1 min read.Updated: 22 Jan 2021, 03:37 PM IST Edited By Anulekha Ray
The drug regulator committee of India last month granted emergency use authorisation for Covaxin in 'clinical trial mode'
Covaxin led to tolerable safety outcomes and enhanced immune responses, according to the results published in The Lancet
Covaxin, India's first vaccine against novel coronavirus, showed enhanced immune response without any serious side-effects in the participants enrolled for the phase I clinical trials, according to the results published in The Lancet Infectious Disease journal.
Dubbed as BBV152, the coronavirus vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune. Bharat Biotech developed an “inactivated" vaccine at its high-containment facility at Genome Valley in Hyderabad.
The drug regulator committee of India last month granted emergency use authorisation for Covaxin in 'clinical trial mode'. The vaccine which is now undergoing phase III trials, had is now undergoing phase III trials, had raised concerns among experts over its emergency approval.
“Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus," Bharat Biotech said. This process leaves the viral proteins, including the spike protein of the coronavirus which it uses to enter the human cells, intact.
Given as 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, the drugmaker stated.
"BBV152 led to tolerable 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 Lancet study said.
During the phase II trial, Covaxin has been tested in 11 hospitals across the country. Volunteers between the ages of 18 and 55 with no co-morbidity conditions have participated in the trial. The vaccine trial took place in Hyderabad, Rohtak, Patna, Kancheepuram, Delhi, Goa, Bhubaneswar and Lucknow among other places. Two intramuscular doses of vaccines were administered 14 days apart.
The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever.