1,720,992 research outputs found

    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

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    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)

    Global Spread of Coronavirus Disease 2019 and Malaria: An Epidemiological Paradox in the Early Stage of A Pandemic

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    In the current work, we discovered and analyzed the epidemiological paradox between coronavirus disease 2019 (COVID-19) and malaria in the initial phase of the ongoing pandemic. From the analysis of distribution data, the endemic presence of malaria seems to protect some populations from COVID-19 outbreak, particularly in the least developed countries. In this sense, molecular and genetic variations associated with malaria (e.g., in ACE2) might play a protective role against coronavirus infection. Moreover, the mechanism of action of some antimalarial drugs, e.g., the antiviral function, suggests their potential role in the chemoprophylaxis of coronavirus epidemics, despite possible adverse effects (e.g., retinal toxicity). All these data provide important insights to understand the spreading mechanisms of COVID-19, and to direct scientific research toward the study of some currently available medications

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

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    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 Bull’s Eye Pattern of the Tear Film in Humans during Visual Fixation on En-Face Optical Coherence Tomography

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    The aim of the study was to define and characterize the optical behavior of the tear film during visual fixation in humans on en-face optical coherence tomography (OCT). We included 20 healthy participants, 60% female, aged from 25 to 42 years (33.05 ± 4.97 [mean ± SD]) and ten patients with severe dry eye, 50% female, aged from 26 to 42 years (33.7 ± 5.31). To perform high-resolution tear film imaging, participants were asked to gaze at the internal fixation point in the spectral-domain anterior segment OCT device, and meanwhile scanning session was executed at the following time-points after blinking: at the 2 nd , 3 rd , 4 th , 5 th , and 6 th second. After one hour, OCT imaging was repeated (second session) by a different operator masked to the study to verify the reliability of results. During each measuring session, a pulse oximetry was used for continuously measuring the heart rate and oxygen saturation (SpO 2 %). A preliminary experiment was also performed to test the absence of geometric patterns from the anterior surface of a motionless artificial eye. OCT imaging showed a motionless, stable anterior surface of the artificial eye and in dry eye patients. Conversely, in the healthy participants of the study, a bull’s eye pattern of the tear film was detected by OCT at the 2 nd , 3 rd , 4 th , 5 th , and 6 th second after blinking, respectively, in 45%, 60%, 45%, 60%, and 40% of OCT scans during the first session, and in 35%, 65%, 65%, 60%, and 35% of cases in the second session. Overall, a total of 200 OCT scans were performed in normal human population. A significant correlation was found between the novel tear film pattern and heart rate during the first and the second session (p < 0.01) in healthy eyes. Conversely, no correlation was revealed with SpO2%. Intraclass correlation (ICC) analysis for OCT imaging of the tear film revealed a statistically significant reproducibility of the results (ICC = 0.838; p < 0.01), indicating the high level of reliability of the method, independently of heart rate and SpO2% variables. There exists a novel, geometric pattern of the tear film during visual fixation detectable by en-face OCT, which is mainly evident as heart rate increases. Its discovery implies in turn the presence of a specific vibration (or imperceptible motion) of the tear film that, at present, is not recognized and corrected by the OCT software (in image postprocessing) unlike other eyeball movements

    Looking for Post-Mortem Metabolomic Standardization: Waiting for Godot—The Importance of Post-Mortem Interval in Forensic Metabolomics

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    A growing body of evidence suggests that the post-mortem interval exerts a strong effect on the metabolome, independently of the biological matrix or the cause of death. A sound and shared approach in standardization is mandatory

    Safety Recommendations and Medical Liability in Ocular Surgery during the COVID-19 Pandemic: An Unsolved Dilemma

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    Ocular surgery is one of the most performed medical procedures in the world. Its limitation or suspension, recursively extended over time, could be associated with a significant increase in the number of blind people worldwide. Indeed, cataract causes more than half of all cases of visual impairment in those countries with limited availability of means for performing eye operations (e.g., Africa or India). In this scenario, the pandemic of coronavirus disease 2019 (COVID-19) quickly resulted in the suspension or sharp reduction of various ophthalmic activities considered non-urgent, including lens replacement surgery or some intraocular injections. Despite the imperative need to continuously practice eye operations to avoid the abovementioned problems, there are currently little-shared and vague recommendations among the various countries on safety in operating rooms (for health care workers and patients) and poor legal protection for surgeons (potentially transmitting the COVID-19 infectious agent). Herein, we individuated and discussed some critical points in safety recommendations and medical liability. A paradigm shift for ocular surgery during the COVID-19 era is now mandatory. While telemedicine has been able to solve some problems in clinical ophthalmology, the lack of adequate health and legal protection for surgeons and patients may result in an excessive reduction in the volume of surgical interventions during a pandemic era and the immediately following period, thus determining inability to ensure health care to all patients

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

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    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

    Fourier-Domain OCT Imaging of the Ocular Surface and Tear Film Dynamics: A Review of the State of the Art and an Integrative Model of the Tear Behavior during the Inter-Blink Period and Visual Fixation

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    In the last few decades, the ocular surface and the tear film have been non invasively investigated in vivo, in a three-dimensional, high resolution, and real-time mode, by optical coherence tomography (OCT). Recently, OCT technology has made great strides in improving the acquisition speed and image resolution, thus increasing its impact in daily clinical practice and in the research setting. All these results have been achieved because of a transition from traditional time-domain (TD) to Fourier-domain (FD) technology. FD-OCT devices include a spectrometer in the receiver that analyzes the spectrum of reflected light on the retina or ocular surface and transforms it into information about the depth of the structures according to the Fourier principle. In this review, we summarize and provide the state-of-the-art in FD-OCT imaging of the ocular surface system, addressing specific aspects such as tear film dynamics and epithelial changes under physiologic and pathologic conditions. A theory on the dynamic nature of the tear film has been developed to explain the variations within the individual compartments. Moreover, an integrative model of tear film behaviour during the inter-blink period and visual fixation is proposed
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