The Waiver of Patent Protections for COVID-19 Vaccines During the Ongoing Pandemic and the Conspiracy Theories: Lights and Shadows of an Issue on the Ground

Vaccines against the coronavirus disease 2019 (COVID-19) currently constitute the main hope for the fight against the ongoing pandemic. Mass immunization against the severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) should be considered as a global battle in which no country can be left behind, in particular the low-income countries. This last aspect may, in fact, favor the uncontrolled replication of the virus with the insurge of new variants. One of the possible solutions to limit this problem is the waiver of patent protections for COVID-19 vaccines. On 2 October 2020, India and South Africa asked the World Trade Organization (WTO) to allow all countries to choose to neither grant nor enforce patents and other intellectual property (IP) related to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic, until global herd immunity is achieved. On 5 May 2021, the United States (US) administration announced the willingness to liberalize intellectual property concerning the COVID-19 vaccines (1, 2). Although this issue is very interesting, its feasibility is particularly complex and intricate. Accordingly, there are discordant opinions among scholars and physicians on the real usefulness of patent liberalization (3–6). It has been suggested that an exception be made to the agreements establishing the World Trade Organization, in particular The Agreement on Trade Related Aspects of Intellectual Property Rights. This request would be based on the theory according to which the vaccines against the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) during a pandemic should be considered as a “common good”, similarly to water, or air. According to the Economic Theory of the Commons, which is supported by Elinor Ostrom, winner of the 2009 Nobel prize in Economics, the aforementioned terms should be considered in the Roman category of “res communes omnium”, meaning not appropriable and precluded from legal trade (7, 8). From a practical point of view, the suspension of patent protections would limit the business models for the legitimate producers of COVID-19 vaccines. Among the potential strategies to encourage the waiver of patent protections it is possible to include: the direct donation of vaccines from the high-income countries, the reduction of the costs of the production lines, the shortening of the duration of patent protections, and a series of preferential patent waivers to countries that manufacture a large fraction of the global vaccines (e.g., India). One of the further possible solutions is represented by the solidarity by several governments or other agencies. This strategy is pursued, for example, by the program for COVID-19 Vaccines Global Access (COVAX). The latter is supported by Global Alliance for Vaccines and Immunization (GAVI), Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) (9, 10)

Post-mortem corneal thickness measurements with a portable optical coherence tomography system: a reliability study

The purpose of this study was to determine the repeatability and reproducibility of post-mortem central corneal thickness (CCT) measurements by using a real-time, portable optical coherence tomography (OCT) system on an animal model, and to prospectively evaluate the time-course of post-mortem changes in CCT. Forty-six ocular globes of sheep (Ovis aries) were analyzed with a portable spectral-domain OCT device by two operators at different postmortem intervals (PMIs) as follows: immediately (i.e. within 10 minutes), at the 30(th) minute, at the 1(st), 6(th), 12(th), 24(th) and 48(th) hour, and later (up to the 96(th) hour). The coefficient of repeatability ranged from 0.3% to 3.5%, and coefficients of reproducibility ranged from 0.2% to 3.7% in the central region of the cornea. The intraclass correlation coefficients were particularly high at different PMIs, thus confirming good measurement reliability with the portable OCT. The average CCT decreased immediately and then increased thereafter, with two peaks at 6 and 24 hours after death. Our results suggest that portable OCT is a reliable tool for monitoring CCT variations after death and may be useful in characterizing corneas before explantation, detecting quantitative variations during post-mortem corneal degeneration or assessing changes in CCT for forensic implications

The architecture of corneal stromal striae on optical coherence tomography and histology in an animal model and in humans

The purpose of this study was to use a portable optical coherence tomography (OCT) for characterization of corneal stromal striae (CSS) in an ovine animal model and human corneas with histological correlation, in order to evaluate their architectural pattern by image analysis. Forty-six eyes from female adult sheep (older than 2 years), and 12 human corneas, were included in our study. The eyes were examined in situ by a portable OCT, without enucleation. All OCT scans were performed immediately after death, and then the eyes were delivered to a qualified histology laboratory. In the ovine animal model, CSS were detected with OCT in 89.1% (41/46) of individual scans and in 93.4% (43/46) of histological slices. In human corneas, CSS were found in 58.3% (7/12) of cases. In both corneal types, CSS appeared as “V”- or “X”-shaped structures, with very similar angle values of 70.8° ± 4° on OCT images and 71° ± 4° on histological slices (p ≤ 0.01). Data analysis demonstrated an excellent degree of reproducibility and inter-rater reliability of measurements (p < 0.001). The present study demonstrated that by using a portable OCT device, CSS can be visualized in ovine and human corneas. This finding suggests their generalized presence in various mammals. The frequent observation, close to 60%, of such collagen texture in the corneal stroma, similar to a ‘truss bridge’ design, permits to presume that it plays an important structural role, aimed to distribute tensile and compressive forces in various directions, conferring resilience properties to the cornea

COVID-19 and Italian Healthcare Workers From the Initial Sacrifice to the mRNA Vaccine: Pandemic Chrono-History, Epidemiological Data, Ethical Dilemmas, and Future Challenges

On March 11, 2020, the World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak a pandemic. Simultaneously, in Italy, in which the first case had occurred on February 18, the rigid phase of the lockdown began. The country has attracted worldwide attention, becoming at the same time a field of study both concerning the spread of the pandemic and advanced assessments of the effectiveness of political, public health, and therapeutic measures. The protagonists of the Italian crisis were the healthcare workers (HCWs) who were exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) without having any perception of what they were facing, courageously contributing to the containment of the epidemic to be defined by the media as “heroes.” However, in the first phase of the pandemic (March–May 2020), the price that the Italian Public Health System had to pay both in terms of the number of positive virus cases and deaths among the HCWs was beyond and represented a peculiarity compared to what happened in other countries. In the current study, after a summary of the evolution of the pandemic in Italy, we offer an analysis of the statistical data concerning contagions and deaths among healthcare workers (physicians in particular). In conclusion, we describe the critical issues that still need to be resolved and the future challenges facing healthcare workers and the general population

A Fatal Case of Metastatic Pulmonary Calcification during the Puerperium

We present an unusual case of a fatal respiratory failure in a young woman developed two weeks after she gave birth at home. Circumstantial and clinical features of the case were strongly suggestive for a ‘classical’ septic origin of the respiratory symptoms. Autopsy, together with histopathological and immunohistochemical analyses allowed demonstrating a massive calcium redistribution consisting of an important osteolysis, especially from cranial bones and abnormal accumulation in lungs and other organs. Such physiopathology was driven by a primary hyperparathyroidism secondary to a parathyroid carcinoma as demonstrated by immunohistochemistry. This very rare case is furthermore characterised by a regular pregnancy course, ended with the birth of a healthy new-born. A complex interaction between pregnancy physiology and hyperparathyroidism might be hypothesised, determining the discrepancy between the relative long period of wellness and the tumultuous cascade occurred in the puerperium

Metabolomics investigation of post-mortem human pericardial fluid

Introduction Due to its peculiar anatomy and physiology, the pericardial fluid is a biological matrix of particular interest in the forensic field. Despite this, the available literature has mainly focused on post-mortem biochemistry and forensic toxicology, while to the best of authors' knowledge post-mortem metabolomics has never been applied. Similarly, estimation of the time since death or post-mortem interval based on pericardial fluids has still rarely been attempted.ObjectivesWe applied a metabolomic approach based on H-1 nuclear magnetic resonance spectroscopy to ascertain the feasibility of monitoring post-mortem metabolite changes on human pericardial fluids with the aim of building a multivariate regression model for post-mortem interval estimation.MethodsPericardial fluid samples were collected in 24 consecutive judicial autopsies, in a time frame ranging from 16 to 170 h after death. The only exclusion criterion was the quantitative and/or qualitative alteration of the sample. Two different extraction protocols were applied for low molecular weight metabolites selection, namely ultrafiltration and liquid-liquid extraction. Our metabolomic approach was based on the use of H-1 nuclear magnetic resonance and multivariate statistical data analysis.ResultsThe pericardial fluid samples treated with the two experimental protocols did not show significant differences in the distribution of the metabolites detected. A post-mortem interval estimation model based on 18 pericardial fluid samples was validated with an independent set of 6 samples, giving a prediction error of 33-34 h depending on the experimental protocol used. By narrowing the window to post-mortem intervals below 100 h, the prediction power of the model was significantly improved with an error of 13-15 h depending on the extraction protocol. Choline, glycine, ethanolamine, and hypoxanthine were the most relevant metabolites in the prediction model.ConclusionThe present study, although preliminary, shows that PF samples collected from a real forensic scenario represent a biofluid of interest for post-mortem metabolomics, with particular regard to the estimation of the time since death

Fear of the COVID-19 and medical liability. Insights from a series of 130 consecutives medico-legal claims evaluated in a single institution during SARS-CoV-2-related pandemic

Objectives: The aim of the current work was to evaluate the frequency and the type of cases of medical liability from a single center in the first ten months of the pandemic as well as to identify critical issues associated with the organization of public health during the coronavirus disease 2019 pandemic. Methods: We compared 130 cases evaluated for medical liability from March 2020 to January 2021 and compared with 159 cases from March 2019 to January 2020. The cases were divided in four pre-established groups: surgical error, diagnostic/therapeutic errors and nosocomial diseases, delays, and problems related to assistance. Results: Analysis showed a significant increase in cases due to delay in treat-ment/hospitalization and shortages in health care of non-autonomous patients [χ2 (1, N = 289) = 5.6746, p = 0.02]. Conclusions: The work showed an increase in medical/legal cases regarding non-COVID-19 emergencies in which the outcome is related to the time of treatment and/or arrival at the hospital. There was also a rise in complaints of deficits in supervision and care for non-autonomous patients. Despite the persistence of preventive measures for the current pandemic, measures should be taken to improve health care in these categories of patients

Creation of an Experimental Animal Model for the Study of Postmortem Dark Scleral Spots

Postmortem dark scleral spots, first described by Sommer in 1833, are well-known in forensic pathology. Background/Objectives: Despite this, their presence is currently considered a nonspecific sign, and their pathogenesis has received little attention in forensic literature. In recent years, however, preliminary studies have suggested new mechanisms in their pathogenesis and links to specific types of death. This study aims to create an experimental model for studying scleral spots. Methods: Twenty sheep, already slaughtered for food, were used. After decapitation, the heads were transported to a room with known temperature and humidity. The right eye underwent eyelid excision, while the left eye’s eyelids were sutured. Continuous observation for approximately 24 h was conducted, with brief interruptions to observe the closed eyes. Results: Dark scleral spots appeared in all open eyes (20/20) after an average of 240.96 ± 58.36 min. The spots did not appear in any of the closed eyes. Conclusions: Experimental data indicate that despite the different location compared to human cadavers, this model serves as an excellent experimental framework for studying postmortem scleral spots

Postmortem Ocular Findings in the Optical Coherence Tomography Era: A Proof of Concept Study Based on Six Forensic Cases

Postmortem analysis of the ocular globe is an important topic for forensic pathology and transplantology. Although crucial elements may be gathered from examining cadaveric eyes, the latter do not routinely undergo in-depth analysis. The paucity of quantitative and objective data that are obtainable using current, invasive necroscopic techniques is the main reason for the limited interest in this highly specialized procedure. The aim of the current study is to describe and to object for the first time the postmortem ocular changes by mean of portable optical coherence tomography for evaluating ocular tissues postmortem. The design involved the postmortem analysis (in situ, and without enucleation) of 12 eyes by portable spectral-domain Optical Coherence Tomography. The scans were performed, in corneal, retinal and angle modality at different intervals: <6 h, 6th, 12th, and 24th hour and after autopsy (25th–72nd hour). The morphological changes in the cornea, sclera, vitreous humor and aqueous humor were easy to explore and objectify in these tissues in first 72 h postmortem. On the other hand, the “in situ” observation of the retina was difficult due to the opacification of the lenses in the first 24 h after death