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Background The immune response to COVID-19 vaccination is inferior in kidney transplant recipients (KTRs) and to a lesser extent in patients on dialysis or with chronic kidney disease (CKD). We assessed the immune response 6 months after mRNA-1273 vaccination in kidney patients and compared this to controls. Methods A total of 152 participants with CKD stages G4/5 (eGFR Results At 6 months after vaccination, S1-specific antibodies were detected in 100% of controls, 98.7% of CKD G4/5 patients, 95.1% of dialysis patients, and 56.6% of KTRs. These figures were comparable to the response rates at 28 days, but antibody levels waned significantly. Neutralization of the ancestral and Delta variants was detected in most participants, whereas neutralization of Omicron was mostly absent. S-specific T-cell responses were detected at 6 months in 75.0% of controls, 69.4% of CKD G4/5 patients, 52.6% of dialysis patients, and 12.9% of KTRs. T-cell responses at 6 months were significantly lower than responses at 28 days. Conclusions Although seropositivity rates at 6 months were comparable to rates at 28 days after vaccination, significantly decreased antibody levels and T-cell responses were observed. The combination of low antibody levels, reduced T-cell responses, and absent neutralization of the newly emerging variants indicates the need for additional boosts or alternative vaccination strategies in KTRs. Clinical Trials Registration NCT04741386. more...

Objectives: Scarce data are currently available on the kinetics of antibodies after vaccination with mRNA vaccines as a whole and, with mRNA-1273, in particular. We report here an ad-interim analysis of data obtained after a 6-month follow-up in a cohort of healthcare workers (HCWs) who received the mRNA-1273 vaccine. These new data provide more insight into whether and in whom a 3rd dose could be necessary. Methods: Our study compared the anti-S antibody kinetics at 2 weeks (T1), 3 months (T3) and 6 months (T4) after the first injection, and 2 weeks after the second injection (T2). The 201 participating HCWs were stratified according to their initial serological status. The vaccine effectiveness was also assessed through a medical questionnaire. Results: We report here a marked and statistically significant antibody decrease (P < 0.05) between T3 and T4, especially in naïve vaccinees. The analysis of potential confounding factors or known risk factors for severe COVID-19 disease did not reveal any influence on the drop observed. Six-month after vaccination, only one, symptomatic, infection was reported in our cohort. Conclusions: In a supply-limited environment, our results plead for reserving the 3rd dose scheme, in the upcoming months, to seronegative individuals prior to vaccination, especially when the serological status is easily accessible. more...

Throughout the pandemic, individuals 65 years and older have contributed most COVID-19 related deaths. To best formulate effective vaccination and other prevention policies to protect older adults, large scale observational studies of these higher risk individuals are needed. We conducted a Vaccine Effectiveness (VE) study during the B.1.617.2 Delta variant phase of the pandemic in July and August 2021 in a cohort of 17 million Medicare beneficiaries of which 5.7 million were fully vaccinated. We found that individuals fully vaccinated with the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 vaccines in January 2021 had 2.5 times higher breakthrough infections and hospitalizations than those fully vaccinated in March 2021, consistent with waning of vaccine-induced immunity. Measuring VE weekly, we found that VE against hospitalization, and even more so against infection, increased from July 2021 through August 2021, suggesting that in addition to the protective role of vaccination, increased masking or social distancing might have contributed to the unexpected increase in VE. Ongoing monitoring of Medicare beneficiaries should be a priority as new variants continue to emerge, and the VE of the new bivalent vaccines remains to be established. This could be accomplished with a large Medicare claims database and the analytics platform used for this study. more...

This prospective study provides data on the long-term humoral immunogenicity of a heterologous off-label vaccine regimen combining the adenoviral-vectored ChAdOx1 nCoV-19 from Astra-Zeneca (ChAd) with the mRNA-1273 vaccine from Moderna (m1273) in comparison with two different homologous mRNA vaccine schedules. Of the 316 COVID-19 naïve adult health care workers (HCW) included to complete a survey on vaccine-associated symptoms (VAS), 197 had received the homologous BNT162b2 mRNA vaccine from Pfizer/BioNTech (BNT/BNT), 76 the homologous m1273/m1273, and 43 the heterologous ChAd/m1273 vaccine regimen. The concentration of antibodies against SARS-CoV-2 spike protein in plasma 5–7 months after the second vaccine dose was higher in the m1273/m1273 and ChAd/m1273 than the BNT/BNT vaccine group. The frequency of systemic VAS after the first vaccine dose was 86% after ChAd compared with 35% and 39% after BNT and m1273, respectively (p < 0.0001), and after the second vaccine dose, the highest (89%) in the m1273/m1273 group (p < 0.001). Individuals with systemic VAS achieved higher levels of antibodies irrespective of vaccine regimen. In conclusion, VAS serve as a strong predictor of long-term humoral immune response, and the heterologous ChAd/m1273 vaccine regimen provides an at least equal long-term humoral immune response compared with the standard vaccine regimens used in Denmark. more...

ObjectiveTo analyze rates of reported severe adverse events after immunization (sAEFI) attributed to SARS-CoV-2 vaccines in the United States (US) using safety surveillance data.MethodsObservational study of sAEFI reported to the vaccine adverse events reporting system (VAERS) between December 13, 2020, to December 13, 2021, and attributed to SARS-CoV-2 vaccination programs across all US states and territories. All sAEFI in conjunction with mRNA (BNT-162b2 or mRNA-1273) or adenovector (Ad26.COV2.S) vaccines were included. The 28-day crude cumulative rates for reported emergency department (ED) visits and sAEFI viz. hospitalizations, life-threatening events and deaths following SARS-CoV-2 vaccination were calculated. Incidence rate ratios (IRRs) of reported sAEFI were compared between mRNA and adenovector vaccines using generalized Poisson regression models.ResultsDuring the study period, 485 million SARS-CoV-2 vaccines doses were administered nationwide, and 88,626 sAEFI reported in VAERS. The 28-day crude cumulative reporting rates per 100,000 doses were 14.97 (95% confidence interval, 14.86–18.38) for ED visits, 5.32 (5.26–5.39) for hospitalizations, 1.72 (1.68–1.76) for life-threatening events, and 1.08 (1.05–1.11) for deaths. Females had two-fold rates for any reported AEFI compared to males, but lower adjusted IRRs for sAEFI. Cumulative rates per dose for reported sAEFI attributed to adenovector vaccine were 2–3-fold higher, and adjusted IRRs 1.5-fold higher than mRNA vaccines.ConclusionsOverall cumulative rates for reported sAEFI following SARS-CoV-2 vaccination in the US over 1 year were very low; single-dose adenovector vaccine had 1.5-fold higher adjusted rates for reported sAEFI, which may however equate with multiple-doses mRNA vaccine regimens. These data indicate absence of high risks of sAEFI following SARS-CoV-2 vaccines and support safety equipoise between mRNA and adenovector vaccines. Public health messaging of these data is critical to overcome heuristic biases. Furthermore, these data may support ongoing adenovector vaccine use, especially in low- and middle-income countries due to affordability, logistical and cold chain challenges. more...

In this case report, we presented a case of myocarditis as a rare complication that developed after Covid mRNA-1273 vaccine. Cases of post-vaccine myocarditis usually progress with mild symptoms. However, it should be a situation that healthcare workers should keep in mind, that myocarditis may develop after vaccination. more...

Introduction The BNT162b2 and mRNA-1273 COVID-19 vaccines are the main vaccines that have been used for mass vaccination in Japan. Information on adverse reactions to COVID-19 vaccines in the Japanese population is limited. Methods We conducted an online survey on self-reported adverse reactions in individuals who had received two doses of the BNT162b2 or mRNA-1273 vaccine. The incidence of adverse events after each dose of vaccine was investigated. Propensity score matching was used to compare the incidence of adverse reactions after the second dose of the BNT162b2 and mRNA-1273 vaccines. Results After the first and second doses of the BNT162b2 vaccine, and the first and second doses of the mRNA-1273 vaccine, 890, 853, 6401, and 3965 individuals, respectively, provided complete responses. Systemic reactions, including fever, fatigue, headache, muscle/joint pain, and nausea were significantly more common in females, individuals aged more...

Chilblains are one of the earliest and most commonly described cutaneous manifestations of COVID-19;1 however, more recent data have failed to suggest an association. As widespread vaccinations are underway, reports of delayed-type hypersensitivity reactions in recipients of the mRNA-1273 vaccine have been brought to attention. Here, we present a case of biopsy-confirmed chilblains developing shortly after vaccination in an asymptomatic healthcare worker, who was not tested for SARS-CoV-2. more...

Antineutrophil cytoplasmic antibody (ANCA) is a systemic autoimmune disorder characterized by antibodies directed against small- and moderate-sized vessels. While there are few reported cases of autoimmune illnesses associated with influenza vaccination, two cases of de-novo anti-proteinase (PR3) ANCA-associated pauci immune glomerulonephritis are reported after the mRNA-1273 coronavirus disease 2019 (COVID-19) vaccine. Here, we report the third case of ANCA-associated glomerulonephritis after the mRNA-1273 COVID-19 vaccine. Our patient presented with acute kidney injury and sub-nephrotic proteinuria four days after receiving the second dose of the COVID vaccine. He was found to have elevated c-ANCA and anti-PR3 antibodies. Renal biopsy confirmed focal necrotizing and diffuse crescentic glomerulonephritis. He was diagnosed with pauci immune glomerulonephritis. The patient achieved remission 10 weeks after the diagnosis with successful treatment. more...

Young adults had been widely perceived as a low-risk group for COVID-19 severity, therefore, they were deprioritised within the mass vaccination strategies as their prognosis of COVID-19 infection is relatively more favourable than older age groups. On the other hand, vaccination of this demographic group is indispensable to achieve herd immunity. A cross-sectional survey-based study was used to evaluate the side effects of mRNA-based COVID-19 vaccines among university students in the Czech Republic. The validated questionnaire was delivered in a digital form, and it consisted of demographic data, COVID-19 vaccine-related anamnesis, and local, systemic, orofacial, and skin-related side effects’ prevalence, onset, and duration. Out of the 539 included participants, 70.1% were females and 45.8% were &lt, 23 years old. The vast majority (95.2%) reported at least one side effect. The most common side effect was injection site pain (91.8%), followed by fatigue (62.5%), headache (36.4%), and muscle pain (34.9%). The majority of local side effects occurred after both doses (74.4%), while most systemic side effects occurred after the second dose only (56.2%). Most local (94.2%) and systemic (93.3%) side effects resolved within three days after vaccination. Females participants’ adjusted odds ratio (AOR) showed they were 2.566 (CI 95%: 1.103–5.970) times more likely to experience post-vaccination side effects, and the participants who received two doses reported an increased AOR of 1.896 (0.708–5.077) for experiencing side effects. The results of this study imply that mRNA-based COVID-19 vaccines are highly probably safe for young adults, and further studies are required to investigate the role of medical anamnesis, prior COVID-19 infection, and gender in side effects incidence. more...

This work was supported by "Investigacion y Desarrollo (I + D) del Sistema Andaluz de Salud (SAS)" and Instituto de Salud Carlos III (Proyecto FIS PI21/01708)., The new vaccines against SARS-CoV-2 have raised a lot of expectations about their ability to induce immunity and the duration of this. This is the case of mRNA vaccines such as Moderna’s mRNA-1273. Therefore, it is necessary to study the humoral and cellular immunity generated by these vaccines. Our objectives are determining what is the normal response of antibody production, and what is the level of protective antibodies and monitoring patients in case of subsequent infection with COVID-19. We present the first results of a longitudinal study of the humoral response in 601 health workers vaccinated with Moderna. The results show a humoral immunity at 90 days after the second dose of 100%, with a strong decrease between the levels of circulating anti-S IgG antibodies between days 30 and 90 postvaccination. Observing a steeper decline in those who had higher titles at the beginning. In addition, we present a cellular response of 86% at three months after the second dose, which is related to low humoral response., Investigacion y Desarrollo (I + D) del Sistema Andaluz de Salud (SAS), Instituto de Salud Carlos III European Commission FIS PI21/01708 more...

SCOPUS: le.j, info:eu-repo/semantics/published

Objectives: Scarce data are currently available on the kinetics of antibodies after vaccination with mRNA vaccines as a whole and, with mRNA-1273, in particular. We report here an ad-interim analysis of data obtained after a 6-month follow-up in a cohort of healthcare workers (HCWs) who received the mRNA-1273 vaccine. These new data provide more insight into whether and in whom a 3rd dose could be necessary. Methods: Our study compared the anti-S antibody kinetics at 2 weeks (T1), 3 months (T3) and 6 months (T4) after the first injection, and 2 weeks after the second injection (T2). The 201 participating HCWs were stratified according to their initial serological status. The vaccine effectiveness was also assessed through a medical questionnaire. Results: We report here a marked and statistically significant antibody decrease (P < 0.05) between T3 and T4, especially in naïve vaccinees. The analysis of potential confounding factors or known risk factors for severe COVID-19 disease did not reveal any influence on the drop observed. Six-month after vaccination, only one, symptomatic, infection was reported in our cohort. Conclusions: In a supply-limited environment, our results plead for reserving the 3rd dose scheme, in the upcoming months, to seronegative individuals prior to vaccination, especially when the serological status is easily accessible., SCOPUS: ar.j, info:eu-repo/semantics/published more...

Objectives Scarce data are currently available on the kinetics of antibodies after vaccination with mRNA vaccines as a whole and, with mRNA-1273, in particular. We report here an ad-interim analysis of data obtained after a 6-month follow-up in a cohort of healthcare workers (HCWs) who received the mRNA-1273 vaccine. These new data provide more insight into whether and in whom a 3rd dose could be necessary. Methods Our study compared the anti-S antibody kinetics at 2 weeks (T1), 3 months (T3) and 6 months (T4) after the first injection, and 2 weeks after the second injection (T2). The 201 participating HCWs were stratified according to their initial serological status. The vaccine effectiveness was also assessed through a medical questionnaire. Results We report here a marked and statistically significant antibody decrease (P more...

We present a case of an 86-year-old woman who presented with a progressive quadriparesis two days after her second dose of Moderna SARS-CoV-2 vaccine, with cerebrospinal fluid (CSF) evidence of cytoalbuminocytological dissociation and electromyogram/nerve conduction studies (EMG/NCS) findings suggestive of acute axonal motor neuropathy. Her clinical symptoms did not improve with plasmapheresis. There appears to be a potential temporal association between the inoculation of mRNA-based SARS-CoV-2 vaccines and the development of Guillain-Barre Syndrome (GBS). Despite this possible association, infection prevention using highly effective mRNA-based vaccines remains highly recommended. Large epidemiological studies of SARS-CoV-2 vaccine-related adverse events are needed. Physicians should be aware of this possible temporal association since the prompt diagnosis and treatment of GBS can drastically improve outcomes. The aim is to report a case of axonal-variant GBS that was temporally associated with an mRNA-based SARS-CoV-2 vaccine. more...

Background: the increasing number of COVID-19 vaccines available to the public may trigger hesitancy or selectivity towards vaccination. This study aimed to evaluate the post-vaccination side effects of the different vaccines approved in Germany, Methods: a cross-sectional survey-based study was carried out using an online questionnaire validated and tested for a priori reliability. The questionnaire inquired about demographic data, medical and COVID-19-related anamneses, and local, systemic, oral, and skin-related side effects following COVID-19 vaccination, Results: out of the 599 participating healthcare workers, 72.3% were females, and 79.1% received mRNA-based vaccines, while 20.9% received a viral vector-based vaccine. 88.1% of the participants reported at least one side effect. Injection site pain (75.6%) was the most common local side effect, and headache/fatigue (53.6%), muscle pain (33.2%), malaise (25%), chills (23%), and joint pain (21.2%) were the most common systemic side effects. The vast majority (84.9%) of side effects resolved within 1–3 days post-vaccination, Conclusions: the mRNA-based vaccines were associated with a higher prevalence of local side effects (78.3% vs. 70.4%, Sig. = 0.064), while the viral vector-based vaccine was associated with a higher prevalence of systemic side effects (87.2% vs. 61%, Sig. &lt, 0.001). Females and the younger age group were associated with an increased risk of side effects either after mRNA-based or viral vector-based vaccines. The gender- and age-based differences warrant further rigorous investigation and standardized methodology. more...

BACKGROUND: In December 2020, Moderna released the mRNA-1273 vaccine. The most common side effects are headache, muscle pain, redness, swelling, and tenderness at the injection site. In addition, there have been dermatological adverse events, such as hypersensitivity reactions. Although rare, various bullous eruptions have been described following vaccination. Bullous pemphigoid has been reported to occur most often after receipt of influenza and the diphtheria-tetanus-pertussis vaccine. To the best of our knowledge, there have been no reports of bullous drug eruptions resulting from mRNA vaccines. CASE SUMMARY: A 66-years-old obese Guyanese male presented with a bullous rash following receipt of a commercial COVID-19 mRNA vaccine. He received the first dose uneventfully. However, within 24 h of receiving the second dose, he developed fever, myalgias, and malaise accompanied by a painful blistering rash of his torso, arms, and legs. His fever and myalgias improved after 24 h, but his painful rash did not, and five days after the initial symptoms, he presented to the hospital. There were many violaceous, poorly demarcated patches on his trunk, arms, and thighs on examination, many of which had large flaccid bullae within, and a few areas on his buttocks, posterior shoulder, and scrotum were eroded. The exam was also significant for lower extremity muscle tenderness, stiffness with preserved strength. A skin biopsy showed epidermal necrosis and sparse perivascular dermatitis concerning Stevens-Johnson syndrome or erythema multiforme. However, in the absence of mucous membrane involvement or targetoid lesions, the diagnosis of an extensive bullous fixed drug eruption was made. CONCLUSION: This case illustrates that the bullae eruption occurred as a result of receiving the Moderna vaccination. more...

info:eu-repo/semantics/published

An outbreak of SARS-CoV-2 involving four residents of a U.S. Veterans Affairs long term care facility occurred following administration of the first dose of the mRNA-1273 vaccine (Moderna) to thirty out of thirty-three residents. Three out of four positive cases were partially vaccinated and remained asymptomatic. One of two partially vaccinated patients who were tested for anti-spike protein antibodies had detectable levels at the time of diagnosis. The mortality rate was lower compared to a prior outbreak reported in this facility. more...

Objectives BNT‐162b2, mRNA‐1273, and Ad26.COV2.S vaccines data regarding adverse events (AEs) are scarce. In this report, we aimed to describe fatal and non‐fatal possible AEs after COVID‐19 vaccine administration. Methods An observational multicenter study investigating the causes of emergency department visits and hospital admissions within 10 days of COVID‐19 vaccination. Patients who received first or second doses of COVID‐19 vaccines and presented to the emergency department (ED), as well as those admitted to the hospitals or intensive care units (ICUs) were included. Causes of ED, hospital, and ICU admissions and discharges were collected based on the International Classification of Diseases, Tenth Revision (ICD‐10) coding system. Results Between December 2020 and March 2021, 1842 patients visited the ED within 10 days of COVID‐19 vaccine administration. The mean age was 70.3 years. Overall, 1221 patients presented after the first dose of the vaccine and 653 after the second dose. Trauma (14.9%), hypertensive emergency/urgency (7.8%), generalized pain and arthralgia (5.7%), and chest pain (4.4%) were the most common causes of presentation to the ED. Of all ED presentations, mortality rate was at 2.2% (41 patients) with a median follow‐up time of 68.0 days, versus 2.6% in unvaccinated ED patients. Postvaccination acute hypoxemic respiratory failure (46.3%), septic shock (24.4%), and cardiogenic shock (12.2%) were the most common causes of death. Conclusion Although reported AEs are not necessarily caused by the vaccination, this study provides further information about possible AEs after COVID‐19 immunization, especially those requiring hospital admission. This study also supports prior data that serious AEs post vaccination are much lower than primary COVID‐19 infections. Further studies are needed to investigate causalities between vaccines and reported AEs across all age groups. more...

Coronavirus disease 2019 (COVID-19) is a declared global pandemic. There are multiple parameters of the clinical course and management of the COVID-19 that need optimization. A hindrance to this development is the vast amount of misinformation present due to scarcely sourced manuscript preprints and social media. This literature review aims to presents accredited and the most current studies pertaining to the basic sciences of SARS-CoV-2, clinical presentation and disease course of COVID-19, public health interventions, and current epidemiological developments. The review on basic sciences aims to clarify the jargon in virology, describe the virion structure of SARS-CoV-2 and present pertinent details relevant to clinical practice. Another component discussed is the brief history on the series of experiments used to explore the origins and evolution of the phylogeny of the viral genome of SARS-CoV-2. Additionally, the clinical and epidemiological differences between COVID-19 and other infections causing outbreaks (SARS, MERS, H1N1) are elucidated. Emphasis is placed on evidence-based medicine to evaluate the frequency of presentation of various symptoms to create a stratification system of the most important epidemiological risk factors for COVID-19. These can be used to triage and expedite risk assessment. Furthermore, the limitations and statistical strength of the diagnostic tools currently in clinical practice are evaluated. Criteria on rapid screening, discharge from hospital and discontinuation of self-quarantine are clarified. Epidemiological factors influencing the rapid rate of spread of the SARS-CoV-2 virus are described. Accurate information pertinent to improving prevention strategies is also discussed. The penultimate portion of the review aims to explain the involvement of micronutrients such as vitamin C and vitamin D in COVID19 treatment and prophylaxis. Furthermore, the biochemistry of the major candidates for novel therapies is briefly reviewed and a summary of their current status in the clinical trials is presented. Lastly, the current scientific data and status of governing bodies such as the Center of Disease Control (CDC) and the WHO on the usage of controversial therapies such as angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) (Ibuprofen), and corticosteroids usage in COVID-19 are discussed. The composite collection of accredited studies on each of these subtopics of COVID-19 within this review will enable clarification and focus on the current status and direction in the planning of the management of this global pandemic. more...

This work was supported by "Investigacion y Desarrollo (I + D) del Sistema Andaluz de Salud (SAS)" and Instituto de Salud Carlos III (Proyecto FIS PI21/01708), co-funded by ERDF-FEDER., The vaccines designed against the SARS-CoV-2 coronavirus are based on the spike (S) protein. Processing of the S protein by antigen-presenting cells (APC) and its subsequent presentation to T cells is an essential part of the development of a humoral response. HLA-class II alleles are considered immune response genes because their codified molecules, expressed on the surface of APCs (macrophages, dendritic, and B cells) present antigenic peptides to T cell via their T cell receptor (TCR). The HLA-class II genes are highly polymorphic, regulating what specific peptides induce follicular helper T cells (TFH) and promote B lymphocyte differentiation into plasma or memory B cells. This work hypothesizes that the presence of certain HLA-class II alleles could be associated with the intensity of the humoral response (amount, length) to the SARS-CoV2 mRNA 1273 vaccine. We have studied the relationship between the HLA-class II typing of 87 health workers and the level of antibodies produced 30 days after vaccination. We show a possible association between the HLA-DRB1* 07:01 allele and the HLA-DRB1*07:01~DQA1*02:01~DQB1*02:02 haplotype to a higher production of antibodies 30 days after the administration of the second dose of mRNA-1273., Investigacion y Desarrollo (I + D) del Sistema Andaluz de Salud (SAS), Instituto de Salud Carlos III European Commission FIS PI21/01708 European Commission more...