Lancet's real-world study compares well with phase 3 clinical trials of Covaxin: Bharat Biotech

The study assessed 2,714 hospital workers at the All India Institute of Medical Sciences in Delhi, from April 15-May 15, who were symptomatic and underwent RT-PCR test for Covid detection.
A health worker displays empty vials of COVAXIN at a vaccination center. (Photo | AP)
A health worker displays empty vials of COVAXIN at a vaccination center. (Photo | AP)

NEW DELHI: Commenting on the study of the Lancet Infectious Diseases on the effectiveness of COVAXIN (BBV152) against symptomatic RT-PCR, the Hyderabad-based Bharat Biotech has said that the results compare well with 65.2 per cent efficacy against Delta variant obtained during controlled phase 3 clinical trials of COVAXIN conducted among the general population.

"These results compare well with the 65.2 per cent efficacy against the delta variant obtained during the controlled phase III clinical trials of COVAXIN conducted among the general population. This study also shows that COVAXIN meets the WHO efficacy criteria for COVID-19 vaccines for the dreaded Delta variant," Bharat Biotech said.

Two doses of COVID-19 vaccine Covaxin (BBV152) are 50 per cent effective against symptomatic COVID-19 disease, according to the first real-world assessment of the COVID-19 vaccine published in the Lancet Infectious Diseases journal.

The study assessed 2,714 hospital workers at the All India Institute of Medical Sciences (AIIMS) in Delhi, from April 15-May 15, who were symptomatic and underwent RT-PCR test for COVID-19 detection.

"2714 symptomatic tested participants remained, of whom 1,617 tested positive for SARS-CoV-2 and 1,097 tested negative," the study said.

"The unadjusted effectiveness of two doses of BBV152 against symptomatic RT-PCR-confirmed SARS-CoV-2, with an interval of at least 14 days between administration of the second dose and day of testing, was 53 per cent. After adjustment, the effectiveness was estimated to be 50 per cent. The adjusted effectiveness of two doses administered at least 28 days before testing was 46 per cent and administered at least 42 days before testing was 57 per cent," it said.

In January this year, Covaxin was approved for emergency use in India for people aged 18 and above. The World Health Organization (WHO) added the vaccine to its list of approved emergency use COVID-19 vaccines earlier this month.

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