HYDERABAD: Amidst the controversy that the Corbevax vaccine had been launched for the paediatric population in India without sufficient approvals from the National Technical Advisory Group on Immunisation (NTAGI), Mahima Datla, Managing Director of Biological E, stated that their most recent meeting with the body was as latest as March 10, ruling out any such possibility of lack of information transfer.
While stressing that Corbevax’s immune response is superior compared to others, she said: “Our process is straightforward. Our first point of sharing of data and information is the drug controller. Until they review the data, make suggestions whether its to the inputs to protocol or the review data, no other body can go through the data.”
“Subsequent to approval from the DGCI our next stop has been NTAGI. There have also been instances, upon their invitation, where we have also shared data which is in the making without approval of DGCI. In fact, our last meeting with the officials was on March 10,” said Mahima Datla while speaking at the launch of their vaccine for Indian population above the age of 12.
The MD of Biological E went on to explain why there was no specific efficacy study done for the vaccine and instead an immuno-bridge study had been done. “Efficacy study is when you don’t have an existing vaccine and you test a new innovation in a naive population. These are possible when you don’t have treatment or intervention. Such studies, however, become unethical when an intervention becomes available, because how do you convince 30,000 people to not take an intervention that’s already available. Second, because of widespread infection, how to bring in a cohort of unimmunised naive people,” she said.
She added that with efficacy not being feasible in this case, they followed up and did a study against Covishield, where DGCI asked them to show if their vaccine produced superior antibodies. “The data we have on the 3,500 subjects is a head-to-head immuno-bridging study to demonstrate superiority against Covishield. We have met these parameters given by DGCI and they have accepted it,” she said.
It may be noted that the Corbevax is a recombinant protein subunit vaccine which uses a vaccine science considered extremely safe and effective in children traditionally as several Hepatitis vaccines are subunit vaccines.
The company has produced 30 crore doses of the same and has supplied five crore doses to the government of India. The vaccine is currently available for all populations above the age of 12 at `800 in the private sector. In government centres, it is free of cost but only available for 12-14 year paediatric age groups.
As per the company, Corbevax induced immune response was over 90 per pent in terms of effectiveness against the original Wuhan strain while it is more than 80 per cent in Delta strain based on the level of neutralising antibody titers.
Immuno-bridge study
Biological E Managing Director Mahima Datla explained why there was no specific efficacy study done for the vaccine and instead an immuno-bridge study had been done. “Efficacy study is when you don’t have an existing vaccine and you test a new innovation in a naive population. These are possible when you don’t have treatment or intervention,” she said