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Objective: SARS-CoV-2 vaccination can bring an important benefit for older people in terms of reduction of mortality and hospitalization; however, reports of rare adverse effects like altered consciousness and delirium among this demographic have raised concerns. This study aimed to assess delirium incidence post-SARS-CoV-2 vaccination and its predictors in older residents across 60 Italian long-term care facilities (LTCFs)., Design: This is a prospective cohort study considering data from GeroCovid Vax, a multicenter cohort study jointly performed by the Italian Society of Gerontology and Geriatrics (SIGG) (Florence, Italy) and the Italian National Institute of Health (Istituto Superiore di Sanità-ISS, Rome, Italy), and sponsored by the Italian Medicines Agency (Agenzia Italiana del Farmaco-AIFA)., Setting and Participants: GeroCovid Vax enrolled LTCFs residents aged ≥60 who received at least 1 anti-SARS-CoV-2 vaccine dose., Methods: Baseline data covered sociodemographic details, chronic diseases, medications, nutritional status, cognitive and functional assessments, mobility, and frailty. Delirium was assessed post-first, second, and booster vaccine doses using DSM-5 criteria. Data analysis involved descriptive statistics, multivariate logistic regression, and network analysis., Results: A total of 2521 participants (mean age 83.10 ± 9.21 years, 70.7% female) were analyzed. Delirium incidence post-first, second, and booster doses was 3.5%, 1.6%, and 1.5%, respectively. Age, preexisting cognitive disorders, and frailty were significant predictors of delirium, with odds ratios (ORs) of 1.70 (95% CI, 1.08-2.77), 2.05 (95% CI, 1.40-2.97), and 1.77 (95% CI, 1.25-2.52), respectively. Prior use of antipsychotics (OR, 1.75; 95% CI, 1.22-2.51) and antidepressants (OR, 1.77; 95% CI, 1.25-2.52) correlated significantly with delirium. Network analysis indicated a strong association between anorexia and delirium., Conclusion and Implications: Post-vaccination delirium is infrequent and decreases with subsequent doses. Timely assessments for frailty and cognitive impairment could aid in stratifying delirium risk among LTCF residents, facilitating enhanced prevention measures and close monitoring for delirium indicators., Competing Interests: Disclosures The authors declare no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

During COVID-19 vaccination campaign, possible ChAdOx1-S-associated risks of thrombosis with thrombocytopenia syndrome led to implement ChAdOx1-S/BNT162b2 heterologous vaccination, despite the limited information on its reactogenicity and safety. We conducted a prospective observational post-marketing surveillance study to assess the safety of this heterologous schedule. A casually selected sample of recipients (n: 85; age: 18-60 years) of ChAdOx1-S/BNT162b2 at the vaccination hub of the Foggia Hospital, Italy, was matched with an equal sample of recipients of homologous BNT162b2. Safety was evaluated 7 days, 1 month and 14 weeks after the primary vaccination series using an adapted version of the "V-safe active surveillance for COVID-19 vaccine safety" CDC standardized questionnaire. After 7 days, local reactions were highly frequent (>80%) in both groups, and systemic reactions were less common (<70%). Moderate or severe pain at the injection site (OR = 3.62; 95%CI, 1.45-9.33), moderate/severe fatigue (OR = 3.40; 95%CI, 1.22-9.49), moderate/severe headache (OR = 4.72; 95%CI, 1.37-16.23), intake of antipyretics (OR = 3.05; 95 CI%, 1.35-6.88), inability to perform daily activities and work (OR = 2.64; 95%CI, 1.24-5.62) were significantly more common with heterologous than homologous vaccination. No significant difference in self-reported health status was recorded 1 month or 14 weeks after the second dose with BNT162b2 or ChAdOx1-S/BNT162b2. Our study confirms the safety of both heterologous and homologous vaccination, with a slight increase in some short-term adverse events for the heterologous regimen. Therefore, administering a second dose of a mRNA vaccine to the recipients of a previous dose of viral vector vaccine may have represented an advantageous strategy to improve flexibility and to accelerate the vaccination campaign.

A real-world population-based longitudinal study, aimed at determining the magnitude and duration of immunity induced by different types of vaccines against COVID-19, started in 2021 by enrolling a cohort of 2,497 individuals at time of their first vaccination. The study cohort included both healthy adults aged ≤65 years and elderly subjects aged >65 years with two or more co-morbidities. Here, patterns of anti-SARS-CoV-2 humoral and cell-mediated specific immune response, assessed on 1,182 remaining subjects, at 6 (T6) and 12 months (T12) after the first vaccine dose, are described. At T12 median anti-Spike IgG antibody levels were increased compared to T6. The determinants of increased anti-Spike IgG were the receipt of a third vaccine dose between T6 and T12 and being positive for anti-Nucleocapside IgG at T12, a marker of recent infection, while age had no significant effect. The capacity of T12 sera to neutralize in vitro the ancestral B strain and the Omicron BA.5 variant was assessed in a subgroup of vaccinated subjects. A correlation between anti-S IgG levels and sera neutralizing capacity was identified and higher neutralizing capacity was evident in healthy adults compared to frail elderly subjects and in those who were positive for anti-Nucleocapside IgG at T12. Remarkably, one third of T12 sera from anti-Nucleocapside IgG negative older individuals were unable to neutralize the BA.5 variant strain. Finally, the evaluation of T-cell mediated immunity showed that most analysed subjects, independently from age and comorbidity, displayed Spike-specific responses with a high degree of polyfunctionality, especially in the CD8 compartment. In conclusion, vaccinated subjects had high levels of circulating antibodies against SARS-CoV-2 Spike protein 12 months after the primary vaccination, which increased as compared to T6. The enhancing effect could be attributable to the administration of a third vaccine dose but also to the occurrence of breakthrough infection. Older individuals, especially those who were anti-Nucleocapside IgG negative, displayed an impaired capacity to neutralize the BA.5 variant strain. Spike specific T-cell responses, able to sustain immunity and maintain the ability to fight the infection, were present in most of older and younger subjects assayed at T12., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2023 Fedele, Schiavoni, Trentini, Leone, Olivetta, Fallucca, Fiore, Di Martino, Abrignani, Baldo, Baldovin, Bandera, Clerici, De Paschale, Diaco, Domnich, Fortunato, Giberti, Gori, Grifantini, Lazzarotto, Lodi, Mastroianni, Prato, Restivo, Vitale, Brusaferro, Merler, Palamara, Stefanelli and the Study Group for the Immunological Monitoring post Covid19 vaccination.)

Background: COVID-19 has been characterised by its global and rapid spread, with high infection, hospitalisation, and mortality rates worldwide. However, the course of the pandemic showed differences in chronology and intensity in different geographical areas and countries, probably due to a multitude of factors. Among these, socio-economic deprivation has been supposed to play a substantial role, although available evidence is not fully in agreement. Our study aimed to assess incidence and fatality rates of COVID-19 across the levels of socio-economic deprivation during the first epidemic wave (March-May 2020) in the Italian Province of Foggia, Apulia Region., Methods: Based on the data of the regional active surveillance platform, we performed a retrospective epidemiological study among all COVID-19 confirmed cases that occurred in the Apulian District of Foggia, Italy, from March 1st to May 5th, 2020. Geocoded addresses were linked to the individual Census Tract (CT) of residence. Effects of socio-economic condition were calculated by means of the Socio-Economic and Health-related Deprivation Index (SEHDI) on COVID-19 incidence and fatality., Results: Of the 1054 confirmed COVID-19 cases, 537 (50.9%) were men, 682 (64.7%) were 0-64 years old, and 338 (32.1%) had pre-existing comorbidities. COVID-19 incidence was higher in the less deprived areas (p < 0.05), independently on age. The level of socio-economic deprivation did not show a significant impact on the vital status, while a higher fatality was observed in male cases (p < 0.001), cases > 65 years (p < 0.001), cases having a connection with a nursing home (p < 0.05) or having at least 1 comorbidity (p < 0.001). On the other hand, a significant protection for healthcare workers was apparent (p < 0.001)., Conclusions: Our findings show that deprivation alone does not affect COVID-19 incidence and fatality burden, suggesting that the burden of disease is driven by a complexity of factors not yet fully understood. Better knowledge is needed to identify subgroups at higher risk and implement effective preventive strategies., (© 2023. The Author(s).)

Background: The COVID-19 pandemic and the restrictive measures associated with it placed enormous pressure on health facilities and may have caused delays in the treatment of other diseases, leading to increases in mortality compared to the expected rates. Areas with high levels of air pollution already have a high risk of death from cancer, so we aimed to evaluate the possible indirect effects of the pandemic on mortality from lung cancer compared to the pre-pandemic period in the province of Taranto, a polluted site of national interest for environmental risk in the south of Italy., Methods: We carried out a retrospective observational study on lung cancer data (ICD-10: C34) from the Registry of Mortality (ReMo) for municipalities in Taranto Province over the period of 1 January 2011 to 31 December 2021. Seasonal exponential smoothing, Holt-Winters additive, Holt-Winters multiplicative, and auto-regressive integrated moving average (ARIMA) models were used to forecast the number of deaths during the pandemic period. Data were standardized by sex and age via an indirect method and shown as monthly mortality rates (MRs), standardized mortality ratios (SMRs), and adjusted mortality rates (AMRs)., Results: In Taranto Province, 3108 deaths from lung cancer were recorded between 2011 and 2021. In the province of Taranto, almost all of the adjusted monthly mortality rates during the pandemic were within the confidence interval of the predicted rates, with the exception of significant excesses in March (+1.82, 95% CI 0.11-3.08) and August 2020 (+2.09, 95% CI 0.20-3.44). In the municipality of Taranto, the only significant excess rate was in August 2020 (+3.51, 95% CI 0.33-6.69). However, in total, in 2020 and 2021, the excess deaths from lung cancer were not significant both for the province of Taranto (+30 (95% CI -77; +106) for 2020 and +28 (95% CI -130; +133) for 2021) and for the municipality of Taranto alone (+14 (95% CI -47; +74) for 2020 and -2 (95% CI -86; +76) for 2021)., Conclusions: This study shows that there was no excess mortality from lung cancer as a result of the COVID-19 pandemic in the province of Taranto. The strategies applied by the local oncological services during the pandemic were probably effective in minimizing the possible interruption of cancer treatment. Strategies for accessing care in future health emergencies should take into account the results of continuous monitoring of disease trends.

Studies reporting vaccine effectiveness against COVID-19 outcomes concentrate mainly on estimates of one single type of vaccine and variant, seldom considering waning effects. We aimed to estimate the effectiveness of the overall COVID-19 vaccination programme implemented in the Apulia region of Italy at preventing SARS-CoV-2 infections, COVID-19-related hospital admissions and deaths during alpha and delta variant dominant periods. We conducted a retrospective cohort study using electronic health records of persons 16 years and older resident in the Apulia region, assessing the effectiveness of the combined use of BNT162b2, mRNA-1273, ChAdOx1-S and Ad26.COV2.S vaccines against confirmed COVID-19 infections, hospitalisations and deaths, for fully and partially vaccinated persons as well as by time since vaccination and variants. Cox regression models yielding hazard ratios were used to calculate the overall vaccination programme effectiveness. From 1 January to 1 December 2021, we included 3,530,967 eligible persons in the cohort, of whom 2,770,299 were fully vaccinated and 158,313 were COVID-19 positive at the end of the study period. The effectiveness of the programme over the entire study period for fully vaccinated persons against COVID-19 infection, hospitalisation and death were 87.69% (CI95% 87.73-88.18), 94.08% (93.58-94.54) and 95.95% (CI95% 95.26-96.54), respectively. The effectiveness against COVID-19 infection of fully vaccinated subjects during the alpha and delta period was respectively 88.20% (CI95% 87.60-99.78) and 59.31% (CI95% 57.91-60.67), against hospitalisation 93.89% (CI95% 92.67-94.90) and 88.32% (CI95% 86.50-89.90) and against death 93.83% (CI95% 91.65-95.45) and 85.91 (CI95% 79.98-90.09). The waning effects of the programme regarding COVID-19 infection during the delta period were stronger than for alpha, with 75.85% (CI95% 74.38-77.24) effectiveness after 1-2 months and 8.35% (CI95% 3.45-13.01) after 5-6 months after full vaccination. The effectiveness against hospitalisation and death during the delta period waned rapidly and at 7-8-months after the full vaccination respectively decreased to 27.67% (CI95% 7.48-43.45) and 48.47 (CI95% 53.97-34.82). Our study suggests that the COVID-19 vaccination program in Apulia was strongly protective against COVID-19 infection, hospitalisation, and death due to alpha as well as delta variants, although its effectiveness is reduced over time., (© 2022. The Author(s).)

To date there has been limited head-to-head evaluation of immune responses to different types of COVID-19 vaccines. A real-world population-based longitudinal study was designed with the aim to define the magnitude and duration of immunity induced by each of four different COVID-19 vaccines available in Italy at the time of this study. Overall, 2497 individuals were enrolled at time of their first vaccination (T0). Vaccine-specific antibody responses induced over time by Comirnaty, Spikevax, Vaxzevria, Janssen Ad26.COV2.S and heterologous vaccination were compared up to six months after immunization. On a subset of Comirnaty vaccinees, serology data were correlated with the ability to neutralize a reference SARS-CoV-2 B strain, as well as Delta AY.4 and Omicron BA.1. The frequency of SARS-CoV-2-specific CD4+ T cells, CD8+ T cells, and memory B cells induced by the four different vaccines was assessed six months after the immunization. We found that mRNA vaccines are stronger inducer of anti-Spike IgG and B-memory cell responses. Humoral immune responses are lower in frail elderly subjects. Neutralization of the Delta AY.4 and Omicron BA.1 variants is severely impaired, especially in older individuals. Most vaccinees display a vaccine-specific T-cell memory six months after the vaccination. By describing the immunological response during the first phase of COVID-19 vaccination campaign in different cohorts and considering several aspects of the immunological response, this study allowed to collect key information that could facilitate the implementation of effective prevention and control measures against SARS-CoV-2., Competing Interests: The authors declare that in this study the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Fedele, Trentini, Schiavoni, Abrignani, Antonelli, Baldo, Baldovin, Bandera, Bonura, Clerici, De Paschale, Fortunato, Gori, Grifantini, Icardi, Lazzarotto, Lodi, Mastroianni, Orsi, Prato, Restivo, Carsetti, Piano Mortari, Leone, Olivetta, Fiore, Di Martino, Brusaferro, Merler, Palamara and Stefanelli.)

Background and Aim: On January 9, 2020, the World Health Organization (WHO) declared that Chinese health authorities had identified a new coronavirus strain never before isolated in humans, the 2019-nCoV later redefined SARS-CoV-2, that still today represent a public health problem. The present survey started on 10 February 2020 with the aim of a) assessing the risk perception in healthcare workers and young students, following the evolution of attitudes, perception and knowledge over time, b) provide useful information to the general population during survey., Results: A study sample consisting of 4116 Italian individuals of both sexes was enrolled. High levels of risk perception, low perception of self-efficacy and low levels of knowledge scores (24.55 ± 5.76 SD) were obtained indicating the need for continuous population monitoring as well as further communication strategies carried out at institution levels., Conclusion: The results of the present study could help public health authorities in carrying out informative campaigns for general population and could be an important tool in evaluating public knowledge and misperceptions during the management of the COVID-19. (www.actabiomedica.it).

Background: From the initial stages of the pandemic in early 2020, COVID-19-related olfactory and gustatory dysfunctions have been widely reported and are emerging as one of the most frequent long-term sequelae of SARS-CoV-2 infection. However, data regarding the long-term recovery of the sense of smell and taste are lacking. This study aimed to characterize the evolution up to one year after the diagnosis of self-reported olfactory and gustatory dysfunctions in COVID-19 cases., Methods: Based on the data of the active surveillance platform of the Apulia region, Italy, we selected the residents of Foggia district who were confirmed positive for SARS-CoV-2 from March 1st to June 16th, 2020, and home-quarantined with paucisymptomatic-to-mild clinical presentation. Self-reported olfactory and gustatory dysfunctions were recorded at baseline through a survey of dichotomous questions. The evolution of these symptoms at approximately one year was prospectively assessed via telephone by the validated sino-nasal outcome test 22 (SNOT-22, Italian version)., Results: Among the 1,175 COVID-19 cases notified in the Foggia district during the first epidemic wave, 488 had paucisymptomatic-to-mild clinical presentation. Of these, 41.2% (n = 201, 95% confidence interval [CI] 36.8-45.7%) reported at least one sensory dysfunction. A total of 178 to 201 (88.5%) patients agreed to participate in the follow-up survey. According to the SNOT-22 results, the persistence of a sensory dysfunction was observed in the 29.8% (n = 53, 95% CI 23.2-37.1%) of them. Particularly, loss of smell persisted in 25.8% (n = 46, 95% CI 19.6-32.9%), loss of taste in 21.3% (n = 38, 95% CI 15.6-28.1%), loss of both in 17.4% (n = 31, 95% CI 12.2-23.8%) of participants in the follow-up. The rates of full recovery increased over time: from 59% at 30 days to 71.9% at 90 days for the sense of smell; from 61.3% at 30 days to 74.7% at 90 days for the sense of taste., Conclusions: The persistence of COVID-19-related olfactory and gustatory dysfunctions up to 12 months after the disease onset in a noteworthy proportion (approximately 3 out of 10) of patients with paucisymptomatic-to-mild clinical presentation deserves further investigations due to its possible pathophysiological implications and impact on the quality of life., (© 2022. The Author(s).)

Early in the COVID-19 pandemic, asymptomatic transmission represented an important challenge for controlling the spread of SARS-CoV-2 through the traditional public health strategies. Further understanding of the contribution of asymptomatic infections to SARS-CoV-2 transmission has been of crucial importance for pandemic control. We conducted a retrospective epidemiological study to characterize asymptomatic COVID-19 cases occurred in the Apulia region, Italy, during the first epidemic wave of COVID-19 outbreak (February 29-July 7, 2020). We analyzed data collected in a regional platform developed to manage surveillance activities, namely, investigation and follow-up of cases and contacts, contact tracing, and laboratory and clinical data collection. We included all asymptomatic cases that were laboratory-confirmed during the appropriate follow-up, defined as persons infected with SARS-CoV-2 who did not develop symptoms/clinical signs of the disease. Between February 29 and July 7, 2020, a total of 4,536 cases were diagnosed with COVID-19 among 193,757 tests performed. The group of persons with asymptomatic SARS-CoV-2 infection consisted of 903 cases; the asymptomatic proportion was 19.9% (95% CI: 18.8-21.1%); this decreased with increasing age (OR: 0.89, 95% CI: 0.83-0.96; p = 0.001), in individuals with underlying comorbidities (OR: 0.55, 95% CI: 0.41-0.73; p < 0.001), and in males (OR: 0.69, 95% CI: 0.54-0.87; p = 0.002). The median asymptomatic SARS-CoV-2 RNA positive period was 19 days (IQR: 14-31) and the cumulative proportion of persons with resolution of infection 14 days after the first positive PCR test was 74%. As the public health community is debating the question of whether asymptomatic and late spreaders could sustain virus transmission in the communities, such cases present unique opportunities to gain insight into SARS-CoV-2 adaptation to human host. This has important implications for future COVID-19 surveillance and prevention., Competing Interests: The authors declare that there is no conflict of interest regarding the publication of this paper., (Copyright © 2022 Domenico Martinelli et al.)

Objectives: The present study aimed to explore differences in COVID-19 outcomes between male and female cases in the Apulian District of Foggia, Italy., Design and Setting: We performed a retrospective epidemiological study among all COVID-19 confirmed cases that occurred in the Apulian District of Foggia from 29 February to 30 June 2020. The surveillance data from a regional registry (GIAVA-COVID) were used., Main Outcomes: The main outcome measures were the proportion of hospitalisations, virus clearance and the case fatality rate., Results: A total of 1175 cases (50.7% female; median age: 55 years) were identified among 55 131 tests performed. The proportion of hospitalisation with COVID-19 diagnosis was 45.4% in men versus 37.9% in women (p<0.01), while the average length of stay in hospitals was 31.3±14.6 days in women versus 26.8±14.4 days in men (p<0.01). The proportion of cases who achieved virus clearance was higher in women (84.2%; days to clearance: 28.0±12.1) than in men (79.3%; days to clearance: 29.4±12.9; p<0.05). Men were associated with a significantly higher risk of dying from COVID-19 than women (case fatality rate 16.1% vs 10.4%; p<0.01). The mean time, from diagnosis to death, was 14.5±14.4 days in women compared with 10.6±10.7 days in men (p<0.01). The male sex, age ≥55 years and presence of at least one underlying comorbidity significantly raised the risk of hospitalisation, persistent infection and death (p<0.05)., Conclusions: This study suggests that more attention should be paid to sex as a variable for the interpretation of COVID-19 data. Sex-disaggregated data will help clinicians to make appropriate patient-tailored medical decisions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

• We conducted a survey on vaccine shortages and stockouts in Europe in 2016–2019. • Vaccine shortages and stockouts were reported by 19 of 21 surveyed countries. • The vaccines most frequently affected were DT-containing and hepatitis B vaccines. • The most commonly reported causes were production issues and global shortage. • Vaccine shortages/stockouts had a relevant impact on vaccine services. National immunisation programmes require an adequate supply of vaccines to function properly but many countries, globally and in Europe, have reported vaccine shortages. A comprehensive view of vaccine shortages and stockouts in the EU/EEA is missing in the published literature. This study was conducted in the framework of the European Joint Action on Vaccination (EU-JAV). Twenty-eight countries, including 20 EU-JAV consortium member states and an additional 8 EU/EEA countries, were invited to participate in a survey aimed at collecting information on vaccine shortages and stock-outs experienced from 2016 to 2019, their main causes, actions taken, and other aspects of vaccine supply. Twenty-one countries completed the survey (response rate 75%), of which 19 reported at least one shortage/stock-out event. Overall, 115 events were reported, 28 of which led to a change in the national immunisation programme. The most frequently involved vaccines were DT- and dT-containing combination vaccines, hepatitis B, hepatitis A, and BCG vaccines. The median duration of shortages/stock-outs was five months (range <1 month–39 months). Interruption in supply and global shortage were the most frequently indicated causes. Only about half of countries reported having an immunization supply chain improvement plan. Similarly, only about half of countries had recommendations or procedures in place to address shortages/stockouts. The survey also identified the occurrence of shortages/stockouts of other biological products (e.g. diphtheria antitoxin in 12 countries). Public health strategies to assure a stable and adequate vaccine supply for immunization programmes require coordinated actions from all stakeholders, harmonized definitions, strengthening of reporting and monitoring systems, the presence of an immunization supply chain improvement plan in all countries, and procedures or recommendations in place regarding the use of alternative vaccines or vaccination schedules in case of shortages/stockouts. [ABSTRACT FROM AUTHOR]