Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges-A Narrative Review.

Pharmacovigilance plays a central role in safeguarding public health by continuously monitoring the safety of vaccines, being critical in a climate of vaccine hesitancy, where public trust is paramount. Pharmacovigilance strategies employed to gather information on adverse events following immunization (AEFIs) include pre-registration data, media reports, clinical trials, and societal reporting. Early detection of AEFIs during clinical trials is crucial for thorough safety analysis and preventing serious reactions once vaccines are deployed. This review highlights the importance of societal reporting, encompassing contributions from community members, healthcare workers, and pharmaceutical companies. Technological advancements such as quick response (QR) codes can facilitate prompt AEFI reporting. While vaccines are demonstrably safe, the possibility of adverse events necessitates continuous post-marketing surveillance. However, underreporting remains a challenge, underscoring the critical role of public engagement in pharmacovigilance. This narrative review comprehensively examines and synthesizes key aspects of virus vaccine pharmacovigilance, with special considerations for specific population groups. We explore applicable legislation, the spectrum of AEFIs associated with major vaccines, and the unique challenges and perspectives surrounding pharmacovigilance in this domain.

An overview on recent patents and technologies on nanoparticles for nucleic acid delivery.

INTRODUCTION: Nucleic acid-based therapeutics offer groundbreaking potential for treating genetic diseases and advancing next-generation vaccines. Despite their promise, challenges in efficient delivery persist due to the properties of nucleic acids. Nanoparticles (NPs) serve as vital carriers, facilitating effective delivery to target cells, and addressing these challenges. Understanding the global landscape of patents in this field is essential for fostering innovation and guiding decision-making for researchers, the pharmaceutical industry, and regulatory agencies. AREAS COVERED: This review provides a comprehensive overview of patent compositions, applications, and manufacturing aspects concerning NPs as nucleic acid delivery systems. It delves into temporal trends, protection locations, market dynamics, and the most influential technological domains. In this work, we provide valuable insights into the advancements and potential of NP-based nucleic acid delivery systems, with a special focus on their pivotal role in advancing cutting-edge therapeutic solutions. EXPERT OPINION: Investment in NPs for nucleic acid delivery has significantly surged in recent years. However, translating these therapies into clinical practice faces obstacles, including the need for robust clinical evidence, regulatory compliance, and streamlined manufacturing processes. To address these challenges, our review article summarizes recent advances. We aim to engage researchers worldwide in the development of these promising technologies.

Distillation of essential oils: An innovative technological approach focused on productivity, quality and sustainability.

Essential oil (EO) distillation units, which are commonly installed on farms, have difficultly accessing knowledge centers. The apparent simplicity of the process hides unwanted losses and deviations that go undetected and, therefore, not corrected. This article proposes improvements to the process that are based on "4.0" technologies in order to detect and correct two important deficiencies, with an impact on the yield, quality and environmental performance. The first deficiency comprises the steam channels that are formed through green mass (channeling), are well known and are considered normal by EO producers. Without detection and correction, this negatively affects the extraction results. The second is the lack of technology that is able to automatically determine the extraction endpoint. Smart sensing, control, self-configuration and the dynamic determination of improved process parameters make up a set of actions undertaken by a smart extraction plant (50-liter capacity). Nineteen experiments using lemongrass (Cymbopogon citratus) exhibited remarkable 24% and 10% improvements in the yield and quality, respectively. Energy consumption and a more than 50% reduction in the processing complete the set of results achieved. In addition to manufacturing costs and the utilization of capacity, better sustainability indicators are positive consequences of this technological updating.

Exotic fruits patents trends: An overview based on technological prospection with a focus on Amazonian.

The Amazon rainforest encompasses one of the largest biodiversities of the world and is home to a wide variety of food and therapeutic plants. Due to the diversity of components, the fruits of the Amazon biome possess essential physicochemical, nutritional, and pharmacological properties, strengthening the idea that fruit consumption may provide benefits to human health. Thus, the objective of this study was to investigate the current scenario of the use of Amazonian fruits on the development of food, pharmaceutical, nutraceutical, or cosmetic products through the study of filed patents. A prospecting strategy conducted focusing on patents was used to investigate the application of the following fruits: Euterpe oleracea, Oenocarpus bacaba, Caryocar brasiliense, Garcinia gardneriana, Nephelium lappaceum, and Astrocaryum vulgare. A total of 264 patent documents were found. In 2016, a peak of 33 applications was reached, followed by a peak in 2019 with 32 applications. The study is distributed in three main application areas: cosmetics, pharmaceuticals, and food. The Asian continent was the region with the world leadership in this theme, followed by Brazil. Thus, technological prospection studies can foster investments in translational research to elucidate the effects and properties of Amazonian fruits, which can generate sustainable development of new products with industrial potential.

RNA Combined with Nanoformulation to Advance Therapeutic Technologies.

Nucleic acid-based therapies have the potential to address numerous diseases that pose significant challenges to more traditional methods. RNA-based therapies have emerged as a promising avenue, utilizing nanoformulation treatments to target a range of pathologies. Nanoformulation offers several advantages compared to other treatment modalities, including targeted delivery, low toxicity, and bioactivity suitable for drug loading. At present, various types of nanoformulations are available, such as liposomes, polymeric nanoparticles (NPs), magnetic NPs, nanoshells, and solid lipid nanoparticles (SLNs). RNA-based therapy utilizes intracellular gene nanoparticles with messenger RNA (mRNA) emerging prominently in cancer therapy and immunotechnology against infectious diseases. The approval of mRNA-based technology opens doors for future technological advancements, particularly self-amplifying replicon RNA (repRNA). RepRNA is a novel platform in gene therapy, comprising viral RNA with a unique molecular property that enables the amplification of all encoded genetic information countless times. As a result, repRNA-based therapies have achieved significant levels of gene expression. In this context, the primary objective of this study is to furnish a comprehensive review of repRNA and its applications in nanoformulation treatments, with a specific focus on encapsulated nanoparticles. The overarching goal is to provide an extensive overview of the use of repRNA in conjunction with nanoformulations across a range of treatments and therapies.

Long-term monitoring of COVID-19 prevalence in raw and treated wastewater in Salvador, the largest capital of the Brazilian Northeast.

Wastewater-based epidemiology (WBE) becomes an interesting epidemiological approach to monitoring the prevalence of SARS-CoV-2 broadly and non-invasively. Herein, we employ for the first time WBE, associated or not with the PEG 8000 precipitation method, for the detection of SARS-CoV-2 in samples of raw or treated wastewater from 22 municipal wastewater treatment stations (WWTPs) located in Salvador, the fourth most populous city in Brazil. Our results demonstrate the success of the application of WBE for detecting SARS-CoV-2 in both types of evaluated samples, regardless of the usage of PEG 8000 concentration procedure. Further, an increase in SARS-CoV-2 positivity rate was observed in samples collected in months that presented the highest number of confirmed COVID-19 cases (May/2021, June/2021 and January/2022). While PEG 8000 concentration step was found to significantly increase the positivity rate in treated wastewater samples (p < 0.005), a strong positive correlation (r: 0.84; p < 0.002) between non-concentrated raw wastewater samples with the number of new cases of COVID-19 (April/2021-February/2022) was observed. In general, the present results reinforce the efficiency of WBE approach to monitoring the presence of SARS-CoV-2 in either low- or high-capacity WWTPs. The successful usage of WBE even in raw wastewater samples makes it an interesting low-cost tool for epidemiological surveillance.

Dengue as a Disease Threatening Global Health: A Narrative Review Focusing on Latin America and Brazil.

Arboviruses constitute the largest known group of viruses. These viruses are the etiological agents of pathologies known as arboviruses, with dengue being one of the most prevalent. Dengue has resulted in important socioeconomic burdens placed on different countries around the world, including those in Latin America, especially Brazil. Thus, this work intends to carry out a narrative-based review of the literature, conducted using a study of the secondary data developed through a survey of scientific literature databases, and to present the situation of dengue, particularly its distribution in these localities. Our findings from the literature demonstrate the difficulties that managers face in controlling the spread of and planning a response against dengue, pointing to the high cost of the disease for public coffers, rendering the resources that are already limited even scarcer. This can be associated with the different factors that affect the spread of the disease, including ecological, environmental, and social factors. Thus, in order to combat the disease, it is expected that targeted and properly coordinated public policies need to be adopted not only in specific localities, but also globally.

Extraction of Antioxidant Compounds from Brazilian Green Propolis Using Ultrasound-Assisted Associated with Low- and High-Pressure Extraction Methods.

The demand for bee products has been growing, especially regarding their application in complementary medicine. Apis mellifera bees using Baccharis dracunculifolia D.C. (Asteraceae) as substrate produce green propolis. Among the examples of bioactivity of this matrix are antioxidant, antimicrobial, and antiviral actions. This work aimed to verify the impact of the experimental conditions applied in low- and high-pressure extractions of green propolis, using sonication (60 kHz) as pretreatment to determine the antioxidant profile in the extracts. Total flavonoid content (18.82 ± 1.15-50.47 ± 0.77 mgQE·g-1), total phenolic compounds (194.12 ± 3.40-439.05 ± 0.90 mgGAE·g-1) and antioxidant capacity by DPPH (33.86 ± 1.99-201.29 ± 0.31 µg·mL-1) of the twelve green propolis extracts were determined. By means of HPLC-DAD, it was possible to quantify nine of the fifteen compounds analyzed. The results highlighted formononetin (4.76 ± 0.16-14.80 ± 0.02 mg·g-1) and p-coumaric acid (

Active Potential of Bacterial Cellulose-Based Wound Dressing: Analysis of Its Potential for Dermal Lesion Treatment.

The use of innate products for the fast and efficient promotion of healing process has been one of the biomedical sector's main bets for lesion treatment modernization process. The aim of this study was to develop and characterize bacterial cellulose-based (BC) wound dressings incorporated with green and red propolis extract (2 to 4%) and the active compounds p-coumaric acid and biochanin A (8 to 16 mg). The characterization of the nine developed samples (one control and eight active wound dressings) evidenced that the mechanics, physics, morphological, and barrier properties depended not only on the type of active principle incorporated onto the cellulosic matrix, but also on its concentration. Of note were the results found for transparency (28.59-110.62T600 mm-1), thickness (0.023-0.046 mm), swelling index (48.93-405.55%), water vapor permeability rate (7.86-38.11 g m2 day-1), elongation (99.13-262.39%), and antioxidant capacity (21.23-86.76 µg mL-1). The wound dressing based on BC and red propolis was the only one that presented antimicrobial activity. The permeation and retention test revealed that the wound dressing containing propolis extract presented the most corneal stratum when compared with viable skin. Overall, the developed wound dressing showed potential to be used for treatment against different types of dermal lesions, according to its determined proprieties.

The Importance of Vaccination in the Context of the COVID-19 Pandemic: A Brief Update Regarding the Use of Vaccines.

The COVID-19 pandemic has led the world to undertake the largest vaccination campaign in human history. In record time, unprecedented scientific and governmental efforts have resulted in the acquisition of immunizers utilizing different technologies (nucleotide acids, viral vectors, inactivated and protein-based vaccines). Currently, 33 vaccines have already been approved by regulatory agencies in different countries, and more than 10 billion doses have been administered worldwide. Despite the undeniable impact of vaccination on the control of the pandemic, the recurrent emergence of new variants of interest has raised new challenges. The recent viral mutations precede new outbreaks that rapidly spread at global proportions. In addition, reducing protective efficacy rates have been observed among the main authorized vaccines. Besides these issues, several other crucial issues for the appropriate combatting of the pandemic remain uncertain or under investigation. Particularly noteworthy issues include the use of vaccine-boosting strategies to increase protection; concerns related to the long-term safety of vaccines, child immunization reliability and uncommon adverse events; the persistence of the virus in society; and the transition from a pandemic to an endemic state. In this review, we describe the updated scenario regarding SARS-CoV-2 variants and COVID-19 vaccines. In addition, we outline current discussions covering COVID-19 vaccine safety and efficacy, and the future pandemic perspectives.

Evaluation of SARS-CoV-2 concentrations in wastewater and river water samples.

There are only a few established methods to determine the concentration of encapsulated viruses, such as SARS-CoV-2, in water matrices, limiting the application of wastewater-based epidemiology (WBE)-an important tool for public health research. The present study compared four methods that are commonly used to concentrate non-encapsulated enteric viruses for determining SARS-CoV-2 concentration in wastewater and wastewater-enriched river water samples. The four methods tested were electronegative membrane with Mg+2 addition, aluminum hydroxide-based precipitation, polyethylene glycol (PEG) 8000 precipitation, and ultrafiltration (with porosity of 10 and 50 kDa). Prior to the concentration step, filtration or centrifugation was performed to remove suspended particles from the samples (pretreatment). To evaluate the recovery efficiency (%), samples of SARS-CoV-2 from nasopharyngeal swabs obtained from RT-qPCR-positive patients were used as spiked samples. The second part of the analysis involved the quantification of the SARS-CoV-2 copy number in analytes without SARS-CoV-2-spiked samples. Among the tested methods, pretreatment via centrifugation followed by ultrafiltration with a 50-kDa cut-off was found the most efficient method for wastewater samples with spiked samples (54.3 or 113.01% efficiency). For the wastewater-enriched river samples with spiked samples, pretreatment via centrifugation followed by filtration using an electronegative membrane was the most efficient method (110.8% and 95.9% for N1 and N2 markers, respectively). However, ultrafiltration of the raw river water samples using 10 or 50 kDa cut-off filters and PEG 8000 precipitation showed the best concentration efficiency based on copy number, regardless of the pretreatment approach or sample type (values ranging from 3 × 105 to 6.7 × 103). The effectiveness of the concentration method can vary depending on the type of sample and concentration method. We consider that this study will contribute to more widespread use of WBE for the environmental surveillance of SARS-CoV-2.

The Importance of RNA-Based Vaccines in the Fight against COVID-19: An Overview.

In recent years, vaccine development using ribonucleic acid (RNA) has become the most promising and studied approach to produce safe and effective new vaccines, not only for prophylaxis but also as a treatment. The use of messenger RNA (mRNA) as an immunogenic has several advantages to vaccine development compared to other platforms, such as lower coast, the absence of cell cultures, and the possibility to combine different targets. During the COVID-19 pandemic, the use of mRNA as a vaccine became more relevant; two out of the four most widely applied vaccines against COVID-19 in the world are based on this platform. However, even though it presents advantages for vaccine application, mRNA technology faces several pivotal challenges to improve mRNA stability, delivery, and the potential to generate the related protein needed to induce a humoral- and T-cell-mediated immune response. The application of mRNA to vaccine development emerged as a powerful tool to fight against cancer and non-infectious and infectious diseases, for example, and represents a relevant research field for future decades. Based on these advantages, this review emphasizes mRNA and self-amplifying RNA (saRNA) for vaccine development, mainly to fight against COVID-19, together with the challenges related to this approach.

Development of Bacterial Cellulose Biocomposites Combined with Starch and Collagen and Evaluation of Their Properties.

One of the major benefits of biomedicine is the use of biocomposites as wound dressings to help improve the treatment of injuries. Therefore, the main objective of this study was to develop and characterize biocomposites based on bacterial cellulose (BC) with different concentrations of collagen and starch and characterize their thermal, morphological, mechanical, physical, and barrier properties. In total, nine samples were produced with fixed amounts of glycerol and BC and variations in the amount of collagen and starch. The water activity (0.400-0.480), water solubility (12.94-69.7%), moisture (10.75-20.60%), thickness (0.04-0.11 mm), water vapor permeability (5.59-14.06 × 10-8 g·mm/m2·h·Pa), grammage (8.91-39.58 g·cm-2), opacity (8.37-36.67 Abs 600 nm·mm-1), elongation (4.81-169.54%), and tensile strength (0.99-16.32 MPa) were evaluated and defined. In addition, scanning electron microscopy showed that adding biopolymers in the cellulose matrix made the surface compact, which also influenced the visual appearance. Thus, the performance of the biocomposites was directly influenced by their composition. The performance of the different samples obtained resulted in them having different potentials for application considering the injury type. This provides a solution for the ineffectiveness of traditional dressings, which is one of the great problems of the biomedical sector.

Evaluation of Different Methods for Cultivating Gluconacetobacter hansenii for Bacterial Cellulose and Montmorillonite Biocomposite Production: Wound-Dressing Applications.

Bacterial cellulose (BC) has received considerable attention due to its unique properties, including an ultrafine network structure with high purity, mechanical strength, inherent biodegradability, biocompatibility, high water-holding capacity and high crystallinity. These properties allow BC to be used in biomedical and industrial applications, such as medical product. This research investigated the production of BC by Gluconacetobacter hansenii ATCC 23769 using different carbon sources (glucose, mannitol, sucrose and xylose) at two different concentrations (25 and 50 g∙L-1). The BC produced was used to develop a biocomposite with montmorillonite (MMT), a clay mineral that possesses interesting characteristics for enhancing BC physical-chemical properties, at 0.5, 1, 2 and 3% concentrations. The resulting biocomposites were characterized in terms of their physical and barrier properties, morphologies, water-uptake capacities, and thermal stabilities. Our results show that bacteria presented higher BC yields in media with higher glucose concentrations (50 g∙L-1) after a 14-day incubation period. Additionally, the incorporation of MMT significantly improved the mechanical and thermal properties of the BC membranes. The degradation temperature of the composites was extended, and a decrease in the water holding capacity (WHC) and an improvement in the water release rate (WRR) were noted. Determining a cost-effective medium for the production of BC and the characterization of the produced composites are extremely important for the biomedical applications of BC, such as in wound dressing materials.

The Main Molecular and Serological Methods for Diagnosing COVID-19: An Overview Based on the Literature.

Diagnostic tests have been considered as the main alternative for the control of coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as a correct diagnosis allows for decision making when facing the disease, particularly as there is a lack of effective therapeutic protocols and vaccines. Thus, in this review, we summarized the main diagnostic approaches currently available for the diagnosis of SARS-CoV-2 infection in humans based on studies available in article databases. The tests can be organized into two main categories: nucleic acid-based tests, recommended for the initial detection of the virus, and serological tests, recommended for assessing the disease progression. The studies have shown that the performance of diagnostic methods depends on different factors, such as the type of samples and the characteristics of each assay. It was identified that the positivity of the tests is mainly related to the onset of symptoms. We also observed that point-of-care diagnoses are considered as one of the main trends in this area, due to the low-cost and simplicity of the assay; however, the analytical performance must be critically analyzed. Thus, the COVID-19 pandemic has highlighted the critical role of diagnostic technologies in the control of infectious diseases.