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Mortality risk after COVID-19 vaccination: A self-controlled case series study
Stanley Xu1, Lina S Sy2, Vennis Hong2
1Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States; Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA, United States.
COVID-19 vaccination showed no increased risk of death from any cause or cardiac events. This study analyzed mortality following primary COVID-19 vaccine series in the US, finding no significant safety concerns.
Area of Science:
- Epidemiology
- Vaccine Safety Research
- Public Health
Background:
- Previous studies on COVID-19 vaccination and mortality risk had potential residual confounding.
- A modified self-controlled case series (SCCS) design was employed to mitigate bias.
- The study focused on non-COVID-19 mortality, all-cause mortality, and specific cardiac-related death outcomes.
Purpose of the Study:
- To assess the risk of non-COVID-19 mortality after primary COVID-19 vaccination.
- To evaluate the risk of all-cause mortality following COVID-19 vaccination.
- To examine the risk of four cardiac-related death outcomes post-COVID-19 vaccination.
Main Methods:
- Utilized a modified SCCS design analyzing deaths from December 2020 to August 2021 across eight Vaccine Safety Datalink sites.
- Calculated relative incidences (RI) for various mortality outcomes after primary COVID-19 vaccine series (Pfizer-BioNTech, Moderna, Janssen).
- Adjusted for seasonality using calendar month and included unvaccinated individuals in analyses, with primary (28-day) and secondary (14-day) risk intervals.
Main Results:
- For Pfizer-BioNTech and Moderna vaccines, relative incidences for all-cause and non-COVID-19 mortality were below 1, with confidence intervals excluding 1.
- For Moderna, two cardiac-related mortality estimates had confidence intervals including 1 (RI=0.78-0.80) 14 days post-second dose in specific subgroups.
- For Janssen vaccine, relative incidences for cardiac-related deaths ranged from 0.68-0.98, with confidence intervals including 1.
Conclusions:
- The modified SCCS design, accounting for temporal trends, found no increased risk of non-COVID-19 mortality or all-cause mortality after primary COVID-19 vaccination.
- No increased risk was identified for four specific cardiac-related death outcomes among recipients of the three main US COVID-19 vaccines.
- The findings support the safety of primary COVID-19 vaccine series regarding mortality risk.
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