Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans.

BACKGROUND: The messenger RNA (mRNA)-based vaccines BNT162b2 and mRNA-1273 are more than 90% effective against coronavirus disease 2019 (Covid-19). However, their comparative effectiveness for a range of outcomes across diverse populations is unknown. METHODS: We emulated a target trial using the electronic health records of U.S. veterans who received a first dose of the BNT162b2 or mRNA-1273 vaccine between January 4 and May 14, 2021, during a period marked by predominance of the SARS-CoV-2 B.1.1.7 (alpha) variant. We matched recipients of each vaccine in a 1:1 ratio according to their risk factors. Outcomes included documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, symptomatic Covid-19, hospitalization for Covid-19, admission to an intensive care unit (ICU) for Covid-19, and death from Covid-19. We estimated risks using the Kaplan-Meier estimator. To assess the influence of the B.1.617.2 (delta) variant, we emulated a second target trial that involved veterans vaccinated between July 1 and September 20, 2021. RESULTS: Each vaccine group included 219,842 persons. Over 24 weeks of follow-up in a period marked by alpha-variant predominance, the estimated risk of documented infection was 5.75 events per 1000 persons (95% confidence interval [CI], 5.39 to 6.23) in the BNT162b2 group and 4.52 events per 1000 persons (95% CI, 4.17 to 4.84) in the mRNA-1273 group. The excess number of events per 1000 persons for BNT162b2 as compared with mRNA-1273 was 1.23 (95% CI, 0.72 to 1.81) for documented infection, 0.44 (95% CI, 0.25 to 0.70) for symptomatic Covid-19, 0.55 (95% CI, 0.36 to 0.83) for hospitalization for Covid-19, 0.10 (95% CI, 0.00 to 0.26) for ICU admission for Covid-19, and 0.02 (95% CI, -0.06 to 0.12) for death from Covid-19. The corresponding excess risk (BNT162b2 vs. mRNA-1273) of documented infection over 12 weeks of follow-up in a period marked by delta-variant predominance was 6.54 events per 1000 persons (95% CI, -2.58 to 11.82). CONCLUSIONS: The 24-week risk of Covid-19 outcomes was low after vaccination with mRNA-1273 or BNT162b2, although risks were lower with mRNA-1273 than with BNT162b2. This pattern was consistent across periods marked by alpha- and delta-variant predominance. (Funded by the Department of Veterans Affairs and others.).

Association Between Early Hypertension Control and Cardiovascular Disease Incidence in Veterans With Diabetes.

OBJECTIVE: Guidelines for hypertension treatment in patients with diabetes diverge regarding the systolic blood pressure (SBP) threshold at which treatment should be initiated and treatment goal. We examined associations of early SBP treatment with atherosclerotic cardiovascular disease (ASCVD) events in U.S. adults with diabetes. RESEARCH DESIGN AND METHODS: We studied 43,986 patients with diabetes who newly initiated antihypertensive therapy between 2002 and 2007. Patients were classified into categories based on SBP at treatment initiation (130-139 or ≥140 mmHg) and after 2 years of treatment (100-119, 120-129, 130-139, 140-159, and ≥160 mmHg). The primary outcome was composite ASCVD events (fatal and nonfatal myocardial infarction and stroke), estimated using inverse probability of treatment-weighted Poisson regression and multivariable Cox proportional hazards regression. RESULTS: Relative to individuals who initiated treatment when SBP was 130-139 mmHg, those with pretreatment SBP ≥140 mmHg had higher ASCVD risk (hazard ratio 1.10 [95% CI 1.02, 1.19]). Relative to those with pretreatment SBP of 130-139 mmHg and on-treatment SBP of 120-129 mmHg (reference group), ASCVD incidence was higher in those with pretreatment SBP ≥140 mmHg and on-treatment SBP 120-129 mmHg (adjusted incidence rate difference [IRD] 1.0 [-0.2 to 2.1] events/1,000 person-years) and in those who achieved on-treatment SBP 130-139 mmHg (IRD 1.9 [0.6, 3.2] and 1.1 [0.04, 2.2] events/1,000 person-years for those with pretreatment SBP 130-139 mmHg and ≥140 mmHg, respectively). CONCLUSIONS: In this observational study, patients with diabetes initiating antihypertensive therapy when SBP was 130-139 mmHg and those achieving on-treatment SBP <130 mmHg had better outcomes than those with higher SBP levels when initiating or after 2 years on treatment.