Study population and setting
This study compared SARS-CoV-2 threshold cycle (Ct) values by self-reported vaccination status from a convenience sample of 83 individuals with COVID-19 between June 28, 2021 and July 24, 2021 in Dane County, Wisconsin. Information as to the vaccine manufacturer in the case of vaccinated individuals was not reported in this preprint. An additional 208 samples from COVID-19 positive individuals from outside Dane County were considered in secondary analyses. For all samples, Ct values were determined by a semi-quantitative PCR assay in the same commercial laboratory. A subset of the of the specimens (50/291) were sequenced to identify whether individuals were infected with the delta variant.
Summary of Main Findings
In the primary sample (n=83), 32 individuals reported being fully vaccinated and 51 individuals reported they had not received any vaccine. There was no significant difference in the Ct values between fully vaccinated individuals and those who reported receiving no vaccination. Of these specimens, only 16 were able to generate sequence data and 14/16 were of the delta lineage. In the entire expanded sample (n=291), there was also no difference in Ct values by vaccination status and 42 of the 50 sequenced specimens were of the delta lineage. Notably, there was a high proportion of vaccinated individuals who had a low Ct value (<30; 84% [66/79]) and an extremely low Ct value (<20; 33% [26/79]).
It is a strength that all laboratory testing was conducted in the same commercial laboratory, which enables direct comparison of Ct values, and individuals were sampled from the same area and time.
The sample size of the study was limited, and only a fraction of the included samples were able to be sequenced. It is a limitation that vaccination status was ascertained by self-report, which may be subject to social desirability bias. The study also did not clearly characterize the individuals included in the study, so it is unclear if vaccinated individuals were similar to unvaccinated individuals by demographics, such as age, comorbidities, timing during infection when samples were collected, and symptoms. In addition, it is probable that symptomatic vaccinated individuals were more likely to get tested than asymptomatic vaccinated individuals resulting in potential selection bias. Furthermore, while Ct values crudely correlate with viral load in an inverse manner, there was no microbiological testing to confirm whether detectable virus was infectious. Finally, the study cannot make conclusions about the rate of breakthrough infections without considering all vaccinated individuals in the population.
As a note, this ESS refers to the version of the study published at medRxiv on July 31, 2021. Subsequently, a revised version, entitled “Shedding of Infectious SARS-CoV-2 Despite Vaccination” was published on August 24, 2021— NCRC has not yet reviewed this version.
This investigation demonstrated that some vaccinated individuals who have a breakthrough infection may carry SARS-CoV-2 RNA in nasal secretions at levels that may contribute to transmission.
This review was posted on: 11 September 2021