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1. Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Author

Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P. W., Bucsa C., Osman A., Liddiard M., Maques F. B., Petrelli G., Sonderlichova S., Thurin N. H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L. A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P. M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M. P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Mastropasqua D., Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P.W., Bucsa C., Osman A., Liddiard M., Maques F.B., Petrelli G., Sonderlichova S., Thurin N.H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L.A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P.M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M.P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., and Mastropasqua D.

Subjects
COVID-19 Vaccines, safety, Surveillance Systems, Pivotal Clinical Trials
Abstract

Background and Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. Results: The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years; n = 250 and adolescents aged 12–17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. Conclusions: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Published
2023

2. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety

Author

Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P. M., Fantini M. P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P.M., Fantini M.P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Luxi, N., Giovanazzi, A., Capuano, A., Crisafulli, S., Cutroneo, P. M., Fantini, M. P., Ferrajolo, C., Moretti, U., Poluzzi, E., Raschi, E., Ravaldi, C., Reno, C., Tuccori, M., Vannacci, A., Zanoni, G., Trifiro, G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., and Montresor V.

Subjects
Allergy, IMPACT, COVID-19 Vaccine, Breastfeeding, Review Article, Toxicology, Settore MED/42 - Igiene Generale E Applicata, CLINICAL CHARACTERISTICS, Pregnancy, Pharmacology (medical), Pregnancy Complications, Infectious, Child, OUTCOMES, education.field_of_study, CANCER, Vaccination, Europe, CORONAVIRUS DISEASE 2019, CLINICAL CHARACTERISTICS, CANCER, RECIPIENTS, SEVERITY, OUTCOMES, IMPACT, RATES, Breast Feeding, Child, Preschool, Practice Guidelines as Topic, Female, 2019-nCoV Vaccine mRNA-1273, Human, Adult, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, BNT162 Vaccine, COVID-19, ChAdOx1 nCoV-19, Humans, Infant, SARS-CoV-2, Hypersensitivity, Immunocompromised Host, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Population, MEDLINE, CORONAVIRUS DISEASE 2019, medicine, RATES, education, Pharmacology, business.industry, medicine.disease, Vaccine efficacy, RECIPIENTS, SEVERITY, Family medicine, Pregnancy Complications, Infectiou, business
Abstract

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit–risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01131-6.

Published
2021

10. Duration of the calcium signal in the mitogenic stimulation of thymocytes

Author

Hesketh, T R, Bavetta, S, Smith, G A, and Metcalfe, J C

Abstract

An increase in the free cytoplasmic Ca2+ concentration in thymocytes can be detected by the fluorescent indicator quin 2 within a few seconds of the addition of concanavalin A and the response is quantified from the increased proportion of quin 2 in the cells chelated by Ca2+ (‘% Ca-quin 2’). The % Ca-quin 2 in untreated cells is 53 +/- 6%, increases to 64 +/- 7% immediately after the addition of concanavalin A and declines spontaneously over 24 h back to the level in untreated cells (53 +/- 6%). The increase in % Ca-quin 2 in response to concanavalin A is completely blocked when 50 mM-alpha-methyl D-mannoside is added before concanavalin A and completely reversed when the competing sugar is added immediately after the mitogen. Addition of alpha-methyl D-mannoside at increasing intervals after concanavalin A addition causes a progressively smaller decrease in % Ca-quin 2 and has a negligible effect after 24 h, when the % Ca-quin 2 is the same as that in untreated cells. The decline in the calcium signal defined by these experiments has a similar time course to cap formation by concanavalin A on the cells. It is concluded that the calcium signal lasts only while concanavalin A is bound to the cell surface and is terminated either by capping or by the addition of alpha-methyl D-mannoside.

Published
1983
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11. Chemical stability of tramadol hydrochloride injection admixed with selected pain drugs

Author

S. Bavetta, V. Di Stefano, Rosa Pitonzo, Piera Polidori, M.G. Sidoti, Di Stefano, V, Pitonzo, R, BAVETTA, S, POLIDORI, P, and SIDOTI, MG

Subjects
Metoclopramide, Admixture, analgesia, ketorolac tromethamine, magnesium sulfate, metoclopramide hydrochloride, stability, Chemistry, Magnesium, Short Communication, Analgesic, chemistry.chemical_element, analgesia, General Medicine, Admixture, Metoclopramide Hydrochloride, stability, Ketorolac Tromethamine, Settore CHIM/08 - Chimica Farmaceutica, Ketorolac, metoclopramide hydrochloride, magnesium sulfate, ketorolac tromethamine, Anesthesia, medicine, Tramadol Hydrochloride, Tramadol, medicine.drug
Abstract

Background: Tramadol hydrochloride (HCl) and ketorolac tromethamine are analgesic drugs, which are commonly used in combination in postoperative pain management. According to some studies, metoclopramide and magnesium sulfate (MgSO4 ) as adjuvant agents can improve analgesia and decrease the need for other pain drugs. Materials and Methods: The chemical stability of tramadol HCl combined with ketorolac tromethamine and metoclopramide HCl has been studied using a stability-indicating high-performance liquid chromatographic assay method. Calibration curves were produced using linear regression of the peak area against concentration of each drug, with an r 2 value ≥ 0.96. Our aim was to investigate the stability of admixture solution of tramadol HCl combined with ketorolac tromethamine and metoclopramide HCl for 48 h (25°C) and 5 days (5°C), with MgSO4 , which has never been assessed. Results: Data obtained for admixtures prepared and stored at temperatures of 25°C and 5°C, show that all drugs have reached at least 98% of the initial concentration. Conclusions: For the purpose of pre-preparing drug admixtures to use with confidence, tramadol HCl infusions may be prepared in advance and then thawed before use in clinical units. On the basis of our results, the intravenous mixture of tramadol (7.69 mg/mL), metoclopramide (0.19 mg/mL), ketorolac (1.15 mg/mL), and magnesium sulfate (77 mg/mL) may be considered for a possible commercial formulation.

Published
2011

12. Measuring autonomy freedom

Author

Sebastiano Bavetta, Vitorocco Peragine, BAVETTA, S, and PERAGINE, V

Subjects
Freedom, Economics and Econometrics, Computer science, media_common.quotation_subject, Freedom of choice, Decision maker, republicanism, International political economy, Social psychology, Mathematical economics, Social Sciences (miscellaneous), Axiom, Autonomy, Philip Pettit, Public finance, Intuition, media_common
Abstract

In the measurement of autonomy freedom, the admissible potential preference relations are elicited by means of the concept of ‘reasonableness’. In this paper we argue for an alternative criterion based on information about the decision maker’s ‘awareness’ of his available opportunities. We argue that such an inter- pretation of autonomy fares better than that based on reasonableness. We then introduce some axioms that capture this intuition and study their logical impli- cations. In the process, a new measure of autonomy freedom is characterized, which generalizes some of the measures so far constructed in the literature.

Published
2006
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13. Measuring freedom of choice: An alternative view of a recent literature

Author

Sebastiano Bavetta and BAVETTA S

Subjects
Economics and Econometrics, Public economics, PREFERENCE, Freedom of choice, OPPORTUNITY, Positive liberty, Ranking, International political economy, Sociology, Positive economics, Social choice theory, Social Sciences (miscellaneous), Axiom, Social policy, Public finance
Abstract

A recent literature has emerged in social choice theory which attributes intrinsic importance to freedom in the evaluation of states of affairs. The literature’s philosophical basis lies in Berlin’s notion of positive liberty. Accordingly, axiomatic measures of availability of choices are developed and the information they convey used for ranking states on the basis of the extent of liberty they offer to individuals. This paper argues that the literature’s contributions have taken Berlin’s analytical framework for granted exceedingly narrowing the philosophical terms of the debate. It is shown that, once freedom is analyzed from the perspective of an alternative structure, the triadic syntax of MacCallum, new normative content can be given to the literature and a more appropriate role can also be provided for its philosophical dimension. In particular, a correspondence between measures and conceptions of liberty is established on the basis of MacCallum’s framework and two conclusions are defended. The first is that the literature is concerned with the measurement of liberty, despite some contrary claims. The second that at least three alternative interpretations of freedom can be envisaged by the analysis of the literature’s contributions. Some brief, final considerations about the appropriateness of the liter- ature’s treatment of freedom are also made.

Published
2004
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14. L'eredità politica di Margaret Thatcher e la costruzione della società aperta

Author

BAVETTA, Sebastiano and Bavetta, S

Subjects
Settore SECS-P/01 - Economia Politica, Politica economica, Margaret Thatcher, liberalismo, società aperta
Abstract

The paper offers a prospective interpretation of Margaret Thatcher’s political legacy and offers some observations about the chances for a reproduction of her pro-freedom policies in the current historical circumstances. In so doing, the paper discusses the political relevance of classical liberalism and suggests that, if we want to increase individual freedoms and affirm the open society, we must change the “book of prescriptions” currently used by classical liberals.

Published
2014

15. Therapeutic Effectiveness of Nutrition Therapy in Pediatric Patients with Chronic Liver Diseases Awaiting Liver Transplantation

Author

M. La Guardia, Danila Di Majo, Marco Giammanco, S. Bavetta, R. Greco, Giammanco, M, Bavetta, S, Greco, R, Di Majo, D, and La Guardia, M

Subjects
medicine.medical_specialty, Calorie, business.industry, medicine.medical_treatment, Immunosuppression, Transplant Waiting List, Liver transplantation, medicine.disease, Settore BIO/09 - Fisiologia, nutrition therapy, pediatric patients, liver transplantation, Surgery, Transplantation, Malnutrition, Internal medicine, medicine, Population study, Medical nutrition therapy, business
Abstract

It is important to prevent protein/calorie malnutrition in children with end stage liver diseases prior to transplantation. This study involved 34 patients between the ages of 10 and 156 months (mean value 25.69 months ± 32.2) (13 females and 21 males) on the liver transplant waiting list. Data collected as of three months before transplant and up to ten months after the procedure concerned gender, age, weight, height, Pediatric End Stage Liver Disease Score, baseline pathology, type of nutrition, type of transplant, immunosuppression, pulse steroid therapy, length of stay, and post transplant complications. Linear regression analysis showed that the length of hospital stay was 24.5 days more for females than for males, but also that intensive nutrition therapy shortens this stay for both female patients (P = 0.085) and younger patients (P = 0.023). The study population was divided into two groups according to the different nutritional therapies adopted. The Student’s t-test and Mann-Whitney test evidenced that the group receiving intensive nutrition therapy grew taller compared with the group following an oral diet (mean -1.37 and Prob = 0.043); that females grew taller compared to males (mean -1.65 +/- 0.56); and that there was an increase in height among the children in the group receiving intensive nutrition therapy despite the presence (-1.37 +/- 0.56) or absence (-14.8 +/- 5.44 and Prob = 0.035) of complications, and despite the administration (-1.03 +/- 0.33) or non administration (-1.48 +/- 0.55 and Prob = 0.019) of steroids. Intensive nutrition therapy enhances the velocity of growth in height and shortens the length of hospital stay, thus optimizing the final prognosis of the baseline pathology.

Published
2013
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16. Microbiological Analysis Conducted on Raw Milk Collected During Official Sampling in Liguria (North-West Italy) over a Ten-Year Period (2014-2023).

Author

Chiarlone SA, Gori A, Ravetta S, Armani A, Guardone L, Pedonese F, Bavetta S, Fiannacca C, Pussini N, Maurella C, and Razzuoli E

Abstract

Milk has been consumed by humans for thousands of years for its nutritional properties. In recent years, raw milk demand has increased, valued for its authenticity and connection to local traditions. In Italy, the sale of raw milk is allowed exclusively through direct sale from the producing farm to the final consumer, either at the producing farm itself or through vending machines. However, the consumption of raw milk is not without risks. Among these, microbiological ones are relevant. These can lead to severe symptoms, particularly in vulnerable populations. For this reason, although consumers are advised to boil raw milk before consumption, producing farms in Italy are required to meet the microbiological criteria outlined in the Provision of 25 January 2007. In this retrospective study, the results of the analyses performed on 355 raw milk samples collected in Liguria between 2014 and 2023 for the detection of Campylobacter spp., Salmonella spp., Listeria monocytogenes , Staphylococcus aureus , and Escherichia coli O157 were analysed to better characterise the associated risk for consumers. The samples were collected during official controls by the local veterinary health services at vending machines of seven producing farms. Overall, six samples tested positive for C. jejuni , while only one sample tested positive for Salmonella enterica subsp. enterica , Serovar Veneziana. Listeria monocytogenes , S. aureus , and E. coli O157 were never responsible for non-compliances. Interestingly, three of the six samples positive for C. jejuni derived from the same producer. In farms where positive samples were detected, certain structural and/or operational non-compliances were identified. It can be concluded that, although the scenario in question does not present any cause for concern, it is nevertheless essential to implement a series of preventive measures in order to guarantee the safety of raw milk. These measures include the implementation of biosecurity practices, the maintenance of strict hygiene protocols during milking, and the adherence to the cold chain distribution protocol until the final stage of distribution.

Published
2025
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17. Cardiac tamponade and heart failure secondary to ventriculo-pleural shunt malfunction: a rare presentation.

Author

Zaman M, Akram H, Haliasos N, and Bavetta S

Subjects
Adult, Humans, Male, Pleura surgery, Cardiac Tamponade etiology, Cerebrospinal Fluid Shunts adverse effects, Heart Failure etiology
Abstract

We report an unusual case of a patient with a ventriculo-pleural shunt presenting with signs and symptoms of heart failure due to massive pericardial effusion. Imaging revealed the distal shunt catheter end within the middle mediastinum to have migrated from the pleural space. The patient underwent a shunt revision procedure resulting in complete resolution of the presenting pathology. We intend to draw the reader's attention to this rare presentation of ventriculo-pleural shunt malfunction.

Published
2011
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