India could get Covid vaccine for kids, Zydus Cadila set to seek approval for ZyCoV-D

New Delhi: Zydus Cadila is testing its Covid-19 vaccine candidate on children in the age group of 12-18 years, apart from adults, and the Ahmedabad-based company is likely to apply for licensure of the vaccine in the next two weeks, a senior government official has said according to a media report.

"Not only Covaxin is conducting child trials — and they will not take long because they are all immunogenic trials — but also Zydus vaccine is already being tested on children. So when Zydus comes for licensure, hopefully in the next two weeks, maybe we will also have enough data on the view of whether that vaccine can be given to children," NITI Aayog (health) member VK Paul said during the briefing of the Health ministry on Friday.

"We have to understand that the child cohort is not a small cohort. My rough guess is that if it is between 12 and 18 years, this itself is about 13 to 14 crore population and for which we will need about 25-26 crore doses," he added.

"We cannot have some people getting and others not getting. So we will have to take this into account when we strategise and make a decision based on how many doses of which vaccines are available," he said.

ZyCov-D, the Zydus vaccine, is being developed with support from the Centre's National Biopharma Mission as part of Biotechnology Industry Research Assistance Council, department of biotechnology.

According to the Phase 3 trial protocol submitted to the clinical trial registry of India, the vaccine, which is to be administered intradermally and in three doses, is being tested on 30,000 volunteers.

"The dosing for the Phase III clinical trials has started in 30,000 healthy adult volunteers as part of the multicentric, randomised, double-blind, placebo-controlled, study. ZyCoV-D was found to be safe, well-tolerated and immunogenic in the Adaptive Phase I/II clinical trials," Zydus Cadila has said.

"The Phase II study of the vaccine ZyCoV-D had been conducted in over 1000 healthy adult volunteers as part of the adaptive Phase I/II dose-escalation, multi-centric, randomized, double-blind placebo-controlled study. The vaccine was found to be safe and elicit a strong immunogenic response," it added.

The vaccine is very stable at 2 to 8 degrees as a result of a normal refrigeration temperature, the vaccine is also very thermostable at 25 degrees, the company said.