Covaxin bharat biotech 1200 (Representative Image)
HYDERABAD: Amid the chorus from several quarters for sharing Covaxin technology with other players on the ground that it had been co-developed along with government bodies, a top Bharat Biotech official has said that there was no technology transfer from Indian Council of Medical Research (ICMR) or National Institute of Virology (NIV), Pune.
The collaboration with ICMR and NIV was only to the extent of procuring the SARSCoV-2 strain and studies that were conducted on large animals, monkeys and hamsters as the private sector does not have access to such large animals, Bharat Biotech joint managing director Suchitra Ella said during panel discussions on vaccines organised by the Confederation of Indian Industry (CII) along with a couple of TV channels late on Friday evening.
“When we reached out to ICMR-NIV we only reached out for the strain of the virus. There was no technology as such coming to the industry from the academic body at that point of time. We just needed our hands on the strain and that’s what we got from Pune. From there on it was developed in-house, completely funded in-house and taken through all the testing, animal, toxicology and human testing…,” Ella said.
BB expects study on children to begin in June
So this is something that I would like to set straight. Yes, the NIV Pune and ICMR have been collaborating to the sense that the animal studies that had to be done on monkeys and hamsters and we in the private industry don’t have access to have such large animals…It is not a technology transfer, it was a strain and then we also did the clinical studies for the large animals with ICMR,” she reiterated.
On the children’s trials of Covaxin, she said the company expects the study to begin in June and have the safety data from the study in the next two to three months after that.
The children’s study will only be a safety study as the immunogenicity and efficacy of Covaxin have already been proven in a large number of volunteers but no trials were conducted on children in the 2-12 years age bracket, she explained.
“If all goes well and the second wave does not get between us…we look at a timeline of 60-90 days maximum…within that timeframe we hope to have good safety data published for children and submitted to the drug controller general,” said Ella, who is also the vicechairperson of CII’s southern region Addressing concerns over testing on children, Ella pointed out that nearly 70% of the company’s vaccines are paediatric vaccines and said the company knows how important and sensitive it is to get the trials rolling especially during the second wave of the pandemic. “…having conducted paediatric trials on more than 5,00,000 babies and infants across 20 countries in the world we know that this is doable…,” she said On the intranasal vaccine, she said the Phase I trials have been completed and the company hopes to finish the Phase II and III trials quickly as the administration pathway is much easier (than an injectable vaccine) but she refused to commit to a timeline on when the vaccine would be ready for use citing regulatory and procedural steps that have to be completed as per international clinical practices.