Veerapu Nagapraveen, Inamdar Dhanashree P, Kumar Baer P Ravi, Anuradha Basavaraju, Guddanti Pavitra, Issapuri Sree D, Ganta Nikhita S, Gopi Arun
Department of Community Medicine, Mamata Medical College, Khammam, Telangana, India.
Department of Microbiology, Mamata Medical College, Khammam, Telangana, India.
Indian J Community Med. 2022 Oct-Dec;47(4):587-590. doi: 10.4103/ijcm.ijcm_273_22. Epub 2022 Dec 14.
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.
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.
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.
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.
2021年1月,印度药品监管机构对在印度生产的COVISHIELD和COVAXIN疫苗发布了受限紧急批准。2021年1月中旬,印度有1050万确诊病例和15万例死亡病例。目的是评估印度生产的2019冠状病毒病(COVID-19)疫苗针对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染的疫苗效力(VE)。
2021年5月至2021年12月,在一所医学院附属医院的逆转录酶聚合酶链反应(RT-PCR)中心对接受SARS-CoV-2 RT-PCR检测的人员进行了为期8个月的检测阴性病例对照研究。从RT-PCR中心收集基线特征和RT-PCR报告。通过电话询问COVID-19疫苗接种情况,或与卫生当局提供的数据进行核对。
应用纳入和排除标准以及病例和对照定义后,共纳入380名参与者(95例病例和285名对照)。两剂COVISHIED疫苗针对有症状SARS-CoV-2感染的调整后疫苗效力为52.2%(41.7至62.1),单剂的调整后疫苗效力为40.88%(31.26至51.29)。两剂COVAXIN疫苗针对SARS-CoV-2感染的调整后疫苗效力为39%(29.40至49.27)。两剂任何疫苗的总体疫苗效力为48.20%(37.90至58.22)。
印度生产的疫苗有效性接近50%。随着SARS-CoV-2新变种的出现,应开展进一步的新研究。我们不知道针对这些变种的疫苗效力,也尚未确定是否需要加强剂量。