Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jan 16;41(3):844-854.
doi: 10.1016/j.vaccine.2022.12.036. Epub 2022 Dec 20.

A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination

Stanley Xu  1 , Runxin Huang  2 , Lina S Sy  2 , Vennis Hong  2 , Sungching C Glenn  2 , Denison S Ryan  2 , Kerresa Morrissette  2 , Gabriela Vazquez-Benitez  3 , Jason M Glanz  4 , Nicola P Klein  5 , Bruce Fireman  5 , David McClure  6 , Elizabeth G Liles  7 , Eric S Weintraub  8 , Hung-Fu Tseng  2 , Lei Qian  2
Affiliations

A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination

Stanley Xu et al. Vaccine. .

Abstract

Background: The safety of COVID-19 vaccines plays an important role in addressing vaccine hesitancy. We conducted a large cohort study to evaluate the risk of non-COVID-19 mortality after COVID-19 vaccination while adjusting for confounders including individual-level demographics, clinical risk factors, health care utilization, and community-level socioeconomic risk factors.

Methods: The retrospective cohort study consisted of members from seven Vaccine Safety Datalink sites from December 14, 2020 through August 31, 2021. We conducted three separate analyses for each of the three COVID-19 vaccines used in the US. Crude non-COVID-19 mortality rates were reported by vaccine type, age, sex, and race/ethnicity. The counting process model for survival analyses was used to analyze non-COVID-19 mortality where a new observation period began when the vaccination status changed upon receipt of the first dose and the second dose. We used calendar time as the basic time scale in survival analyses to implicitly adjust for season and other temporal trend factors. A propensity score approach was used to adjust for the potential imbalance in confounders between the vaccinated and comparison groups.

Results: For each vaccine type and across age, sex, and race/ethnicity groups, crude non-COVID-19 mortality rates among COVID-19 vaccinees were lower than those among comparators. After adjusting for confounders with the propensity score approach, the adjusted hazard ratios (aHRs) were 0.46 (95% confidence interval [CI], 0.44-0.49) after dose 1 and 0.48 (95% CI, 0.46-0.50) after dose 2 of the BNT162b2 vaccine, 0.41 (95% CI, 0.39-0.44) after dose 1 and 0.38 (95% CI, 0.37-0.40) after dose 2 of the mRNA-1273 vaccine, and 0.55 (95% CI, 0.51-0.59) after receipt of Ad26.COV2.S.

Conclusion: While residual confounding bias remained after adjusting for several individual-level and community-level risk factors, no increased risk was found for non-COVID-19 mortality among recipients of three COVID-19 vaccines used in the US.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Absolute standardized mean difference in characteristics among BNT162b2, mRNA-1273, and Ad26.COV2.S recipients and their comparators before and after applying stabilized weights.
See this image and copyright information in PMC

References

    1. CDC. Use of COVID-19 Vaccines in the United States. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-v.... Accessed May 30, 2022.
    1. Oliver S., Gargano J., Marin M., Wallace M., Curran K.G., Chamberland M., et al. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69(50):1922–1924. - PMC - PubMed
    1. Oliver S.E., Gargano J.W., Scobie H., Wallace M., Hadler S.C., Leung J., et al. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Janssen COVID-19 Vaccine - United States, February 2021. MMWR Morb Mortal Wkly Rep. 2021;70(9):329–332. - PMC - PubMed
    1. Oliver S., Gargano J., Marin M., Wallace M., Curran K.G., Chamberland M., et al. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69(5152):1653–1656. - PMC - PubMed
    1. Polack F.P., Thomas S.J., Kitchin N., Absalon J., Gurtman A., Lockhart S., et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603–2615. - PMC - PubMed

Publication types