Adverse events and breakthrough infections associated with COVID-19 vaccination in the Indian population.

Vaccines against COVID-19 provide immunity to deter severe morbidities associated with the infection. However, it does not prevent infection altogether in all exposed individuals. Furthermore, emerging variants of SARS-CoV-2 impose a threat concerning the competency of the vaccines in combating the infection. This study aims to determine the variability in adverse events and the extent of breakthrough infections in the Indian population. A retrospective study was conducted using a pre-validated questionnaire encompassing social, demographic, general health, the status of SARS-CoV-2 infection, vaccination, associated adverse events, and breakthrough infections in the Indian population. Informed consent and ethical approval were obtained as per Indian Council of Medical Research (ICMR) guidelines. Participants, who provided the complete information, were Indian citizens, above 18 years, and if vaccinated, administered with either Covishield or Covaxin, were considered for the study. Data have been compiled in Microsoft Excel and analyzed for statistical differences using STATA 11. The responses from 2051 individuals fulfilling the inclusion criteria were analyzed. Among 2051, 1119 respondents were vaccinated and 932 respondents were non-vaccinated. Among 1119 vaccinated respondents, 7 were excluded because of missing data. Therefore, out of 1112 vaccinated, 413 experienced adverse events with a major fraction of younger individuals, age 18-40 years, getting affected (74.82%; 309/413). Furthermore, considerably more females than males encountered adverse consequences to vaccination (p < 0.05). Among vaccinated participants, breakthrough infections were observed in 7.91% (88/1112; 57.96% males and 42.04% females) with the older age group, 61 years and above (odds ratio, 3.25 [1.32-8.03]; p = 0.011), and males were found to be at higher risk. Further research is needed to find the age and sex-related factors in determining vaccine effectiveness and adverse events.

Alterations in the Reactive Oxygen Species in Peripheral Blood of Chronic Myeloid Leukaemia Patients from Northern India.

INTRODUCTION: There is a significant difference in the Reactive Oxygen Species (ROS) levels of Chronic Myeloid Leukaemia (CML) patients before and during treatment with Tyrosine Kinase Inhibitors (TKIs). This is because high ROS levels support oncogenic phenotype of CML by inducing proliferation pathway and accumulation of further genetic mutations. Often the measurement is done on WBC or serum for ascertaining one type of ROS species, but measurement of global ROS in fresh whole blood will give more accurate estimation of ROS. AIM: To measure global ROS in peripheral blood of CML patients. MATERIALS AND METHODS: A case control study was undertaken to measure ROS in peripheral blood of CML patients from Northern India. CML patients on TKIs (n=40 on imatinib herein called treated) and untreated (n=17, who were not on any TKIs or alternative medicine, called as treatment naive) and 52 healthy controls were also enrolled. Chemiluminescent assay was carried out using luminol as signal enhancer in 400 µl of blood to measure ROS. The chemiluminescence was measured as Relative Light Units (RLU)/sec/104 WBC. Data was presented in terms of mean±SE or geometric mean (95% Confidence Interval) for continuous variables and percentage for categorical variables. Groups were compared using two sample t-test for continuous variables and chi-square test for categorical variables. RESULTS: The WBC profile and ROS levels of patients taking TKIs were quite similar and showed no significant difference (p<0.999) compared to healthy controls. In contrast, significant increase was observed in the ROS levels of CML patients not on TKIs (untreated) compared to patients under treatment (p<0.029) and healthy controls (p<0.007). We also observed that the absolute ROS values and WBC counts were higher in untreated patients compared to patients on TKIs and healthy controls, even though mean ROS value was less. CONCLUSION: To ascertain the alterations in ROS levels of CML patients before and during treatment with TKIs, it is better to measure global ROS in fresh whole blood by chemiluminescent method using luminol. Luminol assay is a quick, easy and inexpensive method to measure global ROS. Patient under treatment with TKIs show significant decrease in ROS levels almost similar to the levels measured in healthy controls yet the mechanisms by which this decrease occurs needs to be elucidated.

Encapsulation efficiency and controlled release characteristics of crosslinked polyacrylamide particles.

Polyacrylamide (pAAm) particles crosslinked with N,N-methylenebis-acrylamide/ethylene glycol dimethacrylate (NNMBA/EGDMA) have been prepared in water-methanol medium by the dispersion polymerization using poly(vinyl pyrrolidone), PVP as a steric stabilizer. 5-fluorouracil an anticancer drug, has been loaded in situ into the crosslinked pAAm particles. Plain as well as drug loaded microparticles have been characterized by differential scanning calorimetry (DSC) and X-ray diffraction studies (XRD) and scanning electron microscopy (SEM). DSC and XRD studies have indicated a molecular level dispersion of the drug in pAAm particles during in situ loading and SEM pictures have shown the formation of spherical and oval-shaped particles. In vitro release of 5-fluorouracil from the crosslinked pAAm particles has been carried out in 7.4 pH buffer medium. Both encapsulation efficiency and release patterns are found to depend on the nature of the crosslinking agent, amount of crosslinking agent used and the amount of drug loaded. In vitro release studies indicated the controlled release of 5-fluorouracil up to 12 h.