As part of postauthorization safety surveillance, the US Food and Drug Administration (FDA) has identified a potential safety concern for Guillain-Barré syndrome (GBS) following receipt of the ...Ad26.COV2.S (Janssen/Johnson & Johnson) COVID-19 vaccine.
To assess reports of GBS received in the Vaccine Adverse Event Reporting System (VAERS) following Ad26.COV2.S vaccination.
Reports of presumptive GBS were identified in a US passive reporting system (VAERS) February-July 2021 and characterized, including demographics, clinical characteristics, and relevant medical history.
Receipt of the Ad26.COV2.S vaccine; the comparator was the background rate of GBS in the general (unvaccinated) population that had been estimated and published based on a standardized case definition.
Presumptive GBS; the reporting rate was analyzed, including calculation of the observed to expected ratio based on background rates and vaccine administration data. Because of limited availability of medical records, cases were not assessed according to the Brighton Collaboration criteria for GBS.
As of July 24, 2021, 130 reports of presumptive GBS were identified in VAERS following Ad26.COV2.S vaccination (median age, 56 years; IQR, 45-62 years; 111 individuals 86.0% were < 65 years; 77 men 59.7%). The median time to onset of GBS following vaccination was 13 days (IQR, 10-18 days), with 105 cases (81.4%) beginning within 21 days and 123 (95.3%) within 42 days. One hundred twenty-one reports (93.1%) were serious, including 1 death. With approximately 13 209 858 doses of vaccine administered to adults in the US, the estimated crude reporting rate was 1 case of GBS per 100 000 doses administered. The overall estimated observed to expected rate ratio was 4.18 (95% CI, 3.47-4.98) for the 42-day window, and in the worst-case scenario analysis for adults 18 years or older, corresponded to an estimated absolute rate increase of 6.36 per 100 000 person-years (based on a rate of approximately 8.36 cases per 100 000 person-years 123 cases per 1 472 162 person-years compared with a background rate of approximately 2 cases per 100 000 person-years). For both risk windows, the observed to expected rate ratio was elevated in all age groups except individuals aged 18 through 29 years.
These findings suggest a potential small but statistically significant safety concern for Guillain-Barré syndrome following receipt of the Ad26.COV2.S vaccine. However, the findings are subject to the limitations of passive reporting systems and presumptive case definition, and they must be considered preliminary pending analysis of medical records to establish a definitive diagnosis.
On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization for Ad.26.COV2.S COVID-19 vaccine. As part of post-authorization safety surveillance, the FDA has ...identified a potential safety concern for thrombocytopenia following receipt of Ad.26.COV2.S COVID-19 vaccine.
Reports of thrombocytopenia were identified in a passive reporting system (Vaccine Adverse Event Reporting System; VAERS) February-December 2021. Demographics, clinical characteristics, laboratory values, and relevant medical history were reviewed. The reporting rate was analyzed, including calculation of the observed-to-expected ratio based on vaccine administration data and the background rate of thrombocytopenia in the general (unvaccinated) population.
As of December 31, 2021, 100 reports of thrombocytopenia were identified in VAERS following vaccination with Ad.26.COV2.S. The median platelet count was 33,000 per µL (interquartile range 8,000–86,000). Fifteen reports (15%) documented a platelet count of 5,000 per µL or lower. The median time to onset of thrombocytopenia was 9 days (interquartile range 3–18.5), with most cases (69; 69%) beginning within 14 days after vaccination. A large majority of cases (84; 84%) were serious, including six deaths. With approximately 16,292,911 doses of Ad.26.COV2.S administered to adults in the US, the crude reporting rate was 0.61 cases of thrombocytopenia per 100,000 doses administered. The overall estimated observed-to-expected rate ratio was 2.43 (95% CI 1.97, 2.95).
These findings suggest an increased risk of thrombocytopenia following receipt of Ad.26.COV2.S.
Purpose
Despite widely available safety information for the COVID‐19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of ...reports of death to the Vaccine Adverse Event Reporting System (VAERS). We aimed to provide information and context about reports of death to VAERS following COVID‐19 vaccination.
Methods
This is a descriptive study evaluating reporting rates for VAERS death reports for COVID‐19 vaccine recipients in the United States between December 14, 2020, and November 17, 2021. Reporting rates were calculated as death events per million persons vaccinated and compared to expected all‐cause (background) death rates.
Results
9201 death events were reported for COVID‐19 vaccine recipients aged 5 years and older (or age unknown). Reporting rates for death events increased with increasing age, and males generally had higher reporting rates than females. For death events within 7 days and 42 days of vaccination, respectively, observed reporting rates were lower than the expected all‐cause death rates. Reporting rates for Ad26.COV2.S vaccine were generally higher than for mRNA COVID‐19 vaccines, but still lower than the expected all‐cause death rates. Limitations of VAERS data include potential reporting bias, missing or inaccurate information, lack of a control group, and reported diagnoses, including deaths, are not causally verified diagnoses.
Conclusions
Reporting rates for death events were lower than the all‐cause death rates expected in the general population. Trends in reporting rates reflected known trends in background death rates. These findings do not suggest an association between vaccination and overall increased mortality.
On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System ...(VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system.
VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated.
During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell’s Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18–64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care.
Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis.
Hepatitis C virus (HCV) screening among individuals born between 1945 and 1965 (ie birth cohort) may augment risk factor–based screening. We assessed HCV seropositivity among injection drug users ...(IDUs) and birth cohort members from New York City. We assessed HCV risk factors and seropositivity in 7722 participants from community health, HIV prevention, syringe exchange and drug treatment programmes. A total of 26.6% were HCV seropositive, 55.8% were born between 1945 and 1965, and 82.2% had ever injected drugs. Among all participants, HCV seropositivity was higher among IDUs compared to non‐IDUs (60.5% versus 7.7%, odds ratio (OR) = 18.5, 95% confidence interval (CI) 16.2, 21.1, P < .0001) and among birth cohort members compared to non‐birth cohort members (31.3% versus 22.3%, OR = 1.6, 95%CI 1.4, 1.8, P < .0001). Within the birth cohort, HCV seroprevalence among IDUs was 68.5% versus 11.8%, OR = 16.2, 95%CI 13.7, 19.3. After adjustment, HCV seroprevalence was higher in IDUs, previously incarcerated, whites (<42 years) and ‘other races’ (versus blacks), HIV‐infected, those who snorted heroin, those with liver disease history, and those who had sex with an HCV‐seropositive partner. HCV seroprevalence among IDU, birth cohort members, was considerably higher than among the general population. In this high‐risk, urban population, the association between IDU and HCV seropositivity was approximately ten times that between birth cohort membership and HCV seropositivity.
Background. Hepatitis C virus (HCV)—infected drug users (DUs) have largely been excluded from HCV care. We conducted a systematic review and meta-analysis of the literature on treatment completion ...and sustained virologic response (SVR) rates in DUs. We assessed the effects of different treatment approaches and services to promote HCV care among DUs as well as demographic and viral characteristics. Methods. Studies of at least 10 DUs treated with pegylated interferon/ribavirin that reported SVR were analyzed. Heterogeneity was assessed (Cochran test) and investigated (meta-regression), and pooled rates were estimated (random effects). Results. Thirty-six studies comprising 2866 patients were retrieved. The treatment completion rate among DUs was 83.4% (95% confidence interval CI, 77.1%–88.9%). Among studies that included addiction-treated and untreated patients during HCV therapy, the higher the proportion of addiction-treated patients, the higher the HCV treatment completion rate (P < .0001). After adjusting for human immunodeficiency virus (HIV)/HCV coinfection, sex, and treatment of addiction, support services during antiviral therapy increased treatment completion (P < .0001). The pooled SVR rate was 55.5% (95% CI, 50.6%–60.3%). Genotype 1/4 (P = .0012) and the proportion of HIV-coinfected DUs (P = .0173) influenced the SVR rate. After adjusting for HCV genotype 1/4 and HIV/HCV coinfection, the SVR rate was positively correlated with involvement of a multidisciplinary team (P < .0001). Conclusions. Treatment of addiction during HCV therapy results in higher treatment completion. Our pooled SVR rate is similar to that obtained in registration trials in the general population. Treatment of addiction during HCV therapy will likely be important for HCV-infected DUs undergoing treatment with more complex regimens including direct-acting antivirals.
Introduction : Severe and critical forms of SARS-CoV-2 pneumonia are associated with high morbidity and mortality. Numerous research studies have been conducted around the world to investigate ...various variables (demographic, clinical, laboratory, etc.) in an attempt to understand the relationships between them and the course and outcome of patients with COVID-19 infection and pneumonia. Aim : To outline predictors of a severe or critical course and fatal outcome in patients with COVID-19–associated pneumonia. Materials and methods : The current study was conducted from August 2021 to April 2022 in the COVID-19 ward of the Clinics of Pulmonology and Phthisiology at St George University Hospital in Plovdiv. It included 146 patients with PCR-confirmed COVID-19 and with anamnestic, laboratory, and imaging evidence of pneumonia. The patients were divided into three groups based on the severity of infection: moderate, severe, and critical. Demographic, clinical, laboratory, and imaging studies were performed for all patients. The data was exported to IBM SPSS v. 23 statistical software and analyzed with descriptive statistics, parametric and non-parametric methods. The relationships between the above-mentioned indicators and the severe or critical course and fatal outcome of the COVID-19 infection were outlined. A regression model was applied if the tested variables had a statistically significant correlation with the lethal outcomes. Results : The age and sex of the patients appeared to be the most important demographic factors: the mean age of the patients who were discharged was 57 years, whereas the mean age of the deceased patients was 71 years. However, there was no statistically significant difference between the mortality rates of the age group under 65 and the age group over 65. Regarding sex, 30.8% of men and 25.5% of women had a fatal outcome, the difference failing to reach statistical significance ( p =0.159). Among the clinical signs at admission, shortness of breath and mental status changes were related to a more severe course of the disease and increased mortality: statistically significant difference was found depending on the absence or presence of dyspnea ( p =0.039). Of the patients without dyspnea, 90.9% were discharged, unlike 79.1% of the patients who had it, which makes a mortality rate of 29% for the latter group. There was also a statistically significant difference in the outcome depending on the presence of mental status changes – 45.5% of patients without mental status changes were discharged, whereas only 12% of those with mental status changes were discharged ( p =0.011). Elevated D-dimers also seemed to affect the outcome – 82.2% of deceased patients had D-dimer levels of >0.5. In terms of illness severity, the disease had a moderate course in 46 (65.2%) patients without raised D-dimers, and a severe course in 75 (72.2%) patients who had elevated D-dimer levels, and a critical course in 22 (76%) patients. There was a statistically significant difference between the pO 2 values and disease severity – the probability of a severe and critical course in those with pO 2 <60 mmHg was 77.2% ( p =0.002). Presence of alveolar infiltrates seen in chest x-ray (CXR) or CT studies also led to a severe or critical course ( p =0.000). The regression model showed that the three independent variables, shortness of breath, confusion at admission, and pO 2 level <60, were found to be statistically significant based on the Wald criterion ( p <0.000). Conclusions : The results of the study indicated that older age, shortness of breath, and altered mental state at admission are predictors of severe or critical course and lethal outcome in patients with COVID-19 pneumonia. Regarding the laboratory tests, the elevated D-dimers and pO 2 levels <60 also indicate high risk and lethal outcomes.
: To answer the research question: "Is prophylactic central neck lymph node dissection (pCNLD) beneficial among differentiated thyroid carcinoma (DTC) patients?"
: This was a retrospective cohort ...study enrolling DTC patients treated at the University Hospital Kaspela, Bulgaria, from 30 January 2019 to October 2021. The predictor variable was presence of pCNLD (total thyroidectomy with vs. without pCNLD). The main outcome variables were postoperative complications (i.e., vocal cord paralysis, hypoparathyroidism, postoperative bleeding, and adjacent organ injury) and recurrence parameters. Appropriate statistics were computed with the significant level at
≤ 0.05.
: During the study period, 300 DTC patients (59.7% with pCNLD; 79.3% females) with an average age of 52 ± 2.8 years were treated. The mean follow-up period of the entire cohort was 45.8 ± 19.1 months. On bivariate analyses, TT with pCNLD, when compared to TT alone, required longer surgical time (mean difference: 9.4 min), caused nearly similar complications (except transient hypothyroidism:
= 0.04; relative risk, 1.32; 95% confidence interval, 1.0 to 1.73), and no significantly different recurrence events, time to recurrence, and recurrent sites. The benefit-risk analyses using the number needed to treat and to harm (NNT; NNH) also confirmed that TT plus pCNLD was not very beneficial in DTC management.
: The results of this study refute the benefit of pCNLD in DTC patient care with TT. Further well-designed studies in a larger cohort with a longer follow-up period are required to confirm this conclusion.
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