Vaccination-related Adverse Events Research Articles

COVID-19 vaccination-related delayed adverse events among people with rheumatoid arthritis: results from the international COVAD survey.

This study aimed to assess COVID-19 vaccination-related AEs in patients with rheumatoid arthritis (RA), in the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2study. An online international cross-sectional survey captured self-reported data on COVID-19 vaccination-related adverse events (AEs) in people with RA, autoimmune diseases (AIDs; rheumatic [r] and non-rheumatic [nr]) and healthy controls (HCs). The survey was circulated by the COVAD study group, comprising 157 collaborators across 106 countries, from February to June 2022. Delayed AEs among RA were compared with other rAIDs, nrAIDs and HCs using multivariable binary regression. A total of 7203 participants were included (1423 [19.7%] RA, 2620 [36.4%] rAIDs, 426 [5.9%] nrAIDs, 2734 [38%] HCs), with 75% female. Compared to HCs, individuals with RA reported higher overall major AEs [OR 1.3 (1.0-1.7)], and an increased number of several minor AEs. Compared to nrAIDs, people with RA had several increased reported minor AEs including myalgia and joint pain. People with active RA had increased major AEs [OR 1.8 (1.1-3.0)] and hospitalisation [OR 4.1 (1.3 - 13.3)] compared to inactive RA. RA patients without autoimmune comorbidities had significantly fewer major and minor AEs than those with other rAIDs. A decreased incidence of hospitalisation was seen in patients taking methotrexate or TNF inhibitors compared to patients not taking these medications. COVID-19 vaccination is associated with minimal to no risks of delayed AEs in patients with RA compared to HCs, and fewer compared to other rAIDs. Active RA and presence of co-existing rAIDs were associated with an increased risk of delayed AEs.

Examining Vaccination-Related Adverse Events in Frequent Neurodegenerative Diseases

Examining Vaccination-Related Adverse Events in Frequent Neurodegenerative Diseases

Reappraisal of Pidotimod: an immunomodulatory agent with 30-year evidence.

Pidotimod (3-L-pyroglutamyl-L-thiaziolidine-4-carboxylic acid) is a synthetic dipeptide with immunomodulatory properties that is indicated for use in adults and children over 3 years of age with documented cell-mediated immunodepression during respiratory and urinary tract infections. Infections are associated with an immune response that helps fight pathogens. In this scenario, inflammatory events occur to improve the antimicrobial reaction. However, defective immunity and/or sustained inflammation may adversely affect the course of the infection. Thus, modulating immune function could be a valuable option in managing patients with infections. The multifaceted mechanism of action of Pidotimod enables it to modulate innate and adaptive immunity. Extensive evidence about Pidotimod, accumulated over the last 30 years, has provided much data on the prevention of recurrent respiratory infections in susceptible children and respiratory exacerbations in patients with chronic bronchitis. Recent studies provide interesting information on how Pidotimod affects the metabolomic profiles of patients with bronchiectasis, clinical and immunological outcomes of elderly patients with pneumonia, clinical and cellular changes in patients with allergic rhinitis and asthma, and beneficial effects on cytokines and humoral immunity in human immunodeficiency virus (HIV) patients. Preliminary experience suggests that Pidotimod can shorten the duration of COVID-19 infection and reduce clinical severity by modulating the immune response, as well as prevent vaccination-related adverse events. In conclusion, the immunomodulatory properties of Pidotimod indicate that it may be a valuable option in managing patients with respiratory infections and other immune-mediated disorders, including allergy, chronic obstructive pulmonary disease, and asthma.

Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Patients with Rheumatic Diseases and Serum Antibody Changes Post-Omicron Variant Infection.

The purpose of this study was to investigate whether the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine has a similar effectiveness and safety profile in patients with rheumatic and musculoskeletal diseases (RMDs) and healthy controls (HCs). Between August 10, 2021 and September 30, 2021, 134 HCs and 269 patients with RMDs were recruited. All participants who tested negative for COVID-19 were vaccinated with SARS-CoV-2 inactivated vaccine. Next, 150 patients with RMDs and 30 HCs infected with the SARS-CoV-2 Omicron variant within the previous 12weeks were recruited between February 20, 2023 and March 1, 2023. Serum samples were collected from each participant, and the serum immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody titers against SARS-CoV-2 were determined using a chemiluminescence assay. No statistically significant difference was found in the titer of anti-SARS-CoV-2 IgG and IgM antibodies, or in the incidence of vaccination-related adverse events between the RMD and HC groups (P = 0.183, P = 0.903, and P = 0.27, respectively). Serum IgG titers of SARS-CoV-2 neutralizing antibodies were significantly higher in patients who received two or more doses of inactivated vaccine than in patients who were unvaccinated or had received one dose of vaccine (244.36 ± 109.79 vs. 66.20 ± 82.50; P < 0.001). SARS-CoV-2 inactivated vaccines have similar protective effects in HCs and patients with RMDs, with an appreciable safety profile. Fully vaccinated patients with RMDs infected with the Omicron variant were able to produce effective neutralizing antibody concentrations.

Characteristics of Persistent Symptoms Manifested after SARS-CoV-2 Vaccination: An Observational Retrospective Study in a Specialized Clinic for Vaccination-Related Adverse Events.

Background: Although many adverse reactions after SARS-CoV-2 vaccination have been reported, there have been few comprehensive studies on persistent symptoms after SARS-CoV-2 vaccination. The aim of this study was to determine the clinical characteristics of patients with various persistent symptoms after SARS-CoV-2 vaccination. Methods: A retrospective descriptive study was performed for patients who visited a specialized clinic established at Okayama University Hospital to evaluate adverse events after SARS-CoV-2 vaccination during the period from April 2021 to March 2023. Results: Descriptive analysis was performed for 121 of 127 patients who visited the clinic during the study period, and separate analysis was performed for the other 6 patients who had serious complications, who required treatment with prednisolone, and who had persistent symptoms. The median [interquartile range] age of the patients was 48 years [31-64 years], and the patients included 44 males (36.4%) and 77 females (63.6%). The most frequent symptoms were sensory impairment (34 patients, 28.1%), general fatigue (30 patients, 24.8%), fever/low-grade fever (21 patients, 17.4%), and headache (21 patients, 17.4%). Serious complications included myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), sarcoidosis, aseptic meningitis, neuromyelitis optica spectrum disorders (NMOSDs), tendon adhesions, and idiopathic thrombocytopenia. Conclusions: Although causal relationships were not determined, 15 persistent symptoms after SARS-CoV-2 vaccination were characterized. All of the symptoms had onset from 12 hours to one week after vaccination, with 10 symptoms persisting for 6 months or longer. The most frequent symptom was sensory impairment.

COVID-19 Vaccine Response in People with Multiple Sclerosis Treated with Dimethyl Fumarate, Diroximel Fumarate, Natalizumab, Ocrelizumab, or Interferon Beta Therapy.

Some multiple sclerosis (MS) disease-modifying therapies (DMTs) impair responses to vaccines, emphasizing the importance of understanding COVID-19 vaccine immune responses in people with MS (PwMS) receiving different DMTs. This prospective, open-label observational study enrolled 45 participants treated with natalizumab (n = 12), ocrelizumab (n = 16), fumarates (dimethyl fumarate or diroximel fumarate, n = 11), or interferonbeta (n = 6); ages 18-65years inclusive; stable on DMT for at least 6months. Responder rates, anti-SARS-CoV-2 spike receptor-binding domain IgG (anti-RBD) geometric mean titers (GMTs), antigen-specific Tcells, and vaccination-related adverse events were evaluated at baseline and 8, 24, 36, and 48weeks after first mRNA-1273 (Moderna) dose. At 8weeks post vaccination, all natalizumab-, fumarate-, and interferonbeta-treated participants generated detectable anti-RBD IgG titers, compared to only 25% of the ocrelizumab cohort. At 24 and 36weeks post vaccination, natalizumab-, fumarate-, and interferonbeta-treated participants continued to demonstrate detectable anti-RBD IgG titers, whereas participants receiving ocrelizumab did not. Anti-RBD GMTs decreased 81.5% between 8 and 24weeks post vaccination for the non-ocrelizumab-treated participants, with no significant difference between groups. At 36weeks post vaccination, ocrelizumab-treated participants had higher proportions of spike-specific Tcells compared to other treatment groups. Vaccine-associated side effects were highest in the ocrelizumab arm for most symptoms. These results suggest that humoral response to mRNA-1273 COVID-19 vaccine is preserved and similar in PwMS treated with natalizumab, fumarate, and interferonbeta, but muted with ocrelizumab. All DMTs had preserved Tcell response, including the ocrelizumab cohort, which also had a greater risk of vaccine-related side effects.

Vaccine-based clinical protection against SARS-CoV-2 infection and the humoral immune response: A 1-year follow-up study of patients with multiple sclerosis receiving ocrelizumab.

Given the varying severity of coronavirus disease 2019 (COVID-19) and the rapid spread of Severe-Acute-Respiratory-Syndrome-Corona-Virus-2 (SARS-CoV-2), vaccine-mediated protection of particularly vulnerable individuals has gained increasing attention during the course of the pandemic. We performed a 1-year follow-up study of 51 ocrelizumab-treated patients with multiple sclerosis (OCR-pwMS) who received COVID-19 vaccination in 2021. We retrospectively identified 37 additional OCR-pwMS, 42 pwMS receiving natalizumab, 27 pwMS receiving sphingosine 1-phosphate receptor modulators, 59 pwMS without a disease-modifying therapy, and 61 controls without MS (HC). In OCR-pwMS, anti-SARS-CoV-2(S)-antibody titers were measured prior to the first and after the second, third, and fourth vaccine doses (pv2/3/4). The SARS-CoV-2-specific T cell response was analyzed pv2. SARS-CoV-2 infection status, COVID-19 disease severity, and vaccination-related adverse events were assessed in all pwMS and HC. We found a pronounced and increasing anti-SARS-CoV-2(S)-antibody response after COVID-19 booster vaccinations in OCR-pwMS (pv2: 30.4%, pv3: 56.5%, and pv4 90.0% were antibody positive). More than one third of OCR-pwMS without detectable antibodies pv2 developed positive antibodies pv3. 23.5% of OCR-pwMS had a confirmed SARS-CoV-2 infection, of which 84.2% were symptomatic. Infection rates were comparable between OCR-pwMS and control groups. None of the pwMS had severe COVID-19. An attenuated humoral immune response was not associated with a higher risk of SARS-CoV-2 infection. Additional COVID-19 vaccinations can boost the humoral immune response in OCR-pwMS and improve clinical protection against COVID-19. Vaccines effectively protect even OCR-pwMS without a detectable COVID-19 specific humoral immune response, indicating compensatory, e.g., T cell-mediated immunological mechanisms.

COVID-19 Vaccination in Patients with Chronic Liver Disease.

Vaccination against SARS-CoV-2 has become a central public health issue, primarily for vulnerable populations such as individuals with Chronic Liver Disease (CLD). Increased COVID-19-related mortality and disease severity has been noted in this subgroup of patients. Severe COVID-19 tends to further deregulate liver function in patients with chronic liver failure or cirrhosis and even reactivate hepatitis in people living with HBV or HCV. In addition, impaired hepatic function leads to several limitations in possible therapeutic interventions. Chronic hepatic dysregulation, along with the underlying cirrhosis-associated immune dysfunction (CAID), leads to a decreased immune response to vaccination that, in turn, may result in reduced efficacy rates and lowered lasting protection. According to current guidelines, timely vaccination and frequent booster shot administration are deemed necessary in this context. Vaccination-related adverse events are mostly mild in nature and similar to those reported in the general population, whereas the incidence of liver injury following vaccination is relatively rare. We aimed to review available evidence and recommendations associated with COVID-19 vaccination in patients with chronic liver disease, and provide insight to current issues and future directions.

COVID-19 vaccination in autoimmune diseases (COVAD) study: vaccine safety and tolerance in rheumatoid arthritis.

The COVID-19 vaccination in autoimmune diseases (COVAD) study aimed to assess short-term COVID-19 vaccination-related adverse events (AEs) in RA patients. An online self-reported questionnaire (March-December 2021) was used to capture data related to COVID-19 vaccination-related AEs in RA, other autoimmune rheumatic diseases (AIRDs) (excluding RA and inflammatory myositis), non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs). Descriptive and multivariable regression analyses were performed. Of the 9462 complete respondents, 14.2% (n = 1347) had been diagnosed with RA; they had a mean (s.d.) age of 50.7 (13.7) years, 74.2% were women and 49.3% were Caucasian. In total, 76.9% and 4.2% of patients with RA reported minor and major AEs, respectively. Patients with active and inactive RA had similar AE and hospitalization frequencies. Overall, AEs were reported more frequently by BNT162b2 and mRNA-1273 recipients and less frequently by BBV152 recipients compared with the rest. Major AE and hospitalization frequencies were similar across recipients of different vaccines. Patients receiving methotrexate and hydroxychloroquine reported fewer minor AEs than those patients not on them. Compared with HCs and patients with other AIRDs, patients with RA reported similar total AEs, overall minor AEs, and hospitalizations. Compared with nrAIDs, patients with RA reported lower frequencies of overall AEs, minor AEs (both odds ratio [OR] = 0.7; 95% CI: 0.5, 0.9), and injection site pain (OR = 0.6; 95% CI: 0.5, 0.8) with similar major AE and hospitalization frequencies. Despite the differences in AE frequency across different COVID-19 vaccines, all were well tolerated in patients with RA and were comparable to HCs, providing reassurance as to the safety of COVID-19 vaccination.

An Update on Complications Associated with SARS-CoV-2 Infection and COVID-19 Vaccination.

Over the past two years, SARS-CoV-2 has dramatically spread worldwide and emerged as a major pandemic which has left an unprecedented mark on healthcare systems and economies worldwide. As our understanding of the virus and its epidemiology continues to grow, the acute phase clinical symptoms and long-term and vaccine-related complications are becoming more apparent. With heterogeneity in presentations, comparisons may be drawn between COVID-19-related sequelae and vaccination related adverse events. The present review article aims to address the currently available literature on the SARS-CoV-2 virus, immune responses, the pathophysiology of clinical presentations, and available vaccinations with its adverse events for the appraisal of its potential impact on the COVID-19 management system.

Acquired hemophilia A following COVID-19 vaccination – The importance of prompt diagnosis: A case report

Acquired hemophilia A (AHA) is a rare coagulopathy characterized by hemorrhagic manifestations. It has been linked to various conditions, including autoimmune disorders, drugs, tumors, lymphoproliferative disorders, and infections. We present a case of AHA in a 71-year-old male patient with cutaneous hematoma occurring 8 days after vaccination for COVID-19. This report aims to highlight the risk of FVIII inhibitor development following an immune stimulus, thus improving our knowledge regarding possible vaccination-related adverse events. Furthermore, we underline how the potential risk of not recognizing disease manifestations promptly, together with specific coagulation alterations, could significantly affect the patient's outcome. Adequate management plans and the diffusion of shared guidelines are of fundamental importance in order to prevent the development of life-threatening complications and initiate appropriate treatment as soon as possible. Data AvailabilityAll data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding author.

COVID-19 Vaccination in Autoimmune Diseases (COVAD) study: Vaccine safety in idiopathic inflammatory myopathies.

Introduction/AimsIn this study we investigated COVID‐19 vaccination–related adverse events (ADEs) 7 days postvaccination in patients with idiopathic inflammatory myopathies (IIMs) and other systemic autoimmune and inflammatory disorders (SAIDs).MethodsSeven‐day vaccine ADEs were collected in an international patient self‐reported e‐survey. Descriptive statistics were obtained and multivariable regression was performed.ResultsTen thousand nine hundred respondents were analyzed (1227 IIM cases, 4640 SAID cases, and 5033 healthy controls [HCs]; median age, 42 [interquartile range, 30‐455] years; 74% female; 45% Caucasian; 69% completely vaccinated). Major ADEs were reported by 76.3% of the IIM patients and 4.6% reported major ADEs. Patients with active IIMs reported more frequent major (odds ratio [OR], 2.7; interquartile range [IQR], 1.04‐7.3) and minor (OR, 1.5; IQR, 1.1‐2.2) ADEs than patients with inactive IIMs. Rashes were more frequent in IIMs (OR, 2.3; IQR, 1.2‐4.2) than HCs. ADEs were not impacted by steroid dose, although hydroxychloroquine and intravenous/subcutaneous immunoglobulins were associated with a higher risk of minor ADEs (OR, 1.9; IQR, 1.1‐3.3; and OR, 2.2; IQR, 1.1‐4.3, respectively). Overall, ADEs were less frequent in inclusion‐body myositis (IBM) and BNT162b2 (Pfizer) vaccine recipients.DiscussionSeven‐day postvaccination ADEs were comparable in patients with IIMs, SAIDs, and HCs, except for a higher risk of rash in IIMs. Patients with dermatomyositis with active disease may be at higher risk, and IBM patients may be at lower risk of specific ADEs. Overall, the benefit of preventing severe COVID‐19 through vaccination likely outweighs the risk of vaccine‐related ADEs. Our results may inform future guidelines regarding COVID‐19 vaccination in patients with SAIDs, specifically in those with IIMs. Studies to evaluate long‐term outcomes and disease flares are needed to shed more light on developing future COVID‐19 vaccination guidelines.

COVID-19 Vaccination and the Rate of Immune and Autoimmune Adverse Events Following Immunization: Insights From a Narrative Literature Review.

Despite their proven efficacy and huge contribution to the health of humankind, vaccines continue to be a source of concern for some individuals around the world. Vaccinations against COVID-19 increased the number of distressed people and intensified their distrust, particularly as the pandemic was still emerging and the populations were encouraged to be vaccinated under various slogans like “back to normal life” and “stop coronavirus”, goals which are still to be achieved. As fear of vaccination-related adverse events following immunization (AEFIs) is the main reason for vaccine hesitancy, we reviewed immune and autoimmune AEFIs in particular, though very rare, as the most worrisome aspect of the vaccines. Among others, autoimmune AEFIs of the most commonly administered COVID-19 vaccines include neurological ones such as Guillain-Barre syndrome, transverse myelitis, and Bell’s palsy, as well as myocarditis. In addition, the newly introduced notion related to COVID-19 vaccines, “vaccine-induced immune thrombotic thrombocytopenia/vaccine-induced prothrombotic immune thrombotic thrombocytopenia” (VITT/VIPITT)”, is of importance as well. Overviewing recent medical literature while focusing on the major immune and autoimmune AEFIs, demonstrating their rate of occurrence, presenting the cases reported, and their link to the specific type of COVID-19 vaccines represented the main aim of our work. In this narrative review, we illustrate the different vaccine types in current use, their associated immune and autoimmune AEFIs, with a focus on the 3 main COVID-19 vaccines (BNT162b2, mRNA-1273, and ChAdOx1). While the rate of AEFIs is extremely low, addressing the issue in this manner, in our opinion, is the best strategy for coping with vaccine hesitancy.

COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study.

ObjectivesCOVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination related adverse events (ADEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey.MethodsThe survey was circulated in early 2021 by > 110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details, and 7-day vaccine ADEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type.Results10900 respondents [42 (30-55) years, 74% females and 45% Caucasians] were analyzed. 5,867 patients (54%) with SAIDs were compared with 5033 HCs.79% had minor and only 3% had major vaccine ADEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs=26%, HCs=24%; OR = 1.1 (1.03-1.3); p = 0.014], abdominal pain [SAIDs=2.6%, HCs=1.4%; OR = 1.5 (1.1-2.3); p = 0.011], and dizziness [SAIDs=6%, HCs=4%; OR = 1.3 (1.07-1.6); p = 0.011], were slightly more frequent in SAIDs. Overall, major ADEs [SAIDs=4%, HCs=2%; OR = 1.9 (1.6-2.2); p < 0.001] and, specifically, throat closure [SAIDs=0.5%, HCs=0.3%; OR = 5.7 (2.9-11); p = 0.010] were more frequent in SAIDs though absolute risk was small (0-4%). Major ADEs and hospitalizations (less than 2%) were comparable across vaccine types in SAIDs.ConclusionVaccination against COVID-19 is relatively safe in SAID patients. SAIDs were at a higher risk of major ADEs than HCs, though absolute risk was small. There are small differences in minor ADEs between vaccine types in SAID patients.

Early Humoral Responses of Hemodialysis Patients After Inactivated SARS-CoV-2 Vaccination.

PurposeTo detect antibody responses to inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in patients undergoing hemodialysis and to investigate vaccine-related adverse events.Patients and MethodsA total of 120 hemodialysis (HD) patients and 24 healthy controls (HCs) who had not been previously infected with SARS-CoV-2 and had received their first dose of the inactivated vaccine (CoronaVac; Sinovac Biotech Ltd) were recruited for this study. All participants were scheduled to receive a second dose of inactivated SARS-CoV-2 vaccine. Serum-specific immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against the SARS-CoV-2 were detected at least 14 days after the second dose of vaccine using a commercial kit. Positive and negative results were defined as a sample/cutoff (S/CO) ratio≥1.00 and <1.00, respectively. Vaccination-related adverse events were assessed using a standardized questionnaire.ResultsThere were no significant differences regarding the seroprevalences of IgG and IgM antibodies against SARS-CoV-2 and the self-reported vaccination-related adverse events between HD patients and HCs. The analysis results for HD patients suggest that 82 (68.3%) and 27 (22.5%) tested positive for IgG and IgM, respectively. The levels of IgG were higher than IgM levels (P<0.0001). In addition, the IgG-positive group had significantly higher serum albumin levels than the IgG-negative group (P<0.05). Only mild vaccine-related adverse events were observed in two patients (1.66%) and in one healthy individual (4.2%).ConclusionThe seroprevalences of IgG and IgM antibodies against SARS-CoV-2 and vaccination-related adverse effects are similar between HD and HCs. The inactivated SARS-CoV-2 vaccine is effective and safe in inducing near-term immunity in hemodialysis patients.

COVID-19 vaccination hesitancy among people with chronic neurological disorders: A position paper.

Background and purposeHealth risks associated with SARS‐CoV‐2 infection are undisputed. Moreover, the capability of vaccination to prevent symptomatic, severe, and fatal COVID‐19 is recognized. There is also early evidence that vaccination can reduce the chance for long COVID‐19. Nonetheless, the willingness to get vaccinated and receive booster shots remains subpar among people with neurologic disorders. Vaccine scepticism not only jeopardizes collective efforts to end the COVID‐19 pandemic but puts individual lives at risk, as some chronic neurologic diseases are associated with a higher risk for an unfavorable COVID‐19 course.MethodsIn this position paper, the NeuroCOVID‐19 Task Force of the European Academy of Neurology (EAN) summarizes the current knowledge on the prognosis of COVID‐19 among patients with neurologic disease, elucidates potential barriers to vaccination coverage, and formulates strategies to overcome vaccination hesitancy. A survey among the Task Force members on the phenomenon of vaccination hesitancy among people with neurologic disease supports the lines of argumentation.ResultsThe study revealed that people with multiple sclerosis and other nervous system autoimmune disorders are most skeptical of SARS‐CoV‐2 vaccination. The prevailing concerns included the chance of worsening the pre‐existing neurological condition, vaccination‐related adverse events, and drug interaction.ConclusionsThe EAN NeuroCOVID‐19 Task Force reinforces the key role of neurologists as advocates of COVID‐19 vaccination. Neurologists need to argue in the interest of their patients about the overwhelming individual and global benefits of COVID‐19 vaccination. Moreover, they need to keep on eye on this vulnerable patient group, its concerns, and the emergence of potential safety signals.

Seroprevalence of SARS-CoV-2-specific antibodies and vaccination-related adverse events in systemic lupus erythematosus and rheumatoid arthritis.

BackgroundThis study aimed to investigate the seroreactivity of Coronavirus disease 2019 (COVID-19) vaccination and its adverse events among systemic lupus erythematosus (SLE) patients, rheumatoid arthritis (RA) patients, and healthy controls (HCs).MethodsA total of 60 SLE patients, 70 RA patients and 35 HCs, who received a complete inactivated COVID-19 vaccine (Vero cells) regimen, were recruited in the current study. Serum IgG and IgM antibodies against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) were determined by using chemiluminescent microparticle immunoassay (CMIA).ResultsThere were no significant differences regarding the seroprevalences of IgG and IgM antibodies against SARS-CoV-2, and the self-reported vaccination-related adverse events among SLE patients, RA patients and HCs. The inactivated COVID-19 vaccines appeared to be well-tolerated and moderately immunogenic. In addition, case-only analysis indicated that in SLE patients, the disease manifestation of rash and anti-SSA autoantibody were associated with seroprevalence of IgG antibody against SARS-CoV-2, whereas the uses of ciclosporin and leflunomide had influence on the seroprevalence of IgM antibody against SARS-CoV-2. In RA patients, rheumatoid factor (RF) appeared to be associated with the seroprevalence of IgG antibody against SARS-CoV-2.ConclusionOur study reveals that the seroprevalences of IgG and IgM antibodies against SARS-CoV-2 and vaccination-related adverse effects are similar among SLE, RA and HCs, suggesting that COVID-19 vaccine is safe and effective for SLE and RA patients to prevent from the pandemic of COVID-19.

Immune response to SARS-CoV-2 vaccination in relation to peripheral immune cell profiles among patients with multiple sclerosis receiving ocrelizumab

BackgroundVaccination has proven to be effective in preventing SARS-CoV-2 transmission and severe disease courses. However, immunocompromised patients have not been included in clinical trials and real-world clinical data point to...

COVID-19 vaccination in gastrointestinal cancer patients receiving chemotherapy: A single institute experience.

30 Background: Early approval of COVID-19 vaccine has significant benefits for cancer patients treated under the COVID-19 pandemic worldwide. However, there has been limited reports that investigated the safety and efficacy of vaccination in cancer patients and the optimal timing of vaccination during chemotherapy. We therefore investigated the effects of vaccination on treatment in cancer patients receiving chemotherapy. Methods: Our retrospective observational study included 52 patients with gastrointestinal (GI) cancer receiving chemotherapy at the medical hospital of Tokyo Medical and Dental University in Tokyo who had two doses of mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna) between May 2021 and September 2021. All patients had no history of COVID-19 infection. Treatment- and vaccination-related adverse events were recorded by outpatient interviews and self-reports. All adverse events were evaluated using CTCAE v5.0. Results: Characteristics of patients were as follows (N = 52): median age, 70y (range, 49–89); male/female, 30/22; ECOG PS 0, 75%; local/metastatic, 12/40; mean BMI, 23.4±4.1; comorbidities in 36 (cardiovascular in 24, diabetes in 8, kidney disease in 8, liver disease in 6, lung disease in 1); treatment (cytotoxic in 45, biologics in 23, immune checkpoint inhibitor in 4). Of the 52 patients, 45 received chemotherapy prior to vaccination; days from last dose to first vaccination, median 11 (range, 1–70); days from first to second vaccinations, median 21 (range, 21–41); days from first vaccination to chemotherapy, median 10 (range, 2–34). 11 patients (24.4%) changed treatment schedule: 3 for safety reasons, 4 for myelosuppression and 4 for convenience. 4 patients stopped treatment due to disease progression. Following the first vaccination, 37 patients (82.2%) had adverse events (AEs): injection site pain (n = 35), fatigue (n = 6), fever (n = 3), headache (n = 2), gastrointestinal symptoms (n = 2), redness (n = 1), insomnia (n = 1). There was no treatment- and vaccine-related deaths. Conclusions: Our findings suggest that vaccine-related AEs in GI cancer patients receiving chemotherapy are tolerable, and treatment schedule changes could be minimized. Although careful monitoring is required, COVID-19 vaccination is also recommended for cancer patients toward the convergence of the COVID-19 pandemic.

SAFETY AND EFFECTIVENESS OF THE BNT162B2 MRNA COVID-19 VACCINE IN A NATIONWIDE COHORT OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE

BACKGROUND & AIMSThe effectiveness of currently available SARS-CoV-2 vaccines in patients with inflammatory bowel disease (IBD) remains unknown. We aimed to determine the effectiveness of the Pfizer-BNT162b2 mRNA vaccine in a nationwide cohort of patients with IBD in Qatar.METHODSUsing a cohort design, we compared 476 IBD patients vaccinated identified between January 1, 2021, and March 31, 2021, with 476 matched unvaccinated controls (matched on age and date of SARS-CoV-2 testing). Study outcomes included documented SARS-CoV-2 infection, symptomatic COVID-19, and COVID-19 related hospitalization. We also studied the side effects of the vaccination, including the effect on IBD exacerbation and hospitalizations related to adverse events.RESULTSTotal follow-up was 23,289 person-days for the vaccinated and 23,653 person-days for the unvaccinated group. Vaccine effectiveness >14 days [AAB1] after the second dose was 85.1% (95% CI: 65.2, 93.6) for confirmed infection, and 87.1% (95% CI: 63.6, 95.4)[AAB2] for symptomatic infection. No patient required hospitalization >14 days after the second vaccine dose. Estimated vaccine effectiveness between 22 to 35 days after the first dose was 14.8% (95% CI: -151.5, 71.2) [AAB3] for any documented infection, and 59.8% (95% CI: -106.1, 92.2) for symptomatic COVID-19 disease. For patients taking biologics with or without immunomodulators, vaccine effectiveness >14 days after the second dose was 94% (95% CI: 53.1, 99.2), and 92.7% (95% CI: 45.1, 99.0) for any documented infection and symptomatic COVID-19 respectively. Vaccine effectiveness was 87.4% (95% CI: 46.0, 97.1) for any documented infection and 91.7% (95% CI: 37.2, 98.9) for symptomatic COVID-19 during the same period for patients taking immunomodulators alone. None of the vaccinated patients required intensive care unit admission or died. No patient had IBD exacerbation or required hospitalization for vaccination-related adverse events.CONCLUSIONIn a nationwide cohort of IBD patients, the BNT162b2 mRNA vaccine was safe and highly effective.