Impact of COVID-19 and effects of BNT162b2 on patient-reported outcomes: quality of life, symptoms, and work productivity among US adult outpatients

Abstract

Background Although there is extensive literature on the clinical benefits of COVID-19 vaccination, data on humanistic effects are limited. This study evaluated the impact of SARS-CoV-2 infection on symptoms, Health-Related Quality of Life (HRQoL) and Work Productivity and Impairment (WPAI) prior to and one month following infection between individuals vaccinated with BNT162b2 and those unvaccinated. Methods Subjects with ≥ 1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022 and 04/30/2022. Socio-demographics, clinical characteristics and vaccination status were evaluated. Self-reported symptoms, HRQoL, and WPAI outcomes were assessed using questionnaires and validated instruments (EQ-5D-5L, WPAI-GH) across acute COVID time points from pre-COVID to Week 4, and between vaccination groups. Mixed models for repeated measures were conducted for multivariable analyses, adjusting for several covariates. Effect size (ES) of Cohen’s d was calculated to quantify the magnitude of outcome changes within and between vaccination groups. Results The study population included 430 subjects: 197 unvaccinated and 233 vaccinated with BNT162b2. Mean (SD) age was 42.4 years (14.3), 76.0% were female, 38.8% reported prior infection and 24.2% at least one comorbidity. Statistically significant differences in outcomes were observed compared with baseline and between groups. The EQ-Visual analogue scale scores and Utility Index dropped in both cohorts at Day 3 and increased by Week 4 but did not return to pre-COVID levels. The mean changes were statistically lower in the BNT162b2 cohort at Day 3 and Week 4. The BNT162b2 cohort reported lower prevalence and fewer symptoms at index date and Week 4. At Week 1, COVID-19 had a large impact on all WPAI-GH domains: the work productivity time loss among unvaccinated and vaccinated was 65.0% and 53.8%, and the mean activity impairment was 50.2% and 43.9%, respectively. Except for absenteeism at Week 4, the BNT162b2 cohort was associated with statistically significant less worsening in all WPAI-GH scores at both Week 1 and 4. Conclusions COVID-19 negatively impacted HRQoL and work productivity among mildly symptomatic outpatients. Compared with unvaccinated, those vaccinated with BNT162b2 were less impacted by COVID-19 infection and recovered faster.

Impact of COVID-19 and effects of booster vaccination with BNT162b2 on six-month long COVID symptoms, quality of life, work productivity and activity impairment during Omicron

“…The study design was previously described [9] (clinicatrials.gov NCT05160636). Briefly, this was a nationwide prospective survey-based patient-reported outcomes (PRO) study targeting adults ≥18 years old with a positive reverse transcription-polymerase chain reaction (RT-PCR) test result and self-reporting at least one symptom suggestive of acute SARS-CoV-2 infection at time of testing [9]. The source population consisted of adults testing for SARS-CoV-2 at one of ~5,000 CVS Health test sites across the US.…”

“…Interim results for the acute phase (up to 4 weeks after infection) were previously presented [9]. This analysis presents the final results, focusing on long-term outcomes until month 6.…”

Assessment of Retrospective Collection of EQ-5D-5L in US Patients with COVID-19

“…study was limited to participants unvaccinated or receiving the BNT162b2 COVID-19 vaccine only. To assess the validity of the retrospective collection methodology, all patients that were enrolled were included [6].…”

“…In the COVID-19 PRO study [6], participants were recruited between 01/31/2022 and 04/30/2022 among US adult outpatients with ≥1 self-reported symptom and positive RT-PCR test for SARS-CoV-2 at CVS Health test sites (ClinicalTrials.gov NCT05160636). The analytic population for the Di Fusco et.…”

“…EQ-5D-5L was used to establish, respectively, the baseline pre-COVID-19 health status and the health status at week 1 and week 4 following infection. Subsequently, the pre-infection and COVID-19 health statuses were compared to evaluate the impact of COVID-19 on HRQoL [6]. This subsequent methodology study utilizing the PRO data collected in the COVID-19 study tests the validity of the use of retrospective collection of EQ-5D-5L for establishing pre-infection status for the first time for COVID-19-related studies.…”