Describing the population experiencing COVID-19 vaccine breakthrough following second vaccination

How to cite: Describing the population experiencing COVID-19 vaccine breakthrough following second vaccination in England: A cohort study from OpenSAFELY The OpenSAFELY Collaborative:, Amelia Green, Helen Curtis, William Hulme, Elizabeth Williamson, Helen McDonald, Krishnan Bhaskaran, Christopher Rentsch, Anna Schultze, Brian MacKenna, Viyaasan Mahalingasivam, Laurie Tomlinson, Alex Walker, Louis Fisher, Jon Massey, Colm Andrews, Lisa Hopcroft, Caroline Morton, Richard Croker, Jessica Morley, Amir Mehrkar, Seb Bacon, David Evans, Peter Inglesby, George Hickman, Tom Ward, Simon Davy, Rohini Mathur, John Tazare, Rosalind M Eggo, Kevin Wing, Angel Wong, Harriet Forbes, Chris Bates, Jonathan Cockburn, John Parry, Frank Hester, Sam Harper, Ian Douglas, Stephen Evans, Liam Smeeth, Ben Goldacre medRxiv 2021.11.08.21265380; doi: https://doi.org/10.1101/2021.11.08.21265380

Abstract

Background: While the vaccines against COVID-19 are considered to be highly effective, COVID-19 vaccine breakthrough is likely and a small number of people will still fall ill, be hospitalised, or die from COVID-19, despite being fully vaccinated. With the continued increase in numbers of positive SARS-CoV-2 tests, describing the characters of individuals who have experienced a COVID-19 vaccine breakthrough could be hugely important in helping to determine who may be at greatest risk.

Methods: With the approval of NHS England we conducted a retrospective cohort study using routine clinical data from the OpenSAFELY TPP database of fully vaccinated individuals, linked to secondary care and death registry data, and described the characteristics of those experiencing a COVID-19 vaccine breakthrough.

Results: As of 01st November 2021, a total of 15,436,455 individuals were identified as being fully vaccinated against COVID-19, with a median follow-up time of 149 days (IQR: 107-179). From within this population, a total of 577245 (<4%) individuals reported a positive SARS-CoV-2 test. For every 1000 years of patient follow-up time, the corresponding incidence rate was 98.02 (95% CI 97.9-98.15). There were 16,120 COVID-19-related hospital admissions, 1,100 COVID-19 critical care admission patients and 3,925 COVID-19-related deaths; corresponding incidence rates of 2.72 (95% C 2.7-2.74), 0.19 (95% C 0.18-0.19) and 0.66 (95% C 0.65-0.67), respectively. When broken down by the initial priority group, higher rates of hospitalisation and death were seen in those in care homes and those over 80 years of age. Comorbidities with the highest rates of breakthrough COVID-19 included chronic kidney disease, dialysis, transplant, haematological malignancy, and immunocompromised

Conclusions: The majority of COVID-19 vaccine breakthrough cases in England were mild with relatively few fully vaccinated individuals being hospitalised or dying as a result. However, some concerning differences in rates of breakthrough cases were identified in several clinical and demographic groups. While it is important to note that these findings are simply descriptive and cannot be used to answer why certain groups have higher rates of COVID-19 breakthrough than others, the emergence of the Omicron variant of COVID-19 coupled with the continued increase in numbers of positive SARS-CoV-2 tests are concerning. As numbers of fully vaccinated individuals increases and follow-up time lengthens, so too will the number of COVID-19 breakthrough cases. Additional analyses, aimed at identifying individuals at higher risk, are therefore required.