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 next two weeks, a senior government official has said.
"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 to 18 years, this itself is about 13 to 14 crore population and for which we will need about 25-26 crore doses," "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 the 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, randomized, 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 in a normal refrigeration temperature, the vaccine is also very thermostable at 25 degrees, the company said.
Next 5-12 years old children
Reports have said that Zydus Cadila is planning to start the trials of ZyCoV-D in children in the age group of 5-12 years after covering adults and 800 children in 12-18 years age group under its ongoing clinical trials.
"We will have a good amount of data on children in this age group. If everything goes well in terms of safety, the vaccine will potentially be approved for use in children aged 12 to 18 years," Cadila Healthcare's managing director Sharvil Patel told the Times of India.
Patel said vaccine development takes place in phases, starting with adults, followed by 12-18 years age group and then for under 12 years children, when asked about plans to test the vaccine for use in children below 12 years age.
Patna's All India Institute of Medical Sciences (AIIMS) began the Phase 2/3 clinical trials of Covaxin, developed by the Bharat Biotech International Limited, on children in the age group of 2 to 18 years on Tuesday. As many as 54 children registered at the institute for the trials of which 16 were in the 12-18 years age group.
"We began the children's trials by administering the vaccine on three volunteers in the 12-18 years age group," said Dr Lokesh Tiwari, additional professor and head, department of pediatrics, also one of the investigators in the trials at AIIMS Patna.
"We are commencing the trials today in the reverse order of age from today. Children in the 12 to 18 years age group will be given the shots first. We will then proceed with the 6 to 12 years age category before inoculating children in the 2 to 6 years age bracket," said Dr CM Singh, professor of community and family medicine, also the principal investigator of the trial at AIIMS-Patna and medical superintendent.
According to ANI, AIIMS Delhi is also planning to start the pediatric trials for Bharat Biotech's Covid-19 vaccine, Covaxin, in few days.