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Phase 1 Trial Results Show Covaxin Has Tolerable Safety and Enhanced Immunity: Lancet Study | India News


NEW DELHI: India’s first indigenous COVID-19 vaccine, Covaxin, showed an enhanced immune response without serious side effects in participants enrolled in Phase 1 trials, according to results published in The Lancet Infectious Disease.
Developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, the vaccine has been authorized for emergency use in clinical trial mode by the Indian government.
Covaxin, which is now undergoing phase 3 trials, had expressed concern among experts over its emergency approval earlier this month by India’s drug regulator.
The vaccine, codenamed BBV152, was well tolerated in all dose groups with no serious vaccine-related adverse events, noted the authors of the Bharat Biotech-funded study.
The same results were previously published on the medRxiv prepress server in December.
However, there have been no new data published in the public domain that can demonstrate a greater safety and efficacy of the preventive.
The authors said that all adverse events were mild and moderate and were more frequent after the first dose, adding that one adverse event was reported, but not related to the vaccine.
The randomized phase 1 trial to assess the safety and immunogenicity of BBV152 was carried out in 11 hospitals in India.
Adults aged 18 to 55 who were considered healthy by the researcher were eligible.
Between July 13 and 30 of last year, 827 participants were examined, of which 375 were registered.
Among enrolled participants, 100 of each were randomized to the three vaccine groups and 75 were randomized to the control group.
Two intramuscular doses of vaccines were administered with an interval of 14 days.
“BBV152 led to tolerable safety results and improved immune responses. The vaccine was well tolerated in all dose groups with no serious vaccine-related adverse events,” the study authors said.
The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever.
Covaxin is an inactivated vaccine developed by chemically treating new coronavirus samples to render them unable to reproduce.
This process leaves viral proteins intact, including the coronavirus spike protein that it uses to enter human cells.
Given in two doses, three weeks apart, the viral proteins in the vaccine activate the immune system and prepare people for future infections with the actual infectious virus.
According to Bharat Biotech, the therapeutic can be stored at room temperature for at least a week.

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