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1.
Future Microbiology ; 17:417-424, 2022.
Article in English | MEDLINE | ID: covidwho-1834212

ABSTRACT

Background: Emergence of vaccine-escaping SARS-CoV-2 variants is a serious problem for global public health. The currently rampant Omicron has been shown to possess remarkable vaccine escape;however, the selection pressure exerted by vaccines might pave the way for other escape mutants in the near future. Materials & methods: For detection of neutralizing antibodies, the authors used the recently developed HiBiT-based virus-like particle neutralization test system. Sera after vaccination (two doses of Pfizer/BioNTech mRNA vaccine) were used to evaluate the neutralizing activity against various strains of SARS-CoV-2.

2.
Internal Medicine ; 61(7):1033-1037, 2022.
Article in English | MEDLINE | ID: covidwho-1834090

ABSTRACT

A 28-year-old woman experienced gross hematuria after the administration of the second dose of an messenger ribonucleic acid (mRNA) vaccine (BNT162b2). She was diagnosed with Immunogloblin A nephropathy (IgAN) by a renal biopsy two weeks after vaccination, which revealed a mild increase in mesangial cells and a matrix with co-depositions of galactose-deficient IgA1 and C3 in the mesangial region. The gross hematuria and proteinuria gradually improved without any medication, suggesting that immune activation by the mRNA vaccine may not elicit continuous disease progression of IgAN. Thus, further studies investigating the relationship between mRNA vaccines against COVID-19 and the progression of IgAN should be conducted.

3.
PLoS ONE [Electronic Resource] ; 17(3):e0265011, 2022.
Article in English | MEDLINE | ID: covidwho-1833636

ABSTRACT

While mass vaccination campaigns against COVID-19 have inoculated almost 200 million Americans and billions more worldwide, significant pockets of vaccine hesitancy remain. Research has firmly established that vaccine efficacy is an important driver of public vaccine acceptance and choice. However, current vaccines offer widely varying levels of protection against different adverse health outcomes of COVID-19. This study employs an experiment embedded on a survey of 1,194 US adults in June 2021 to examine how communications about vaccine efficacy affect vaccine choice. The experiment manipulated how vaccine efficacy was defined across four treatments: (1) protection against symptomatic infection;(2) protection against severe illness;(3) protection against hospitalization/death;(4) efficacy data on all three metrics. The control group received no efficacy information. Subjects were asked to choose between a pair of vaccines-a one-dose viral vector vaccine or two-dose mRNA vaccine-whose efficacy data varied across the four experimental treatment groups. Efficacy data for each vaccine on each dimension were adapted from clinical trial data on the Johnson & Johnson/Janssen and Pfizer/BioNTech vaccines. Among all respondents, only modest preference gaps between the two vaccines emerged in the control group and when the two vaccines' roughly equivalent efficacy data against hospitalization and death were reported. Strong preferences for a two-dose mRNA vaccine emerged in treatments where its higher efficacy against symptomatic or severe illness was reported, as well as in the treatment where data on all three efficacy criteria were reported. Unvaccinated respondents preferred a one-dose viral vector vaccine when only efficacy data against hospitalization or death was presented. Black and Latino respondents were significantly more likely to choose the one-shot viral vector vaccine in the combined efficacy treatment than were whites. Results speak to the importance of understanding how communications about vaccine efficacy affect public preferences in an era of increasing uncertainty about efficacy against variants.

4.
AAPS PharmSciTech ; 23(5):135, 2022.
Article in English | PubMed | ID: covidwho-1833435

ABSTRACT

Lipid nanoparticles (LNPs) can be used as delivery vehicles for nucleic acid biotherapeutics. In fact, LNPs are currently being used in the Pfizer/BioNTech and Moderna COVID-19 vaccines. Cationic LNPs composed of 1,2-dioleoyl-3-trimethylammonium-propane (DOTAP)/cholesterol (chol) LNPs have been classified as one of the most efficient gene delivery systems and are being tested in numerous clinical trials. The objective of this study was to examine the effect of the molar ratio of DOTAP/chol, PEGylation, and lipid to mRNA ratio on mRNA transfection, and explore the applications of DOTAP/chol LNPs in pDNA and oligonucleotide transfection. Here we showed that PEGylation significantly decreased mRNA transfection efficiency of DOTAP/chol LNPs. Among non-PEGylated LNP formulations, 1:3 molar ratio of DOTAP/chol in DOTAP/chol LNPs showed the highest mRNA transfection efficiency. Furthermore, the optimal ratio of DOTAP/chol LNPs to mRNA was tested to be 62.5 µM lipid to 1 μg mRNA. More importantly, these mRNA-loaded nanoparticles were stable for 60 days at 4 °C storage without showing reduction in transfection efficacy. We further found that DOTAP/chol LNPs were able to transfect pDNA and oligonucleotides, demonstrating the ability of these LNPs to transport the cargo into the cell nucleus. The influence of various factors in the formulation of DOTAP/chol cationic LNPs is thus described and will help improve drug delivery of nucleic acid-based vaccines and therapies.

5.
BMJ Case Reports ; 15(4):29, 2022.
Article in English | MEDLINE | ID: covidwho-1832379

ABSTRACT

A middle age man with a history of diabetes mellitus type 2, hypertension, migraine and eosinophilic granulomatosis with polyangiitis (EGPA) with polyneuropathy in remission presented with paresthesia and motor weakness soon after receiving the Pfizer-BioNTech COVID-19 messanger RNA (mRNA) vaccine. The patient had polyneuropathy 10 years ago secondary to EGPA, which had resolved. EGPA was diagnosed on the basis of typical symptoms and positive sural nerve biopsy. Five days after receiving the first dose of COVID-19 vaccine, he developed heaviness and reduced dexterity of both the upper extremities, which progressed to patchy and asymmetric motor weakness of all four extremities. Given the lack of clear alternative explanation after a thorough work up, recrudescence of underlying asymptomatic polyneuropathy due to a possible reaction to COVID-19 mRNA vaccine was considered although a temporal association with vaccine dose does not prove causality. He was treated with corticosteroids with slow improvement of his symptoms.

6.
J Obstet Gynaecol Res ; 2022.
Article in English | PubMed | ID: covidwho-1832164

ABSTRACT

To investigate the vaccination status and adverse reactions to the COVID-19 vaccine among pregnant women in Japan, we conducted an online questionnaire survey from October 5 to November 22, 2021. The number of participants in the online survey was 6576. Of the participants, 4840 (73.6%) were vaccinated twice, and 557 (8.5%) were vaccinated once. A total of 1179 (17.9%) responders had never been vaccinated against COVID-19. The most frequent adverse reaction was local pain at the injection site. The incidence of local adverse reactions was almost identical after the first and the second vaccinations, while systemic reactions, such as fever and fatigue/malaise, and adverse reactions outside the vaccination site such as headache and arthralgia, were more frequent after the second vaccination than after the first vaccination. Regarding the obstetrical complications, uterine tension and/or contraction was observed in 1.65% of the pregnant women after the first vaccination and in 2.98% after the second vaccination, and uterine pain appeared in 1.06% of the pregnant women after the second vaccination. However, serious symptoms, such as hemorrhage, decreased fetal movement, edema, increased blood pressure, and amniorrhexis, were seen in less than 1% of vaccinated women after both the first and second vaccinations. This study clarified the characteristics of vaccination, adverse reactions, and obstetrical symptoms in pregnant women in Japan who had the COVID-19 vaccine up to the second dose. As a booster vaccination is currently underway, further study is needed to improve the management of pregnant women during the current pandemic.

7.
Journal of Clinical Psychopharmacology ; 42(3):317-320, 2022.
Article in English | MEDLINE | ID: covidwho-1831460
8.
Molecular Therapy: the Journal of the American Society of Gene Therapy ; 30(5):1941-1951, 2022.
Article in English | MEDLINE | ID: covidwho-1829691

ABSTRACT

Lipid nanoparticle (LNP)-formulated nucleoside-modified mRNA vaccines have proven to be very successful in the fight against the coronavirus disease 2019 (COVID-19) pandemic. They are effective, safe, and can be produced in large quantities. However, the long-term storage of mRNA-LNP vaccines without freezing is still a challenge. Here, we demonstrate that nucleoside-modified mRNA-LNPs can be lyophilized, and the physicochemical properties of the lyophilized material do not significantly change for 12 weeks after storage at room temperature and for at least 24 weeks after storage at 4degreeC. Importantly, we show in comparative mouse studies that lyophilized firefly luciferase-encoding mRNA-LNPs maintain their high expression, and no decrease in the immunogenicity of a lyophilized influenza virus hemagglutinin-encoding mRNA-LNP vaccine was observed after 12 weeks of storage at room temperature or for at least 24 weeks after storage at 4degreeC. Our studies offer a potential solution to overcome the long-term storage-related limitations of nucleoside-modified mRNA-LNP vaccines.

9.
EClinicalMedicine ; 45(29), 2022.
Article in English | CAB Abstracts | ID: covidwho-1828409

ABSTRACT

Background: mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) have been shown to be efficacious but have not been compared in head-to-head clinical trials.

11.
Internal Medicine Alert ; 44(9), 2022.
Article in English | ProQuest Central | ID: covidwho-1824365

ABSTRACT

Post-COVID-19 vaccination changes to the menstrual cycle have been reported, particularly through social media, but little evidence exists.1,2 Fewer than 200 individuals have self-reported menstrual disturbances through the Vaccine Adverse Event Reporting System. The authors of this retrospective analysis used prospectively collected menstrual cycle data from the FDA-cleared digital fertility awareness application “Natural Cycles” to assess associations between changes in the menstrual cycle or menses length and the COVID-19 vaccine. When stressors occur during the first half of the menstrual cycle (the follicular phase, when a dominant follicle is recruited and matures), cycle length can change.3 The immune response generated by mRNA vaccines could function as a stressor and temporarily affect the H-P-O axis, depending on the timing of vaccination. Because of the 21-day dosing schedule for the Pfizer mRNA vaccine and 28-day dosing schedule for the Moderna mRNA vaccine, receiving two doses in a single cycle necessitates that the first dose occurs during the early follicular phase for a normal cycling individual.

12.
Case Reports in Ophthalmology ; 13(1):124-127, 2022.
Article in English | ProQuest Central | ID: covidwho-1824043

ABSTRACT

This report describes a case of acute uveitis following COVID-19 vaccination. A 21-year-old patient was referred to our department for decreased visual acuity and injection of the left eye. Two days prior, the patient received her second dose of the severe acute respiratory syndrome coronavirus 2 vaccine (BNT162b2, Pfizer-BioNTech). On ocular examination, her left eye’s best-corrected visual acuity was 20/250, and its intraocular pressure was 16 mm Hg on a noncontact tonometer. Hypopyon, 4+ cells, and flares were observed in the anterior chamber. The patient was diagnosed with acute uveitis. She received topical dexamethasone (0.1%) hourly and systemic prednisone (50 mg/day). After 7 days, her inflammatory symptoms were mostly resolved. COVID-19 vaccination can cause acute anterior uveitis, which is responsive to steroids.

13.
Case Reports in Ophthalmology ; 13(1):210-214, 2022.
Article in English | ProQuest Central | ID: covidwho-1823996

ABSTRACT

A 72-year-old male patient was referred to our outpatient clinic with a painful left eye protrusion accompanied by marked conjunctival chemosis and external ophthalmoplegia being progressed despite topical and oral antibiotic therapy. He developed ocular symptoms 9 days after receiving his second SARS-CoV-2 vaccine (VeroCell). Of note, in previous history, 2 weeks after the first dose of the COVID-19 vaccine, he also developed a life-threatening laryngeal oedema treated at an emergency care unit. MRI of the orbit excluded pansinusitis as possible origin of the orbital cellulitis, and repeated COVID-19 antigen and antibody PCR tests were negative during his hospitalization. On the next day after his admittance, parenteral dexamethasone 250 mg/die treatment was commenced resulting in a quick and complete resolution of the symptoms. Due to the facts regarding this case, such as the temporal coincidence and the lack of respective comorbidity, there might be a causative relationship between the vaccination and the presented orbital cellulitis. To the best of our knowledge, this is the first report on orbital cellulitis as a possible ocular adverse event following COVID-19 vaccination.

14.
Journal of Neuroimmunology ; : 577883, 2022.
Article in English | ScienceDirect | ID: covidwho-1821374

ABSTRACT

Introduction Large-scale vaccination is considered one of the most effective strategies to control the pandemic of COVID-19. Since its start, different complications have been described thought to be related to vaccination. Here, we present a rare case where encephalopathy, myocarditis, and thrombocytopenia developed simultaneously following the second dose of Pfizer-BioNTech mRNA vaccine (BNT162b2). Case presentation A 15-years-old female presented with fever, altered consciousness, and convulsions after taking the second shot of the vaccine. Clinical and laboratory workup was notable for the presence of thrombocytopenia and myocarditis. No alternative causes of encephalitis were found. The patient responded significantly to methylprednisolone suggesting underlying immune pathogenesis responsible for the clinical features. The diagnostic criteria for possible autoimmune encephalitis were also fulfilled. Conclusion Although rare, the clinician should be aware of the possible adverse events following COVID-19 vaccination. Further research with large pooled data is needed to get more insight into its pathogenesis and causal relationship.

15.
eBioMedicine ; 80:104048, 2022.
Article in English | ScienceDirect | ID: covidwho-1821212

ABSTRACT

Summary Background COVID-19 mRNA vaccines elicit strong T and B cell responses to the SARS-CoV-2 spike glycoprotein in both SARS-CoV-2 naïve and experienced patients. However, it is unknown whether the post-vaccine CD4+ T cell responses seen in patients with a history of COVID-19 are due to restimulation of T cell clonotypes that were first activated during natural infection or if they are the result of new clones activated by the vaccine. Methods To address this question, we analyzed the SARS-CoV-2 spike glycoprotein-specific CD4+ T cell receptor repertoire before and after vaccination in 10 COVID-19 convalescent patients and 4 SARS-CoV-2 naïve healthy donor vaccine recipients. We used the viral Functional Expansion of Specific T cells (ViraFEST) assay to quantitatively identify specific SARS-CoV-2 and common cold coronavirus CD4+ T cell clonotypes post COVID-19 disease resolution and post mRNA SARS-CoV-2 vaccination. Findings We found that while some preexisting T cell receptor clonotypes persisted, the post-vaccine repertoire consisted mainly of vaccine-induced clones and was largely distinct from the repertoire induced by natural infection. Vaccination-induced clones led to an overall maintenance of the total number of SARS-CoV-2 reactive clonotypes over time through expansion of novel clonotypes only stimulated through vaccination. Additionally, we demonstrated that the vaccine preferentially induces T cells that are only specific for SARS-CoV-2 antigens, rather than T cells that cross-recognize SARS-CoV-2/common cold coronaviruses. Interpretation These data demonstrate that SARS-CoV-2 vaccination in patients with prior SARS-CoV-2 infection induces a new antigen-specific repertoire and sheds light on the differential immune responses induced by vaccination versus natural infection. Funding Bloomberg∼Kimmel Institute for Cancer Immunotherapy, The Johns Hopkins University, The Bill and Melinda Gates Foundation, NCI U54CA260492, NIH.

17.
Biomaterials ; : 121570, 2022.
Article in English | ScienceDirect | ID: covidwho-1821147

ABSTRACT

The mRNA vaccine technology has promising applications to fight infectious diseases as demonstrated by the licensing of two mRNA-based vaccines, Comirnaty® (Pfizer/BioNtech) and Spikevax® (Moderna), in the context of the Covid-19 crisis. Safe and effective delivery systems are essential to the performance of these vaccines and lipid nanoparticles (LNPs) able to entrap, protect and deliver the mRNA in vivo are considered by many as the current “best in class”. Nevertheless, current mRNA/LNP vaccine technology has still some limitations, one of them being thermostability, as evidenced by the ultracold distribution chain required for the licensed vaccines. We found that the thermostability of mRNA/LNP, could be improved by a novel imidazole modified lipid, DOG-IM4, in combination with standard helper lipids. DOG-IM4 comprises an ionizable head group consisting of imidazole, a dioleoyl lipid tail and a short flexible polyoxyethylene spacer between the head and tail. Here we describe the synthesis of DOG-IM4 and show that DOG-IM4 LNPs confer strong immunization properties to influenza HA mRNA in mice and macaques and a remarkable stability to the encapsulated mRNA when stored liquid in phosphate buffered saline at 4 °C. We speculate the increased stability to result from some specific attributes of the lipid's imidazole head group.

18.
Clinical Infectious Diseases ; : 5, 2022.
Article in English | Web of Science | ID: covidwho-1819773

ABSTRACT

COVID-19 breakthrough cases among vaccinated individuals demonstrate the value of measuring long-term immunity to SARS-CoV-2 and its variants. We demonstrate that anti-spike T-cell responses and IgG antibody levels are maintained but decrease over time and are lower in BNT162b2- versus mRNA-1273-vaccinated individuals. T-cell responses to the variants are relatively unaffected.

19.
Cancer Treatment Reviews ; : 102405, 2022.
Article in English | ScienceDirect | ID: covidwho-1819470

ABSTRACT

mRNA vaccines have gained popularity over the last decade as a versatile tool for developing novel therapeutics. The recent success of coronavirus disease (COVID-19) mRNA vaccine has unlocked the potential of mRNA technology as a powerful therapeutic platform. In this review, we apprise the literature on the various types of cancer vaccines, the novel platforms available for delivery of the vaccines, the recent progress in the RNA-based therapies and the evolving role of mRNA vaccines for various cancer indications, along with a future strategy to treat the patients. Literature reveals that despite multifaceted challenges in the development of mRNA vaccines, the promising and durable efficacy of the RNA in pre-clinical and clinical studies deserves consideration. The introduction of mRNA-transfected DC vaccine is an approach that has gained interest for cancer vaccine development due to its ability to circumvent the necessity of DC isolation, ex vivo cultivation and re-infusion. The selection of appropriate antigen of interest remains one of the major challenges for cancer vaccine development. The rapid development and large-scale production of mRNA platform has enabled for the development of both personalized vaccines (mRNA 4157, mRNA 4650 and RO7198457) and tetravalent vaccines (BNT111 and mRNA-5671). In addition, mRNA vaccines combined with checkpoint modulators and other novel medications that reverse immunosuppression show promise, however further research is needed to discover which combinations are most successful and the best dosing schedule for each component. Each delivery route (intradermal, subcutaneous, intra tumoral, intranodal, intranasal, intravenous) has its own set of challenges to overcome, and these challenges will decide the best delivery method. In other words, while developing a vaccine design, the underlying motivation should be a reasonable combination of delivery route and format. Exploring various administration routes and delivery route systems has boosted the development of mRNA vaccines.

20.
Clin Chem Lab Med ; 2022.
Article in English | PubMed | ID: covidwho-1817523

ABSTRACT

OBJECTIVES: The waning of humoral immunity after COVID-19 vaccine booster (third dose) has not yet been fully evaluated. This study updates data on anti-SARS-CoV-2 spike protein receptor binding domain (S-RBD) binding antibodies (bAb) and neutralizing antibodies (NAb) levels in individuals with homologous vaccination 3-4 months after receiving the booster dose. METHODS: Fifty-five healthcare workers (HCW) from Padova University-Hospital were asked to collect serum samples for determining antibodies (Ab) at 12 (t(12)) and 28 (t(28)) days, at 6 months (t(6m)) after their first Comirnaty/BNT162b2 inoculation, and 3-4 months after receiving the 3rd homologous booster dose. HCW were monitored weekly for SARS-CoV-2 infection. Ab titers were measured by two chemiluminescent immunoassays, one targeting the S-RBD immunoglobulin G (IgG), and one surrogate viral neutralization test (sVNT), measuring NAb. RESULTS: Twenty of the HCW had natural COVID-19 infection (COVID+) at different times, before either the first or the second vaccination. Median S-RBD IgG and NAb levels and their interquartile ranges 3-4 months after the 3rd dose were 1,076 (529-3,409) kBAU/L and 15.8 (11.3-38.3) mg/L, respectively, for COVID-, and 1,373 (700-1,373) kBAU/L and 21 (12.8-53.9) mg/L, respectively, for COVID+. At multivariate regression analyses, with age and gender included as covariates, S-RBD IgG bAb and sVNT NAb levels were closely associated with the time interval between serological determination and the 3rd vaccine dose (log(10) _(coeff)=-0.013, p=0.012 and log(10) _(coeff)=-0.010, p=0.025) for COVID+, whereas no such association was found in COVID- individuals. CONCLUSIONS: The third booster dose increases anti-SARS-CoV-2 Ab levels, elevated levels persisting for up to 3-4 months. Waning of Ab levels appears to be less pronounced for COVID+ individuals.

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