Adverse Events Following COVISHIELD and VERO CELL Vaccination Campaigns Against COVID-19.

BACKGROUND: Vaccination against COVID-19 for Nepalese was initiated in January 2021 for various age groups. People were anxious about receiving the vaccines and were concerned about the safety profile of the vaccine they received. In this study, we have tried to observe the Adverse Events Following Immunization of two different vaccines namely COVISHIELD (ChAdOx1 nCOV-19) and VERO CELL (CZ02 strain), used in different phases of vaccination by the government of Nepal. METHODS: We conducted a cross-sectional study among people who received COVID-19 vaccines in this study using a self-administered questionnaire.  Data was cleaned and then exported to IBM SPSS v.20 for analysis, Chi-square test was used to see the association between different variables and a p-value<0.05 was considered statistically significant. RESULTS: Out of 303 respondents, all had received the first and 270 participants had received the second dose of the COVID-19 vaccine, among which, 133 (43.89%) reported at least one side effect after the first dose of vaccination while 58 (21.48%) had self-reported side effects after the second dose of vaccination. Seventeen percent of the respondents had COVID-19 infection within the past 3 months before receiving COVID-19 vaccine. Three percent of participants had re-infection with COVID-19 after receiving the first or the second dose of the COVID-19 vaccine. Among participants who experienced adverse events, 42% and 62.1% of participants experienced mild adverse events following the first dose and second dose of the vaccine, respectively.  Conclusions: The adverse events following immunization for both vaccines after both doses of vaccination were quite low, with 43.89% of participants reporting side effects after the first dose and 21.48% of participants reporting side effects after the second dose. Adverse events were most frequently reported within 24 hours of vaccination and were mostly mild. There was no statistical significance of adverse events between both vaccines.

Conducting a phase III clinical trial in children during the COVID- 19 pandemic: Experience and lessons learnt from a clinical research facility of Nepal.

Clinical trials in humans are vital to test safety and efficacy of new interventions and are accompanied with the complexity of related regulatory guidelines, stringent time frame and financial burden particularly when participants are children. Conducting clinical trials in low and middle income countries, where 90% of global diseases occur, increases the complexity as resources, infrastructures, and experience related to clinical trials may be limited in some countries. During the COVID-19 pandemic, due to multiple infection control measures such as social distancing, lock-down of the societies, and increased work load of hospital workers, conducting clinical trials seemed very challenging. Related guidelines and recommendations on clinical trials required updates to adapt the situation for ongoing clinical trials to be continued and new clinical trials to be initiated. In this review report, we described the lessons learnt through our experiences, challenges we faced, and the mitigation measures implemented as a response while conducting a phase III clinical trial on a non-COVID-19 vaccine at a government children's hospital during the COVID-19 pandemic. We hope this report will contribute in lowering the obstacles to allow the successful completion of future studies, in countries where people live with the burden of vaccine-preventable diseases.

Perceptions around COVID-19 and vaccine hesitancy: A qualitative study in Kaski district, Western Nepal.

Burgeoning morbidity and mortality due to COVID-19 pandemic including the peaks in outbreaks due to different variants have attracted global attention. Although the development and rolling out of vaccines have been impressive, low- and middle-income countries suffer from a double burden: (1) lack of adequate vaccines; and (2) low vaccine uptake (vaccine hesitancy). The main objective of this study was to explore perceptions around COVID-19 and vaccine hesitancy among urban and rural population in Western Nepal. A qualitative study was conducted in six urban wards of Pokhara municipality and four rural municipalities in Kaski district of Nepal. A semi-structured interview guide was used to interview participants who were selected purposively to explore the perceived burden of COVID-19 pandemic, roles, and contributions of vaccine. Nineteen interviews were conducted by telephone following a government recommendation to avoid face-to-face meetings. Audio-recorded interviews were thematically analysed after transcription and translation into English. COVID-19 is a major (public) health concern and affects people at an individual, societal and national level. People dreaded its health hazards and consequences and seemed to be compliant with public health measures such as maintaining social distance, wearing masks and maintaining hygiene. Vaccine was considered to be a major intervention to fight the pandemic, nonetheless, the rationale and benefits of vaccines were blemished by the perceived lack of the vaccine's effectiveness, duration of protection, and its potential side-events. Expedited development of vaccine was embraced with suspicion that vaccine may have incurred compromise in quality. Science and rationale behind vaccine were smeared by misinformation and clearly counteracting the misinformation were deemed critical. Providing information about vaccines through government entities (who are trusted) and respected individuals may engender trust and uptake of vaccine. Fighting off misinformation of COVID-19 is critical to curb the course of pandemic. Increased attention towards monitoring and investing in legitimacy of information and offering information through trusted sources can help improve the vaccine coverage.