COVID-19 Vaccination Breakthrough Infections in a Real-World Setting: Using Community Reporters to Evaluate Vaccine Effectiveness

Abstract

Matthew W Reynolds,1 Yiqiong Xie,1 Kendall B Knuth,1 Christina D Mack,1 Emma Brinkley,1 Stephen Toovey,2 Nancy A Dreyer1 1Real World Solutions, IQVIA, Cambridge, MA, USA; 2Virology, Pegasus Research, London, UKCorrespondence: Matthew W Reynolds, Real-World Solutions, IQVIA, 201 Broadway, Cambridge, MA, 02139, USA, Email [email protected]: Coronavirus disease 2019 (COVID-19) has highlighted the need for new methods of pharmacovigilance. Here, we use adult community volunteers to obtain systematic information on vaccine effectiveness and the nature and severity of breakthrough infections.Methods: Between December 15, 2020 and September 16, 2021, 11,826 unpaid community-based volunteers reported the following information to an on-line registry: COVID-19 test results, vaccination (Pfizer, Moderna, or Johnson & Johnson) and COVID-19 symptoms. COVID-19 infections were described based on vaccination status at the time of infection: 1) fully vaccinated, 2) partially vaccinated (received first of two-dose vaccines or were 97%) fully vaccinated participants reported no symptoms or only mild symptoms compared to 89.3% of the unvaccinated cases. Only 1.4% of fully vaccinated participants reported experiencing at least 3 moderate-to-severe symptoms compared to 7.8% in the unvaccinated.Conclusion: Person-generated health data, also referred to as patient-reported outcomes, is a useful approach for quantifying breakthrough infections and their severity and for comparing vaccines.Trial Registration: Clinicaltrials.gov NCT04368065, EU PAS Register EUPAS36240.Keywords: COVID-19, vaccines, breakthrough infections, SARS-CoV-2, symptoms, patient-reported outcomes

Keywords

• covid-19
• vaccines
• breakthrough infections
• sars-cov-2
• symptoms
• patient-reported outcomes