The role of miRNAs in viral myocarditis, and its possible implication in induction of mRNA-based COVID-19 vaccines-induced myocarditis.

Background: Several reports of unheeded complications secondary to the current mass international rollout of SARS-COV-2 vaccines, one of which is myocarditis occurring with the FDA fully approved vaccine, Pfizer, and others. Main body of the abstract: Certain miRNAs (non-coding RNA sequences) are involved in the pathogenesis in viral myocarditis, and those miRNAs are interestingly upregulated in severe COVID-19. We hypothesize that the use of mRNA-based vaccines may be triggering the release of host miRNAs or that trigger the occurrence of myocarditis. This is based on the finding of altered host miRNA expression promoting virus-induced myocarditis. Short conclusion: In conclusion, miRNAs are likely implicated in myocarditis associated with mRNA vaccines. Our hypothesis suggests the use of miRNA as a biomarker for the diagnosis of mRNA vaccine-induced myocarditis. Additionally, the interplay between viral miRNA and the host immune system could alter inflammatory profiles, hence suggesting the use of therapeutic inhibition to prevent such complications.

A Rare Case of Longitudinally Extensive Transverse Myelitis Following Pfizer-BioNTech COVID-19 Vaccination with a Favourable Outcome.

Introduction: mRNA COVID-19 vaccines are very safe, but rare adverse events such as transverse myelitis have been reported after COVID-19 vaccination. Case Description: We report the case of 50-year-old man who presented with progressive lower extremity weakness, back pain and urinary retention after his second dose of the Pfizer COVID-19 vaccine. MRI of the spine revealed longitudinally extensive transverse myelitis (LETM). He recovered completely after treatment with intravenous methylprednisone and physical therapy. Discussion: This case highlights the rare association between LETM and COVID-19 vaccines and encourages clinicians to maintain a high index of suspicion for prompt diagnosis and treatment. LEARNING POINTS: Longitudinally extensive transverse myelitis (LETM) is rare adverse events after mRNA COVID-19 vaccination.Clinicians should maintain a high index of suspicion for prompt diagnosis of vaccine-induced transverse myelitis.Vaccine-induced LETM should show marked clinical improvement after appropriate treatment.

Humoral Responses to Repetitive Doses of COVID-19 mRNA Vaccines in Patients with CAR-T-Cell Therapy.

Background: Due to B-cell aplasia following CAR-T-cell therapy, patients are at risk of severe SARS-CoV-2 course. Methods: COVID-19 vaccines were assessed by IgG antibody tests against SARS-CoV-2 spike protein (anti-S1/S2). Vaccination procedures: group (1): CAR-T-cells followed by two to four vaccine doses; group (2): Two vaccine doses prior to CAR-T-cells, followed by doses 3 or 4. Results: In group 1 (n = 32), 7/30 patients (23.2%) had positive antibody tests after a second dose, 9/23 (39.1%) after a third dose, and 3/3 patients after a fourth dose. A third dose led to seroconversion in 5 of 21 patients (23.8%) with available data, while a fourth dose did so in 2/3 patients. Higher B-cells (AUC: 96.2%, CI: 89-100, p = 0.0006) and lower CAR-T-cell copies (AUC: 77.3%, CI: 57-97, p = 0.0438) were predictive of positive humoral vaccine response. In group 2 (n = 14), 6/14 patients (42.9%) had a positive antibody test after a second dose, 3/8 patients (37.5%) after a third dose, and 3/4 patients after a fourth dose. A third dose led to seroconversion in 1/8 patients (12.5%), while a fourth dose did so in 3/4 patients. Conclusion: Additional vaccine doses increased seroconversion rates whilst high B-cell counts and low CAR-T-cell copy numbers were associated with positive antibody response.

Myths, misconceptions, and hesitancy in people residing in Qatar toward mRNA COVID-19 vaccines: An experience exchange from Qatar University health center.

The hesitancy in taking COVID-19 vaccines is a complex process influenced by several factors, including individual, social, and cultural. Health literacy and community awareness around mRNA COVID-19 vaccines are critical for successfully combating the pandemic. Healthcare professionals, including family physicians and nurses, can help increase community awareness and mitigate some misconceptions and hesitancy regarding mRNA COVID-19 vaccines in people's attitudes. Therefore, in this study, we aimed to explore how the interaction between an individual's social identities such as gender, ethnicity, culture, knowledge, and belief impact their hesitancy and attitudes toward mRNA COVID-19 vaccines. We aimed to describe our experience in dealing with people residing in Qatar from the perspective of healthcare practitioners from the Qatar University Health Center during the period when mRNA COVID-19 vaccines was introduced in a time frame of 6 months (April to October, 2021). We identified several factors associated with the reluctance to receive mRNA COVID-19 vaccines once vaccination services were available, affordable, and accessible to everyone in Qatar (Table 1). Most individuals were hesitant and refused to take mRNA COVID-19 vaccines owing to the unjustified myths and fear about potential side effects of vaccines in general and unknown long-term effects of vaccination, especially among women who were uneducated. We believe we have been able to put forth a fair, unbiased, and balanced argument between an individual's right to take or refuse the vaccine and the overall benefits to the public and community health in terms of the overall community immunity when the vast majority of the population will be vaccinated. Our experience could assist in developing culturally sensitive and tailored community outreach programs to increase community awareness as it is the cornerstone on which public health can fight the irrational myths, fear, misconceptions, vaccine hesitancy, and improve vaccination coverages. Moreover, our shared experiences might be able to better prepare future launching of pandemic vaccination campaigns in order to minimize vaccine hesitancy.

Myocarditis following AstraZeneca (an adenovirus vector vaccine) COVID-19 vaccination: A case report.

Coronavirus disease-19 (COVID-19) vaccines are massively administered globally and some adverse events, such as myocarditis, are being reported. Most of the reported cases of post-vaccination myocarditis have occurred following mRNA vaccinations. However, there have also been recent reports of myocarditis following adenovirus vector vaccinations. We present a case of a 32-year-old female patient who developed myocarditis following the administration of the first dose of the AstraZeneca vaccine. The patient developed inappropriate exertional tachycardia and exertional dyspnea from Day 3 and was diagnosed with myocarditis by subsequent echocardiography about 3 months later. We are unable to confirm a direct association between myocarditis and AstraZeneca vaccination. However, we would like to increase awareness regarding the possibility of developing myocarditis following AstraZeneca vaccination.

Delayed adverse reaction to a natural dermal filler mimicking salivary gland neoplasia.

Background: Cosmetic dermal fillers are a sought-after procedure globally. However, despite the safety claims of filler materials by the manufacturers, adverse reactions still occur. Case presentation: This case report is of a 66-year-old female who presented with a late-onset complication of a hyaluronic acid dermal filler that clinically mimicked a salivary gland neoplasm. The patient presented with firm peri-oral swellings of short duration that clinically mimicked a pleomorphic adenoma and mucoepidermoid carcinoma. The diagnosis was that of a foreign-body granulomatous response to dermal fillers. Although other mimics of a similar nature are reported a knowledgeable clinician, careful choice of filler material, knowledge of the product, thorough pre-procedural history taking and post-procedural patient follow-up can drastically minimize a possible misdiagnosis. The reaction was treated with a combination of hyaluronidase, betamethasone and 5-flurouracil intra-lesional injections monthly for 11 consecutive months, with total clinical resolution. Conclusions: Patient education of the procedure, product name and the possibility of an adverse reaction occurring, even years later or at a site distant to the initial site of placement, is vital. Further, we review the recent reported adverse association of the new mRNA COVID-19 vaccines and dermal filler placement.

mRNA COVID-19 Vaccines and Long-Lived Plasma Cells: A Complicated Relationship.

mRNA COVID-19 vaccines have hegemonized the world market, and their administration to the population promises to stop the pandemic. However, the waning of the humoral immune response, which does not seem to last so many months after the completion of the vaccination program, has led us to study the molecular immunological mechanisms of waning immunity in the case of mRNA COVID-19 vaccines. We consulted the published scientific literature and from the few articles we found, we were convinced that there is an immunological memory problem after vaccination. Although mRNA vaccines have been demonstrated to induce antigen-specific memory B cells (MBCs) in the human population, there is no evidence that these vaccines induce the production of long-lived plasma cells (LLPCs), in a SARS-CoV-2 virus naïve population. This obstacle, in our point of view, is caused by the presence, in almost all subjects, of a cellular T and B cross-reactive memory produced during past exposures to the common cold coronaviruses. Due to this interference, it is difficult for a vaccination with the Spike protein alone, without adjuvants capable of prolonging the late phase of the generation of the immunological memory, to be able to determine the production of protective LLPCs. This would explain the possibility of previously and completely vaccinated subjects to become infected, already 4-6 months after the completion of the vaccination cycle.

Myocarditis and COVID-19 mRNA vaccines: a mechanistic hypothesis involving dsRNA.

While tolerance to COVID-19 vaccination is considered satisfactory, a phenomenon of myocarditis, although rare, is becoming a safety concern in mRNA COVID-19 vaccination. The presence of low residual levels of double-strand RNA (dsRNA) has been reported in mRNA COVID-19 vaccine preparations. dsRNA is a known inducer of immune-inflammatory reactions. dsRNA present in vaccine nanoparticles may be suspected to be at the origin of the still unexplained cases of myocarditis.

Myocarditis and pericarditis in adolescents after first and second doses of mRNA COVID-19 vaccines.

AIMS: While some concerns about vaccination-related pericarditis and/or myocarditis have been raised, no published data are available on pericarditis and/or myocarditis with mRNA COVID-19 vaccines in the age group of adolescents, particularly 12-15 years. The objective of this study was to determine whether the risk of reporting pericarditis and/or myocarditis with mRNA COVID-19 vaccines varied according to dose of vaccination, age, sex, and type of pericarditis and/or myocarditis in adolescents between 12 and 17 years. METHODS AND RESULTS: We performed an observational study reviewing all reports of adolescents vaccinated with mRNA COVID-19 vaccines and recorded in VigiBase®, the World Health Organization global database of individual case safety reports. We included all reports registered between 1 January 2021 and 14 September 2021. Reporting odds ratios (RORs) with their 95% confidence interval (CI) were calculated to estimate the risk of reporting pericarditis and/or myocarditis. Among 4942 reports with mRNA COVID-19 vaccines in adolescents, we identified 242 pericarditis and/or myocarditis. Compared with the first dose of mRNA COVID-19 vaccines, the second dose was associated with an increased risk of reporting pericarditis and/or myocarditis (ROR 4.95; 95% CI 3.14, 7.89). The risk of reporting pericarditis and/or myocarditis was 10 times higher in boys than in girls and no difference between the two types of vaccines could be demonstrated. CONCLUSION: This investigation including only adolescent data suggests for the first time that the second dose of mRNA COVID-19 vaccines increases the risk of reporting myocarditis/pericarditis compared with the first dose particularly in boys without significant difference between tozinameran and elasomeran.

Reactogenicity within 2 weeks after mRNA COVID-19 vaccines: Findings from the CDC v-safe surveillance system.

BACKGROUND: Post-authorization monitoring of mRNA-based COVID-19 vaccines is needed to better characterize their reactogenicity. We assessed reactions reported during the 2 weeks after receipt of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines. METHODS: We monitored persons who enrolled in v-safe after vaccination health checkerSM, a U.S. smartphone-based vaccine monitoring system, after receiving BNT162b2 or mRNA-1273. V-safe participants received text message prompts to complete web-based surveys. We analyzed responses from persons who received BNT162b2 or mRNA-1273 from December 14, 2020 through March 14, 2021 and completed at least one survey by March 28, 2021. We measured the proportion of participants reporting local and systemic reactions solicited in surveys completed days 0 through 7 post-vaccination. For day 14 surveys, participants described new or worsening symptoms in a free-text response. We assessed the proportion of participants reporting new or worsening local and systemic reactions. RESULTS: One-third of participants were aged <45 years, two-thirds were female, and approximately half received BNT162b2 vaccine. A total of 4,717,908 participants reported during the 7 days after dose 1 and 2,906,377 reported during the 7 days after dose 2. Most reported at least one injection-site reaction (68.5% after dose 1; 72.9% after dose 2) or at least one systemic reaction (50.6% after dose 1; 69.5% after dose 2). Reactogenicity was greater after dose 2 and among mRNA-1273 recipients, persons aged <45 years, and females. New or worsening local and systemic reactions were uncommon during week 2 after either dose; the most frequent were local reactions for dose 1 mRNA-1273 recipients (2.6%). These reactions were reported more often among females after dose 1 mRNA-1273 (3.6%). CONCLUSIONS: During post-authorization monitoring among >4 million vaccinees, local and systemic reactions were commonly reported following mRNA-based vaccines. Reactions were most common during the first week following dose 2 and among persons aged <45 years, females, and mRNA-1273 recipients.

Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS).

BACKGROUND: The objective of this study is to assess cases of thrombocytopenia, including immune thrombocytopenia (ITP), reported to the Vaccine Adverse Event Reporting System (VAERS) following vaccination with mRNA COVID-19 vaccines. METHODS: This case-series study analyzed VAERS reports of thrombocytopenia after vaccination with Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. RESULTS: Fifteen cases of thrombocytopenia were identified among 18,841,309 doses of Pfizer-BioNTech COVID-19 Vaccine and 13 cases among 16,260,102 doses of Moderna COVID-19 Vaccine. The reporting rate of thrombocytopenia was 0.80 per million doses for both vaccines. Based on an annual incidence rate of 3.3 ITP cases per 100,000 adults, the observed number of all thrombocytopenia cases, which includes ITP, following administration of mRNA COVID-19 vaccines is not greater than the number of ITP cases expected. CONCLUSIONS: The number of thrombocytopenia cases reported to VAERS does not suggest a safety concern attributable to mRNA COVID-19 vaccines at this time.