The future for COVID-19 vaccines: public health assessment and perspectives based on scientific evidence

SUMMARY The development and use of messenger RNA-based (mRNA) vaccines against the SARS-CoV-2 spike protein have proven to be highly effective against symptomatic COVID-19, especially for severe forms. Since the declaration of a public health emergency in early 2020, however, the SARS-CoV-2 virus has continuously evolved, giving rise to several variants that have caused and continue to cause concern in the scientific community. Currently, viruses circulating worldwide belong to the Omicron lineage, with several identified sub-variants. In response to virus mutation, mRNA vaccines have been adapted into bivalent vaccines containing two mRNAs: one encoding the original Wuhan SARS-CoV-2 spike protein and one encoding the BA.1 or BA.4–5 spike protein of the Omicron sub-variant. This strategy is based on the hypothesis that the immune system's response improves when variants are included in the vaccine, leading to an increase in the magnitude and diversity of both the humoral and cellular immune response. The evidence gathered to date confirms the use of bivalent vaccines as the optimal strategy. In the light of current knowledge, and in the awareness of the impossibility of making precise predictions on the evolution of the COVID-19 pandemic, as a group of experts we propose some considerations for the progressive evolution of vaccination against SARS-CoV-2 from pandemic to endemic vaccination.

The future for COVID-19 vaccines: public health assessment and perspectives based on scientific evidence.

The development and use of messenger RNA-based (mRNA) vaccines against the SARS-CoV-2 spike protein have proven to be highly effective against symptomatic COVID-19, especially for severe forms. Since the declaration of a public health emergency in early 2020, however, the SARS-CoV-2 virus has continuously evolved, giving rise to several variants that have caused and continue to cause concern in the scientific community. Currently, viruses circulating worldwide belong to the Omicron lineage, with several identified sub-variants. In response to virus mutation, mRNA vaccines have been adapted into bivalent vaccines containing two mRNAs: one encoding the original Wuhan SARS-CoV-2 spike protein and one encoding the BA.1 or BA.4-5 spike protein of the Omicron sub-variant. This strategy is based on the hypothesis that the immune system's response improves when variants are included in the vaccine, leading to an increase in the magnitude and diversity of both the humoral and cellular immune response. The evidence gathered to date confirms the use of bivalent vaccines as the optimal strategy. In the light of current knowledge, and in the awareness of the impossibility of making precise predictions on the evolution of the COVID-19 pandemic, as a group of experts we propose some considerations for the progressive evolution of vaccination against SARS-CoV-2 from pandemic to endemic vaccination.

Clinical Severity in Different Waves of SARS-CoV-2 Infection in Sicily: A Model of Smith's "Law of Declining Virulence" from Real-World Data.

BACKGROUND: The COVID-19 epidemic had a rapid spread worldwide with a continuous and fast mutation of the virus, resulting in the emergence of several variants of concern (VOC). The aim of this study was to evaluate the severity of each VOC among SARS-CoV-2 infected subjects by investigating deaths, ICU admissions, intubations, and severe critical symptoms. METHODS: An ecological observational study was performed to evaluate mortality rates and clinical characteristics of 321,490 unvaccinated Sicilian SARS-CoV-2 cases observed from 2 March 2020 to 27 March 2022. Odds ratios (OR) and 95% confidence intervals (CI) were calculated by multivariate logistic regression analysis evaluating factors determining a clinical worsening. RESULTS: Delta (adj-OR 3.00, 95% Cls 2.70-3.33) and wild-type (adj-OR 2.41, 95% Cls 2.2-2.62) variants had a higher risk than the Omicron strain for developing critical COVID-19 necessitating intubation and eventually undergoing death. Moreover, males appeared to be significantly more susceptible to developing the worst clinical outcome considered, as did older subjects. CONCLUSIONS: The present study provides evidence of factors implicated in the worsening of SARS-CoV-2-infection-related clinical outcomes. The study highlighted the different roles of VOC, in particular Delta and wild-type, and being male and elderly in the development of a worse clinical outcome.

Increased Risk of Hospitalization for Pneumonia in Italian Adults from 2010 to 2019: Scientific Evidence for a Call to Action.

Background: Understanding trends in pneumonia-associated hospitalizations can help to quantify the burden of disease and identify risk conditions and at-risk populations. This study evaluated characteristics of hospitalizations due to pneumonia that occurred in Italy in a 10-year period from 2010 to 2019. Methods: All hospitalizations with a principal or secondary diagnosis of pneumonia over the 10-year period were included, which were identified by hospital discharges for all-cause pneumonia and pneumococcal pneumonia in the anonymized hospital discharge database of the Italian Health Ministry. Results: A total of 2,481,213 patients were hospitalized for pneumonia between 2010 and 2019; patients aged 75−86 years accounted for 30.1% of hospitalizations. Most hospitalizations (88.1%) had an unspecified pneumonia discharge code. In-hospital death was recorded in 13.0% of cases. The cumulative cost for pneumonia hospitalizations of the 10-year period were EUR 11,303,461,591. Over the observation period, the incidence rate for hospitalized all-cause pneumonia in any ages increased from 100 per 100,000 in 2010 to over 160 cases per 100,000 per year in 2019 (p < 0.001). Overall, there was a significant increase in annual percent changes in hospitalization rates (+3.47 per year), in-hospital death (+4.6% per year), and costs (+3.95% per year) over the 10-year period. Conclusions: Our analysis suggests that hospitalizations for pneumonia are increasing over time in almost all age groups, especially in the elderly. Given the substantial burden of pneumonia in terms of mortality, healthcare resources, and economic costs, greater public health efforts should thus be made to promote vaccinations against influenza and pneumococcus, particularly in high-risk groups.

Exploring the effectiveness of the Digital Green Certificate Law as Public Health instrument to increase anti-COVID-19 vaccination in a sample of working-age adult population in the Palermo Metropolitan Area.

Counteracting vaccine hesitancy should be considered an absolute priority for Public Health Authorities. A correct health communication represents one of the best ways to increase adhesion to vaccination among hesitant population. In order to increase vaccination coverage rates against COVID-19, the Italian government has issued a legislative decree with a mandatory "Digital Green Certificate" (DGC) to access workplaces for some categories considered at risk. Methods: We conducted a cross-sectional study with the aim to highlight the factors associated with the anti-COVID-19 vaccine acceptance and to estimate the influence of the introduction by law of the Digital Green Certificate (DGC) on the adhesion to the COVID-19 vaccination campaign in a sample of individual accessing one of the main vaccination centres of the metropolitan area of Palermo, Italy. An anonymous and validated questionnaire was self-administered through the Google Documents® platform, between October 2021 and March 2022. Results: Among the 467 subjects enrolled, 43.3% were influenced on their vaccination choice by the introduction of the DGC. The multivariate analysis showed that among the respondents emerged contrasting feelings with a self-reported significantly higher sense of freedom (Adj-OR = 2.45, 95%CIs = 1.51-3.97, p-value: < 0.001) but a lower sense of safety (Adj-OR = 0.19, 95%CIs = 0.12-0.29, p-value: < 0.001) after vaccine administration. Conclusions: Our findings, in line with the available literature, suggest that the introduction of DGC has led to a significant increase in the immunization rate and, together with an appropriate communicative approach, it could represent an effective strategy to counteract vaccine hesitancy.

Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial.

BACKGROUND: The efficacy of early treatment with convalescent plasma in patients with COVID-19 is debated. Nothing is known about the potential effect of other plasma components other than anti-SARS-CoV-2 antibodies. METHODS: To determine whether convalescent or standard plasma would improve outcomes for adults in early phase of Covid19 respiratory impairment we designed this randomized, three-arms, clinical trial (PLACO COVID) blinded on interventional arms that was conducted from June 2020 to August 2021. It was a multicentric trial at 19 Italian hospitals. We enrolled 180 hospitalized adult patients with COVID-19 pneumonia within 5 days from the onset of respiratory distress. Patients were randomly assigned in a 1:1:1 ratio to standard of care (n = 60) or standard of care + three units of standard plasma (n = 60) or standard of care + three units of high-titre convalescent plasma (n = 60) administered on days 1, 3, 5 after randomization. Primary outcome was 30-days mortality. Secondary outcomes were: incidence of mechanical ventilation or death at day 30, 6-month mortality, proportion of days with mechanical ventilation on total length of hospital stay, IgG anti-SARS-CoV-2 seroconversion, viral clearance from plasma and respiratory tract samples, and variations in Sequential Organ Failure Assessment score. The trial was analysed according to the intention-to-treat principle. RESULTS: 180 patients (133/180 [73.9%] males, mean age 66.6 years [IQR 57-73]) were enrolled a median of 8 days from onset of symptoms. At enrollment, 88.9% of patients showed moderate/severe respiratory failure. 30-days mortality was 20% in Control arm, 23% in Convalescent (risk ratio [RR] 1.13; 95% confidence interval [CI], 0.61-2.13, P = 0.694) and 25% in Standard plasma (RR 1.23; 95%CI, 0.63-2.37, P = 0.544). Time to viral clearance from respiratory tract was 21 days for Convalescent, 28 for Standard plasma and 23 in Control arm but differences were not statistically significant. No differences for other secondary endpoints were seen in the three arms. Serious adverse events were reported in 1.7%, 3.3% and 5% of patients in Control, Standard and Convalescent plasma arms respectively. CONCLUSIONS: Neither high-titer Convalescent nor Standard plasma improve outcomes of COVID-19 patients with acute respiratory failure. Trial Registration Clinicaltrials.gov Identifier: NCT04428021. First posted: 11/06/2020.

Effectiveness of mRNA COVID-19 Vaccines in Adolescents Over 6 Months.

BACKGROUND AND OBJECTIVES: On June 4, 2021, Italy launched the coronavirus disease 2019 (COVID-19) vaccination of adolescents to slow down the COVID-19 spread. Although clinical trials have evaluated messenger ribonucleic acid (mRNA) vaccine effectiveness in adolescents, there is limited literature on its real-world effectiveness. Accordingly, this study aimed to estimate the effectiveness of mRNA COVID-19 vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and mild or severe COVID-19 in a cohort of Sicilian adolescents within a 6 month observation period. METHODS: A retrospective cohort study was conducted with adolescents aged 12 to 18 years, residents of Sicily, who were followed from July 15 to December 31, 2021. SARS-CoV-2 infections, mild and severe COVID-19, and COVID-19-related intubation or deaths during the study period were compared between subjects vaccinated with 2 doses of mRNA vaccines and unvaccinated individuals. The Cox regression analysis, adjusted for age and sex, was performed to compare the 2 groups. RESULTS: Overall, the study included a total at-risk population of 274 782 adolescents with 61.4% of them having completed the vaccination cycle by the end of the study. Unvaccinated subjects had higher incidence rates of SARS-CoV-2 (1043 × 10 000 vs 158.7 × 10 000 subjects), mild COVID-19 (27.7 × 10 000 vs 1.8 × 10 000 subjects) and severe COVID-19 (1.41 × 10 000 vs 0 subjects) compared with the vaccinated population. The estimated adjusted vaccine effectiveness against SARS-CoV-2 infection was 71.2%, reaching 92.1% and 97.9% against mild and severe COVID-19, respectively. CONCLUSIONS: This study provides rigorous evidence of mRNA COVID-19 vaccines' effectiveness in protecting adolescents from both SARS-CoV-2 infection and COVID-19.

Knowledge, Attitudes, Perceptions and Vaccination Acceptance/Hesitancy among the Community Pharmacists of Palermo's Province, Italy: From Influenza to COVID-19.

In Italy, following the start of the SARS-CoV-2 vaccination campaign, community pharmacies (CPs) were recruited on a voluntary basis in order to administer COVID-19 vaccines as part of their activities. The aim of the present study was to investigate the knowledge, attitudes, and practices regarding SARS-CoV-2 infection prevention, and vaccine acceptance/hesitancy towards COVID-19 and influenza vaccinations among the community pharmacists operating in the Palermo Province. A cross-sectional study was conducted, with two different questionnaires administered before and after the conduction of the vaccination campaign against SARS-CoV-2 at the COVID-19 vaccination center of the Palermo University Hospital (PUH). The baseline survey showed that 64% of community pharmacists (CPs) declared that they planned to vaccinate against SARS-CoV-2, and 58% were vaccinated against influenza during the 2020/2021 season. Factors significantly associated with willingness to receive the COVID-19 vaccination were confidence in vaccines (adjOR 1.76; CI 1.11-2.80), fear of contracting SARS-CoV-2 infection (adjOR 1.50; CI 1.06-2.11), considering COVID-19 vaccination to be the best strategy to counteract SARS-CoV-2 (adjOR 1.79; CI 1.39-2.29), and adherence to influenza vaccination during the 2020/2021 season (adjOR 3.25; CI 2.23-4.25). The adherence among CPs of the Palermo Province to COVID-19 vaccination was 96.5%. From the post-vaccination survey, the main reasons for changing opinions on vaccination adherence were the introduction of mandatory vaccinations, fear of contracting COVID-19, and limitations on work activities in the case of vaccine refusal. The achievement of very high COVID-19 vaccination coverage rates among healthcare professionals (HCPs) in the present study was mainly due to the mandatory vaccination policies; nevertheless, a willingness for COVID-19 vaccination was relatively high among pharmacists before the beginning of the vaccination campaign. HCPs and CPs should receive training on vaccination, which is recommended in the national immunization plan and is also suggested by the respondents in our study, in order to routinely re-evaluate their own vaccination profiles, as well as those of their patients.

Multidimensional Frailty and Vaccinations in Older People: A Cross-Sectional Study.

It is known that influenza, herpes zoster, pneumococcal and pertussis infections may increase morbidity and mortality in older people. Vaccinations against these pathogens are effective in older adults. Frailty seems to be an important determinant of vaccination rates, yet data supporting this association are still missing. Therefore, we aimed to investigate the prevalence of four recommended vaccinations (influenza, herpes zoster, pneumococcal and diphtheria-tetanus-pertussis) and the association with multidimensional frailty assessed using a self-reported comprehensive geriatric assessment tool, i.e., the multidimensional prognostic index (SELFY-MPI). Older participants visiting the outpatient clinic of Azienda Ospedaliera Universitaria, Palermo, Italy were included. The SELFY-MPI questionnaire score was calculated based on eight different domains, while the vaccination status was determined using self-reported information. We included 319 participants from the 500 initially considered (63.8%). Vaccination against influenza was observed in 70.5% of the cases, whilst only 1.3% received the vaccination against diphtheria-tetanus-pertussis. Participants with higher SELFY-MPI scores were more likely to report vaccination against pneumococcus (45.6 vs. 28.3%, p = 0.01), whilst no significant differences were observed for the other vaccinations. In conclusion, the coverage of recommended vaccinations is low. Higher SELFY-MPI scores and vaccination status, particularly anti-pneumococcus, appear to be associated, but future studies are urgently needed for confirming that frailty is associated with vaccination status in older people.

Wastewater-based epidemiology for early warning of SARS-COV-2 circulation: A pilot study conducted in Sicily, Italy.

There is increasing evidence of the use of wastewater-based epidemiology to integrate conventional monitoring assessing disease symptoms and signs of viruses in a specific territory. We present the results of SARS-CoV-2 environmental surveillance activity in wastewater samples collected between September 2020 and July 2021 in 9 wastewater treatment plants (WTPs) located in central and western Sicily, serving over 570,000 residents. The presence of SARS-CoV-2, determined in 206 wastewater samples using RT-qPCR assays, was correlated with the notified and geo-referenced cases on the areas served by the WTPs in the same study period. Overall, 51% of wastewater samples were positive. Samples were correlated with 33,807 SARS-CoV-2 cases, reported in 4 epidemic waves, with a cumulative prevalence of 5.9% among Sicilian residents. The results suggest that the daily prevalence of SARS-CoV-2 active cases was statistically significant and higher in areas with SARS-CoV-2 positive wastewater samples. According to these findings, the proposed method achieves a good sensitivity profile (78.3%) in areas with moderate or high viral circulation (≥133 cases/100,000 residents) and may represent a useful tool in the management of epidemics based on an environmental approach, although it is necessary to improve the accuracy of the process.

Effectiveness of mRNA COVID-19 Vaccination on SARS-CoV-2 Infection and COVID-19 in Sicily over an Eight-Month Period.

In order to reduce the spread of SARS-CoV-2 infection and the burden of disease, since 27 December 2020, Sicily has introduced a regional COVID-19 vaccination campaign. This study aimed at estimating the effectiveness of mRNA COVID-19 vaccines on SARS-CoV-2 infections and COVID-19. A retrospective cohort study was carried out on 3,966,976 Sicilian adults aged 18 years or more, who were followed-up from 1 January 2021 to 30 September 2021. The risk of SARS-CoV-2 infection, severe COVID-19, and COVID-19 death or intubation during the study period was compared among vaccinated with two mRNA doses and unvaccinated individuals. Cox regression, adjusted for age and sex, and a joint-point analysis on rate trends were performed. Overall, 2,469,320 (62.2%) subjects have been vaccinated and a total of 103,078 (2.6% of the entire population) SARS-CoV-2-positive subjects have been observed including 4693 (0.12%) severe COVID-19, 277 (0.01%) intubated, and 2649 (0.07%) deaths. After two months from vaccination, adjusted vaccine effectiveness was 81.3% against SARS-CoV-2 infection, 96.1% against severe COVID-19, and 93.4% against intubation/death. During the eight-month follow-up, statistically significant decreasing effectiveness trends were observed for all the evaluated outcomes (-4.76% per month against SARS-CoV-2 infection; -2.27% per month against severe COVID-19 and -2.26% per month against COVID-19 intubation/death). The study results confirm that mRNA COVID-19 vaccines have high real-world effectiveness, especially in the first months after vaccination. The vaccine effectiveness decreases over time and, even if the decrease is relatively small against severe outcomes, the increasing protection wane suggests the need for booster vaccination campaigns.

Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance System.

To date, Coronavirus disease (COVID-19) has caused high morbidity and mortality worldwide. To counteract the pandemic scenario, several vaccines against the etiological factor of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were developed and tested. At the end of December 2020, BNT162b2 (Comirnaty, Pfizer-BioNTech) was the first and only authorized vaccine in Italy for selected categories, such as healthcare workers, fragile patients and people aged over 80 years old. To master our knowledge about BNT162b2 adverse reactions (ARs), an active surveillance system based on instant messaging was realized for voluntary participants who had been vaccinated at COVID-19 Vaccination Center of the Palermo University Hospital. Overall, 293 vaccinated persons were included in this study, which were more frequently healthcare workers (n = 207, 70.6% with a median age of 36 years, IQR = 29-55) followed by health professional students (n = 31, 10.6% with a median age of 27 years, IQR = 25-29), reporting 82.6% of at least one local or systemic AR. In details, the frequency of at least one local or systemic AR after the second dose of Comirnaty (n = 235, 80.2%) was statistically significant with higher value in comparison to the first one (n = 149, 50.9%; p < 0.001). However, local pain, swelling, joint pain and muscular pain after the second dose were the symptom causing a statistically significant working limitation. The youngest persons showed a higher risk to have either local or systemic ARs (aOR = 7.5, CI 95% = 2.9-18.9), while females had a higher risk of having systemic ARs (aOR = 1.8, CI 95% = 1.1-3.0). Despite the small sample examined, this active surveillance system by instant messaging seems to detect a higher ARs prevalence with respect to data obtained by the passive surveillance. Further studies could be required in order to optimize this clinical monitoring that could be considered an efficient and timely active surveillance.

Direct RNA Nanopore Sequencing of SARS-CoV-2 Extracted from Critical Material from Swabs.

In consideration of the increasing prevalence of COVID-19 cases in several countries and the resulting demand for unbiased sequencing approaches, we performed a direct RNA sequencing (direct RNA seq.) experiment using critical oropharyngeal swab samples collected from Italian patients infected with SARS-CoV-2 from the Palermo region in Sicily. Here, we identified the sequences SARS-CoV-2 directly in RNA extracted from critical samples using the Oxford Nanopore MinION technology without prior cDNA retrotranscription. Using an appropriate bioinformatics pipeline, we could identify mutations in the nucleocapsid (N) gene, which have been reported previously in studies conducted in other countries. In conclusion, to the best of our knowledge, the technique used in this study has not been used for SARS-CoV-2 detection previously owing to the difficulties in the extraction of RNA of sufficient quantity and quality from routine oropharyngeal swabs. Despite these limitations, this approach provides the advantages of true native RNA sequencing and does not include amplification steps that could introduce systematic errors. This study can provide novel information relevant to the current strategies adopted in SARS-CoV-2 next-generation sequencing.

Educational Interventions on Pregnancy Vaccinations during Childbirth Classes Improves Vaccine Coverages among Pregnant Women in Palermo's Province.

Maternal immunization is considered the best intervention in order to prevent influenza infection of pregnant women and influenza and pertussis infection of newborns. Despite the existing recommendations, vaccination coverage rates in Italy remain very low. Starting from August 2018, maternal immunization against influenza and diphtheria-tetanus-pertussis were strongly recommended by the Italian Ministry of Health. We conducted a cross sectional study to estimate the effectiveness of an educational intervention, conducted during childbirth classes in three general hospitals in the Palermo metropolitan area, Italy, on vaccination adherence during pregnancy. To this end, a questionnaire on knowledge, attitudes, and immunization practices was structured and self-administered to a sample of pregnant women attending childbirth classes. Then, an educational intervention on maternal immunization, followed by a counseling, was conducted by a Public Health medical doctor. After 30 days following the interventions, the adherence to the recommended vaccinations (influenza and pertussis) was evaluated. At the end of the study 326 women were enrolled and 201 responded to the follow-up survey. After the intervention, among the responding pregnant women 47.8% received influenza vaccination (+44.8%), 57.7% diphtheria-tetanus-pertussis vaccination (+50.7%) and 64.2% both the recommended vaccinations (+54.8%). A significant association was found between pregnant women that received at least one vaccination during pregnancy and higher educational level (graduation degree/master's degree), employment status (employed part/full-time) and influenza vaccination adherence during past seasons (at least one during last five years). The implementation of vaccination educational interventions, including counseling by healthcare professionals (HCPs), on maternal immunization during childbirth courses improved considerably the vaccination adherence during pregnancy.

Respiratory Syncytial Virus: New Challenges for Molecular Epidemiology Surveillance and Vaccination Strategy in Patients with ILI/SARI.

Several respiratory pathogens are responsible for influenza-like illness (ILI) and severe respiratory infections (SARI), among which human respiratory syncytial virus (hRSV) represents one of the most common aetiologies. We analysed the hRSV prevalence among subjects with ILI or SARI during the five influenza seasons before the emergence of SARS-CoV-2 epidemic in Sicily (Italy). Respiratory specimens from ILI outpatients and SARI inpatients were collected in the framework of the Italian Network for the Influenza Surveillance and molecularly tested for hRSV-A and hRSV-B. Overall, 8.1% of patients resulted positive for hRSV. Prevalence peaked in the age-groups <5 years old (range: 17.6-19.1%) and ≥50 years old (range: 4.8-5.1%). While the two subgroups co-circulated throughout the study period, hRSV-B was slightly predominant over hRSV-A, except for the season 2019-2020 when hRSV-A strongly prevailed (82.9%). In the community setting, the distribution of hRSV subgroups was balanced (47.8% vs. 49.7% for hRSV-A and hRSV-B, respectively), while most infections identified in the hospital setting were caused by hRSV-B (69.5%); also, this latter one was more represented among hRSV cases with underlying diseases, as well as among those who developed a respiratory complication. The molecular surveillance of hRSV infections may provide a valuable insight into the epidemiological features of ILI/SARI. Our findings add new evidence to the existing knowledge on viral aetiology of ILI and SARI in support of public health strategies and may help to define high-risk categories that could benefit from currently available and future vaccines.

Attitudes toward the SARS-CoV-2 and Influenza Vaccination in the Metropolitan Cities of Bologna and Palermo, Italy.

Vaccine hesitancy (VH) is known to play a relevant role in thwarting the efforts toward reaching satisfactory influenza vaccination coverage, and has caused similar difficulties during the COVID-19 pandemic. This study aims to describe the phenomenon and produce insights on the reasons behind VH. A survey was administered between December 2020 and February 2021 to adults living in the cities of Bologna and Palermo. Of the 443 subjects enrolled, 47.3% were likely to get the influenza vaccination, while 75.6% were willing to receive the COVID-19 vaccination. The most frequent determinants that motivated the willingness to get the COVID-19 vaccine were trust in the safety of vaccines and belief that the vaccine is an effective tool. As for people's unwillingness to be vaccinated, being exposed to information that produced doubts about the vaccine and lack of trust in a newly developed vaccine were the most frequently involved determinants. Statistically significant positive associations were found between the willingness to be vaccinated and postgraduate education and the propensity towards influenza vaccination. A negative association with being over 40 years old and of female gender was also found. These results might have an impact in better understanding individual reasons behind VH, identifying which categories are more exposed to it and which strategies should be implemented.

Sensory Stimulation in the NICU Environment: Devices, Systems, and Procedures to Protect and Stimulate Premature Babies.

Prematurity deprives infants of the prenatal sensory stimulation essential to their correct development; in addition, the stressful environment of the NICU impacts negatively on their growth. The purpose of this review was to investigate the effects of NICU noise pollution on preterm infants and parents. We focused on the systems and projects used to control and modulate sounds, as well as on those special devices and innovative systems used to deliver maternal sounds and vibrations to this population. The results showed beneficial effects on the preterm infants in different areas such as physiological, autonomic, and neurobehavioral development. Although most of these studies highlight positive reactions, there is also a general acknowledgement of the current limits: small and heterogeneous groups, lack of structured variable measurements, systematic control groups, longitudinal studies, and normative values. The mother's presence is always preferred, but the use of music therapy and the devices analyzed, although not able to replace her presence, aim to soften her absence through familiar and protective stimuli, which is a very powerful aid during the COVID-19 pandemic.

The Dual/Global Value of SARS-CoV-2 Genome Surveillance on Migrants Arriving to Europe via the Mediterranean Routes.

Despite the pandemic, 34,154 migrants, refugees or asylum-seekers landed in Sicily (Italy) in 2020, representing the main point of entry by sea into Europe. The SARS-CoV-2 surveillance program among migrants arriving to Sicily via the Mediterranean Sea, made by the combination of clinical examination and molecular testing, has been integrated by full-genome sequencing strains using the NGS technology from the last week of February. To date, more than one hundred full-genome strains have been sequenced and 8 different lineages have been identified mostly belonging to the lineages B.1.1.7 and B.1.525. As global access to COVID-19 vaccines should be ensured, the need to provide more detailed information to inform policies and to drive the possible re-engineering of vaccines needed to deal with the challenge of new and future variants should be highlighted.