Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 18, 2024
Date Accepted: Jan 24, 2025
Date Submitted to PubMed: Feb 4, 2025
Real-world Effectiveness of COVID-19 Vaccine (ChAdOx-1s, CoronaVac, BBIBP-CorV, mRNA-1273, and BNT162b2) in Jakarta: Protocol for Test-negative Design of Healthcare Data
ABSTRACT
Background:
ChAdOx-1s, CoronaVac, BBIBP-CorV, mRNA-1273, and BNT162b2 are the five common COVID-19 vaccines that have been used in Jakarta. Randomized control trials have provided robust evidence of safety and efficacy profile of these vaccines, but their real-world vaccine effectiveness against symptomatic COVID-19 and deaths in communities with social inequalities and healthcare constraints remains unclear.
Objective:
The study aims to evaluate the real-world effectiveness of these COVID-19 vaccines during the wave associated with delta and Omicron variants by analyzing existing electronic healthcare sources.
Methods:
Population-based study using test-negative case-control design to evaluate COVID-19 vaccine effectiveness (VE) in Jakarta, focusing on the Delta and Omicron waves. It includes adults aged 18 and older who underwent RT-PCR testing for symptomatic COVID-19, classifying them as cases or controls based on their test results. The analysis will consider multiple COVID-19 vaccines introduced during these periods, with participants categorized by vaccination status. Several potential confounders will be assessed, including demographic factors and comorbidities. Data will be linked from various health datasets, and statistical analyses will be performed to determine vaccine effectiveness and potential waning immunity over time. After data linkage, subjects' identities will be encrypted.
Results:
The research, funded from 2022 to 2024, involved proposal preparation and ethical review in 2023, with enrollment from early 2024 to July 2024, resulting in about 4 million linked data points. Data analysis is ongoing, with initial results expected for publication in early 2025.
Conclusions:
This study will be the first to evaluate the effectiveness of different platform of COVID-19 vaccines (inactivated, viral-vector, and mRNA) used in Jakarta during the pandemic, providing valuable scientific evidence to inform future vaccination strategy in the country.
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