By Administrator_ India
Ahmedabad-based pharma major Cadila Healthcare (Zydus Cadila) is planning to start clinical trials on children aged 5 years and above soon for its DNA-plasmid technology-based Covid-19 vaccine, claimed a senior official.
Meanwhile, the company is awaiting approval from the Drugs Controller General of India (DCGI) for its vaccine ZyCoV-D. It has sought approval for use in children above 12 years, and has already submitted safety and tolerability data from the phase 2 clinical trials, and has generated data on 1,000 adolescents (between 12 to 18 years) from its phase 3 trials too. The 1,000-volunteer data will be submitted to the regulator soon.
“We now plan to start trials on children aged five years and above if the regulator approves,” said Sharvil Patel, managing director of Zydus Cadila. So far, no other vaccine has been approved globally for children below 12 years. India’s Bharat Biotech is now in the middle of conducting clinical trials on children above 2-years for Covaxin.
If things go well, ZyCoV-D could be the first approved vaccine for adolescents. Zydus has also claimed that its vaccine works against the Delta variant; as the trials carried out in more than 50 clinical sites spread across the country and during the peak of the second wave of Covid-19 has shown the vaccine’s efficacy against the new mutant strains, especially the delta variant.
At the moment, the DCGI and its expert committee are reviewing the data submitted by Zydus from a 28,000 people phase 3 efficacy trial. According to sources, the Subject Expert Committee (SEC) is likely to take up the review of ZyCoV-D this week. So far the regulator and experts have been studying the data submitted.
ZyCoV-D has shown a 66.6 percent efficacy in an interim analysis of phase 3 trials and can be stored at 25 degrees Celsius for three months. It is a three-dose vaccine given on day zero, day 28, and day 56.