The vaccine, which was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune, has been given emergency use authorisation in clinical trial mode” by the Indian government.
According to findings reported in The Lancet Infectious Disease journal, Covaxin, India’s first indigenous vaccine against COVID-19, showed enhanced immune response without any significant side effects in phase 1 trials participants.
The vaccine, which was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune, has been given emergency use authorization in clinical trial mode” by the Indian government.
Experts were concerned about Covaxin’s emergency approval by India’s drug regulator earlier this month, which is now in phase 3 trials.
According to the authors of the Bharat Biotech-funded report, the vaccine, codenamed BBV152, was well tolerated in all dose groups, with no vaccine-related serious adverse effects.
The same findings were previously reported in December on the preprint server medRxiv.
However, no new evidence has been published in the public domain that could show the preventive’s continued protection and efficacy.
According to the authors, all adverse effects were mild to moderate in severity and occurred more often after the first dose, with one adverse event recorded but unrelated to the vaccine.
BBV152 was tested in 11 hospitals across India in a randomised phase 1 trial to determine its safety and immunogenicity.
Adults between the ages of 18 and 55 who were considered stable by the researcher were eligible.
Last year, 827 people were screened between July 13 and July 30, with 375 of them enrolling.
100 people were randomly assigned to each of the three vaccine groups, and 75 people were randomly assigned to the control group.
Two vaccine doses were given intramuscularly 14 days apart.
“BBV152 resulted in tolerable protection and improved immune responses. According to the study’s authors, the vaccine was well tolerated in all dose groups, with no vaccine-related severe adverse effects.
Pain at the injection site was the most common adverse event, accompanied by headache, exhaustion, and fever.
Covaxin is an inactivated vaccine created by chemically destroying the ability of new coronavirus samples to reproduce.
This process leaves the viral proteins intact, including the coronavirus’s spike protein, which it uses to penetrate human cells.
The viral proteins in the vaccine stimulate the immune system and brace people for potential infections with the real infectious virus when given in two doses three weeks apart.
The therapeutic can be kept at room temperature for at least a week, according to Bharat Biotech.