Both the indigenously developed vaccine candidates against the Coronavirus disease (Covid-19) have shown excellent safety profile, Union minister of state Ashwini Kumar Choubey said in a written reply in the Lok Sabha.
However, Immunogenicity testing, to determine whether the vaccine provokes the body’s immune response, is still in progress, the minister added.
Bharat Biotech International Ltd’s inactivated whole virus candidate vaccine (BBV152) for SARS-CoV-2, the virus that causes Covid-19, is developed using the virus isolate (NIV-2020-770) provided by the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV), Pune.
Characterization of the vaccine candidate has been undertaken at ICMR-NIV followed by safety and tolerability studies in small animals like rats, mice and rabbits.
“Phase I clinical trials along with parallel studies in hamsters and rhesus macaques have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing,” said Choubey’s reply.
Another make in India vaccine candidate by Cadila Health Ltd. is a DNA-based vaccine (ZyCov-D). Pre-clinical toxicity studies were conducted in small animals: mice, rats, rabbits and guinea pigs. The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR to conduct parallel pre-clinical studies in rhesus macaques.
Status of clinical trials for this vaccine candidate is the same as Bharat Biotech’s vaccine candidate, with Phase I clinical trials having been completed revealing excellent safety of the candidate vaccine. Immunogenicity testing is in progress, and phase II clinical trials are ongoing.
Also, Serum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates that are in different stages of trials.
“ChAdOx1-S, which is a non- replicating viral vector vaccine, developed by University of Oxford-AstraZeneca, is undergoing phase III clinical trials in Brazil. Phase II/III bridging studies have been initiated by ICMR at 14 clinical trial sites. ICMR-National Institute for Research in Tuberculosis (NIRT), Chennai is the lead institution. ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from USA. The trial will be initiated in the second half of October after the vaccine is manufactured by SII. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune,” Choubey said.
According to the department of biotechnology and department of science and technology, at least 30 vaccine candidates have been supported by the government that are currently in different stages of development.