Safety monitoring of precautionary third dose of COVID-19 vaccines in a district in Northern India.

Background: The World Health Organization (WHO) declared Coronavirus disease-19 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) a pandemic on March 11, 2020. On 16th January 2021, India began its vaccination programme using two COVID-19 vaccines (Covishield and Covaxin). Precautionary dose (booster shots) was administered to health and front-line workers in the beginning and then to all eligible populations. Material and Methods: This was a descriptive observational study conducted in the COVID-19 vaccination centres of Karnal district and the ADR monitoring centre, KCGMC, Karnal. During the visits to vaccination centres, all beneficiaries of the precautionary third dose of COVID-19 vaccines as well as healthcare workers were sensitized to report in case of any adverse event following vaccination as part of the policy of the vaccination programme run by the government and Pharmacovigilance Programme of India. The data were collected in suspected adverse drug reaction (ADR) reporting form version 1.4, and causality assessment was done as per the WHO-UMC scale. The data were analysed as simple proportions and percentages. Results: The booster dose was administered to 72,853 individuals, while the 1st dose and 2nd dose were given to 13,30,042 and 10,73,050, respectively. Only three ADRs were reported with the booster dose in 34 vaccination centres in the Karnal district. These three ADRs were classified as unlikely on causality assessment and hence not included in the analysis. Conclusion: The booster dose administered for the prevention of COVID-19 has been found to be reasonably safe. The population who received COVID-19 booster doses was significantly less than the populations who received the first and second doses, which suggests a low acceptance rate.

Adverse events following Covaxin administration among adolescents (15-18 years) - A pharmacovigilance study in a district in Northern India.

Introduction: The study was undertaken to observe the adverse event following immunization (AEFI) to the Covaxin vaccine in young adolescents in the age group of 15-18 years in a district in Northern India. The study was conducted to assess the safety profile of the COVAXIN vaccine. Methodology: This was a prospective observational study conducted at rural and urban health centers of a district in Northern India. We included the beneficiaries of the COVAXIN between the age of 15 and 18 years. The administration of the COVAXIN occurred in our district from January 2022. Periodic visits were conducted to the urban and rural health centers of the city to record any suspected adverse drug reaction following immunization in the defined population. The study was conducted for a period of 1 year (January 2022 to December 2022). Results: A total of 72,771 adolescents (15-18 years) received the first dose of Covaxin and 49,046 received the second dose. No adverse drug event following immunization was reported during the study. Conclusion: Thus, it can be concluded that Covaxin was found to be safe in adolescents (15-18 years).

ADR Profile of the Covishield Vaccine Among Healthcare Workers in a Tertiary Care Teaching Hospital in India.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/2019-nCoV). Though many classes of drugs have been advocated/used for the treatment of this disease, vaccines are being targeted for its ultimate prevention. Indian Government has approved Covishield (ChAdOx1 nCoV19 Corona Virus Vaccine-Recombinant) for restricted use in emergency circumstances. OBJECTIVE: This study is aimed at evaluating the safety profile of the Covishield vaccine among healthcare workers in a tertiary care hospital. METHODS: All Adverse Drug Reactions (ADRs) reported to the ADR monitoring centre by healthcare workers who received the Covishield vaccine during the study period of 3 months were analysed on various parameters, and the assessment was done using the WHO-UMC scale. RESULTS: During the study period, a total of 1216 beneficiaries were vaccinated with 1st dose of Covishield, and out of these, 727 beneficiaries also received 2nd dose of the vaccine. Out of the 1216 beneficiaries vaccinated, 69 ADRs were reported in 24 healthcare workers. The most common ADR reported was fever (24.64%), followed by myalgia (18.84%). No death or any serious anaphylactic reaction was observed. None of the healthcare workers experienced any adverse event during the observation period of 30 minutes. Serious reactions were reported in 4 healthcare workers as per the Pharmacovigilance Programme of India (PvPI) criteria of serious AEFI. 92% of healthcare workers recovered from ADRs during the study period. 84% of ADRs were classified as probable as per the WHO-UMC scale. CONCLUSION: As per the Government of India directives, all the healthcare workers in the institute were encouraged to take both doses of the Covishield vaccine. The beneficiaries were kept under observation for 30 minutes and monitored for any adverse drug reaction following vaccination. The vaccine was found to be safe with a very low incidence of ADRs.

Impact of Climatic Variations on Drug-induced Skin Reactions in Two Different Regions of India.

BACKGROUND: Around 2-3% of hospitalizations have been reported due to dermatological adverse drug reactions. Recent studies suggest that climatic variations affect the skin barrier function and extreme conditions aggravate skin disorders. OBJECTIVE: The present study was designed to compare the impact of climatic variations on drug-induced skin reactions in the Northern and Eastern regions of India. METHODS: We performed a one-year retrospective study to evaluate the impact of climatic variations (temperature and humidity) on drug-induced skin reactions in the Eastern (Kalyani, West Bengal) and Northern (Karnal, Haryana) regions. Drug-induced skin reactions were reported month-- wise in both the Eastern and Northern regions. Temperature and humidity levels were also noted month-wise in both regions. The direct correlation between climatic variations and the number of drug reactions were assessed using Pearson's correlation and quadratic regression analysis. RESULTS AND DISCUSSION: Overall, 99 and 81 dermatological adverse drug reactions were reported in tertiary care hospitals in the Northern and Eastern regions, respectively. During the summer season, the humidity level was found to be low in the Northern region as compared to the Eastern region. During this period, drug-induced skin reactions were reported significantly (p<0.05) more in the Northern region as compared to the Eastern region. Furthermore, quadratic regression analysis revealed that climatic variations contributed to drug reaction variability in the Northern region (68.5%) and Eastern region (23.5%). CONCLUSION: Therefore, the difference in the prevalence of drug-induced skin reactions may be related to the different climatic conditions among these two regions. Further studies in controlled climatic conditions should be performed for definitive correlations and to look into possible solutions.

Role of oral misoprostol for treatment of incomplete abortion.

To study the role of oral misoprostol in the management of Incomplete abortion, 98 women with a clinical diagnosis of incomplete abortion and the uterine size < 12 weeks were recruited for this study. A single dose of 600 microg of oral misoprostol was given to these patients. If abortion was clinically complete at follow-up after 3 days, the woman was released from the study. If it was still incomplete, immediate suction and evacuation was performed. Percentage of successful abortion (success defined as no secondary surgical intervention needed) and adverse effects were observed. Success was achieved in 96 (97.96%) out of 98 cases. In 32.6% cases adverse effects were found. Misoprostol used orally in the management of incomplete abortion, forms an alternative treatment modality, particularly in resource poor set up. It is highly effective with little adverse effects.