HYDERABAD: Amid refraining from several quarters to share the experience with other players on the ground that it was co-developed with government bodies, a top Bharat Biotech official has said that there is no expertise change from the Medical Council of India. Was.
Analysis (ICMR) or Nationwide Institute of Virology (NIV), Pune.
Suchitra Ella, Joint Managing Director, Bharat Biotech, said the collaboration with ICMR and NIV was only for the procurement of research and research done on large animals, monkeys and hamsters as the private sector does not have access to such large animals. During a panel discussion on vaccines organized by the Confederation of Indian Trade (CII) with some TV channels late Friday night.
“Once we reached ICMR-NIV we only reached for the virus pressure. At that time there was no experience like coming from academia to industry. We just wanted our fingers on the pressure and this is what we got from Pune. From there it was developed in-house, fully funded in-house and brought through all testing, animal, toxicology and human testing…,” Ella said.
Bibi hopes to start investigation on children in June
So that’s something I want to straighten out. Sure, NIV Pune and ICMR are collaborating in the sense that animal research to be done on monkeys and hamsters and we don’t have access to such large animals in private business… it’s not a specialization switch, it was a pressure that Later we also did scientific research for larger animals with ICMR,” he reiterated.
On the children’s trial, he said that the company expects that the examination will start in June and after that in the next two to three months, the safety information will be received from the examination.
He explained that the children’s trial will only be a safety trial as its immunogenicity and efficacy have been confirmed in several volunteers, but no trials have been conducted on children aged 2-12 years.
“If all goes well and the second wave doesn’t come between us… we look at a timeline of 60-90 days at most… within that time frame we will be able to print good safety information for youth and Drug controllers are expected to submit normally. Considering testing on children, said Ella, who is also vice president of CII’s southern region, Ella identified that about 70% of the company’s vaccines are pediatric vaccines.
And said the company is aware of how urgent and delicate it is to get it. Trials are ongoing, especially through the second wave of the pandemic.” … more than 500,000 babies and toddlers in 20 countries around the world But after doing the pediatric trials, we all know it’s possible…,” she said on the intranasal vaccine, adding that the Phase I trials have been completed and the company hopes to complete Part II and III trials soon.
Because the administration route is much simpler (compared to an injectable vaccine), however, they cite regulatory and procedural steps as to when the vaccine should be used. declined to set a timeline on what could be prepared to do so. According to scientific practices around the world.