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

Abstract

Purpose 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 <14 days post-final dose), or 3) unvaccinated. Results Among 8554 participants who received any COVID-19 vaccine, COVID-19 infections were reported by 74 (1.0%) of those who were fully vaccinated and 198 (2.3%) of those who were partially vaccinated at the time of infection. Among the 74 participants who reported a breakthrough infection after full vaccination, the median time from vaccination to reported positive test result was 104.5 days (interquartile range: 77–135 days), with no difference among vaccine manufacturers. One quarter (25.7%) of breakthrough infections in the fully vaccinated cases were asymptomatic and most (>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.

Presenting clinical symptoms of post-COVID-19 breakthrough infection: Predictors of mortality in a Middle Eastern population

“…Previously published studies found that males are more likely to get infected [8] , [5] , [6] . Another study done in the United States found that females are more likely to get infected [7] , this can be due to the different baseline genetics, ethnicity and demographics of our population. In addition, we found that the incidence of COVID-19 breakthrough infection was higher in the 15–45 age group, and this is similar to what was reported in a study done in the United States that showed the average age of infection is 44.5 years old [7] .…”

“…Another study done in the United States found that females are more likely to get infected [7] , this can be due to the different baseline genetics, ethnicity and demographics of our population. In addition, we found that the incidence of COVID-19 breakthrough infection was higher in the 15–45 age group, and this is similar to what was reported in a study done in the United States that showed the average age of infection is 44.5 years old [7] . Reopening of schools and universities likely explains this finding, in addition to maintaining limited social activities for the older population.…”

“…Gender differences in the incidence of post-COVID vaccination infection showed variable results, although more reports state that males are more likely to develop breakthrough infection [5] , [6] , [7] , [8] . Older age is an independent risk factor for poor clinical outcome in patients who develop post vaccination infection, although the incidence is higher in younger age groups [2] , [7] , [9] , [10] .…”

Death Reporting in Breakthrough and Unvaccinated SARS-CoV-2 Infection Cases

“…This result supports earlier research demonstrating that vaccination offers considerable protection against the most severe COVID-19 disease signs as well as general infection protection. 10 To evaluate vaccine safety and surveillance, it is important to follow the fully vaccinated individuals to diagnose any serious complications or infections especially severe cases or dead people due to COVID-19 disease. According to the CDC report, a total of 10,262 SARS-CoV-2 vaccine breakthrough infections were diagnosed in 46 states of the United States until April 30, 2021; of those 160 (2%) cases have died.…”

Factors associated with antibody titer levels among an occupational cohort of fully vaccinated individuals and subsequent risk of COVID‐19 infection: A cohort study

“…Vaccination is an essential component to build immunity against COVID‐19; however, evidence suggests immunity wanes over time, and booster doses are necessary for additional protection against severe acute respiratory syndrome‐coronavirus‐2 (SARS‐CoV‐2) infection and morbidity 1,2 . Follow‐up of vaccine trial participants and real‐world effectiveness studies 3,4 show a growing risk of breakthrough infection with greater time from initial vaccination 5 …”