The Gujarat-based pharma company Zydus Cadila is expected to provide additional data related to immunogenicity and safety of its vaccinate candidate ZyCoV-D to the Drugs Controller General of India (DCGI) this week, according to sources.
Zydus’ three-dose vaccine was reported to be 66.6 per cent effective against symptomatic Covid cases and 100 per cent effective for moderate infection. NITI Aayog member VK Paul had said that the vaccine could be considered for inoculating children aged between 12 and 18 years based on the results of scientific data.
The company submitted results on safety and tolerability from its phase two and three trials, which included 1,000 adolescents. Bharat Biotech’s Covaxin is also being tested for children aged six to twelve years.
Trials for Covid-19 vaccine for children are underway in India ahead of an anticipated third wave of the Covid-19 pandemic. Earlier, AIIMS director Dr Randeep Guleria said the vaccine for children could likely be available in September.
Zydus had previously submitted the immunogenicity data from a two-dose regimen (using 3 mg doses) trial to the Drugs Controller General of India, which shows ‘equivalent immunogenicity’ with that of the three-dose regimen.
If Zydus gets approval from the DCGI, ZyCov-D will become the fifth vaccine to be authorised for use in India. The country has already approved vaccines from Moderna, AstraZeneca and partner Serum Institute of India, Bharat Biotech, and Russia’s Gamaleya Institute.