Comparison of WHO-UMC and Naranjo Scales for Causality Assessment of Reported Adverse Drug Reactions.

OBJECTIVES: The 2 most commonly used scales worldwide are the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) and the Naranjo scales. The present study was planned to assess the degree of agreement between the 2 scales when the same adverse drug reactions (ADR) were assessed by 5 raters independently. METHODS: One hundred individual case safety reports were selected randomly from the ADR database of our institute and the details were emailed to 5 different experts (raters), who were DM Clinical Pharmacology residents from different institutes in India. An independent causality assessment of these ADRs was performed independently by these raters using both the WHO-UMC and Naranjo causality assessment scales. The agreement between the 2 scales was assessed for each rater using Cohen κ, and the overall interrater agreement was assessed using Fleiss κ. RESULTS: The Cohen κ level of agreement between the 2 scales for the 5 raters were substantial, fair, substantial, moderate, and substantial, respectively. The most common causality assessment category as per WHO-UMC scale was "possible" but varied among the raters on the Naranjo scale. No ADR was categorized as "certain" by any rater on the Naranjo scale. The Fleiss κ value for agreement among the 5 raters was found to be 0.2 (slight) for the WHO-UMC scale and 0.297 (fair) for the Naranjo scale. CONCLUSIONS: A moderate level of agreement was observed in this study between the WHO-UMC and Naranjo scales. The level of agreement among these 5 raters was found to be similar for the WHO-UMC and the Naranjo scales, indicating a similar degree of subjectivity for the 2 scales. Hence, more robust and less subjective scales are required for causality assessment.

Evaluation of satisfaction and reasons for participation in a Covid-19 vaccine clinical trial: A single-centre, observational study.

Background In May 2020, WHO recognized the role of extensive immunization for interrupting the transmission of the SARS-CoV-2 virus. The development of such vaccines in clinical trials relies upon participants who are expected to be vested in the research process. Assessment of participant factors such as motivation and satisfaction are hence important to gauge perspective and ensure successful conduct and completion of these trials. Methods We administered a validated three-domain questionnaire to and documented the binary categorical responses (yes/no) of participants (after informed consent) who had taken both doses of COVOVAX™ in a phase 3 trial at our institute. Association of the dependent variables (participant responses) with the independent variables (participant demographics and socioeconomic strata) was computed using Chi-square test at 5% significance. In case of a significant association, Bonferroni post-hoc test was applied for multiple comparisons. Results Of the 78 participants who were administered the questionnaire, two-thirds were highly satisfied with their experience at our site. Gaining access to a new vaccine was a primary motivation overall (74%) and also in graduates (p=0.03) and middle-class population (p=0.002), whereas the lower-middle class population (p<0.0001) and those educated till secondary school (p=0.003) took part due to the long wait for government-approved vaccines. Conclusion Participants in a Covid-19 vaccine trial at Mumbai were largely satisfied with the care given to them though altruism did not feature as a primary reason for participation.

Evaluation of Allergic Reactions following COVID - 19 Vaccination in Patients with Documented Allergies.

BACKGROUND AND RATIONALE: The government guidance regarding COVID-19 vaccination lists food allergy, drug allergy and history of anaphylaxis as contraindications for receiving vaccination. This study was planned to evaluate such patients listed in the database of an allergy center and who took any COVID-19 vaccine. METHODS: Data on n=255 patients was mined. Inclusions were those over 18 years, any allergic diathesis and receipt of at least one dose of any COVID-19 vaccine. Age, gender, nature of allergy and type of COVID vaccine taken along with outcome of interest [occurrence or otherwise of all allergic reaction post vaccination] was collated. RESULTS: Data of 227 patients were finally analysed. Eighty one took the first dose and 33 took both doses. None with food and/or drug allergy and/or a history of anaphylaxis developed any adverse event (AE) post vaccination. Three AEs were seen in those with other allergic diathesis. Two AEs [One to COVAXIN™ and one to COVISHIELD™] were only generalized itching that were self-limiting. A female patient had itching with palmar erythema [post COVISHIELD™] which subsided after a week's treatment with an antihistamine. She had a history of allergy to radiocontrast media containing polyethylene glycol/PEG] indicating possible allergy to polysorbate 80 [PEG related compound contained in COVISHIELD™]. CONCLUSION: No patient fitting contraindications for COVID-19 vaccination laid down by the Indian government developed any allergic reaction post vaccination. The guidelines for vaccination may be revisited to make them more inclusive with appropriate training of the vaccination centre staff.