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  1. Article ; Online: COVID-19 treatments approved in the European Union and clinical recommendations for the management of non-hospitalized and hospitalized patients.

    Bellino, Stefania

    Annals of medicine

    2022  Volume 54, Issue 1, Page(s) 2856–2860

    Abstract: Background: The COVID-19 pandemic caused by SARS-CoV-2 continues to have a serious impact on public health worldwide. Most patients develop mild to moderate symptoms and recover without requiring special treatment, but up to 15% develop severe (dyspnea, ...

    Abstract Background: The COVID-19 pandemic caused by SARS-CoV-2 continues to have a serious impact on public health worldwide. Most patients develop mild to moderate symptoms and recover without requiring special treatment, but up to 15% develop severe (dyspnea, hypoxia, lung involvement) or critical symptoms (respiratory failure, septic shock, thromboembolism, multiorgan dysfunction). Although vaccination is having a substantial impact on case numbers, hospitalizations and deaths, there remains a need for new effective treatments against COVID-19.
    Methods: This short review aims at reporting on current therapeutics against SARS-CoV-2 focussing on new drugs authorized in the European Union, describing the treatment strategies and the clinical recommendations for the management of hospitalized and non-hospitalized COVID-19 patients based on the available guidelines for clinical practice.
    Results: New effective drugs, like antiviral medications and monoclonal antibodies, have been developed as therapy against severe and life-threatening disease courses. Specifically, the European Medicines Agency has authorized two antiviral medicines (nirmatrelvir/ritonavir, remdesivir), supporting also early use of molnupiravir before marketing authorization, and four monoclonal antibodies (regdanvimab, casirivimab/imdevimab, sotrovimab, tixagevimab/cilgavimab). In addition, three drugs (anakinra, tocilizumab, baricitinib) previously authorized for the treatment of rheumatoid arthritis are also available to treat COVID-19.
    Conclusions: Recommendations and guidelines for clinical practice should be regularly updated as further evidence becomes available in favour or against specific interventions, to inform all stakeholders involved in the health care of COVID-19 patients both in the community and in the hospital setting, aiming at improving the quality of care and therefore the patient outcome.KEY MESSAGESCOVID-19 has been recognized as a multisystem disorder affecting many body systems; this wide spectrum of clinical patterns made difficult an appropriate choice of treatments able to counteract severe symptoms of the disease and alleviate the burden on the healthcare system.New effective drugs, like antiviral medications and monoclonal antibodies, have been developed and approved by the European Medicines Agency as therapy against severe and life-threatening disease courses.Recommendations and guidelines should be regularly updated as further evidence becomes available in favour or against specific interventions aiming at improving the quality of care and therefore the patient outcome.
    MeSH term(s) Humans ; COVID-19/drug therapy ; SARS-CoV-2 ; Pandemics ; Ritonavir ; Interleukin 1 Receptor Antagonist Protein ; European Union ; Antibodies, Monoclonal/therapeutic use ; Antiviral Agents/therapeutic use ; Hospitalization
    Chemical Substances imdevimab (2Z3DQD2JHM) ; casirivimab (J0FI6WE1QN) ; sotrovimab (1MTK0BPN8V) ; tixagevimab ; regdanvimab (I0BGE6P6I6) ; cilgavimab (1KUR4BN70F) ; Ritonavir (O3J8G9O825) ; Interleukin 1 Receptor Antagonist Protein ; Antibodies, Monoclonal ; Antiviral Agents
    Language English
    Publishing date 2022-10-19
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1004226-x
    ISSN 1365-2060 ; 1651-2219 ; 0785-3890 ; 1743-1387
    ISSN (online) 1365-2060 ; 1651-2219
    ISSN 0785-3890 ; 1743-1387
    DOI 10.1080/07853890.2022.2133162
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: COVID-19 vaccines approved in the European Union: current evidence and perspectives.

    Bellino, Stefania

    Expert review of vaccines

    2021  Volume 20, Issue 10, Page(s) 1195–1199

    MeSH term(s) COVID-19/prevention & control ; COVID-19/virology ; COVID-19 Vaccines/administration & dosage ; COVID-19 Vaccines/adverse effects ; Drug Approval/legislation & jurisprudence ; European Union ; Humans ; Immunization Programs/organization & administration ; Public Health ; SARS-CoV-2/isolation & purification
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2021-08-06
    Publishing country England
    Document type Editorial
    ZDB-ID 2181284-6
    ISSN 1744-8395 ; 1476-0584
    ISSN (online) 1744-8395
    ISSN 1476-0584
    DOI 10.1080/14760584.2021.1962304
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Quality of outcome reporting for clinical trails on medullary thyroid cancer registered on ClinicalTrials.gov.

    Fanciulli, Giuseppe / Bellino, Stefania / LA Salvia, Anna

    Minerva endocrinology

    2023  

    Language English
    Publishing date 2023-05-09
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 3062786-2
    ISSN 2724-6116
    ISSN (online) 2724-6116
    DOI 10.23736/S2724-6507.23.04034-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Cell-based medicinal products approved in the European Union: current evidence and perspectives.

    Bellino, Stefania / La Salvia, Anna / Cometa, Maria Francesca / Botta, Rosanna

    Frontiers in pharmacology

    2023  Volume 14, Page(s) 1200808

    Abstract: Advanced Therapy Medicinal Products (ATMPs) are innovative clinical treatments exploiting the pharmacological, immunological, or metabolic properties of cells and/or gene(s) with the aim to restore, correct, or modify a biological function in the ... ...

    Abstract Advanced Therapy Medicinal Products (ATMPs) are innovative clinical treatments exploiting the pharmacological, immunological, or metabolic properties of cells and/or gene(s) with the aim to restore, correct, or modify a biological function in the recipient. ATMPs are heterogeneous medicinal products, developed mainly as individualized and patient-specific treatments, and represent new opportunities for diseases characterized by a high-unmet medical need, including rare, genetic and neurodegenerative disorders, haematological malignancies, cancer, autoimmune, inflammatory and orthopaedic conditions. Into the European Union (EU) market, the first ATMP has been launched in 2009 and, to date, a total of 24 ATMPs have been approved. This review aims at reporting on current evidence of cell-based therapies authorized in the EU, including Somatic Cell Therapies, Tissue Engineering Products, and Cell-based Gene Therapy Products as Chimeric Antigen Receptor (CAR) T-cells, focusing on the evaluation of efficacy and safety in clinical trials and real-world settings. Despite cell-based therapy representing a substantial promise for patients with very limited treatment options, some limitations for its widespread use in the clinical setting remain, including restricted indications, highly complex manufacturing processes, elevated production costs, the lability of cellular products over time, and the potential safety concerns related to the intrinsic characteristics of living cells, including the risk of severe or life-threatening toxicities, such as CAR-T induced neurotoxicity and cytokine release syndrome (CRS). Although encouraging findings support the clinical use of ATMPs, additional data, comparative studies with a long-term follow-up, and wider real-world evidences are needed to provide further insights into their efficacy and safety profiles.
    Language English
    Publishing date 2023-07-31
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2023.1200808
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: The influence of meteorological factors on COVID-19 spread in Italy during the first and second wave

    Balboni, Erica / Filippini, Tommaso / Rothman, Kenneth J. / Costanzini, Sofia / Bellino, Stefania / Pezzotti, Patrizio / Brusaferro, Silvio / Ferrari, Fabrizio / Orsini, Nicola / Teggi, Sergio / Vinceti, Marco

    Environmental Research. 2023 July, v. 228 p.115796-

    2023  

    Abstract: The relation between meteorological factors and COVID-19 spread remains uncertain, particularly with regard to the role of temperature, relative humidity and solar ultraviolet (UV) radiation. To assess this relation, we investigated disease spread within ...

    Abstract The relation between meteorological factors and COVID-19 spread remains uncertain, particularly with regard to the role of temperature, relative humidity and solar ultraviolet (UV) radiation. To assess this relation, we investigated disease spread within Italy during 2020. The pandemic had a large and early impact in Italy, and during 2020 the effects of vaccination and viral variants had not yet complicated the dynamics. We used non-linear, spline-based Poisson regression of modeled temperature, UV and relative humidity, adjusting for mobility patterns and additional confounders, to estimate daily rates of COVID-19 new cases, hospital and intensive care unit admissions, and deaths during the two waves of the pandemic in Italy during 2020. We found little association between relative humidity and COVID-19 endpoints in both waves, whereas UV radiation above 40 kJ/m² showed a weak inverse association with hospital and ICU admissions in the first wave, and a stronger relation with all COVID-19 endpoints in the second wave. Temperature above 283 K (10 °C/50 °F) showed a strong non-linear negative relation with COVID-19 endpoints, with inconsistent relations below this cutpoint in the two waves. Given the biological plausibility of a relation between temperature and COVID-19, these data add support to the proposition that temperature above 283 K, and possibly high levels of solar UV radiation, reduced COVID-19 spread.
    Keywords COVID-19 infection ; hospitals ; pandemic ; relative humidity ; research ; temperature ; ultraviolet radiation ; vaccination ; Italy ; COVID-19 ; Humidity ; Meteorological factors
    Language English
    Dates of publication 2023-07
    Publishing place Elsevier Inc.
    Document type Article ; Online
    ZDB-ID 205699-9
    ISSN 1096-0953 ; 0013-9351
    ISSN (online) 1096-0953
    ISSN 0013-9351
    DOI 10.1016/j.envres.2023.115796
    Database NAL-Catalogue (AGRICOLA)

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  6. Article ; Online: Substantial impact of mobility restrictions on reducing COVID-19 incidence in Italy in 2020.

    Vinceti, Marco / Balboni, Erica / Rothman, Kenneth J / Teggi, Sergio / Bellino, Stefania / Pezzotti, Patrizio / Ferrari, Fabrizio / Orsini, Nicola / Filippini, Tommaso

    Journal of travel medicine

    2022  Volume 29, Issue 6

    Abstract: Background: Italy was the first country after China to be severely affected by the COVID-19 pandemic, in early 2020. The country responded swiftly to the outbreak with a nationwide two-step lockdown, the first one light and the second one tight. By ... ...

    Abstract Background: Italy was the first country after China to be severely affected by the COVID-19 pandemic, in early 2020. The country responded swiftly to the outbreak with a nationwide two-step lockdown, the first one light and the second one tight. By analyzing 2020 national mobile phone movements, we assessed how lockdown compliance influenced its efficacy.
    Methods: We measured individual mobility during the first epidemic wave with mobile phone movements tracked through carrier networks, and related this mobility to daily new SARS-CoV-2 infections, hospital admissions, intensive care admissions and deaths attributed to COVID-19, taking into account reason for travel (work-related or not) and the means of transport.
    Results: The tight lockdown resulted in an 82% reduction in mobility for the entire country and was effective in swiftly curbing the outbreak as indicated by a shorter time-to-peak of all health outcomes, particularly for provinces with the highest mobility reductions and the most intense COVID-19 spread. Reduction of work-related mobility was accompanied by a nearly linear benefit in outbreak containment; work-unrelated movements had a similar effect only for restrictions exceeding 50%. Reduction in mobility by car and by airplane was nearly linearly associated with a decrease in most COVID-19 health outcomes, while for train travel reductions exceeding 55% had no additional beneficial effects. The absence of viral variants and vaccine availability during the study period eliminated confounding from these two sources.
    Conclusions: Adherence to the COVID-19 tight lockdown during the first wave in Italy was high and effective in curtailing the outbreak. Any work-related mobility reduction was effective, but only high reductions in work-unrelated mobility restrictions were effective. For train travel, there was a threshold above which no further benefit occurred. These findings could be particular to the spread of SARS-CoV-2, but might also apply to other communicable infections with comparable transmission dynamics.
    MeSH term(s) COVID-19/epidemiology ; COVID-19/prevention & control ; Communicable Disease Control/methods ; Humans ; Incidence ; Italy/epidemiology ; Pandemics/prevention & control ; SARS-CoV-2
    Language English
    Publishing date 2022-07-23
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1212504-0
    ISSN 1708-8305 ; 1195-1982
    ISSN (online) 1708-8305
    ISSN 1195-1982
    DOI 10.1093/jtm/taac081
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: The influence of meteorological factors on COVID-19 spread in Italy during the first and second wave.

    Balboni, Erica / Filippini, Tommaso / Rothman, Kenneth J / Costanzini, Sofia / Bellino, Stefania / Pezzotti, Patrizio / Brusaferro, Silvio / Ferrari, Fabrizio / Orsini, Nicola / Teggi, Sergio / Vinceti, Marco

    Environmental research

    2023  Volume 228, Page(s) 115796

    Abstract: The relation between meteorological factors and COVID-19 spread remains uncertain, particularly with regard to the role of temperature, relative humidity and solar ultraviolet (UV) radiation. To assess this relation, we investigated disease spread within ...

    Abstract The relation between meteorological factors and COVID-19 spread remains uncertain, particularly with regard to the role of temperature, relative humidity and solar ultraviolet (UV) radiation. To assess this relation, we investigated disease spread within Italy during 2020. The pandemic had a large and early impact in Italy, and during 2020 the effects of vaccination and viral variants had not yet complicated the dynamics. We used non-linear, spline-based Poisson regression of modeled temperature, UV and relative humidity, adjusting for mobility patterns and additional confounders, to estimate daily rates of COVID-19 new cases, hospital and intensive care unit admissions, and deaths during the two waves of the pandemic in Italy during 2020. We found little association between relative humidity and COVID-19 endpoints in both waves, whereas UV radiation above 40 kJ/m
    MeSH term(s) Humans ; COVID-19/epidemiology ; SARS-CoV-2 ; Temperature ; Italy/epidemiology ; Meteorological Concepts ; Humidity
    Language English
    Publishing date 2023-04-03
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 205699-9
    ISSN 1096-0953 ; 0013-9351
    ISSN (online) 1096-0953
    ISSN 0013-9351
    DOI 10.1016/j.envres.2023.115796
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Hospital discharges-based search of acute flaccid paralysis cases 2007-2016 in Italy and comparison with the National Surveillance System for monitoring the risk of polio reintroduction.

    Stefanelli, Paola / Bellino, Stefania / Fiore, Stefano / Fontana, Stefano / Amato, Concetta / Buttinelli, Gabriele

    BMC public health

    2019  Volume 19, Issue 1, Page(s) 1532

    Abstract: Background: Acute flaccid paralysis (AFP) surveillance has been adopted globally as a key strategy for monitoring the progress of the polio eradication initiative. Hereby, to evaluate the completeness of the ascertainment of AFP cases in Italy, a ... ...

    Abstract Background: Acute flaccid paralysis (AFP) surveillance has been adopted globally as a key strategy for monitoring the progress of the polio eradication initiative. Hereby, to evaluate the completeness of the ascertainment of AFP cases in Italy, a hospital-discharges based search was carried out.
    Methods: AFP cases occurring between 2007 and 2016 among children under 15 years of age were searched in the Italian Hospital Discharge Records (HDR) database using specific ICD-9-CM diagnostic codes. AFP cases identified between 2015 and 2016 were then compared with those notified to the National Surveillance System (NSS).
    Results: Over a 10-year period, 4163 hospital discharges with diagnosis of AFP were reported in Italy. Among these, 956 (23.0%) were acute infective polyneuritis, 1803 (43.3%) myopathy, and 1408 (33.8%) encephalitis, myelitis and encephalomyelitis. During the study period, a decreasing trend was observed for all diagnoses and overall the annual incidence rate (IR) declined from 5.5 to 4.5 per 100,000 children. Comparing NSS with HDR data in 2015-2016, we found a remarkable underreporting, being AFP cases from NSS only 14% of those recorded in HDR. In particular, the acute infective polyneuritis cases reported to NSS accounted for 42.6% of those detected in HDR, while only 0.9% of myopathy cases and 13.1% of encephalitis/myelitis/encephalomyelitis cases have been notified to NSS. The highest AFP IRs per 100,000 children calculated on HDR data were identified in Liguria (17.4), Sicily (5.7), and Veneto (5.1) Regions; regarding the AFP notified to the NSS, 11 out of 21 Regions failed to reach the number of expected cases (based on 1/100,000 rate), and the highest discrepancies were observed in the Northern Regions. Overall, the national AFP rate was equal to 0.6, therefore did not reach the target value.
    Conclusions: AFP surveillance data are the final measure of a country's progress towards polio eradication. The historical data obtained by the HDR have been useful to assess the completeness of the notification data and to identify the Regions with a low AFP ascertainment rate in order to improve the national surveillance system.
    MeSH term(s) Adolescent ; Child ; Child, Preschool ; Female ; Hospital Records ; Humans ; Infant ; Italy/epidemiology ; Male ; Paralysis/epidemiology ; Paralysis/virology ; Patient Discharge/statistics & numerical data ; Poliomyelitis/complications ; Poliomyelitis/epidemiology ; Population Surveillance
    Language English
    Publishing date 2019-11-15
    Publishing country England
    Document type Journal Article
    ISSN 1471-2458
    ISSN (online) 1471-2458
    DOI 10.1186/s12889-019-7617-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Determinants of vaccination uptake, and influenza vaccine effectiveness in preventing deaths and hospital admissions in the elderly population; Treviso, Italy, 2014/2015-2016/2017 seasons.

    Bellino, Stefania / Piovesan, Cinzia / Bella, Antonino / Rizzo, Caterina / Pezzotti, Patrizio / Ramigni, Mauro

    Human vaccines & immunotherapeutics

    2019  Volume 16, Issue 2, Page(s) 301–312

    Abstract: Seasonal influenza is an important cause of morbidity and mortality, particularly among the elderly population. Determinants of vaccination uptake and its impact on health outcomes in the seasons 2014/2015-2016/2017 in elderly living in Treviso area ( ... ...

    Abstract Seasonal influenza is an important cause of morbidity and mortality, particularly among the elderly population. Determinants of vaccination uptake and its impact on health outcomes in the seasons 2014/2015-2016/2017 in elderly living in Treviso area (Veneto Region, North-Eastern Italy) were evaluated. A retrospective cohort study was conducted combining information from several health administrative databases, and multiple Poisson regression models were applied to evaluate the influenza vaccine effectiveness, also adjusting for confounding factors. MF59-adjuvanted trivalent-inactivated vaccine was mainly administered. Data from more than 83,000 elderly people were analyzed by year. Vaccine coverage was about 50%; influenza vaccination uptake was independently associated with older age, male sex, increasing number of underlying chronic conditions, previous pneumococcal vaccination, annual expenses for specialist medical cares, and general practitioner to whom the elderly was in charge. After adjusting for previously described characteristics, vaccination was associated with lower mortality and influenza-related hospitalization rates. Specifically, during influenza season the adjusted incidence rate ratio of death and of influenza-related hospitalizations for vaccinated compared to unvaccinated persons was 0.63 [95% confidence interval (CI) 0.58-0.69,
    MeSH term(s) Aged ; Aged, 80 and over ; Female ; Hospitalization ; Hospitals ; Humans ; Influenza Vaccines ; Influenza, Human/epidemiology ; Influenza, Human/prevention & control ; Italy/epidemiology ; Male ; Retrospective Studies ; Seasons ; Vaccination
    Chemical Substances Influenza Vaccines
    Language English
    Publishing date 2019-10-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2664176-8
    ISSN 2164-554X ; 2164-5515
    ISSN (online) 2164-554X
    ISSN 2164-5515
    DOI 10.1080/21645515.2019.1661754
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Brand-specific estimates of influenza vaccine effectiveness for the 2021-2022 season in Europe: results from the DRIVE multi-stakeholder study platform.

    Stuurman, Anke L / Carmona, Antonio / Biccler, Jorne / Descamps, Alexandre / Levi, Miriam / Baum, Ulrike / Mira-Iglesias, Ainara / Bellino, Stefania / Hoang, Uy / de Lusignan, Simon / Bonaiuti, Roberto / Lina, Bruno / Rizzo, Caterina / Nohynek, Hanna / Díez-Domingo, Javier

    Frontiers in public health

    2023  Volume 11, Page(s) 1195409

    Abstract: Introduction: Development of Robust and Innovative Vaccine Effectiveness (DRIVE) was a European public-private partnership (PPP) that aimed to provide annual, brand-specific estimates of influenza vaccine effectiveness (IVE) for regulatory and public ... ...

    Abstract Introduction: Development of Robust and Innovative Vaccine Effectiveness (DRIVE) was a European public-private partnership (PPP) that aimed to provide annual, brand-specific estimates of influenza vaccine effectiveness (IVE) for regulatory and public health purposes. DRIVE was launched in 2017 under the umbrella of the Innovative Medicines Initiative (IMI) and conducted IVE studies from its pilot season in 2017-2018 to its final season in 2021-2022.
    Methods: In 2021-2022, DRIVE conducted four primary care-based test-negative design (TND) studies (Austria, Italy, Iceland, and England; involving >1,000 general practitioners), nine hospital-based TND studies (France, Iceland, Italy, Romania, and Spain, for a total of 21 hospitals), and one population-based cohort study in Finland. In the TND studies, patients with influenza-like illness (primary care) or severe acute respiratory infection (hospital) were enrolled, and laboratory tested for influenza using RT-PCR. Study contributor-specific IVE was calculated using logistic regression, adjusting for age, sex, and calendar time, and pooled by meta-analysis.
    Results: In 2021-2022, pooled confounder-adjusted influenza vaccine effectiveness (IVE) estimates against laboratory-confirmed influenza (LCI) overall and per type and subtype/lineage was produced, albeit with wide confidence intervals (CI). The limited circulation of influenza in Europe did not allow the network to reach the optimal sample size to produce precise IVE estimates for all the brands included. The most significant IVE estimates were 76% (95% CI 23%-93%) for any vaccine and 81% (22%-95%) for Vaxigrip Tetra in adults ≥65 years old and 64% (25%-83%) for Fluenz Tetra in children (TND primary care setting), 85% (12%-97%) for any vaccine in adults 18-64 years (TND hospital setting), and 38% (1%-62%) in children 6 months-6 years (population-based cohort, mixed setting).
    Discussion: Over five seasons, DRIVE collected data on >35,000 patients, more than 60 variables, and 13 influenza vaccines. DRIVE demonstrated that estimating brand-specific IVE across Europe is possible, but achieving sufficient sample size to obtain precise estimates for all relevant stratifications remains a challenge. Finally, DRIVE's network of study contributors and lessons learned have greatly contributed to the development of the COVID-19 vaccine effectiveness platform COVIDRIVE.
    MeSH term(s) Adult ; Aged ; Child ; Humans ; Cohort Studies ; COVID-19 ; COVID-19 Vaccines ; Europe/epidemiology ; Influenza Vaccines ; Influenza, Human/epidemiology ; Influenza, Human/prevention & control ; Seasons ; Vaccine Efficacy ; Male ; Female ; Adolescent ; Young Adult ; Middle Aged
    Chemical Substances COVID-19 Vaccines ; Influenza Vaccines
    Language English
    Publishing date 2023-07-20
    Publishing country Switzerland
    Document type Meta-Analysis ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2711781-9
    ISSN 2296-2565 ; 2296-2565
    ISSN (online) 2296-2565
    ISSN 2296-2565
    DOI 10.3389/fpubh.2023.1195409
    Database MEDical Literature Analysis and Retrieval System OnLINE

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