et al. Antibody response in immunocompromised patients after the administration of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine BNT162b2 or mRNA-1273: a randomized controlled trial. Clin Infect Dis. 2022; 75(1):e585–e593. doi: 10.1093/cid/ciac169.
   PubMed Web of Science ®Google Scholar
• Sun J, Zheng Q, Madhira V, et al. Association between immune dysfunction and COVID-19 breakthrough infection after SARS-CoV-2 vaccination in the US. JAMA Intern Med. 2022;182(2):153. doi: 10.1001/jamainternmed.2021.7024.
   PubMed Web of Science ®Google Scholar
• Bergman P, Blennow O, Hansson L, et al. Safety and efficacy of the mRNA BNT162b2 vaccine against SARS-CoV-2 in five groups of immunocompromised patients and healthy controls in a prospective open-label clinical trial. EBioMedicine. 2021; 74:103705. doi: 10.1016/j.ebiom.2021.103705.
   PubMed Web of Science ®Google Scholar
• Abhishek A, Boyton RJ, Peckham N, et al. Effect of a 2-week interruption in methotrexate treatment versus continued treatment on COVID-19 booster vaccine immunity in adults with inflammatory conditions (VROOM study): a randomised, open label, superiority trial. Lancet Respir Med. 2022;10(9):840–850. doi: 10.1016/S2213-2600(22)00186-2.
   PubMed Web of Science ®Google Scholar
• Doherty J, Morain NO, Stack R, et al. Reduced serological response to COVID-19 vaccines in patients with IBD is further diminished by TNF inhibitor therapy; early results of the VARIATION study (VAriability in response in IBD against SARS-COV-2 immunisation). J Crohns Colitis. 2022;16(9):1354–1362. doi: 10.1093/ecco-jcc/jjac029.
   Web of Science ®Google Scholar
• Krasselt M, Wagner U, Nguyen P, et al. Humoral and cellular response to COVID-19 vaccination in patients with autoimmune inflammatory rheumatic diseases under real-life conditions. Rheumatology. 2022;61(SI2):SI180–SI188. doi: 10.1093/rheumatology/keac089.
   PubMed Web of Science ®Google Scholar
• Mandl P, Tobudic S, Haslacher H, et al. Response to SARS-CoV-2 vaccination in systemic autoimmune rheumatic disease depends on immunosuppressive regimen: a matched, prospective cohort study. Ann Rheum Dis. 2022;81(7):1017–1022. doi: 10.1136/annrheumdis-2021-221788.
   PubMed Web of Science ®Google Scholar
• Dhodapkar MV, Dhodapkar KM, Ahmed R. Viral immunity and vaccines in hematologic malignancies: implications for COVID-19. Blood Cancer Discov. 2021; 2(1):9–12. doi: 10.1158/2643-3230.bcd-20-0177.
   PubMedGoogle Scholar
• Haggenburg S, Lissenberg-Witte BI, van Binnendijk RS, et al. Quantitative analysis of mRNA-1273 COVID-19 vaccination response in immunocompromised adult hematology patients. Blood Adv. 2022; 6(5):1537–1546. doi: 10.1182/bloodadvances.2021006917.
   PubMed Web of Science ®Google Scholar
• Boyarsky BJ, Werbel WA, Avery RK, et al. Antibody response to 2-dose SARS-CoV-2 mRNA vaccine series in solid organ transplant recipients. JAMA. 2021;325(21):2204–2206. doi: 10.1001/jama.2021.7489.
   PubMed Web of Science ®Google Scholar
• Boyarsky BJ, Werbel WA, Avery RK, et al. Immunogenicity of a single dose of SARS-CoV-2 messenger RNA vaccine in solid organ transplant recipients. JAMA. 2021;325(17):1784–1786. doi: 10.1001/jama.2021.4385.
   PubMed Web of Science ®Google Scholar
• Kwon JH, Tenforde MW, Gaglani M, et al. mRNA vaccine effectiveness against COVID-19 hospitalization among solid organ transplant recipients. J Infect Dis. 2022;226(5):797–807. doi: 10.1093/infdis/jiac118.
   Web of Science ®Google Scholar
• Chukwu CA, Mahmood K, Elmakki S, et al. Evaluating the antibody response to SARS-COV-2 vaccination amongst kidney transplant recipients at a single nephrology centre. PLOS One. 2022;17(3):e0265130. doi: 10.1371/journal.pone.0265130.
   PubMed Web of Science ®Google Scholar
• Boey L, Curinckx A, Roelants M, et al. Immunogenicity and safety of the 9-valent human papillomavirus vaccine in solid organ transplant recipients and adults infected with human immunodeficiency virus (HIV). Clin Infect Dis. 2021;73(3):e661–e671. doi: 10.1093/cid/ciaa1897.
   PubMed Web of Science ®Google Scholar
• Eckerle I, Rosenberger KD, Zwahlen M, et al. Serologic vaccination response after solid organ transplantation: a systematic review. PLOS One. 2013;8(2):e56974. doi: 10.1371/journal.pone.0056974.
   PubMed Web of Science ®Google Scholar
• Trakarnvanich T, Ngamvichchukorn T, Phumisantiphong U, et al. Immune response after COVID-19 vaccination among patients with chronic kidney disease and kidney transplant. Vaccine. 2022; 40(45):6499–6511. doi: 10.1016/j.vaccine.2022.09.067.
   PubMed Web of Science ®Google Scholar
• Park JS, Minn D, Hong S, et al. Immunogenicity of COVID-19 vaccination in patients with End-Stage renal disease undergoing maintenance hemodialysis: the efficacy of a mix-and-match strategy. J Korean Med Sci. 2022; 37(23):e180. doi: 10.3346/jkms.2022.37.e180.
   PubMed Web of Science ®Google Scholar
• Abo-Helo N, Muhammad E, Ghaben-Amara S, et al. Specific antibody response of patients with common variable immunodeficiency to BNT162b2 coronavirus disease 2019 vaccination. Ann Allergy Asthma Immunol. 2021;127(4):501–503. doi: 10.1016/j.anai.2021.07.021.
   PubMed Web of Science ®Google Scholar
• Barmettler S, DiGiacomo DV, Yang NJ, et al. Response to SARS-CoV-2 initial series and additional dose vaccine in patients with predominant antibody deficiency. J Allergy Clin Immunol Pract. 2022;10(6):1622–1634.e4. doi: 10.1016/j.jaip.2022.03.017.
   Web of Science ®Google Scholar
• van Leeuwen LPM, GeurtsvanKessel CH, Ellerbroek PM, et al. Immunogenicity of the mRNA-1273 COVID-19 vaccine in adult patients with inborn errors of immunity. J Allergy Clin Immunol. 2022; 149(6):1949–1957. doi: 10.1016/j.jaci.2022.04.002.
   PubMed Web of Science ®Google Scholar
• Yek C, Warner S, Wiltz JL, et al. Risk factors for severe COVID-19 outcomes among persons aged ≥18 years who completed a primary COVID-19 vaccination series - 465 health care facilities, United States, december 2020-October 2021. MMWR Morb Mortal Wkly Rep. 2022; 71(1):19–25. doi: 10.15585/mmwr.mm7101a4.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States [updated May 12, 2023; last reviewed June 14, 2023]. Available at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#:∼:text=COVID%2D19%20vaccination%20is%20recommended,younger%20than%20age%206%20months.
   Google Scholar
• Harpaz R, Dahl RM, Dooling KL. Prevalence of immunosuppression among US adults, 2013. JAMA. 2016;316(23):2547–2548. doi: 10.1001/jama.2016.16477.
   PubMed Web of Science ®Google Scholar
• Wallace BI, Kenney B, Malani PN, et al. Prevalence of immunosuppressive drug use among commercially insured US adults, 2018–2019. JAMA Netw Open. 2021; 4(5):e214920. doi: 10.1001/jamanetworkopen.2021.4920.
   PubMed Web of Science ®Google Scholar
• Walsh EE, Frenck RW, Jr., Falsey AR, et al. Safety and immunogenicity of two RNA-based covid-19 vaccine candidates. N Engl J Med. 2020;383(25):2439–2450. doi: 10.1056/NEJMoa2027906.
   PubMed Web of Science ®Google Scholar
• Sadoff J, Gray G, Vandebosch A, et al. Final analysis of efficacy and safety of single-dose Ad26.COV2.S. N Engl J Med. 2022;386(9):847–860. doi: 10.1056/NEJMoa2117608.
   PubMed Web of Science ®Google Scholar
• Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2 - preliminary report. N Engl J Med. 2020;383(20):1920–1931. doi: 10.1056/NEJMoa2022483.
   PubMed Web of Science ®Google Scholar
• US Census Bureau. American Community Survey 5-Year Data Profile (2013-2017) 2017 Available from: https://www.census.gov/programs-surveys/acs/data.html.
   Google Scholar
• U.S. Bureau of Labor Statistics. Consumer Price Index [April 25, 2022]. Available from: https://www.bls.gov/cpi/home.htm.
   Google Scholar
• Quan H, Li B, Couris CM, et al. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011; Mar173(6):676–682. doi: 10.1093/aje/kwq433.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. COVID data tracker Atlanta, GA: US Department of Health and Human Services; [updated April 19, 2023;April 19, 2023]. Available from: https://covid.cdc.gov/covid-data-tracker/#trends_weeklycases_7daycasesper100k_00.
   Google Scholar
• Salerno S, Messana JM, Gremel GW, et al. COVID-19 risk factors and mortality outcomes among medicare patients receiving long-term dialysis. JAMA Netw Open. 2021; 14(11):e2135379. doi: 10.1001/jamanetworkopen.2021.35379.
   PubMed Web of Science ®Google Scholar
• Kliger AS, Silberzweig J. Mitigating risk of COVID-19 in dialysis facilities. Clin J Am Soc Nephrol. 2020; May 715(5):707–709. doi: 10.2215/CJN.03340320.
   PubMed Web of Science ®Google Scholar
• Rabb H. Kidney diseases in the time of COVID-19: major challenges to patient care. J Clin Invest. 2020; 130(6):2749–2751. doi: 10.1172/JCI138871.
   PubMed Web of Science ®Google Scholar
• DeMartino JK, Swallow E, Goldschmidt D, et al. Direct health care costs associated with COVID-19 in the United States. J Manag Care Spec Pharm. 2022; 28(9):936–947. doi: 10.18553/jmcp.2022.22050.
   PubMed Web of Science ®Google Scholar
• Centers for Medicare and Medicaid Services. COVID-19 experiences among the Medicare population: summer 2020 [updated October 2020;March 28, 2023]. Available from: https://www.cms.gov/files/document/medicare-current-beneficiary-survey-summer-2020-covid-19-data-snapshot.pdf.
   Google Scholar
• Tenforde MW, Patel MM, Ginde AA, et al. Effectiveness of severe acute respiratory syndrome coronavirus 2 messenger RNA vaccines for preventing coronavirus disease 2019 hospitalizations in the United States. Clin Infect Dis. 2022; 74(9):1515–1524. doi: 10.1093/cid/ciab687.
   PubMed Web of Science ®Google Scholar
• Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA covid-19 vaccine in solid-organ transplant recipients. N Engl J Med. 2021; 385(7):661–662. doi: 10.1056/NEJMc2108861.
   PubMed Web of Science ®Google Scholar
• Simon B, Rubey H, Treipl A, et al. Haemodialysis patients show a highly diminished antibody response after COVID-19 mRNA vaccination compared with healthy controls. Nephrol Dial Transplant. 2021;36(9):1709–1716. doi: 10.1093/ndt/gfab179.
   PubMed Web of Science ®Google Scholar
• Agha ME, Blake M, Chilleo C, et al. Suboptimal response to coronavirus disease 2019 messenger RNA vaccines in patients with hematologic malignancies: a need for vigilance in the postmasking era. Open Forum Infect Dis. 2021; 8(7):ofab353.
   PubMed Web of Science ®Google Scholar
• Cheung MW, Dayam RM, Shapiro JR, et al. Third and fourth vaccine doses broaden and prolong immunity to SARS-CoV-2 in immunocompromised adult patients. medRxiv. 2023:2023.03.01.23286513.
   Google Scholar
• Tartof SY, Slezak JM, Puzniak L, et al. Effectiveness of a third dose of BNT162b2 mRNA COVID-19 vaccine in a large US health system: a retrospective cohort study. Lancet Reg Health Am. 2022; 9:100198. doi: 10.1016/j.lana.2022.100198.
   PubMedGoogle Scholar
• Food and Drug Administration. Emergency use authorizations for drugs and non-vaccine biological products [updated March 17, 2023;March 29, 2023]. Available from: https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products.
   Google Scholar
• De Vito A, Colpani A, Saderi L, et al. Impact of early SARS-CoV-2 antiviral therapy on disease progression. Viruses. 2022; 15(1):71. doi: 10.3390/v15010071.
   PubMed Web of Science ®Google Scholar
• Rahmah L, Abarikwu SO, Arero AG, et al. Oral antiviral treatments for COVID-19: opportunities and challenges. Pharmacol Rep. 2022; 74(6):1255–1278. doi: 10.1007/s43440-022-00388-7.
   PubMed Web of Science ®Google Scholar
• Klaassen F, Chitwood MH, Cohen T, et al. Changes in population immunity against infection and severe disease from SARS-CoV-2 Omicron variants in the United States between December 2021 and November 2022. Clin Infect Dis. 2023:ciad210. doi: 10.1093/cid/ciad210.
   Web of Science ®Google Scholar
• ClinicalTrials.gov. Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA). NCT05648110 [updated March 17, 2023;March 29, 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT05648110.
   Google Scholar
• Amruta N, Chastain WH, Paz M, et al. SARS-CoV-2 mediated neuroinflammation and the impact of COVID-19 in neurological disorders. Cytokine Growth Factor Rev. 2021; 58:1–15. doi: 10.1016/j.cytogfr.2021.02.002.
   PubMed Web of Science ®Google Scholar
• Khare S, Gurry C, Freitas L, et al. GISAID’s role in pandemic response. China CDC Wkly. 2021;3(49):1049–1051. doi: 10.46234/ccdcw2021.255.
   PubMedGoogle Scholar
• Centers for Disease Control and Prevention. COVID data tracker. Nowcast estimates. Atlanta, GA: US Department of Health and Human Services; [updated May 6, 2023;January 20, 2023]. Available from: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
   Google Scholar