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. 2023 Oct 31;11(11):1669.
doi: 10.3390/vaccines11111669.

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

Manuela Di Fusco  1 , Xiaowu Sun  2 , Laura Anatale-Tardiff  2 , Alon Yehoshua  1 , Henriette Coetzer  2 , Mary B Alvarez  1 , Kristen E Allen  1 , Thomas M Porter  1 , Laura Puzniak  1 , Santiago M C Lopez  1 , Joseph C Cappelleri  1
Affiliations

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

Manuela Di Fusco et al. Vaccines (Basel). .

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.

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Conflict of interest statement

M.D.F., J.C.C., A.Y., M.B.A., K.E.A., T.M.P., L.P., A.C.S. and S.M.C.L. are employees of Pfizer Inc. and hold stock and/or stock options of Pfizer, Inc. X.S. is an employee of CVS Health and holds stock of CVS Health. L.A.-T. and H.C. were employees of CVS Health when the study was conducted and are now employees of Blue Health Intelligence (BHI), the trade name of Health Intelligence Company, LLC, an independent licensee of the Blue Cross Blue Shield Association.

Figures

Figure 1
Figure 1
Study participant flowchart.
Figure 2
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
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
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
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
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.
See this image and copyright information in PMC

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