Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Results from an active pharmacovigilance study in central Italy.

This survey investigated on adverse events after vaccination with mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine in children aged 5-11 years in central Italy through active surveillance reporting. During December 2021-January 2022, parents of children who undergone vaccination were interviewed using a structured questionnaire. 197 out of 208 contacted parents participated (94.7% response rate), of whom 166 (84.3%) had one child. Of the 229 children, the mean age was 8.9 years, 50.7% were female. 193 (84.3%) had at least one adverse event after the first dose (mean age 9.1 years; 54.4% female), and 146 (73.4%) of 199 after the second (mean age 8.9 years; 54.8% female), which was not administered to 30 children due to previous COVID-19 history. Local symptoms after the first and second dose occurred in 183 (94.8%) and 141 (96.6%) recipients (p = .435), respectively, while systemic reactions in 62 (32.1%) and 34 (23.3%) (p = .074). Mild events were reported by 81.7% and 69.8% children after the first and second dose, followed by moderate (3.9% and 10.6%) and severe (1.3% and 0.5%). After each dose, injection site reactions (79.5% and 68.8%) were the most frequent, followed by headache (13.1%) and lymphadenopathy (8.5%) after the first and second dose, respectively. The adverse events were reported to pediatricians only for 5.7% and 3.9% of children and treated for 17.6% and 15.8%. This is the first report about safety profile through active surveillance of mRNA BNT162b2 among children in Italy, revealing temporary and mild-to-moderate symptoms with no serious events after each vaccine dose.

A SARS-CoV-2 Outbreak Among Nursing Home Residents Vaccinated with a Booster Dose of mRNA COVID-19 Vaccine.

This study describes a SARS-CoV-2 outbreak caused by the Delta (B.1.617.2) variant in a nursing home in Central Italy during October-November 2021. Trained interviewers collected data from residents, staff, and administration officers with an agreed informed consent procedure. Thirty-two (44.5%) out of 72 residents (median age 89 years) and six (26.1%) of 23 healthcare workers were found to be infected with SARS-CoV-2. Infections occurred more often among residents with a higher index of independence in daily living activities, suggesting an increased risk for those with more interactions. Twenty-five infected residents (78.1%) received the booster dose of mRNA anti-COVID-19 vaccine > 7 days before SARS-CoV-2 onset. Half of the infected residents had mild symptoms, and only three required hospitalisation, one of whom died from COVID-19 complications. The study underlines the effectiveness of a booster dose in providing a high protection against severe disease and hospitalisation even among vulnerable individuals infected with the Delta variant of concern.

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.

A Cross-Sectional Study of Untoward Reactions Following Homologous and Heterologous COVID-19 Booster Immunizations in Recipients Seventeen Years of Age and Older.

A booster dose after primary COVID-19 vaccination series was considered crucial after the emergence of the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants. Active surveillance was used to investigate reporting of adverse events post-booster dose of either of the licensed mRNA Comirnaty (Pfizer/BioNTech) or Spikevax (Moderna) vaccines in adult (17 years and older) recipients in central Italy. Eligible participants were enrolled and interviewed via phone using a structured questionnaire. Primary outcomes related to the occurrence of adverse events post-booster were stratified by vaccine, and frequency of local/systemic, mild/moderate/severe events. Of a total of 622 participants interviewed, 554 (89.1%) reported at least one adverse event (88.2% and 92.9% after the Comirnaty or Spikevax vaccine, respectively): 63.4% were female, and 78.5% aged 17 to 64 years, regardless of vaccine. 87.7% and 68.2% of all recipients described at least one local or systemic reaction, respectively: 97.3, 38.6 and 4.7% reported mild, moderate, or severe events, respectively. The most frequent adverse reactions were pain, redness, or swelling at the injection site and fatigue, while malaise and fever significantly occurred after the Comirnaty, and vomiting after the Spikevax booster. Compared to the primary vaccination, lymphadenopathy was more common after the booster (p < 0.001), especially after Comirnaty vaccine. The study findings revealed no serious or unexpected adverse events, and are in agreement with data available on booster dose for both mRNA vaccines. The transient, mild to moderate, and common to very common side reactions reported should be used to reassure potential recipients of the lack of safety concerns.

Active Surveillance of Adverse Events in Healthcare Workers Recipients After Vaccination with COVID-19 BNT162b2 Vaccine (Pfizer-BioNTech, Comirnaty): A Cross-Sectional Study.

In this cross-sectional study, adverse events after the first and second dose of BNT162b2 mRNA (Pfizer-BioNTech, Comirnaty) vaccine against coronavirus disease 2019 were investigated among employees of clinics in central Italy. A 42-items questionnaire was administrated to vaccine recipients. Adverse events were classified based on severity and occurrence as reported in the literature. A descriptive/univariate analysis using Chi-square or Fisher's Exact tests was performed. Odds ratio (OR) and 95% confidence intervals were calculated to assess risk factors. 340 individuals (61.5% females; median age 49 years) participated. Adverse events were reported by 279 (82%) and 281 (82.6%) individuals as induced by the first and second dose, respectively. Mild reactions were mainly reported (80.9% and 80.3%), followed by moderate (11.8% and 37.1%) and severe (3.8% and 4.7%). Adverse events were identical to those already described as very common (81.8% and 80.6%), although vaccine-coincidental events not cited in the literature were reported by 6% and 15.6% following each dose. Age ≤ 55 years was a risk factor for any adverse event after each injection (ORs: 2.942 and 2.818), as well as female sex for those mild (ORs: 1.856 and 2.818) and common (ORs: 3.452 and 2.145). Findings were consistent with national reports as most of the adverse events were mild and associated with female sex and young age, while investigations are needed for reactions not described elsewhere. Data are useful to support the vaccine safety profile, also because largely targeted healthcare personnel more skilled than general population in self-diagnosis of health-related issues.

A Coronavirus Outbreak Linked to a Funeral Among a Romani Community in Central Italy.

Background: The epidemic dynamics of COVID-19 in the Molise region, central Italy, has dramatically changed from the beginning of May 2020, which was when infections were reported amongst Romani people. The aims of this study were to describe the characteristics of an outbreak that occurred in the Romani community and the interventions implemented for control. Methods: A retrospective analysis of outbreak data was performed to describe the SARS-CoV-2 transmission dynamics. Results: A young Romani woman was the first case reported and epidemiological investigation established a possible link with the funeral of a deceased member of this community. In total, 150 close contacts within 34 family groups in two cities were traced, and 109 (72.7%) Romani individuals were found to be infected by COVID-19. The patient's median age was 31 years, 58% were female, and the highest (20.2%) incidence occurred in the 0-9 years age group. A total of 26 (23.8%) patients developed typical SARS-CoV-2 symptoms, 15 (57.8%) were hospitalized, and 21 (22.1%) had comorbidities [most commonly hypertension (28.6%) and/or coronary heart diseases (23.8%)]. The outbreak was effectively controlled through compulsory quarantine and enhanced active surveillance. Conclusions: This is the first study providing insight into COVID-19 transmission dynamics among a Romani population living in Italy. These findings support general conclusions about the role of crowded social gatherings in SARS-CoV-2 spread, the high communicability among close contacts and household settings, and the impact of asymptomatic carriers. These features are of relevance to certain Romani customs where family gatherings are a fundamental pillar of their lives. Although difficulties emerged in interacting with Romani people related to cultural drivers, beliefs, and lifestyle, the outbreak management was effective and should be considered as a valuable model applicable to similar incidents occurring in minority populations.

Precision Medicine and Public Health: New Challenges for Effective and Sustainable Health.

The development of high-throughput omics technologies represents an unmissable opportunity for evidence-based prevention of adverse effects on human health. However, the applicability and access to multi-omics tests are limited. In Italy, this is due to the rapid increase of knowledge and the high levels of skill and economic investment initially necessary. The fields of human genetics and public health have highlighted the relevance of an implementation strategy at a national level in Italy, including integration in sanitary regulations and governance instruments. In this review, the emerging field of public health genomics is discussed, including the polygenic scores approach, epigenetic modulation, nutrigenomics, and microbiomes implications. Moreover, the Italian state of implementation is presented. The omics sciences have important implications for the prevention of both communicable and noncommunicable diseases, especially because they can be used to assess the health status during the whole course of life. An effective population health gain is possible if omics tools are implemented for each person after a preliminary assessment of effectiveness in the medium to long term.