RESUMO
Background: Vaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following Immunization (AEFIs) reported for COVID-19 vaccines from India. Methods: Secondary data analysis of the causality assessment reports for the 1112 serious AEFIs published by the Ministry of Health & Family Welfare, Government of India, was conducted. For the current analysis, all the reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal association and the thromboembolic events. Results: The majority of the serious AEFIs assessed were either coincidental (578, 52%) or vaccine product related (218, 19.6%). All the serious AEFIs were reported among the Covishield (992, 89.2%) and COVAXIN (120, 10.8%) vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted analysis, females, the younger age group and non-fatal AEFIs showed a statistically significant consistent causal association with COVID-19 vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant association with higher age and case fatality rate. Conclusion: Deaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the COVID-19 vaccines than the recovered hospitalizations in India. No consistent causal association was found between the thromboembolic events and the type of COVID-19 vaccine administered in India
RESUMO
Objective: Human Immunodeficiency Virus (HIV) Key Populations (KPs) include Female Sex Workers (FSWs), men who have sex with men (MSM), transgender (TG), and transsexual (TS) persons. This study assessed coronavirus disease 2019 (COVID-19) vaccine uptake among KPs for HIV in India, adverse events following immunization (AEFI), and breakthrough infections among the vaccinated.Materials and Methods: This retrospective cohort study was conducted among 421 KPs enrolled in 41 Targeted Intervention (TI) clusters in 31 districts of the Tamil Nadu State Acquired Immunodeficiency Syndrome (AIDS) Control Society (TANSACS), India, from June to September 2022. A semi-structured, bilingual (English and Tamil), interviewer-administered questionnaire was used to collect data on socio-demographic characteristics, vaccination status, AEFIs, and breakthrough infections among the KPs under the TIs.Results: Among the KPs, 45.4% were FSWs, 37.1% were MSM, 16.2% were TG, and 1.4% were TS persons. Among them, 4.3% had HIV, and 2.9% had syphilis or other sexually transmitted infections (STIs). The COVID-19 vaccine uptake rate was 96%. Among the KPs, TG/TS persons had the highest vaccine uptake (98.6%), followed by FSWs (96.3%) and MSM (94.2%). AEFIs were reported by 85.4% of the participants. HIV positive status was significantly associated with the incidence of AEFI. The breakthrough infection rate was 5.4% among the vaccinated participants.Conclusion: The COVID-19 vaccine uptake among HIV KPs was high in Tamil Nadu. AEFIs and breakthrough infections among COVID-19 vaccinated HIV KPs may be low, with mild AEFIs.