ABSTRACT
Background: In January 2021, India's drug regulator issued restricted emergency approval for COVISHIELD and COVAXIN, which were manufactured in India. In mid-January 2021, in India, there were 10.5 million confirmed cases and 0.15 million deaths. The objectives were to evaluate vaccine effectiveness (VE) of coronavirus disease 2019 (COVID-19) vaccines made in India against severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) infection. Materials and Methods: A test-negative case-control study was conducted from May 2021 to December 2021 for a duration of 8 months among people attending a reverse transcriptase polymerase chain reaction (RT-PCR) center at a medical college hospital for RT-PCR test for SARS-CoV-2. The baseline characteristics and RT-PCR report were collected from the RT-PCR center. The exposure to COVID-19 vaccines was enquired via phone call or was checked with data available with the health authorities. Results: After applying inclusion and exclusion criteria and case and control definitions, a total of 380 participants (95 cases and 285 controls) were included. The adjusted VE of two doses of COVISHIED vaccine against symptomatic SARS-CoV-2 infection was 52.2% (41.7 to 62.1), and that of a single dose was 40.88% (31.26 to 51.29). The adjusted VE of two doses of COVAXIN vaccine against SARS-CoV-2 infection was 39% (29.40 to 49.27). The overall VE was 48.20% (37.90 to 58.22) for two doses of any vaccines. Conclusions: Vaccines made in India were nearly 50% effective. Further new studies should be conducted as new variants of SARS-CoV-2 are emerging. We do not know the VE against the variants, and whether booster doses are required or not is not yet established.