Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19–Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions — VISION Network, September 2022–April 2023
2023; Elsevier BV; Volume: 23; Issue: 7 Linguagem: Inglês
10.1016/j.ajt.2023.06.004
ISSN1600-6143
AutoresRuth Link‐Gelles, Zachary A. Weber, Sarah E. Reese, Amanda B. Payne, Manjusha Gaglani, Katherine Adams, Anupam B. Kharbanda, Karthik Natarajan, Malini B. DeSilva, Kristin Dascomb, Stephanie A. Irving, Nicola P. Klein, Shaun J. Grannis, Toan C. Ong, Peter J. Embí, Margaret M. Dunne, Monica Dickerson, Charlene McEvoy, Julie Arndorfer, Allison L. Naleway, Kristin Goddard, Brian E. Dixon, Eric P. Griggs, John Hansen, Nimish R. Valvi, Morgan Najdowski, Julius Timbol, Christian M. Rogerson, Bruce Fireman, William F. Fadel, Palak Patel, Caitlin Ray, Ryan E. Wiegand, Sarah W. Ball, Mark W. Tenforde,
Tópico(s)Bacterial Infections and Vaccines
ResumoSummaryWhat is already known about this topic?Bivalent mRNA COVID-19 vaccines help provide protection against medically attended COVID-19–associated illness. However, the durability of this protection is uncertain.What is added by this report?Among adults aged ≥18 years without immunocompromising conditions, bivalent booster vaccine effectiveness (VE) against COVID-19–associated hospitalization declined from 62% at 7–59 days postvaccination to 24% at 120–179 days compared with VE among unvaccinated adults. Among immunocompromised adults, lower bivalent booster VE was observed. However, bivalent booster VE was sustained against critical COVID-19–associated outcomes, including intensive care unit admission or death.What are the implications for public health practice?Adults should stay up to date with recommended COVID-19 vaccines. Optional additional bivalent vaccine doses are available for older adults and persons with immunocompromising conditions. What is already known about this topic? Bivalent mRNA COVID-19 vaccines help provide protection against medically attended COVID-19–associated illness. However, the durability of this protection is uncertain. What is added by this report? Among adults aged ≥18 years without immunocompromising conditions, bivalent booster vaccine effectiveness (VE) against COVID-19–associated hospitalization declined from 62% at 7–59 days postvaccination to 24% at 120–179 days compared with VE among unvaccinated adults. Among immunocompromised adults, lower bivalent booster VE was observed. However, bivalent booster VE was sustained against critical COVID-19–associated outcomes, including intensive care unit admission or death. What are the implications for public health practice? Adults should stay up to date with recommended COVID-19 vaccines. Optional additional bivalent vaccine doses are available for older adults and persons with immunocompromising conditions. On September 1, 2022, CDC's Advisory Committee on Immunization Practices (ACIP) recommended a single bivalent mRNA COVID-19 booster dose for persons aged ≥12 years who had completed at least a monovalent primary series. Early vaccine effectiveness (VE) estimates among adults aged ≥18 years showed receipt of a bivalent booster dose provided additional protection against COVID-19–associated emergency department and urgent care visits and hospitalizations compared with that in persons who had received only monovalent vaccine doses;1Tenforde M.W. Weber Z.A. Natarajan K. et al.Early estimates of bivalent mRNA vaccine effectiveness in preventing COVID-19–associated emergency department or urgent care encounters and hospitalizations among immunocompetent adults—VISION Network, nine states, September–November 2022.MMWR Morb Mortal Wkly Rep. 2023; 71 (PMID:36921274): 1637-1646https://doi.org/10.15585/mmwr.mm7153a1Crossref PubMed Google Scholar however, insufficient time had elapsed since bivalent vaccine authorization to assess the durability of this protection. The VISION Network aSites from the CDC-funded VISION Network that contributed data for this analysis were HealthPartners (Minnesota and Wisconsin), Intermountain Healthcare (Utah), Kaiser Permanente Northern California (California), Kaiser Permanente Center for Health Research (Oregon and Washington), and Regenstrief Institute (Indiana). assessed VE against COVID-19–associated hospitalizations by time since bivalent vaccine receipt during September 13, 2022–April 21, 2023, among adults aged ≥18 years with and without immunocompromising conditions. During the first 7–59 days after vaccination, compared with no vaccination, VE for receipt of a bivalent vaccine dose among adults aged ≥18 years was 62% (95% CI = 57%–67%) among adults without immunocompromising conditions and 28% (95% CI = 10%–42%) among adults with immunocompromising conditions. Among adults without immunocompromising conditions, VE declined to 24% (95% CI = 12%–33%) among those aged ≥18 years by 120–179 days after vaccination. VE was generally lower for adults with immunocompromising conditions. A bivalent booster dose provided the highest protection, and protection was sustained through at least 179 days against critical outcomes, including intensive care unit (ICU) admission or in-hospital death. These data support updated recommendations allowing additional optional bivalent COVID-19 vaccine doses for certain high-risk populations. All eligible persons should stay up to date with recommended COVID-19 vaccines. The VISION Network evaluated VE of bivalent vaccines against COVID-19–associated hospitalization by length of time since receipt of the most recent dose during September 13, 2022–April 21, 2023, across five sites in seven states. VE methods used by the VISION Network have been previously described.2Thompson M.G. Natarajan K. Irving S.A. et al.Effectiveness of a third dose of mRNA vaccines against COVID-19–associated emergency department and urgent care encounters and hospitalizations among adults during periods of Delta and Omicron variant predominance—VISION Network, 10 states, August 2021–January 2022.MMWR Morb Mortal Wkly Rep. 2022; 71 (PMID:35085224): 139-145https://doi.org/10.15585/mmwr.mm7104e3Crossref PubMed Google Scholar For this analysis, adults aged ≥18 years with and without immunocompromising conditions who were hospitalized with COVID-19–like illness bMedical events with a discharge code consistent with COVID-19–like illness were included. COVID-19–like illness diagnoses were obtained from ICD-10 discharge codes. The specific codes used were COVID-19 pneumonia: J12.81 and J12.82; influenza pneumonia: J09.X1, J10.0, J10.00, J10.01, J10.08, J11.0, J11.00, and J11.08; other viral pneumonia: J12∗; bacterial and other pneumonia: J13, J14, J15∗, J16∗, J17, and J18∗; influenza disease: J09∗, J10.1, J10.2, J10.8∗, J11.1, J11.2, and J11.8∗; acute respiratory distress syndrome: J80; chronic obstructive pulmonary disease with acute exacerbation: J44.1; asthma acute exacerbation: J45.21, J45.22, J45.31, J45.32, J45.41, J45.42, J45.51, J45.52, J45.901, and J45.902; respiratory failure: J96.0∗, J96.2∗, and R09.2; other acute lower respiratory tract infections: J20∗, J21∗, J22, J40, J44.0, J41∗, J42, J43∗, J47∗, J85, J85.0, J85.1, J85.2, J85.3, and J86∗; acute and chronic sinusitis: J01∗ and J32∗; acute upper respiratory tract infections: J00∗, J02∗, J03∗, J04∗, J05∗, and J06∗; acute respiratory illness signs and symptoms: R04.2, R05, R05.1, R05.2, R05.4, R05.8, R05.9, R06.00, R06.02, R06.03, R06.1, R06.2, R06.8, R06.81, R06.82, R06.89, R07.1, R09.0∗, R09.1, R09.2, R09.3, and R09.8∗; acute febrile illness signs and symptoms: R50∗, R50.81, and R68.83; acute nonrespiratory illness signs and symptoms: R19.7, R43∗, R51∗, R51.9, M79.1∗, M79.10, M79.18, R65∗, R53.81, R53.83, R57.9, R41.82, R40∗, R53.1, R11.0, R11.10, R11.11, R11.15, R11.2, R21∗, R10.0, R10.1∗, R10.2, R10.3∗, R10.8, R10.81∗, R10.84, and R10.9. All ICD-10 codes with ∗ include all child codes under the specific parent code. were included if the patient received molecular testing (e.g., real-time reverse transcription–polymerase chain reaction) for SARS-CoV-2 during the 14 days preceding or up to 72 hours after hospital admission. Patients were categorized as immunocompromised or not based on International Classification of Diseases, Tenth Revision (ICD-10) discharge codes. cImmunocompromising conditions were obtained from ICD-10 discharge codes. The specific codes used were Hematological Malignancy: C81.∗, C82.∗, C83.∗, C84.∗, C85.∗, C86.∗, C88.∗, C90.∗, C91.∗, C92.∗, C93.∗, C94.∗, C95.∗, C96.∗, D46.∗, D61.0∗, D61.2, D61.9, D70.0, and D71.∗; Solid Malignancy: C00.∗, C01.∗, C02.∗, C03.∗, C04.∗, C05.∗, C06.∗, C07.∗, C08.∗, C09.∗, C10.∗, C11.∗, C12.∗, C13.∗, C14.∗, C15.∗, C16.∗, C17.∗, C18.∗, C19.∗, C20.∗, C21.∗, C22.∗, C23.∗, C24.∗, C25.∗, C26.∗, C27.∗, C28.∗, C29.∗, C30.∗, C31.∗, C32.∗, C33.∗, C34.∗, C35.∗, C36.∗, C37.∗, C38.∗, C39.∗, C40.∗, C41.∗, C42.∗, C43.∗, C44.∗, C45.∗, C46.∗, C47.∗, C48.∗, C49.∗, C50.∗, C51.∗, C52.∗, C53.∗, C54.∗, C55.∗, C56.∗, C57.∗, C58.∗, C59.∗, C60.∗, C61.∗, C62.∗, C63.∗, C64.∗, C65.∗, C66.∗, C67.∗, C68.∗, C69.∗, C70.∗, C71.∗, C72.∗, C73.∗, C74.∗, C75.∗, C76.∗, C77.∗, C78.∗, C79.∗, C7A.∗, C7B.∗, C80.∗, D3A.∗, Z51.0, Z51.1∗, and C4A.∗; Transplant: T86.0, T86.1, T86.2, T86.3, T86.4, T86.5, T86.81, T86.85, D47.Z1, Z48.2.∗, Z94.∗, and Z98.85; rheumatologic/inflammatory disorders: D86.∗, E85, E85.1, E85.2, E85.3, E85.4, E85.8∗, E85.9, G35.∗, J67.9.∗, L40.54, L40.59, L93.0.∗, L93.2.∗, L94.∗, M05.∗, M06.∗, M07.∗, M08.∗, M30.∗, M31.3∗, M31.5∗, M32.∗, M33.∗, M34.∗, M35.3∗, M35.8∗, M35.9∗, M46.∗, and T78.40∗; Other intrinsic immune condition of immunodeficiency: D27.9, D72.89, D80.∗, D81, D81.0, D81.1, D81.2, D81.4, D81.5, D81.6, D81.7, D81.8∗, D81.9, D82.∗, D83.∗, D84.∗, D87.89, D89, D89.0, D89.1, D89.3, D89.4∗, D89.8∗, D89.9, K70.3∗, K70.4∗, K72.∗, K74.3, K74.4, K74.5, K74.6, N04.∗, R18.0; HIV: B20.∗, B21.∗, B22.∗, B23.∗, B24.∗, B97.35, O98.7∗, and Z21∗. All ICD-10 codes with ∗ include all child codes under the specific parent code. Patients were classified on the index date dThe index date for each hospitalization was defined as either the date of collection of a respiratory specimen associated with the most recent positive or negative SARS-CoV-2 test result before the hospital admission or the admission date (if testing occurred only after the admission). as unvaccinated (no COVID-19 vaccine doses received), vaccinated with monovalent doses only, or vaccinated with one mRNA bivalent booster dose (regardless of number of previous monovalent doses received). Patients who received only monovalent doses were included if they received any combination of 1–4 doses (or 1–5 doses if immunocompromised) monovalent mRNA (Moderna or Pfizer-BioNTech), Janssen (Johnson & Johnson), or Novavax vaccine doses; recipients of a single monovalent mRNA dose or a single Novavax dose were excluded. In addition, patients were excluded if any vaccine dose was received 1 bivalent dose was received. eOn April 19, 2023, CDC authorized an additional bivalent vaccine dose for adults aged ≥65 years and additional doses for persons who are immunocompromised. https://www.cdc.gov/media/releases/2023/s0419-covid-vaccines.html Patients aged 3 monovalent doses. Patients were considered to have critical illness if they were admitted to an ICU, died, or both. fDeath was identified at each individual site and was defined as a death while hospitalized or ≤28 days after hospital admission. Absolute VE was estimated using a test-negative case-control design comparing the odds of vaccination (either bivalent booster or monovalent doses only versus being unvaccinated) among case- and control patients. Relative VE was calculated by comparing those who received a bivalent booster with those who received monovalent doses only. A combined model was generated and included patients who had only received monovalent vaccination ≥7 days before their index date, or a bivalent mRNA booster dose at 7–59, 60–119, or 120–179 days before their index date, compared with an unvaccinated reference group. Odds ratios and 95% CIs were estimated using multivariable logistic regression controlling for age, race and ethnicity, sex, calendar day (days since January 1, 2021), and geographic region. Age and calendar day were modeled as natural cubic splines. VE was modeled separately for persons with and without immunocompromising conditions, by age group (18–64 and ≥65 years), and for each outcome (hospitalization and critical illness). gFor VE against critical illness, case-patients were persons admitted to an ICU or who experienced in-hospital death associated with COVID-19, and control patients were persons hospitalized without COVID-19. Analyses were conducted using R (version 4.2.2; The R Foundation). This study was conducted consistent with applicable federal law and CDC policy and was reviewed and approved by Institutional Review Boards at participating sites or under a reliance agreement with the Institutional Review Board of Westat, Inc. h45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect. 552a; 44 U.S.C. Sect. 3501 et seq. Among 66,141 hospitalized patients without immunocompromising conditions who met inclusion criteria, 6,907 (10.4%) were case-patients and 59,234 (89.6%) were control patients (Table 1). Median age of case- and control patients was 76 years and 71 years, respectively. Among case- and control patients, 25.9% and 23.2% were unvaccinated, respectively; a bivalent vaccine dose had been received by 16.3% of case-patients and 20.6% of control patients. VE against COVID-19–associated hospitalization was similar across age groups, but waned over time, from 62% during the first 7–59 days after the bivalent dose to 24% by 120–179 days among adults aged ≥18 years (Table 2). Among those who received monovalent doses only, VE was 21% a median 376 days after the last dose. VE against critical illness was 69% during the 7–59 days after receipt of a bivalent dose and was more sustained (50% at 120–179 days after bivalent vaccination) than VE against hospitalization.TABLE 1Characteristics of hospitalizations among immunocompetent adults aged ≥18 years with COVID-19–like illness,aHospitalizations with a discharge code consistent with COVID-19–like illness were included. COVID-19–like illness diagnoses included acute respiratory illness, respiratory signs or symptoms or febrile signs or symptoms using diagnosis codes from the International Classification of Diseases, Tenth Revision. Clinician-ordered molecular assays (e.g., real-time reverse transcription–polymerase chain reaction) for SARS-CoV-2 occurring ≤14 days before to 0.20 indicates a nonnegligible difference in variable distributions between hospitalizations for vaccinated versus unvaccinated patients, or for patients with a positive SARS-CoV-2 test result versus patients with a negative SARS-CoV-2 test result. For mRNA COVID-19 vaccination status, a single SMD was calculated by averaging the absolute SMDs obtained from pairwise comparisons of each vaccinated category versus unvaccinated. Specifically, it was calculated as the average of the absolute value of the SMDs for 1) vaccinated with only MV doses, ≥7 days earlier versus unvaccinated, 2) vaccinated with an mRNA BV dose, 7–59 days earlier versus unvaccinated, 3) vaccinated with an mRNA BV dose, 60–119 days earlier versus unvaccinated, and 4) vaccinated with an mRNA BV dose, 120–179 days earlier versus unvaccinated.Vaccination status,dVaccination was defined as having received the last MV or BV dose within the specified range of days before the index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before the admission date, or the admission date if testing only occurred after the admission. no. (row %)SMDcAn absolute SMD >0.20 indicates a nonnegligible difference in variable distributions between hospitalizations for vaccinated versus unvaccinated patients, or for patients with a positive SARS-CoV-2 test result versus patients with a negative SARS-CoV-2 test result. For mRNA COVID-19 vaccination status, a single SMD was calculated by averaging the absolute SMDs obtained from pairwise comparisons of each vaccinated category versus unvaccinated. Specifically, it was calculated as the average of the absolute value of the SMDs for 1) vaccinated with only MV doses, ≥7 days earlier versus unvaccinated, 2) vaccinated with an mRNA BV dose, 7–59 days earlier versus unvaccinated, 3) vaccinated with an mRNA BV dose, 60–119 days earlier versus unvaccinated, and 4) vaccinated with an mRNA BV dose, 120–179 days earlier versus unvaccinated.Case-patients (positive)Control patients (negative)UnvaccinatedPrimary series with or without MV booster, ≥7 days earliereIncludes persons who received a single dose of Janssen (Johnson & Johnson) vaccine. Persons who received a single dose of Pfizer-BioNTech, Moderna, or Novavax vaccine were excluded from the analysis.BV mRNA dose, 7–59 days earlierBV mRNA dose, 60–119 days earlierBV mRNA dose, 120–179 days earlierAll hospitalizations (row %)66,141 (100.0)6,907 (10.4)59,234 (89.6)NA15,514 (23.5)37,269 (56.3)4,857 (7.3)5,191 (7.8)3,310 (5.0)NAVariant-predominant periodfVariant predominance was defined as the period when a variant accounted for ≥50% of all sequenced specimens in the U.S. Department of Health and Human Services region where the site is located. XBB-related sublineages predominated at Intermountain Healthcare beginning January 28, 2023; at HealthPartners, KPNC, and Regenstrief Institute beginning February 4, 2023; and at KPCHR beginning February 11, 2023.BA.4/BA.5–related47,065 (71.2)5,219 (11.1)41,846 (88.9)0.1111,240 (23.9)27,594 (58.6)4,439 (9.4)3,525 (7.5)267 (0.6)1.09XBB-related19,076 (28.8)1,688 (8.8)17,388 (91.2)4,274 (22.4)9,675 (50.7)418 (2.2)1,666 (8.7)3,043 (16.0)SiteHealthPartners5,354 (8.1)646 (12.1)4,708 (87.9)0.11969 (18.1)2,716 (50.7)678 (12.7)643 (12.0)348 (6.5)2.72Intermountain Healthcare7,572 (11.4)933 (12.3)6,639 (87.7)2,041 (27.0)3,994 (52.7)538 (7.1)595 (7.9)404 (5.3)KPCHR4,974 (7.5)414 (8.3)4,560 (91.7)1,232 (24.8)2,565 (51.6)458 (9.2)465 (9.3)254 (5.1)KPNC23,294 (35.2)2,271 (9.7)21,023 (90.3)2,147 (9.2)15,152 (65.0)2,017 (8.7)2,338 (10.0)1,640 (7.0)Regenstrief Institute24,947 (37.7)2,643 (10.6)22,304 (89.4)9,125 (36.6)12,842 (51.5)1,166 (4.7)1,150 (4.6)664 (2.7)Age group, yrs18–499,656 (14.6)552 (5.7)9,104 (94.3)0.354,047 (41.9)4,880 (50.5)288 (3.0)283 (2.9)158 (1.6)2.2550–6413,200 (20.0)995 (7.5)12,205 (92.5)3,986 (30.2)7,488 (56.7)671 (5.1)652 (4.9)403 (3.1)65–7415,002 (22.7)1,496 (10.0)13,506 (90.0)3,206 (21.4)8,531 (56.9)1,240 (8.3)1,242 (8.3)783 (5.2)75–8416,791 (25.4)2,155 (12.8)14,636 (87.2)2,702 (16.1)9,671 (57.6)1,582 (9.4)1,726 (10.3)1,110 (6.6)≥8511,492 (17.4)1,709 (14.9)9,783 (85.1)1,573 (13.7)6,699 (58.3)1,076 (9.4)1,288 (11.2)856 (7.4)SexMen30,327 (45.9)3,412 (11.3)26,915 (88.7)0.087,503 (24.7)16,802 (55.4)2,163 (7.1)2,333 (7.7)1,526 (5.0)0.23Women35,814 (54.1)3,495 (9.8)32,319 (90.2)8,011 (22.4)20,467 (57.1)2,694 (7.5)2,858 (8.0)1,784 (5.0)Race and ethnicityBlack or African American, non-Hispanic5,953 (9.0)481 (8.1)5,473 (91.9)0.111,923 (32.3)3,317 (55.7)263 (4.4)275 (4.6)175 (2.9)1.17White, non-Hispanic45,101 (68.2)4,976 (11.0)40,125 (89.0)10,399 (23.1)24,751 (54.9)3,593 (8.0)3,892 (8.6)2,466 (5.5)Hispanic or Latino5,622 (8.5)517 (9.2)5,105 (90.8)944 (16.8)3,736 (66.5)364 (6.5)350 (6.2)228 (4.1)Other,gOther race includes American Indian or Alaska Native, Asian, Native Hawaiian or other Pacific Islander, other races not listed, and multiple races. Because of small numbers, these categories were combined. non-Hispanic6,054 (9.2)566 (9.3)5,488 (90.7)926 (15.3)3,716 (61.4)496 (8.2)553 (9.1)363 (6.0)Unknown3,411 (5.2)367 (10.8)3,044 (89.2)1,322 (38.8)1,749 (51.3)141 (4.1)121 (3.5)78 (2.3)SARS-CoV-2 test result statusCase-patients (positive)6,907 (10.4)6,907 (100.0)0 (—)NA1,791 (25.9)3,988 (57.7)327 (4.7)486 (7.0)315 (4.6)NAControl patients (negative)59,234 (89.6)0 (—)59,234 (100.0)13,723 (23.2)33,281 (56.2)4,530 (7.6)4,705 (7.9)2,995 (5.1)No. of MV doses received015,599 (23.6)1,798 (11.5)13,801 (88.5)NA15,514 (99.5)0 (—)36 (0.2)30 (0.2)19 (0.1)NA11,402 (2.1)116 (8.3)1,286 (91.7)0 (—)1,259 (89.8)53 (3.8)54 (3.9)36 (2.6)212,948 (19.6)1,340 (10.3)11,608 (89.7)0 (—)11,936 (92.2)404 (3.1)407 (3.1)201 (1.6)321,860 (33.1)2,199 (10.1)19,661 (89.9)0 (—)16,684 (76.3)1,959 (9.0)1,972 (9.0)1,245 (5.7)414,332 (21.7)1,454 (10.1)12,878 (89.9)0 (—)7,390 (51.6)2,405 (16.8)2,728 (19.0)1,809 (12.6)MV product received, by manufacturerhBecause persons might have received vaccine from more than one manufacturer, columns might sum to >100%.Pfizer-BioNTech29,721 (58.7)2,950 (9.9)26,771 (90.1)NANA21,435 (72.1)3,018 (10.1)3,203 (10.8)2,065 (6.9)NAModerna23,048 (45.5)2,384 (10.3)20,664 (89.7)NA16,887 (73.3)2,242 (9.7)2,409 (10.4)1,510 (6.6)Janssen (Johnson & Johnson)3,230 (6.4)286 (8.9)2,944 (91.1)NA2,770 (85.8)176 (5.4)177 (5.5)107 (3.3)Novavax1 (0)0 (—)1 (100.0)NA1 (100.0)0 (—)0 (—)0 (—)COVID-19 vaccination statusUnvaccinated15,514 (23.5)1,791 (11.5)13,723 (88.5)0.1415,514 (100.0)0 (—)0 (—)0 (—)0 (—)NAPrimary series with or without MV booster37,269 (56.3)3,988 (10.7)33,281 (89.3)0 (—)37,269 (100.0)0 (—)0 (—)0 (—)mRNA BV dose, 7–59 days earlier4,857 (7.3)327 (6.7)4,530 (93.3)0 (—)0 (—)4,857 (100.0)0 (—)0 (—)mRNA BV dose, 60–119 days earlier5,191 (7.8)486 (9.4)4,705 (90.6)0 (—)0 (—)0 (—)5,191 (100.0)0 (—)mRNA BV dose, 120–179 days earlier3,310 (5.0)315 (9.5)2,995 (90.5)0 (—)0 (—)0 (—)0 (—)3,310 (100.0)Most recent dose product manufacturerPfizer-BioNTech29,892 (59.0)2,968 (9.9)26,924 (90.1)0.040 (—)20,271 (67.8)3,441 (11.5)3,732 (12.5)2,448 (8.2)NAModerna19,084 (37.7)2,004 (10.5)17,080 (89.5)0 (—)15,347 (80.4)1,416 (7.4)1,459 (7.6)862 (4.5)Janssen (Johnson & Johnson)1,650 (3.3)144 (8.7)1,506 (91.3)0 (—)1,650 (100.0)0 (—)0 (—)0 (—)Novavax1 (0)0 (—)1 (100.0)0 (—)1 (100.0)0 (—)0 (—)0 (—)One or more chronic respiratory conditionYes39,469 (59.7)4,286 (10.9)35,183 (89.1)0.058,602 (21.8)22,383 (56.7)3,067 (7.8)3,314 (8.4)2,103 (5.3)0.46No26,672 (40.3)2,621 (9.8)24,051 (90.2)6,912 (25.9)14,886 (55.8)1,790 (6.7)1,877 (7.0)1,207 (4.5)One or more chronic nonrespiratory conditionYes54,754 (82.8)5,843 (10.7)48,911 (89.3)0.0511,322 (20.7)31,413 (57.4)4,344 (7.9)4,679 (8.5)2,996 (5.5)1.28No11,387 (17.2)1,064 (9.3)10,323 (90.7)4,192 (36.8)5,856 (51.4)513 (4.5)512 (4.5)314 (2.7)ICU admissionYes12,197 (18.4)1,023 (8.4)11,174 (91.6)0.113,146 (25.8)6,763 (55.4)848 (7.0)886 (7.3)554 (4.5)0.22No53,944 (81.6)5,884 (10.9)48,060 (89.1)12,368 (22.9)30,506 (56.6)4,009 (7.4)4,305 (8.0)2,756 (5.1)Receipt of invasive mechanical ventilationYes3,293 (5.0)250 (7.6)3,043 (92.4)0.08804 (24.4)1,857 (56.4)229 (7.0)254 (7.7)149 (4.5)1.89No44,995 (68.0)4,814 (10.7)40,181 (89.3)7,984 (17.7)26,340 (58.5)3,850 (8.6)4,151 (9.2)2,670 (5.9)Unknown17,853 (27.0)1,843 (10.3)16,010 (89.7)6,726 (37.7)9,072 (50.8)778 (4.4)786 (4.4)491 (2.8)In-hospital deathiIn-hospital death was identified at each individual site and was defined as a death while hospitalized or ≤28 days after admission.Yes2,735 (4.1)331 (12.1)2,404 (87.9)0.04727 (26.6)1,433 (52.4)183 (6.7)246 (9.0)146 (5.3)0.09No63,406 (95.9)6,576 (10.4)56,830 (89.6)14,787 (23.3)35,836 (56.5)4,674 (7.4)4,945 (7.8)3,164 (5.0)Abbreviations: BV = bivalent; ICU = intensive care unit; KPCHR = Kaiser Permanente Center for Health Research; KPNC = Kaiser Permanente Northern California; MV = monovalent; NA = not applicable; SMD = standardized mean or proportion difference.a Hospitalizations with a discharge code consistent with COVID-19–like illness were included. COVID-19–like illness diagnoses included acute respiratory illness, respiratory signs or symptoms or febrile signs or symptoms using diagnosis codes from the International Classification of Diseases, Tenth Revision. Clinician-ordered molecular assays (e.g., real-time reverse transcription–polymerase chain reaction) for SARS-CoV-2 occurring ≤14 days before to 0.20 indicates a nonnegligible difference in variable distributions between hospitalizations for vaccinated versus unvaccinated patients, or for patients with a positive SARS-CoV-2 test result versus patients with a negative SARS-CoV-2 test result. For mRNA COVID-19 vaccination status, a single SMD was calculated by averaging the absolute SMDs obtained from pairwise comparisons of each vaccinated category versus unvaccinated. Specifically, it was calculated as the average of the absolute value of the SMDs for 1) vaccinated with only MV doses, ≥7 days earlier versus unvaccinated, 2) vaccinated with an mRNA BV dose, 7–59 days earlier versus unvaccinated, 3) vaccinated with an mRNA BV dose, 60–119 days earlier versus unvaccinated, and 4) vaccinated with an mRNA BV dose, 120–179 days earlier versus unvaccinated.d Vaccination was defined as having received the last MV or BV dose within the specified range of days before the index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before the admission date, or the admission date if testing only occurred after the admission.e Includes persons who received a single dose of Janssen (Johnson & Johnson) vaccine. Persons who received a single dose of Pfizer-BioNTech, Moderna, or Novavax vaccine were excluded from the analysis.f Variant predominance was defined as the period when a variant accounted for ≥50% of all sequenced specimens in the U.S. Department of Health and Human Services region where the site is located. XBB-related sublineages predominated at Intermountain Healthcare beginning January 28, 2023; at HealthPartners, KPNC, and Regenstrief Institute beginning February 4, 2023; and at KPCHR beginning February 11, 2023.g Other race includes American Indian or Alaska Native, Asian, Native Hawaiian or other Pacific Islander, other races not listed, and multiple races. Because of small numbers, these categories were combined.h Because persons might have received vaccine from more than one manufacturer, columns might sum to >100%.i In-hospital death was identified at each individual site and was defined as a death while hospitalized or ≤28 days after admission. Open table in a new tab TABLE 2COVID-19 vaccine effectivenessaVE was calculated as (1 − odds ratio) x 100%, estimated using a test-negative case-control design, adjusted for age, sex, race and ethnicity, geographic region, and calendar time (days since January 1, 2021). against laboratory-confirmed COVID-19–associated hospitalizations and critical illnessbPatients were considered to have critical illness if they were admitted to an intensive care unit or died. Death was identified at each individual site and was defined as a death while hospitalized or ≤28 days after admission. among adults aged ≥18 years, by age group and immunocompromise status — seven states,cCalifornia (September 13, 2022–April 21, 2023), Indiana (September 13, 2022–April 12, 2023), Minnesota and Wisconsin (September 13, 2022–April 21, 2023), Oregon and Washington (September 13, 2022–April 14, 2023), and Utah (September 13, 2022–April 21, 2023). September 2022–April 2023Clinical status/Age group, yrs/Vaccine type and doses received, interval since receipt of BV doseWithout documented immunocompromising conditionsWith documented immunocompromising conditionsTotalPositive SARS-CoV-2 test result, no. (%)Median interval since last dose, days (IQR)VE, % (95% CI)TotalPositive SARS-CoV-2 test result, no. (%)Median interval since last dose, days (IQR)VE, % (95% CI)Hospitalization≥18Unvaccinated (Ref)15,5141,791 (11.5)NARef3,109314 (10.1)NARefMV only37,2693,988 (10.7)376 (270 to 505)21 (16 to 26)11,1401,134 (10.2)355 (237 to 474)3 (−12 to 16)BV, 7–59 days earlier4,857327 (6.7)34 (21 to 47)62 (57 to 67)1,612143 (8.9)33 (19 to 46)28 (10 to 42)BV, 60–119 days earlier5,191486 (9.4)87 (73 to 103)47 (41 to 53)1,829140 (7.6)88 (74 to 104)41 (26 to 53)BV, 120–179 days earlier3,310315 (9.5)144 (132 to 159)24 (12 to 33)1,244103 (8.3)144 (131 to 159)13 (−13 to 33)18–64Unvaccinated (Ref)8,033591 (7.4)NARefNANANANAMV only12,368821 (6.6)403 (306 to 534)17 (7 to 26)NANANANABV, 7–59 days earlier95938 (4.0)33 (21 to 45)61 (44 to 72)NANANANABV, 60–119 days earlier93566 (7.1)86 (72 to 101)25 (1 to 43)NANANANABV, 120–179 days earlier56131 (5.5)143 (131 to 158)16 (−24 to 43)dThese estimates are imprecise, which might be because of a relatively small number of persons in each level of vaccination or case status. This imprecision indicates the actual VE could be substantially different from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual could increase precision and allow appropriate interpretation.NANANANA≥65Unvaccinated (Ref)7,4811,200 (16.0)NARefNANANANAMV only24,9013,167 (12.7)362 (245 to 484)24 (18 to 29)NANANANABV, 7–59 days earlier3,898289 (7.4)35 (21 to 48)64 (58 to 68)NANANANABV, 60–119 days earlier4,256420 (9.9)87 (73 to 103)51 (45 to 57)NANANANABV, 120–179 days earlier2,749284 (10.3)145 (132 to 159)27 (15 to 37)NANANANACritical illnesseFor VE against critical illness, case-patients were persons admitted to an intensive care unit or who experienced death associated with COVID-19, and control patients were persons hospitalized without COVID-19.≥18Unvaccinated (Ref)14,090367 (2.6)NARef2,88186 (3.0)NARefMV only33,925644 (1.9)375 (269 to 505)31 (21 to 40)10,263257 (2.5)354 (235 to 474)16 (−10 to 36)BV, 7–59 days earlier4,57949 (1.1)34 (21 to 47)69 (57 to 77)1,50132 (2.1)33 (19 to 46)40 (7 to 61)dThese estimates are imprecise, which might be because of a relatively small number of persons in each level of vaccination or case status. This imp
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