Phase 1 trial results show Covaxin has tolerable safety, enhanced immunity: Lancet

INSUBCONTINENT EXCLUSIVE:
India's first indigenous vaccine against COVID-19, Covaxin, showed enhanced immune response without any serious side effects in the
participants enrolled for the phase 1 trials, according to the results published in The Lancet Infectious Disease journal.Developed by
Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, the
phase-3 trials, had raised concerns 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 vaccine-related serious adverse events, noted the authors of the study
funded by Bharat Biotech.The same results were earlier published in the preprint server medRxiv in December.However, there has been no new
events were mild and moderate, and were more frequent after the first dose, adding that one adverse event was reported but was unrelated to
the vaccine.The randomised phase 1 trial to assess the safety and immunogenicity of BBV152 was carried at 11 hospitals across India.Adults
aged 18-55 years who were deemed healthy by the investigator were eligible.Between July 13 and 30, last year, 827 participants were
screened, of whom 375 were enrolled.Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75
safety outcomes and enhanced immune responses
The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events," the authors of the study 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 novel coronavirus samples to make them incapable of reproduction.This process leaves the viral proteins, including the
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.Click on Deccan Chronicle Technology and Science for the