Search

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.

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.

Il mondo occidentale e' percorso da due grandi generi di conflitto: il primo riguarda la sfera dei valori, il secondo quella degli interessi. Si tratta di conflitti che il liberalismo ha difficolta' ad affrontare, nonostante esso veda nella competizione di idee e nella concorrenza di interessi le forze motrici del progresso. Oggi, infatti, queste aspre tensioni coinvolgono le stesse regole della democrazia liberale. Ne sono sovente drammatico esempio le societa' multiculturali, la ricerca scientifica e i processi di globalizzazione. Gli Autori, introducendo una sfera della politica non necessariamente statuale, disegnano una forma di liberalismo conservatore che a una societa' nutrita di un saldo spirito civico affianca uno Stato il cui compito, oltre alla difesa dei diritti di proprieta', e' garantire ai cittadini la possibilita' di risolvere con maggiore autonomia i conflitti.

In this essay we ground the theoretical foundations of an empirical measure of the degree of freedom perceived by individuals on the Millian view of affirmation and development of individuality. We then discuss the implications of such a measure for policy and institutional design

Watershed infarction has previously been described after cerebral trauma, when it is due to raised intracranial pressure or systemic hypotension. A case is reported, so far as is known for the first time, of bilateral watershed infarction following blunt systemic trauma, without injury to the head or neck. The importance of resuscitation in preventing secondary brain injury caused by systemic hypotension is highlighted. The advantages of HMPAO-SPET in detecting cerebral perfusion defects are discussed.

Despite recent empirical evidence on the importance of perceived inequality, its analysis is still underexplored. In this paper we study whether unobserved perceptions of inequality are reflected in observed individual opinions in a consistent fashion. Inconsistency is relevant to ealuate the level of agreement that individuals share with respect to different domains of inequality. Using the wave from the 2009 International Social Survey Program in the US, we show that inequality is a complicated concept prone to inconsistencies and propose a testing procedure to an empirical appraisal. We find that inconsistencies exist though they may not extend to all the domains of inequality. This inconsistency also emerges by analyzing the relation between unobserved perceptions and political treatment suggesting the hypothesis that inconsistency may be associated with a set of relevant political preferences.

This paper analyses the role of peaceful and violent protest in the democratization process. We interpret the democratization process as a sequence of phases so as to allow citizens' and elites' preferences for democracy to vary according to the particular phase that a country is experiencing. By doing so we jointly model the probability of protest and of moving through different phases of democracy taking into account time-constant and time-varying unobserved heterogeneity. In particular, we develop a multivariate finite mixture model that introduces a latent variable to capture unobservable factors. On a sample of 171 countries from 1971 to 2010, we provide evidence that protest matters in all phases of democratization, especially peaceful citizens’ demonstrations. On the contrary, violent protest has ambiguous consequences, as it favours initial democratic transitions but at the cost of threatening democratic consolidation. We also find that, after conditioning for economic and institutional controls, there is evidence of time-varying unobserved heterogeneity.

A substantial literature finds that freedom in the sense of an expanded opportunity set is positively related to happiness. A contrasting literature, however, finds that an excess of choice can have socially undesirable outcomes. We test the effect of two types of freedom—autonomy and political—on happiness using five waves of World Values Survey data (1981–2008). We find evidence supporting the claim that equipping people with the tools to direct the course of their lives (i.e. increasing autonomy freedom) incentivizes the desire to investigate alternatives (e.g. political parties) before making a decision. The effect of freedoms on happiness is diminished in contexts where individuals have less experience with evaluating alternatives, such as in authoritarian or transitional countries.

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.

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.

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.

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.

La crisi che l’Italia attraversa ha radici nell’ingombrante estensione dello stato e conseguenze sulla dimensione economica, politica e morale della vita sociale del paese. Per rimettere l’Italia in un sentiero virtuoso in cui la prosperità, materiale e immateriale, torni a crescere occorre ripartire dalla libertà. Non solo la libertà da uno stato invadente, come prescrive il liberalismo classico. Occorre un’assunzione morale di responsabilità da parte di tutti gli italiani attraverso l’affermazione della propria autonomia personale. Il libro descrive e misura empiricamente la libertà come autonomia e ne illustra gli effetti sulla vita economica, politica ed etica del paese. Emerge un percorso innovativo per riformare in senso liberale l’Italia, in cui la libertà è strumento – e non solo fine – della politica economica. Un percorso che, mostrando i vantaggi della libertà, vede nell’affermazione dell’autonomia e nella costruzione di una società aperta la migliore opportunità per il paese di uscire dalla crisi in cui si dibatte.

What is freedom? Can we measure it? Does it affect policy? This book develops an original measure of freedom called 'Autonomy Freedom', consistent with J. S. Mill's view of autonomy, and applies it to issues in policy and political design. The work pursues three aims. First, it extends classical liberalism beyond exclusive reliance on negative freedom so as to take autonomous behavior explicitly into account. Second, it grounds on firm conceptual foundations a new standard in the measurement of freedom that can be fruitfully coupled with existing gauges. Third, it shows empirically that individual preferences for redistribution and cross-country differences in welfare spending in Organisation for Economic Co-operation and Development (OECD) countries are driven by the degree of 'autonomy freedom' that individuals enjoy. By means of an interdisciplinary approach and a sophisticated econometric methodology, the book takes an explicit stand in defense of freedom and sets the basis for a liberalism based upon people's actions and institutions.

In this paper we study the determinants of peopleís attitudes toward income inequality and their economic consequences. We argue that an individualís atti- tudes toward inequality depend upon the extent of freedom of choice and control over life outcomes he enjoys. We construct a two-stage empirical model where people Örst choose the level of income transfers and then their optimal level of ef- fort. We Önd that the higher the extent of an individualís free choice and control over life outcomes, the greater the probability that he supports larger income di§erences as incentives for individual e§ort. We also show that this relationship determines important consequences for the individualís willingness to work.