Real-world comparative effectiveness of mRNA-1273 and BNT162b2 vaccines among immunocompromised adults identified in administrative claims data in the United States

• Published in: Vaccine Vol. 40; no. 47; pp. 6730 - 6739
• Main Authors: Mues, Katherine E., Kirk, Brenna, Patel, Deesha A., Gelman, Alice, Chavers, L. Scott, Talarico, Carla A., Esposito, Daina B., Martin, David, Mansi, James, Chen, Xing, Gatto, Nicolle M., Van de Velde, Nicolas
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 08.11.2022; Elsevier Limited; The Authors. Published by Elsevier Ltd
• Subjects: 2019-nCoV Vaccine mRNA-1273; Adult; Adults; Allergy and Immunology; Antigens; blood; BNT162 Vaccine; Comparative studies; Confidence intervals; Coronaviruses; COVID-19; COVID-19 - epidemiology; COVID-19 - prevention & control; COVID-19 infection; COVID-19 Testing; COVID-19 Vaccines; Diagnosis; disease severity; Drug dosages; Effectiveness; Female; females; Health care policy; Health insurance; Health Insurance Portability & Accountability Act 1996-US; HIV; Hospitalization; Human immunodeficiency virus; Humans; Immunocompromised; Immunodeficiency; immunosuppression; Immunosuppressive agents; Infections; Insurance claims; Male; Middle Aged; mRNA; mRNA Vaccines; mRNA-1273; organ transplantation; Pharmacy; Polymerase chain reaction; Population; Primary immunodeficiencies; probability; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Statistical analysis; Statistical models; United States - epidemiology; Vaccine effectiveness; Vaccine efficacy; Vaccines; United States; United States > US; FDA; CDC; PS; Immunocompromised; VE; COVID-19; EUA; SARS-CoV-2; ASD; TTS; mRNA-1273; Vaccine effectiveness; ACIP; HIPAA; IC; absolute standardized difference; thrombocytopenia syndrome; Advisory Committee on Immunization Practice; Centers for Disease Control and Prevention; severe acute respiratory syndrome coronavirus 2; Emergency Use Authorization; Food and Drug administration; coronavirus disease 2019; Health Insurance Portability and Accountability Act; propensity score
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2022.09.025

•A real-world head-to-head study of mRNA vaccines in IC adults prior to omicron.•A 2-dose regimen of mRNA-1273 was compared to a 2-dose regimen of BNT1262b2.•mRNA-1273 is more effective against COVID-19 vs BNT162b2.•Open medical/pharmacy claims gave consistent effect estimates to closed claims. Head-to-head studies comparing COVID-19 mRNA vaccine effectiveness in immunocompromised individuals, who are vulnerable to severe disease are lacking, as large sample sizes are required to make meaningful inferences. This observational comparative effectiveness study was conducted in closed administrative claims data from the US HealthVerity database (December 11, 2020-January 10, 2022, before omicron). A 2-dose mRNA-1273 versus BNT162b2 regimen was assessed for preventing medically-attended breakthrough COVID-19 diagnosis and hospitalizations among immunocompromised adults. Inverse probability of treatment weighting was applied to balance baseline characteristics between vaccine groups. Incidence rates from patient-level data and hazard ratios (HRs) using weighted Cox proportional hazards models were calculated. Overall, 57,898 and 66,981 individuals received a 2-dose regimen of mRNA-1273 or BNT161b2, respectively. Among the weighted population, mean age was 51 years, 53 % were female, and baseline immunodeficiencies included prior blood transplant (8%–9%), prior organ transplant (7%), active cancer (12%–13%), primary immunodeficiency (5–6%), HIV (20%–21%), and immunosuppressive therapy use (60%–61%). Rates per 1,000 person-years (PYs; 95% confidence intervals [CI]s) of breakthrough medically-attended COVID-19 were 25.82 (23.83–27.97) with mRNA-1273 and 30.98 (28.93, 33.18) with BNT162b2 (HR, 0.83; 95% CI, 0.75–0.93). When requiring evidence of an antigen or polymerase chain reaction test before COVID-19 diagnosis, the HR for medically-attended COVID-19 was 0.78 (0.67–0.92). Breakthrough COVID-19 hospitalization rates per 1,000 PYs (95% CI) were 3.66 (2.96–4.51) for mRNA-1273 and 4.68 (3.91–5.59) for BNT162b2 (HR, 0.78; 0.59–1.03). Utilizing open and closed claims for outcome capture only, or both cohort entry/outcome capture, produced HRs (95% CIs) for COVID-19 hospitalization of 0.72 (0.57–0.92) and 0.66 (0.58–0.76), respectively. Among immunocompromised adults, a 2-dose mRNA-1273 regimen was more effective in preventing medically-attended COVID-19 in any setting (inpatient and outpatient) than 2-dose BNT162b2. Results were similar for COVID-19 hospitalization, although statistical power was limited when using closed claims only. NCT05366322.