Impact of Bivalent BA.4/5 BNT162b2 COVID-19 Vaccine on Acute Symptoms, Quality of Life, Work Productivity and Activity Levels among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy

Abstract

Evidence on the impact of COVID-19 vaccination on symptoms, Health-Related Quality of Life (HRQoL) and Work Productivity and Activity Impairment (WPAI) is scarce. We analyzed associations between bivalent BA.4/5 BNT162b2 (BNT162b2) and these patient-reported outcomes (PROs). Symptomatic US adults testing positive for SARS-CoV-2 were recruited between 2 March and 18 May 2023 (CT.gov NCT05160636). PROs were assessed using four questionnaires measuring symptoms, HRQoL and WPAI (a CDC-based symptom survey, PROMIS Fatigue, EQ-5D-5L, WPAI-GH), from pre-COVID to Week 4 following infection. Multivariable analysis using mixed models for repeated measures was conducted, adjusting for several covariates. The study included 643 participants: 316 vaccinated with BNT162b2 and 327 unvaccinated/not up-to-date. Mean (SD) age was 46.5 years (15.9), 71.2% were female, 44.2% reported prior infection, 25.7% had ≥1 comorbidity. The BNT162b2 cohort reported fewer acute symptoms through Week 4, especially systemic and respiratory symptoms. All PROs were adversely affected, especially at Week 1; however, at that time point, the BNT162b2 cohort reported better work performance, driven by less absenteeism, and fewer work hours lost. No significant differences were observed for HRQoL COVID-19 negatively impacted patient outcomes. Compared with unvaccinated/not up-to-date participants, those vaccinated with bivalent BA.4/5 BNT162b2 reported fewer and less persistent symptoms and improved work performance.

Keywords: BA.4/5 BNT162b2; COVID-19; COVID-19 symptoms; HRQoL; PROMIS Fatigue; SARS-CoV-2; WPAI; bivalent; humanistic; quality of life.

Figure 1

Study participant flowchart.

Figure 2

Distribution of study participants across ordinal categories of number of symptoms and vaccination status, across time points. Index day: time of testing.

Figure 3

Least-square mean estimates of EQ−5D−5L and their changes from pre-COVID-19 baseline by assessment time and vaccination status. ^a p value of t-test comparing least-square mean score changes from baseline between BNT162b2 and Unvaccinated cohorts.

Figure 4

Least-square mean estimates of PROMIS Fatigue and their changes from pre-COVID-19 baseline by assessment time and vaccination status. ^a p value of t-test comparing least-square mean score changes from baseline between BNT162b2 and Unvaccinated cohorts.

Figure 5

Least-square mean estimates of WPAI:GH scores and their changes from pre-COVID-19 baseline by assessment time and vaccination status. ^a p value of t-test comparing least-square mean score changes from baseline between BNT162b2 and Unvaccinated cohorts.

Figure 6

Least-square mean estimates of work hours lost and worked and their changes from pre-COVID-19 baseline by assessment time and vaccination status. ^a p value of t-test comparing least-square mean score changes from baseline between BNT162b2 and Unvaccinated cohorts.