Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Author's reply to correspondence.

Dear Editor, We would like to reply to "Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11years: Correspondence" regarding our article entitled "Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNTech) vaccine in children aged 5-11years: Results from an active pharmacovigilance study in central Italy."

Public health, personalized medicine, and COVID-19 in the pre-vaccination phase: a narrative review of the literature on unfavorable prognostic factors in Italian patients.

OBJECTIVES: to provide an outline of the factors mainly influencing severe disease and fatal outcome among Italian COVID-19 patients in the pre-vaccination phase, also describing the impact of the scenarios driven by variants, vaccines, and available therapies. DESIGN: a literature search was carried out for peer-reviewed articles searching for COVID-19 and prognosis, including severe disease and death. SETTING AND PARTICIPANTS: Italian patients with COVID-19. MAIN OUTCOME MEASURES: the association between risk factors and severe disease and death as the main outcomes was assessed through epidemiological measures, including relative risk, odds ratio, and hazard ratio. RESULTS: advanced age, obesity, overweight, non-0 blood group, and male gender were the factors more associated with severe disease. Fatal outcome mostly correlated with old age, non-0 blood group, and obesity, together with cardiovascular diseases, diabetes, hypertension, cancer, chronic kidney disease, and acute kidney injury. CONCLUSIONS: clinical and epidemiological characteristics of the Italian population, integrated with omics data, could be highly valuable to stratify risk of worse prognosis among patients, and to address targeted prevention and treatment interventions.