COVID-19 Vaccine Refusal and Delay among Adults in Italy: Evidence from the OBVIOUS Project, a National Survey in Italy.

BACKGROUND: Vaccine hesitancy was defined by the World Health Organization (WHO) in 2019 as a major threat to global health. In Italy, reluctance to receive vaccines is a widespread phenomenon that was amplified during the COVID-19 pandemic by fear and mistrust in government. This study aims to depict different profiles and characteristics of people reluctant to vaccinate, focusing on the drivers of those who are in favor of and those who are opposed to receiving the COVID-19 vaccine. METHODS: A sample of 10,000 Italian residents was collected. A survey on COVID-19 vaccination behavior and possible determinants of vaccine uptake, delay, and refusal was administered to participants through a computer-assisted web interviewing method. RESULTS: In our sample, 83.2% stated that they were vaccinated as soon as possible ("vaccinators"), 8.0% delayed vaccination ("delayers"), and 6.7% refused to be vaccinated ("no-vaccinators"). In general, the results show that being female, aged between 25 and 64, with an education level less than a high school diploma or above a master's degree, and coming from a rural area were characteristics significantly associated with delaying or refusing COVID-19 vaccination. In addition, it was found that having minimal trust in science and/or government (i.e., 1 or 2 points on a scale from 1 to 10), using alternative medicine as the main source of treatment, and intention to vote for certain parties were characteristics associated with profiles of "delayers" or "no-vaccinators". Finally, the main reported motivation for delaying or not accepting vaccination was fear of vaccine side effects (55.0% among delayers, 55.6% among no-vaccinators). CONCLUSION: In this study, three main profiles of those who chose to be vaccinated are described. Since those who are in favor of vaccines and those who are not usually cluster in similar sociodemographic categories, we argue that findings from this study might be useful to policy makers when shaping vaccine strategies and choosing policy instruments.

Physical Well-Being of Children and Adolescents during the SARS-CoV-2 Pandemic: Findings from the "Come te la Passi?" Cross Sectional Survey in Bologna, Italy.

BACKGROUND: The COVID-19 had a strong impact on the physical and general well-being of the youngest. In Italy, citizens were forced to change their habits, especially during the national lockdown, causing increased levels of sedentary and unhealthy behaviors. "Come te la passi?" was a cross-sectional study aimed at investigating changes in the physical activity levels (PA) and well-being of children and adolescents in the City of Bologna. METHODS: An anonymous survey was administered to parents/guardians of children and adolescents aged 6-18 years. RESULTS: 1134 questionnaires were collected during June 2021; 457 (40.3%) were females, and the mean age was 13.0 ± 3.4 years. Regarding the general well-being perception, 61.3% of the participants reported concerns about the future, 46.3% reported sleep difficulties, and 72.8% reported experiencing attention difficulty, with higher percentages among adolescents. Considering the PA frequency, an overall reduction was found, with the percentage of those who rarely did PA and those who frequently did PA both increasing. No gender differences were found. CONCLUSIONS: Our findings suggest that the current pandemic has strongly impacted the well-being of children and adolescents. It appears to have primarily affected adolescents, with a significant reduction in PA levels, even after the end of the national lockdown.

Biased, wrong and counterfeited evidences published during the COVID-19 pandemic, a systematic review of retracted COVID-19 papers

In 2020 COVID-19 led to an unprecedented stream of papers being submitted to journals. Scientists and physicians all around the globe were in need for information about this new disease. In this climate, many articles were accepted after extremely fast peer-reviews to provide the scientific community with the latest discoveries and knowledge. Unfortunately, this also led to articles retraction due to authors’ misconduct or errors in methodology and/or conclusions. The aim of this study is to investigate the number and characteristics of retracted papers, and to explore the main causes that led to retraction. We conducted a systematic review on retracted articles, using PubMed as data source. Our inclusion criteria were the following: English-language retracted articles that reported original data, results, opinions or hypotheses on COVID-19 and Sars-CoV-2. Twenty-seven retracted articles were identified, mainly reporting observational studies and opinion pieces. Many articles published during the first year of the pandemic have been retracted, mainly due to the authors' scientific misconduct. Duplications, plagiarism, frauds and absence of consent, were the main reasons for retractions. In modern medicine, researchers are required to publish frequently, and, especially during situations like the COVID-19 pandemic, when articles were rapidly published, gaps in peer-reviews system and in the path to scientific publication arose.

Obesity and COVID-19 in Children and Adolescents: Reciprocal Detrimental Influence-Systematic Literature Review and Meta-Analysis.

The dramatic lifestyle changes forced by COVID-19-related lockdown promoted weight gain, with a stronger impact on obese subjects, at higher risk of severe infection. The PubMed database was searched to identify original studies assessing: (1) the extent and risk factors of lockdown-induced weight increase; and (2) the impact of obesity on the risk of hospital admission in children and adolescents. A systematic literature review and meta-analyses were performed. Twenty out of 13,986 identified records were included. A significant weight increase was reported in the majority of subjects, with no apparent gender or age differences. It was induced by a higher consumption of hypercaloric/hyperglycemic/junk food and/or the reduction of physical activity, often associated with an altered sleep-wake cycle. On the other hand, obesity increased the risk of hospitalization (OR = 4.38; 95% C.I. 1.46-13.19; p = 0.009; I2 = 96%) as compared to the normal weight population. COVID-19 and obesity represent epidemic conditions with reciprocal detrimental impact. Urgent public health interventions, targeting the various age and social strata, and involving governmental authorities, health care personnel, teachers and families are warranted to increase awareness and actively promote healthy lifestyles to contrast pediatric obesity and its detrimental consequences at a global level.

Obesity and COVID-19 in Children and Adolescents: Reciprocal Detrimental Influence. Systematic Literature Review and Meta-Analysis

The dramatic lifestyle changes forced by COVID-19-related lockdown promoted weight gain, with a stronger impact on obese subjects, at higher risk of severe infection. The PubMed database was searched to identify original studies assessing: (1) the extent and risk factors of lockdown-induced weight increase;and (2) the impact of obesity on the risk of hospital admission in children and adolescents. A systematic literature review and meta-analyses were performed. Twenty out of 13,986 identified records were included. A significant weight increase was reported in the majority of subjects, with no apparent gender or age differences. It was induced by a higher consumption of hypercaloric/hyperglycemic/junk food and/or the reduction of physical activity, often associated with an altered sleep–wake cycle. On the other hand, obesity increased the risk of hospitalization (OR = 4.38;95% C.I. 1.46–13.19;p = 0.009;I2 = 96%) as compared to the normal weight population. COVID-19 and obesity represent epidemic conditions with reciprocal detrimental impact. Urgent public health interventions, targeting the various age and social strata, and involving governmental authorities, health care personnel, teachers and families are warranted to increase awareness and actively promote healthy lifestyles to contrast pediatric obesity and its detrimental consequences at a global level.

ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance.

Background: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up on the ROCCA study, focused on the older population, by describing adverse effects following immunisation (AEFIs) rates and characteristics in all age groups for the first time in a real-world context. Methods: An active surveillance study on recipients of at least one dose of the Gam-COVID-Vac vaccine was conducted. Participants were administered online questionnaires through live/phone interviews with physicians, by e-mail or by scanning a QR code at different points in time after the first dose: one week (Q1) one month (Q2), and three months (Q3) between March and August 2021. Findings: Overall, 6190 vaccine recipients were recruited. Mean age was 52·4 ± 18·2 years. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at injection site and myalgia. Grade 3 or 4 AEFIs were reported by 2·7% and 1·1% of the participants, respectively. Multivariate analysis showed younger age, being a woman and food allergies are risk factors for more severe AEFIs. Interpretation: Our results confirm a good tolerability profile for the population aged 18 and over providing useful data for vaccination campaigns ongoing in countries planning to use Gam-COVID-Vac. Funding: None.

Sexual and Reproductive Health and Education of Adolescents during COVID-19 Pandemic, Results from "Come Te La Passi?"-Survey in Bologna, Italy.

Social distancing measures adopted to face the COVID-19 pandemic had a detrimental impact on adolescent education and their interaction with peers and adults, secondary to the limitation of school and recreational activities, with repercussions on social and sexual life. The "Come te la passi?" ("How is it going?") study, performed in the Metropolitan City of Bologna (Italy), aimed at investigating the type of information sources adopted by adolescents for their sexual and reproductive health (SRH) knowledge and education, the age of their sexual debut, and the way in which the COVID-19 pandemic affected their relationships and sexual life in order to help local health care professionals and educators designing SRH education programs. A purposely designed online survey was administered during the COVID-19 pandemic to 378 high school students (age > 14 yo) in July 2021. Based on the study results, the most common source of SRH education was the web, followed by peers (friends). A total of 61.3% of 17-year-olds already had sexual intercourse, and 90% of 15-year-olds had experienced romantic or sexual attraction. For 58.2% of the adolescents, the COVID-19 pandemic had negative effects on their relationships/sexual life. The current research emphasizes the need to involve health care professionals and educators in structured programs to promote SRH education tailored to adolescents' needs and started from early ages.

Vaccinations and Healthy Ageing: How to Rise to the Challenge Following a Life-Course Vaccination Approach.

In the context of an ageing population, one of the major Public Health goals is to promote healthy ageing. To rise to this challenge, rethinking conventional prevention paradigms and implementing them with vaccination at all stages of life is necessary. Indeed, vaccinations are able to both prevent pathogen specific diseases and all their downstream effects and to increase overall immune system plasticity and resilience. Our aim is to discuss the obstacles and opportunities in pursuing a "life-course vaccination approach" and to highlight the role of vaccines in healthy ageing. In doing so, we address the close connections between immunology and vaccinology advances and introduce the novel concept of immune fitness. Finally, we conclude that even though vaccinology is making giant steps towards tailored vaccination strategies, more studies are needed to investigate this topic.

Gam-COVID-Vac (Sputnik V) and Pfizer-BioNTech Vaccines Adverse Events following Immunization in Patients Affected by Parkinson's Disease and Multiple Sclerosis: A Longitudinal Study.

The Republic of San Marino COVID-19 vaccination campaign used Gam-COVID-Vac and Pfizer-BioNTech vaccines. To assess adverse events following immunization (AEFIs), approximately 6000 vaccine recipients were monitored by the ROCCA study, including subgroups with Parkinson's Disease (PD) and Multiple Sclerosis (MS). The purpose of this study is to evaluate short-term AEFIs through a 1-month follow-up. We conducted a longitudinal study, using active surveillance to evaluate the safety profiles of COVID-19 vaccines in PD and MS patients. Participants were actively administered a standardized online questionnaire to collect information on AEFIs. Among all PD and MS assisted by the San Marino hospital, a total of 82 patients completed the questionnaires. One week after administration of the first dose, vaccine recipients reported AEFIs in 26% of cases in the PD group, 67% in the MS group, and 68% in the control group. Participants reported slightly higher rates of AEFIs after dose 2 compared with dose 1, being 29%, 75%, and 78% for PD, MS, control group, respectively. Most of the reported symptoms were mild. Patients with PD and MS reported few AEFIs after administration of the COVID-19 vaccines. The frequency of AEFIs in the PD population was significantly lower than in the control group.

ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance.

BACKGROUND: In August 2020, Sputnik V was registered as Gam-COVID-Vac by the Russian Ministry of Health, and since December 2020 it has been distributed in 61 countries worldwide. On 25 February 2021, the Republic of San Marino started its vaccination campaign, which includes Sputnik V. Our aim was to describe the adverse events following immunization (AEFIs) with this vaccine through participant-based active surveillance in the country. METHODS: Beginning from 4 March to 8 April 2021, a nationwide study was conducted on San Marino's population aged 18-89 years who received one or two doses of Sputnik V. E-questionnaire dissemination occurred through e-mails, QR-codes or live/phone interviews ~7 days after the first and second vaccine dose. A descriptive analysis was conducted to quantify AEFI incidence on both occasions, stratifying results by type and severity of symptoms. FINDINGS: Mean age of the 2558 vaccine recipients was 66±14 years. First-dose AEFI incidence was 53.3% (systemic reactions at 42.2%), while second-dose AEFI incidence was 66.8% (systemic reactions at 50.4%) (n = 1288). In general, 76.0% of two-dose recipients reported some AEFIs after either vaccine dose, and 2.1% suffered severe reactions; in 60- to 89-year-olds (n = 1021), AEFI incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache and joint pain. INTERPRETATION: Our results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs. FUNDING: None.