Twelve-Month All-Cause Mortality after Initial COVID-19 Vaccination with Pfizer-BioNTech or mRNA-1273 among Adults Living in Florida
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Objective
To examine the relative impact of the initial series of the messenger RNA (mRNA) BNT162b2 (Pfizer) and mRNA-1273 (Moderna) on all-cause and non-COVID-19 mortality among Florida residents.
Design
Matched cohort with cumulative and adjusted assessments of risk over 12 month follow up.
Setting
Florida’s state-level public health databases with records about COVID-19 vaccination, sociodemographic characteristics of vaccine recipients, location of vaccination, and vital statistics.
Participants
Matched cohort of 1,470,100 noninstitutionalized adult Florida residents receiving at least two doses, less than six weeks apart, of either the BNT162b2 or mRNA-1273 mRNA vaccine between December 18, 2020, and August 31, 2021.
Intervention
Initial vaccination with two doses of either BNT162b2 or mRNA-1273
Main outcome measures
All-cause, cardiovascular, COVID-19, and non-COVID-19 mortality within 12 months after the second COVID-19 vaccine dose
Results
There were 9,162,484 noninstitutionalized adult Florida residents who met inclusion criteria, including 5,328,226 BNT162b2 vaccine recipients and 3,834,258 mRNA-1273 vaccine recipients. A total of 1,470,100 vaccinees were matched 1-to-1 based on seven criteria, including census tract. Compared with mRNA-1273 recipients, BNT162b2 recipients had significantly higher risk for all-cause mortality (847.2 vs. 617.9 deaths per 100,000; odds ratio, OR [95% CI]: 1.384 [1.331, 1.439]), cardiovascular mortality (248.7 vs. 162.4 deaths per 100,000 persons; OR [95% CI]: 1.540 [1.431, 1.657]), COVID-19 mortality (55.5 vs. 29.5 deaths per 100,000 persons; OR [95% CI]: 1.882 [1.596, 2.220]) and non-COVID-19 mortality (791.6 vs. 588.4 deaths per 100,000 persons; OR [95% CI]: 1.356 [1.303, 1.412]). Negative control outcomes did not show any indication of meaningful unobserved residual confounding.
Conclusion
Florida adults who received BNT162b2 had significantly higher risk of 12-month all-cause, cardiovascular, COVID-19, and non-COVID-19 mortality compared to matched mRNA-1273 recipients. These findings are suggestive of differential non-specific effects of the BNT162b2 and mRNA-1273 COVID-19 vaccines, and potential concerning adverse effects on all-cause and cardiovascular mortality. They underscore the need to evaluate vaccines using clinical endpoints that extend beyond their targeted diseases.
Summary boxes
What is already known on this topic
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Vaccines may have health effects beyond the diseases they target, including potential effects on all-cause mortality.
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The relative impact of the initial series of the messenger RNA (mRNA) BNT162b2 (Pfizer) and mRNA-1273 (Moderna) on all-cause and non-COVID-19 mortality is not well-studied.
What this topic adds
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Florida adults who received BNT162b2 had significantly higher risk of 12-month all-cause, cardiovascular, COVID-19, and non-COVID-19 mortality compared to carefully matched mRNA-1273 recipients.
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These findings are suggestive of differential non-specific effects of the BNT162b2 and mRNA-1273 COVID-19 vaccines, and potential concerning adverse effects on all-cause and cardiovascular mortality.