COVID-19 Vaccination Did Not Increase the Risk of Potentially Related Serious Adverse Events: 18-Month Cohort Study in an Italian Province

Abstract

This cohort study on the entire population of an Italian Province assessed the incidence of potentially vaccine-related serious adverse events (PVR-SAEs) by COVID-19 vaccination status. From January 2021 to July 2022, we extracted all deaths and hospitalizations due to several cardiovascular diseases, pulmonary embolism, and deep vein thrombosis from National Healthcare System official data. During the follow-up, 5743 individuals died, and 2097 were hospitalized for PVR-SAEs. Vaccinated subjects (n = 259,821) did not show an increased risk of all-cause death, non-COVID death, or any PVR-SAEs, as compared to the unvaccinated (n = 56,494). These results were consistent across genders, age-classes, vaccine types, and SARS-CoV-2 infection status and did not vary in Cox models adjusting for age, gender, SARS-CoV-2 infection, and selected comorbidities. In the infected population, any dose of vaccine was associated with a lower likelihood of death and PVR-SAE. In the uninfected population, subjects who received one or two doses showed a significantly higher incidence of most outcomes, likely due to a large selection bias introduced by the Italian restriction policies targeting uninfected subjects who received less than three doses. In conclusion, COVID-19 vaccination was not associated with an increase of mortality or selected PVR-SAEs incidence. Further research is warranted to evaluate the long-term safety of COVID-19 vaccines.

Athlete deaths during the COVID-19 vaccination campaign: contextualisation of online information

“…Nevertheless, a recent Italian cohort study demonstrated that vaccinated individuals had a significantly lower all-cause mortality and reduced risk of stroke, thrombo-embolism, and cardiac arrest compared to unvaccinated controls. 20 Although myocarditis is a generally acknowledged, rare side effect of mRNA-based COVID-19 vaccines, and can be complicated by ventricular arrhythmia and SCA/SCD, it is a rather infrequent cause of SCD, 2,3,6,9,10 also in the present study (Tables 1 and 2), and there is currently no evidence to attribute significant numbers of young athlete deaths to this vaccine-induced condition. Male adolescents and male young adults (12-29 years) are mainly affected by myocarditis (incidence 1 in 6,800-35,000), usually 2-4 days after the second mRNA dose.…”

“…Nevertheless, a recent Italian cohort study demonstrated that vaccinated individuals had a significantly lower all-cause mortality and reduced risk of stroke, thrombo-embolism, and cardiac arrest compared to unvaccinated controls. 20…”

Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases, in Patients with Cardiac Issues, and in the Healthy Population

“…There is a possibility, not discussed, that those who were less affected by the vaccines could have decided to receive the third doses more promptly. As also stated by the authors, further research in the coming years will be required to evaluate the long-term safety of the COVID-19 vaccines [ 202 ]. Other studies are needed.…”

All-Cause Mortality According to COVID-19 Vaccination Status: an analysis of the UK Office for National Statistics Public Data

“…Another retrospective cohort study [25] has been just published on the entire population of the Italian Province of Pescara, where 259,821 subjects were vaccinated with ≥1 dose and 56,494 remained unvaccinated from January 2021 to July 2022. The authors reported much lower rates of all-cause mortality in the vaccinated group.…”

“…Another limitation is that the study [25] does not seem to have considered the evolution of risks over time. The risks of the vaccinated, expressed as averages over the entire follow-up period, could underestimate those of the last few months of 2022.…”