Analysis of approaches to sterility testing of COVID-19 prevention vaccines.

Preventive vaccination against SARS-CoV-2 infection is currently receiving close attention in the Russian Federation. Improving public confidence in immunisation with new vaccines largely depends on a guarantee of the absence of side effects caused by contamination. A high risk of contamination is inherent to biological products, including coronavirus prevention vaccines, due to their properties and the nature of raw materials used. This risk adds to the need for using effective contaminant detection approaches. The aim of the study was to evaluate the possibility to improve sterility testing of preventive vaccines against SARS-CoV-2 infection. This article presents an analysis of the procedures proposed by pharmaceutical developers for sterility testing of ten Russian vaccines approved in the country for COVID-19 prevention. The authors considered specific characteristics of these vaccines, including their physical and chemical properties, the presence of antimicrobial components, and other critical factors affecting the correctness of the experimental setup. The results suggest that it is possible to improve sterility testing. According to the authors, the main directions for its improvement are the proposal to develop an alternative procedure based on compendial method 2 (OFS.1.2.4.0003.15, Ph. Rus. XIV), as well as the use of a universal culture medium. If used for refining the established procedures and developing new ones, the authors' recommendations will improve the reliability and applicability of sterility testing during both manufacturing and pre-approval regulatory assessment of updated coronavirus vaccines for subsequent release to the market. The proposed approaches can be applied to testing other medicinal products for sterility.Copyright © 2023 National Electronic-Information Consortium (NEICON). All rights reserved.

Misinformation as a Societal Problem in Times of Crisis: A Mixed-Methods Study with Future Teachers to Promote a Critical Attitude towards Information

Global society is facing major challenges, which are to be met by pursuing the Sustainable Development Goals (SDGs). Digitalization processes bring many opportunities for achieving SDGs, but they also bring pitfalls. For example, on one hand, social media makes it easier for more parts of society to participate. On the other hand, the ability to rapidly circulate unfiltered information can lead to the spread of misinformation and subsequently interfere with the achievement of SDGs. This effect could be observed during the COVID-19 pandemic and continues to occur in the context of climate change. Young people are especially likely to be exposed to misinformation on social media. With this in mind, it is enormously important for schools to prepare young people to critically handle the overload of information available online. The aim of this study was to provide future middle and high school teachers with a fruitful approach to foster a critical attitude towards information in classrooms. To this end, we expanded an existing approach by implementing active, technique-based inoculation and technique-based debunking within the COVID-19 content framework in a teacher education course. This implementation was monitored by a mixed-methods study with n = 24 future middle and high school teachers who participated in two courses in subsequent semesters. By performing statistical analysis on pretests and posttests and qualitative content analysis on reflective journal entries, we found that future teachers' self-efficacy expectations for detecting and debunking misinformation, as well as their debunking skills, increased throughout the courses. In addition, our results show that future teachers perceive active, technology-based inoculation as a helpful approach for their future teaching. They feel that this approach can be a way to implement education for sustainable development in schools with a focus on the promotion of critical thinking. In summary, we believe that the approach presented in this article may be beneficial for teaching the critical treatment of information in various thematic contexts. © 2023 by the authors.

COVID-associated pernio: Mechanistic insights to an abortive, seronegative SARS-CoV-2 infection

Introduction: SARS-CoV-2 replicates primarily in the airways but generates a systemic immune response mediated by Type I interferons (IFN-I). Pernio is a rare skin manifestation of disorders characterized by excessive IFN-I signalling. Although pernio increased in incidence during the pandemic, the relationship to SARS-CoV-2 remains controversial. Because of the pivotal nature of interferons in COVID-19 outcomes, pernio offers a window to investigate the biology underlying host resiliency to SARS-CoV-2 infection. Method(s): To further assess COVID-associated pernio, we characterized clinical samples from affected patients across 4 waves of the pandemic and investigated mechanistic feasibility in a rodent model. Patients were followed longitudinally with banking of blood and tissue. Golden hamsters were mock-treated or intra-nasally infected with SARS-CoV-2 and harvested at 3-and 30-days post-infection. Result(s): In affected tissue, immunophenotyping utilizing multiplex immunohistochemistry profiled a robust IFN-1 signature characterized by plasmacytoid dendritic cell activation. Viral RNA was detectable in a subset of cases using in situ hybridization for the SARS-CoV-2 S gene transcript. Profiling of the systemic immune response did not reveal a durable type 1 interferon signature. Consistent with previous literature, antibody and T-cell specific responses to SARS-CoV-2 were not detected. Nasopharyngeal SARS-CoV-2 inoculation in hamsters resulted in rapid dissemination of viral RNA and the generation of an IFN-I response that were both detectable in the paws of infected animals. Conclusion(s): Our data support a durable local IFN signature, with direct evidence of viral SARS-CoV-2 RNA in acral skin and suggest that COVID-associated pernio results from an abortive, seronegative SARS-CoV-2 infection.

Immune Responses and Pathogenesis following Experimental SARS-CoV-2 Infection in Domestic Cats.

Several reports demonstrated the susceptibility of domestic cats to SARS-CoV-2 infection. Here, we describe a thorough investigation of the immune responses in cats after experimental SARS-CoV-2 inoculation, along with the characterization of infection kinetics and pathological lesions. Specific pathogen-free domestic cats (n = 12) were intranasally inoculated with SARS-CoV-2 and subsequently sacrificed on DPI (days post-inoculation) 2, 4, 7 and 14. None of the infected cats developed clinical signs. Only mild histopathologic lung changes associated with virus antigen expression were observed mainly on DPI 4 and 7. Viral RNA was present until DPI 7, predominantly in nasal and throat swabs. The infectious virus could be isolated from the nose, trachea and lungs until DPI 7. In the swab samples, no biologically relevant SARS-CoV-2 mutations were observed over time. From DPI 7 onwards, all cats developed a humoral immune response. The cellular immune responses were limited to DPI 7. Cats showed an increase in CD8+ cells, and the subsequent RNA sequence analysis of CD4+ and CD8+ subsets revealed a prominent upregulation of antiviral and inflammatory genes on DPI 2. In conclusion, infected domestic cats developed a strong antiviral response and cleared the virus within the first week after infection without overt clinical signs and relevant virus mutations.

Anti-hepatitis B surface antigen as a biomarker for immunity acquisition against SARS-CoV-2

Background: More than a year has passed since the first coronavirus vaccines were widely used. However, some healthcare workers are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) despite full vaccination. The immune effect of SARSCoV- 2 vaccines attenuates in a few months in contrast to other universal vaccines, such as the hepatitis B vaccine, which have an immune effect that lasts for a longer time. In addition, the neutralizing antibody (Ab) titers can be measured only in limited medical institutions. In this study, we aimed to investigate the factors that predict SARS-CoV-2 infection in healthcare workers after vaccination. Method(s): In this study, we enrolled one thousand one hundred and thirty-three healthcare workers (826 women, 307 men) after second inoculation of the BNT162b2 vaccine (Pfizer /BioNTech) in February- April 2021. Medical checkups and self-reported questionnaires were used to collect medical histories and demographic characteristics. The Alinity SARS-CoV-2 IgG II Quant (Abbott) quantitative IgG spike protein serology assay was examined in a cohort of participants 1, 4, 6 months after the second vaccination, and 1 month after the third vaccination of the BNT162b vaccine. Lower Ab titers were defined under median at each time point. The relationships between SARS-CoV-2 infection and these factors were analyzed. Result(s): The mean observation period was four hundred and fortyeight days. The median titers at 1, 4, 6 months after the second vaccination were 9293 U/mL (interquartile range [IQR], 5840-14392 U/mL), 1658 U/mL (IQR, 999-2676) and 832 U/mL (IQR, 523-1300), respectively. The risk factors for lower Ab titers were age (60 years older, odds ratio [OR], 2.08), presence of current illness (OR 1.52), smoking habit (OR 2.36), and no fever after the second vaccination (OR 2.44). The median titers at 1 month after the third vaccination was 13780 U/mL (IQR, 9085-22722), and the risk factor for lower Ab titers was hepatitis B surface Ab (HBsAb) negative (OR 1.38). The total 1-year cumulative infection rate was 4.9%. The median infection period was three hundred and twenty days (IQR, 298-365) after the second vaccination. The risk factors of infection were age (30 s and 40 s), and HBsAb negative. The 1-year cumulative infection rate of 30-40 s and other ages were 6.6% and 3.7%, respectively (p<0.01). The 1-year cumulative infection rate of HBsAb negative participants with 30-40 s and other age were 7.7% and 4.9%, respectively (p = 0.064), while that of HBsAb positive participants with 30-40 s and other age were 6.7% and 1.7%, respectively (p<0.01). Conclusion(s): HBsAb and age can become prognostic factors to be infected with SARS-CoV-2 after vaccination. Especially, HBsAb negative people under 50 years old should pay attention to SARSCoV- 2 infection even after second vaccination.

Analysis of approaches to sterility testing of COVID-19 prevention vaccines

Preventive vaccination against SARS-CoV-2 infection is currently receiving close attention in the Russian Federation. Improving public confidence in immunisation with new vaccines largely depends on a guarantee of the absence of side effects caused by contamination. A high risk of contamination is inherent to biological products, including coronavirus prevention vaccines, due to their properties and the nature of raw materials used. This risk adds to the need for using effective contaminant detection approaches. The aim of the study was to evaluate the possibility to improve sterility testing of preventive vaccines against SARS-CoV-2 infection. This article presents an analysis of the procedures proposed by pharmaceutical developers for sterility testing of ten Russian vaccines approved in the country for COVID-19 prevention. The authors considered specific characteristics of these vaccines, including their physical and chemical properties, the presence of antimicrobial components, and other critical factors affecting the correctness of the experimental setup. The results suggest that it is possible to improve sterility testing. According to the authors, the main directions for its improvement are the proposal to develop an alternative procedure based on compendial method 2 (OFS.1.2.4.0003.15, Ph. Rus. XIV), as well as the use of a universal culture medium. If used for refining the established procedures and developing new ones, the authors' recommendations will improve the reliability and applicability of sterility testing during both manufacturing and pre-approval regulatory assessment of updated coronavirus vaccines for subsequent release to the market. The proposed approaches can be applied to testing other medicinal products for sterility.Copyright © 2023 National Electronic-Information Consortium (NEICON). All rights reserved.

Isolation and Characterization of Porcine Sapelovirus from the PDCoV-Positive Sample and Its Molecular Epidemiology in Henan Province, China

Porcine sapelovirus (PSV) is an emerging swine enteric virus that can cause various disorders including acute diarrhea, respiratory distress, reproductive failure, and polioencephalomyelitis in pigs. In this study, we isolated a PSV strain HNHB-01 from a clinical porcine deltacoronavirus- (PDCoV-) positive intestinal content of a diarrheic piglet. PSV was first identified using the small RNA deep sequencing and assembly, and further identified by the electron microscopic observation and the immunofluorescence assay. Subsequently, this virus was serially passaged in swine testis (ST) cells, and the complete genomics of PSV HNHB-01 passage 5 (P5), P30, P60, and P100 were sequenced and analyzed. 9 nucleotide mutations and 7 amino acid changes occurred in the PSV HNHB-01 P100 strain when compared with the PSV HNHB-01 P5. Pathogenicity investigation showed that orally inoculation of PSV HNHB-01 P30 could cause obvious clinical symptoms and had broad tissue tropism in 5-day-old piglets. Epidemiological investigation revealed that PSV infections and the coinfections of diarrhea coronaviruses were highly prevalent in swine herds. The complete genomes of 8 representative PSV epidemic strains were sequenced and analyzed. Phylogenetic analysis revealed that the PSV epidemic strains were closely related to other PSV reference strains that located in the Chinese clade. Furthermore, recombination analysis revealed that the recombination events were occurred in downstream of the 2C region in our sequenced PSV HNNY-02/CHN/2018 strain. Our results provided theoretical basis for future research studies of the pathogenic mechanism, evolutionary characteristics, and the development of vaccines against PSV.

SARS-CoV-2 VARIANTS-DEPENDENT INFLAMMASOME ACTIVATION

Background: Innate immunity is the first line of defense in response to pathogens, which acts locally and also leads the stimulation of adaptive immunity through at least with IL-1beta secretion. It has been shown that SARSCoV- 2 infection triggered the NLRP-3 inflammasome activation and the IL-1beta secretion. The aim of this study was to analyze and compare the level of IL-1beta secretion that is one of the most important innate immunity cytokines, in monocyte-like cells infected with 6 different variants of the SARS-CoV-2. Method(s): Six SARS-CoV-2 variants (historical (B.1, D614G), Alpha, Beta, Gamma, Delta and Omicron BA.1) were isolated from COVID-19 hospitalized patients. Viral stocks were obtained by inoculation in Vero and Vero-TRMPSS2 cells. THP-1 monocyte-like cells were cultured with RPMI-hepes 10% FBS-0.05 mM 2-mercaptoethanol. A total of 5 x 104 of THP-1 cells was plated per well in 96-wells plate and differentiated with 10nM of PMA for 24h. Differenciated- THP-1 were first primed with LPS 1mug/ml for 2h and infected with different SARS-CoV-2 variants with a MOI 0.1. IL-1beta was measured by luminescence in the supernatant after 24 h of infection. Result(s): We analyzed and compared IL-1beta secretion between SARS-CoV-2 virus 6 sublineages after infection of monocytes like THP-1. We observed that THP-1 cells infected with SARS-CoV-2 variants presented a significantly higher IL-1beta secretion than non-infected cells. Moreover, some SARS-CoV-2 variants led to a stronger IL-1beta secretion, and particularly we observed a significantly higher level of IL-1beta cells infected with Omicron BA.1 sublineage compared to other variants. Indeed, Omicron BA.1 infected cells presented the higher IL-1beta secretion (median 385.7 pg/ml IQR[302.6-426.3]) follows by the Delta variants and the historical variants (median 303.6 [266.3-391.9] and 281.9 [207.2-410], respectively). Alpha, Beta and Gamma variants presented the lowest IL-1beta secretion (median 228.1 [192.5-276.4], 219.1 [185.1-354.2] and 211 [149.8- 228.8]). Conclusion(s): We observed the inflammasome activation for the 6 SARS-CoV-2 sublineages with a variation in level of IL-1beta secretion. Indeed, our results suggested that Omicron BA.1 was more recognized by the innate immune cells than other SARS-CoV-2, which could in part, with its upper respiratory tract tropism, possibly explain its less clinical virulence. Taking together, these results suggest that the innate immunity response and precisely, IL-1beta secretion pathways were activated in a SARS-CoV-2 variants-dependent manner.

Comparing the effectiveness of virtual and semi-attendance Stress Inoculation Training [SIT] techniques in improving the symptoms of anxiety, depression, and stress of pregnant women with psychological distress: a multicenter randomized controlled trial.

BACKGROUND: Some studies indicate that more than 10% of pregnant women are affected by psychological problems. The current COVID-19 pandemic has increased mental health problems in more than half of pregnant women. The present study compared the effectiveness of virtual (VSIT) and semi-attendance Stress Inoculation Training (SIT) techniques on the improvement of the symptoms of anxiety, depression, and stress of pregnant women with psychological distress. METHODS: This study was conducted on 96 pregnant women with psychological distress in a 2-arm parallel-group, randomized control trial between November 2020 and January 2022. The semi-attendance SIT received treatment for six sessions, sessions 1, 3 and 5 as individual face-to-face and sessions 2, 4 and 6 as virtual once a week for 60 min continuously [n = 48], and the virtual SIT received six sessions simultaneously once a week for 60 min (n = 48) in pregnant women of 14-32 weeks' gestation referred to two selected hospitals. The primary outcome of this study was BSI-18 [Brief Symptom Inventory] and NuPDQ-17 [Prenatal Distress Questionnaire]. The secondary outcomes were the PSS-14 [Cohen's General Perceived Stress Scale]. Both groups completed questionnaires measuring anxiety, depression, pregnancy-specific stress, and generally perceived stress questionnaires before and after the treatment. RESULTS: The post-intervention results showed that the stress inoculation training technique in both VSIT and SIT interventions effectively reduced anxiety, depression, psychological distress, pregnancy-specific stress and general perceived stress [P < 0.01]. Also, the SIT interventions on decreasing anxiety [P < 0.001, η2 = 0.40], depression [P < 0.001, η2 = 0.52] and psychological distress [P < 0.001, η2 = 0.41] were more considerable than that of VSIT. However, There was no significant difference between SIT and VSIT intervention in terms of their effects on pregnancy-specific stress [P < 0.38, η2 = 0.01] and general stress [P < 0.42, η2 = 0.008]. CONCLUSION: The semi-attendance SIT group has been a more effective and practical model than the VSIT group, for reducing psychological distress. Therefore, semi-attendance SIT is recommended for pregnant women.

How I learned to hate you. Parasocial interactions in echo chambers and their spillover effects

This article analyzes the most influential posts on Facebook related to COVID-19, for the first two years of the pandemic, to explain how parasocial opinion leaders created echo chambers, in the Romanian public sphere, and to discuss the cumulative spillover effects these echo chambers had on society at large. A database of the 233,242 most influential posts in Romanian about COVID-19, from the first two years of the pandemic, is investigated using a mixed methods approach, to 1) verify statistically if issue-related echo chambers existed and 2) to describe, qualitatively, how they functioned. A special focus is devoted to trolling in the form of reactions to posts, such as haha reactions for messages about COVID-related deaths. Using the literature on parasocial interaction, inoculation theory, online disinhibition effect and echo chambers, the article shows how echo chambers supported trolling behavior, for radicalized Facebook users, how they polluted the public discussion and how they made dialog impossible for social groups that ended up identifying each other as the enemy. Based on these research results, the author proposes two policy recommendations for social platforms.

Is the COVID-19 bad news game good news? Testing whether creating and disseminating fake news about vaccines in a computer game reduces people's belief in anti-vaccine arguments.

Improving vaccination eagerness is crucial, especially during the ongoing COVID-19 pandemic and establishing new procedures to achieve that goal is highly important. Previous research (Roozenbeek & van der Linden, 2019a, 2019b) has indicated that playing the "Bad News" game, in which a player spreads fake news to gain followers, reduces people's belief in fake news. The goal of the present paper was to test an analogous new game called "COVID-19 Bad News (CBN)" to improve one's eagerness to vaccinate against coronavirus. CBN was constructed to examine whether creating and disseminating fake news focused on vaccinations and the COVID-19 pandemic has a similar effect and improves people's attitudes toward vaccination. Two experiments were conducted where participants played CBN or Tetris and afterwards evaluated the credibility of statements about vaccines against COVID-19 and finally filled out a questionnaire concerning their attitudes toward vaccination. The results show that playing CBN does not reduce evaluations of the credibility of all statements that are unfavorable to vaccines (false as well as true). Additionally, it does not enhance readiness to vaccinate. Future research and limitations are discussed.

Protecting against disinformation: Using inoculation to cultivate reactance towards astroturf attacks

The theoretically-driven inoculation strategy has increasingly become used to counter disinformation regarding pivotal societal issues such as COVID-19 and climate change. The current study examines its ability to cultivate psychological reactance toward unethical public relations attacks called astroturf, ultimately making the disinformation less persuasive. To do so, a between-subjects online experiment (N = 534) was conducted. Results show: 1) the use of inoculation messages outperforms the often-recommended paracrisis no response strategy, 2) combining inoculation with explicit details and autonomy support can elicit reactance toward disinformation, and 3) the use of this strategy can influence attitudes and future behavioral intentions to engage with the attacked organization. Guidance and implications for increasing the development of proactive PR messages within research and practice are discussed. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Polyethylene glycol sensitization in patients with recurrent urticaria: Something to consider before the administration of the mRNA COVID-19 vaccine

Background: Polyethylene glycol (PEG) and polysorbate are two commonly used excipients in cosmetics, therapeutics, and processed foods. They are used not just to stabilize and preserve but also to influence the pharmacokinetics and bioavailability of the active ingredients of these products. Numerous reports have described patients with recurrent urticaria self-reporting multiple unrelated products hypersensitivities. We aim to describe a case series of sensitization to PEG in patients with recurrent urticaria and its implications to the currently available COVID-19 vaccines in Malaysia. Method(s): Data of all patients during the peak vaccination period (March 2021 -May 2021) who had positive intradermal test to surrogate PEG and polysorbate 80 were retrieved and analyzed. They were tested with PEG 4000 (macrogol), PEG 400 (Systane Ultra eye drop) and polysorbate 80 (Tween 80). Result(s): A total of eight patients were skin test positive to PEG and/ or polysorbate 80. The mean age was 35.1 +/- 10.5 years. Only one patient was male. Everyone reported history of multiple product reactions with recurrent urticaria as the major symptom. Majority (75%) had multiple unrelated products hypersensitivities. Four of them had urticarial reactions after the first dose of mRNA vaccine. Two patients were skin test negative to the lower molecular weight PEG 400. Cross sensitization between PEG 4000 and polysorbate 80 was 100%. All patients were subsequently inoculated with two doses of inactivated virus COVID-19 vaccine without any serious sequalae. Conclusion(s): The validity of skin testing towards PEG is not yet clear. Nonetheless it is a promising tool in diagnosing PEG sensitization in selected patients reporting recurrent urticaria with multiple unrelated products. Pretesting of this select group may be considered before the inoculation of PEG-containing COVID-19 vaccine.

Research status of coronavirus disease 2019 mRNA vaccine-associated lymphadenopathy.

After administration of coronavirus disease 2019 (COVID-19) mRNA vaccine (BNT162b2 vaccine of Pfizer/BioNTech incorporation and mRNA-1273 vaccine of Moderna incorporation), some vacci- nators develop vaccination-associated lymphadenopathy (VAL). VAL usually occurs 2 to 4 days after vacci- nation, or 2 weeks later. The incidence of VAL after the second dose of vaccine is higher than that after the first dose. Some vaccinators develop VAL after both the first and second doses of vaccination. The clinical manifestations of VAL are enlarged lymph nodes with pain in axilla, supraclavicular, neck, and inguen on the same side of the inoculation site. Imaging examination shows enlarged lymph nodes with diffuse or focal cortical thickening, etc. The pathological diagnosis is benign reactive lymphadenopathy. VAL does not need treatment and generally subsides spontaneously 5 to 16 days after onset. The mechanism of lymphadenopathy after administration of COVID-19 mRNA vaccine is unclear.Copyright © 2021 Science Press (China).

Management of adverse reactions to COVID-19 vaccines by a Portuguese centre

Background: Since the introduction of COVID-19 vaccines, many reports have focused on adverse reactions. However, there is no global agreement on how to manage those patients. We aim to assess the management of adverse reactions by an immunoallergology department and its outcomes. Method(s): Retrospective analysis of the patients sent to our centre from January to October 2021 for adverse reactions to a COVID-19 vaccine, and who were considered ineligible for a 2nd dose by general practitioners. We collected data on the reported reactions, allergological study and outcomes. Result(s): 123 patients with adverse reactions were included (77% women, n = 95), mean age 55 years-old (min 12;max 92). Pfizer/ BioNTech Vaccine was inoculated in 64 patients (52%);Moderna in 15 (12%);AstraZeneca in 44 (36%). 65 patients (53%) presented symptoms compatible with allergic reactions: 86% (n = 56) with mucocutaneous symptoms, mainly urticaria-like lesions and/or angioedema;17% (n = 11) with suspected anaphylaxis and 5% (n = 3) with Steven-Johnson Syndrome. 19 patients performed skin testing with: PEG2000 (n = 17);polysorbate 80 (n = 15);COVID-19 vaccines (n = 21). Four patients had at least one positive test. 58 patients (47%) presented with non-allergic reactions. They showed great variability of symptoms. Most mild: 47% reported non-specific symptoms (such as malaise, headache, myalgia, fever, or fatigue) and 26% reported local reactions on the inoculation site. Some severe: 6 with deep vein or pulmonary thrombosis, 4 with myocarditis, 2 with stroke or myocardial infarction, and 1 with VITT. Patients with positive skin tests or severe previous reactions (n = 36, 29%) were referred for an alternative vaccine. Those with suspected allergic reaction but negative skin tests were premedicated with antihistamines before the 2nd dose. Follow-up showed: of the 81 patients (66%) who received an additional dose, 25% (n = 20) reported an adverse reaction, which was mild, and no case of anaphylaxis was reported. 16 (13%) refused a 2nd dose, and for 26 (21%) the information could not be obtained. Conclusion(s): The intervention of an allergologist had a significant positive impact on vaccination rates, with 2/3 of patients being reclassified as eligible for a 2nd dose. Allergological study and intervention identified vaccine-allergic patients and guided the decision on vaccine change and premedication, which resulted in a considerably lower number of adverse reactions to the 2nd dose, or at least its severity.

Adverse reactions to COVID-19 vaccines: Differences and similarities

Background: COVID-19 virus vaccines are associated with adverse events. We aim to characterize and compare adverse reactions to different COVID-19 vaccines in a Portuguese centre. Method(s): Retrospective analysis of patients with adverse reactions to COVID-19 vaccines referred to our Immunoallergology Department between January and October 2021. The patients were divided according to the vaccine used: Pfizer/BioNTech (Pf), Moderna (M), or AstraZeneca (AZ). Result(s): 123 patients were included. 64 patients (52%) reacted to the Pf vaccine (77% women, mean age 49 years old);15 (12%) to the M vaccine (87% females, mean age 50 years old);and 44 (36%) to the AZ vaccine (75% women, mean age 64.8 years old). All groups showed a higher number of non-immediate reactions (>6h after inoculation): 59% for Pf, 60% for M, and 91% for AZ. Reactions to Pf and M were more frequently allergic-like (63% and 60%, respectively). Reactions to AZ were predominantly non-allergic (64%). The most frequently reported reactions for Pf and M were: sensation of throat tightness (Pf 31%, M 20%), urticaria (Pf 30%, M 27%), angioedema (Pf 17%, M 33%), constitutional non-specific symptoms (Pf 25%, M 27%), and local reactions on the inoculation site (Pf 20%, M 33%). There were 8 (13%) patients with suspected anaphylaxis with Pf, 3 (20%) with M, and none with AZ. The most frequently reported reactions for AZ were cardiovascular events (30%): myocardial, cerebral or pulmonary thromboembolic events (n = 6), phlebitis (n = 5), myocarditis (n = 1), and vaccine-induced immune thrombotic thrombocytopenia (n = 1). Other common reactions were constitutional non-specific symptoms (32%), local reactions on the inoculation site (18%), urticaria (23%), angioedema (14%), and non-urticaria rash (14%). Conclusion(s): Adverse reactions were more common in women. The mRNA vaccines were more frequently associated with allergic-like reactions, including anaphylaxis. In contrast, AZ vaccine was associated with nonallergic cardiovascular reactions. Up to 1/3 of patients in each group reported constitutional non-specific symptoms and local reactions on the inoculation site.

Smallpox Immunization in Colonial America: All Too Relevant Today

Smallpox Immunization in Colonial America: All Too Relevant Today The Contagion of Liberty: The Politics of Smallpox in the American Revolution By Andrew Wehrman Baltimore, MD:Johns Hopkins Press;2022 Hardcover: 401 pp;$32.00 ISBN-10: 1-4214-4466-6 ISBN-13: 978-1-4214-4466-6

Correlation between antibody response and neutralization capability induced by SARS-COV- 2 vaccine BNT162b2 in the CORIMUN study

Background: In the last two years the pandemic Coronavirus Disease 19 (Covid19), caused by the virus SARS-CoV- 2, described for the first time in Wuhan (China) at the end of 2019, has caused over 359 million cases of infections and 5 million deaths worldwide. To fight this emergency, the pursuit of science has focused on vaccines development against SARS-CoV- 2, including the vaccine BNT162b2. This vaccine contains mRNA translating for SARS-CoV- 2 spike protein wrapped in lipid nanoparticles and its use was approved at the end of 2020. It has been proved that both the BNT162b2 vaccine and the SARS-CoV- 2 infection result in the production of neutralizing antibodies but remains to be clarified the duration of these responses, also versus variants of concern. Method(s): The present study aimed to prospectively analyse and correlate the antibody response and the neutralization capability induced by vaccination with BNT162b2 in a cohort of Sardinian subjects, including a group previously Cov2 infected. Each participant was evaluated for serum SARS-CoV2 Ab IgG RDB, 7 (T1) and 30 (T2) days after the second inoculum of BNT162b2, with chemiluminescent immunoassays (CLIA) and microneutralization assay (MNA) determining the highest serum dilution protecting 90 % of the infected wells. Result(s): All the participants, with or without previous infection, developed a positive antibody response (IgG anti-RBD > 1 AU/ml) within 7 and 30 days from the second vaccine dose and a strong correlation was found between IgG antibody levels and neutralizing activity. A strong difference was observed between the antibody levels of the naive subjects and the ones previously infected, specifically the antibody levels were higher (both at T1 and T2) in the latter group. No significant antibody differences were found for gender and age groups. In addition, there were no significant differences in antibody titre between healthy and immune-mediated subjects. Conclusion(s): In conclusion, this study confirms observed differences in vaccine responses between infection-naive and subjects with history of natural infection, with the presence in the second group of a significantly higher neutralizing and anti-RBD antibody titer. It also demonstrates the strong correlation between anti-RBD antibody titre and neutralizing activity, without significant differences between healthy subjects and subjects with immuno-mediated disease in the short-term. Further follow-up is ongoing in this cohort.

Mpox first skin lesion location: A reflection of mode of transmission?

The 2022 mpox outbreak affected 84,318 individuals in 110 countries. Mpox is transmitted by multiple modalities, including direct contact, respiratory droplets, and fomites among others. Identifying skin lesions aids prompt diagnosis. Variation in initial skin lesion location is not well understood;it is hypothesized that mode of transmission may determine primary inoculation site and subsequent clinical presentation. This study sourced healthcare provider-reported data from the AAD/ILDS Dermatology COVID-19, Mpox, and Emerging Infections Registry to explore factors related to the location of the first skin lesion in mpox cases. Out 119 mpox cases,115 had primary lesion location data. 97% were male with a median age of 37. Most (83/115, 72%) patients had first skin lesions in the genito-anal area, and 32/115 (27%) had lesions elsewhere or had morbilliform rash. 74% of males had the first lesion in the genito-anal region compared to females (25%, p=0.03). Males in same-sex relationships had ano-genital lesions more often than men in other relationships (77% vs. 44%, p=0.03). The type of mpox exposure was also associated with first lesion location: 83% of patients who contracted mpox from a spouse or other sexual contact had ano-genital lesions as compared to a non-sexual contact (0%, p=<0.01). This analysis characterized factors associated with the first mpox skin lesion location, which can aid healthcare providers in diagnosis and shed light on transmission. This data suggests that type of exposure and mode of transmission may be associated with primary lesion location;patients who contracted mpox from sexual contact were more likely to have ano-genital lesions.Copyright © 2023

COVID-19 vaccination in a patient with positive intradermal testing and likely PEG allergy

Case report Background: P olyethylene g lycol ( PEG) a llergy i s g enerally c onsidered a contraindication to COVID-19 mRNA vaccines as they are formulated in lipid nanoparticles that contain a PEGylated lipid. However, there is an uncertain risk of allergy to mRNA vaccines in PEG-allergic patients and sensitivity of skin testing in the diagnosis of PEG allergy is poor. Our patient presented to Allergy and Immunology Clinic with a history of systemic reaction to PEG (in bowel prep), now requiring a mRNA booster. The patient had tolerated two doses of the AstraZeneca vaccine prior but this vaccine was no longer available in our health region due to safety concerns. Method(s): The chart was reviewed, skin prick testing to polyethylene glycol (PEG) 3350 (Restoralax diluted in water) was negative. Intradermal testing to the Pfizer-BioNTech vaccine at a dilution of 1:100 was positive at 11mm. Histamine and saline controls were appropriate. Result(s): Graded administration of the Pfizer-BioNTech vaccine was offered and consent was obtained. The patient tolerated administration of the vaccine in four divided doses (0.03cc, 0.06cc, 0.09cc, and 0.12cc). The patient was observed for 20 minutes between doses and an hour after the last dose with no reaction. Conclusion(s): We found that skin test reactivity to the Pfizer-BioNTech COVID-19 vaccine, at a nonirritating concentration (1:100), does not reliably predict reactivity on vaccine inoculation. This case highlights that it is possible to safely administer COVID-19 mRNA vaccines to patients with positive intradermal testing to the vaccine and a high suspicion for PEG allergy.