Getting Proactive with Pharma Packaging

According to market research, the pharmaceutical packaging sector is expected to grow at a compound annual rate of 7.4% between 2022 and 2031, reaching an estimated USS178.8 billion (€171.8 billion) by the end of the forecast period (1). "Pharmaceutical waste continues to be a huge problem, so to eliminate non-biodegradable and single-use plastics from the supply chain, more research is taking place around bio-based PET [polyethylene terephthalate]. "By designing a product's primary and secondary packaging well from the outset (including investing ample resources into the process), manufacturers can reduce the amount of materials used and wasted, test new eco materials, ensure safety compliance and efficacy, and benefit from cheaper transportation costs," Quelch surmises. [...]pharma companies can benefit from a packaging supplier with a true global footprint," he says.

Prospects of TiO2-based photocatalytic degradation of microplastic leachates related disposable facemask, a major COVID-19 waste

COVID-19 is one of the serious catastrophes that have a substantial influence on human health and the environment. Diverse preventive actions were implemented globally to limit its spread and transmission. Personnel protective equipment (PPE) was an important part of these control approaches. But unfortunately, these types of PPE mainly comprise plastics, which sparked challenges in the management of plastic waste. Disposable face masks (DFM) are one of the efficient strategies used across the world to ward off disease transmission. DFMs can contribute to micro and nano plastic pollution as the plastic present in the mask may degrade when exposed to certain environmental conditions. Microplastics (MPs) can enter the food chain and devastate human health. Recognizing the possible environmental risks associated with the inappropriate disposal of masks, it is crucial to avert it from becoming the next plastic crisis. To address this environmental threat, titanium dioxide (TiO2)-based photocatalytic degradation (PCD) of MPs is one of the promising approaches. TiO2-based photocatalysts exhibit excellent plastic degradation potential due to their outstanding photocatalytic ability, cost efficiency, chemical, and thermal stability. In this review, we have discussed the reports on COVID-19 waste generation, the limitation of current waste management techniques, and the environmental impact of MPs leachates from DFMs. Mainly, the prominence of TiO2 in the PCD and the applications of TiO2-based photocatalysts in MPs degradation are the prime highlights of this review. Additionally, various synthesis methods to enhance the photocatalytic performance of TiO2 and the mechanism of PCD are also discussed. Furthermore, current challenges and the future research perspective on the improvement of this approach have been proposed.

Dose-Dependent Production of Anti-PEG IgM after Intramuscular PEGylated-Hydrogenated Soy Phosphatidylcholine Liposomes, but Not Lipid Nanoparticle Formulations of DNA, Correlates with the Plasma Clearance of PEGylated Liposomal Doxorubicin in Rats.

PEGylated lipid nanoparticle-based Covid-19 vaccines, including Pfizer's BNT162b2 and Moderna's mRNA-1273, have been shown to stimulate variable anti-PEG antibody production in humans. Anti-PEG antibodies have the potential to accelerate the plasma clearance of PEGylated therapeutics, such as PEGylated liposomes and proteins, and compromise their therapeutic efficacy. However, it is not yet clear whether antibody titers produced by PEGylated Covid-19 vaccines significantly affect the clearance of PEGylated therapeutics. This study examined how anti-PEG IgM levels affect the pharmacokinetics of PEGylated liposomal doxorubicin (PLD) and compared the immunogenicity of a lipid nanoparticle formulation of linear DNA (DNA-LNP) to standard PEG-HSPC liposomes. DNA-LNP was prepared using the same composition and approach as Pfizer's BNT162b2, except linear double-stranded DNA was used as the genetic material. PEGylated HSPC-based liposomes were formulated using the lipid rehydration and extrusion method. Nanoparticles were dosed IM to rats at 0.005-0.5 mg lipid/kg body weight 1 week before evaluating the plasma pharmacokinetics of clinically relevant doses of PLD (1 mg/kg, IV) or PEGylated interferon α2a (Pegasys, 5 µg/kg, SC). Plasma PEG IgM was compared between pre- and 1-week post-dose blood samples. The results showed that anti-PEG IgM production increased with increasing PEG-HSPC liposome dose and that IgM significantly correlated with the plasma half-life, clearance, volume of distribution, and area under the curve of a subsequent dose of PLD. The plasma exposure of Pegasys was also significantly reduced after initial delivery of 0.005 mg/ml PEG-HSPC liposome. However, a single 0.05 mg/kg IM dose of DNA-LNP did not significantly elevate PEG IgM and did not alter the IV pharmacokinetics of PLD. These data showed that PEGylated Covid-19 vaccines are less immunogenic compared to standard PEGylated HSPC liposomes and that there is an antibody threshold for accelerating the clearance of PEGylated therapeutics.

Erratum: Intradermal testing with COVID-19 mRNA vaccines predicts tolerance.

[This corrects the article DOI: 10.3389/falgy.2022.818049.].

Polyethylene Glycol and Polysorbate 80 Skin Tests in the Context of an Allergic Risk Assessment for Hypersensitivity Reactions to Anti-SARS-CoV-2 mRNA Vaccines.

Concern has arisen about hypersensitivity reactions in patients with allergic reactions to drugs containing polyethylene glycol (PEG) or polysorbate 80 (PS80), excipients of currently available anti-SARS-CoV-2 mRNA vaccines. However, the actual utility of PEG and PS80 skin allergy testing is currently still debated. We retrospectively analyzed all cases of patients on whom we performed allergometric skin tests for PEG and PS80 in the context of a pre-vaccination screening (for patients with multiple hypersensitivity reactions to drugs for which these excipients were among the suspected agents) or following suspected hypersensitivity reactions to anti-SARS-CoV-2 vaccines. A total of 134 tests were performed for PEG and PS80, eight of which produced uninterpretable results (due to dermographism or non-specific reactions). Of the remaining 126 cases (85 pre-vaccinal and 41 post-vaccine reactions), 16 (12.7%) were positive for PEG and/or PS80. Stratifying by clinical indication, there were no statistically significant differences in the proportion of positive tests between patients evaluated in the context of the pre-vaccination screening and those evaluated after a vaccine reaction (10.6% vs. 17.1%, respectively, p = 0.306). Allergometric skin tests for PEG and PS80 in our case series resulted positive in an unexpectedly high proportion of patients, suggesting that testing for allergy to these two excipients should not be ignored in case of reasonable clinical suspicion.

Studying how administration route and dose regulates antibody generation against LNPs for mRNA delivery with single-particle resolution.

Following the recent approval of both siRNA- and mRNA-based therapeutics, nucleic acid therapies are considered a game changer in medicine. Their envisioned widespread use for many therapeutic applications with an array of cellular target sites means that various administration routes will be employed. Concerns exist regarding adverse reactions against the lipid nanoparticles (LNPs) used for mRNA delivery, as PEG coatings on nanoparticles can induce severe antibody-mediated immune reactions, potentially being boosted by the inherently immunogenic nucleic acid cargo. While exhaustive information is available on how physicochemical features of nanoparticles affects immunogenicity, it remains unexplored how the fundamental choice of administration route regulates anti-particle immunity. Here, we directly compared antibody generation against PEGylated mRNA-carrying LNPs administered by the intravenous, intramuscular, or subcutaneous route, using a novel sophisticated assay capable of measuring antibody binding to authentic LNP surfaces with single-particle resolution. Intramuscular injections in mice were found to generate overall low and dose-independent levels of anti-LNP antibodies, while both intravenous and subcutaneous LNP injections generated substantial and highly dose-dependent levels. These findings demonstrate that before LNP-based mRNA medicines can be safely applied to new therapeutic applications, it will be crucial to carefully consider the choice of administration route.

Updated Guidance Regarding The Risk ofAllergic Reactions to COVID-19 Vaccines and Recommended Evaluation and Management: A GRADE Assessment, and International Consensus Approach.

This guidance updates 2021 GRADE recomendations regarding immediate allergic reactions following COVID-19 vaccines and addresses re-vaccinating individuals with 1st dose allergic reactions and allergy testing to determine re-vaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 re-vaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommenations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the UK, and the US formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy, and re-vaccination after a prior immediate allergic reaction. We suggest against >15-minute post-vaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest re-vaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise, in a properly equipped setting. We suggest against pre-medication, split-dosing, or special precautions because of a comorbid allergic history.

Did the COVID-19 pandemic play a role in the spatial and temporal variations of microplastics? Evidence from a tropical river in southern India.

Personal protective equipment (PPE) use has increased because of COVID-19, producing more microplastics (MPs). The pandemic's impact on MP pollution in Indian rivers is little understood. In this study, the Netravathi River in Karnataka was investigated for the spatiotemporal distribution of MPs. The MPs abundance, size, and categories varied seasonally, with a higher concentration during the monsoon seasons. The reduction in rainfall during MON20 and the COVID-19 lockdown can be the reasons for the significant decrease in the MP concentration when compared to MON19. Polyethylene and polyethylene terephthalate were the most abundant polymers, with a shift from polyethylene to the latter (74 %) during post-monsoon season post-lockdown. The situation of MP pollution in Western Ghats can be mitigated with the aid of appropriate waste management of plastic trash and greater public awareness about the disposal of single-use plastics, which has risen significantly during the COVID-19 pandemic.

Fluctuations of Dry and Total Mass of Cells Exposed to Different Molecular Weights of Polyethylene Glycol

Polyethylene glycol (PEG) is used in many applications, and in the clinical field, it is one of the main components of the latest Covid vaccines. Its wide use is justified by a relatively safe profile and few known side effects. However, little is known about the biophysical effects of PEG on cells such as, cell stiffness, dry mass, and total mass. Herein, exploiting a digital holographic microscope, an inertial picobalance, and a nanoindenter, these properties are characterized in rat embryonic fibroblast exposed to different molecular weights of PEG. Immediately after the first minutes of PEG exposure to the cells, a reduction in cell dry mass can be observed as well as a rapid fluctuation in total cell weight. Cell stiffness decreases significantly after 48 h, while no important morphological changes are observed. Here, it is revealed how dry mass and total mass are rapidly and finely regulated, highlighting how the maintenance of cell density is of primary importance in cellular activities.

A polyethylene glycol enhanced ligation-triggered self-priming isothermal amplification for the detection of SARS-CoV-2 D614G mutation.

We presented a polyethylene glycol (PEG) enhanced ligation-triggered self-priming isothermal amplification (PEG-LSPA) for the detection D614G mutation in S-glycoprotein of SARS-CoV-2. PEG was employed to improve the ligation efficiency of this assay by constructing a molecular crowding environment. Two hairpin probes (H1 and H2) were designed to contain 18 nt and 20 nt target binding site at their 3' end and 5' end, respectively. In presence of target sequence, it complemented with H1 and H2 to trigger ligation by ligase under molecular crowding condition to form ligated H1-H2 duplex. Then 3' terminus of the H2 would be extended by DNA polymerase under isothermal conditions to form a longer extended hairpin (EHP1). 5' terminus of EHP1 with phosphorothioate (PS) modification could form hairpin structure due to the lower Tm value. The resulting 3' end overhang would also fold back as a new primer to initiate the next round of polymerization, resulting in the formation of a longer extended hairpin (EHP2) containing two target sequence domains. In the circle of LSPA, long extended hairpin (EHPx) containing numerous target sequence domains was produced. The resulting DNA products can be monitored in real-time fluorescence signaling. Our proposed assay owns an excellent linear range from 10 fM to 10 nM with a detection limit down to 4 fM. Thus, this work provides a potential isothermal amplification method for monitoring mutations in SARS-CoV-2 variants.

Using molecular tools to compare various concentration protocols prior to detecting SARS-CoV-2 RNA in wastewater. (Special Issue: Chemistry and global challenges (part A).)

Background: Reports showed presence of SARS-CoV-2 genetic material in wastewater. Wastewater concentration methods are optimized for detection of non-enveloped viruses so need to be adopted for enveloped viruses and their genetic material. Methods: Conventional (cRT-PCR) and quantitative real time RT-PCR (qRT-PCR) were used as readouts to compare 4 water concentration methods namely, (A) filtration on negatively charged membrane followed by extracting RNA from it, (B) adsorbtion-elution method, (C) flocculation with skimmed milk and (D) polyethylene glycol precipitation, to detect SARS-CoV-2 RNA and 229E human coronavirus (229E-HCoV) as a model for spike-containing enveloped virus from fresh and wastewater. Results: On using cRT-PCR: recovery rate of SARS-CoV-2 RNA was better using method A then B for fresh water and method B then D for wastewater. 229E-HCoV recovery from fresh water was better using method C then A and methods B then D for wastewater. On using qRT-PCR, both methods A and B were better for SARS-CoV-2 RNA recovery from both fresh and wastewater. For the 229E-HCoV methods A was the most efficient for fresh water and method B for wastewater. Conclusion: Method B is recommended for SARS-CoV-2 RNA or whole 229E-HCoV recovery from wastewater.

Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination.

BACKGROUND: The mechanism for anaphylaxis following mRNA COVID-19 vaccination has been widely debated; understanding this serious adverse event is important for future vaccines of similar design. A mechanism proposed is type I hypersensitivity (i.e., IgE-mediated mast cell degranulation) to polyethylene glycol (PEG). Using an assay that, uniquely, had been previously assessed in patients with anaphylaxis to PEG, our objective was to compare anti-PEG IgE in serum from mRNA COVID-19 vaccine anaphylaxis case-patients and persons vaccinated without allergic reactions. Secondarily, we compared anti-PEG IgG and IgM to assess alternative mechanisms. METHODS: Selected anaphylaxis case-patients reported to U.S. Vaccine Adverse Event Reporting System December 14, 2020-March 25, 2021 were invited to provide a serum sample. mRNA COVID-19 vaccine study participants with residual serum and no allergic reaction post-vaccination ("controls") were frequency matched to cases 3:1 on vaccine and dose number, sex and 10-year age category. Anti-PEG IgE was measured using a dual cytometric bead assay (DCBA). Anti-PEG IgG and IgM were measured using two different assays: DCBA and a PEGylated-polystyrene bead assay. Laboratorians were blinded to case/control status. RESULTS: All 20 case-patients were women; 17 had anaphylaxis after dose 1, 3 after dose 2. Thirteen (65 %) were hospitalized and 7 (35 %) were intubated. Time from vaccination to serum collection was longer for case-patients vs controls (post-dose 1: median 105 vs 21 days). Among Moderna recipients, anti-PEG IgE was detected in 1 of 10 (10 %) case-patients vs 8 of 30 (27 %) controls (p = 0.40); among Pfizer-BioNTech recipients, it was detected in 0 of 10 case-patients (0 %) vs 1 of 30 (3 %) controls (p >n 0.99). Anti-PEG IgE quantitative signals followed this same pattern. Neither anti-PEG IgG nor IgM was associated with case status with both assay formats. CONCLUSION: Our results support that anti-PEG IgE is not a predominant mechanism for anaphylaxis post-mRNA COVID-19 vaccination.

Controversies around COVID-19 Vaccines and Antidepressants: Scope and Perspective in Malaysia.

BACKGROUND: Individuals with severe mental illness are prone to severe COVID-19 infection with increased morbidity and mortality. Psychiatric patients are often concerned about the potential interactions between the newly approved COVID-19 vaccines in Malaysia and psychotropic drugs like antidepressants. To date, such data are unavailable. OBJECTIVES: This review aims to clear the polemics of COVID-19 vaccine-antidepressants interaction in these 3 aspects: (1) cytokines and cytochrome P450 pathway, (2) blood-brain barrier (BBB) involvement and (3) and its interaction with polyethylene glycol (PEG), the potential allergenic culprit following COVID-19 vaccination. METHODS: A systemic scoping approach was employed to search for peer-reviewed journal articles across four healthcare and scientific databases (PubMed, MEDLINE, PsycINFO and Cumulative Index to Nursing and Allied Health Literature (CINAHL)). RESULTS: Antidepressants metabolism often involve the CYP450 enzymes. Vaccine-antidepressants interactions are probable, likely to be triggered by interactions of CYP450 enzymes and inflammatory cytokines, resulting in diminished drug metabolism and chemical detoxification. Aside, PEG, the excipient in mRNA-based COVID-19 vaccines and antidepressants, has been reported as the anaphylaxis causative allergen. However, whether it leads to a synergistic, potentiation or antagonistic effects when used in combination, remains to be elucidated. CONCLUSION: Psychotropic medications, including antidepressants, showed potentially relevant safety risk for COVID-19 patients. These vulnerable patient group must be prioritized for early access to safe and efficacious COVID-19 vaccines, as vaccination remains the most important public health intervention to tackle the ongoing COVID-19 pandemic.

Strategic use of thermo-chemical processes for plastic waste valorization

Plastic is one of the most widely used materials in industries including packaging, building, and construction due to its lightweight, low cost, durability, and versatility. However, the mass production of plastics has exacerbated plastic pollution. Globally, plastic waste is predominantly incinerated, landfilled, or released into the environment;only 5-6% is recycled in the United States. Although conventional management protocols such as incineration and landfilling are evidently effective for plastic waste disposal, they are associated with significant environmental and societal challenges. In addition, most recycled plastic is downcycled, and thus does not provide sufficient incentive to use recycled materials instead of virgin materials. This review discusses thermo-chemical upcycling processes such as (catalytic) pyrolysis and heterogeneous catalysis. Furthermore, we present the recent progress in the thermo-chemical upgrading of single-type plastic waste, heterogeneous plastic mixtures, and post-consumer plastic waste obtained from different locations and, finally, suggest future research directions.

COVID-19 Waste as Source of Microplastics in the Environment: Implication for Aquatic Species, Human, and Remediation Measures- A Review

Coronavirus (COVID-19) pandemic ushered in a new era that led to the adjustments of diverse ecosystems. The pandemic restructured the global socio-economic events which prompted several adaptation measures as a response mechanism to cushion the negative impact of the disease pandemic. Critical health safety actions were impera-tive to curtail the spread of the disease such as wearing personal protective equipment (PPEs), masks, goggles, and using sanitizers for disinfection purposes. The daily de-mands for the products by individuals and medical personnel heightened their pro-duction and consumption, leading to a corresponding increase of COVID-19 wastes in the environment following indiscriminate waste disposal and poor waste management. The persistent occurrence of COVID-19 wastes aggravated microplastics (MPs) con-tamination in the aquatic ecosystem following the breakdown of PPEs-based plastics via oxidation, fragmentation, and photo-degradation actions. These MPs are transport-ed in the aquatic environment via surface runoff and wind action, apart from discrete sources. MPs' presence in the aquatic systems is not without repercussions. Ingestion of MPs by aquatic organisms can cause several diseases (e.g., poor growth, oxidative distress, neurotoxicity, developmental toxicity, reproductive toxicity, immunotoxicity, and organ toxicity). Humans are at high risk of MPs uptake. Apart from aerial and soil contamination sources, consumption of aquatic food products is a critical pathway of MPs into the human body. MP toxicities in humans include liver disorder, respiratory failure, infertility, hormonal imbalance, diarrhea, developmental disorder, and mortal-ity. Measures to alleviate the effect of COVID-19 waste litters include effective waste management plans and the adoption of technologies to extract cum degrade MPs from the aquatic and terrestrial environment.

Nanopore single-molecule analysis of biomarkers: Providing possible clues to disease diagnosis

Biomarker detection has attracted increasing interest in recent years due to the minimally or non-invasive sampling process. Single entity analysis of biomarkers is expected to provide real-time and accurate biological information for early disease diagnosis and prognosis, which is critical to the effective disease treatment and is also important in personalized medicine. As an innovative single entity analysis method, nanopore sensing is a pioneering single-molecule detection technique that is widely used in analytical bioanalytical fields. In this review, we overview the recent progress of nanopore biomarker detection as new approaches to disease diagnosis. In highlighted studies, nanopore was focusing on detecting biomarkers of different categories of communicable and noncommunicable diseases, such as pandemic COVID-19, AIDS, cancers, neurologic diseases, etc. Various sensitive and selective nanopore detecting strategies for different types of biomarkers are summarized. In addition, the challenges, opportunities, and direction for future development of nanopore-based biomarker sensors are also discussed.Copyright © 2023 Elsevier B.V.

A Course-Based Undergraduate Research Experience (CURE) using Ocean Plastic Microbes as a Framework that Is Impactful for Both In-Person and Online Course Modalities

A course-based undergraduate research experience (CURE) is described, both in its original, field-based and in-person design, as well as its adaptation to online delivery during the COVID-19 pandemic. The CURE experience was centered around the topic of microbes attaching to ocean plastic debris, and included connecting nontraditional undergraduate students attending a primarily teaching institution to personnel of a research-intensive institution. The CURE was implemented in nonmajors and majors' general biology laboratory courses, as well as in an introductory microbiology lab course for health majors. Student perception of the CURE was assessed quantitatively through self-administered retrospective surveys, and qualitatively using open-ended survey questions and focus group interviews. Survey questions were grouped into four themes: (1) research at the research institution, (2) research at the teaching institution, (3) laboratory skills, and (4) interest in science. To assess impact of the CURE by modality, major and course level, theme scores were analyzed using ANOVAs (α = 0.05). Changes in student perception of learning were measured by comparing the "before” and "after” survey scores in each theme. The main source of variation in the model was time, followed by theme and major, while modality had a negligible effect. Overall, there were increases in student perception of learning across all themes across modality, major, and course level;however, not all were statistically significant. Highest gains were observed among nonmajors, while those of the majors' upper division courses were the lowest. On the other hand, majors' overall scores were the highest. Health majors' survey gains were mostly between those of nonmajors and majors. Qualitative data contextualized the quantitative results. The online adaptation was a valuable alternative, especially for nonmajors, as it expanded the range of students reached, with results similar to the in-person alternative. Preliminary data show a positive effect of the CURE in student success majoring in biology.

A Combined Method Based on the FIPV N Monoclonal Antibody Immunofluorescence Assay and RT-nPCR Method for the Rapid Diagnosis of FIP-Suspected Ascites

Feline infectious peritonitis (FIP), which is caused by feline infectious peritonitis virus (FIPV), is a fatal and immunologically mediated infectious disease among cats. At present, due to the atypical clinical symptoms and clinicopathological changes, the clinical diagnosis of FIP is still difficult. The gold standard method for the differential diagnosis of FIP is immunohistochemistry (IHC) which is time-consuming and requires specialized personnel and equipment. Therefore, a rapid and accurate clinical diagnostic method for FIPV infection is still urgently needed. In this study, based on the etiological investigation of FIPV in parts of southern China, we attempted to explore a new rapid and highly sensitive method for clinical diagnosis. The results of the etiological investigation showed that the N gene of the FIPV BS8 strain had the highest homology with other strains. Based on this, a specific FIPV BS8 N protein monoclonal antibody was successfully prepared by expression of the recombinant proteins, immunization of mice, fusion and selection of hybridoma cell lines, and screening and purification of monoclonal antibodies. Furthermore, we carried out a time-saving combination method including indirect immunofluorescence assay (IFA) and nested reverse transcription polymerase chain reaction (RT-nPCR) to examine FIP-suspected clinical samples. These results were 100% consistent with IHC. The results revealed that the combined method could be a rapid and accurate application in the diagnosis of suspected FIPV infection within 24 hours. In conclusion, the combination of IFA and RT-nPCR was shown to be a fast and reliable method for clinical FIPV diagnosis. This study will provide insight into the exploitation of FIPV N antibodies for the clinical diagnosis of FIP-suspected ascites samples.

Material Design for Next-Generation mRNA Vaccines Using Lipid Nanoparticles

Vaccine development is among the critical issues for ceasing the COVID-19 pandemic. This review discusses the current usage of biomaterials in vaccine development and provides brief descriptions of the vaccine types and their working mechanisms. New types of vaccine platforms (next-generation vaccines and DNA- or mRNA-based vaccines) are discussed in detail. The mRNA vaccine encoding the spike protein viral antigen can be produced in a cell-free system, suggesting that mRNA vaccines are safer than "classic vaccines" using live or inactivated virus. The mRNA vaccine efficacy is typically high at approximately 95%. However, most mRNA vaccines need to be maintained at −20 or −70 degrees for storage for long periods (half a year) and their transportation because of mRNA vaccine instability in general, although mRNA vaccines with unmodified and self-amplifying RNA (ARCT-154, Arcturus), which have a lyophilized form, have recently been reported to be kept at room temperature. mRNA vaccines are typically entrapped in lipid nanoparticles composed of ionizable lipids, polyethylene glycol (PEG)-lipids, phospholipids, and cholesterol. These components and their composition affect mRNA vaccine stability and efficacy and the size of the mRNA vaccine. The development of an improved mRNA vaccine entrapped in sophisticated biomaterials, such as novel lipid nanoparticles, using new types of biopolymers or lipids is necessary for high efficacy, safe transportation and long-term storage of the next generation of mRNA vaccines under mild conditions. [ FROM AUTHOR] Copyright of Polymer Reviews is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Safety of COVID-19 vaccination among patients with history of allergic reactions.

Introduction: Vaccination is considered the most effective method of preventing diseases and their complications. Unfortunately, many people question their legitimacy and safety. At the beginning of 2021, a few months after the announcement of the SARS-CoV-2 pandemic by the World Health Organization (WHO), the first COVID-19 vaccines were granted a conditional marketing authorization. mRNA vaccines have attracted great interest due to the use of new technology and the content of polyethylene glycol (PEG 2000) in their composition, which may induce anaphylaxis. Due to vaccine tolerance concerns, some vaccination centres have refused to administer the vaccine to patients. Aim(s): Risk assessment of allergic reactions after administration of the COVID-19 vaccine. Material(s) and Method(s): 115 patients were admitted to the Department of Allergology and Clinical Immunology in Katowice, including 107 patients with a high risk of anaphylaxis after vaccination according to the referring physician and 8 patients with a history of hypersensitivity reactions after the first dose of COVID-19 vaccination. Patients were referred for diagnosis of hypersensitivity to components of the Pfizer/BioNTech COVID-19 vaccine and administration of the vaccine in a hospital setting. During hospitalization, all patients underwent skin prick and intradermal tests with the Pfizer/BioNTech COVID-19 vaccine components, with negative results. Patients were administered the Pfizer/BioNTech COVID-19 vaccine intramuscularly, followed by at least 60 minutes of observation in the Department. Result(s): No symptoms of early hypersensitivity were observed. One patient developed urticarial lesions on the skin of the neck approximately 4-5 hours after vaccination. Conclusion(s): The risk of anaphylaxis after COVID-19 vaccine administration is low, and only a small group of patients with an allergic history require a specialised diagnostics. Physicians authorised to administer the vaccine should be acquainted with the latest recommendations, assess the risk of anaphylaxis and avoid unnecessary delays in administering a vaccine that can protect against severe morbidity and death.Copyright © 2023, Termedia Publishing House Ltd.. All rights reserved.