Asthma in the elderly and COVID-19: results of the 90-day post-hospital follow-up.

Background. After the first wave of the new SARS-CoV-2 coronavirus infection, the researchers focused on identifying potential short-and long-term complications of COVID-19, especially in high-risk patients, after prolonged hospitalization and intensive care. Objective. To study the outcomes, adverse effects of severe COVID-19 and their predictors 90 days after hospital discharge in elderly patients with asthma. Material and methods. The study included elderly patients (101 subjects, 42 males and 59 females;median age 74 (67;79) years) with asthma, discharged from the hospital after treatment of severe COVID-19. They were followed up for 90 days after discharge. In the hospital, COVID-19 was confirmed by laboratory tests (polymerase chain reaction method) and/or clinically and radiologically. All patients had a documented history of asthma according to GINA 2020 criteria. Results and discussion. During the 90-day post-hospital follow-up, 86 (85%) patients survived, and 15 (15%) died after discharge. Deaths were reported within 1 to 4 weeks after discharge: 6 subjects died during re-hospitalization, 6 at home, and 3 in a rehabilitation center. The multivariate regression analysis model, adjusted for all statistically significant indicators, and the ROC analysis showed the most significant predictors of 90-day post-hospital mortality and their threshold values. They include the Charlson comorbidity index >=4 points, lung damage according to computed tomography >=30%, the absolute number of eosinophils <=100 cells/muL, and concomitant diabetes mellitus. The analysis showed that 90-day post-hospital mortality depends on combinations of identified risk factors;a combination of two, three, and especially four risk factors statistically significantly is associated with patients' lower average survival time. Conclusion. The key risk factors for 90-day post-hospital mortality in elderly patients with asthma after severe COVID-19 include the Charlson comorbidity index, lung damage >=30% according to computed tomography, the absolute number of eosinophils <=100 cells/muL, and concomitant diabetes mellitus. The 90-day post-hospital survival rate is correlated with the number of risk factors identified in patients. The effect of asthma severity on 90-day post-hospital mortality in elderly patients was not observed.Copyright © 2023, Media Sphera Publishing Group. All rights reserved.

Post-authorization safety surveillance of Ad.26.COV2.S vaccine: Reports to the Vaccine Adverse Event Reporting System and v-safe, February 2021-February 2022.

BACKGROUND: On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system. METHODS: VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated. RESULTS: During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care. CONCLUSION: Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis.

Cutaneous Adverse Events After COVID-19 Vaccination.

Purpose: The morphology and timing of cutaneous reactions after Coronavirus disease (COVID-19) vaccines have been well described; however, data on the rates and risk factors are limited. Therefore, this study aimed to measure the incidence of cutaneous adverse reactions (CARs) after COVID-19 vaccination in Thailand, describe the rash characteristics according to the doses or types of vaccine, and assess the risk factors for developing CARs. Patients and Methods: This was a prospective observational study of adults who received COVID-19 vaccination and provided informed consent. Cutaneous diagnoses were made by expert dermatologists with supporting skin biopsies, as needed. Data were analyzed using descriptive statistics and logistic regression to examine the independent risk of developing a CAR. Results: Between July 2021 and January 2022, 7505 participants were vaccinated. Vaccine-related CARs occurred in 92 patients with an overall risk of 1.2%. CARs occurred after the first (n=41), second (n=23), third (n=27), and fourth (n=1) doses. Among the 92, 75 (81%) developed CARs within 7 days and 61 (66%) resolved within 7 days. Urticaria, injection site reaction, and a delayed (≥ 3 days post vaccine) local reaction were the three most common CARs occurring in 59 cases (64%). In total, 51 (55%) patients received only symptomatic and supportive treatment. Underlying urticaria and psoriasis were the independent factors for developing a CAR: adjusted odd rations of 15.63 (6.02-40.57, p < 0.001) and 5.36 (1.57-18.36, p = 0.007), respectively. A total of 6/34 (17%) and 4/31 (12%) patients developed urticarial and psoriasis flare post vaccine. Our study found superficial perivascular and intraepidermal eosinophil infiltration, which may be unusual pathological findings in vaccine-induced pemphigus foliaceous. Conclusion: CARs after COVID-19 vaccination had a low incidence and were mostly mild in severity and transient in nature. Underlying urticaria and psoriasis were risk factors for CAR development.

Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system.

Background: Risankizumab, a humanized IgG1 monoclonal antibody that selectively inhibits IL-23, is currently approved for the treatment of moderate-to-severe plaque psoriasis and Crohn's disease. The real-world safety study of risankizumab in a large- sample population is currently lacking. The aim of this study was to evaluate risankizumab-associated adverse events (AEs) and characterize the clinical priority through the data mining of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods: Disproportionality analyses were performed by calculating the reporting odds ratios (RORs), deemed significant when the lower limit of the 95% confidence interval was greater than 1, to quantify the signals of risankizumab-related AEs from the second quarter (Q2) of 2019 to 2022 Q3. Serious and non-serious cases were compared, and signals were prioritized using a rating scale. Results: Risankizumab was recorded in 10,235 reports, with 161 AEs associated with significant disproportionality. Of note, 37 PTs in at least 30 cases were classified as unexpected AEs, which were uncovered in the drug label, such as myocardial infarction, cataract, pancreatitis, diabetes mellitus, stress, and nephrolithiasis. 74.68%, 25.32%, and 0% PTs were graded as weak, moderate, and strong clinical priorities, respectively. A total of 48 risankizumab-related AEs such as pneumonia, cerebrovascular accident, cataract, loss of consciousness, cardiac disorder, hepatic cirrhosis, and thrombosis, were more likely to be reported as serious AEs. The median TTO of moderate and weak signals related to risankizumab was 115 (IQR 16.75-305) and 124 (IQR 29-301) days, respectively. All of the disproportionality signals had early failure type features, indicating that risankizumab-associated AEs gradually decreased over time. Conclusion: Our study found potential new AE signals and provided valuable evidence for clinicians to mitigate the risk of risankizumab-associated AEs based on an extensive analysis of a large-scale postmarketing international safety database.

Orbital Cellulitis following COVID-19 Vaccination.

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.

Four cases of audio-vestibular disorders related to immunisation with SARS-CoV-2 mRNA vaccines.

OBJECTIVE: To gain medical insight into the clinical course and safety of otolaryngologic disorders following immunisation with severe acute respiratory coronavirus (SARS-CoV-2) mRNA-based vaccines. DESIGN: Case description. STUDY SAMPLE: We report four cases of transient audio-vestibular symptoms, which occurred shortly after inoculation of two BNT162b2 (Pfizer-BioNTech®) and mRNA-1273 (Moderna®) vaccines. RESULTS: Hearing loss was unilateral in all cases and recovered at least partially: it was associated with persistent gait instability in two cases, after 1 and 7 months. Trigger mechanisms underpinning audio-vestibular impairment remain uncertain. Immune tolerance mechanisms with off-target innate activation of T-lymphocytes may be involved in vestibulocochlear nerve disorders, as for other cranial nerves involvement. CONCLUSIONS: The occurrence of audio-vestibular manifestations following mRNA-based vaccines needs ENT monitoring to support their causality in such rare vaccine-related adverse events. Audio-vestibular disorders appeared of transitory nature, including hearing loss, and should not deter further efforts in large-scale vaccination campaigns against SARS-CoV-2.

Attitudes towards and safety of the SARS-CoV-2 inactivated vaccines in 188 patients with systemic lupus erythematosus: a post-vaccination cross-sectional survey.

Vaccination is key in mastering the COVID-19 pandemic. Data on attitudes towards and safety of the SARS-CoV-2 inactivated vaccines in patients with systemic lupus erythematosus (SLE) are limited. A post-vaccination cross-sectional survey was conducted to obtain data on attitudes towards and safety of the SARS-CoV-2 inactivated vaccines in SLE patients compared to healthy controls. A post-vaccination cross-sectional survey was conducted in 188 patients with SLE and in 190 healthy controls who had received at least one dose of SARS-CoV-2 inactivated vaccine to find out post-vaccination adverse event (AE) or SLE flares. A total of 188 patients with SLE and 190 healthy controls vaccinated with the two-dose regimen SARS-CoV-2 inactivated vaccine were enrolled in the study. The two groups were matched in age, sex, medical background, income, and education level. All the SLE patients were in disease remission or with low disease activity with a median age of 35 years, a sex constituent ratio of 87.4% female, and a median disease duration of 4 years. SLE patients had much more concerns about vaccination safety (44.7% vs. 15.8%, P < 0.001), and were much less willing to get vaccinated (57.4% vs. 88.4%, P < 0.001). SLE patients had more mild adverse events after the first vaccine dose (43.6% vs. 25.3%, P = 0.008), and less mild adverse events after the second vaccine dose (19.8% vs. 34.9%, P = 0.024), compared with healthy controls. The AEs were minor and there were no serious or major adverse events in both groups. In patients with SLE, the post-vaccination disease activity remained stable. One previously undiagnosed female progressed into symptomatic SLE after one week of vaccination. Although SLE patients had concerns about the safety of the SARS-CoV-2 vaccines, the inactivated vaccination was safe in patients with stable SLE.

COVID-19 vaccine short-term adverse events in the real-life family practice in Krakow, Poland.

BACKGROUND: In manufacturers' trials, vaccination against COVID-19 proved to be safe and effective. The officially reported frequency of vaccine adverse events (VAEs) in Poland is lower than that declared by the manufacturers. The anti-vaccination activists questioned the trustworthiness of official data. OBJECTIVES: The aim was to explore the real-life prevalence of VAEs in general practice settings and the factors that may influence it. METHODS: In this pragmatic, mixed prospective and retrospective study, patients vaccinated against COVID-19 between May and October 2021 in three GP practices in Krakow, Poland, were enrolled. Their demographic (age, sex, level of education) and clinical data (weight and height, smoking status, history of allergies, COVID-19 and chronic diseases) were collected. Then, they were interviewed about VAEs they experienced. RESULTS: Out of 1530 patients invited to participate, 1051 (69%) agreed and were eligible for analyses. Only 8.8% did not report any VAE. Pain at the injection site was the most frequently reported reaction (800, 76.2%). The most prevalent systemic ones were excessive fatigue/lethargy (527, 50.6%), sleep/circadian rhythm disturbances (433, 41.6%) and headache (399, 38.3%). Fifty required medical assistance - 39 experienced presyncope (3.7%) and 11 loss of consciousness (1.1%). Only two others were hospitalised. Females, younger adults, those with higher education and with a history of COVID-19 reported systemic VAEs more frequently, while those who were older and obese were less likely to report local reactions. CONCLUSION: Although more than 90% of patients vaccinated against COVID-19 in general practice settings may experience VAEs, in short-term observation, the vast majority are localised and mild.

Investigating the risk of deep vein thrombosis with JAK inhibitors: a disproportionality analysis using FDA Adverse Event Reporting System Database (FAERS).

BACKGROUND: Janus kinase (JAK) inhibitors are immune-modulating medications used to treat conditions including rheumatoid arthritis, COVID-19, ulcerative colitis, atopic dermatitis, myelofibrosis, and polycythemia Vera. However, these medications have been associated with higher incidence of deep vein thrombosis. The objective of this study was to investigate potential safety signals for DVT associated with JAK inhibitors using disproportionality analysis from the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: The authors retrospectively investigated case/non-case analysis using Openvigil 2.1-MedDRA-v24 (2004Q1 to 2022Q4). The preferred term used was 'deep vein thrombosis,' and the drugs included were baricitinib, tofacitinib, and upadacitinib. Reporting odds ratio, proportional reporting ratio, and information component were used to detect signals. RESULTS: Overall 114,005 AE reports related to JAK inhibitors were identified, of which 647 reports (baricitinib - 169, tofacitinib - 425, and upadacitinib - 53) associated with DVT were obtained from FAERS. On analysis, baricitinib and tofacitinib had greater signal strength for age group of 65-100 years and all three had the highest signal strength for male gender. CONCLUSIONS: Our study identified signals for DVT with baricitinib, tofacitinib, and upadacitinib. Further research using well-designed epidemiological data is needed to validate these results.

Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the EU DisCoVeRy clinical trial.

The current COVID-19 pandemic was an exceptional health situation, including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different drug candidates were proposed. In this article, we present the challenges for an academic Safety Department to manage the global safety of a European trial during the pandemic. The National Institute for Health and Medical Research (Inserm) conducted a European multicenter, open-label, randomized, controlled trial involving three repurposed and one-in development drugs (lopinavir/ritonavir, IFN-ß1a, hydroxychloroquine, and remdesivir) in adults hospitalized with COVID-19. From 25 March 2020 to 29 May 2020, the Inserm Safety Department had to manage 585 Serious Adverse Events (SAEs) initial notification and 396 follow-up reports. The Inserm Safety Department's staff was mobilized to manage these SAEs and to report Expedited safety reports to the competent authorities within the legal timeframes. More than 500 queries were sent to the investigators due to a lack of or incoherent information on SAE forms. At the same time, the investigators were overwhelmed by the management of patients suffering from COVID-19 infection. These particular conditions of missing data and lack of accurate description of adverse events made evaluation of the SAEs very difficult, particularly the assessment of the causal role of each investigational medicinal product. In parallel, working difficulties were accentuated by the national lockdown, frequent IT tool dysfunctions, delayed implementation of monitoring and the absence of automatic alerts for SAE form modification. Although COVID-19 is a confounding factor per se, the delay in and quality of SAE form completion and the real-time medical analysis by the Inserm Safety Department were major issues in the quick identification of potential safety signals. To conduct a high-quality clinical trial and ensure patient safety, all stakeholders must take their roles and responsibilities.

[Recurrent livedo-like skin lesions following a vector-based COVID-19 vaccine]. / Rezidivierende Livedo-artige Hautveränderungen nach einer Vektor-basierten COVID-19-Impfung.

Starting in 2020, the global health system faced unprecedent challenges due to the coronavirus disease 2019 (COVID-19) pandemic and the consequences are still felt. All the more fascinating and of particular importance for health policy was the development of potent vaccines within about one year by several research groups after the first reports of COVID-19 infections. To date, three types of COVID-19 vaccines are available, i.e., messenger RNA-based vaccines, adenoviral vector vaccines, and inactivated whole-virus vaccines. We report a woman who developed reddish, partially urticarial skin lesions on her right arm and flank shortly after the first dose with the corona vaccination from AstraZeneca/Oxford (ChAdOx1). The lesions were transient, however reoccurred in loco and at other locations over several days. The clinical presentation was unusual and was correctly assigned due to the clinical course.

Challenges in Assessing COVID-19 Vaccines Safety Signals-The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft Rejection.

The rapid and large-scale roll-out of new COVID-19 vaccines has led to unprecedented challenges in assessing vaccine safety. In 2021, the European Medicines Agency (EMA) processed about 1.7 million safety reports related to COVID-19 vaccines in the EudraVigilance (EV) database and identified more than 900 potential signals. Beyond the large amount of information to be processed, the evaluation of safety signals has faced several difficulties and limitations, both in the assessment of case reports and in the investigation of databases. The evaluation of a signal of corneal graft rejection (CGR) with Vaxzevria® was no exception to this. In this commentary, we present the challenges encountered in making regulatory decisions in the context of evolving evidence and knowledge. The pandemic crisis emphasised the importance of quick and proactive communication to address the many questions and, above all, to ensure the transparency of safety data.

Identification of behavioural changes in reporting adverse events early during COVID-19: An ambulatory care perspective in Israel.

This study examined adverse event reporting centred on three significant dates in the months before the pandemic arrived in Israel. On these dates, broad media coverage exposed citizens and health care providers with indications about the forthcoming pandemic. The current study tracked whether parameters related to reporting adverse medical events provided early indications that a large crisis was unfolding. The method for analysing the data was based on a statistical test called Regression Discontinuity Design, which helped identify parameters related to medical reporting patterns which significantly changed. The examination indicated nurses' reports were unique in relation to others and indicated three phases: (1) upon declaration of the upcoming pandemic, there was a rise in reporting; (2) when the disease was named, there was moderation and maintenance in a steady quantity of reports, and finally, (3) when the first case arrived in Israel, a slight decrease in reporting began. Nurses' behaviours manifested as changes in reporting patterns. In this process of increase, moderation and decrease, it can be concluded that these are three stages that may characterise the beginning of a large event. The research method presented reinforces the need for forming tools by which significant events such as the COVID-19 pandemic can be identified quickly, and aid in proper planning of resources, optimise staffing and maximise utilization of the health systems.

Acute abducens nerve palsy with acute disseminated encephalomyelitis-like presentation following COVID-19 vaccination.

We report two adult cases of abducens nerve palsy presenting immediately (within weeks) after they received the first dose of Covishield vaccination. Magnetic resonance imaging (MRI) of the brain obtained after the onset of diplopia demonstrated demyelinating changes. The patients had associated systemic symptoms. Post-vaccination demyelination typically known as acute disseminated encephalomyelitis (ADEM) associated with several vaccines is more common in children. Although the mechanism of the nerve palsy remains unclear, it is suspected to be related to the post-vaccine neuroinflammatory syndrome. Cranial nerve palsies and ADEM-like presentations may represent part of the neurologic spectrum following COVID-vaccination in adults, and ophthalmologists should be aware of these sequelae. Although cases of sixth nerve palsy following COVID vaccination are already reported, associated MRI changes have not been reported from India.

Facial Palsy Induced by Covaxin in Adolescent Female - A Rare Case Report.

BACKGROUND: The world has seen nearly 2 years of a pandemic caused by the SARS-CoV-2 virus, notoriously known as COVID-19. Several vaccines have been approved under Emergency Use Authorization (EUA) to combat the disease, one of which is Covaxin, an inactivated adjuvant SARSCoV- 2 vaccine that is generally well tolerated and has fewer side effects. However, we recently have seen a rare case of facial palsy (paralysis) following Covaxin vaccination in an adolescent girl. CASE PRESENTATION: A 16 years old adolescent girl presented with chief complaints of left side deviation of mouth with difficulty in closing right eye after 29 days of receiving the first dose of Covaxin, which was finally diagnosed as a "Covaxin induced facial palsy". Her symptoms were alleviated with some supportive measures, steroid and antiviral treatment, with full recovery. CONCLUSION: The case depicts facial nerve paralysis following Covaxin use, possibly the first of its kind. This case illustrates plausible explanation to Covaxin use and occurrence of facial palsy, however, further studies required to establish causal relationship.

Structure of Adverse Events Following Immunisation against Coronavirus Infection (COVID-19) in the Kyrgyz Republic.

There is considerable interest worldwide in developing safe and effective vaccines against COVID-19. Pharmacovigilance of adverse events following immunisation (AEFIs) is a key to making informed decisions regarding the global COVID-19 vaccination campaign. In the Kyrgyz Republic, there have been developed a national immunisation information system (IIS) for automated recording of vaccines, vaccinated persons, and AEFIs and a mobile application for AEFI reporting, called Den Sooluk. The aim of the study was to analyse the pattern of AEFIs against COVID-19 in the Kyrgyz Republic. Material(s) and Method(s): the study analysed the spontaneous safety reports submitted to the national IIS database through the Den Sooluk mobile application from 29.03.2021 to 25.09.2022. Result(s): according to the data available by 25.09.2022, the total number of vaccinated people in the country amounted to 2,940,082. At the time, the IIS database included 2111 AEFIs: 1 fatal (and coincidental), 3 severe and 2108 minor ones. AEFIs were more frequent in the young and middle-aged population (81.5%), than in the elderly (18.5%). The following AEFIs were reported: injection site pain (21.25%), fatigue (20.7%), headache (19.8%), body temperature above 38 C (10.10%), miscellaneous symptoms (5.12%), chills (4.41%), dizziness (4.32%), sore throat (3.36%), myalgia (2.9%), and nausea (2.2%). Conclusion(s): all COVID-19 vaccines used in the Kyrgyz Republic can be considered adequately safe. Pharmacovigilance of AEFIs is an integral part of the requirements to ensure the safe use of vaccines, and collecting of spontaneous reports on AEFIs supports adequate functioning of the post-marketing surveillance system. It is essential to provide access to electronic information platforms to health professionals and patients in order to ensure vaccination transparency and coordination and enable quick and safe reporting of AEFIs associated with the use of COVID-19 vaccines.Copyright © NEICON ISP LLC. All rights reserved.

Comparing the Use of a Mobile App and a Web-Based Notification Platform for Surveillance of Adverse Events Following Influenza Immunization: Randomized Controlled Trial.

BACKGROUND: Vaccine safety surveillance is a core component of vaccine pharmacovigilance. In Canada, active, participant-centered vaccine surveillance is available for influenza vaccines and has been used for COVID-19 vaccines. OBJECTIVE: The objective of this study is to evaluate the effectiveness and feasibility of using a mobile app for reporting participant-centered seasonal influenza adverse events following immunization (AEFIs) compared to a web-based notification system. METHODS: Participants were randomized to influenza vaccine safety reporting via a mobile app or a web-based notification platform. All participants were invited to complete a user experience survey. RESULTS: Among the 2408 randomized participants, 1319 (54%) completed their safety survey 1 week after vaccination, with a higher completion rate among the web-based notification platform users (767/1196, 64%) than among mobile app users (552/1212, 45%; P<.001). Ease-of-use ratings were high for the web-based notification platform users (99% strongly agree or agree) and 88.8% of them strongly agreed or agreed that the system made reporting AEFIs easier. Web-based notification platform users supported the statement that a web-based notification-only approach would make it easier for public health professionals to detect vaccine safety signals (91.4%, agreed or strongly agreed). CONCLUSIONS: Participants in this study were significantly more likely to respond to a web-based safety survey rather than within a mobile app. These results suggest that mobile apps present an additional barrier for use compared to the web-based notification-only approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT05794113; https://clinicaltrials.gov/show/NCT05794113.

A febrile reaction is associated with high IgG antibody titers after the second and third BNT162b2 vaccination in Japan.

Adverse events are potentially associated with an IgG response after the BNT162b2 vaccination for severe acute respiratory syndrome coronavirus 2. In this study, we investigated the side effects of BNT162b2 vaccination using a health questionnaire and examined its relationship with IgG antibody titers. Serum samples were collected from participants 3 months after the second vaccination, just before the third vaccination, and 1 and 3 months after the third vaccination. A total of 505 participants who received three doses of vaccination were eligible for analysis. The results showed that post-vaccination body temperature correlated with anti-spike-receptor-binding domain (anti-S-RBD) antibody titers analyzed 3 months after the second (r = 0.30, p < 0.001) and third (r = 0.14, p < 0.001) vaccinations. Multivariate linear regression analysis revealed that age and severe swelling were negatively associated with log-transformed anti-S-RBD antibody levels, whereas sex (female), body temperature, and heat sensation were positively associated after the second vaccination. After the third vaccination, body temperature, and fatigue were positively associated with log-transformed anti-S-RBD antibody levels, and sex (female) was negatively associated. These results indicate that post-vaccination fever may be a marker of increased antibody titer.

The incidence and clinical characteristics of myocarditis and pericarditis following mRNA-based COVID-19 vaccination in Republic of Korea adolescents from July 2021 to September 2022.

OBJECTIVES: Age-specific information regarding myocarditis/pericarditis in adolescents following mRNA-based coronavirus disease 2019 (COVID-19) vaccination in Asia remains insufficient. This study investigated the incidence and clinical characteristics of myocarditis/pericarditis in Republic of Korea adolescents after mRNA-based COVID-19 vaccination. METHODS: This retrospective descriptive study utilized patient data from the Korea Immunization Management System. Incidence rates were calculated according to age and sex. Clinical characteristics (symptoms/signs, laboratory values, and imaging results) were compared between mild and severe cases. RESULTS: Between July 19, 2021 and September 30, 2022, 3,728,224 individuals aged 12 to 19 years received 6,484,165 mRNA-based COVID-19 vaccines, and 173 cases met the case definition for myocarditis/pericarditis: 151 mild (87.3%) and 22 severe (12.7%). The incidence was 3.8-fold higher in males than in females. Troponin I/ troponin T was elevated in 96% of myocarditis cases, demonstrating higher sensitivity than creatine kinase-myocardial band (67.6%) or C-reactive protein (75.2%). ST-segment or Twave on electrography abnormalities were found in 60.3% (85/141). Paroxysmal/sustained atrial/ventricular arrhythmias were more common in severe than in mild cases (45.5% vs. 16.8%, p=0.008). Edema on T2-weighted magnetic imaging occurred in 21.6% (8/37) and 62.5% (5/8) of mild and severe cases, respectively (p=0.03). Abnormal pericardial fluid collection or pericardial inflammation was found in 75.4% of pericarditis cases (49/65). CONCLUSION: Myocarditis/pericarditis occurred in rare cases following mRNA-based COVID-19 vaccination. Most cases were mild, but the incidence was higher in adolescent males and after the second dose. As bivalent severe acute respiratory syndrome coronavirus 2 mRNA vaccination started in Republic of Korea in October 2022, the post-vaccination incidence of myocarditis/pericarditis should be closely monitored, considering clinical characteristics.

Immune responses related to the immunogenicity and reactogenicity of COVID-19 mRNA vaccines.

Vaccination for the prevention of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) infection is considered the most promising approach to control the pandemic of coronavirus disease 2019 (COVID-19). Although various COVID-19 vaccines have been developed worldwide using several modalities, the vaccines that have shown the highest efficacy to date are mRNA vaccines. Despite their extensive usage, the mechanisms that stimulate the immune responses associated with their immunogenicity and reactogenicity remain largely unknown. In this review, we summarize and discuss current knowledge on immune responses to COVID-19 mRNA vaccines, including potential immune responses and correlating factors underlying the immunogenicity and reactogenicity of mRNA vaccines. We also describe recent trends in the optimization of lipid nanoparticles and vaccination routes. Further understanding of vaccine-elicited immune responses will guide the development of more effective and safe vaccines.