Vaccination In Subjects Research Articles

Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study.

Background: Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs. those without a history of allergy. Methods: From February 2021 to February 2023, a web-based prospective study gathered vaccinee-reported outcomes using electronic questionnaires across eleven European countries. Baseline and up to six follow-up questionnaires captured data on vaccinee demographics, as well as both solicited and unsolicited adverse reactions. Results: Overall, 3476 vaccinees with a history of allergy were matched with 13,872 vaccinees from the general population at the first vaccination cycle and were included in the analysis. A total of 825 vaccinees with a history of allergy who had received a booster dose, matched to 3297 vaccinees from the general population, were included in the analysis. Higher rates of ADRs occurred after the first vaccination cycle compared to after the booster dose (64-91% vs. 56-79%). However, most reported ADRs were solicited and not serious, and no case of anaphylaxis was reported. Women and vaccinees with a history of allergy reported ADRs more frequently than men and the matched controls, respectively. Compared to other COVID-19 vaccines, a higher proportion of vaccinees experiencing at least one ADR following their first vaccination cycle was observed with Comirnaty and Vaxzevria. Statistically significant differences were observed among the study cohorts for median TTO after the second dose, and for median TTR following the first vaccination cycle and booster dose (p < 0.001). Conclusions: Typically, any drug or vaccine use carries a risk of severe allergic reactions, yet the benefits of vaccination generally outweigh these potential risks, as shown with the COVID-19 vaccines.

Covid-19 vaccination coverage and associated factors among older hypertensive patients in Hangzhou, China.

Vaccination could provide effective protection against coronavirus disease 2019 (COVID-19). This study aims to describe the COVID-19 vaccination coverage and influential factors in Chinese older hypertensive patients. Using a cross-sectional design, participants were randomly selected from the electronic health records system during the pandemic era in Hangzhou, China. Logistic regression models were employed to compute the OR and 95% CI in order to assess the relationships between variables and the extent of COVID-19 vaccination coverage. As of 3 August 2022, among a sample of 77 970 individuals, 75.11% had completed the full COVID-19 vaccination, while 57.66% had received a booster dose. Disparities in coverage were observed across genders, regions and age groups. Unhealthy lifestyles, cardiovascular disease, cancer, uncontrolled blood pressure, abnormal fasting plasma glucose, dyslipidemia and renal dysfunction were risk factors for COVID-19 vaccination coverage. The coverage rates continuously declined along with the number of risk factors. The ORs for full and booster vaccination in subjects with ≥4 risk factors were 2.55 (2.12∼3.07) and 2.60 (2.16∼3.13), compared to individuals without risk factors. The COVID-19 vaccination program for older hypertensive patients must be strengthened further. Emphasis should be placed on patients who reside in urban areas, have comorbidities or multiple risk factors.

Neutralizing antibody and T-cell responses against SARS-CoV-2 variants by heterologous CoronaVac/ChAdOx-1 vaccination in elderly subjects with chronic obstructive pulmonary disease

BackgroundData on humoral and cellular immune responses against SARS-CoV-2 after receiving heterologous CoronaVac/ChAdOx-1 (CoVac/ChAd) vaccination in subjects with chronic obstructive pulmonary disease (COPD) are still limited. Therefore, we determined the neutralizing antibody (NAb) and T-cell responses against SARS-CoV-2 wild type (WT) and variants of concern (VOCs) in COPD patients. MethodsThe levels of NAb as well as specific CD4 and CD8 T-cell responses against SARS-CoV-2 WT and VOCs were determined in COPD patients before and after vaccination. ResultsFour weeks after vaccinations, the median levels of % inhibition of NAb against SARS-CoV-2 WT, Alpha, Beta, and Delta variants were significantly higher compared to pre-vaccination. The induction of NAb against Omicron was very low compared to other variants. At four weeks after vaccination, in comparison to pre-vaccination, the increasing trend of TNF-α-, IFN-γ-, IL-4-, IL-17-, IL-10-, and FasL-producing CD4 T-cells upon stimulation with WT spike peptides were demonstrated. No difference in T-cell responses to spike peptides of Alpha, Beta, and Delta variants and their WT homologs was observed. ConclusionHeterologous CoVac/ChAd vaccine induced the production of NAb against SARS-CoV-2 WT, Alpha, Beta, and Delta variants, but low for Omicron in COPD patients. Induction of CD4 T-cell subset responses was slightly observed by this vaccine regimen.Clinical Trials Registry: This study was approved by the Clinical Trials Registry (Study ID: TCTR20210822002).

Serum concentration of antigen-specific IgG can substantially bias interpretation of antibody-dependent phagocytosis assay readout

Because virus neutralization cannot solely explain vaccine-induced, antibody-mediated protection, antibody effector functions are being considered as a potential correlate of protection (CoP). However, measuring effector functions at a fixed serum dilution for high throughput purposes makes it difficult to distinguish between the effect of serum antibody concentration and antibody properties such as epitopes, subclass, and glycosylation. To address this issue, we evaluated antibody-dependent cellular phagocytosis (ADCP) assay against SARS-CoV-2 spike. Adjustment of serum samples to the same concentration of antigen-specific IgG prior to the ADCP assay revealed concentration-independent differences in ADCP after mRNA vaccination in subjects with and without prior SARS-CoV-2 infection not detectable in assay performed with fixed serum dilution. Phagocytosis measured at different concentrations of spike-specific IgG strongly correlated with the area under the curve (AUC) indicating that ADCP assay can be performed at a standardized antibody concentration for the high throughput necessary for vaccine trial analyses.

Potential side effects after paediatric anti-Covid19 vaccination in subjects with existing comorbidities, congenital and otherwise

Potential side effects after paediatric anti-Covid19 vaccination in subjects with existing comorbidities, congenital and otherwise

Is SARS-CoV-2 Vaccination of Subjects with a Prior History of Allergies Dangerous? Experiences in the Veneto Region of Italy.

Adverse events after SARS-CoV-2 vaccinations have caused alarm to some individuals with previously diagnosed allergies. The aim of this study was to investigate whether the risk of adverse reactions was actually higher in this subgroup. To this end, we carried out an observational descriptive analysis of vaccines administered in a "protected setting" in the Veneto region of Italy between December 2020 and December 2022. Reactions were classified using systemic organic classification (SOC), and their severity was assessed using the criteria of the Italian Drug Agency (AIFA). A total of 421 subjects were vaccinated with 1050 doses, 95.0% of which were administered without adverse events. In all, 53 subjects reported 87 SOC reactions (1.6 reactions/person), and 18.3% of these reactions were severe. One person was hospitalized, but all subjects enjoyed complete remission. Reporting rates were 9.0%, 3.1%, and 1.2% for first, second, and third doses, respectively. The most frequent reactions involved the respiratory system (2.3%), the cutaneous and subcutaneous systems (2.1%), and the nervous system (1.7%). Multivariate analyses (adjOR (95% CI)) revealed that the probability of experiencing at least one reaction significantly declined with increases in age [0.95 (0.94-0.97)] and in the number of doses received, i.e., 75% [0.25 (0.13-0.49)] for second doses and 88% [0.12 (0.04-0.39)] for third doses. These results indicated that vaccinations could be safely administered; few reactions were reported, and there were no permanent adverse outcomes.

Influenza vaccination trend and related factors among patients with diabetes in Korea: Analysis using a nationwide database.

Subjects with diabetes are at higher risk of serious influenza-related complications. We aimed to investigate the yearly trend of influenza vaccination and factors associated with being unvaccinated for influenza in subjects with diabetes using a nationwide observational study performed within the recent decade. Among 105,732 subjects from the Korea National Health and Nutrition Examination Survey between 2007 and 2019, 8,632 with diabetes were included. We investigated the yearly trend of influenza vaccination and factors associated with being unvaccinated for influenza. During the study period, the prevalence of influenza vaccination in subjects with diabetes showed a tendency to increase every year, reaching almost 60% in 2019, which was higher than the rate in subjects without diabetes. Younger age (adjusted hazard ratio (aHR) [95% CI] 11.29 [8.63-14.75] for < 50 years; 6.16 [5.21-7.29] for 50-65 years), male (aHR 1.67 [1.52-1.87]), current smoker (aHR 1.31 [1.00-1.72], lower-income status (aHR 1.46 [1.17, 1.84]), and high education level (aHR 1.30 [1.01-1.67]) were associated with being unvaccinated. Also, a poorer glycemic control with HbA1c ≥ 9% was found to be correlated with unvaccinated status (aHR 1.48 [1.15-1.90]). The influenza vaccination rate is still unsatisfactory in subjects with diabetes. Young age, males, low-income level, high education level, and poor glycemic control were associated with unvaccinated status. Considering the risk-benefits of influenza vaccination in patients with diabetes, physicians should make an effort to increase vaccination rates, especially in low vaccination rate groups.

Influenza vaccine coverage in 6months-64 years-old patients affected by chronic diseases: A retrospective cohort study in Italy

ABSTRACT At the beginning of each flu season, the Italian Ministry of Health defines the categories at higher risk of influenza complications, for which vaccination is actively and freely offered. The vaccine coverage (VC) of the influenza vaccine in subjects from 6 months to 64 years of age suffering from diseases that increase the risk of complications from influenza during the 2020–2021 season was evaluated. Our study wants to evaluate the VCs of the influenza vaccine in these subjects during the 2020/2021 season in Apulia. The digital archives relative to the Apulian population were used. A retrospective cohort study design was performed. 484,636 Apulian residents aged between 6 months and 64 years suffered from at least one chronic disease; 139,222 of 484,636 subjects received the influenza vaccine (VC: 28.7%) from October 2020 to January 2021. Considering the single comorbidities, the greatest values are found for pathologies for which major surgical interventions are planned and chronic renal failure/adrenal insufficiency patients, while the worst for chronic liver diseases and pathologies for which major surgical interventions are planned. In any case, it would seem that better VC is achieved in subjects with more than one chronic condition. Influenza vaccination must be promoted as a central public health measure, also because by reducing the burden on hospitals, it can greatly benefit the management of COVID-19 patients. Greater efforts by public health institutions must be implemented in order to achieve better VC in the target categories, including chronic patients.

The factors correlated with COVID-19 vaccination coverage in Chinese hypertensive patients managed by community general practitioner

ABSTRACT This study aims to describe COVID-19 vaccination coverage and its influential factors in hypertensive patients who were administered by community general practitioners in China. A cross-sectional survey was carried out using data from electronic health record systems. The subjects were hypertensive patients who had been involved in the health management of the Essential Public Health Service (EPHS) program in Hangzhou City, China. As of Aug 3, 2022, the full and booster vaccination rates were 77.53% and 60.97% in randomly selected 96,498 subjects. There were disparities across regions, age, and gender in the distribution of COVID-19 vaccination coverage. Obesity and daily alcohol consumption were factors in the promotion of COVID-19 vaccination. Current smoking, non-daily physical exercise, irregular medication adherence, and comorbidities were risk factors for COVID-19 vaccination. Coverage rates have decreased depending on the number of risk factors. The ORs (95% CI) were 1.78 (1.61 ~ 1.96) of full vaccination and 1.74 (1.59 ~ 1.89) of booster vaccination in subjects with ≥4 risk factors, compared to those without risk factors. In summary, the progress of COVID-19 vaccination among community hypertensive patients lagged behind that of the general population during the same period. Individuals who lived in urban areas, were elderly, and had an irregular medication adherence, comorbidities, and multiple risk factors should be highlighted in the COVID-19 vaccination campaign.

Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors

ABSTRACT The incidence of severe immune-related adverse events (irAEs) in cancer subjects receiving immune checkpoint inhibitors (ICIs) following COVID-19 vaccination and the relationship between the incidence of severe irAE and the interval between COVID-19 vaccination and ICI dose have not been established. We performed a retrospective study evaluating the incidence of irAEs in solid tumor subjects receiving ICI therapy who received any COVID-19 vaccinations since FDA authorization. irAEs were defined as severe with one or more grade 3 or above events (CTCAE v5.0), multiple organ involvement, or requiring hospitalization for management. Two hundred and eighty-four subjects who received COVID vaccinations from December 2020 and February 2022 were included in this analysis [median age at vaccination 67 years (IQR 59.0–75.0); 67.3% male]. Twenty-nine subjects (10.2%) developed severe irAEs, of which 12 subjects (41.4%) received ICI monotherapy, 10 subjects (34.5%) received combination ICI therapy with nivolumab and ipilimumab, and 7 subjects (24.1%) received ICI plus VEGFR-TKI therapy. Hospitalization occurred in 62% of subjects with severe irAEs, with a median duration of 3 days (IQR: 3.0–7.5 days). Immunosuppressive therapy was required in 79.3%, with a median duration of 103 days (IQR: 42.0–179.0). ICI therapy was discontinued in 51.7% of subjects with severe irAE; dosing was held or interrupted in 34.5%. Among severe irAEs, the median interval between vaccination and ICI treatment closest to the occurrence of severe irAE was 15.5 days (IQR: 10.0–23.0). In solid tumor cancer subjects receiving ICIs, COVID-19 vaccination is not associated with an increased incidence of severe irAEs compared to historical data and may be safely administered during ICI cancer therapy in subjects who lack contraindications.

Humoral Immune Response Against Sars-Cov-2 Variants (Omicron Ba.1, Ba.4/5, Beta and Delta) of Phh-1v Booster Vaccine in Subjects Previously Vaccinated with a Mrna Vaccine. Results of a Randomised Controlled Trial Up to 6 Months

Humoral Immune Response Against Sars-Cov-2 Variants (Omicron Ba.1, Ba.4/5, Beta and Delta) of Phh-1v Booster Vaccine in Subjects Previously Vaccinated with a Mrna Vaccine. Results of a Randomised Controlled Trial Up to 6 Months

Reduced early response to SARS-CoV2 vaccination in people with type 1 and type 2 diabetes, a 6months follow-up study: The CoVaDiab study I.

Diabetes mellitus worsens the prognosis of SARS-CoV-2 infection, and vaccination has been the major tool for reducing the risk of hospitalisation, and mortality. The primary aim of this study was to evaluate the response to the SARS-CoV-2 vaccine in subjects with diabetes and controls. Differences between type 1 (T1D) and type 2 (T2D) diabetes and clinical determinants of vaccination response were also evaluated. 128 subjects with diabetes (60 with T1D and 62 with T2D) and 202 subjects acting as controls who completed a full vaccination cycle with two doses of mRNA vaccine were enroled. People with previous SARS-CoV-2 infection were excluded. Antibodies (Ab) directed against the spike protein of the SARS-CoV-2 were evaluated at one and 6months after vaccination. In the whole cohort, the Ab level was higher among women than in men (p=0.011) and negatively correlated with age (rho=-0.155, p=0.005). Subjects with diabetes showed decreased levels of Ab after one month compared to controls (1217[747-1887]BAU/mL vs. 1477[942-2556]BAU/mL, p=0.002), even after correction for age and gender (p=0.002). No difference was found between subjects with T1D and T2D. After 6months, antibody levels significantly decreased in people with and without diabetes, with no differences between groups, although some subjects were lost at follow-up. In subjects with diabetes, only a significant correlation was found between Ab level and renal function (rho 0.190, p=0.042). Both T1D and T2D are associated with a reduced early response to vaccination. The serum concentration of Ab significantly reduced over time in both groups, highlighting the relevance of vaccination boosters independently of the presence of diabetes.

Neutralizing Antibody and T-Cell Responses against SARS-CoV-2 Wild-Type and Variants of Concern in Chronic Obstructive Pulmonary Disease Subjects after ChAdOx-1/ChAdOx-1 Homologous Vaccination: A Preliminary Study.

Data on immunogenicity of adenovirus-vectored vaccine in chronic obstructive pulmonary disease (COPD) patients is limited. Therefore, we aimed to determine the humoral and cellular immune responses after homologous ChAdOx-1 vaccination in subjects with COPD. COPD subjects and age- and sex-matched healthy elderly receiving ChAdOx-1 homologous vaccination were included. The levels of neutralizing antibodies (NAb) and specific CD4 and CD8 T-cell responses against SARS-CoV-2 wild-type (WT) and variants of concern (VOCs: Alpha, Beta, Delta, and Omicron) were measured. Eight COPD patients were matched with eight control participants. After vaccination for 4 and 12 weeks, % inhibition of NAb against Alpha, Beta, and Delta in both groups were comparable and significantly higher than baseline. The percentage inhibition of NAb at the 12th week was significantly dropped from the 4th week in each group. The NAb against the Omicron variant, however, were much lower than Alpha, Beta, Delta variants. The increasing trend in the number of CD4 T-cells producing TNF-α, IFN-γ, IL-10, and FasL upon stimulation with spike peptides of WT and VOCs was observed in COPD patients compared to the healthy group. These responses were not observed in CD8 T-cells. Homologous ChAdOx-1 vaccination could induce comparable NAb against the SARS-CoV-2 WT, Alpha, Beta, Delta, and Omicron variants between COPD and healthy elderly. The CD4 T-cell responses did not differ between COPD patients and healthy control.

Navigating Coronavirus Disease 2019 Vaccination and Uveitis: Identifying the Rates and Risk of Recurrent Uveitis after Coronavirus Disease Vaccination

To identify rates of uveitis reactivation both before and after the coronavirus disease (COVID) 2019 vaccine in subjects with a previous diagnosis of uveitis. Retrospective study. Subjects were identified from the Inflammatory Eye Disease Registry at Auckland District Health Board diagnosed with uveitis between January 1, 2010, and December 31,2020. Date of COVID vaccination was determined from the patient clinical record. Rate of flare was calculated for 3 months before vaccination and 3 months after each vaccination. Uveitis flare was defined as the presence of new uveitis activity or increased activity that required a change in uveitis treatment. A total of 4184 eyes of 3008 patients were included in the study with a total of 8474 vaccinations given during the study period. Median age was 54.8 years, and 1474 (49.0%) were female. Noninfectious etiology was most common, occurring in 2296 patients (76.3%) and infectious etiology occurring in 712 patients (23.7%). Rate of uveitis flare was 12.3 per 1000 patient-months at baseline, 20.7 after the first dose, 15.0 after the second dose, 12.8 after the third dose, and 23.9 after the fourth dose. The median period of quiescence before flare was 3.9 years. An increase in uveitis flare was seen in both infectious uveitis (baseline 13.1 compared with 20.2 after first dose, 154% increase) and noninfectious uveitis (baseline 12.4 compared with 20.9 after first dose, 169% increase). Risk factors for uveitis flare were identified to be recurrent uveitis, chronic uveitis, shorter period of quiescence, and first dose of vaccine. Median time to uveitis flare was 0.53 months after the first vaccination, 1.74 months after the second vaccination, and 1.35 months after the third vaccination. The current study demonstrates an increased risk of uveitis flare after the first dose of COVID vaccination. This risk was highest in those with previous recurrences, chronic uveitis, and shorter period of quiescence. Proprietary or commercial disclosure may be found after the references.

Trust in Science as a Possible Mediator between Different Antecedents and COVID-19 Booster Vaccination Intention: An Integration of Health Belief Model (HBM) and Theory of Planned Behavior (TPB).

As the literature highlights, many health behavior theories try to explain both social and psychological variables influencing an individual’s health behavior. This study integrates insights relative to the antecedents of getting vaccinated from health behavior theories, particularly including the health belief model (HBM), the theory of planned behavior (TPB), and the different socio-demographic factors. Furthermore, we considered the possible mechanism of impact of distrust in science on individuals’ hesitance and resistance to taking up SARS-CoV-2 vaccination in subjects living in Italy. A correlational study of 1095 subjects enrolled when the national vaccination campaign for the third dose was launched. A questionnaire was used to measure: Italian Risk Perception; subjective norm; trust in science, trust in the vaccine; fear of COVID-19; fear of the vaccine; perceived knowledge about SARS-CoV-2; booster vaccination intention. Principal results show that: (i) the positive relationship provided by HBM theory between perceptions of SARS-CoV-2 risk (vulnerability and severity) and intention to have the vaccine, through fear of COVID-19; (ii) the positive relationship between subjective norms and both trust in science and vaccination intention; (iii) that trust in science plays a crucial role in predicting vaccination intention. Finally, the results provided indications about a positive relationship between subjective norms and fear of COVID-19, and a full mediation role of trust in science in the relationships between determinants of both TPA and HBM, fear of COVID-19, and vaccination intention. In conclusion, an individual’s intention (not) to get vaccinated requires the consideration of a plethora of socio-psychological factors. However, overall, trust in science appears to be a key determinant of vaccination intention. Additional strategies promoting healthy behavior are needed.

Immunogenicity and safety of an egg culture-based quadrivalent inactivated non-adjuvanted subunit influenza vaccine in subjects ≥3 years: A randomized, multicenter, double-blind, active-controlled phase III, non-inferiority trial

Subunit influenza vaccine only formulated with surface antigen proteins has better safety profiles relative to split-virion influenza vaccine. Compared to the traditional quadrivalent split-virion influenza vaccine, a novel quadrivalent subunit influenza vaccine is urgently needed in China. We completed a phase 3, randomized, double-blind, active-controlled, non-inferiority clinical study at two sites in Henan Province, China. Eligible volunteers were split into four age cohorts (3–8 years, 9–17 years, 18–64 years, and ≥ 65 years, based on their dates of birth) and randomly assigned (1:1) to the subunit and the split-virion ecNAIIV4 groups. All volunteers were intramuscularly administered a single vaccine dose at baseline, and children aged 3–8 years received a boosting dose at day 28. And the immune response was evaluated by measuring hemagglutinin-inhibition antibody titers against the four vaccine strains in blood samples. Safety profiles had nonsignificant differences between the study groups in ≥ 3 years cohort. Most adverse reactions post-vaccination, both local and systemic, were mild to moderate and resolved within 3 days. And no serious adverse events occurred. The immunogenicity of the trial vaccine was non-inferior to the comparator. Further, a two-dose vaccine series can provide better seroprotection than that of a one-dose series in children aged 3–8 years, with clinically acceptable safety profiles.Clinical Trials Registration. ChiCTR2100049934.

Fever following Covid-19 vaccination in subjects with Brugada syndrome: Incidence and management.

BackgroundFever is a potential side effect of the Covid‐19 vaccination. Patients with Brugada syndrome (BrS) have an increased risk of life‐threatening arrhythmias when experiencing fever. Prompt treatment with antipyretic drugs is suggested in these patients.Aim of the studyTo evaluate the incidence and management of fever within 48 h from Covid‐19 vaccination among BrS patients.MethodsOne hundred sixty‐three consecutive patients were enrolled in a prospective registry involving five European hospitals with a dedicated inherited disease ambulatory.ResultsThe mean age was 50 ± 14 years and 121 (75%) patients were male. Prevalence of Brugada electrocardiogram (ECG) pattern type‐1, ‐2, and ‐3 was 32%, 44%, and 24%, respectively. Twenty‐eight (17%) patients had an implantable cardioverter‐defibrillator (ICD). Fever occurred in 32 (19%) BrS patients after 16 ± 10 h from vaccination, with a peak of body temperature of 37.9° ± 0.5°. Patients with fever were younger (39 ± 13 vs. 48 ± 13 years, p = .04). No additional differences in terms of sex and cardiovascular risk factors were found between patients with fever and not. Twenty‐seven (84%) out of 32 patients experienced mild fever and five (16%) moderate fever. Pharmacological treatment with antipyretic drugs was required in 18 (56%) out of 32 patients and was associated with the resolution of symptoms. No patient required hospital admission and no arrhythmic episode was recorded in patients with ICD within 48 h after vaccination. No induced type 1 BrS ECG pattern and new ECG features were found among patients with moderate fever.ConclusionFever is a common side effect in BrS patients after the Covid‐19 vaccination. Careful evaluation of body temperature and prompt treatment with antipyretic drugs may be needed.

Fever following Covid-19 vaccination in subjects with Brugada syndrome: incidence and management

Funding AcknowledgementsType of funding sources: None.BackgroundFever is a potential side effect of Covid-19 vaccination. Patients with Brugada syndrome (BS) have an increased risk of life-threatening arrhythmias when experiencing fever. A prompt treatment with antipyretic drugs is suggested in these patients.Aim of the study: To evaluate the incidence and management of fever within 48 hours from Covid-19 vaccination among BS patients.Methods163 consecutive patients were enrolled in a prospective registry involving 5 European hospitals with a dedicated inherited disease ambulatory.ResultsMean age was 50 ±14 years and 121 (75%) patients were male. Prevalence of Brugada ECG pattern type-1,-2 and -3 was 32 %, 44%, 24%, respectively. Twenty-eight (17%) patients had an implantable cardioverter defibrillator.Fever occurred in 32 (19%) BS patients after 16±10 hours from vaccination, with peak of body temperature of 37.9±0.5 degrees. Patients with fever were younger (39±13 vs 48±13 years, p=0.04). No additional differences in term of sex and cardiovascular risk factors were found between patients with fever and not.Twenty-seven (84%) out of 32 patients experienced mild fever and five (16%) moderate fever. Pharmacological treatment with antipyretic drugs was required in 18 (56%) out of 32 patients and was associated with resolution of symptoms.No patient required hospital admission and no arrhythmic episode was recorded in patients with ICD within 48 hours after vaccination.ConclusionFever is a common side effect in BS patients after Covid-19 vaccination. Careful evaluation of body temperature and prompt treatment with antipyretic drug may be needed.

Antibody levels in people with diabetes after one dose of the ChAdOx1 nCoV-19 (AZD1222) vaccine

Patients with diabetes and coexistent coronavirus disease 2019 (COVID-19) have a higher risk of COVID-19 complications. Therefore, it is critical that sustained and effective immunogenicity against COVID-19 is achieved in such patients. This study evaluates the antibody response for 56 days after the first dose of the AZD1222 vaccine in subjects with and without diabetes to assess the potential risk of delaying the second dose. This study included 282 people who received one dose of AZD1222. The geometric mean concentration of antibodies specific for severe acute respiratory syndrome coronavirus 2 IgG at 56 days was significantly (P < 0.001) lower in people with type 2 diabetes mellitus (T2D; 15.13 BAU/mL, 95% confidence interval [CI] = 10.7–21.4) than in those without diabetes (40.20 BAU/mL, 95% CI = 33.43–48.36), as confirmed by a geometric mean ratio of 0.37 (95% CI = 0.25–0.54). Weaker immune responses were also observed in diabetic patients ≥ 65 years old (10.09 BAU/mL, 95% CI = 6.09–16.71) compared with their younger counterparts (22.31 BAU/mL, 95% CI = 13.98–35.59, P = 0.034). People with T2D had weaker antibody responses than those without diabetes after the first dose of AZD1222. Older age was associated with weaker antibody responses in elderly patients with diabetes.

SARS-CoV-2 vaccine humoral response in adults with Down syndrome

ObjectivePeople with Down syndrome (DS) are particularly vulnerable to coronavirus disease 2019 (COVID-19) and show altered immune response to vaccination. We aimed to evaluate the immune response of a group of adults with DS treated with standard regimens of SARS-CoV-2 vaccine as compared with an age- and sex-matched group of persons without DS. MethodsWe compared antibody responses between 42 subjects with DS (41.6 ± 10.8 years, 57% male), and an age- and sex-matched comparison group of healthy health care workers (HCW) (41.4 ± 8.8 years, 54.8% male) after SARS-CoV-2 vaccination with the standard regimen of BNT162b2 mRNA COVID-19. Receptor binding domain (RBD) IgG antibodies were assessed at 4 time points (baseline, 21 days after the first dose, 21 days after the second dose, and 6 months after the first dose) with Siemens SARS-CoV-2 IgG (COV2G) antibody test. ResultsWe observed significantly different antibody responses at all time points after vaccination (HCW vs. DS: 7.9 ± 3.9 vs. 1.4 ± 3.6 IU/mL at 21 days after first dose; 358.5 ± 3.8 vs. 38.1 ± 3.0 IU/mL at 21 days after second dose; 34.6 ± 2.4 vs. 7.9 ± 3.1 IU/mL at 6 months after vaccination) and a significantly different time course of decline in antibody titers between the two groups. DiscussionSubjects with DS have a valid antibody response to SARS-CoV-2 vaccination. However, this response is lower than that of subjects in the HCW group. This finding could indicate a more rapid decline in the protective effects of the vaccination in subjects with DS and could suggest that people with DS may benefit from a booster dose of vaccine.